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Traditional Knowledge and Genetic Resources
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Part III
Analysis of Different Areas of
Indigenous Resources
Section 1
Traditional Knowledge
Antony Taubman and Matthias Leistner*
I. FINDINGS AT THE FACTUAL LEVEL
1. Recognizing the Characteristics of Traditional Knowledge
As a first step into the snarl of legal and policy issues that surround ‘traditional
knowledge’ (TK) and its complex linkages with intellectual property (IP) law and
policy, it can be helpful to dwell on the distinctive characteristics of TK, before
the debate moves into legalism. Many conceptual difficulties arise in policy and
legal debate when limiting preconceptions are imposed on the notion of TK.
Knowledge is not ‘traditional’ because of its object, nor its subject matter or
content, nor its age or antiquity, nor its aesthetic qualities. What makes it
* This section builds on the approach developed by Matthias Leistner for the first edition of this
book, and the guidance, insights and scholarship in the earlier version have been indispensable
for the preparation of the current text. The views expressed here are the authors’ personal
views and should in no way be attributed to WIPO, its Secretariat or its Member States.
S. von Lewinski (ed.), Indigenous Heritage and Intellectual Property, 59–180.

© 2008 Kluwer Law International BV, The Netherlands.
60 Antony Taubman and Matthias Leistner
traditional is the way it has been preserved and transmitted between generations
within a community: ‘its nature relates to the manner it develops rather than to its
antiquity’.1 By virtue of this traditional context, TK has a profoundly local quality.
The social structures that create, use, preserve, and pass down TK between
generations and the customary laws and protocols that govern these processes, are
deeply rooted in their traditional location and community setting, and indeed may
be conceived as integral to the land and environment itself.
This leads to the observation that TK cannot be dealt with simply as useful
information. It has an inherent normative and social component. The central
problem in recognizing and protecting TK is that, as information, it can be easily
communicated beyond its original context, while the norms, social practices and
values that define its ‘traditional’ aspect, being intrinsically local and innate to a
traditional community, are much less readily transmitted. The inherent qualities
that distinguish TK from other forms of knowledge begin to break down once it
leaves the community: alienation of components of a TK system from the original
community – by its consent or otherwise – inevitably entails loss of legal, cultural
and intellectual context. The far-ranging debate over the interplay between IP and
TK systems can boil down to this one question: what kind of legal liability should
continue to reach back to the source community when elements of a TK system
are transferred and used by third parties beyond the community?
Nor is TK inert or ossified: it is a form of innovation and creativity, which is
essentially dynamic in nature and continues to respond to the evolving needs and
shared intellectual life of a community. The development of TK is often a
collective or community-based process of incremental innovation and transmis-
sion to future generations. Hence the recognition and promotion of TK cannot be
seen simply in terms of access to, storage of and dissemination of raw facts or
mere data: a broader perspective would view TK in terms of community
knowledge systems. Preserving and protecting TK may entail closer attention to
the underlying systems of innovation and transmission of knowledge.
TK can be characterized as:
the content or substance of knowledge resulting from intellectual activity

in a traditional context, and includes the know how, skills, innovations,
practices and learning that form part of traditional knowledge systems,
and knowledge embodying traditional lifestyles of indigenous and local
communities, or contained in codified knowledge systems passed be-
tween generations. It is not limited to any specific technical field, and
may include agricultural, environmental and medicinal knowledge, and
knowledge associated with genetic resources.2
1 Draft Decision on Traditional Knowledge, annexed to WTO, Taking Forward the Review of
Article 27.3(b) of the TRIPS Agreement, Joint Communication from the African Group, WTO
Doc. IP/C/W/404 (26 June 2003), e.g. Art. 2(b)(iii).
2 Annex to WIPO, The Protection of Traditional Knowledge: Revised Objectives and Prin-
ciples, WIPO/GRTKF/IC/11/5(c) (reproducing WIPO/GRTKF/IC/9/5) (26 April 2007) (‘draft
Analysis of Different Areas of Indigenous Resources 61
Given the deep historical and cultural roots of TK, and its distinctive social and
intellectual characteristics, it is striking that international policy attention to the
protection of TK and TK systems has been limited until very recently. Numerous
programmes had been undertaken to document and otherwise to preserve
elements of TK, but little attention was given to the legal protection of TK, in the
interest of its originators and holders, nor to the recognition and protection of
traditional knowledge systems. Until the middle of the 1980s, international policy
discussion on the legal protection of intellectual creativity of indigenous peoples3
had focused on the protection of ‘expressions of folklore’ against illicit exploita-
tion and other prejudicial actions,4 culminating in an international soft-law
instrument5 which in turn influenced many national and some regional forms of
protection.6
Since that time, greater attention has been paid to the need for systematic
legal protection of TK, as a complementary and distinct set of policy challenges
related to protection of expressions of folklore. From the late 1980s, three
convergent trends accentuated attention to the protection of TK as such: (i)
broader recognition among policymakers, social scientists such as ethno-
biologists and anthropologists, and conservation and development agencies, of
the importance not merely of TK as utilitarian information but also of pre-
served indigenous knowledge systems (‘indigenous science’7) for attaining
sustainable development and appropriate technologies for ecological protection,
health, agriculture, land management, housing and other aspects of grass-roots
WIPO TK provisions’, first circulated in this form as WIPO, The Protection of Traditional
Knowledge: Revised Objectives and Principles, WIPO/GRTKF/IC/8/5 (8 April 2005)), Art. 3.
3 Concerning the term ‘indigenous people’, for the various definitional approaches see in
general Kingsbury, ‘Indigenous Peoples in International Law: A Constructivist Approach to
the Asian Controversy’, (1998) AJIL 92, 414–457; see discussion below on the question of
indigenous peoples (Sec. 3.I.1.3.(a)(bb).
4 The term ‘folklore’ itself has been controversial because for some indigenous peoples in
certain countries it has a pejorative connotation, see Blakeney, ‘The Protection of Traditional
Knowledge under Intellectual Property Law’, [2000] EIPR, 251; Lucas-Schloetter, III.3 in this
volume; for this reason, the term ‘traditional cultural expressions’ has become widely used as
a synonym of ‘expressions of folklore’ as it is considered more neutral and accurately
descriptive.
5 UNESCO-WIPO Model Provisions for National Laws on the Protection of Expressions of
Folklore Against Illicit Exploitation & Other Prejudicial Actions (1983).
6 WIPO, Consolidated Analysis of the Legal Protection of Traditional Cultural Expressions/
Expressions of Folklore (WIPO Publication No. 785E, 2004).
7 ‘Many indigenous people avoid the term “traditional knowledge” because “traditional”
implies that the knowledge is old, static, and passed down from generation to generation
without critical re-evaluation, change or further development. In other words, the implication
is that TK is not “science” in the formal sense of a systematic body of knowledge that is
continually subject to empirical challenges and revision. Rather the term implies something
“cultural” and antique. What) . . . (the international community needs to protect is “ indig-
enous science.” ’ Written comments from Prof. Russell Barsh, cited in Intellectual Property
Needs and Expectations of Traditional Knowledge Holders, WIPO Report on Fact-Finding
Missions on Intellectual Property and Traditional Knowledge (1998–1999) WIPO, Geneva,
2001 (‘WIPO Fact-Finding report’).
development,8 as well as forming the basis for recognition of land tenure and
forms of indigenous governance based on customary law and practices;9 (ii) the
advances in biotechnology and the changing commercial patterns – exemplified
by a growing middle-class taste for so-called ‘alternative’ or natural medicines –
that opened possibilities for deriving commercial and industrial value from the
insights of the traditional lifestyles of indigenous peoples and local communities,
particularly in those parts of the world which remained rich in biodiversity and
-rich areas of the world also by benefiting from of these areas; and (iii) perhaps
most importantly, a growing political awareness of, and concern about, their
cultural integrity on the part of indigenous peoples and other local communities,
who saw greater respect and recognition of their knowledge systems as, literally,
essential to their survival as culturally distinct communities.10 For example,
despite having been banned in some countries during colonial times as ‘witch-
craft’, traditional medicine reportedly serves the health needs of 80 per cent of the
population in developing countries, and has been consciously revived as a
deliberate policy choice as a means of sustainable public health;11 at the same
time, it serves as a valuable input to pharmaceutical research.
Early policy consultations on protection of TK took a broad sweep,
recognizing the holistic character of indigenous and other traditional cultural and
knowledge systems, with concerns that knowledge should not be commodified or
compartmentalized, in tension with its original context and full characteristics.
But policy attention also turned to specific technical fields in which TK had
significant practical and economic potential: for instance, traditional medicine
and healing knowledge,12 agricultural systems conserving the biodiversity and
protecting the environment;13 the contribution of agricultural TK to the
8 See Dutfield, ‘TRIPS-Related Aspects of Traditional Knowledge’, [2001] Case W. Res. J. Int’l
L., Vol. 33, 240; Dutfield, ‘The Public and Private Domains’, (March 2000) Science
Communication, Vol. 21, No. 3, 277.
9 See for example, Norvill & Milera v. Chapman & Ors, Tickner v. Chapman & Ors (1995) 133
ALR 226 (‘Hindmarsh Bridge’); Republic of the Philippines, Indigenous Peoples’ Rights Act.
10 See fn. 24 infra.
11 E.g. South Africa, Indigenous Knowledge Systems policy, fn. 35 and fn. 39, infra.
12 See further Barsh, ‘The Epistemology of Traditional Healing Systems’, Human Organization,
Vol. 56, No. 1, (1997) 28 et seq.; Blakeney, ‘Bioprospecting and the Protection of Traditional
Medical Knowledge of Indigenous Peoples: An Australian Perspective’, (1997) 6 EIPR, 298;
Wilder, ‘Protection of Traditional Medicine’, unpublished manuscript prepared for Working
Group IV World Health Organization’s Commission on Macroeconomics and Health.
13 See Barsh, ‘Fire on the Land’, (Fall 1997) Alternatives Journal, 23:4, 36 et seq.; Barsh, ‘How
Do You Patent a Landscape? The Perils of Dichotomizing Cultural and Intellectual Property’,
(1999) International Journal of Cultural Property, Vol. 8, No. 1, 14 et seq.; Coombe,
‘Intellectual Property, Human Rights & Sovereignty: New Dilemmas in International Law
Posed by the Recognition of Indigenous Knowledge and the Conservation of Biodiversity’,
(1998) Global Legal Studies Journal, Vol. 6, 59 et seq.; Verma, ‘Biodiversity and Intellectual
Property Rights’, [Spring 2000] CASRIP Newsletter, 20 et seq.
development of major food crops;14 its role in reversing desertification;15 and its
role in the conservation of biodiversity.16 This growing recognition of the
economic and broader utilitarian significance of TK is not confined to the
developing world, as is illustrated by the widespread and growing use of
traditional medicine, both directly and as a feedstock for research, and the use
and trans-generational development of landraces through traditional exchange
systems that contributes to agriculture on a global scale. Traditional knowledge
of farmers about crop varieties and their characteristics has become central to the
further (sustainable) development of agricultural systems, as a means of
preserving the environment and engendering global food security.
Yet the growing interest in TK from economic, commercial, industrial and
other utilitarian perspectives has not been matched by growing respect for or
recognition for the concerns, needs and expectations of the communities that have
developed TK, nor the distinctive knowledge systems that sustain TK. This sense
of neglect and systemic bias against traditional knowledge systems has led to
demands for more effective and appropriate protection of TK, either through the
application or adaptation of the traditional IP system or by means of new sui
generis rights, which may fall within the general category of IP17 or may take the
form of broader rights such as traditional resource rights18 and community
resource rights.19
The approach followed here attempts to analyse the factual situation, initially
especially the actual needs of the TK holders, to evaluate whether and to what
extent the IP system or other systems can fulfil these needs, or whether new kinds
of rights are necessary.20
14 The recognition of farmers’ rights under the Food and Agricultural Organization, International
Treaty on Plant Genetic Resources for Food and Agriculture (adopted by the FAO Conference
on 3 November 2001, entry into force 29 June 2004) (‘FAO ITPGRFA’), Art. 9.2; discussed
infra in Sec. III.4(a)(bb)(2).
15 United Nations Convention to Combat Desertification, (adopted in Paris on 17 June 1994,
entry into force on 26 December 1996): Parties shall, inter alia, ‘exchange information on
local and traditional knowledge, ensuring adequate protection for it and providing appropriate
return from the benefits derived from it, on an equitable basis and on mutually agreed terms,
to the local populations concerned’ (Art. 16(g)) and shall, in relation to research activities,
‘protect, integrate, enhance and validate traditional and local knowledge, know-how and
practices, ensuring, subject to their respective national legislation and/or policies, that the
owners of that knowledge will directly benefit on an equitable basis and on mutually agreed
terms from any commercial utilization of it or from any technological development derived
from that knowledge’ (Art. 17(c)).
16 CBD Art. 8(j), discussed infra in Secs II.2(a) and III.1(c).
17 Cottier, ‘The Protection of Genetic Resources and Traditional Knowledge: Towards More
Specific Rights and Obligations in World Trade Law’, [1998] Journal of International
Economic Law, 555–584.
18 Posey, Darrell, Traditional Resource Rights: International Instruments for Protection and
Compensation for Indigenous Peoples and Local Communities. Gland, Switzerland: IUCN,
the World Conservation Union (1996).
19 See Gibson, Community Resources (London, 2005).
20 See for the general approach of the study, von Lewinski, Part I above.
2. Sources of Factual Information
In surveying the main sources of factual information regarding TK, it is important

to distinguish:
– TK conceived of simple information drawn from a traditional source –

such as the content of databases and other collections of ethno-botanical
information acquired from traditional communities;
– TK considered holistically as an integral element or an embodiment of
traditional lifestyles, values and worldview of traditional communities; and
– Those aspects of TK that are susceptible to appropriation and use by third
parties, for instance for commercial or industrial use, and that form the
focus of legal protection.
The current controversies over misappropriation, misuse and appropriate and

inappropriate forms of protection of TK turn on this question of whether TK is
dealt with as bare information, or as intrinsically connected to the identity and
cultural context of the originating community. TK as simple information has been
more effectively diffused and disseminated than has any form of basic recognition
of the values, customary law and cultural concerns of the communities that
develop and maintain TK. What distinguishes TK from other forms of knowledge
is above all the fact that there are strong, intrinsic linkages with the life and
cultural and intellectual identity of a community.
This understanding of the distinctive characteristics is present most tellingly
in the most prosaic of contexts: documentation standards. Recognizing this
distinctive character of TK, the WIPO data standards for TK documentation
provide for distinct fields concerning constraints on use and dissemination – in
contrast to all other forms of IP documentation which are typically assumed to be
in the public domain. Along with other conventional bibliographic information,
these standards specify the inclusion of:
– Name and address of the custodian of TK or associated biological/genetic

resources;
– Conditions for access for different users, categories and purposes to the
record of the TK element or related biological/genetic resource, including
socio/cultural taboos and restrictions;
– Approval of, and arrangements with, the holder(s) of the TK or related
resource concerning its compilation, dissemination and application, if any,
and if required.21
21 Technical Proposals to the WIPO Intergovernmental Committee on IP and Genetic Resources,

Traditional Knowledge and Folklore, WIPO/GRTKF/IC/4/14, Proposal by the Asian Group, 6
December 2002, annex, p. 8; adopted by the 5th Session of the IGC (WIPO/GRTKF/IC/5/15).
Reflecting this community-centric approach, WIPO’s initial work on TK issues
was guided not by secondary sources such as anthropological and ethno-botanical
publications, but on the findings of nine so-called fact-finding missions (FFMs)
which included consultations directly with indigenous peoples, local communities
and other TK holders, as well as supplementary consultations with some 5,000
government officials, academics, research institutions and non-governmental
organizations, in 60 locations and 28 countries in the South Pacific, Southern and
Eastern Africa, South Asia, North America, Central America, West Africa, the
Arab countries, South America and the Caribbean.22 Further consultations
including additional FFMs have continued since then, and community represen-
tatives have been active in substantive policy debate. This process led to a set of
recommendations that distilled the needs and expectations expressed by TK
holders during the consultations; these recommendations have been steadily
implemented and continue to guide policy development.23 In summary, the 22
recommendations covered the following:
– Clarifying and reframing IP discourse: it is noteworthy that needs and

expectations related to how IP discourse were structured and how it dealt
with TK and the interests of TK holders, so that recommendations included
selecting appropriate terms, defining or describing what is meant by these
terms for IP purposes, studying the relationship between the collectivity of
TK and IPRs and customary laws and protocols in local and traditional
communities.
– Promoting the voice of TK holders: promoting greater understanding by
the IP community of the perspectives, expectations and needs of TK
holders, facilitating dialogue and contact between TK holders, the private
sector, governments, NGOs and other stakeholders to promote cooperation
at community, national, regional and international levels; enhanced par-
ticipation by IP community in TK-related processes dealing with IP issues.
– Capacity-building and awareness-raising, such as clarifying the role and
nature of IP protection in relation to TK, promoting understanding of the
IP system, particularly among indigenous and local communities, testing
the applicability and use of existing IP tools for TK protection, through
practical and technical community-level pilot projects and case studies and
related technical information and training; assistance with assessing the
economic value of TK.
– Practical initiatives, such as preventing unauthorized acquisition of IPRs
(particularly patents) over TK, analysing prior art relevant to patent
examination in the context of TK; facilitating access to the IP system for
22 WIPO Fact-Finding Report, note 7 supra; for a concise synopsis of the results, see Wendland,
‘Intellectual Property, Traditional Knowledge and Folklore: WIPO’s Exploratory Program’
(1998–2001), [2002] IIC, 485.
23 See for example the analysis of work undertaken to address these recommendations set out in
Annex II to Overview of Activities and Outcomes of the Intergovernmental Committee,
WIPO/GRTKF/IC/11/9 (18 May 2007).
TK holders; providing legal/technical assistance with TK documentation,
including information and advice on the IP implications of TK documen-
tation; and assistance and training for TK holders in the negotiation,
drafting, implementation and enforcement of contracts.
– Longer term structural developments: longer-term recommendations for
‘new IP tools to protect TK not protected by existing IP tools, the
elaboration of an international framework for TK protection . . . and the
development of a sui generis system of “community” or “collective” rights
to protect TK’; and the development and testing, with the close involve-
ment of indigenous peoples and local communities, of ‘best contractual
practices’, guidelines and model clauses for contracts.
Indigenous communities have since reinforced the understandings conveyed in

these discussions, through direct contributions to international policy debate on
the interplay between TK and IP. While these perspectives have been naturally and
inevitably diverse, several key themes can be discerned:
– A call for the protection against misuse and misappropriation not for
simple economic arguments, but for the very preservation of the distinctive
cultural identity of communities and their survival as communities: ‘[f]rom
the indigenous perspective, misuse of TK can cause severe physical or
spiritual harm to the individual caretakers of the knowledge or their entire
tribe from their failure to ensure that the Creator’s gifts were properly used,
even if misuse was used by others outside of the tribe, or by tribal members
who were outside of the control of customary authority. For this reason
. . . misappropriation and misuse [is] not simply a violation of “moral
rights” leading to a collective offense, but a matter of cultural survival for
many indigenous peoples.’24
– A call for the recognition of the local context, including the customary law
of indigenous communities, as the legal basis of protection, thus shifting
the principle, normative endeavour from seeking to codify or to create
entirely new forms of legal protection towards instead giving effect more
broadly to the rules or norms that already govern TK in its customary
context, or what one leading voice has termed a principle of locality: ‘to
resolve any disputes over the acquisition and use of indigenous people’s
heritage according to the customary laws of the indigenous peoples
concerned’,25 akin to the principle of lex loci.
24 Representative of the Tulalip Tribes, WIPO Intergovernmental Committee on Intellectual

Property and Genetic Resources, Traditional Knowledge and Folklore, 5th Session. Rep., Doc.
WIPO/GRTKF/IC/5/15, (4 Aug. 2003) p. 56.
25 Dr. E. A. Daes, ‘Defending Indigenous Peoples’ Heritage’, Keynote Address at the Conference
on Protecting Knowledge: Traditional Resource Rights in the New Millennium, Union of
British Columbian Indian Chiefs (February 2000).
– A critique of the epistemological assumptions and values that underpin
conventional IP law, including its focus on individual creativity and
innovation and its generally relatively brief timeframe, but also extending
to a critique of assumptions about the alter ego of the IP system, the public
domain: ‘indigenous peoples have rarely placed anything in the so called
“public domain”, a term without meaning to us . . . the public domain is a
construct of the IP system and does not take into account domains
established by customary indigenous laws’.
The increasingly powerful voice of TK-holding communities in IP policymaking

brings to the foreground a past failure of dialogue and mutual incomprehension.
Two distinct policy domains – concerning the law and policy of IP, and
concerning a cluster of inter-related indigenous and environmental issues – had
hitherto largely been considered discrete and isolated from one another, often
assumed to be at odds in terms of values.26 This past failure of communication has
encouraged an assumption that the policymaker’s role is one of damage control,
effectively seeking forms of accommodation, ‘reconciliation’ or ‘balance’ between
two sets of norms and values, conceived as antinomies. This counter-position of
opposed value systems raises a pointed methodological question about how the
issues should be addressed and framed, whose perspective should be dominant –
drawing an analytical tool from linguistic anthropology,27 the contrast is essen-
tially between the ‘emic’ or ‘etic’ approaches, the subjective worldview of the
insider and community member, or the purportedly objective external perspective
of the analyst and observer. While an IP approach has been characterized as
inherently inimical to the outlook of TK holders and indigenous communities, the
WIPO programme on TK was initiated with an ‘emic’ point of view, inviting TK
holders to comment on IP issues from their perspective. This fieldwork has been
described as ‘global first-hand information on the intellectual property-related
needs of the stakeholders in the TK field’.28 In contrast to many publications in the
intellectual property literature, the WIPO at least aimed at a truly ‘emic’ approach,
taking the perspective of TK holders and the inherent characteristics of the subject
matter to be protected as the starting point of the considerations.29 Further sources
of practical insight and normative guidance in this process have included
submissions of WIPO Member States, regional bodies and intergovernmental
organizations to the WIPO Intergovernmental Committee on Intellectual Property
26 Notably, the recommendations received from TK holders around the world that were distilled
in the WIPO Fact Finding Report (fn. 7 supra) emphasize various avenues to promoting
greater mutual awareness of these two policy communities.
27 Kenneth Pike, Language in relation to a unified theory of the structure of human behavior,
(The Hague: Mouton, 1954).
28 Matthias Leistner, ‘Traditional Knowledge’ (first edition of volume), p. 51.
29 On the ‘emic’ – ‘etic’ distinction in anthropology and its importance in the TK field, see
further Fikentscher/Ramsauer “Traditionswissen-Tummelplatz immaterialgüterrechtlicher
Prinzipien”, in: Ganea/Health/Schricker (eds), Festschrift für Adolf Dietz (Munich, 2001)
pp. 25, 27, 30. For a more general perspective see Fikentscher, Modes of Thought – A Study
in the Anthropology of Law and Religion (Tübingen, 1995), pp. 116–149.
and Genetic Resources, Traditional Knowledge and Folklore (the ‘IGC’)30 have
been used which provide factual information (and proposals) from governments,
regional and multinational organizations. However, a key development in the
work of the IGC has been incremental steps to ensure that the voices of
indigenous and local communities, and other holders of TK, have been central to
the work of this formally intergovernmental process, with the goal of sustaining
an ‘emic’ approach to continue to guide the search for international norms and
understandings of the role of IP mechanisms in serving communities’ needs and
expectations. Among the practical and procedural steps undertaken to promote
inclusion and diversity has been accreditation of over 180 organizations as active
participants in the IGC’s work, the majority representing local and indigenous
communities; panels of indigenous representatives putting community perspec-
tives to the IGC; direct input from communities into the IGC’s working
documents; and the creation of a Voluntary Fund to provide practical support for
participation of local and indigenous communities.31
3. Terms and Definitions
The WIPO FFMs highlighted the need for terminological clarity in defining the
subject matter ‘traditional knowledge’ ;32 subsequent policy debate has confirmed
this need, given that the boundaries around what is considered ‘traditional
knowledge’ have taken on ever greater legal and policy status.33 At the same time,
policy discussion has identified clear limits on the move towards greater precision
in defining TK.
Three distinct elements of terminology may be considered:
(a) the choice of an appropriate term or terms;

(b) the identification or description of the subject matter to be covered by the
term or term selected; and
(c) the determination of the scope of that subject matter which is actually to
be granted legal protection.34
30 See the review of the work of the IGC in WIPO/GRTKF/IC/11/9 (note 23 supra).
31 For a full account see WIPO/GRTKF/IC/11/9 (note 23 supra), pp. 11–15.
32 See WIPO Fact-Finding Report (note 7 supra), p. 210 et seq.
33 As an example, a current proposal to revise the WTO TRIPS Agreement makes reference to
‘traditional knowledge’ in the form of a precise legal obligation (see Brazil, India and others,
Doha Work Programme: The Outstanding Implementation Issue on the Relationship Between
the TRIPS Agreement and the Convention on Biological Diversity: Revision, WTO IP/C/W/
474, Add. 1 and Add. 2, WT/GC/W/564/Rev. 2 and TN/C/W/41/Rev. 2 (5 July 2006)).
34 See ‘Traditional Knowledge – Operational Terms and Definitions’, WIPO/GRTKF/IC/3/9 (20
May 2002).
(a) Choice of Terminology
(aa) General
None of these elements can be taken for granted, and the choices taken have
profound normative and policy implications for the legal scope, policy impact,
practical effectiveness and perceived legitimacy of any legal instrument. For
example, some have called for a specific focus not on ‘traditional knowledge’, as
being too broad and diffuse, but rather on ‘indigenous knowledge’ or ‘indigenous
science’.35 Moreover, there has been considerable uncertainty over whether the
term ‘traditional knowledge’, should embrace the better-established legal concept
of ‘expressions of folklore’ (now frequently substituted by ‘traditional cultural
expressions’ in view of the pejorative associations of ‘folklore’ for many
communities.36) In the specific context of legal protection against misappropria-
tion and misuse, there is an emerging practice of distinguishing TK as a
descriptive broader concept (lato sensu) from traditional knowledge in a more
strict legal and policy sense (stricto sensu). TK stricto sensu refers to the content
or substance of knowledge – what is known – and is distinguished, for example,
from its distinctive form of expression (which may indeed be through TCEs, such
as songs and narratives) and from the genetic resources that are frequently
intertwined with TK. Recognizing the maturing and focusing of the debate, this
chapter will not address traditional creativity and cultural expressions (in the
sense of the former term ‘folklore’);37 equally, despite the close linkage between
much TK and genetic resources, the latter subject is also treated separately.38
(bb) Addressing Indigenous Knowledge in Particular
A significant choice in terminology, a matter with major policy and legal

implications, lies between ‘traditional knowledge’ as a broader concept, referring
to knowledge held in diverse local and traditional contexts, and ‘indigenous
knowledge’ or ‘indigenous science’ as such, referring to the knowledge systems of
peoples identified as having distinct indigenous status. For instance, the South
African Government has initiated a wide-ranging Indigenous Knowledge Systems
35 See the comments of Barsh, fn. 7 supra, and South Africa’s position: ‘After much debate
within the South African policy development on IKS context the Minister of Science and
Technology ruled in favour of the use of the concept ‘Indigenous Knowledge and Indigenous
Knowledge Systems’ against ‘Traditional Knowledge and Traditional Knowledge Systems’.
The argument took cognizance of the genesis of the use of traditional as against modern. It
rejects the dichotomy that was created to diminish the significance of indigenous knowledge
system when counter-posed against modernity’, document WIPO/GRTKF/IC/11/5(a), The
Protection of Traditional Knowledge: Table of Written Comments on Revised Objectives and
Principles (18 May 2007).
36 See fn. 4, supra.
37 See the discussion by Lucas-Schloetter, in this volume.
38 See Part III, Section 2 in this volume.
Policy,39 and calls for distinct recognition of indigenous knowledge, entirely
consistent with broader initiatives regionally within Africa and internationally to
create distinct legal protection of TK, an intrinsically broader concept.
This means, however, that the choice of term for the subject of protection can
have significant normative implications, that go beyond the nature of the
knowledge itself to embrace the cultural and legal identity and character of the
community as such: the choice of terminology can even touch on the sensitive
issue of the very legal personality of indigenous peoples, including their
recognition under international law and self-determination, a matter which has
been the subject of considerable debate well beyond the issue of TK.40
Precisely because of the intrinsic community context of TK, the definition
and scope of TK will be inflected according to the identity and characteristics of
the community that holds the knowledge. This question – whether or not to limit,
or focus, efforts to protect TK essentially on indigenous communities and
distinctly identifiable indigenous knowledge – has been a consistent theme in
policy debate. The debate naturally touches on what distinguishes a people as
‘indigenous’. Where protectable subject matter is defined independently from the
notion of ‘indigenous groups and peoples’, it can merely beg the question of what
communities are to be set apart and determined to be specifically entitled to
benefit from protection of TK and in particular to have the potential right to
prevent certain uses of knowledge. The TK debate has, in any event, highlighted
both the distinction between indigenous people – for example, as formerly
independent and subsequently conquered and suppressed people – and other local
and distinct cultural communities. As far as the TK debate is concerned, different
emphases and approaches are apparent in more recently colonized continents such
as America and Oceania, than in areas with a longer history of various waves of
immigration (for example, the Indian subcontinent and Southeast Asia41). Inter-
national legal instruments specifically recognizing the rights of indigenous
39 See document WIPO/GRTKF/IC/9/11: Republic of South Africa: Indigenous Knowledge

Systems Policy.
40 Recognition of indigenous communities’ interests in sharing of benefits as an equitable
principle in international law finds an interesting parallel in the Cayuga Indian arbitral case,
Great Britain v. United States, R.I.A.A. 173 (1926). The tribunal did not recognize the Cayuga
as having distinct identity in international law (‘so far as an Indian tribe exists as a legal unit,
it is by virtue of the [applicable] domestic law and so far only as that law recognizes it’); but
it held that the general principles of equity, fair dealing and justice recognized by international
law entitled the Cayuga to an equitable share in the annuities that had been agreed in a treaty
between the Cayuga Nation and the State of New York concluded in 1795, which had not been
paid since 1810 to Cayuga who had migrated to Canada in the context of the war of 1810. The
tribunal observed that its arbitral award would be justifiable on the basis of international
equitable principles alone. Id., p. 179–84.
41 See for example the statement of the Delegation of India, document WIPO/GRTKF/IC/10/7:
‘The definition of the TK holder needed to be broadened to include the country or region as
a whole as the sole holder of TK in the case of codified but non-customary knowledge systems
of health care such as Ayurveda, Siddha and Yoga in India . . . relating to beneficiaries of
protection, logically it followed that the country’s government or nation as a whole should be
peoples as such do of course exist,42 and form an integral part of the policy and
legal framework for protection of TK.
Even setting aside the important distinction between indigenous peoples and
more diffuse conceptions of local and other cultural communities, seeking to
define TK can frequently beg the question of how eligible communities are to be
determined: the criteria that should apply, and who should apply them.
Self-identification is arguably an element of self-determination, and some have
essentially called for communities to have the capacity to determine their own
eligibility – an essentially subjective test.43 In practice, it is difficult to imagine a
fully international approach to this question, and a case-by-case determination
under national law, perhaps guided by international rules or guidelines, may be
inevitable. This approach is included in the draft Agreement on the Free Trade
Area of the Americas. A heavily-bracketed chapter on intellectual property,44
which provides for ‘safeguarding and respecting’ TK of indigenous and local
communities, stipulates that each party ‘shall provide for a definition of local
communities in its national legislation’.45
(b) Subject Matter to be Covered: Characterizing Traditional

Knowledge
(aa) Holistic Approach
The second step identified above is to describe or characterize the nature of TK

or indigenous knowledge. This is a descriptive matter, but with strong normative
implications: since firm needs and expectations have been expressed concerning
traditional knowledge as such – and a fortiori indigenous knowledge or science –
the step of determining what knowledge is considered ‘traditional’ or ‘indig-
enous’, as distinct from simply collective or historic knowledge, forms part of the
factual matrix that helps define norms for TK holders themselves as well as their
expectations of external parties. One distinctive characteristic is that traditional
and local communities, and especially indigenous peoples, tend to regard their
included and entitled to benefit-sharing, where officially recognized and regulated TK systems
are involved’ (at 88–89)
42 United Nations Declaration on the Rights of Indigenous Peoples, adopted by the Human
Rights Council (29 June 2006), and recommended for adoption by the United Nations General
Assembly (document A/HRC/1/L.10).
43 A central thesis in Johanna Gibson, Community Resources, (London, 2005).
44 Chapter XX, Draft Agreement, FTAA – Free Trade Area of the Americas, FTAA.TNC/w/133/
Rev. 3 (21 November 2003).
45 Chapter XX Intellectual Property Rights, SubSec. B.2.f. [Traditional Knowledge and Access
to Genetic Resources under the Intellectual Property Framework] [Relationship between the
Protection of Traditional Knowledge and Intellectual Property, as well as the Relationship
between Access to Genetic Resources and Intellectual Property] [The Protection of Traditional
Knowledge, Access to Genetic Resources, and Intellectual Property], Art. 1.1. It should be
noted that this Agreement is in draft only, and is not currently under active development; it is
cited here for illustration only.
knowledge as intrinsically intertwined with the land, with the local environment
and ecology, with a way of life and a world view, even a cosmology. Knowledge
is of a piece with the landscape, with ancestral territories, and with cultural
heritage, as inherently cultural creations in which their intellectual creations are
inseparably embedded.46 TK is typically conceived in fully holistic terms,47 while
‘western’ or conventional science and knowledge systems are argued to be
reductionist.48 Consequently, a tension is posited between the approach to
knowledge systems and cultural expressions in conventional IP law and the
perspective within indigenous cultures. This plays out in the distinction between
the domain of distinct forms of protected IP, on the one hand, and collectively held
cultural property, traditional knowledge systems and associated genetic resources,
on the other hand, which have generally been assumed in the terms of
conventional law and policy to fall into the domaine public, even though this
assumption has been forcefully argued to be perilous to the very root concepts of
the development of traditional knowledge.49 This raises a difficult dilemma, at the
heart of calls for an holistic approach to protection of TK: should intellectual
property law be broadened and diversified to recognize the full context of TK and
its linkages with the environment, culture and spiritual domain, or should it focus
on those aspects of TK that are most readily or most commonly appropriated by
third parties? Or might the holistic characteristics of TK be better dealt with by
different legal mechanisms dealing with its different facets, leaving just the
‘intellectual property’ aspect to intellectual property law?50 This dilemma is
discussed below, when the question of what aspects of TK should be protectable
through IP mechanisms is addressed.
(bb) Diversity
The diverse nature and scope of TK systems means that it is impossible to define
TK by reference to its subject matter or even its policy field. International
46 See Barsh, ‘How Do You Patent a Landscape?’, (1999) International Journal of Cultural
Property, vol. 8, nos. 1, 14–47.
47 See for references, Dutfield, ‘The Public and Private Domains’ (note 8 supra), 275 et seq; for
a decidedly critical view, see Agrawal, ‘Indigenous and scientific knowledge: Some critical
thoughts’, [1995] Indigenous Knowledge and Development Monitor, 3, 3–6.
48 Shiva, ‘Staying Alive: Women, ecology and development’ (1989). Others deny that there is a
fundamental difference between ‘western’ science and traditional knowledge at all, see
Hecht/Posey, ‘Preliminary results on soil management techniques of the Kayapo Indians’,
[1989] Advances in Economic Botany 7, 174–188.
49 See Antony Taubman, ‘Saving the Village: Conserving Jurisprudential Diversity in the
International Protection of Traditional Knowledge’, in International Public Goods and
Transfer of Technology Under a Globalized Intellectual Property Regime, Keith E. Maskus
and Jerome H. Reichman (eds), (2005), p. 521.
50 This is also the approach followed by the WIPO FFMs which tried to determine the
‘intellectual property’ needs of the stakeholders, limiting the resulting report to the
‘identification of those needs and expectations to which the IP system is or may be able to
respond’, though keeping in mind not to view the FFMs exclusively from an IP perspective,
see WIPO Fact-Finding Report (fn. 7 supra), p. 209.
instruments that deal with TK refer to its role in agriculture,51 in the conservation
of biodiversity,52 in combating desertification,53 in promoting appropriate medi-
cine,54 and in preserving cultural diversity and the rights of indigenous peoples.55
Accordingly, a general descriptive approach would not define its subject matter
but rather describe its context – in other words, taking for granted that
‘knowledge’ is in some form the fruit or content of human intellectual activity, the
emphasis lies on defining the traditional context. Accordingly, one early working
definition referred to
all tradition based (i.e., generally developed on the basis of transmission

from generation to generation) intellectual (i.e., based on intellectual
activity) creations and innovations, in the very broadest sense, which are
constantly evolving in response to a changing environment and are
generally regarded as pertaining to a particular people or territory.56
However, given the greater maturity of the debate and the broadening cultural and
policy context for considering of these issues, the tendency has been towards
stronger and distinct legal recognition of TK as such,57 with complementary and
coordinated protection of TCEs/expressions of folklore.58 Equally, genetic re-
sources are already governed by a well established international legal frame-
work,59 leading to a focus more on how protection of TK that is associated with
genetic resources can and should operate congruently with these existing norms:
the CBD itself already establishes a general standard for the recognition of TK
associated with biodiversity.
(cc) Self-Referential Aspect of Defining TK
In view also of the growing salience of TK in many public policy debates, it is

important to more clearly characterize this form of knowledge, and to use this
51 FAO ITPGRFA, fn. 14 supra.

52 Convention on Biological Diversity (Rio de Janeiro, 5 June 1992), Art. 8(j).
53 Desertification Convention, fn. 15 supra.
54 WHO Declaration of Alma-Ata, International Conference on Primary Health Care, Alma-Ata,
(6–12 September 1978).
55 UN Declaration on the Rights of Indigenous Peoples (fn. 42 supra).
56 WIPO Fact-Finding Report (fn. 7 supra) p. 25.
57 For instance, the draft approach to protection of TK as such against misuse and misappro-
priation set out in the draft WIPO TK provisions, fn. 2 supra, Art. 3.2.
58 See the distinctive approach to protection of expressions of folklore (traditional cultural
expressions) in the Berne Convention, the WPPT, UNESCO-WIPO Model Provisions and
most recently in the annex to WIPO, The Protection of traditional cultural expressions/
expressions of folklore: Revised Objectives and Principles, WIPO/GRTKF/IC/11/4(c) (repro-
ducing WIPO/GRTKF/IC/9/4) (26 April 2007) (‘draft WIPO TCE provisions’), the last
developed consciously to complement the draft WIPO TK provisions (and vice versa).
59 Principally by the CBD and the FAO ITPGRFA, but by several other instruments: see Chapter
III.2, infra.
clearer general understanding as the basis for more precise definitions of what
forms of TK should be protected in different ways. Some definitional ambiguity
or uncertainty is inevitable, but the lack of any settled understanding would
impair the prospects for systematic protection, especially at the international
level. On the other hand, the legitimacy and appropriateness of any mechanism
for legal protection requires recognition of the inherently localized and subjective
aspect of TK. The very right of self-determination of indigenous groups and local
communities is argued to extend to a right to decide what constitutes their own
traditional knowledge and the ways in which it should be defined and protected.
This self-referential or radically subjective aspect of defining TK, and indeed
defining the communities which hold it,60 is perhaps the most distinctive aspect
of TK considered as the subject of IP protection. Conventional IP law does have
space for subjective judgments, for instance when the courts endeavour to make
an objective judgment about what would subjectively take place in other minds in
relation to distinctiveness of trademarks, or the similarity of designs. The courts
have acknowledged the lack of firm objective basis for judging similarity of
designs: ‘I cannot say that the present case is any exception to the rule that the
eye, like the heart according to Pascal, has its reasons that reason does not
know’.61 But for the right holders to have the entitlement to determine the scope
or subject matter of their own rights would be a significant further step for IP law,
with the need for practicality and workability suggesting the benefits of a broad
objective definition with scope for a subjective element in its actual application.
(dd) The Role of a Definition of TK
Following a review of approaches taken to terminology in other areas of IP, one

study observes concerning a formal international definition that:
(i) while illustrative or descriptive characterizations of “traditional knowl-

edge” may be developed in isolation to promote discussion, analysis and
debate, it may only be possible (or desirable) to settle on a particular
definition in the context of a specific legal instrument and with a defined
policy goal;
(ii) the degree of precision required in a definition may depend on the level
and extent of harmonization and uniformity in national laws that are
expected to result from an international legal instrument;
(iii) clarity about the policy objectives of the legal instrument and the kind
of protection that is intended may be a necessary ingredient for a firm
definition of “traditional knowledge”: for instance, does the legal
instrument concern defensive or positive protection; is it concerned
with active protection of cultural heritage or simply suppression of
commercial misuse; and is it intended additionally to promote a distinct
60 See Gibson, fn. 43 supra.

61 In re Wolanski’s Registered Design, (1953) 88 CLR 278, per Kitto J.
public policy objective, such as equitable management of genetic
resources and conservation of biodiversity?
(iv) it could be in keeping with international practice for a definition to be
broad and open-ended, with greater precision applying at the national
level or in the scope of specific areas of protection; or, at least, the
absence of a single, comprehensive and exhaustive definition need not
be an obstacle to the international coordination or harmonization of
domestic legal systems;
(v) a definition of “traditional knowledge” could be expressed in a general
or indeterminate way, while the actual scope of legal protection may be
separately defined as a distinct step, taking into account the nature and
policy orientation of the protection, for instance:
– with reference to specific conditions (e.g. that it not already be in the
public domain, or that it be traditional knowledge associated with in
situ biodiversity conservation)
– by excluding some areas of subject matter (e.g. secret or sacred
traditional knowledge may be excluded from a system that provides
protection by publishing details of traditional knowledge)
– by specifying that some particular subject matter is deemed to fall
within the scope of protection (e.g. clarifying that unfixed TK is
included in the definition).62
From an intellectual property policy perspective, it is necessary to be clear about

the function of any definition. It would be impertinent and irrelevant for external
policymakers to seek to encapsulate the full character and holistic qualities of
indigenous and other traditional knowledge systems within a single definition. An
‘emic’ approach would above all recognize as an element of self-determination
and integrity of their cultural identity for communities themselves to define their
own systems of knowledge and to determine both the essence of their episte-
mologies and the normative systems that govern knowledge systems within their
own community. The potential conflict between the quest for an ostensibly
objective definition and the necessary deference to the community which sustains
the knowledge is resolved by maintaining suitable reserve in relation to the
function of a definition. There is no need or obvious benefit for external
policymakers or legislative drafters to seek to capture the full diversity of
knowledge systems within a formal definition. Ultimately the goal of IP
policymaking is not to document an epistemological system or to conduct
comparative anthropological analysis of diverse forms of knowledge, but to
establish those forms of use and appropriation that third parties are constrained
from undertaking, so as to serve either claims of inherent natural justice over
knowledge or to promote utilitarian objectives, such as the creation of public
62 WIPO/GRTKF/IC/3/9, fn. 34 supra, para. 12.

goods.63 A broad characterization of indigenous and other traditional knowledge
systems may be helpful as an awareness raising mechanism for external parties.
But the only defensible function of a formal definition would be to establish those
aspects of traditional knowledge that would be the subject of legal constraints on
third parties, including third parties in foreign jurisdictions. This requires a
particular focus on those aspects of traditional knowledge systems that are most
readily appropriated by third parties. Hence a descriptive characterization of
diverse knowledge systems can be distinguished from the formulation of a
definition of protected subject matter as such. Equally, in more conventional areas
of IP law, protected subject matter is a necessary artifice of the policy process: a
patentable invention is distinct from a full innovation process; a protectable
trademark is distinct from the full reputation, image and goodwill of a concern;
copyright works published by faculty members are distinct from the full body of
knowledge held by a university faculty.
By distinguishing the general characteristics of traditional knowledge sys-
tems from those aspects of knowledge that are protected against certain third party
appropriation and usage, one can set in a clearer context the debate over whether
there is a principal (and ‘definable’) difference between ‘western’ science and
traditional knowledge at all, and terminologically only accept traditional knowl-
edge as a ‘science’ with certain specific characteristics.64 The search for a single
quiddity distinguishing ‘traditional’ from other forms of knowledge can often
overlook the fact that ‘knowledge’ itself is hardly a settled, hard, concept
susceptible to bright-line legal definitions. To the contrary, the debate over TK
protection has the salutary effect of recalling the embedded assumptions about
knowledge systems that shape IP laws as deliberate public policy interventions.
The interpretation and implementation of mainstream IP law naturally draws
on specific customs or conventions about the forms of knowledge, expression and
distinctive personality that policy objectives require to be protected: indeed, this
is the essence of the TK critique of conventional IP law. Forms of knowledge that
are validated by IP systems for certain public policy purposes are recognized and
protected partly because of their conformity with established modes of analysis
and selection that have an implicit customary element (‘all knowledge is
traditional’). Second, in their actual operation, IP systems do in practice reflect
distinctive local or cultural qualities that may not be apparent from objective
international IP standards (‘all IP protection is customary’). The intergenerational,
cumulative and collective aspects of traditional knowledge are rightly stressed in
the policy debate; yet most forms of knowledge are founded on antecedents, are
passed between generations and are in some sense the consequence of cumulative
endeavour.
63 Regarding TK protection in the context of global public goods, see Taubman, Saving the
Village, fn. 49 supra.
64 Hecht/Posey, ‘Preliminary results on soil management techniques of the Kayapo Indians’, (fn.
fn. 48, supra) 174–188; Johnson, M., ‘Research on traditional environmental knowledge: Its
development and its role’, in: Johnson, M. (ed.), Lore: Capturing traditional environmental
knowledge (Ottawa, 1992), p. 7 et seq.
(ee) Linkage with Traditional Community and Dynamic,
Intergenerational Quality
The essential characteristics of traditional knowledge are its linkage with a

traditional community as such and its dynamic, intergenerational quality. Fre-
quently there is a spiritual and cultural element, and an historical, ethical and
religious dimension that taps into the very identity of the respective indigenous
group or local community,65 and may be ‘symbolic of a deeper order or belief
system’.66 The linkage with the community may be expressed in explicit or
implicit customary laws or practices, but it is rare to insist on these additional
elements as essential to what is accepted as TK. Within this traditional context,
knowledge is generally developed and held in a collective fashion, although
individuals within the community may have a distinct status and linkage, for
instance as holders or practitioners of certain elements of TK:67 this status may
also be recognized under customary law. Further, knowledge is ‘traditional’ not
because it is confined in or rooted to a distinct past era or a past lifestyle, seen as
pristine and unspoiled, prior to contact with now-dominant cultures, but because
of this intergenerational and community context.
TK can therefore overlap with the established categories of protected subject
matter in IP law, without coinciding with any of those categories: an innovation
within a traditional knowledge system may well be a patentable invention, even
if it would run contrary to some communities’ values actively to seek to patent
such innovations (in other cases, there are no such concerns, and many patents are
granted on legitimate innovations within TK systems68).
This approach lends itself to a broad and descriptive characterization of TK.
For instance, the WIPO objectives and principles characterize the term ‘TK’ as
referring
to the content or substance of knowledge resulting from intellectual

activity in a traditional context, and includes the know how, skills,
innovations, practices and learning that form part of traditional knowl-
edge systems, and knowledge embodying traditional lifestyles of indig-
enous and local communities, or contained in codified knowledge
systems passed between generations. It is not limited to any specific
65 Fikentscher/Ramsauer (fn. 4 supra), p. 31.

66 WIPO Fact-Finding Report (fn. 7 supra), p. 211.
67 Gupta, Statement at WIPO Roundtable on Intellectual Property and Traditional Knowledge,
Geneva, 1–2 November 1999, as quoted in the WIPO Report (fn. 12), p. 219; Downes, ‘How
Intellectual Property Could be a Tool to Protect Traditional Knowledge’, [2000] Columbia
Journal of Environmental Law, 253 et seq.
68 For example, the ‘China Traditional Chinese Medicine (TCM) Patent Database’ was reported
in 2002 as containing 12,124 deeply indexed Chinese-language records of China TCM patent
literature with 32,603 TCM formulas in Chinese. Inventory of Existing Online Databases
Containing Traditional Knowledge Documentation Data, WIPO/GRTKF/IC/3/9 (10 May
2002) p. 12.
technical field, and may include agricultural, environmental and medici-
nal knowledge, and knowledge associated with genetic resources.69
The approach is not dispositive of what actual protection would be afforded,

whether through existing, adapted or altogether new forms of IP, or through
non-IP legal mechanisms. It merely maps out a general field in which some forms
of protection may be applied.
(c) Scope of Legally Protected TK
Accordingly, the third step identified above is to identify those aspects or elements
of TK, as broadly defined, which would be eligible for specific forms of
protection, or which should otherwise be considered subject to the custodianship,
ownership or control of certain TK holders. Any attempt to define protectable
subject matter inherently frames the issues, and inevitably creates boundary
issues: what TK should be considered to be irreversibly in the public domain;
what public domain TK could in effect be repatriated to the source community;
what TK should be subject to exclusive rights or other constraints on its access,
use and appropriation? More broadly, the question provokes a deeper question as
to what form of legal protection is appropriate and necessary, and what aspects of
that protection can and should be achieved by IP or IP-like mechanisms. The ideal
would be protection that is at once global in reach, holistic in scope and fully
deferential to the local quality of TK and TK systems. Yet any practical protection
mechanism that reaches beyond the community is necessarily selective and cannot
faithfully replicate the full local context, and the worldview of the source
community. Remedies that are both holistic and global entail choices, choices that
should aim at the best mix of practicable measures. ‘Holism’ requires that the sum
be greater than its parts, not that one part should be the whole.
Communities rarely need external instruction on how to protect their own TK
when defining or organizing themselves as communities. But they may choose
external support to bolster their innate capacities when parties beyond the
community abuse or profit from their resources. By one perspective, to apply IP
to TK would ‘fundamentally transform the subject matter of protection in ways
that make it incompatible with the interests of community’.70 This comment
usefully focuses attention on determining the legitimate role of IP mechanisms
within a broader framework of protection and preservation of TK. Arguably, one
role of IP should be to thwart the misappropriation and misuse of intangible
knowledge. Certain facets of TK are readily appropriable by third parties, and
legal rights would protect those facets against such appropriation. ‘TK’ in its
customary context is categorically distinct from the legal rights that constrain its
misappropriation in a foreign jurisdiction. Such ‘protection’ that has external legal
effect may usefully supplement internal governance, without seeking to mimic or
69 See Draft WIPO TK provisions, fn. 2 supra, Art. 3.2.

70 Gibson, fn. 43 supra.
to replicate the source community’s full way of life, its view of itself as a
community, its value system and its cosmology.
There is a risk of a circular critique if one defines ‘IP’ as inherently at odds
with the needs and values of indigenous communities, then IP is plainly
inappropriate for ‘protecting’ TK. Certainly, no IP or IP-like law can express the
essence of a culture or cosmology, but it may usefully protect those aspects that
are susceptible to misuse or misappropriation. It is such illicit acts, not the
availability of IP-based remedies against them, which distort or commodify TK.
As one element of an holistic response, a judicious IP approach may respect the
indigenous perspective, reinforcing the space for diversity and self-determination,
dealing with third-party abuses, but keeping its nose out of a community’s proper
concerns.
Accordingly, ‘protection’ of TK in foreign jurisdictions, or in any environ-
ment beyond the original community, need not mimic collective practices,
customary laws and practices, forms of cultural and intellectual diffusion, that
characterize irreducibly diverse communities. If a cosmetic manufacturer misap-
propriates the sacred knowledge of an indigenous community in a foreign country
and traduces that community’s values and its very identity, an effective remedy
would restrain use of that specific knowledge, as a readily misappropriated aspect
of the indigenous knowledge system, but need not require the community to
educate a foreign court on its full cosmology. Rarely is a traditional knowledge
system appropriated in all its holistic breadth, or an entire cosmology pirated.
Suitably tailored IP measures are not a commodification of TK, but rather serve
as a remedy to the commercial misappropriation of TK, a defence against
commodification. The overarching policy and legal challenge is to clarify and
enforce third parties’ legal liabilities towards the cultural, intellectual and legal
community systems that sustain TK. An ‘IP approach’ cannot meet all challenges
of maintaining communities’ knowledge systems, cultural heritage, and the
integrity of their collective identities. ‘IP protection’ in its essential form is no
stand-alone solution. But, however it is constructed and developed, any global,
holistic, effective approach to protecting TK must include somehow this kind of
legal mechanism unless all TK is to be assumed to rest wholly in the public
domain.
Accordingly, if there is to be a distinct form of IP protection for TK as such,
protection should focus on those aspects which are particularly susceptible to
misappropriation or misuse. Rather than characterize the knowledge further in an
objective and isolated manner, the need is to define more clearly the relationship
of the knowledge with a community. In other words, the knowledge to be
protected is not considered a disembodied tradable nugget of practical informa-
tion, but can be defined according to its link with the source community. One
working definition therefore defines protectable TK as being:
(i) generated, preserved and transmitted in a traditional and intergenera-

tional context;
(ii) distinctively associated with a traditional or indigenous community or
people which preserves and transmits it between generations; and
(iii) integral to the cultural identity of an indigenous or traditional commu-
nity or people which is recognized as holding the knowledge through a
form of custodianship, guardianship, collective ownership or cultural
responsibility. This relationship may be expressed formally or infor-
mally by customary or traditional practices, protocols or laws.71
These elements of a definition of protectable TK are based on the experience of

existing national sui generis TK laws, consultations with community representa-
tives, and the extensive IGC debate. Amidst the immense diversity in TK systems,
three common elements emerged: (i) a traditional, intergenerational character, (ii)
a distinctive association with its traditional holders, and (iii) a sense of linkage
with the identity of the TK holding community, or a community’s own
self-identification by and through the knowledge (a broader concept than
conventionally recognized forms of ‘ownership’, extending to traditional custo-
dianship). As the commentary to this provision points out:
TK might be integral to the identity of an indigenous or traditional

community if there is a sense of obligation to preserve, use and transmit
the knowledge appropriately among the members of the community or
people, or a sense that to allow misappropriation or offensive uses of the
TK would be harmful.72
Of course to build a definition of protectable TK upon its link with the community
simply begs the question of how to tell whether a community should be eligible.
This can be a sensitive legal, cultural and political question, reaching to the core
of questions of collective identity. Arguably such issues never can or should be
resolved in the context of general rules for the protection of TK, whether through
existing, adapted or new IP mechanisms, any more than existing international IP
treaties deal with questions of nationality and the legal personality of unincorpo-
rated associations.73 It is unlikely that the question of defining a community as a
legal entity can ever be fully resolved on the international plane. The nature, scope
and membership of communities are likely to legally defined by the customary
laws, protocols, practices and way of life of the communities themselves, possibly
with a more formal expression through municipal law. As a rough analogy, the
boundaries of a region recognized in a geographical indication have never been
drawn up directly through international negotiation, but rather are developed
71 Draft WIPO TK provisions, fn. 2 supra, p. 22.

72 Draft WIPO TK provisions, fn. 2 supra, p. 23.
73 But see Paris Convention, Art. 7bis, discussed below in Sec. III.1.II.1.(a)(bb).
under national laws through consultations with the communities concerned.74 One
practical response has been to incorporate an association or other legal vehicle as
a means of practically identifying a legal owner or custodian to serve the broader
community. In other cases, the State itself has asserted ownership or custodian-
ship, potentially in a trustee role, of TK, particularly when the knowledge is
deeply infused within society at large, and has been widely disseminated and
documented as a codified body of knowledge.75
4. TK and IP Protection in an Holistic Context
Clarifying ideas of ownership and custodianship – first conceptually, then legally

– is integral to any progress towards systematic protection of TK. The denial of
individual ‘ownership’ of property in communally-held TK has actually united
some critics and proponents of sui generis protection: sceptics of protection of TK
point to its diffuse unbounded character, in contrast to well-defined IP rights;
proponents of TK protection point to the collective, cumulative character of forms
of custodianship of TK which appears to be at odds with the individualistic,
commercially-oriented ownership paradigms seemingly embedded within the IP
system. And indeed where clearly defined or documented ownership of distinct,
bounded property rights are lacking, this uncertainty has encouraged an assump-
tion that TK remains in the public domain – a public domain that is in turn defined
and maintained in contradistinction to IP laws that are founded on specific
conceptions of knowledge, reputation and expressions that merit specific protec-
tion. But, again, this distinction highlights the need to distinguish between (i)
forms of protection that target the undesirable or illegitimate forms of external use
of readily appropriable aspects of TK, and (ii) holistic forms of preservation and
protection that are embedded within the traditional life and worldview of the
original community. Rejecting individualist assumptions embedded within current
constructs of the IP system should not lead to an implicit acceptance of public
domain status of TK; the notion of IP protection need not be confined just to those
legal modes that identify individual owners and are exercised in the commercial
mainstream.
Customary law systems, as outlined above, provide a clear example of a third
path between these two extreme positions – ownership or custodial responsibili-
ties over TK may be vested in an indigenous or local communities, with particular
individuals in those communities responsible for certain custodial responsibilities.
It does not require an ‘emic’ perspective, but just an objective view of customary
law responsibilities to see how this state of affairs refutes assumptions that TK
74 See for example, Coonawarra Penola Wine Industry Association Inc & Others and
Geographical Indications Committee [2001] AATA 844 (5 October 2001); See also Geo-
graphical Indications Committee v. The Honourable Justice O’Connor [2000] FCA 1877 (20
December 2000).
75 See the distinctions between forms of holding TK that are made in WIPO/GRTKF/IC/10/7,
intervention of the Delegation of india (fn. 41, supra).
should have public domain status;76 and there is sufficient case law in conven-
tional IP law to see how this works in practice.77
Yet even taking this broader view of the role of IP systems – not
commodification, but defence against illegitimate commodification – IP could
never serve the full range of needs for protection and preservation of TK systems
nor provide forms of governance and innovation that take full account of claims
for access and custodianship of ancestral lands and recognition of the collective
cultural and even legal identity of communities: The TK issue, is situated at the
crossroads of intellectual property, cultural heritage, land rights and biodiversity
protection. Solutions, too, should ideally be ‘embedded in much broader-based
negotiations . . . in which the most fundamental concerns of these peoples and
communities, such as self-determination (for indigenous peoples), territorial
rights, and human rights, are openly and comprehensively addressed’.78 Yet such
an approach need not be prejudiced by specific international processes that focus
on one or the other aspect of an holistic, coordinated approach to this cluster of
issues. To the contrary, with appropriate coordination, this focused approach may
yield more powerful, deeply rooted outcomes than confining the full range of
issues to one forum or one process. Thus the current working draft of the
International Regime on Access and Benefit-sharing under negotiation within the
CBD COP includes a proposal that the regime ‘will take into account the work of
the WIPO/IGC on the intellectual property aspects of sui generis systems for the
protection of traditional knowledge and folklore against misappropriation and
misuse’.79 In turn, a linkage between such protection and the broader survival of
indigenous peoples as distinct peoples has been strongly argued, in view of the
dynamic linkage between protection of TK against third party activities and the
conservation of cultural, epistemological and jurisprudential diversity.80
5. Needs and Expectations for the Protection of Traditional

Knowledge
The concerns, needs and expectations of TK holders are naturally diverse and are
nuanced by social, cultural, historical and environmental context; a single
characterization is not attempted here as it would be impertinent and inaccurate.
Nonetheless, to distil a subtle and diverse discourse, TK holders have expressed
their concerns on the relationship between IP and TK at two general levels. First,
at a broad holistic level, TK should be viewed as integral to the community’s
conception of itself and therefore its survival as a community, including
continuing traditional ways of life and maintaining customary usages of land and
genetic resources, Legally, it falls within the full context of the law of human
76 Dutfield (fn. 58), p. 62.

77 e.g.
78 Dutfield (fn. 3), p. 239, 265.
79 CBD COP decision VIII/4, document UNEP/CBD/COP/8/31.
80 Representative of Tulalip Tribes, fn. 24 supra.
rights, environmental protection, cultural diversity and other key aspects of public
law; any IP system – new, adapted or conventional – should respect this context
and not undermine it, for instance through perverse acts of misappropriation.
Second, inasmuch as TK holders regard IP matters as being of concern or priority
to them, two general forms of protection of TK against such misappropriation and
misuse are typically identified:
– positive protection, or the creation or recognition of positive rights over

how TK, or protected aspects of it, are to be used, if at all, by others; and
– defensive protection, or the steps taken to ensure that third parties do not
obtain IP rights over TK subject matter, or that once obtained such rights
are revoked or rendered unenforceable.
A typical – but by no means universal – experience is for TK holders first to call

for action on defensive protection, as a response to concerns that their TK, and
derivatives or applications of it, are being appropriated by others through the IP
system. Then as the limitations of defensive protection become apparent – for
instance, the realization that many defensive protection strategies entail squarely
placing TK in the public domain, and otherwise do not translate into specific
benefits (economic or otherwise) for TK holders, including even possible loss of
simple attribution – interest turns to a combined approach, with a suitable mix of
defensive measures and positive recognition and assertion of rights over the TK
as such. Positive protection should not be conflated with commercialization or
trivialization: rather, as for any form of IP, it concerns the positive entitlement to
object to third parties undertaking such actions; such protection may, of course,
form the foundation of appropriate engagement with commercial partners when
TK holders choose this pathway, but does not necessitate it in principle.81
(a) Positive Protection
Positive protection may entail the use of:
– IP rights (whether rights recognized under the conventional IP system or

sui generis rights specifically created to protect TK) to prevent unautho-
rized use, and to seek remedies when unauthorized use has occurred
(especially commercial use, or offensive and abusive use);
– the same conventional or sui generis IP rights as the basis for commercial,
research and cultural partnerships with third parties, including for defining
and sharing benefits from use of TK/TCEs beyond the traditional environ-
ment;
81 This is a generalization. Some forms of IP protection – while at core, still concerning the right
to restrain acts of appropriation and use by third parties – do of course require some form of
commercial use to remain immune from challenge, such as trademark use requirements (see
for example TRIPS Art. 19).
– other non IP legal tools to protect TK (as well as related genetic resources),
such as contracts and legislation for the protection of the environment and
the interests of indigenous communities; and
– technical tools, such as databases with security systems, to prevent third
parties from gaining unauthorized access to TK/TCEs.
WIPO surveys of existing forms of IP protection for TK illustrated a wide

divergence of approaches in current practice, ranging across the full spectrum of
conventional IP systems (such as the use of patents to protect legitimate
innovations within traditional knowledge systems) and sui generis approaches.82
Thus a comprehensive response to the calls for more effective and equitable
protection of TK for the benefit of its custodians entails reviewing all aspects of
protection, essentially:
– more effective, equitable and culturally appropriate access to existing

forms of IP law;
– adaptations and extensions of conventional IP law to address, for instance,
the collectively held character of much TK, and the non-commercial
character of much of the harm that infringement can cause;
– new, distinct sui generis systems with varying degrees of congruence with
the underlying principles of conventional IP law, with variations in terms
of the proprietary nature of protection and the degree of focus on
illegitimate acts by third parties as against defining the use rights of and
within the source community.
The underlying interests of the TK holders clearly go well beyond the commercial
exploitation of knowledge that is the general – but not exclusive – focus of
practice of conventional IP rights. Rather than limiting remedies or entitlements
of TK holders simply to an equitable share from commercialization – an inevitable
constraint of compensatory liability schemes, for instance – the claim may be
simply to allow the TK to be maintained and to develop undisturbed within its
traditional context: even a TK protection scheme that generously allocates an
equitable share of commercial profits from external use of TK is still a form of
commodification, which may be at odds with a community’s collective interests,
values and customary law and practices.
For these reasons, the notion has developed – challenging, perhaps, to
mainstream IP law and policy but nonetheless fully consonant with the ‘emic’
perspective – of a form of ‘moral rights’ over TK. For instance, this idea is
82 See inter alia Comparative Summary of Existing National Sui Generis Measures and Laws for
the Protection of Traditional Knowledge (WIPO/GRTKF/IC/5/INF/4), Consolidated Survey of
Intellectual Property Protection of Traditional Knowledge (WIPO/GRTKF/IC/5/7), Composite
Study on the Protection of Traditional Knowledge (WIPO/GRTKF/IC/5/8), and The Protec-
tion of Traditional Knowledge: Revised Outline of Policy Options and Legal Mechanisms
(WIPO/GRTKF/IC/9/INF/5).
captured within the draft WIPO objectives and principles which suggests as one
aspect of misappropriation –
willful offensive use of traditional knowledge of particular moral or

spiritual value to its holders by third parties outside the customary
context, when such use clearly constitutes a mutilation, distortion or
derogatory modification of that knowledge and is contrary to ordre
public or morality.83
Given that TK is typically defined in terms of its connection with the collective
identity of a community, this broader perspective suggests that the underlying
need is to consider TK protection in terms of defending the integrity of a
collective identity, the very personality – legal and cultural – of the community
that maintains and identifies with the TK system of which appropriable elements
of TK form part.84
The spiritual and cultural perspective can therefore militate against any form
of commercial exploitation, just as the right of personality under common law
can embrace the right to be let alone. In a parallel case concerning TCEs,
Fikentscher85 describes the snake dance of the Hopi Indians of New Mexico. Only
initiated members of the Hopi tribe are admitted to the dance; non-initiated Hopi
and strangers are not permitted to participate. Other groups filmed the ceremony
by helicopter, recalling the classic confidentiality cases concerning photographic
intrusion86 and breach of customary law constraints on the dissemination of sacred
knowledge.87 This helps clarify the linkage between IP protection – the right to
object when another party breaches confidentiality or undertakes fixation of
performances – and the defence of a collective right, rooted in customary law, to
be left alone.
(b) Defensive Protection
The interest ‘to be left alone’ also finds an impression in initiatives for defensive
protection, or the endeavour to forestall or revoke third parties’ IP rights when
these are seen as misappropriating the knowledge of TK holders. Thus the WIPO
draft objectives and principles identify as one form of misappropriation ‘false
claims or assertions of ownership or control over traditional knowledge, including
acquiring, claiming or asserting intellectual property rights over traditional
knowledge related subject matter when those intellectual property rights are not
83 WIPO/GRTKF/IC/9/5 (9 January 2006), annex, p. 12.

84 Discussed more fully in Taubman, ‘Is there a right of collective personality?’, European
Intellectual Property Review, (2006) vol. 28, no 9, 485–492.
85 Fikentscher/Ramsauer (fn. 4), p. 34.
86 E.I. duPont deNemours & Company, Inc. v. Rolfe Christopher et al., (1970)431 F.2d 1012
87 Foster v. Mountford and Rigby (1976) 29 FLR 233
validly held in the light of that traditional knowledge and any conditions relating
to its access’.88
While it seems almost tautological to define illegitimate patenting as a form
of misappropriation, the normative basis of the demand for strong defensive
protection requires careful consideration. Defensive protection through pre-
empting or voiding illegitimate or inappropriate patenting is not, in any event, a
self-sufficient form of protection, unless TK holders wish their knowledge
definitively to enter the public domain. Defensive protection of TK may entail
publication or further dissemination of TK to the detriment of TK holders,
potentially in violation of prior informed consent or customary law constraints. In
particular, there are fundamental concerns that holders of TK should not disclose
their TK to third parties or to undertake or consent to its documentation or
publication without fully considering the implications and possible damage to
their interests, particularly in the absence of clear legal measures to prevent or to
remedy other acts of misappropriation of disclosed TK. In short, defensive
protection should not function as a de facto waiver of positive protection rights,
and practical initiatives may need to be conducted with a clear focus on the
framework of positive rights.
Initiatives to prevent granting of patents, often in foreign jurisdictions, over
TK directly or over inventions derived from TK may lack clear commercial
logic – especially if a community is opposed to the commercialization of
particular elements of their knowledge, little may be gained from invalidating or
precluding an exclusive commercial right on the part of other parties in a foreign
country since the TK would then be free for all to commercialize. And few patents
are granted on TK in such a way that the claims directly conflict with pre-existing
commercialized forms of TK to the point of interfering with legitimate trading
activities derived from the source community. Yet such an analysis overlooks the
cultural aspect – the sense that a patent on TK, even in a remote foreign country,
may yet be sensed as a form of intrusion on the community, and a partial
appropriation of a collective identity. Bridging these radically different under-
standings of the nature of the patenting process is perhaps at the heart of a
systemic reconciliation of classical IP policy perspectives and the outlook of many
TK holders.
In some scenarios, defensive protection may actually undermine the interests
of TK holders, particularly when this involves giving the public access to TK
which is otherwise undisclosed, secret or inaccessible. In the absence of positive
rights, public disclosure of TK may actually facilitate the unauthorized use of TK
which the community wishes to protect. Defensive protection strategies that make
use of the patent system have two aspects, described as follows:
a legal aspect, ensuring that information is published or documented in

such a way as to meet the legal criteria to be counted as prior art in the
jurisdiction concerned (this may include, for instance, ensuring that there
88 Draft WIPO TK provisions, (fn. 2) supra, p. 12.

is a clear date of publication, and that the disclosure enables the reader
to put the technology into effect); and a practical aspect, ensuring that in
fact the information is available to search authorities and patent
examiners, and is readily accessible (such as through being indexed
or classified), so that it is likely to be found in a search for relevant
prior art.89
6. The Focus on the Point of Access
(a) General
For practical capacity building and when clarifying the legal character of TK, the
focus must be the point of actual access to TK by those who are beyond the
original community or the traditional context. The call for additional protection is
often triggered when someone – the academic researcher, the bio-prospector, the
documentary filmmaker, the emigrating community member, the commercial
partner, or the simple observer – in some way alienates TK from the original
community circle, such as through publishing a journal article, adding an entry to
a database, or recording a traditional narrative which is used to convey the TK
within the community. Crucial questions can be determined at the time of access,
and the terms, implicit or explicit, and legal circumstances under which access to
and transfer of the TK from the source community takes place. It is at this point,
for instance, that the customary law and practices of the source community begin
to interface with or conflict with the laws and practices of the external actors.
Uncertainty about legal status, or the failure to take such essential steps as
defining the terms of a confidentiality agreement, can lead to the unwitting and
undesired transfer by the TK holders of knowledge into what is considered by
external parties as being the unencumbered public domain. Thus the need for legal
clarity and practical capacity building converge on this critical point – the point
of access. Communities need to have the capacity to identify and promote their
interests exactly at that point, before they grant actual access to TK. It can
subsequently be extremely difficult retrospectively to rectify problems that arise
from inappropriate access. Pre-empting such problems requires an integrated
approach to strengthening capacity to use existing rights and defensive options
and to enhancing the practical availability of legal avenues for protection, together
with practical support for documentation.
(b) Initiatives for Documentation Measures – Advantages

and Disadvantages
A growing number of initiatives seek to use databases, registries and other

documentation measures to conserve and protect TK and genetic resources. These
89 Defensive Protection Measures Relating to Intellectual Property, Genetic Resources and Tradi-
tional Knowledge: An Update, WIPO/GRTKF/IC/6/8 (15 December 2003), p. 2.
initiatives vary greatly in what they seek to protect, and how they operate. Some
seek to conserve and disseminate such material for wider public access. Others
seek to protect and restrict access to it, and to reserve it strictly for the community
itself. Still others take a combined approach, reserving some knowledge for
restricted access to those community members entitled under customary law, other
knowledge to be protected as having potential commercial value and other
knowledge as being consensually committed to the public domain. Naturally, such
initiatives provoke concern about the IP implications of distinct choices, and the
legal and practical needs of the TK holders when such initiatives unfold.
These initiatives generally aim at promoting the interests of TK holders and
local and indigenous communities. But in some cases, there is apprehension that
recording TK will actually undercut the IP rights of TK holders, or override
customary law restrictions associated with the knowledge. These concerns raise
questions of how to clarify and give practical effect to the policy objectives of
such initiatives; how to ensure that TK is collected, represented and accessed
consistent with cultural and customary law norms; how to ensure full community
participation and prior informed consent of TK holders; how databases can govern
access to TK according to the wishes of TK holders, including confidentiality
requirements; how databases can work effectively to promote IP interests of TK
holders; and how to avoid problems about the legal status of information stored
in the registry or database. In order to resolve these questions, a better
understanding of the needs, objectives and priorities of the different stakeholders
is essential.
The first global, systematic study of stakeholder needs and objectives in
databases and registries was initiated through the WIPO IGC. A survey90
identified a range of IP objectives for TK databases, including defensive
protection (such as preventing the grant of patents on disclosed TK); public notice
of positive rights over TK under conventional IP systems (such as patents on
traditional medicine); registries used in sui generis protection of TK; participation
in IP information networks; and management of IPRs relating to documented TK
and genetic resources. Non-IP objectives for databases identified in the same
survey included preserving TK, promoting recognition and awareness of the value
of TK ; forging links between mainstream science with TK systems; the use of TK
for natural resource conservation and management; information exchange be-
tween indigenous peoples and local communities; sustainable development; and
dissemination of TK to the general public, for non-commercial use only or in
confidence to commercial partners, only to custodians of TK and genetic
resources, or subject to other dissemination restrictions.
While responses to this specific survey of TK holders have not yet been
published, the terms of the survey help illustrate the multiple purposes and
functions of TK documentation initiatives. Databases, for instance, may conserve
90 Intergovernmental Committee On Intellectual Property And Genetic Resources, Traditional

Knowledge And Folklore, Questionnaire on Databases and Registries Related to Traditional
Knowledge and Genetic Resources, February 2003, WIPO/GRTKF/IC/Q.4.
TK for future generations within a community, or may even serve to restore
alienated TK to the community again, while at the same time protecting sensitive
elements against further appropriation or dissemination in violation of customary
law, keeping in confidence commercially valuable but otherwise not sensitive
information, and making general information about TK available to the public
when the community chooses to do so. The data structures and access controls of
TK databases may actually mirror and thus give practical effect to customary law
constraints on access to and dissemination and use of TK.91
7. The Role of Customary Law
During the debate over appropriate forms of protection of TK, a consistent call of
indigenous and local communities has been for customary law to be used as the
lynchpin of protection, in particular through the recognition of customary law
beyond the original community. Relatively little attention has been given to the
question of what legal mechanisms would be used to recognize and apply
customary law.92 Understanding both the characteristics of customary law,
practice and protocols, and the means of recognizing them in a systematic way
beyond the original community, are integral to appropriate TK protection. The
options generally range across recognizing customary law, practice and protocols
as:93
– the fundamental legal basis or source of law for communities’ legal rights
over TK;
– a factual element in establishing communities’ collective rights over TK;
– an element of the definition of TK, or can otherwise establishing the
relationship to community that is central to the concept of TK;
– determining or guiding the procedures to be followed in securing a
community’s free prior informed consent for access to or certain usage of
TK;
91 See for example, the customary law element of the ‘digital repatriation’ movement described
in Ancient Traditions Preserved, AUSTRALIAN IT, 10 June 2003, available at <www.
news.com.au>: ‘the entire intellectual system of Elcho Island’s various clans is being
reconceived in digital form, and shaped into an elaborate, multi-level database’, with discrete
levels for public, private and secret knowledge; see also the Tulalip Tribes Cultural Stories
project, and the Indigenous Collections Management Project (Jane Hunter et al., Software
Tools for Indigenous Knowledge Management (Sept. 2002) and Kathryn Wells, A Model and
Pilot Options for Digital Image and Text Archive of Indigenous Arts and Knowledge: A
Progress Report (1997)).
92 See for example, Cooter/Fikentscher, ‘Indian Common Law: The Role of Custom in American
Indian Tribal Courts’, [1998] American Journal of Comparative Law 46, 314.
93 Following a taxonomy developed for the WIPO Issues paper, entitled Customary Law & the
Intellectual Property System in the Protection of Traditional Cultural Expressions and
Traditional Knowledge: Issues Paper – version 3.0 (December 2006) <www.wipo.int/tk/
resources>.
– defining specific user rights or exceptions, exempting the continuing
customary uses and practices from other legal restrictions on the use of TK;
– guiding the assessment of cultural or spiritual offence or damage caused by
inappropriate forms of use of TK;
– determining or guiding how benefits from the use of TK should be shared
equitably within a community;
– determining appropriate forms of remedies, sanctions or restitution follow-
ing the breach of rights over TK;
– serving as an avenue for resolving disputes over ownership or other forms
of custodianship over TK; or
– determining the transmission of rights over TK from one generation to a
following generation, or from one custodian to a succeeding custodian.
Non-legal measures may also promote understanding of and respect for customary
law and practices by third parties, beyond the community itself. For instance,
research guidelines or academic protocols may include information on customary
law and practices, and may encourage researchers to seek guidance from
communities on their customary law and practices, and to comply with such law
and practices as far as possible in their work.
8. Use of Certification and Collective Marks and

Geographical Indications
Consultations with TK holders have frequently touched on the possibility of using

collective and certification marks, and geographical indications (GIs), to protect
not TK as such but traditional products that make use of TK. One frequently cited
example is the indigenous label of authenticity, developed by the National
Indigenous Arts Advocacy Association (NIAAA) with the backing of the
Aboriginal and Torres Strait Islander Commission (ATSIC) and the Australian
Council for the Arts and launched in 1999.94 Ironically, given the attention paid
to it as a model, this initiative has since faltered, but more focused initiatives
closer to the community level have been under development in Australia and
elsewhere to promote consumer recognition of authentic aboriginal art and other
articles. In New Zealand the Maori Made Mark (Toi Iho) was launched recently
in order to provide a means for limited protection of Maori cultural expressions,
by decreasing the market for copycat works made by non-Maori.95
The FFM report concerning Eastern and Southern Africa addressed the
possibility of GIs as means of protecting TK, but noted the need for a regional
agreement or understanding without which ‘geographical indications would not
be a workable tool . . . within more than one country’.96 The report on West Africa
also mentions the possibility of protecting ‘bogolan’ or mud cloth by means
94 See the case study in Terri Janke, Minding Culture, Geneva, 2004.
95 Reported in WIPO/GRTKF/IC/4/INF/2, 25 November 2002, no. 79 et seq.
96 WIPO Fact-Finding Report, fn. 7 supra.
of GIs or appellations of origin in particular, and the possibility is covered in
general terms concerning the Caribbean97 and Central American98 regions.
From a policy point of view, the law and policy of GIs and collective/
certification trademarks recalls that the IP system in general is not only concerned
about innovation – but about distinctive reputation, often, a reputation linked with
local traditions. Numerous GIs and trademarks (TMs) protect the reputation and
distinctiveness of products that embody forms of TK, and indeed the rules and
regulations governing use of GIs, certification TMs, often codify and define
traditional production methods. For example, the application for protection of
Roquefort as a GI in Europe specified that
[i]n the manufacture of Roquefort unchanging methods are respected.

The Penicillium roqueforti is introduced either in liquid form when the
rennet is added or by sprinkling the curds when they are put into
the moulds. After draining and salting, the cheeses are transported to the
caves of Roquefort sur Soulzon, in fallen rock from the Combalou
mountain, where it is specified that the ripening process must take
place . . . The special quality of Roquefort is a product of intimate
collaboration between man and nature. It derives on the one hand from
the characteristics of the traditional breeds of ewe that are fed in
accordance with local custom and on the other hand from the unique
atmosphere of the natural cellars in caves entirely hewn out of the rocks
at the foot of the limestone cliffs of the Combalou, where a miracle of
nature takes place to give Roquefort its incomparable flavour.99
Unsurprisingly, then, there is a high degree of commonality in the conceptual

themes addressed by concurrent debates on the protection of GIs and on the
protection of TK:100
– the appropriate form of protection – what is its proper scope;

– the linkage between jurisdictions, the implications and expectations of
protection abroad based on protection in source country, and the juridical
basis or independence of protection in one country vis-à-vis protection at
source;
97 Ibid.
98 Ibid.
99 Granted to the Confédération Générale des Producteurs de Lait de Brebis et des Industriels
de Roquefort under European Commission Regulation (EC) No. 2081/92; see also at the
national level, Ministère de l’agriculture et de la pêche, Décret du 22 janvier 2001 relatif à
l’appellation d’origine contrôlée (Roquefort) NOR: AGRP0001838D, J.O n° 21 du 25 janvier
2001, p. 1283 and Reglement d’application du decret relatif a l’appellation d’origine
controlee ‘Roquefort’, available at <www.roquefort.fr>, codifying production methods in
considerable detail.
100 See Antony Taubman, Geographical indications and the protection of traditional knowledge,
International Symposium on Geographical Indications, (Beijing, June 2007).
– the challenge of recognizing intrinsically local characteristics abroad, in a
distinct legal and cultural environment; and
– the uncertainty of the due legal character of protection: should it be a
distinct property right, or a bare cause of action for an aggrieved party, akin
to a cause for unfair competition? Is it protected as collective or even State
property, as a private right, or simply through ‘legal means to prevent’
certain uses?
– How should continuity of protection be squared with claims for a healthy
public domain? When is the defining link with the origin lost, and can it
ever be reinstated, in effect reversing public domain status?
Both debates revolve around deep questions of legal recognition of collective

identity in a global environment, and resolving competing claims to recognition
of tradition, distinctiveness and identity, on the one hand, and a healthy public
domain on the other.
II. EXISTING LEGAL PROVISIONS REGARDING THE PROTECTION

OF TRADITIONAL KNOWLEDGE
1. TK as Subject Matter for Intellectual Property Rights
During a wide-ranging debate, virtually all branches of IP law have been

considered, both as models and as direct mechanisms, for protection of aspects of
TK. Here, it is crucial to emphasize the distinction between protection of TK as
such and the protection of those specific aspects, faces, elements or derivatives of
TK that are most readily appropriated and commercially exploited by third parties
beyond the traditional community. In principle, TK and aspects of TK (such as
traditional handicrafts embodying TK) can be protected through conventional IP
law just as any other form of knowledge and concrete expressions of knowledge
may be protected: knowledge does not lose its IP significance simply because it
can also be characterized as traditional. In some cases, a distinct reference is made
to TK as being unpatentable, essentially defining TK as being inherently
unpatentable prior art,101 rather than denying patents to legitimate innovations
within traditional settings.
(a) International Level
Multilateral IP Conventions
The following section outlines elements and standards of the core international IP
treaties that deal with forms of protection that may be relevant to the protection
101 India, Patents Amendment Act, 2002, s. 3(p) excluding from patentable subject matter ‘an
invention which, in effect, is traditional knowledge or which is an aggregation or duplication
of known properties of traditionally known component or components’.
of diverse aspects of TK. The following are the central elements that have been
most widely explored in this context:
– The Paris Convention – protection of collective and certification marks,
protection of armorial bearings, flags, other State emblems, official signs
and hallmarks (Article 6ter), the protection of industrial designs, the
protection of patents on innovation in a traditional context, and the
suppression of unfair competition under Article 10 bis, including false
indications that products are traditional or associated with an indigenous or
local community as well as a broader doctrine of unfair competition that
may provide juridical roots for a conception of misappropriation of TK;
– The WIPO Performances and Phonograms Treaty (WPPT) – the protection
of performances of expressions of folklore as a means of safeguarding the
transmission of TK through traditional cultural expressions;
– The Lisbon Agreement – the protection of appellations of origin related to
products that embody TK or are associated with traditional cultures;
– The Madrid Agreement Concerning the International Registration of
Marks (and the Madrid Protocol) – the protection of certification marks
relating to products of traditional origin or embodying TK;
– The Patent Cooperation Treaty (PCT) – the PCT system is used to facilitate
protection for legitimate innovations within a traditional context; it has
also been reformed to enhance recognition of TK, such as when the
minimum documentation specified under the PCT has been expanded to
give more explicit recognition of TK as prior art;
– The Strasbourg Convention on the International Patent Classification
(IPC): the IPC was revised to take better account of TK subject matter, and
further proposals are under development; and
– The WTO Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) covers a range of IP rights that are applicable to TK-related
subject matter; apart from each of those categories noted above (including
Paris which TRIPS directly incorporates by reference), TRIPS creates fully
multilateral obligations for two specific categories of protection that have
been used for the protection of TK-related subject matter: geographical
indications (a category broader in scope than appellations of origin) and
undisclosed information (confidential information or trade secrets), again
linking both forms of protection to the suppression of unfair competition
under Article 10bis of the Paris Convention.
PCT discussion
(aa) Patents
TRIPS establishes substantive standards for the patent system in WTO Members,
especially concerning patentable subject matter, patentability criteria, exceptions
and limitations, use by third parties not authorized by the patentee, and
enforcement. TRIPS also incorporates the earlier standards established by the
Paris Convention, for instance the entitlement of the inventor to be identified as
such in a patent – a standard of direct relevance in the debate over patents that are
alleged to appropriate others’ TK (see the discussions above on inventorship). Yet
there is no accepted international standard defining such core issues at the heart
of the TK debate as (i) definition of invention; (ii) criteria for determining novelty,
inventive step and utility; and (iii) inventorship and entitlement to apply or to hold
a patent. In addition, there is considerable foment on the question of creating
enhanced patent disclosure obligations specifically applying to genetic resources
and TK, including a formal proposal to amend the TRIPS Agreement.102
For international patent applications, the Patent Cooperation Treaty (PCT)
establishes standards for international patent search and examination, including
non-binding standards on novelty and inventive step. The PCT system can be
useful for the practical recognition of TK as prior art at an early stage in the
processing of a typical patent application.
The debate over TK and the patent system has generally focused on defensive
protection rather than the positive protection of TK-based innovation as legitimate
inventions within the patent system. However, in some fields of TK, this pattern
is shifting as several developing countries make increasing use of their heritage of
TK as the basis for research and development, and the recognition of genuine
indigenous innovation. This trend may be seen through one simple example, the
comparative geographical distribution of PCT filings relating to the use of neem
firstly since its operational establishment in 1978, and secondly since 2001. The
proportion of indigenous innovation since 2001 has risen sharply, the most recent
statistics suggesting a trend of over 50 per cent indigenous innovation using this
key resource and the rich heritage of associated TK.
Figure Neem-related filings in the international patent system since 1978 (source:
PatentScope)
102 Doha Work Programme – The Outstanding Implementation Issue on the Relationship Between
the TRIPS Agreement and the Convention on Biological Diversity (Communication from
Brazil, China, Colombia, Cuba, India, Pakistan, Peru, Thailand and Tanzania), WT/GC/W/
564/Rev. 2, TN/C/W/41/Rev. 2, IP/C/W/474 (5 July 2006).
Figure Neem-related filings in the international patent system since 2001 (source:
PatentScope)
(1) Positive Protection of TK Innovations through the Patent

System
The key issues for consideration concerning positive protection of TK include:
(i) TK as inherent subject matter for patent protection;

(ii) Cultural and legal constraints on use of patent system by TK holders;
(iii) Inventorship in a traditional context; and
(iv) Application of patentability standards such as novelty, inventive step and
adequacy of disclosure in the context of traditional knowledge systems.
(i) TK as Inherent Subject Matter for Patent Protection

Under TRIPS, ‘patents shall be available for any inventions, whether products or
processes, in all fields of technology, provided that they are new, involve an
inventive step and are capable of industrial application’, and patents must be
‘available and patent rights enjoyable without discrimination as to the place of
invention, the field of technology and whether products are imported or locally
produced’.103 One of the first fundamental lessons learned in the process of
bridging between the distinct ‘emic’ perspectives of TK holding communities and
conventional IP policymakers and practitioners was the simple fact that TK can
indeed be novel, inventive and useful:
the skills, knowledge and institutions evolved by people on the margins,

who have already been coping with [environmental] stresses for the last
several millennia, will become a major source of survival. Is this the
103 TRIPS, Art. 27.1.

reason why global institutions are suddenly finding so much merit in
local knowledge?104
Indeed, the controversy over misappropriation of TK reveals the striking fact that
the trend towards appropriation of TK and the fruits of TK systems within
mainstream commerce, industry and technology is a backhanded form of
acknowledgement and validation of the scientific and technological value of TK
and the systems that sustain it and make it intelligible and useful. The principle of
non-discrimination in TRIPS recalls a positive obligation to set aside pre-emptive
assumptions about the lack of innovation within indigenous and local communi-
ties. Accordingly, TK from within a particular knowledge system must not be
considered in principle any less patentable when knowledge from any other
source, and the general criteria of novelty, inventive step and industrial applica-
bility should be applied. Of course, this does not positively require TK holders to
seek patent protection for their innovations, and many have actively rejected this
option for a range of diverse reasons – a possibility for any innovator.
Hence elements of TK as such should not be considered inherently unpat-
entable subject matter. Where there is specific statutory exclusion of ‘traditional
knowledge’ from patentable subject matter,105 this must presumably be construed
as referring to knowledge, such as codified knowledge systems, that is either
squarely in the public domain or is considered already an established component
of the collective heritage of a community, rather than the inventive product of an
individual TK practitioner or a small collective of TK practitioners. In other
words, again one must distinguish between the background of collectively-held
knowledge and the foreground of specific innovations or individual contributions
that are developed within a TK system as communities respond to changing
environmental and social needs.
What clearly cannot be directly protected under the conventional patent
system is the knowledge system as such. Here, once again, it is vital to reflect on
the distinction between the holistic community-based, environmentally-rooted
conception of traditional knowledge systems within a cultural and spiritual
context and those aspects of the knowledge system that are readily appropriated
and exploited by those external to the community concerned: in this case, one can
distinguish between the collectively held base of wisdom, and distinct practical
insights that may be considered distinct innovations within the traditional context.
For instance, the Pacific Regional Framework for the Protection of Traditional
Knowledge and Expressions of Culture distinguishes between traditional cultural
rights in TK or expressions of culture, and so called ‘additional rights’. Such
traditional cultural rights ‘are in addition to, and do not affect, any rights that may
subsist under any law relating to copyright, trademarks, patents, designs or other
intellectual property’.
104 Anil K. Gupta, ‘Centres on the Periphery: Coping with Climatic and Institutional Change’, 13
HONEY BEE 1 (Sept. 2002).
105 See the discussion below (Sec. III.1.II.1.(c)(aa)(3)(i)) concerning the amendment of the Indian
Patent Act to exclude certain TK-related material from patentable subject matter.
(ii) Cultural and Legal Constraints on Use of Patent System
by TK Holders
Nonetheless, the technical eligibility of tradition-based innovations for patent
protection (discussed below) does not mean that it is necessarily culturally
appropriate or even legally possible – given customary law constraints within
some communities – for individuals to make use of the patent system. As a very
rough parallel in conventional patent law, a contracted researcher, an employee or
a faculty member is not necessarily entitled to make free resort of the patent
system for their genuine inventions, because of background legal obligations and
responsibilities. Prior informed consent procedures and customary protocols may
need to be followed within the community context to determine entitlement to
exploit knowledge that is derivative from TK and is subject to customary law
constraints. Equally, drawing on the analogue of copyright law cases in which
original works making use of motifs bound by customary law constraints have
created an equitable interest on the part of the community,106 an individual
innovator working within a customary context may have a fiduciary responsibility,
expressed through customary law, to manage and defend the integrity of the
knowledge which she or he has drawn on in the innovation. This in turn may
create either an equitable or a direct ownership interest on the part of the
community that stands behind the individual innovator.
A further, more practical constraint is the relatively high cost of patent
procedures in many countries, and certainly in multiple countries. The need for
equity of access to the patent system for the benefit of legitimate innovators
working within traditional contexts is a reminder that moves towards reducing
administrative costs and practical red-tape complications within the patent system
are not regressive but may be a key component of delivering practical equity.
(iii) Inventorship in a Traditional Context

According to the Paris Convention, ‘[t]he inventor shall have the right to be
mentioned as such in the patent’,107 but no international instrument establishes
clear rules for inventorship, even though this is a crucial question for determining
the ultimate entitlement of the actual applicant to obtain a patent; even when the
inventor or joint inventor is not entitled to the patent, title to the patent must still
106 John Bulun Bulun v. R & T Textiles Pty. Ltd, [1998] AILR 39; (1998) 3 AILR 547: ‘The law
and customs of the Banalbingu people require that the use of the ritual knowledge and the
artistic work be in accordance with the requirements of law and custom, and that the author
of the artistic work do whatever is necessary to prevent any misuse. The artist is required to
act in relation to the artwork in the interests of the Ganalbingu people to preserve the integrity
of their culture, and ritual knowledge. This is not to say that the artist must act entirely in the
interests of the Ganalbingu people. The evidence shows that an artist is entitled to consider
and pursue his own interests, for example by selling the artwork, but the artist is not permitted
to shed the overriding obligation to act to preserve the integrity of the Ganalbingu culture
where action for that purpose is required. In my opinion, the nature of the relationship between
Mr Bulun Bulun and the Ganalbingu people was a fiduciary one which gives rise to fiduciary
obligations owed by Mr Bulun Bulun’ (per von Doussa J.).
107 Art. 4ter; cf PCT Art. 4(1)(v).
derive from a legitimate act of invention. Determining inventorship entails
assessing which individuals substantially contributed to the claimed invention,
and forms the basis of the legitimacy of the patent application and any patent right
granted. When a patented invention is derived from TK, and the TK holder made
an active contribution to an inventive process which was also undertaken by those
working within a conventional scientific paradigm, the question of inventorship
may be complex and entail cross-cultural judgments. The question of bridging
between distinct epistemologies was discussed by Lord Hoffman as follows:
The Amazonian Indians have known for centuries that cinchona bark can
be used to treat malarial and other fevers. They used it in the form of
powdered bark. In 1820, French scientists discovered that the active
ingredient, an alkaloid called quinine, could be extracted and used more
effectively in the form of sulphate of quinine. In 1944, the structure of
the alkaloid molecule (C20 H24 N2 O2) was discovered. This meant that
the substance could be synthesized.
Imagine a scientist telling an Amazonian Indian about the discoveries of

1820 and 1944. He says:
“We have found that the reason why the bark is good for fevers is that
it contains an alkaloid with a rather complicated chemical structure
which reacts with the red corpuscles in the bloodstream. It is called
quinine.” The Indian replies: “That is very interesting. In my tribe, we
call it the magic spirit of the bark.” Does the Indian know about quinine?
My Lords, under the description of a quality of the bark which makes it
useful for treating fevers, he obviously does. I do not think it matters that
he chooses to label it in animistic rather than chemical terms. He knows
that the bark has a quality which makes it good for fever and that is one
description of quinine.
On the other hand, in a different context, the Amazonian Indian would

not know about quinine. If shown pills of quinine sulphate, he would not
associate them with the cinchona bark. He does not know quinine under
the description of a substance in the form of pills and he certainly would
not know about the artificially synthesized alkaloid.
The quinine example shows that there are descriptions under which
something may in a relevant sense be known without anyone being
aware of its chemical composition or even that it has an identifiable
molecular structure. This proposition is unaffected by whether the
substance is natural or artificial. So far I have been considering what it
means to know about something in ordinary everyday life. Do the same
principles apply in the law of patents? Or does patent law have a
specialized epistemology of its own?108
This uncertainty arises in assessing inventorship of an invention that is at least

guided by the insight of a TK holder, even if the TK holder did not fully complete
the invention. One of the pressing conceptual demands on the patent system is to
recognize TK holders not as passive receptacles of acquired knowledge but as
active practitioners of the development and application of useful knowledge,
albeit within distinct knowledge systems other than those disciplines of science
and technology that have conventionally been validated by the patent system in
Western jurisdictions. For this reason, the term ‘indigenous science’ has been
preferred by some commentators.109
Should an invention be derived from another person’s knowledge (whether
traditional or not), so that this knowledge forms a substantive part (or all) of the
invention, and that person is not identified as an inventor, substantial legal
implications follow. That person may be entitled to a partial or full share of
ownership of the patent, or the patent may be revoked. If the knowledge had been
disclosed to the public (for instance by the TK holder) prior to the patent’s priority
date, then it could also invalidate the claimed invention owing to lack of novelty.
The obligation to disclose the inventor has immediate bearing on the debate over
misappropriation of TK, given the claim that some patented inventions may
incorporate TK without authorization or acknowledgement of its provider. Patent
law has dealt at length with cases concerning ‘inventive contribution’, which can
be highly contentious, even before considering the cross-cultural issues that arise
from the use of TK within innovation processes. These cases seek to establish
objective criteria for determining what kind of contribution to the development of
an invention amounts to substantial inventorship (including co-inventorship).
Bently and Sherman comment that under United Kingdom patent law, ‘the
generation of the idea or avenue for research, that is the formulation of the
problem to be addressed, has also been treated as inventive’, citing a case110 in
which
it was held that a person (A) was a joint inventor of a new method of
securing electric cables, where it was unlikely that the main inventor (B)
would have turned his mind to the question without having been
prompted by (A) . . . [the tribunal] was influenced by the fact that the
principal inventor, who did not work in the field, was only alerted to the
possibility of the improvement by A.111
108 Merrell Dow Pharmaceuticals Inc. v. H.N. Norton & Co. Ltd., [1996] RPC 76, at 88 (per Lord
Hoffmann).
109 See comments from Prof. Russell Barsh, fn. 7 supra, and the discussion on terminology in Sec.
III.1.I.3(a) supra.
110 Staeng’s Patent [1996] RPC 183.
111 L. Bently & B. Sherman, ‘Intellectual Property Law’, (Oxford, 2001) p. 476.
On the other hand, ‘the decision to pursue a particular goal is unlikely to be
treated as being sufficiently creative for it to be recognized as an inventive
contribution’.112
If a TK holder simply provides TK which is more in the manner of a lead or
a hint, and the TK is not part of the invention as such, then TK holders or TK
providers may not be considered a co-inventor as such – although difficult cases
arise when the contribution was indispensable to achieving the invention but was
not actually part of the invention. (This is distinct from one conception of
misappropriation in which one illegitimately acquires TK which is then used to
develop a distinct, objectively patentable invention.) Cases in which TK provides
a directly relevant lead or constitutes the first step of the inventive process are
likely to provide borderline cases which may be resolved very differently in
distinct national legal systems. And, indeed, the prospect of different determina-
tions under divergent national standards for determining inventorship is acknowl-
edged in the PCT. Rule 4.6 (c) of the Regulations under the PCT provides for the
possibility of a request filed with an international application to ‘indicate different
persons as inventors where, in this respect, the requirements of the national laws
of the designated States are not the same’.
The following practical scenario highlights the potential difficulties in
resolving overlapping claims of inventorship:
A patent application claims a combination of known traditional ingredi-

ents, with the claim that it has a surprising therapeutic effect. This surpris-
ing effect may have been disclosed by a traditional medical practitioner,
who had discovered it during the course of their own experimentation and
adaptation of traditional healing methods. In this case, the traditional
healer may be the actual inventor, and the title to apply for a patent may
need to be legally derived from that person. If the effect, claimed to be sur-
prising, apparently seems to be consistent with an established traditional
medicine system then it may be necessary to consider whether it would be
obvious to a person skilled in the art, a test which may include practitio-
ners of this form of traditional medical knowledge.113
(iv) Application of Patentability Standards in the Context

of TK Systems
As the discussion by Lord Hoffman above indicates, the application of patent-
ability standards to inventions derived from or linked to TK systems raises the
question of whether there is a distinct epistemology recognized by the patent
system, and in turn how to reconcile different epistemologies. This is not merely
a teasing theoretical question, but a direct practical problem as the trend towards
112 Ibid.
113 WIPO Secretariat, ‘Recognition of Traditional Knowledge within the Patent system’,
WIPO/GRTKF/IC/11/7(6 June 6 2007), at 18–19.
TK-based patenting activity only increases. Where an invention is purported to be
a patentable advance on background knowledge which may include TK, assessing
patentability may require a fresh look at established criteria.
Novelty: whether the invention has been disclosed in the past, and what forms
of disclosure amount to effectively providing the public with sufficient knowledge
to put the invention into practice. In this context, the distinction between past oral
and written disclosure, recognized in some jurisdictions (for example the ‘relative
novelty’ which only counts oral disclosure as prior art if it occurred in the
jurisdiction in question, while accepting as prior art written disclosure globally),
may be controversial as it is perceived as effectively discounting or discriminating
against essentially oral knowledge traditions, notwithstanding the procedural and
evidential problems attached to oral disclosure for routine patent procedure: oral
disclosure by its very nature is only likely to emerge in inter partes proceedings
as it is difficult for a patent examiner to locate relevant oral disclosure in the
course of routine search and examination (but later documentary evidence of prior
oral disclosure may be located). The trend nonetheless is towards a universal
standard of disclosure. For instance, the work on substantive harmonization of
patent law in the WIPO Standing Committee on the Law of Patents (SCP) has
produced a draft Substantive Patent Law Treaty (SPLT) which would legally
recognize as prior art any information made available to the public anywhere in
the world in any form,114 thus removing any inherent de jure bias against oral or
traditional forms of knowledge transmission.
Prior art for the purposes of the international search required under
Article. 15(2) of the PCT is defined in rule 33(1)(a) of the PCT Regulations as
consisting of:
everything which has been made available to the public anywhere in the
world by means of written disclosure (including drawings and other illus-
trations) and which is capable of being of assistance in determining that
the claimed invention is or is not new and that it does or does not involve
an inventive step [i.e., that it is or is not obvious], provided that the making
available to the public occurred prior to the international filing date.
Oral disclosure is dealt with by rule 33(1)(b), which provides:
when any written disclosure refers to an oral disclosure, use, exhibition,

or other means whereby the contents of the written disclosure were made
available to the public, and such making available to the public occurred
on a date prior to the international filing date, the international search
114 See for example, the draft text of a future Substantive Patent Law Treaty WIPO Doc. SCP/9/2,
of 3 March 2003; for the Draft Regulations and Practice Guidelines Under the Draft
Substantive Patent Law Treaty, WIPO Doc. SCP/9/3, of 3 March 2003 & SCP/9/4, of 3 March
2003. For a comparison of the prior art definition in several Member States, see WIPO Doc.
SCP/6/INF/2, of 2 November 2001.
report shall separately mention that fact and the date on which it occurred
if the making available to the public of the written disclosure occurred on
a date which is the same as, or later than, the international filing date.
Further, ‘the date on which the written disclosure was made available to the public
may have been after the filing date of the international application’.115 Hence,
there is the possibility during the international phase of earlier oral disclosures
being taken account of, provided that they are subsequently recorded in a written
disclosure. Since no binding decision is taken on patentability during the
international phase, any detailed questions of evidence and the full content of
earlier oral disclosure would need to be resolved after an application entered the
national phase. For procedural reasons, TK that is purely orally transmitted would
be difficult to identify during an international search.
Inventive step or non-obviousness: as this criterion is typically assessed with
reference to what would be obvious to the person skilled in the art, a TK-based
invention begs the question of what that person would be, for example in the case
of a medicinal product developed from a background of TK, would the notional
person skilled in the art be a practitioner of traditional medicine, a western
pharmacologist, or a hybrid of the two? Apart from the juridical question of how
this notional person is to be constructed, there is a practical challenge for patent
offices which may have a concentration of skills at one end of the continuum
between traditional medicine systems and conventional western medicine, but not
the necessary hybrid expertise.
Adequacy of disclosure: who is the notional addressee of a patent which
claims an invention derived from TK; that is to say, what standard and background
of knowledge can be assumed in the reader of a patent specification when it draws
on two distinct cultures and again two distinct epistemologies? Again, the notional
reader is typically defined to be a person skilled in the art, but which art? This
criterion raises the possibility that a patent granted on a TK-derived invention
could be argued to be invalid because, while the disclosure may be adequate and
intelligible for a western-trained technologist, it would not be sufficient for a
practitioner of the relevant TK system. TRIPS currently establishes a standard for
disclosure of an invention in conventional terms, requiring an applicant to
‘disclose the invention in a manner sufficiently clear and complete for the
invention to be carried out by a person skilled in the art’, reflecting a conventional
requirement in patent law and provides for the possibility of requiring the
applicant ‘to indicate the best mode for carrying out the invention known to the
inventor’ and ‘to provide information concerning the applicant’s corresponding
foreign applications and grants’.116
115 PCT International Search Guidelines Chapter VI, 1.2.

116 TRIPS, Art. 28.
Other disclosure requirements are present in conventional patent law,117 such
as the requirement to disclose known prior art relevant to the patentability of the
claimed invention. In some national laws, this creates, in effect, an obligation to
disclose known TK that is relevant to patentability. Accordingly, there are two
disclosure scenarios relevant to TK under current patent law principles:
– TK that is prior art, known to the applicant, which is relevant to the

assessment of whether the invention as claimed is novel and not obvious;
– TK provided by a TK holder which is directly used in developing the
invention, to the extent that the TK holder is a potential co-inventor,
entitled to be recognized as such.
Patents for inventions drawing on TK often do make at least partial mention of

relevant TK, even those patents which have been characterized as exemplifying
bio-piracy.
But, further, the general principle of disclosure under patent law has been
taken up as an opportunity to construct new forms of defensive protection against
patenting of TK seen as illegitimate. Concerns about misappropriation of TK
through the patent system have led to proposals to strengthen disclosure
requirements, and in particular to go beyond the mere disclosure of TK as such,
and the proposal to make it mandatory for countries to require disclosure also of
the source or origin of TK, evidence of prior informed consent for its use, and
arrangements for equitable benefit-sharing, in parallel with such enhanced
disclosure requirements relating to genetic resources.118
In a relatively short space of time, the grounds of the debate have shifted from
whether such additional disclosure mechanisms are consistent with TRIPS
obligations119 to the formulation of a positive proposal to revise TRIPS to make
such requirements mandatory for WTO Members.120 The EU has made a similar
proposal in the work of the WIPO IGC.121 Further, Switzerland has proposed that
the PCT be amended clearly to permit such a disclosure requirement.122
117 See the complete survey in WIPO, Technical Study on Patent Disclosure Requirements
Related to Genetic Resources and Traditional Knowledge, (2004).
118 Discussed in Taubman, ‘Genetic Resources’, in this volume (Sec. III.2.IV.1.infra).
119 A key study was Pires de Carvalho, ‘Requiring Disclosure of the Origin of Genetic Resources
and Prior Informed Consent in Patent Applications Without Infringing the TRIPS Agreement:
The Problem and The Solution’, (2000)2 Wash. UJL& Pol’y, 371. According to Pires de
Carvalho, failure to disclose could lead to the unenforceability of a patent, in line with the
equitable doctrine of ‘clean hands’.
120 See note 102 supra.
121 ‘Disclosure of Origin or Source of Genetic Resources and Associated Traditional Knowledge
in Patent Applications’ document submitted by the European Community and its Member
States, WIPO/GRTKF/IC/8/11 (17 May 2005).
122 See PCT/R/WG/4/13 and, with identical contents, PCT/R/WG/5/11 Rev; PCT/R/WG/6/11;
and PCT/R/WG/7/7. This proposal was recently transferred to the WIPO Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and
Folklore following the conclusion of the current phase of PCT reform: see document
(2) Defensive Protection in the Patent System: the PCT and IPC
(i) Recognition of TK in the Patent System

Equally, the focus has also fallen on patent offices to step up their capacity to rec-
ognize and take account of TK when undertaking patent search and examination in
technological areas. Some offices are developing distinctive expertise. For instance,
in the years up to 2002, the Chinese State Intellectual Property Office (SIPO)
reportedly received 20,864 patent applications in the field of traditional Chinese
medicine (TCM).123 A team of over 30 patent examiners who are specialists in the
field of TCM deals with this workload. In general, those countries with distinctive
backgrounds in certain fields of TK are likely to develop a stronger capacity than
others in making judgments about whether claimed inventions are truly novel or in-
ventive, having regard to the standards and conceptual framework of the TK holders
and traditional communities themselves. This experience would illustrate how the
conceptions of novelty, inventive step and person skilled in the relevant art may be
adapted and applied most appropriately to innovations based on TK. This could in
time lead to the recognition of certain regional or national patent offices in countries
which are the source of certain TK systems as having specific expertise in providing
at least an initial judgment on the validity of patent claims directed to material using
such TK systems. The need to take practical steps to improve the quality and
accurate focus of patent examination in the field of TK-related technologies
has already led to specific international initiatives, laying the groundwork for con-
crete cooperation on the recognition of TK.
(ii) International Patent Classification
The International Patent Classification (IPC) has been updated and expanded to
take better account of TK subject matter, especially medicinal products based on
plant extracts. A WIPO Task Force on Classification of Traditional Knowledge
developed a new main group for the IPC, designated A61K 36/00, with
approximately 200 subgroups, in the field of medicinal preparations containing
plants. The aim was to increase the likelihood that patent examiners will locate
already published TK that is relevant to claimed inventions in patent applications,
without adversely affecting the legal status of TK from the point of view of TK
holders.124 The new classification was incorporated into the eighth edition of the
IPC which entered into force on 1 January 2005.
(iii) Patent Cooperation Treaty
The Patent Cooperation Treaty (PCT), a WIPO-administered treaty, provides for
international cooperation in the field of patents, including an international phase
in which search and examination is undertaken. Article 15(4) of the PCT provides
that in the context of international searches ‘[t]he International Searching
WIPO/GRTKF/IC/11/10 (6 June 2007), Declaration of the Source of Genetic Resources and

Traditional Knowledge in Patent Applications: Proposals by Switzerland.
123 See WIPO/GRTKF/IC/6/8, fn. 89 supra.
124 IPC Revision Working Group, document IPC/WG/10/3 Prov.
Authority . . . shall endeavour to discover as much of the relevant prior art as its
facilities permit, and shall, in any case, consult the documentation specified in the
Regulations’. The ‘documentation specified in the Regulations’ – the ‘PCT
minimum documentation’125 – has recently been expanded so as to give explicit
recognition to a set of TK-related publications, in order to ensure that TK is
considered more systematically during international patent procedures.
(iv) WIPO Recommendations on the Recognition of TK

To supplement this international cooperation, increasing focus is being laid on the
capacity of patent offices themselves, and the need to take a more systematic and
effective approach to recognizing the full significance of TK systems in search and
examination. The WIPO IGC has accordingly formulated draft recommendations
for patent offices dealing with TK-related subject matter,126 under a general
encouragement to undertake ‘specific and systemic initiatives to ensure that
granted patents are valid in the light of TK and genetic resources, and with respect
to relevant TK systems’ and to give
appropriate priority to recognizing relevant TK and to the practical implica-

tions of such recognition in policy development, resource deployment
and strategic planning of their operations; to consider the practical implica-
tions of TK for search and examination; and [to explore] practical solutions
to enhancing the validity of patents in the light of TK and TK systems.127
Specific recommendations cover such areas as:
– training and awareness in TK and TK systems for patent examiners, ideally

delivered directly by TK holders working within a traditional context, and
including analysis of TK systems and TK relevant for patentability criteria;
– greater diversity of knowledge systems applied when assessing patent
validity, such as considering the relevance of disclosure from the point of
view of a TK holder, considering the traditional context when considering
non-obviousness (or inventive step), and taking account of TK systems and
TK practitioners in the test of the ‘person skilled in the art;’
– weighing inventorship, where possible, including the possibility that a TK
holder may be an unacknowledged inventor or that the applicant did not de-
rive the entitlement from a TK holder who was the source of the invention, or
that the applicant was otherwise not entitled to apply for a patent;
– including disclosed TK systematically in search procedures, and training
staff accordingly;
125 Rule 34.1(b)(iii) of the Regulations under the PCT.

126 See Recognition of Traditional Knowledge within the Patent System, WIPO/GRTKF/IC/11/7
(6 June 2007).
127 Ibid., annex, pp. 11–12.
– consultative and cooperative mechanisms, recognizing that awareness of
and familiarity with specific TK systems may be held mostly within those
countries where the TK system is indigenous; and
– sharing experience with specific search and examination guidelines estab-
lished relevant to TK-based inventions, and specific disclosure measures
established concerning TK-based inventions, from the point of view of
search and examination.
But the recommendations provide that patent search and examination should not
‘accelerate or facilitate the public dissemination of TK that is not disclosed with
the consent of TK holders’.128
These draft recommendations, which remain informal in nature, do provide a
measure of the practical challenge that the increasing de facto convergence
between TK systems and patenting activity poses, not merely for developing
countries but for the developed economy patent authorities. Indeed, the strong
expertise on locally-based TK systems that is held in many developing countries
– such as on Ayurvehdic medicine in India and on Traditional Chinese Medicine
in China – suggests a future pathway for cooperation in patent examination that
would see coordination of the search and examination effort – either based on an
agreed legal framework, or through ad hoc cooperation – so that those offices in
developing countries with special expertise could in effect provide South-North
development assistance on patentability of TK-based inventions. As the draft
recommendations suggest, cooperation may include:
to seek opinions, search or examination reports, or background informa-

tion concerning specific TK-related applications from those offices with
a recognized expertise in specific knowledge systems or traditions, from
offices which have established a search or examination unit concentrat-
ing on a particular TK system or sector of TK.129
(v) The Dilemma of Pyrrhic Protection

One specific problem with defensive protection and moves to enhance recognition
of TK in patent procedures concerns what has been termed ‘Pyrrhic protection’.130
The goal of defeating novelty or inventive step in TK-based patents may entail
putting knowledge into the public domain so that it is practically available to
examiners and so that it is legally relevant prior art that can be cited against a
patent claim. This may either destroy the confidentiality of certain TK by
publishing it, or it may facilitate third parties’ access to knowledge that – while
not formally, legally protectable as confidential information – would otherwise in
practice be very difficult to access. In either case, the prospect of third parties
128 Ibid., annex, p. 27.

129 lbid., annex, p. 27.
130 Taubman, Saving the Village, note 49 supra, p. 553.
making commercial use of the knowledge would increase significantly, even
though the original community may view such use as misappropriation. To some
extent, this is a true dilemma: to disclose and document TK, and thus provide
greater guarantees that it will not be the subject of illegitimate patenting, while
facilitating third parties to exploit the knowledge without legal or practical
encumbrance; or to maintain it either as confidential or at least as very difficult to
access in practice, but increasing the risk that it may be the subject of illegitimate
patents since it would not be accessible to patent offices?
One approach that is being explored in this area, to avoid the perverse
outcome of disclosure defeating patent grant but facilitating unwanted appropria-
tion of knowledge, is the development of databases with limited access governed
by confidentiality agreement, to be used effectively as convenient search tools to
locate TK relevant to a candidate patent application; should relevant TK be
located, then it would be the underlying original publication pointed to by the
database, not the electronic database entry itself, that would be legally cited as
prior art against the patent claim. Another option, covered in the draft recom-
mendations noted above, would be to use such databases to expose prima facie
evidence that the purported inventor is not the true inventor, where it appears the
inventor as listed in the patent application is not linked to the holder of
undisclosed TK recorded in a confidential database.
(bb) Geographical Indications and Certification Marks
International standards on protection of geographical indications and other

distinctive signs have been extensively explored as a means of protecting TK, for
instance in both the WTO TRIPS Council131 and the WIPO IGC.132 The European
Union has raised the possibility of using GIs to identify products originating from
a ‘protected area’ that are relevant to in situ conservation of genetic resources
under the CBD133 where producers decide to link their collective production
standards and related to conservation goals.134 The unlimited term of protection
available for GIs is cited as particularly relevant to TK.135 However, there is an
obvious limitation in that protection of GIs only concerns the identification in the
marketplace of certain products that use TK; it cannot protect TK as knowl-
edge.136 Thus, in the example cited above,137 the GI protection available for
Roquefort cheese can prevent other cheese makers from referring to their cheese
131 See for example, TRIPS Council documents EC, IP/C/W/254; South Africa, IP/C/M/43, para.
66; Venezuela, IP/C/M/32, para. 136.
132 See for example, document WIPO/GRTKF/IC/5/7.
133 Defined under the CBD, Art. 2, as ‘a geographically defined area which is designated or
regulated and managed to achieve specific conservation objectives’.
134 EC, IP/C/W/254.
135 Venezuela, IP/C/M/43, para. 50.
136 EC, IP/C/M/43, paras 42, 65.
137 See s.III.1.I.8 supra.
as ‘Roquefort’, and in a stronger version138 from even describing their cheese with
reference to Roquefort (such as ‘Roquefort-style’), but they would be free to use
the know-how and traditional methods as such, as well as the specific bacterium
Penicillium roqueforti.
International standards on GIs and collective marks provide guidance on how
collective interests may be recognized legally within the IP system, without
necessarily requiring the interested parties to have formal legal personality as such
– a potential obstacle to appropriate recognition of holdings of TK which may not
neatly be linked to one distinct legal person. Thus these standards may be relevant
in the development of sui generis rights over TK. For instance, protection of GIs
under TRIPS does not require the creation of a distinct property right vested in a
defined ‘owner’ but merely ‘legal means’ that enables ‘interested parties’ to
prevent certain proscribed acts.139 Similarly, even though collective marks must
by contrast be held by a defined owner, the Paris Convention specifically requires
flexibility in the recognition of such owners, not confining eligibility to specific
legal entities, but rather requiring protection of ‘collective marks belonging to
associations the existence of which is not contrary to the law of the country of
origin, even if such associations do not possess an industrial or commercial
establishment’.140 These forms of protection recall, also, that there are approaches
to IP protection that do not protect individual property rights, but correspond to a
collective interest, as is typically the case for TK:141 the original, French, text of
the Paris Convention refers not to ‘une association’ but ‘une collectivité’.142
The diplomatic history of the recognition of collective marks in the Paris Con-
vention also underscores the non-commercial role of some forms of IP protection.
Article 7bis was adopted at the 1911 Washington revision conference, as a compro-
mise, in view of concerns on the part of some countries such as Great Britain that
collective marks should not be held by associations with commercial interests.
Article 7bis (2) allows that ‘[e]ach country shall be the judge of the particular con-
ditions under which a collective mark shall be protected and may refuse protection
if the mark is contrary to the public interest’. The ‘public interest’ that may be
invoked in this context was declared by the British delegation to the London Con-
ference of 1934 to be the entitlement to refuse protection to an association that was
undertaking regular commercial activities.143 From this perspective, at least,
138 For instance, if Art. 23 of TRIPS were applied to such products, as some countries hope to
establishing through an amendment of TRIPS: see for example, Communication from the
European Communities, Geographical Indications, WT/GC/W/547, TN/C/W/26, TN/IP/W/11,
(14 June 2005).
139 See TRIPS, Arts 22, 23.
140 Paris Convention, Art. 7bis Marks: Collective Marks.
141 See concerns expressed on this account in TRIPS Council discussions by, e.g. Brazil,
IP/C/W/228; India, IP/C/W/198; and Venezuela, IP/C/M/25, para. 86.
142 Recalling that WIPO fact-finding missions learned that one concern of TK holders was the
‘testing of options for the collective acquisition, management and enforcement of IPRs by TK
holders’ associations’, WIPO fact-finding report, fn. 7 supra.
143 Records of the London Conference, 1934; see discussion in Stephen Ladas, ‘Patents,
Trademarks and Related Rights’, Harvard, 1975, vol. II, 1295.
protection might be denied to an association if it were undertaking normal business
rather than primarily pursuing other objectives – such as cultural or spiritual144
activities; however, actual practice has tended towards the registration of collective
marks by trade associations and the like, for instance to support local agricultural
products, leading to a crossover with GI protection.
(cc) Suppression of Unfair Competition
The Paris Convention provides for the suppression of unfair competition in very
general terms, as an obligation to assure ‘effective protection against unfair
competition’. (Art. 10bis(1)). In principle, the scope is very broad, as an act of
unfair competition is defined as ‘[a]ny act of competition contrary to honest
practices in industrial or commercial matters’. The standard commentary clarifies
that this includes reference to ‘honest practices in international trade’,145 in other
words an international standard of fairness and honesty, and is not limited to
practices deemed dishonest by local standards. The general focus of this provision
had in the past been on such questions as consumer protection against confusing,
misleading or deceptive statements, and derogatory references to a competitor (as
evidenced by the particular examples of unfair competition listed in Article
10bis(3)). In itself, this potentially provides a measure of protection for those
products that embody TK with the consent or involvement of the TK holders
against imitative or misleadingly presented products. Accordingly, the WIPO draft
objectives and principles provide that:
Traditional knowledge holders should also be effectively protected

against other acts of unfair competition, including acts specified in
Article 10bis of the Paris Convention.146
However, the general rule against unfair competition has been developed in three
further ways that are directly relevant to the protection of TK. First, it is one of
the elements of protection of GIs under TRIPS147. Second, it was used as the
doctrinal basis of the protection of undisclosed information under TRIPS.148 And,
third, it has provided a doctrinal root or a model for the expression of a distinct
norm against misappropriation of TK.
144 E.g. UK registered collective mark 2030852 (17 August 1995) in the name of the Association
of Vineyard Churches, cited in Jeffrey Belson, Certification Marks, Sweet and Maxwell,
(2002), 38.
145 G.H.C. Bodenhausen, Guide to the Application of the Paris Convention for the Protection of
Industrial Property as Revised at Stockholm in 1967, (Geneva, 1968), p. 144.
146 See draft WIPO TK provisions, fn. 2, 12–13.
147 See TRIPS Art 22(2)(b); see the discussion supra at III.1.I.8.
148 See TRIPS Art. 39.1: ‘In the course of ensuring effective protection against unfair competition
as provided in Article 10bis of the Paris Convention (1967), Members shall protect
undisclosed information in accordance with para. 2’.
On the second point, TRIPS requires protection of undisclosed information
provided it is ‘secret in the sense that it is not, as a body or in the precise
configuration and assembly of its components, generally known among or readily
accessible to persons within the circles that normally deal with the kind of
information in question; has commercial value because it is secret; and has been
subject to reasonable steps under the circumstances, by the person lawfully in
control of the information, to keep it secret’.149 On the face of it, this would not
require protection of undisclosed TK if it had no commercial value whatever;
however, it would presumably cover TK that is not of commercial value to its
holders (who may indeed actively resist and resent the suggestion that their TK,
such as sacred TK, should be valued commercially), but is of commercial value
to third parties beyond the community, in a classical bio-prospecting scenario.
And where protection of undisclosed information is based on a fiduciary
obligation, as is generally the case in common law jurisdictions, rather than on the
basis of the protection of a strictly commercial asset through dedicated trade
secret legislation, the lack of commercial value of TK would not be a bar to
protection,150 and the protection afforded would touch on privacy and protection
of collective personality.151
On the third point, the Delegation of Norway proposed ‘to provide protection
for TK . . . using Article 10bis [of the Paris Convention] as a model when consider-
ing the framework of a sui generis system for TK’ and ‘to have a general interna-
tional norm that obliged the States to offer protection against unfair exploitation of
TK . . . supplied with internationally agreed guidelines on how to apply the
norm’.152 The Committee decided to develop an amended draft of the elements of
sui generis protection, ‘taking into account the suggestion made by the Delegation
of Norway’153 and to ‘discuss whether it would be possible to provide protection for
TK along similar lines as in article 10bis of the Paris Convention concerning unfair
competition’.154 This work evolved over time into the draft WIPO TK provisions155
that spell out five broad areas of misappropriation, on the model of Article 10bis:
first, a broad normative statement;156 second, a general characterization of
misappropriation/unfair competition;157 and, third, a list of specific acts considered
to be acts of misappropriation or of unfair competition respectively.158 This ap-
proach applies the protection against unfair competition in Paris as a model or an
analogue, rather than as a formal doctrinal basis for a specific norm for protection
149 TRIPS, Art. 39(1).

150 See for example, Foster v. Mountford, fn. 87 supra.
151 See Taubman, ‘Is there a right of collective personality?’, fn. 84 supra.
152 Report of the Third Session of the IGC, WIPO/GRTKF/IC/3/17, para. 227.
153 Report of the Third Session of the IGC, WIPO/GRTKF/IC/3/17, para. 249, item 3.
154 Ibid.
155 Draft WIPO TK provisions, i.e. the draft objectives and principles for TK protection, see fn.
2 supra.
156 Art. 1.1 of the draft WIPO TK provisions, cf. Art. 10bis(1)) of Paris.
157 Art. 1.2 of the draft WIPO TK provisions cf. Art. 10bis(2)) of Paris.
158 Art. 1.3 of the draft WIPO TK provisions cf. Art. 10bis(3)) of Paris.
against misappropriation of TK. Even so, there is significant doctrinal overlap be-
tween the two concepts. The law of unfair competition may potentially provide re-
inforcement for a norm against misappropriation of TK as such. First, and most
directly, existing unfair competition standards can clearly be invoked by confirming
that widely recognized acts of false attribution of products, such as indications of
indigenous endorsement or benefit-sharing, may be considered forms of
misappropriation of TK, akin to the US Indian Arts and Crafts Act,159 and the
proposal in the WIPO draft TK provisions that protection of TK against misappro-
priation under existing Paris rules on unfair competition would include ‘false or
misleading representations that a product or service is produced or provided with
the involvement or endorsement of TK holders, or that the commercial exploitation
of products or services benefits holders of traditional knowledge’ as well as ‘acts
of such a nature as to create confusion with a product or service of traditional
knowledge holders; and false allegations in the course of trade which discredit the
products or services of traditional knowledge holders’.160 Second, and more specu-
latively, invoking the standard commentary that the suppression of unfair competi-
tion under Paris entails any actions contrary to ‘honest practices in international
trade’,161 the possibility exists that gaining any inequitable commercial benefit
from access to or use of TK may be considered an act of unfair competition. While
this is undoubtedly stretching the existing text, it should be recalled that entire cat-
egories of IP protection are explicitly founded on this provision under TRIPS – such
as the protection of confidential information and regulatory data – and that unfair
competition is invoked as an explicit means of implementing other sui generis
forms of protection, such as protection of phonograms162 and integrated circuits.163
(dd) Sui generis Protection
Despite these potential doctrinal roots in the law of suppression of unfair competi-
tion, international IP law does not currently provide for sui generis protection of TK
as such, although several current policy processes seek to develop such protection,
both within and beyond the IP framework. One potentially related doctrinal root for
sui generis protection is the increasing recognition of a principle of prior informed
consent over TK, even though this has not yet been enshrined in an international le-
gal instrument.164 While the operation of existing IP mechanisms should not be
conflated with the broader principle of prior informed consent, various IP mecha-
nisms can function as a means of giving practical effect to a right to consent to ac-
cess to knowledge. As discussed above,165 the point of access to TK is the critical
159 Discussed infra, Sec. III.1.II.1.(c)(ee).

160 Draft WIPO TK provisions, fn. 2 supra, annex pp. 12–13.
161 See Bodenhausen, fn. 143 supra.
162 See Phonograms Convention Art. 3.
163 See Washington Treaty, Art. 4.
164 See discussion at III.1.II.1.(c)(ee) 6(i) infra.
165 See III.1.I.6(a) supra.
stage in the practical protection of TK against undesired use by third parties. Ac-
cordingly, one mechanism to give effect to prior informed consent over undisclosed
TK is afforded by the protection of confidential information, discussed above,
where the elements are present that establish confidentiality.
Another practical scenario arises when a fixation or recording is made of the
traditional forms of expressions that are frequently the means of alienation of
orally-transmitted TK from its traditional context. This applies especially to TK
held within an oral tradition: until such TK is recorded in a fixed form, it is
difficult for it to be appropriated from its source community. So the act of physical
fixation of the actual expression in which TK is customarily transmitted may be
the first step towards transmission of the content of the TK to third parties beyond
the traditional context, who may then use it for their own purposes. Hence one
means of exercising prior informed consent over TK is asserting a right over the
means of capture and subsequent transmission of TK. The fixation of perfor-
mances of traditional cultural expressions or expressions of folklore may well be
the first occasion on which the content of TK is captured in a form that makes it
available for third parties to capture the benefits.
Accordingly, the right of the performer of the expression of folklore may be
reconceived as a mechanism for exerting prior informed consent over any TK that
is transmitted through traditional forms of cultural expression. The WPPT defines
‘performers’ to include those ‘who act, sing, deliver, declaim, play in, interpret, or
otherwise perform literary or artistic works or expressions of folklore’. The treaty
provides for moral and economic rights over performances of expressions of
folklore, including economic rights over the fixation of unfixed performances:166
underscoring the relevance of so-called economic rights to control the down-
stream exploitation of fixations of expressions that convey TK in customary form,
an Agreed Statement clarifies that the right to remuneration for broadcasting and
communication to the public does not prevent the granting of exclusive rights ‘to
performers of folklore and producers of phonograms recording folklore where
such phonograms have not been published for commercial gain’.167 Prefiguring,
also, the deference to traditional context, including the customary law context,
that is considered in proposals to create a form of collective moral right for
indigenous communities,168 the WPPT provides for moral rights that empower the
performer to ‘object to any distortion, mutilation or other modification of his
performances that would be prejudicial to his reputation’.169 Accordingly, while
this legal mechanism falls short of the protection of TK per se, the WPPT can be
seen as establishing one means of giving effect to the right of prior informed
consent over TK as well as controlling the downstream exploitation of TK, by
granting a right, first, to object to the material fixation of a customary means of
oral expression of the knowledge, namely the expression of folklore, secondly to
166 WPPT, Art. 5.

167 Agreed statement concerning Art. 15, WPPT.
168 Australia, Copyright Amendment (Indigenous Communal Moral Rights) Bill 2005.
169 Art. 5.1, WPPT.
an equitable return from commercial exploitation even where the original fixation
was not undertaken for commercial purposes (as is frequently the case when
academic researchers take field recordings of TK holders), and thirdly to object to
downstream uses of the recorded expression of TK that damage the reputation of
the TK holder and customary oral source within her or his own community.
Nonetheless, this indirect means of exercising prior informed consent over TK is
not a direct form of protection of TK as such. The extension of performers’ rights
over expressions of folklore is naturally dealt with fully under the discussion on
folklore in this volume.170
(b) Regional Level
(aa) Andean Community
The best-established regional legal framework that deals directly with TK

protection is Decision 486 of the Commission of the Andean Community,
establishing a Common Intellectual Property Regime, which provides in Article 3,
on ‘Biological and Genetic Heritage and Traditional Knowledge’, as follows:
The Member Countries shall ensure that the protection granted to

intellectual property elements shall be accorded while safeguarding and
respecting their biological and genetic heritage, together with the
traditional knowledge of their indigenous, African American, or local
communities. As a result, the granting of patents on inventions that have
been developed on the basis of material obtained from that heritage or
that knowledge shall be subordinated to the acquisition of that material
in accordance with international, Andean Community, and national law.
The Member Countries recognize the right and the authority of indig-
enous, African American, and local communities in respect of their
collective knowledge.
To give effect to these principles, the Decision provides that patent applications
should be accompanied ‘if applicable’ by
a copy of the document that certifies the license or authorization to use

the traditional knowledge of indigenous, African American, or local
communities in the Member Countries where the products or processes
whose protection is being requested was obtained or developed on the
basis of the knowledge originating in any one of the Member Countries,
pursuant to the provisions of Decision 391 and its effective amendments
and regulations (Article 26(i)).
170 See Chapter III.4.II.1(a)(bb).

And among the grounds of invalidity for patents is the following:
when pertinent, the products or processes whose protection is being

requested have been obtained or developed on the basis of traditional
knowledge belonging to indigenous, African American, or local commu-
nities in the Member Countries, if the applicant has failed to submit a
copy of the document certifying the existence of a license or authoriza-
tion for use of that knowledge originating in any one of the Member
Countries (Article 75(h)).
This provides a legal framework therefore for a strictly defensive form of protection
of TK, although expressing a positive doctrine of a right to give or withhold consent
for the use of TK sourced from within the Andean Community in products or
processes that are patented in a Member Country. The complementary regional
instrument, Decision 391, provides also for positive rights over TK in broad terms:
The Member Countries, in keeping with this Decision and their comple-
mentary national legislation, recognize and value the rights and the
authority of the native, Afro-American and local communities to decide
about their know-how, innovations and traditional practices associated
with genetic resources and their by-products.171
Implementation of this broad regional provision under national legislation is

perhaps exemplified by Peru’s law on the protection of TK discussed below,172 as
well as the regulation of genetic resources, which is not covered by this chapter.
(bb) European Patent Convention
(1) Novelty and Inventive Step under the EPC
The economic and technological significance of the European patent system,

established under the European Patent Convention (EPC),173 means that—among
regional IP systems—European patents relating to TK have been subject to
particular scrutiny, even though there are no specific rules and little jurisprudence
regarding TK. Importantly, from the perspective of defensive protection of TK, no
distinction is made in the EPC between oral and written disclosure and between
domestic and foreign location of disclosure. Novelty and the prior art base are
defined in the following terms:
171 Andean Community Decision 391, Art. 7.

172 See Sec. III.1.II.1.(c)(ee) infra.
173 Convention on the Grant of European Patents (European Patent Convention) of 5 October
1973.
[a]n invention shall be considered to be new if it does not form part of
the state of the art. The state of the art shall be held to comprise
everything made available to the public by means of a written or oral
description, by use, or in any other way, before the date of the filing of
the European patent application.174
The EPO examination guidelines175 call attention to ‘the width of this defini-
tion . . . There are no restrictions whatever as to the geographical location where,
or the language or manner in which the relevant information was made available
to the public; also no age limit is stipulated for the documents or other sources of
information’.
(2) Cases on Patenting TK-Related Inventions
In a recent survey of recognition of TK and genetic resources in the patent

system,176 the European Patent Office reported on two patents in which TK
formed the basis of an appeal against a decision to grant a patent. They are
summarized briefly here:
Patent EP 0436257: ‘Method for controlling fungi on plants by the aid of a
hydrophobic extracted neem oil’, revoked in opposition proceedings:
This patent concerned a fungicidal agent extracted from the seeds of the neem
tree, a tree native to South Asia and found through South-East Asia. The neem tree
had considerable cultural and spiritual significance of the neem tree to many
communities. Much TK is associated with the tree, including concerning the
pesticidal, fungicidal and medical properties of various extracts from it. This case
sparked intense controversy, perhaps accentuated by the fact that the applicants
were jointly a United States based company and an US-government agency. The
patent accordingly took on symbolic value in a general debate about recognition
of TK within the patent system, seemingly exemplifying the extraction of
commercial value in the North from use of TK originating from the South.
The main claim as filed had read:
An insecticide and foliar fungicide comprising neem oil which is

substantially free of azadirachtin and salannin, said neem oil prepared
by: (a) extracting dried, coarsely ground neem seeds with a non-polar,
hydrophobic solvent to obtain a neem oil extract, (b) removing the
solvent to obtain the neem oil product.
174 Art. 54(2), EPC.

175 ‘Guidelines for Examination in the European Patent Office’ (EPO) (Part C, Chapter IV, para.
5.1).
176 First Collation of Responses to the Questionnaire on Recognition of Traditional Knowledge and
Genetic Resources in the Patent System, WIPO/GRTKF/IC/9/INF/6 (27 February 2006).
This claim was narrowed after various prior art publications were cited against it
and it was held by the examiner to be non-novel in this form. The revised claim
was limited to fungicidal use of neem oil obtained by hydrophobic extraction from
the seed:
A method of controlling fungi on plants comprising contacting the fungi

with a neem oil formulation containing 0.1 to 10 [per cent] of a
hydrophobic extracted neem oil which is substantially free of azadirach-
tin, 0.005 to 5.0 [per cent] of emulsifying surfactant and 0 to 99 [per
cent] water.
The prior art teaching was that azadirachtin the principal antifungal component of
neem oil, and azadirachtin would only be extracted by a hydrophilic solvent and
not by non-polar hydrophobic solvents such as hexane. Hence, on the face of it,
it was new and unexpected that a neem extract free of azadirachtin would also
have fungicidal effect.
Three opponents sought revocation of the granted patent on the grounds of lack
of novelty (Article 54(1)(2) EPC), lack of inventive step (Article 56 EPC), insuffi-
cient disclosure (Article 83 EPC) and because it would be contrary to morality
(Article 53a EPC). The opponents asserted that the patent threatened the livelihood
of millions of custodians of the neem tree, that the neem tree had been used by the
Indian people for millennia for various practical applications. Use of this knowl-
edge was immoral. At first instance, the EPO opposition division pointed out that
the patent gave no rights over activities in India, given the territoriality of rights
granted under a patent. Traditional knowledge relevant to determining the state of
the art for assessment of novelty but the patent gave its proprietor no right to pro-
hibit any acts in India. The patent did not claim the neem tree, its seeds nor neem oil
in general, and there was no direct linkage between a claim on a method of control-
ling fungi by a specified use of a neem extract using hydrophobic solvents within a
European patent, and the use of neem in India. The opposition division did not ac-
cept the representation that the patent was invalid on the basis of the morality and
ordre public exception177 and instead assessed it on the basis of novelty and inven-
tive step. TK was potentially relevant from that perspective.
At first instance, the chief evidence was an affidavit and testimony from an
Indian agricultural scientist concerning field trials in 1985 and 1986, in
Maharashtra, prior to the priority date of the patent. These field trials used an
extract of neem from a hydrophobic solvent (hexane), combined with a
conventional emulsifying surfactant. The trials were open to local farmers who
were given samples of the extracts used as well as instructions on their
preparation. The opposition division found that the revised patent was not
inventive in the light of this prior art.
177 EPC, Art. 53(a).

The case was appealed to the Technical Boards of Appeal, which upheld the
revocation of the patent,178 on the same grounds – lack of inventive step – but on
a different evidentiary basis. The disclosure in one single document in a scientific
journal (‘document (8)’) was found to be an adequate basis to reject the patent:179
The skilled person faced with the problem defined above [viz, putting
into practice a method of controlling fungi on plants by using an
extracted neem oil] knows that she or he has to put in contact the fungi
with formulations containing neem oil in some concentration. This is an
obvious requirement of the known methods of controlling fungi on
plants . . . document (8) specifies that . . . the use of a solvent for the
extraction is compulsory. However, document (8) does not disclose
which solvent should be used. Accordingly, the skilled person would use
his or her general knowledge of the isolation of natural products from
plants. This commonly takes place by means of solvent extraction and
solvent elution. These are well-known practices used in all laboratories
of natural products and merely imply arranging the solvents to be used
according to their solvent strength. Basically, whatever the technique
chosen, it is normally started with a non-polar hydrophobic solvent (first
option) and then it is continued in increasing degree of polarity up to
hydrophilic solvents (water included).
On the basis of the disclosure in document (8) together with general laboratory
practice in the preparation of extractions from natural products, the patent was
found not to involve an inventive step ‘since it was obvious to try to use
formulations such as those defined in the claim for controlling fungi on plants’.180
Patent application WO 98/46243 (EP 98917372.9): ‘Pharmaceutical compo-
sitions having appetite suppressant activity’, refused in examination on the basis
of a written disclosure of TK, but accepted on appeal.
CSIR applied for a patent claiming use as an appetite suppressant of an
extract from a plant of the genus Trichocaulon or Hoodia, and of certain
compounds isolated from these plants, in particular a defined steroid glycoside
‘P57’. Hoodia gordonii is a South African succulent plant, and the TK of the San
people was well documented – in particular their use of the plant to ‘quench thirst
and hunger for extended periods’. The examining division rejected the application
on the basis that the claimed genera were known to contain appetite suppressing
ingredients. Preparing an extract with appetite-suppressant activity was obvious
for the person skilled in phytochemistry or phytopharmacology.
178 EPO Boards of Appeal Decision of 8 March 2005, Case: T 0416/01–3.3.2, Application
Number: 90250319.2, Publication Number: 0436257, ‘Method for controlling fungi on plants
by the aid of a hydrophobic extracted neem oil’ (Thermo Trilogy Corporation, et al.)
Opponents: Aelvoet, Magda. MEP, The Green Group in the European Parliament, et al.
179 H.B. Singh and U.P. Singh, ‘Effect of Volatiles of Some Plant Extracts and their Oils on
Conidia of Erysiphe polygoni DC’. Australian Plant Pathology, (1981) pp. 66–67.
180 Case Number: T 0416/01–3.3.2, at p. 21.
The applicants appealed, revising the main claim to read:
Use, in the manufacture of a medicament having appetite-suppressant

activity for treating, preventing or combating obesity of a human or
animal, of an extract from a plant of the genus Trichocaulon or the genus
Hoodia, which extract contains an effective amount of an appetite-
suppressant steroidal glycoside from said plant, wherein the steroidal
glycoside has the formula
The Technical Board of Appeal upheld the patent with this narrower claim.181
The Board acknowledged that a skilled person would know from a prior art
document that consumption of parts of a fibrous, water-storing plant of the genus
Trichocaulon very efficiently ‘removed the pangs of hunger’. But that person
‘could not obviously derive from this disclosure that an extract from the plant
could be used for the manufacture of an appetite-suppressant, antiobesity
medicament’. The Board found that the appellants had shown that ‘a consumer
eating the stems of the plant or sucking the sap of the fresh plant is not able to
absorb a sufficient amount of the active moiety contained in an extract of the plant
which is responsible for its appetite-suppressing activity’. The effect disclosed in
the prior art ‘can be explained by the stomach-filling properties of the plants in
question, which had been used as ‘bush-food’ by the original inhabitants of the
Kalahari desert for a long time’.182 The Board concluded that on the basis of the
prior art on file, the skilled person
would not be prompted to use an extract from a plant of the genus

Trichocaulon or the genus Hoodia in the manufacture of a medicament
having appetite-suppressant activity, according to claim 1, or to admin-
ister to a human or animal a foodstuff or beverage comprising said
extract in order to reduce their total calorific intake, according to claim 14.
181 ‘Decision of the Technical Board of Appeal 3.3.4’ of 27 January 2005, Case : T 0543/04–
3.3.4, Application Number: 98917372.9, Publication Number: 0973534, Pharmaceutical
compositions having appetite suppressant activity, Applicant: CSIR.
182 At p. 12–13.
Accordingly, the invention as claimed was found to involve an inventive step.
Separately from its fate in the EPO, the so-called hoodia patent has provoked
considerable controversy over the use of the TK of the San people as, at the very
least, a lead in the development of the invention as claimed. There was no
suggestion, however, that TK holders should be considered as co-inventors, as
their knowledge was dealt with strictly as part of the prior art base against which
inventiveness was assessed. A considerable controversy arose183 as to the
equitable sharing of benefits from the invention, given the undoubted technical
contribution of the San people in the development of the invention and their role
as custodians of the original hoodia plant, and an ex post facto agreement was
struck between CSIR and the San people.184 In addition, the wild hoodia was a
protected plant and the commercial interest aroused in its use both in the patented
invention and more generally as a natural product provoked concerns over its
survival in the wild. However, these widely debated issues did not come before
the EPO which was concerned with technical validity of the patent as such.
These two cases, both widely debated and both emblematic of the commer-
cialization of derivatives from TK and related genetic resources, were actually
striking for their relatively conventional resolution before the EPO. The focus
remained on the technical validity of the patent as claimed, and there was no scope
for such broader considerations as the equity of benefit-sharing arrangements
(being essentially a matter of how the patent once granted is exercised in practice)
and the morality or ordre public exception (given that to uphold this exception is
necessary to find that the actual exercise of the invention would be contrary to
morality or ordre public, and it was not considered inherently contrary to morality
to make use of TK in developing a new process).
The novelty and inventive step questions were resolved in a conventional
manner in both cases. The field trials and scientific publication successfully cited
against the Neem patent actually had the character more of conventional scientific
knowledge, rather than traditional or even local knowledge. The Hoodia case
actually deals more directly with the dilemmas associated with the use of TK as
a feedstock in ‘mainstream’ innovation. In the Hoodia case, the board explored the
territory identified by Lord Hoffman (discussed above) between the way an
indigenous community would view the chemical properties of a natural product,
and the perspective of a Western pharmacologist who had identified and extracted
a distinct chemical compound from that product, guided by the community’s TK.
The person skilled in the art as constructed by the Board in its decision was
arguably the most likely such notional person to make the linkage between the
disclosed TK and the invention as finally claimed – more so, arguably, than the
183 Rachel Wynberg, ‘Rethoric, Realism and Benefit-Sharing: Use of Traditional Knowledge of
Hoodia Species in the development of an Appetite Suppressant’, (November 2004)Journal of
World Intellectual Property, Vol. 4, No. 4, 851–876.
184 Roger Chennels, ‘Genetic Research, Ethics and Law; Indigenous Peoples, Biodiversity,
Biotechnology and the Protection of Traditional Knowledge’, (St. Louis, 4–6 April 2003); see
also Council for Scientific and Industrial Research (24 March 2003) The San and the CSIR
announce a benefit-sharing agreement for potential anti-obesity drug.
traditional holder of the knowledge. Hence debate over the case pivoted more over
the equity of benefit sharing arrangements, and the possible need for strong
codification and enforcement of such obligations, rather than the technical validity
of the patent as claimed over and above the TK base.
Both cases also illustrate the increasing capacity of developing countries to
make use of their indigenous knowledge and genetic resources: the applicant in
the Hoodia case discussed above was a public scientific research institute in a
developing country, and the majority of international patent filings on Neem-
derived inventions published since 2004 are sourced from India.
(cc) Regional Models for Protection
Two of the most significant regional models for protection are the African Model
Legislation for the Protection of the Rights of Local Communities, Farmers and
Breeders, and for the Regulation of Access to Biological Resources (2000), and the
Pacific Regional Framework for the Protection of Traditional Knowledge and Ex-
pressions of Culture (2002). These have been discussed in Section II(c)(ee) below,
to enable comparative analysis against the leading national sui generis laws.
(dd) Bilateral Agreements
The recent profusion of bilateral trade agreements touching on intellectual

property protection has barely touched on TK protection, even though the bilateral
route offers a test bed for new norms that may mature into multilateral standards.
One recent exception, however, is the United States – Peru Trade Promotion
Agreement which was signed on April 12, 2006 together with an ‘Understanding
Regarding Biodiversity and Traditional Knowledge’ which recognized the ‘im-
portance of traditional knowledge and biodiversity, as well as the potential
contribution of traditional knowledge and biodiversity to cultural, economic, and
social development’. In light of this recognition, it articulates principles and
emphases relevant to the defensive protection of TK and genetic resources, as well
as certain positive rights concerning access equitable benefit sharing. In relation
to TK in particular, the Understanding recognized ‘the importance of equitably
sharing the benefits arising from the use of traditional knowledge’ and ‘promoting
quality patent examination to ensure the conditions of patentability are satisfied’.
To this end, the parties to the understanding
recognize that access to . . . traditional knowledge, as well as the

equitable sharing of benefits that may result from use of . . . that
knowledge, can be adequately addressed through contracts that reflect
mutually agreed terms between users and providers.
The parties endeavoured to
seek ways to share information that may have a bearing on the

patentability of inventions based on traditional knowledge or genetic
resources by providing: (a) publicly accessible databases that contain
relevant information; and (b) an opportunity to cite, in writing, to the
appropriate examining authority prior art that may have a bearing on
patentability.
(c) National Level
(aa) Patent Law
(1) General Considerations and Some Cases: TK under

National Patent Law
At the level of national law, the same issues arise concerning the interaction
between TK and the patent system as are dealt with internationally: the positive
and defensive element (that is, the use of the patent system either to grant
legitimate rights over TK in the interests of TK holders or to defend against
illegitimate taking of TK through patent grant).
Protection of TK under the patent system has both legal and practical aspects:
the legal aspect concerns the rules established to determine patentability, such as
the defined prior art basis for the assessment of novelty and inventive step, and the
practical aspect concerns, for instance, the actual sources of information are
routinely searched in practice when a patent application is examined for
patentability, given that no practical examination regime could possibly check all
conceivable sources of information that accord with the legal definition of prior
art. Hence, while legal analysis naturally focuses on the need to take account of
orally disclosed TK in foreign jurisdictions as relevant prior art, to prevent its
illegitimate patenting, this distinction is unlikely to arise in any but a small
number of routine patent cases – because of the practical limitations in locating
information about purely oral disclosures in foreign jurisdiction in normal ex
parte patent prosecution. Inter partes proceedings may bring to light oral
testimony (as in the EPO Neem case discussed above), but in routine patent
procedure the main practical distinction between relative and absolute novelty
regimes, would arise when the key prior art citation is a readily accessible
documentary, dated subsequent to the priority date, which establishes oral
disclosure in a foreign jurisdiction prior to the priority date.
Accordingly, unlike the EPC, which requires absolute novelty, US patent law
differentiates between the domestic and foreign context in defining novelty,
precluding entitlement to a patent unless:185
the invention was known or used by others in this country, or patented or

described in a printed publication in this or a foreign country, before the
invention thereof by the applicant for patent, or . . . the invention was
185 35 United States Code (U.S.C.), Sec. 102 (a) and (b).
patented or described in this or a foreign country or in public use or on
sale in this country, more than one year prior to the date of the
application for patent in the United States.
An oft-cited example of the difficulties of recognizing TK as prior art in the

United States is the case of US Patent 5401504 (March 28, 1995), ‘Use of
turmeric in wound healing’, which principally claimed ‘a method of promoting
healing of a wound in a patient, which consists essentially of administering a
wound-healing consisting of an effective amount of turmeric powder to said
patient’. The patent provoked a storm of controversy as it was typically pointed
out that ‘every Indian grandmother’ used this method to heal simple wounds. It
was often overlooked in the debate that the patent specification did disclose
specific clinical trials undertaken by the applicants which focussed on a particular
health problem, that of finding an affordable treatment for leg ulcers suffered by
the homeless (‘the indigent population’) who had limited resources and little
access to conventional health care. The patent situated the claimed invention in
the context that ‘the need to address the problem of skin ulcers is apparent. No
current animal model, single factor or drug exists (Rasmussen L H et al, Ann.
Surg, 216:684–691, 1992). The literature has stressed more on carcinogenic,
inflammatory metabolic modulatory or the oxidation properties of turmeric but no
one has used this agent singly for wound healing’. It then claims that the ‘present
inventors are the first ones to use turmeric topically and orally as a single agent
modality for wound healing’.
The claims solely concerned the use of turmeric in wound healing as a
method of medical treatment, not turmeric as such. When an inter partes request
for re-examination of this patent was made by the Council of Scientific and
Industrial Research of India (CSIR), the case probed this distinction between the
legal and the practical aspects of defensive protection: to what extent was this a
question of practically and systematically communicating to the examiner
evidence of prior use of the claimed method, an essentially practical matter, and
to what extent did it turn on the distinction between oral transmission of the
knowledge or disclosure to the public which occurred outside the United States
(as opposed to documentary disclosure). At least five broad bodies of evidence
were potentially available: evidence of oral transmission or other non-
documentary public knowledge or use in India, evidence of oral transmission or
other non-documentary public knowledge or use in the United States (potentially
by members of the Indian diaspora), ancient documentation of TK sourced in
India, documentation of more recent research into the wound-healing properties of
turmeric, and the evidence of actual products (therapeutic creams which used
turmeric to treat minor wounds) which had been widely marketed in India and
were potentially available in the United States. Both practically and legally, the
patent was on shaky ground, as was confirmed by the subsequent cancellation of
all six claims, as the evidence was compelling. Notably, only the first of these five
categories of evidence would have been legally inadmissible on the grounds that
it solely entailed public knowledge and use outside the United States. The legal
distinction between oral disclosure abroad and in the United States was no
obstacle to cancellation of the claims. The case turned on how practically to
assemble the necessary evidence of prior art (and then, for policymakers, how to
embed TK more systematically into the initial examination process so that inter
partes proceedings would not be necessary in future for evidence of such TK to
be taken into account as prior art.) However, the case might have turned out
differently for TK that was not, as in this case, part of an established body of a
codified and well documented TK system, was not so widely diffused, and was
restricted to oral transmission and undocumented disclosure beyond the United
States. In such a case, there may be an argument that relative novelty especially
discriminated against oral TK holders in foreign countries. This point was made
during work on the draft SPLT: as noted above, the draft text set a universal prior
art base.
The United States has a uniquely extensive jurisprudence on the positive
obligation to disclose to the patent office all known information relevant to
patentability. Under US patent law (37 C.F.R. 1.56), and consistent with a broad
equitable principle of ‘clean hands’, any person involved with the filing and
subsequent prosecution of a patent application has a duty of candour and good
faith in their dealings with the USPTO. This entails a positive duty to disclose all
information that is known to be material to patentability of the subject invention.
The obligation extends to supplying to the examiner any material that is only
questionably material to patentability. Given that this obligation refers only to
information material to patentability, there would arguably be no obligation to
disclose known public use or oral disclosure in foreign jurisdictions as prior art
relevant to patentability, provided that there was no documentation whatever.
Again, this seems more pertinent to scenarios other than the present case: the
description did, in fact, refer to past use in India and also contained the absolute
assertion that the inventors were the first to use turmeric as a single agent for
wound-healing, a statement that was not qualified geographically. If it were a
matter of simply appropriating TK from others without independently developing
a patentable invention, the question of the legitimacy of the claim to inventorship
would also arise. The obligation to disclose the true inventor – stipulated in the
Paris Convention and thus applied also through TRIPS – would also catch
situations in which the applicant claimed to have invented TK that actually
originated elsewhere.
(2) Positive Protection of TK under National Law
Legitimate positive protection of TK through the patent system necessarily

focuses on those specific elements that can be identified as patentable inventions,
even where they form part of a traditional knowledge system. There is also, clearly,
no basis for patent protection with a retrospective character, beyond conventional
grace period allowances, given the necessarily rigid stipulations against patenting
publicly disclosed knowledge. Thus for those countries whose policy concerns
focus on the protection of cumulative, collective knowledge systems, and
protecting knowledge systems of which some elements at least have been publicly
disclosed in some way, the patent system has had relatively little attraction in
contrast to sui generis protection and other adapted forms of protection (such as
confidential information and protection of distinctive signs) that correspond more
to collective knowledge systems, community custodianship, and recognition of
the longer time-lines for cumulative innovation.
There are exceptions to this general observation. For example, as discussed
above, the protection of inventions in China within the field of traditional Chinese
medicine is effectively integrated within the regular patent system; reportedly some
4,000 applications a year are submitted in this field. This activity is increasingly en-
tering the international patent system through the PCT.186 Similarly, Indian re-
searchers are taking a more active role in creating and patenting inventions based on
the TK heritage of their country: of 60 published domestic patent applications filed
since 1998 that refer to Neem-based inventions, fully 59 are from domestic appli-
cants; the international patent statistics show a growing trend for nations to take a
more active stake in innovations derive from their own TK.
(3) Defensive Protection of TK against Illegitimate Patenting
Nonetheless, from a legal and policy perspective, much of the activity in TK-rich
jurisdictions relating to the patent system as such tends to be defensive in
character, in other words calculated to suppress the patenting of illegitimately
acquired TK. Two broad developments can be identified: (i) per se exclusions of
certain forms of TK; and (ii) enhanced disclosure requirements relating to TK.
(i) Per se Exclusions of TK from Patentability under National Law

India’s Patents (Amendment) Act, 2002, revised the list of inherently unpatentable
subject matter to exclude from patent protection ‘an invention which, in effect, is
traditional knowledge or which is an aggregation or duplication of known
properties of traditionally known component or components’. Given the experi-
ence of vigorous grass-roots innovation at the local level,187 drawing on India’s
rich and diverse heritage of TK, and the level of legitimate patent activity in the
area of TK based inventions within India, it seems improbable this exclusion is to
be read as excluding tradition-based innovation. The exclusion of an otherwise
patentable invention from patentability purely because it is undertaken in a
traditional context (setting aside whether a traditional innovator chooses to seek
patent protection) would not only ironically discriminate against practitioners of
traditional knowledge systems but would raise questions of consistency with the
186 As one example among many, see PCT application WO/2004/052382 (publishing 24 June 24
2004), for ‘A Kind of Traditional Chinese Medicine Having Efficacy of Reducing Blood-Fat’.
187 See for example, Honey Bee Network, an initiative of the Society for Research Initiatives for
Sustainable Technologies (SRISTI). Widely discussed in the literature, e.g. recently by
Graham Dutfield, Promoting Local Innovation as a Development Strategy. Innovations Case
Discussion: The Honey Bee Network (2006).
international standards discussed above.188 While the practical interpretation of
this provision is clearly a matter for the domestic authorities, it is submitted the
text should be taken to refer to TK in the sense of publicly known and widely
orally communicated knowledge transmitted in traditional contexts, rather than
excluding legitimate innovation within a traditional context. Hence, the measure
may be seen in a positive light as a statutory correction to any potential practical
bias against the recognition of oral or other informal knowledge systems,189 such
as traditions of Sruti (hearing) and Smriti (remembering),190 reflecting the
extensive codified and widely known and used knowledge systems present in the
Indian sub-continent.
The Costa Rican Biodiversity Law191 provides for protection of TK both by
conventional IP law and by sui generis community IP rights: ‘[t]he State shall
grant protection . . . by means of patents, trade secrets, plant breeders’ rights, sui
generis community intellectual rights, copyrights and farmers’ rights’,192 but this
law excludes from protection
inventions essentially derived from knowledge which is associated with

traditional or biological practices in the public domain and inventions
which, to be commercially exploited through a monopoly, can affect
farming or fishing processes or products which are considered basic for
the food and health of the inhabitants of the country.193
While this provision may prima facie appear to present questions about compat-
ibility with international standards (such as TRIPS obligations for new, inventive
and useful inventions to be considered patentable without discrimination as to the
field of technology), the interpretation and application of such a provision may be
guided by established principles in patent law – the concept of inventions
188 See Sec. III.1.II.1(a) supra.

189 In another intellectual tradition, Plato questioned the presumption that oral transmission was
somehow inferior in intellectual content to written cultures: ‘Writing, Phaedrus, has this
strange quality, and is very like painting; for the creatures of painting stand like living beings,
but if one asks them a question, they preserve a solemn silence. And so it is with written
words; you might think they spoke as if they had intelligence, but if you question them,
wishing to know about their sayings, they always say only one and the same thing. And every
word, when once it is written, is bandied about, alike among those who understand and those
who have no interest in it, and it knows not to whom to speak or not to speak; when ill-treated
or unjustly reviled it always needs its father to help it; for it has no power to protect or help
itself’. (Phaedrus, at 275d-e).
190 See Dasgupta, S; Utkarsh, G; Gadgil, M. ‘Protecting People’s Knowledge in the Emerging
Regime of Intellectual Property Rights (IPRs)’. Bangalore. National Law School of India
University, Centre for Ecological Sciences, Indian Institute of Science. (2001), p. 1–25., 19
et seq.; Cullet, Philippe, ‘Property Rights over Biological Resources: India’s Proposed
Legislative Framework’, [2001] Journal of World Intellectual Property 4, 220 et seq.
191 Biodiversity Law, Law No. 7788 of the Legislative Assembly of the Republic of Costa Rica
(see full discussion in Sec. III.1.II.1.(c)(ee)).
192 Art. 76.
193 Art. 78.
‘essentially derived’194 from certain public domain knowledge, for example, may
be construed in terms of lack of inventive step or as referring to an obvious
derivative from public domain knowledge. By contrast, the reference to monopo-
lies impairing basic agriculture may come closer to the law of essential facilities
and eminent domain, and may possibly be construed as the kind of measure
‘necessary to public health and nutrition, and to promote the public interest in
sectors of vital importance to . . . socio-economic and technological develop-
ment’195 that TRIPS foresees as permissible when WTO Members formulate or
amend laws or regulations with the important limitation ‘that such measures are
consistent with [TRIPS] provisions’.196
(ii) Enhanced Disclosure Mechanisms under National Law

Mirroring the proposals to strengthen disclosure obligations within international
standards, a number of countries have introduced revisions to their patent laws to
create positive obligations on patent applicants to make disclosures specifically
concerning TK used in a claimed invention (these generally overlap with similar
provisions regarding genetic resources.)197
In some cases, this measure is expressed in the substantive requirements for
patentability. For instance, Egypt’s patent law stipulates that ‘where the invention
involves . . . traditional medicinal, agricultural, industrial or handicraft knowledge,
cultural or environmental heritage, the inventor should have acquired the sources
in a legitimate manner’. The Andean Community decision 486 provides that ‘the
granting of patents on inventions that have been developed on the basis of . . . [the
traditional knowledge of their indigenous, African American, or local communi-
ties] shall be subordinated to the acquisition of that material in accordance with
international, Andean Community, and national law’.
South Africa’s Patent Amendment Act, 2005, provides that before acceptance
of an application, an applicant must ‘lodge with the registrar a statement in the
prescribed manner stating whether or not the invention for which protection is
claimed is based on or derived from an indigenous biological resource, genetic
resource, or traditional knowledge or use’.198 In that event, the registrar shall call
upon the applicant to furnish proof ‘as to his or her title or authority to make use
of’ this material.
A number of other enhanced disclosure mechanism refer exclusively to
genetic or biological material, and do not refer specifically to TK; these are
covered in the chapter on genetic resources.199
194 A concept possibly drawn from the law of plant variety protection, and in that context
discussed in III.2.III.3(a)(dd).
195 TRIPS, Art. 8.1.
196 Ibid.
197 See Chapter III.2.IV.1.
198 S. 3(A).
199 III.2.IV.1.
(bb) Trademarks, Public Certification Systems and Geographical
Indications
(1) Collective Marks and Certification Marks (Annette Kur)
To register traditional names, indigenous names, tribe names or any other word or
pictorial element, etc., as certification or collective marks is certainly one of the
most adequate and easiest ways for TK holders to profit from the IP system as it
presently stands.200 The reason for this effect can be found in the specific features
of trademark law and the manner in which it is distinguished from all other areas
of IP law. Unlike copyright, patent or design law, trademark law does not (or at
least does not primarily) protect an achievement as such. Instead it serves to
indicate the identity and genuineness of the achievement as coming from a certain
commercial source. This means that even when the manufacturing and prolifera-
tion of a product or achievement as such cannot be prohibited as is frequently the
case with items of TK falling short of the requirements of patent or copyright law,
the registration and use of collective marks can help to maintain at least a certain
degree of exclusivity in the sense that the proprietor (e.g., an organization
representing the interests of TK stakeholders) retains the exclusive right to control
and authorize the use of the mark for those articles it deems fit. It is therefore little
wonder that the registration and use of collective and certification marks (together
with geographical indications) have been mentioned in all of the chapters
contained in this study as a possible, although somewhat limited remedy against
the deficiencies of the IPR system when it comes to protection of TK.201
As noted in the section on international instruments above,202 Article 7 bis of
the Paris Convention obliges Member States to provide for registration and
protection of collective marks, i.e., marks belonging to associations which are
lawfully established in their home countries, irrespective of the fact that they do
not possess an industrial or commercial establishment. It therefore follows that
collective marks are a practically worldwide-acknowledged category of distinc-
tive signs.203 The legal rules under which such marks are protected in the
individual countries may, of course, vary in their details. Usually, collective marks
are subject to specific provisions, the aim of which is to grant the public
authorities a certain degree of control over the use of such signs. For instance, one
typical provision that can be found in most trademark laws with respect to
collective marks, is the obligation to deposit a copy of the statutes of the
200 See Annas, ‘The Label of Authenticity: A Certification Trademark for Goods and Services of
Indigenous Origin 3190’, [1997]Aboriginal Law Bulletin 4–8.
201 See in this respect the references made to registration in the various contributions to the
advantages of collective and guarantee marks.
202 See discussion supra, at III.1.II.1.(a)(bb).
203 This does not necessarily mean that every trademark contains specific rules on collective
marks. For instance, in the discussion paper by the Maori Trademark Focus Group (Sec. 3,
fn. 59) it was pointed out at p. 31 that the New Zealand trademark law at that time did not
provide for special provisions on collective marks.
association, in particular the clauses regulating the use of the sign, in order to
allow for public inspection and supervision.
Certification marks (guarantee marks) are a special form of collective marks
which guarantee to the public that the products bearing them fulfil certain quality
standards, which are specified and controlled by the association for which the
mark has been registered. Often, but not necessarily, the trademark acts distin-
guish between both types of marks and stipulate even stronger public control
measures for certification marks than for ‘ordinary’ collective marks.
Collective and guarantee marks have played an important role in the history
of trademark legislation. Their number today as compared to ordinary, individual
marks is relatively small, which does not mean that they are insignificant in
practice. In many industrialized countries, the interest in collective marks, in
particular the so-called eco-labels, has increased in recent years in proportion to
rising ecological awareness. Therefore, it is quite plausible to assume that there
might also be a growing marketing potential for marks certifying the authenticity
of traditionally manufactured items or other products, etc.
Of course, the generally very positive options resulting from the registration
of collective marks are not without certain difficulties and drawbacks. This is also
reflected in some of the comments contained in the FFM reports, where it is
pointed out that a major disadvantage of trademark protection lies in the fact that
registration is costly. This is certainly true. The financial aspects become even
more onerous when taking into account not only the registration fees as such, but
also possible costs arising in the larger context of trademark management, such as
monitoring and litigation. A scheme for reduced fees in favour of indigenous
(collective) marks, as has been proposed in the FFM reports, would be of some
help, although it would only be effective with regard to the fees, and would not
alleviate the financial burden with respect to other costs incurred in connection
with trademark maintenance. Of course, it is also possible that those other
expenses should be borne to some extent by public sources, as will typically be
the case when the organization registering the mark is wholly or partly funded by
the state, or is entitled to claim subsidies.
One important element to be considered if collective marks are to function to
the benefit of indigenous communities or other holders of TK is the legal structure
that must be in place for handling the registration and use of the mark. Ideally, the
right holder should be an organization - private or public – representing all or at
least a substantial part of TK holders whose interests may be affected.204 Other
constructions are, of course, also possible; any lawfully founded association is
204 The authenticity label developed in Australia (see Part III. Sec.Sec. 3,I.) was intended to be
administered by the National Indigenous Arts Advocacy Association (NIAAA), with the
assistance of The Aboriginal and Torres Strait Islander Commission (ATSIC), but the initiative
has since faltered and both organizations have ceased to exist. The more recently launched
Maori Made Mark (supra, I. 8.) is a registered mark which for the time being is owned by the
Arts Council of New Zealand (Creative New Zealand). However, it is envisaged that after
establishment of the mark, ownership will be transferred to an autonomous Maori entity; see
WIPO/GRTKF/IC/4/INF/2, at no. 80. For the administration of the ‘igloo’ tag in Canada, a
entitled as a matter of principle, to register collective marks in its own name. It can
be assumed however, that the beneficial effects to be gained from the use of such
marks are clearly linked to the ‘moral legitimization’ of the right holder, i.e., to the
respect and confidence it receives from those indigenous groups who are the
primary producers of the goods to be designated by the sign.
Apart from the issue of organizational structure, a successful use of collective
marks depends, like any trademark use, on the marketing strategy applied. This
means, inter alia, that a marketing concept has to be developed and the
commercial aims must be clearly defined before the mark is launched. The overall
concept must further include the establishment and supervision of distribution
channels and the development of schemes for accompanying advertising cam-
paigns and further public relations measures.
The rights conferred by collective and guarantee marks are usually the same
as for ordinary trademarks, i.e., the mark is generally protected against the
likelihood of confusion resulting from the use of an identical or similar mark for
the same or similar products. In certain countries, protection may also be granted
against the use for dissimilar goods, if the mark is famous (or has a reputation),
and the use is abusive or detrimental to its reputation or distinctive character.
However, the use of the sign by others must be tolerated as long as it only occurs
outside the commercial sphere, and when it is used for descriptive purposes.
Unlike in the case of ordinary trademarks,205 it is generally accepted that
collective marks, and in particular guarantee marks, are subject to injunction and
cancellation if they do not fulfil their quality function, i.e., if the products to which
the mark is applied no longer live up to the promised standard. In order to ensure
this, guarantee marks are frequently subject to some kind of public control - for
instance, a public authority or a board established by branch organizations may be
entitled to examine, on a more-or-less regular basis, whether the specific quality
claim implied in the mark is still justified. Without such control measures being
taken out by neutral instances, the marks may easily lose their credibility.
(2) Public Certification Systems (Annette Kur)
In order to conclude this survey on the possibilities of making affirmative use of

trademark rights, a concept which to some extent is related to guarantee marks is
considered, although its legal foundations are totally different: certification stamps
and hallmarks administered and granted solely by public authorities. Although
they fulfil largely the same function as (private) guarantee marks, namely to
promote the orientation of consumers towards products having a certain quality or
other certified characteristics, they do not fall into the trademark law
system has been developed which is a combination between public certification stamps and
(private) guarantee marks; see below on this point.
205 The question whether ordinary trademarks own a ‘quality function’ which is protected in the
interest of the general public, i.e., independent of the will and intention of the trademark
owner, is one of the contested issues in trademark law. Usually however, this question is
answered in the negative – in contrast to guarantee marks, as is set out in the text above.
regimes proper, but the regulations on which they are founded form part of
administrative law. Often, these kinds of public certification marks are not
registered as trademarks by the public authorities, although that possibility is not
excluded as a matter of principle. Of course, this does not mean that they are
defenceless vis-à-vis unauthorized use of the same or a similar symbol; only the
legal grounds for sanctions and enforcement would be different: this aspect is
usually regulated in the framework of the administrative rules establishing the
certification stamp or hallmark.
To establish a system of public control marks in order to certify, for example,
that the authenticity of articles manufactured by Aboriginal groups using
traditional techniques has some advantages over the use of ‘private’ guarantee
marks, official stamps are usually considered by the public as being more reliable
because control and management are considered to be more unbiased and stable
than in the case of private, commercially-oriented associations. Another advan-
tage of the creation of a public stamp or hallmark would be that it could be notified
under Article 6ter of the Paris Convention to other Member States, through which
would be granted worldwide immunity against unlawful registration as a
trademark. On the other hand, the implementation of public hallmark systems is
frequently burdened with bureaucracy. Generally speaking, private collective or
guarantee marks systems have an advantage with respect to flexibility and
commercial efficiency.
There is no definite answer as to which model would be the most beneficial
from the point of view of TK stakeholders. The best solution would probably be
to provide the legal and administrative framework for a coexistence between all
possible forms of certification marks, ranging from collective marks used by
associations established on a private basis with a clearly commercial orientation
over mixed structures (guarantee marks used by associations which are party or
wholly funded by the state) to a scheme of one or several public certification
stamps.
An example taken from folklore, the ‘igloo’ tag which has been developed in
Canada in order to distinguish articles of genuine Inuit art from fake products,
shows how the different models can be combined in practice. The sign has been
registered by the Canadian government as a trademark (i.e., it was not just
established by an administrative act). Only legitimate Inuit artists and their
agencies are entitled to attach the sign to their products. In order to ensure control,
each agency is identified by a number which is printed on the label. Labels may
only be printed upon permission by the Department of Indian Affairs and Northern
Development (DIAND).
(3) Geographical Indications (Roland Knaak)
The protection for geographical indications is related to the term ‘indication’. The
indication for a product is the subject matter of this protection, not the product
itself. For this reason tradition-based innovations and creations, as indicated in the
WIPO Report on Fact-Finding Missions on Intellectual Property and Traditional
Knowledge, cannot enjoy protection per se by means of geographical indications.
The protection of geographical indications may only apply to signs indicating
these innovations and creations. In order to be protected as a geographical
indication, indigenous authenticity must have a name or be designated by any
other means indicating its geographical origin. Innovations and creations as such
are covered by other intellectual property rights and only indirectly protected by
geographical indications.
(4) Conclusions (Annette Kur)
The potential of trademark law with respect to proactive protection of products of

TK deserves to be emphasized strongly. By registration of trademarks, in
particular certification marks, at least some degree of indirect protection may be
obtained for achievements that would otherwise fall short of existing protection
schemes, such as traditionally manufactured items, aboriginal instruments, etc.
That the protection obtained in this way can only be called ‘indirect’ is due to the
fact that according to the legal structure of trademark law, it is not the
achievement as such that is protected but rather the sign indicating the commercial
source, or, in certain cases, the geographical origin. In other words, while no
restrictions are imposed with regard to the manufacturing of the object as such, it
is forbidden to commercialize it under the same name. Trade mark protection for
items of TK, or products stemming from a certain region, especially if combined
with rules ensuring control of authenticity and quality, can help to gain a
favourable position on the market for products bearing the mark in question.
It must be noted however, that to make use of the trademark system in a
proactive manner usually requires considerable investments of time and money.
Apart from the costs for the registration as such, the launching of product lines
under a certification mark will only be successful if it is based on solid
organizational structures, and if it is accompanied by thoroughly planned and
closely monitored marketing schemes.
Nevertheless, the use of positive possibilities of trademark protection via
registration of collective or certification marks for indigenous products stemming
from a certain commercial source or geographical region, and/or living up to
specific requirements controlled by a neutral and reliable body, seems to be a way
which is highly recommendable for the future. As was pointed out, no general
preference can be given in that respect to a specific legal structure implementing
the certification mark scheme. Therefore, in conclusion, it is reiterated that the
best solution would be to provide the legal and administrative framework for a
coexistence between all possible forms of certification marks, ranging from
collective marks used by associations established on a private basis with a clearly
commercial orientation over mixed structures (guarantee marks used by associa-
tions that are party or wholly funded by the state) to a scheme of one or more
public certification stamps.
(5) Related Regulation
Other forms of regulation of the labelling agricultural products recognize the

value of TK as embedded in traditional products. Such regulations offer insight
into how tradition may be recognized as the object of specific protection, even
through the indirect means of regulating how products are packaged and labelled.
Notably, EU regulation of traditional specialities guaranteed206 defines ‘tradi-
tional’ as ‘proven usage on the Community market for a time period showing
transmission between generations; this time period should be the one generally
ascribed to one human generation, at least 25 years’.207 It provides for the
registration of agricultural products or foodstuffs, falling within defined catego-
ries, that ‘shall either be produced using traditional raw materials or be
characterized by a traditional composition or a mode of production and/or
processing reflecting a traditional type of production and/or processing’,208 while
expressly excluding products or foodstuffs ‘the specific character of which is due
to its provenance or geographic origin.’ This regulation provides a nuanced form
of protection for the integrity of products that embody TK, such as mozzarella
cheese and lambic beers, without reserving for any particular group or locality
either the use of these traditional methods or the right to label their products.
(cc) Trade Secrets and Confidential Information
The above discussion on international standards concerning unfair competition209

sketches out how the law of trade secrets, confidential information or undisclosed
information may apply to undisclosed TK. Some of the potential limitations
concern the stipulation in some legal standards that information must have
commercial value because of its confidentiality210 (in contrast, say, to purely
spiritual or cultural value); evidentiary difficulties when the basis of the
confidential information is ‘informal’ or not fully documented;211 potential
diffuseness where the boundaries between an indigenous community and the
broader public may be unclear – when does disclosure within an indigenous
community become public?212 – and the ‘privity’ question – given that much TK
206 EC Council Regulation No. 509/2006 of 20 March 2006 on agricultural products and
foodstuffs as traditional specialities guaranteed, Offıcial Journal of the European Union,
(31 March 2006), L 93/1.
207 Ibid., Art. 2.
208 Ibid., Art. 3.
209 See III.1.II.1.(a)(cc) supra.
210 Among numerous examples, see U.S. Economic Espionage Act of 1996 (18 U.S.C.
1831–1839), at § 1839 defining ‘trade secret’ with reference to information that ‘derives
independent economic value, actual or potential, from not being generally known to, and not
being readily ascertainable through proper means by, the public’.
211 Norvill & Milera v. Chapman & Ors, Tickner v. Chapman & Ors (1995) 133 ALR 226;
Margaret Simons, ‘The Meeting of the Waters’ – The Hindmarsh Island Affair, 2003.
212 See Dutfield, ‘TRIPS – Related Aspects of Traditional Knowledge’, [2001] Case W. Res. J.
Int’l L., Vol. 33, 239, 264 et seq., citing the Congressional Research Service, ‘if a shaman or
is commercialized not by the first individual accessing and alienating the
knowledge from the community213 but by downstream actors, it may be difficult
to construct a chain of liability reaching back to the originator of the knowledge.
As noted, on this last point, TRIPS standards do importantly provide a reach-
through requirement, so that a third party cannot benefit inequitably from access
to undisclosed information even when they are not bound directly by the original
obligation to maintain confidentiality. Another key development under national
law was the recognition that indigenous customary law may provide the basis for
the fiduciary relationship and bond of confidentiality when the established legal
conditions are met:214 in effect, customary law constraints on the diffusion of TK
may substitute for the more conventional construction of a duty of confidence.
The development of a right to privacy has also tilted the balance away from a
strictly commercial conception of confidentiality, so that the implementation of
Article 8 of the European Convention on Human Rights (concerning a right of
respect for private and family life) in national law markedly influences the
doctrinal basis of confidentiality, arguably linking it more firmly to a right of
personality.215 Thus the protection of undisclosed TK may be construed as a
defence of the collective personality of an indigenous people.216
As noted, the more limited focus of most trade secret protection, in contrast
to the more general and supple protection of confidential information under
common law, may restrict protection to TK that has commercial value by virtue
of its secrecy. Some communities do elect to commercialize certain aspects of
their knowledge as trade secrets. For instance, one WIPO survey reports: ‘the
Unaaq Fisheries, owned by the Inuit people of Northern Quebec and Baffin Island
is involved in fisheries management. The company regularly transfers proprietary
technologies to other communities using its own experience in the commercial
fishing industry. The techniques it develops are protected as trade secrets’.217
Documentation of TK has at times led to the unwitting and detrimental loss
of confidentiality of TK and the entry of TK into the public domain. Accordingly,
documentation projects need to be planned and implemented so as to safeguard
and reinforce desirable confidentiality, rather than to erode or negate it. Practical
capacity building initiatives, directed to the communities themselves, have
accordingly been launched to strengthen and safeguard confidentiality even while
other individual has exclusive access to information because of his status in the group, that
individual or the indigenous group together probably has a trade secret’ ; see also Cottier, ‘The
Protection of Genetic Resources and Traditional Knowledge: Towards More Specific Rights
and Obligations’ in [1998] World Trade Law, Journal of International Economic Law, 570.
213 Russell Barsh, Pharmacogenomics and Indigenous Peoples: Real issues and actors. Cardozo
Journal of Comparative and International Law 11 (2): 365–391.
214 Foster v. Mountford and Rigby (1976) 29 FLR 233.
215 Campbell v. MGN Ltd [2004] 2 A.C. 457.
216 A construction discussed in Taubman, supra.
217 WIPO/GRTKF/IC/2/9, at 5.
documentation continues.218 Dutfield219 reports a project in Ecuador that tries to
establish trade secret protection as the basis of standardized know-how licences in
the TK field. An NGO known as Ecociencia is documenting the knowledge of
participating groups in closed-access databases. To do this, a cross-check is
performed to see whether the knowledge is already in the public domain or
whether it is co-owned by other communities. The resulting entries, which
constitute trade secrets, are used as the basis for standardized benefit-sharing
contracts with companies to which the respective knowledge is then disclosed
upon request. The Cultural Ecosystem Stories Project under development by the
Tulalip Tribes provides for preservation of TK – ‘half-a-million records related to
biodiversity conservation, indigenous rights, traditional knowledge, sustainable
livelihoods, conservation biology, community-based conservation, poverty
alleviation and related topics’ which is compiled together with distinct safeguards
for tribal traditional knowledge that is sacred or sensitive ‘and is held privately by
the Tulalip Tribes’.220 By contrast, the Tribes have decided concerning some
non-traditional knowledge ‘to make this publicly available in order to help
promote intercultural understanding and the better protection of Mother Earth’.
(dd) Recognition of Customary Law in National IP Laws
As discussed above,221 a consistent need identified by indigenous and local

communities has been for protection to recognize the customary law of the
communities. Recognition of customary law is often counter-posed against IP law:
contrasting and distinct sui generis forms of TK protection based on customary
law would redress inherent deficiencies in IP law. However, at the level of
principle, there is no fundamental dichotomy between IP law as such and the
recognition of customary law. Customary law may impose constraints on the use
of TK by certain third parties other than the recognized holder of TK, in the
manner of IP laws. Even conventional IP laws can apply customary law to
determine such matters as ownership and equitable interest. In practice, it is no
novelty, but is a reasonably well established practice, for the existing system of IP
law to give discrete recognition to distinct aspects of customary law. Such
practical recognition of applicable elements of customary law may be more useful
than integrating entire bodies of customary law as binding law within IP laws of
wider application, and may be more equitable than entirely setting aside
customary law as irrelevant or wholly inapplicable. Existing IP law systems have
already acknowledged customary law, as a specific point of reference rather than
as a complete legal system, in a number of practical contexts. These include
references to customary law either as fact or as law:222
218 WIPO/GRTKF/IC/5/5.
219 Dutfield, Graham, “Intellectual Property Rights, Trade and Biodiversity” (London, 2000).
220 <www.culturalstories.net/>.
221 Sec. III.1.I.7 supra.
222 The following analysis is draws directly on the author’s earlier analysis in Taubman, Saving
the Village, note 49 supra.
– to establish legal standing223 of a collective entity (such as a tribe or
community) recognized under customary law, even on the part of an
unincorporated entity,224 or to establish other relevant legal capacity: this
may be important where an IP or other law requires recognition of a
collective or community as a ‘legal person’;
– to apply customary dispute settlement mechanisms to resolve or reconcile
competing claims of ownership, and to resolve disputes more generally
between or within traditional communities;225
– to assert an equitable interest (in rem) in IP that is nominally owned by
another, or a more general fiduciary relationship (in personam) between
traditional owners and an individual IP right holder;226
– to sustain a claim of breach of confidence relating to secret sacred
material,227 and to recognize customary law considerations as ‘substantial
concerns’ in sustaining a claim of confidentiality;228
– to confer legal identity on a community as the basis of collective ownership
of an IP right;229
– as the basis of a general right over biological resources and TK,230
including specific rights to grant access to biological resources231 and the
application of prior informed consent for access, as well as general rights
to benefit from TK;
– to enshrine a distinct right for continuing customary use in spite of or in
parallel with formally recognized rights in TK;
– as the basis for a claim against public order, cultural offence232 or
vilification, or more specifically to determine entitlement for damages
223 Onus v. Alcoa of Australia Ltd. ((1981) 149 CLR 27): ‘the members of the [Gournditichjmara]
community are the guardians of the relics according to their laws and customs and they use
the relics. I agree . . . that in these circumstances the applicants have a special interest in the
preservation of these relics, sufficient to support locus standi’, per Mason J.
224 Foster v. Mountford and Rigby (1976) 29 FLR 233, concerning the Pitjantjatjara Council.
225 See Republic of the Philippines, Indigenous Peoples’ Rights Act, Sec. 65.
226 Bulun Bulun v. R&T Textiles Pty Ltd (1998) 41 IPR 513.
227 Foster v. Mountford and Rigby, fn. 87 supra.
228 Gordon Coulthard v. The State of South Australia.
229 Note the latitude accorded to the definition of ‘association’ in the Paris Convention (Art. 7bis)
for collective marks, requiring the protection of collective marks ‘belonging to associations
the existence of which is not contrary to the law of the country of origin, even if such
associations do not possess an industrial or commercial establishment’ even where ‘such
association is not established in the country where protection is sought or is not constituted
according to the law of the latter country’.
230 Art. 8, African Model Legislation, fn. 235 supra.
231 Art. 8(1)(ix), African Model Legislation, fn. 235 supra.
232 For example, New Zealand’s Trade Marks Act 2002 (Sec. 17(1)(b)) establishes absolute
grounds for refusal of a trademark that would ‘offend a significant section of the community,
including Maori.
based on ‘personal and cultural hurt’,233 including establishing the basis for
and quantum of damages; and
– to determine the status of a claimant as a member of an Indigenous or other
traditional community, to identify a community as being an eligible local
or traditional community,234 or to establish a specific Indigenous or
aboriginal right.235
Customary law considerations can therefore be acknowledged in practice within

legal systems that are theoretically distinct or even legally independent from the
original legal reach of customary law obligations. Customary law can also apply
to the operation of IP law on such matters as the legal identity of communities as
such, ownership or inheritance of rights, equitable interests in an IP right, and a
continuing right to use material covered by an IP right.
(ee) Sui Generis Protection of TK under National Law
(1) General
The following section reviews twelve representative sui generis and related laws
that provide an overview of the diverse approaches taken at the national level236
and at the regional level: for clarity of analysis, two regional model laws237 are
233 M*v. Indofurn Pty Ltd (1995) 30 IPR 209, discussed in Terri Janke, ‘Minding Culture’,
WIPO/GRTKF/STUDY/1, 2002.
234 The definition of local community in Brazil’s sui generis law refers to a group that
traditionally organizes itself through successive generations and through its own customs and
preserves its social and economic institutions (Art. 7(iii)).
235 For example, the definition of ‘aboriginal right’ in R. v. Van der Peet, (1996) 2 SCR 507,
subsequently elaborated in Delgammuukw v. British Columbia ([1997] 2 SCR 1010) to
incorporate both common law and aboriginal perspectives, including prior aboriginal law.
236 Brazilian Provisional Measure No. 2186–16 of 2001 Regulating Access to the Genetic Heritage,
Protection of and Access to Associated Traditional Knowledge (‘Brazilian law’); Chinese Patent
Law of 2000 (‘Chinese Patent Law’) and the Regulations on the Protection of Varieties of Chi-
nese Traditional Medicine (‘TCM Law’); Costa Rican Law No. 7788 of 1998 on Biodiversity;
Indian Biological Diversity Act of 2002 (‘Costa Rican Law’); Panama Law on The Special In-
tellectual Property Regime upon Collective Rights of Indigenous Communities, for the Protec-
tion of their Cultural Identities and Traditional Knowledge (‘Panama Law’); Peruvian Law No.
27,811 of 2002 Introducing a Protection Regime for the Collective Knowledge of Indigenous
Peoples Derived from Biological Resources (‘Peruvian Law’); the Philippines Indigenous
Peoples Rights Act of 1997 (‘Philippines Law’); the Portuguese Decree Law No.118 of 2002 Es-
tablishing a Legal Regime of Registration, Conservation, Legal Custody and Transfer of Plant
Endogenous Material (‘Portuguese Law’); Thai Act on Protection and Promotion of Traditional
Thai Medicinal Intelligence, B.E 2542 (‘Thai Law’); and the United States of America Indian
Arts and Crafts Act of 1990 (‘US Law’) as well as the Database of Official Insignia of Native-
American Tribes maintained by the US Patent and Trademark Office.
237 African Model Legislation for the Protection of the Rights of Local Communities, Farmers
and Breeders, and for the Regulation of Access to Biological Resources of 2000 (‘African
law’); and Pacific Regional Framework for the Protection of Traditional Knowledge and
Expressions of Culture (2002);
also covered here rather than in a separate section. This section therefore covers
many of the laws that contributed to the work of the WIPO IGC on sui generis
protection,238 and that were therefore a key source in the formulation of the draft
objectives and principles discussed above.239 These laws are diverse in their
objective and their legal form, in their linkage with TK and in diverse ways of
‘protecting TK’. They range from
– elaborations of mainstream patent law principles applied to TK

subject matter (the protection of many new formulations of
traditional Chinese medicine under the Chinese Patent Law),
– through various forms of biodiversity legislation implementing
national obligations under the CBD that also have the effect of
protecting relevant TK (such as the Costa Rican and Indian laws)
in a manner akin to IP protection,
– through distinct sui generis rights over TK as such, with specific
registration mechanisms (Peruvian Law) and a focus on specific
areas of technology (such as the concentration on medical
knowledge in the Thai law),
– through broader systems of recognizing indigenous rights (Phil-
ippines Law),
– to a sui generis unfair competition style measure (US law) aimed
at protecting traditional handicrafts embodying TK to some extent
(more suitably classified as traditional cultural expressions, but
cited here as exemplifying the inevitable crossover between the
two areas of subject matter).
The chief common element is that they operate in some way to protect TK in the
essential IP-related sense of providing for measures to prevent certain third-party
acts of use or appropriation of TK itself or of readily appropriable aspects of TK.
Analysts and commentators often set ‘IP protection’ in opposition to sui
generis protection, generally with a view to criticizing the IP approach for being
ill-adapted to TK subject matter — in contrast, for instance, with protection based
on the customary law of the source community so as to avoid unwanted
propertization or commodification of TK. However, this form of analysis may
238 See in particular the summary of the laws in document WIPO/GRTKF/IC/5/INF/4, and the
many references to these laws passim in documents WIPO/GRTKF/IC/5/7, WIPO/GRTKF/
IC/5/8, WIPO/GRTKF/IC/6/4, WIPO/GRTKF/IC/7/5, WIPO/GRTKF/IC/7/6, WIPO/GRTKF/
IC/8/5 and WIPO/GRTKF/IC/9/INF/5. The present review does not replicate this analysis but
draws on the text of the same laws to provide a general survey of the range of sui generis laws
and models at the national and regional level.
239 Establishment of a Database Containing the Official Insignia of Federally and State Recognized
Native American Tribes, United States Patent and Trademark Office, Number 165), Federal
Register: 24 August 2001 (Volume 66, Number 165), p. 44603–44605. See also Jeanne Holden,
‘The U.S. Approach: Genetic Resources, Traditional Knowledge, And Folklore, Focus on Intel-
lectual Property’, at <usinfo.state.gov/products/pubs/intelprp/approach.htm> (January 2006).
entail a category error: the IP aspect of protection essentially relates to the
entitlement to determine the rights of third parties concerning access, use or
dissemination of TK or products or processes making use of TK, or connected in
some other manner; from another viewpoint, it concerns the liabilities of third
parties to respect the originators or custodians of TK: as Cornish has observed,
‘ “intellectual property” shades off into surrounding forms of civil liability’.240
Thus a comprehensive holistic approach to sui generis protection would deal with
third parties’ responsibilities, constraints and use entitlements – the general IP
aspect – whether or not through the formal institution of property rights as such,
just as the broader law of IP may equivocate on the question of whether distinct
property rights are granted (as it does in the case of the law of confidentiality,
passing off, geographical indications and other variants of the law of unfair
competition).
(2) Objectives of Sui Generis Protection
The diversity of policy frameworks for protecting is illustrated by the distinct

objectives articulated in these laws, despite the common thread of a sui generis
protection of aspects or forms of TK:
– The omnibus African Union model law aims ‘to ensure the conservation,
evaluation and sustainable use of the biological resources, and knowledge
and technologies in order to maintain and improve their diversity;’ and
to recognize, protect and support the inalienable rights of local commu-
nities, including farming communities, over their . . . knowledge and
technologies; to recognize and protect the rights of breeders; to provide
an appropriate system for access to . . . community knowledge and tech-
nologies; to promote mechanisms for fair and equitable sharing of ben-
efits arising from the use of . . . knowledge and technologies; to ensure
the effective participation of concerned communities in deciding on the
distribution of benefits deriving from . . . knowledge and technologies;
to encourage national and grassroots scientific and technological capac-
ity; to provide mechanisms for implementation and enforcement of
rights of local communities and conditions of access to biological re-
sources, community knowledge and technologies.
– The Brazilian law regulates
access to components of the genetic heritage . . . access to traditional
knowledge relating to the genetic heritage; the fair and equitable
sharing of the benefits deriving from exploitation of . . . associated
240 W.R. Cornish, Intellectual Property, (1999), p. 761, cited in document WIPO/GRTKF/IC/7/5
(20 August 2004)
traditional knowledge; and access to and transfer of technology for the
conservation and use of biological diversity.
– The Chinese Patent Law aims ‘to encourage inventors, and promote
technological innovation; and to provide an important and effective means
of intellectual property protection for traditional medicine’, and the
Regulations on the Protection of Varieties of Chinese Traditional Medicine
aim inter alia to promote ‘the equitable distribution of the environmental,
economic and social benefits to all sectors of society, paying special
attention to local communities and indigenous peoples’.
– Costa Rican Biodiversity Law aims
to regulate access and in so doing make possible the equitable
distribution of the environmental, economic and social benefits to all
sectors of society, paying special attention to local communities and
indigenous peoples; to recognize and provide compensation for the
knowledge, practices and innovations of indigenous peoples and local
communities in the conservation and sustainable use ecological of the
components of biodiversity; to recognize the rights deriving from the
contribution of scientific knowledge to the conservation and sustain-
able ecological use of the components of biodiversity.
– The Indian Law provides for conservation of biological diversity, sustain-
able use of its components and fair and equitable sharing of the benefits
arising out of the use of biological resources and knowledge.
– Peru’s sui generis TK law aims
to promote respect for and the protection, preservation, wider appli-
cation and development of the collective knowledge of indigenous
peoples; to promote the fair and equitable distribution of the benefits
derived from the use of that collective knowledge; to promote the use
of the knowledge for the benefit of the indigenous peoples and
mankind in general; to ensure that the use of the knowledge takes
place with the prior informed consent of the indigenous peoples; to
promote the strengthening and development of the potential of the
indigenous peoples and of the machinery traditionally used by them to
share and distribute collectively generated benefits under the terms of
the regime established by the law; and to avoid situations where
patents are granted for inventions made or developed on the basis of
collective knowledge of the indigenous peoples of Peru without any
account being taken of that knowledge as prior art in the examination
of the novelty and inventiveness of the said inventions.
– The Philippines Indigenous Peoples Rights Act aims
to recognize, protect, and promote the rights of Indigenous Cultural
Communities and Indigenous Peoples; to provide for a system of
community intellectual rights protection in respect of the innovative
contribution of both local and indigenous cultural communities in the
matter of development and conservation of genetic resources and
biological diversities; to recognize, preserve and maintain the knowl-
edge, innovations and practices of small farmers and local communi-
ties embodying traditional lifestyles relevant for the conservation and
sustainable use of plant agrobiodiversity and to promote their wider
application with the involvement of the holders of such knowledge; to
stimulate and contribute to their conservation for coming generations
as a part of the national heritage and the heritage of mankind; to
promote the conservation, legal safeguarding and transfer of autoch-
thonous plant material of current or with potential interest to agrarian,
agroforest and landscape activity, including the local varieties and
spontaneously occurring material.
– The Thai law focuses on protection and promotion of traditional Thai
medicinal intelligence, defined as knowledge and capability concerning
medicinal procedures, traditional Thai massage, the production of tradi-
tional Thai drugs and the invention of medical devices on the basis of
knowledge or texts that are passed between generations.
– The United States measures are intended to protect and preserve cultural
heritage; and to prevent commercial interests from falsely associating their
goods or services with indigenous peoples’,241 this objective underscores
the closer linkage of these laws to the protection of TCEs as such but also
highlights the crossover between IP protection, general consumer protec-
tion and truth in marketing measures: in this connection, a recent report has
proposed that the UN Permanent Forum on Indigenous Issues ‘might be
able to advocate initiatives, such as the creation of an indigenous label
similar to the Fairtrade Certification mark, in order to identify indigenous
ownership’.242
(3) Legal Basis for Protection
A WIPO study on legal options for sui generis protection243 identified five main
doctrinal approaches that had been employed:
– the grant of exclusive rights for TK, including (i) use of existing IP rights;
(ii) modified, adapted or extended forms of conventional IP rights; or (iii)
sui generis measures granting newly defined exclusive property rights;
– the principle of prior informed consent applied to TK;
241 WIPO/GRTKF/IC/3/10, at p. 38–39.

242 Note supra, at 17; see also discussion of certification and collective marks passim in this
chapter.
243 Outline Of Policy Options And Legal Elements, WIPO/GRTKF/IC/7/6 (27 August 2004).
– a compensatory liability or domaine public payant approach;
– an unfair competition approach;
– the recognition of customary law.
These doctrines are mutually exclusive, and two or more elements may be linked
together in the one legal measure: for instance, customary law may provide the
procedural framework for the grant of prior informed consent, or for determining
ownership or other entitlements such as equitable compensation. As well as this
cluster of IP-related doctrines, sui generis TK laws also commonly provide for the
complementary objectives of preservation (the documentation, registration or
other recordal of TK) and promotion (policy measures to foster the maintenance
and application of TK for social welfare in relation to health, the environment and
the protection of cultural heritage, addressing either the interests of society as a
whole or of designated communities of beneficiaries). The following analysis
concentrates on the IP aspects of protection, not to scant these other important
policy objectives, but to respect the particular focus of this chapter. These laws
promote such policy objectives by engendering a climate of respect and specific
legal means of protecting the legitimate interests of the holders of TK, and
creating incentives for the preservation intact of TK systems or for continuing
innovation within the traditional framework (for instance, both the Chinese and
Thai laws cited here explicitly recognize innovation within their respective
traditions of medical knowledge).
(4) Forms of Knowledge Protected
The nature of the aspects or manifestations of TK that are protected under these
laws differs considerably: this reflects the inevitable, natural diversity in knowl-
edge systems as much as the diverse policy contexts of these laws. Several laws,
reflecting their structure and objective as laws protecting genetic resources,
explicitly yoke protectable TK to biodiversity or similar concepts such as genetic
heritage, an implicitly limiting condition that would on the face of it exclude
forms of TK such as medical techniques or the know-how used to create certain
handicrafts (the broader term ‘biological resources’ would create a less narrow
condition, not requiring for instance the presence of functional units of heritage
that help define ‘genetic resources’244):
– Brazil’s law protects ‘associated traditional knowledge’, defined as:

‘information or individual or collective practices of an indigenous or local
community having real or potential value and associated with the genetic
heritage’ (Article 7(ii);
– India’s law references the protection of ‘knowledge of local people relating
to biological diversity’ (Article 36(5)): other initiatives in India would
244 Convention on Biological Diversity, Art. 2.

address TK as such more generally (such as systems of codified medical
knowledge);
– Peru’s Law, while a self-standing system of TK protection, extends
protection to ‘collective knowledge of Indigenous peoples that is con-
nected with biological resources’ (Article 3): in turn, ‘collective knowl-
edge’ is defined as ‘the accumulated, transgenerational knowledge evolved
by indigenous peoples and communities concerning the properties, uses
and characteristics of biological diversity’ (Article 2(b));
– The Pacific model defines TK as any knowledge that generally: (a) is or has
been created, acquired or inspired for traditional economic, spiritual, ritual,
narrative, decorative or recreational purposes; and (b) is or has been
transmitted from generation to generation; and (c) is regarded as pertaining
to a particular traditional group, clan or community of people in [Enacting
country]; and (d) is collectively originated and held.
The African model law is the most comprehensive. It covers biological resources,
their derivatives, ‘and community knowledge and technologies’. (Article 2(1)(i)-
(iii)), and defines ‘community knowledge’ as ‘the accumulated knowledge that is
vital for conservation and sustainable use of biological resources and/or which is
of socio-economic value, and which has been developed over the years in
indigenous/local communities’. Accordingly, it is linked with but is not limited to
the CBD objectives of conservation and sustainable use of genetic resources. A
distinctive approach is found in the Thai law which, in line with its specific
purpose, is restricted to Thai medical knowledge, including forms of treatment
and massage, as well as formulations and innovations, but for the purpose of
defining the manner of IP protection the law categorizes formulas of Thai drugs
or texts on traditional Thai medicine as being national (of particular value and
significance), general (widely diffused through society), or personal (TK that is
personally-invented, improved or inherited). Similarly, the Peruvian law identifies
three forms of registration of collective knowledge of indigenous peoples: a
Public National Register, a Confidential National Register, and Local Registers.
The Portuguese Law defines TK as comprising
all intangible elements associated with the commercial or industrial

utilization of local varieties and other autochthonous material developed
in a non-systematic manner by local populations, either collectively or
individually, which form part of the cultural and spiritual traditions of
those populations.
This includes but is not limited to
knowledge of methods, processes, products and designations with

applications in agriculture, food and industrial activities in general,
including traditional crafts, commerce and services, informally associ-
ated with the use and preservation of local varieties and other sponta-
neously occurring autochthonous material covered by the Law.
(5) Beneficiaries of Protection
A general principle is clearly recognized in these laws: protection of TK should

benefit the traditional holders or custodians. But cultural and legal differences, as
well as differences in the objectives of protection, lead in practice to much
diversity in how beneficiaries or right holders are defined national legislation:
– ‘Local Community’ defined as ‘a human population in a distinct geographi-

cal area, with ownership over its biological resources, innovations,
practices, knowledge, and technologies governed partially or completely
by its own customs, traditions or laws’. (African Model Law)
– ‘Local community’, defined as ‘a human group, distinguished by its
cultural conditions, that traditionally organizes itself throughout successive
generations and through its own customs and preserves its social and
economic institutions’ (Brazil)
– Indigenous Cultural Communities and Indigenous Peoples (ICCs/IPs),
defined as
a group of people or homogenous societies identified by self-
ascription and ascription by others, who have continuously lived as
organized community on communally bounded and defined territory,
and who have, under claims of ownership since time immemorial,
occupied, possessed and utilized such territories, sharing common
bonds of language, customs, traditions and other distinctive cultural
traits, or who have . . . became historically differentiated from the
majority of Filipinos. (Philippines)
– indigenous peoples and communities’, defined as ‘aboriginal peoples
holding rights that existed prior to the formation of the Peruvian State,
maintaining a culture of their own, occupying a specific territorial area and
recognizing themselves as such’. (Peru)
– An entity that represents the interests of the region from where the
knowledge originated. (Portugal)
– ‘those who have registered their intellectual property rights on traditional
Thai medical intelligence under the law’ (Thailand)
– any Indian tribe, band, nation, Alaska Native village, or other
organized group or community which is recognized as eligible for the
special programmes and services provided by the United States to
Indians because of their status as Indians; or any Indian group that has
been formally recognized as an Indian tribe by a State legislature or by
a State commission or similar organization legislatively vested with
State tribal recognition authority. (United States)
– A title holder ‘determined by a participatory process with indigenous and
small farmer communities’ (Costa Rica)
– Benefit claimers, defined as including ‘creators and holders of knowledge
and information relating to the use of such biological resources, innova-
tions and [associated] practices’ (India).
– the group, clan or community of people; or the individual who is
recognized by a group, clan or community of people as the individual; in
whom the custody or protection of the [TK] are entrusted in accordance
with the customary law and practices of that group, clan or community.
(Pacific law)
The factors typically drawn on in establishing entitlement include (i) self-

identification as a community; (ii) external recognition, whether for the purposes
of the law itself (such as through registration under the law) or under more general
laws recognizing specific communities; and (iii) ownership or custodianship of
the knowledge, or other form of association with a knowledge tradition.
(6) Manner of Protection
Corresponding to diverse legal bases and doctrines for protection, the form and
scope of protection also differs considerably between these laws, although there is
fundamental commonality at the level of principle: recognition of residual rights
and interests in TK, forms of prior informed consent, acknowledgement of the
originators of TK, and an equitable flow of benefits back to them.
(i) Prior Informed Consent

Given the crucial importance of protection at the point of access of TK – which
may also be construed as the first act of alienation or appropriation of knowledge
from its traditional environment – one legal mechanism is the establishment or
recognition of a specific entitlement to grant or withhold prior informed consent
(PIC). This form of TK protection extends the principle of PIC that is more
generally recognized in the context of genetic resources,245 and can overlap
directly laws granting PIC over genetic resources associated with the TK.246
Hence the Peruvian law requires access to collective knowledge for scientific,
commercial or industrial use to be conditional on the prior informed consent of the
representative of indigenous peoples owning that knowledge.247 One explict
objective of the law is to ensure that TK is used with the PIC of indigenous
peoples. Brazil’s law requires a Management Council to deliberate on ‘authori-
zation of access to associated TK, subject to the prior consent of the owner’.248
Establishing the prior informed consent of an indigenous community fre-
quently entails reference to customary law. The Peruvian law was amended during
245 Convention on Biological Diversity, Art. 15.4.

246 Free prior informed consent is increasingly referred to in policy discourse, in view of the
evolution of this principle as applied to TK (see discussion at III.1.II.1.(c)(ee) 6(i)).
247 Peruvian law (Art. 6).
248 Brazilian law, Art. 11(IV)(b).
the legislative process to confirm this linkage. The Philippines law conditions
access to indigenous knowledge related to the conservation, utilization and
enhancement of biological and genetic resources within ancestral lands and
domains of the on the ‘free and prior informed consent of [ICCs/IPs], obtained in
accordance with customary laws of the concerned community’. (Section 35) Free
and prior informed consent is defined as ‘the consensus of all members of the
ICCs/IPs to be determined in accordance with their respective community laws
and practices, free from any external manipulation, interference and coercion, and
obtained after fully disclosing the intent and scope of the activity, in a language
and process understandable to the community’. (Section 3(g)).
The Philippines Law provides for the primacy of customary law in the event
of conflict of law:
Customary laws, traditions and practices of the ICCs/IPs of the land

where the conflict arises shall be applied first with respect to property
rights, claims and ownerships, hereditary succession and settlement of
land disputes. Any doubt or ambiguity in the application and interpre-
tation of laws shall be resolved in favor of the ICCs/IPs. (Section 63)
In other cases, access is subject to a distinct decision-maker, who must take due
account of the traditional holders. Thus the Portuguese law provides that access to
TK for purposes of study, research, improvement or biotechnological applications
shall be subject to prior authorization by [a defined Technical Council], the owner
of the registration having been heard. (Article 7(1)). Due process and consultation
is a common emphasis in prior informed consent provisions. The Peruvian law
requires that indigenous representative organization whose PIC is sought ‘shall
inform the greatest possible number of indigenous peoples possessing the
knowledge that it is engaging in negotiations and shall take due account of their
interests and concerns, in particular those connected with their spiritual values or
religious beliefs’.
(ii) Exclusive Rights

The mainstream approach to protection is the definition of IP-style rights over TK,
in effect the vesting in beneficiaries or owners the entitlement to take or request
legal action in the event of third parties undertaking prescribed use of the TK.
Typically, the rights cover acts of commercialization or industrial use, but (closer
in form to copyright or protection of confidential information) may also cover
acts of dissemination or diffusion of the knowledge; exceptionally, forms of
‘moral rights’ or rights to object to distortion or offensive use may also be
recognized.249 These ‘IP rights’ may fall short of true intangible property rights
249 For instance, in relation to TK, the Pacific law provides for the right of attribution of
ownership, the right not to have ownership falsely attributed to them, and the right not to have
their TK subject to derogatory treatment. The African model law recognizes the linkage
between third party use and the erosion of cultural identity, recognizing the right of local
(for instance, they may not be freely assignable), yet illustrate the uncertainty of
the boundary between intangible property rights as such and the broader law of
civil liability.
The relationship between exclusive rights so conceived and the right to give
prior informed consent is exemplified in the Pacific model law, which provides for
a specific offence if ‘a person makes a non-customary use’ of TK (commercial or
otherwise), and ‘the traditional owners have not given their prior and informed
consent to that use’.
Reflecting its broad objectives, the Philippines Law provides for a wide range
of entitlements that extend well beyond IP-style rights as such, including rights to
practice and revitalize cultural traditions and customs; rights to restitution of
cultural, intellectual, religious and spiritual property taken without their free and
prior informed consent or in violation of their laws, traditions and customs; and
rights to special measures to control, develop and protect their sciences,
technologies and cultural manifestations. Thus even the IP aspect of protection
extends to indigenous science and technology systems conceived as such, not only
atomistic components or items of TK.
Peru’s law protects against the disclosure, acquisition or use of collective
knowledge without the consent of the indigenous peoples and in an improper
manner, and against unauthorized disclosure in conflict with a confidentiality
agreement. Portugal’s law provides for a right of objection to ‘direct or indirect
reproduction, imitation and/or use by unauthorized third parties for commercial
purposes;’ unusually, the right holder is entitled to assign or transfer their rights
in the TK.
Under the Thai law, reflecting an approach broadly analogous to patent rights,
the right holder is accorded exclusive rights over the production of the drug and
the sole right over the research, distribution, improvement or development of
formulas corresponding to the registered text. By contrast, the United States law,
reflecting its focus on truth in marketing, prohibits the offering or displaying for
sale or selling of any good, in a manner that falsely suggests it is Indian produced,
an Indian product, or the product of a particular Indian or Indian tribe or Indian
arts and crafts organization. The Chinese law, naturally reflecting its character as
a patent law, gives the entitlement to ‘prevent third parties not having the right
holders’ consent from making, using, offering for sale, selling or importing the
patented invention’.
The African model law takes a broad sweep, recognizing the rights of
communities over
their innovations, practices, knowledge and technologies acquired

through generations; the right to collectively benefit from the utilization
of their innovations, practices, knowledge and technologies; and their
communities ‘to refuse access to their TK where such access will be detrimental to the
integrity of their natural or cultural heritage’.
rights to use their innovations, practices, knowledge and technologies in
the conservation and sustainable use of biological diversity.
Brazil’s law grants to communities that create, develop, hold or preserve TK

associated with genetic heritage a form of moral right – the right ‘to have the
origin of the access to TK mentioned in all publications, uses, exploitation and
disclosures’ – as well as rights to prevent unauthorized third parties from
undertaking certain acts, including research, further disclosure or dissemination,
and economic exploitation. As in Peru, TK holders are entitled to assign their
rights in TK, a characterestic more in line with true intangible property rights.
In several cases, the scope of rights associated with the protected TK will be
settled through a consultative process, in a radically sui generis form of
protection: thus the Costa Rican law provides that the ‘scope of sui generis
community intellectual rights shall be determined by a participatory process with
indigenous and small farmer communities to be defined by the National
Commission for the Management of Biodiversity’. Similarly, the Indian law
provides that the scope of rights shall be ‘as recommended by the National
Biodiversity Authority’.
While providing a framework for licensing of protected TK, Peru’s law sets
a certain legislative safeguard for guaranteed returns from licensed TK: thus
licenses must at least provide for an upfront payment, which goes towards the
maintenance of collective knowledge, and a percentage of at least 5 per cent of the
value of the gross sales resulting of the commercialization of the products
developed from the licensed collective knowledge. This formula sets an unusually
precise legislative benchmark for what is to be considered equitable remuneration
from the use of TK.
(iii) Domaine Public Payant

Peru’s law recognizes a distinct body of public domain TK – collective knowledge
that has already passed from the traditional context to the general public,
specifically ‘when it has been made accessible to persons other than the
indigenous peoples by mass communication media such as publication or, when
the properties, uses or characteristics of a biological resource are concerned,
where it has become extensively known outside the confines of the indigenous
peoples and communities’. Similarly to domaine public payant systems or
arrangements for recognition of equitable interests when copyright protection is
extended retrospectively, the law deals with the sensitive question of retrospective
recognition of such public domain TK by allowing third party use to continue
subject to equitable remuneration: when TK is used within twenty years of its
falling into the public domain, ‘a percentage of the value, before tax, of the gross
sales resulting from the marketing of the goods developed on the basis of that
knowledge shall be set aside for the Fund for the Development of Indigenous
Peoples’.
(7) Registration
Registration or other recordal of TK for legal purposes remains controversial and

problematic. On the one hand, some degree of clarity and objectivity of title is
valuable to put third parties, including good faith users of TK, on notice as to what
rights are held by TK holders, and what liabilities they owe to TK holders. Some
form of accessible register may therefore be desirable for several IP-related
purposes: (i) clarity of title or custodianship; (ii) positive notice of enforceable
rights; (iii) ease of enforcement. Registration may simply provide notice of an
underlying right, or may actually create the right in itself. In addition, registers
may assist in the promotion and preservation of TK, quite apart from its protection
against illegitimate use by third parties. On the other hand, any requirement for
registration or other formalities creates potential difficulties, including (i) the
enforced disclosure of secret or sacred TK (with potential for accelerating its
misappropriation and misuse), and the inappropriate rendering in fixed form
inherently oral forms of transmission, possibly also stripping the knowledge of its
customary law context; (ii) burdensome procedural requirements on indigenous
and local communities with limited resources, creating the possibility of better
‘organized’ and resourced parties gaining advantages at the expense of more
‘authentic’ or ‘local’ communities.
The laws surveyed here do provide for a wide range of approaches to
registration or documentation. The Panama law provides for registration of TK, at
the request of indigenous authorities, who must undertake certain steps to achieve
this recognition. In view of concerns about equity of access to the system,
registration is free of official fees and does not require the involvement of a legal
practitioner.
Portugal’s law bases protection of TK on its identification, description and
registration in a government register, published in an official gazette. The
registration must be made in a way that allows third parties who reproduce or use
the knowledge to obtain the same results as those obtained by the knowledge
holder. In view of concerns that registration may cause confidential TK to be
divulged to the public, TK holders may keep their knowledge confidential and
restrict publication to information about the existence of the knowledge and the
plant varieties with which it is associated: in that case, however, the rights
afforded are modified to correspond to trade-secret style protection, specifically
protecting against use of the knowledge when unfairly obtained by third parties.
The most elaborate registration system is that of the Peruvian law: as
discussed above, it provides for three levels of registration, reflecting the
perceived need for nuance and responsiveness to the diversity of forms of TK in
the construction of legal mechanisms for its protection: a register of public
domain collective knowledge which is publicly accessible and used to be used as
prior art in examination in the ‘main patent offices in the world’, a national
confidential register of collective knowledge, and local registers of collective
knowledge organized by indigenous peoples in accordance with their practices
and customs, assisted, upon request, by the national IP office. The registers have
the purposes of preserving and safeguarding collective knowledge and the rights
of indigenous peoples to their knowledge, and of providing the authorities with
information enabling it to defend the interests of indigenous peoples concerning
collective knowledge. However, rights to TK are inherent rights, and no formality
is required to acquire or maintain rights. Registration of collective knowledge is
therefore optional, although any license agreements for agreed benefit-sharing
must be registered in order to monitor their compliance with minimum standards
for benefit sharing and transparency.
Registers in general therefore have multiple functions – to register, give
notice of or (more rarely) constitute rights over TK; to promote the use of the
knowledge in accordance with public policy; and to provide information for
reference in patent examination to promote accuracy of decisions on patent grant.
But these purposes map across directly to corresponding roles of patent registers
– recalling that patents are registered to establish title, to pass knowledge to the
public domain and to enhance patent quality. The Traditional Chinese Medicine
database is itself a patent database, which has been used in an international pilot
programme to enhance the recognition of TK in patent proceedings. Generally,
however, given the sensitivities over disclosure of TK, registries tend only to be
optional and may be confidential in nature. The CBD COP has observed that
registers ‘are only one approach to the protection of traditional knowledge’ and
that ‘their establishment should be voluntary, not a prerequisite for protection.
Registers should only be established with the prior informed consent of indig-
enous and local communities’.250 This suggests that – in direct contrast to the
patent system – the general practice in the sui generis protection of TK does not
pivot on the idea of a contract with the public exchanging limited exclusive rights
with full disclosure of the knowledge. This distinctive characteristic suggests that
rights over TK have a different doctrinal and policy basis, and certainly the
discourse concerning rights over TK has a stronger ‘natural law’ or inherent equity
basis than the positivist construction of patent law, which typically resides at the
more utilitarian end of the jurisprudential spectrum. However, the CBD, reviewed
below, illustrates how the utilitarian and equitable bases of TK protection may in
fact be reconciled. The preservation of jurisprudential diversity and protection
against misappropriation of TK may be integral to the conservation of traditional
knowledge systems as a higher-order public good.251
(8) Recognition of Customary Law
Responding to the emphasis laid on recognition of customary law in the

appropriate protection of TK in line with the interests and values of the
250 Convention on Biological Diversity, Conference of Parties Decision VIII/5 (‘Article 8(j) and
related provisions’).
251 An analysis elaborated in Taubman, Saving the Village, note 49 supra.
communities that hold TK,252 sui generis systems for TK protection recognize
customary law in diverse ways, such as:
– Regimes that regulate biological and genetic resources may require prior
informed consent of traditional communities for access to TK.253 This may
entail the application of customary law in the process for determining the
community’s consent, even without any explicit reference.
– The Philippines Indigenous Peoples’ Rights Act of 1997 establishes a
‘right of restitution of cultural, intellectual, religious and spiritual property’
taken inter alia ‘in violation of [indigenous] laws, traditions and cus-
toms’.254 Access to indigenous knowledge is subject to prior informed
consent obtained in accordance with customary laws.255 When a dispute
arises, ‘customary laws and practices shall be used to resolve the
dispute’.256
– Under Costa Rica’s Biodiversity Law257 sui generis community IP rights
and the question of ownership are determined by a participatory process
with indigenous and small farmer communities. Custom is recognized as a
source of law for establishing a sui generis community IP right, which
‘exists and is legally recognized by the mere existence of the cultural
practice or knowledge’ and does not need ‘prior declaration, explicit
recognition nor official registration’.
– The registration of collective IP and TK rights under Panamanian law258
requires the rules of use of the collective right to be determined in part with
reference to the ‘history (tradition) of the collective right’. Some laws for
protecting TK recognize customary practices as exceptions to sui generis
rights,259 so that the creation of new forms of protection does not
unwittingly create a legal barrier to continuing customary practices.
– One objective of the Peruvian Sui Generis Law is ‘to promote the fair and
equitable distribution of the benefits derived from the use of . . . collective
knowledge’.260 The Law recognizes customary laws and protocols in the
context of benefit-sharing, stating that ‘indigenous peoples . . . may have
252 See Secs III.1.I.7 supra.

253 E.g. the need for ‘prior informed consent of the representative organizations of the indigenous
peoples possessing collective knowledge’, Art. 6 of Peru’s Law No. 27,881 of 2002,
Introducing a Protection Regime for the Collective Knowledge of Indigenous Peoples derived
from Biological Resources.
254 s. 32.
255 s. 35.
256 s. 65.
257 Law No. 7788 of 1998, at Arts 82–84.
258 Art. 7(iiii), Executive Decree No. 12 (2001) regulating Law No. 20 of 26 June 2000, on the
Special Intellectual Property Regime Governing the Collective Rights of Indigenous Peoples
for the Protection and Defence of their Cultural Identity and their Traditional Knowledge.
259 See for example, Sec. III.1.II.1(c)(ee)(8) infra.
260 Art. 5(b), Peruvian Sui Generis Law.
recourse to their traditional systems for the purposes of the distribution of
benefits’.261
– The Pacific Regional Model, 2002 defines traditional owners of TK or
expressions of culture as the group, clan or community, or individual
recognized as part of group, clan or community, in whom the custody or
protection of the TK or expressions of culture are entrusted in accordance
with customary law and practices. Disputes over ownership of TK or
expressions of culture are to be resolved according to customary law or
other means.
– Exceptions under sui generis laws for continuing customary use by TK
holders are contained in Article 2(2)(ii) of the African Model Legisla-
tion262; Article 4 of the Brazilian Provisional Measure; Article 4 of the
Peruvian Law; and the Thai law.263
Thus customary law is used in very diverse ways in TK laws at the national level
– as a direct source of law, as part of the factual matrix which the law draws upon,
and as a reserve right safeguarded against the operation of the law. On the one
hand, this suggests that customary law is an important, arguably inevitable,
component of a suitable, tailored means of giving legal protection to TK; on the
other hand, it suggests that no one legal mechanism for the recognition or
application of customary law is likely to be acceptable to all countries establishing
sui generis protection of TK. The international level could provide mechanisms
for mutual recognition of different bodies of customary law or could articulate
broad principles of recognition.
2. Forms of Legal Protection beyond Intellectual Property

at the International Level
(a) Convention on Biological Diversity
The Convention on Biological Diversity (CBD) is a key element of the broader

public international law context for IP protection of TK, together with cultural
heritage law,264 recognition of self-determination265 and human rights law.266 The
three objectives of the CBD concern conservation of biodiversity, the sustainable
261 Art. 10, Peruvian Sui Generis Law. See also Art. 39 which provides that administration of
benefit-sharing through the Fund for the Development of Indigenous Peoples ‘shall to the
extent possible use the machinery traditionally used – by indigenous peoples – for allocating
and distributing collectively-generated benefits’.
262 ‘No legal barriers shall be placed on the traditional exchange system of the local communities
in the exercise of their rights’ (Art. 21(2)) and ‘The legislation does not affect ‘access, use and
exchange of knowledge and technologies by and between local communities;’ (Art.2(2)(ii).
263 Art. 4, Peruvian Sui Generis Law: excludes from this regime ’the traditional exchange
between indigenous peoples of the collective knowledge protected under this regime’.
264 On the role of cultural heritage law in traditional knowledge protection, see further Blake, ‘On
Defining Cultural Heritage’, [2000] International and Comparative Law Quarterly, 61–85.
use of its components, and the equitable sharing of benefits arising from the use of
these resources: this is an environmental treaty, not an IP model law. Yet knowledge
management — the preservation and protection of TK — is recognized as having an
integral relationship with the attainment of the CBD objectives, and there are ac-
cordingly specific obligations under the CBD concerning biodiversity-related TK.
In particular, the knowledge of indigenous peoples and local communities is central
to the sustainable use of the components of biodiversity,267 such as the identification
and application of the active compounds within genetic resources that are used in
the effective application of genetic resources for broader utilitarian objectives.268
The integral relationship of TK and genetic resources is recognized in the
work under the CBD on access and benefit-sharing of genetic resources. The
proposed International Regime on Access and Benefit-Sharing, under negotiation
within the CBD, is currently in the form of a heavily-bracketed set of textual
options in the Annex to CBD COP decision VIII/4 which simply ‘reflects the
range of views held by Parties’ at the relevant working group session.269 This
working text contains numerous references to TK within the overall framework of
an access and benefit-sharing regime for genetic resources, including several
references with an intellectual property element or flavour, such as the itemization
of certain acts of misappropriation concerning genetic resources and associated
TK, and proposed measures to prevent certain uses of associated TK in violation
of the international regime. While the contours of the international regime are
currently still under development and negotiation, it appears likely that it will
have elements of protection of TK associated with genetic resources, including
forms of protection that accord with broader conceptions of IP (in strengthening
the right of PIC over knowledge as such, and defining illegitimate forms of use of
TK by third parties), and some degree of practical or legal interaction with
conventional forms of IP such as the patent system.
In the general debate over TK protection, policymakers, particularly those
working within an essentially utilitarian IP policy framework, have wrestled with
the question of whether IP incentives are required or are appropriate for TK270 –
265 See Simpson, ‘Indigenous Heritage and Self-Determination – The Cultural and Intellectual
Property Rights of Indigenous Peoples,onbehalfoftheForestPeoplesProgramme’(Copenhagen,
1997).
266 On the role of human rights in traditional knowledge protection, see further Coombe,
‘Intellectual Property Human Rights and Sovereignty: New Dilemmas in International Law
Posed by the Recognition of Indigenous Knowledge and the Conservation of Biodiversity’,
[1998] Global Legal Studies Journal 6, 59 et seq.
267 Straus, AIPPI Yearbook 1998/IX, 99 et seq.; Straus, [1993] IIC, 602 et seq.
268 See Seiler & Dutfield, Regulating Access and Sharing of Benefits: Basic issues, legal
instruments, policy proposals, UNEP doc. UNEP/CBD/WG-ABS/1/INF/4, p. 38; see also
Hassemer, Sec. 2.
269 CBD COP decision VIII/4, ‘Access and benefit-sharing’, UNEP/CBD/COP/8/31.
270 This dilemma over incentives is explored further within the setting of a global public goods
policy framework, in Taubman, Saving the Village, fn. 49 supra.
one argument being that almost by definition TK already exists and will continue
to be developed according to existing customary practices without any supple-
mentary incentives being required; that very characteristic is what seems to make
TK ‘traditional’. Yet this argument breaks down in two ways: first, social change
and other external pressures can lead to a loss in incentive to conserve and
maintain TK through traditional means, practices and legal structures. Much TK
is being lost together with its intellectual and juridical context as a new Dark Age
emerges, even as original cultural forms are occluded by the dazzle of mainstream
media; and second, incentives may be needed for TK to be shared beyond the
traditional circle so that the broader public can benefit from its use and
application. The CBD exemplifies how incentives for in situ conservation are
linked to promotion of sustainable ex situ use and sharing of genetic resources.
The linkage is held together, crucially, by a guarantee that benefits from this wider
use will be equitably shared, in turn reinforcing confidence that conservation
efforts will be adequately resourced and encouraged. Thus the CBD both provides
an analogy for the protection and promotion of TK through appropriate incentives,
and provides directly for the preservation of biodiversity-related TK as integral to
the conservation of biological diversity. Within the provision generally concerning
in situ conservation, Article 8(j) requires each Contracting Party,
as far as possible and as appropriate, subject to its national legislation,

[to] respect, preserve and maintain knowledge, innovations and practices
of indigenous and local communities embodying traditional lifestyles
relevant for the conservation and sustainable use of biological diversity
and promote their wider application with the approval and involvement
of the holders of such knowledge, innovations and practices and
encourage the equitable sharing of benefits arising from the utilization of
such knowledge, innovations and practices.
Within the formula ‘traditional knowledge, innovations and practices,’

‘traditional’ qualifies all three elements, not just ‘knowledge.’ This provision
therefore valuably acknowledges that innovation does take place in a traditional
(‘in situ’) context,271 and should be respected and promoted as such – displacing
the widespread assumption that any TK material is uninventive, or has long ago
fallen into the public domain. In turn, this provision clarifies the doctrinal basis for
the sui generis protection of TK. Some uncertainty has lingered over the scope of
TK covered by Article 8(j). Its scope is crucially qualified as ‘embodying
traditional lifestyles relevant for the conservation and sustainable use of biological
diversity’; biological diversity is separately defined as ‘the variability among
living organisms from all sources’. Since this provision falls within the scope of
a general article on in situ preservation on biodiversity, the specific focus is on the
271 Dutfield,(fn. 8 supra), p. 35.

close interaction between knowledge, practice, ways of life and the physical
environment; importantly, other complementary elements of Article 8 deal with
the protection, rehabilitation and restoration of ecosystems. Given that much TK
entails the sustainable use of biological materials (if not genetic resources as
such), this focus may not be seen as unduly restrictive, although there are two key
implications: first, it would exclude TK that has no link to the conservation or use
of biodiversity (such as traditional healing methods which do not make use of
biological materials); and second, it would exclude means of protection and use
of TK that run contrary to the sustainable use of biodiversity, such as when
exploitation of TK actually threatens the conservation of species.272
This specific category of biodiversity-related TK is the subject of direct
protection in a number of countries within national biodiversity laws implement-
ing the obligations under the CBD, such as the Costa Rican and Indian examples
discussed above.
(b) FAO International Treaty
The FAO International Treaty also places the recognition of TK in the context of
its role in the development and maintenance of genetic diversity, in this instance,
plant genetic resources for food and agriculture (‘PGRFA’). In particular, there is
recognition that farmers, and local and indigenous communities have historically
developed the major food crops. Thus the Treaty calls upon Contracting Parties to
recognize the enormous contribution that the local and indigenous

communities and farmers of all regions of the world, particularly those
in the centres of origin and crop diversity, have made and will continue
to make for the conservation and development of plant genetic resources
which constitute the basis of food and agriculture production throughout
the world.273
Hence the concept of ‘farmers’ rights’ is established, based on ‘the past, present
and future contributions of farmers in all regions of the world, particularly those
in centres of origin and diversity, in conserving, improving and making available’
PGRFA.274
272 Reportedly, unlicenced harvesting of the traditional herb Tongkat Ali in Sarawak has led to its
listing as a protected plant: V. Chandrasekaran, ‘The Star’, 30 January 2001: ‘The demand for
tongkat ali, the plant reputed to have aphrodisiac properties, is causing rampant encroach-
ments into forest reserves. The raids have become so frequent that the Forestry Department is
worried that the plant species may become extinct if immediate steps are not taken to stop the
wanton uprooting’.
273 FAO ITPGRFA, Art. 9.1.
274 Ibid.
The Treaty does not lay down detailed standards for the recognition of
farmers’ rights, but stipulates that ‘the responsibility for realizing Farmers’ Rights,
as they relate to plant genetic resources for food and agriculture, rests with
national governments’. Acknowledging different national needs and priorities and
the constraints of existing domestic legislation, the Treaty provides that ‘each
Contracting Party should . . . take measures to protect and promote Farmers’
Rights, including: (a) protection of traditional knowledge relevant to
[PGRFA]’.275
In this context, the protection of TK is addressed in conjunction with a right
to equitable benefit sharing and recognition of farmers’ standing in national
policymaking processes relating to conservation and sustainable use. However, no
guidance is given on the legal form of protection, or the scope of TK that is to be
protected, other than its ‘relevance’ to PGRFA. In its policy context, such
protection is likely to focus upon, if not be limited to, that TK which is concerned
with the conservation and sustainable use of diversity in food crops, especially
traditional agricultural and agronomic know-how and related environmental
management. And given the treaty objectives, the goal of protection should at
least be consistent with and preferably directive supportive of ‘the conservation
and sustainable use of [PGRFA] and the fair and equitable sharing of the benefits
arising out of their use’.276
(c) International Covenant on Economic, Social

and Cultural Rights
Situating the protection of TK within the broader human rights context, the 2005
General Comment on Article 15(1)(c) of the International Covenant on Economic,
Social and Cultural Rights recognizes the collective ‘interests of indigenous
peoples relating to their productions, which are often expressions of their cultural
heritage and traditional knowledge’, and proposes ‘measures to recognize, register
and protect the individual or collective authorship of indigenous peoples under
national intellectual property rights regimes’ and the prevention of ‘the unautho-
rized use of scientific, literary and artistic productions of indigenous peoples by
third parties’,277 the latter establishing a clear doctrinal framework for the
protection of TK against misappropriation and misuse.

277 Committee on Economic, Social and Cultural Rights, General Comment No. 17 (2005), ‘The
right of everyone to benefit from the protection of the moral and material interests resulting
from any scientific, literary or artistic production of which he or she is the author’, adopted
21 November 2005, document E/C.12/GC/17, at para. 32.
III. DRAFT LAWS AND OTHER MODELS
1. International Level
(a) WIPO Draft Sui Generis Protection against Misuse and

Misappropriation of TK and Related WIPO Developments
(aa) Draft Provisions
The conception of misappropriation is the essential element of the most fully

developed proposal for sui generis protection of TK at the international level –
protection, that is to say, in the IP sense of defining constraints on third-party use
of TK – which is contained in the draft ‘objectives and principles’ developed
within the WIPO IGC.278 These so-called ‘draft provisions’ were based on the
extensive survey and analysis of existing sui generis laws, and sui generis
measures within IP and other laws;279 they do not represent any form of agreed
international standard, and have not attracted consensus support, but do represent
a widely-consulted synthesis of diverse normative elements and extensive policy
debate over approaches to protection. The approach to protection pivots around an
inclusive general principle on the suppression of misappropriation. The essential
characteristics of this form of protection have been summarized in working
documents as follows:280
(a) The concept of “misappropriation” is clarified as including a range of acts

typically prohibited under diverse laws and norms: this includes acqui-
sition or appropriation of TK by unfair or illicit means, as well as misuse
of TK and the concept of unjust enrichment or reaping unfair commercial
benefit from TK
(b) Five specific aspects of misappropriation are set out, again corresponding
to the acts that are most frequently identified in debate about TK
protection and are addressed in many laws:
(i) direct acts of deliberate misappropriation,
(ii) misappropriation through the breach of legal arrangements for prior
informed consent and benefit sharing,
(iii) misappropriation through attempts to obtain illegitimate IP rights
over TK,
(iv) misappropriation in the form of unfair competition or unjust
enrichment, deriving commercial benefit when this is manifestly
inequitable, and
278 Draft WIPO TK provisions, fn. 2 supra.

279 See for example, documents WIPO/GRTKF/IC/5/7, WIPO/GRTKF/IC/5/8, and the analysis of
the laws of the African Union, Brazil, China, Costa Rica, India, Peru, Philippines, Portugal,
Thailand and the United States of America in WIPO/GRTKF/IC/5/INF/4, WIPO/GRTKF/IC/
5/INF/6 and WIPO/GRTKF/IC/5/INF/7.
280 Document WIPO/GRTKF/IC/10/5, para. 20.
(v) certain forms of willful misuse and offensive behaviour regarding
TK.
(c) Consistent with existing international standards, the principles identify
other relevant forms of unfair competition, such as misuse of the
reputation of TK holders and acts creating confusion with traditional
products.
(d) The principles suggest that customary practices, norms, laws and
understandings should guide the protection against misappropriation of
TK, including determination of equitable sharing and distribution of
benefits.
(e) TK is defined in general, indicative terms as the content or substance of
knowledge resulting from intellectual activity in a traditional context, and
is not limited to any specific field, extending to agricultural, environmen-
tal and medicinal knowledge, and knowledge associated with genetic
resources.
(f) However, the draft suggests that to be eligible for specific protection
against misuse or misappropriation, more precision is needed, and that
TK should (i) exist in a traditional and intergenerational context; (ii) be
distinctively associated with a traditional or indigenous community or
people which preserves and transmits it between generations; and (iii) be
integral to the cultural identity of an indigenous or traditional community
or people which is recognized as holding the knowledge through a form
of custodianship, guardianship, collective ownership or cultural respon-
sibility. This relationship may be expressed formally or informally by
customary or traditional practices, protocols or laws.
(g) Beneficiaries of protection would also be defined in more rigorous terms
to be the communities who generate, preserve and transmit the knowl-
edge in a traditional and intergenerational context, who are distinctively
associated with it, and who culturally identify with it. Benefits may flow
to communities as such, or recognized individuals within communities.
Again, customary protocols, understandings, laws and practices should
guide or determine entitlement to the benefits of protection.
(h) Exceptions and limitations also draw on existing experience and respond
to policy concerns, and safeguard the customary practice, exchange, use
and transmission of TK by TK holders; uses such as traditional household
use and public health ; and fair use of TK that is already readily available
to the general public, subject to equitable compensation for industrial and
commercial usage.
(i) Protection of TK against misappropriation should last as long as the TK
fulfills the criteria of eligibility for protection, as mentioned in paragraph
(f), above.
(j) Given the importance of TK for biological diversity, in case of
biodiversity-related TK, access to, and use of, that TK shall be consistent
with national laws regulating access to those components of biological
diversity.
(k) The principles foresee a flexible form of national treatment, which would
ensure that eligible foreign TK holders should be entitled to protection
against misappropriation and misuse of their TK, provided that they are
located in a country which is prescribed as eligible.
Accordingly, the key characteristics of this approach to protection are the specific
focus on misappropriation, as forming the central normative gap identified by
many countries and TK holders in the course of an extensive debate, and the
flexibility of legal forms for the suppression of misappropriation, again respond-
ing to the requirements of many TK holders who have resisted the creation of new
intangible property rights per se (while yet others have identified with more
culturally appropriate forms of collective property rights). The definition of
protectable TK refers to the intergenerational character of TK as well as its
objective and subjective linkage to the cultural identity of a community.
These objectives and principles remain at present in draft form, not attracting
the consensus of the IGC even as a working draft. Yet just as these provisions were
distilled from many national, regional and international legal instruments, they are
now drawn on in many international, regional and national policy or legislative
processes in a positive feedback loop. Hence, as noted above, the draft proposal
for an international regime on access and benefit-sharing under consideration by
the CBD refers to the possibility of taking into account the IGC’s work ‘on the
intellectual property aspects of sui generis systems for the protection of traditional
knowledge and folklore against misappropriation and misuse’.281 Draft regional
instruments in Africa and South Asia make use of these provisions as a benchmark
and as a source of textual material, and several countries are developing national
TK protection laws by adapting and applying the draft WIPO provisions to their
national circumstances; Mongolia is a recent example.
The doctrinal root of the draft provisions is the clear articulation of a norm
against misappropriation of TK as such (Article 1.1), in a form analogous to the
norm against unfair competition within the Paris Convention (Article 10bis (1)).
This essential principle is then elaborated, consciously in parallel with the Paris
Convention rules on unfair competition, firstly (cf. Article 10bis (2)) by
characterizing the nature of misappropriation (including direct illicit appropriation
and inequitable commercial gain), and secondly (cf. Article 10bis (2)) by
specifying specific acts that are considered to be acts of misappropriation. For
instance, by identifying illicit assertion of IP rights over TK as a form of
misappropriation – consistently with essential patent law principles – the draft
provisions spell out for the first time a clear doctrinal basis for enhanced
disclosure mechanisms relating to TK used in a claimed invention. The provisions
identify forms of misuse of TK beyond purely commercial misappropriation, and
address ‘willful offensive use of traditional knowledge of particular moral or
spiritual value to its holders by third parties outside the customary context, when
such use clearly constitutes a mutilation, distortion or derogatory modification of
281 See fn. 79 supra.

that knowledge and is contrary to ordre public or morality’, by rough analogy with
a broadened conception of moral rights in copyright law and the rule in patent law
against patenting inventions the commercialization of which is contrary to ordre
public and morality, but again rooted in the needs and expectations of TK holders
that have been consistently stated since the first fact-finding consultations.
(b) Related Developments
The work of WIPO in the field of TK has several aspects, ranging across various
elements of capacity building and policy debate; the development of the draft
objectives and principles for TK protection described above is one element of a
broader programme activities. A recent review of the work of the WIPO
Intergovernmental Committee included the following outcomes relevant to TK:282
– a series of studies on legal protection of TK, based on some 61 responses

to two questionnaires,283 including surveys of national experiences with IP
protection of TK,284 analysis of the elements of a sui generis TK system,285
analysis of the definition of TK,286 and a composite study;287
– consideration of the use of databases, registries and other collections and
inventories for the protection of TK: clarifying that databases could be
used for the preservation, positive protection and defensive protection of
TK. Positive protection of TK was shown in the use of databases with
security or access controls which give effect to customary laws and
protocols governing the authorized access and distribution of knowl-
edge.288 A database of patents granted on traditional medical knowledge
illustrated another way of linking positive protection and TK databases;289
– analysis of the use of databases and other collections of information in the
context of general defensive protection strategies, focussing on approaches
to ensuring that existing TK was taken into account in the patent
examination process.
282 The following points are extracted with minor editing only from document WIPO/GRTKF/
IC/11/9, fn. 23 supra, from para. 91 et seq.
283 See document WIPO/GRTKF/IC/2/7 and WIPO/GRTKF/IC/Q.1.
284 See documents WIPO/GRTKF/IC/2/9, WIPO/GRTKF/IC/3/7, WIPO/GRTKF/IC/4/7 and
WIPO/GRTKF/IC/5/7.
285 See documents WIPO/GRTKF/IC/3/8 and WIPO/GRTKF/IC/4/8.
286 See document WIPO/GRTKF/IC/3/9.
288 See document WIPO/GRTKF/IC/3/17, para. 158.
289 See document WIPO/GRTKF/IC/3/17, para. 160.
– based on responses to widely distributed questionnaires, collation of
inventories of relevant on-line databases290 and periodicals291 to assist in
the creation of tools for more ready access to publicly disclosed TK in
searches for relevant prior art;
– creation of a TK portal as a pilot version of a potential searching tool for
patent examiners,292 not to induce the disclosure of TK, but to ensure that
any TK already disclosed would be taken into account when potentially
relevant patent claims were being assessed. This approach led to steps to
enhance the coverage of documented TK in the minimum documentation
of the Patent Cooperation Treaty (PCT) system293 and to expand the
International Patent Classification to provide for more accurate and
focussed searching for relevant TK during the patent examination pro-
cess;294
– analysis of the use of disclosure requirements in the patent system to
ensure disclosure of TK (and potentially also its origin and the legal
circumstances surrounding its access) that is used in the development of a
claimed invention;
– Consideration of TK protection including the wide range of potential
applications of databases, registries and other collections as both positive
and defensive protection tools: this ranged from databases or registries
which contained information about IP rights over TK subject matter
(granted under conventional or sui generis IP systems), through databases
establish to preserve TK subject to strictly limited access based on
customary protocols, to databases which may be entitled to distinct sui
generis protection (either of the database itself or of its individual
elements), and databases that facilitate access for patent examiners to TK
already in the public domain;
– In the light of the wide range of TK documentation projects currently
planned or under way, aimed at diverse goals (ranging from preservation to
various forms of positive and defensive protection), and the potential
damage to TK holders’ interests and cultural integrity that may arise from
documentation of TK, endorsement of the development of a toolkit for the
management of the IP implications of TK documentation.295 This is being
developed with extensive consultation with TK stakeholders and in
coordination with other international initiatives, so that traditional com-
munities may be in a stronger position to identify and defend their
IP-related interests in advance of any documentation project.

292 The TK Portal of Online Databases: <www.wipo.int/globalissues/databases/tkportal/
index.html>.
293 See documents PCT/CTC/20/5; PCT/MIA/7/3 and PCT/MIA/7/5.
294 See document IPC/CE/32/12.
295 See documents WIPO/GRTKF/IC/4/5 and WIPO/GRTKF/IC/5/5.
The key IGC outcomes on TK have been summarized296 as including objectives
and principles for the protection of TK (the ‘draft provisions’); policy options and
legal mechanisms for the protection of TK; review of existing intellectual property
protection of TK; elements of a sui generis system for the protection of TK;
comparative summary of sui generis legislation for TK protection ; a composite
study on TK protection; an overview of legal and policy options for TK
protection; an inventory of TK related publications for reference as prior art;
recommendations for taking account of TK in patent examination; a survey of
patent office practice in examining TK-related patent documents; a documentary
standard on databases and registries of TK and biological/genetic resources; a
draft toolkit for managing intellectual property when documenting TK and genetic
resources; several practical mechanisms for the defensive protection of TK and
genetic resources within the patent system; and a technical study on disclosure
requirements related to genetic resources and TK.
At the time of writing, the mandate of the IGC is under consideration for
possible renewal by the WIPO General Assembly,297 and the WIPO Member
States are yet to agree on the status and future development of the draft WIPO
provisions on TK protection298 or the development of other specific agreed text on
TK protection as an outcome of the IGC process. In parallel with the discussions
on the draft provisions, the IGC has recently focussed on ten core issues that need
to be addressed in any agreement on international sui generis protection of TK:
1. Definition of TK that should be protected.

2. Who should benefit from any such protection or who hold the rights to
protectable TK?
3. What objective is sought to be achieved through according intellectual
property protection (economic rights, moral rights)?
4. What forms of behavior in relation to the protectable TK should be
considered unacceptable/illegal?
5. Should there be any exceptions or limitations to rights attaching to
protectable TK?
6. For how long should protection be accorded?
7. To what extent do existing IPRs already afford protection? What gaps
need to be filled?
8. What sanctions or penalties should apply to behavior or acts considered
to unacceptable/illegal?
9. Which issues should be dealt with internationally and which nationally,
or what division should be made between international regulation and
national regulation?
10. How should foreign rights holders/beneficiaries be treated?299
296 WIPO/GRTKF/IC/11/9, fn. 23 supra,

297 See Matters Concerning the Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore, WO/GA/34/9 (17 August 2007).
298 Fn. 2 supra.
299 Annex II, Report of the Tenth Session of the IGC, WIPO/GRTKF/IC/10/7.
This consultative process has elicited a unique body of collective commentary300
on the policy choices that remain before the international community in this
domain, and may provide a sounder, more deeply rooted international outcome
that squarely addresses the fundamental policy implications of such an important
addition to the international law of IP – the very momentousness of the policy
choices has, seemingly paradoxically, led to calls both for greater urgency in
working towards filling a clear normative gap and to restore equity and balance in
the international IP legal system, and for more caution and consultation precisely
because of the weight of these issues. According to one view,
the IGC [is] on a path to build a third pillar for the world IP community
– a pillar which would complement the pillars of the Berne and Paris
Conventions. This pillar . . . would provide appropriate protection for TK.
However . . . haste without reconciliation would undermine the possibil-
ity of building this third pillar.301
(c) Convention on Biological Diversity
The implementation of the CBD has unfolded with ever-increasing emphasis on

the role of TK in conservation and sustainable use of genetic resources, building
on the general normative guidance provided by Article 8(j). Recalling that the
recognition of TK in the CBD is cast in broad language,302 there has been
considerable analysis and review of the scope and implications of these provi-
sions, in particular concerning the rights and entitlements it provides for local and
indigenous communities, and the extent to which it can or should serve as the
doctrinal basis for sui generis systems of TK protection. This provision sets the
respect and preservation of TK within a broader policy context, including its
importance in conserving in situ biodiversity as such,303 the linkage of knowledge
with traditional lifestyles, and the need for preservation of knowledge to be linked
with its wider application subject to the approval and involvement of knowledge
holders and with an encouragement of equitable benefit-sharing when the
knowledge is used. The direct legal effect of this provision is modulated by the
treaty text – it is limited by the condition ‘as far as possible and appropriate’ and
the reference to national law – but an intense policy focus has underscored the
strong commitment of governments to carry through the implementation of this
300 E.g. document WIPO/GRTKF/IC/11/.

301 Report of the WIPO General Assembly, Thirtieth (16th Ordinary) Session, WO/GA/30/8
(1 October 2003), p. 13.
302 CBD, Art. 8(j); see Sec. III.1.II.2(a) supra.
303 The CBD preamble recognizes ‘the close and traditional dependence of many indigenous and
local communities embodying traditional lifestyles on biological resources, and the desirability
of sharing equitably benefits arising from the use of traditional knowledge, innovations and
practices relevant to the conservation of biological diversity and the sustainable use of its
components’.
provision. This provision has been the subject of a long-standing distinct policy
track under the CBD, with the creation of an Ad Hoc Open-Ended Working Group
and an associated programme of work to oversee implementation of Article 8(j)
and related provisions, endorsed by the CBD COP.304
The programme itself has a normative aspect to it, as it establishes general
principles for implementation: this includes the requirement that TK ‘should be
valued, given the same respect and considered as useful and necessary as other
forms of knowledge’, and – very importantly from an IP point of view – the
explicit articulation of a principle of prior informed consent over TK:
Access to traditional knowledge, innovations and practices of indigenous

and local communities should be subject to prior informed consent or
prior informed approval from the holders of such knowledge, innova-
tions and practices.
While non-binding, and simply a guide to implementation of these CBD

provisions, this principle is an important gloss on the implementation of 8(j). Prior
informed consent of indigenous and local communities is often assumed to be a
legal requirement of the CBD, but is not actually present in its text, and – on the
basis of Article 8(j) – is difficult to educe as a formal, legal element of the treaty.
Recognition of PIC over TK in the Bonn Guidelines therefore contributes policy
background to the recognition of this principle in the concurrent work of WIPO
on draft provisions for the protection of TK against misappropriation and
misuse.305 The CBD work programme on Article 8(j) covers a broad range of
tasks well beyond IP matters; specifically on IP, the Working Group is tasked
to assess existing subnational, as appropriate, national and international

instruments, particularly intellectual property rights instruments, that
may have implications on the protection of the knowledge, innovations
and practices of indigenous and local communities with a view to
identifying synergies between these instruments and the objectives of
Article 8(j)
and to develop guidelines to assist implementation of Article 8(j) and its related
provisions. Further work includes standards and guidelines for the reporting and
prevention of unlawful appropriation of TK and related genetic resources.
The development of a composite report306 on CBD-related TK has since been
overseen by the COP,307 which has for instance requested the Secretariat to
explore the possibility of developing technical guidelines for recording and
documenting traditional knowledge, innovations and practices, and to analyse the
potential threats of such documentation to the rights of holders of TK, innovations
304 Decision V/16 (adopted at the fifth meeting of the COP, May 2000).
305 Discussed in Sec. III.1.III.1(a)(aa) infra above.
306 UNEP/CBD/WG8J/INF/1.
307 See CBD COP Decisions VI/10, VII/16 E, VIII/5/B/I.
and practices, with the full and effective participation of indigenous and local
communities.
In line with the guidance of the CBD COP, specific activities on TK have
included work on:
– reporting on the status and trends regarding knowledge, innovations and

practices relevant to the conservation and sustainable use of biodiversity308
– elements of sui generis systems for the protection of the knowledge,
innovations and practices of indigenous and local communities309
– an ethical code of conduct to ensure respect for the cultural and intellectual
heritage of indigenous and local communities relevant to the conservation
and sustainable use of biological diversity310
– possible development of technical guidelines for recording and document-
ing traditional knowledge, innovations and practices, and analysis of
potential threats of such documentation to the rights of knowledge
holders311
An important set of soft-law norms was adopted by the Seventh CBD COP, the
Akwé: Kon guidelines,312 voluntary guidelines for the conduct of cultural,
environmental and social impact assessment regarding developments proposed to
take place on, or which are likely to impact on, sacred sites and on lands and
waters traditionally occupied or used by indigenous and local communities; they
take their name from a Mohawk term meaning ‘everything in creation’. The
guidelines include provisions on ‘how to take into account traditional knowledge,
innovations and practices as part of the impact assessment processes’.
In practice, and for reasons of consistency and regulatory competence, the
implementation of Article 8(j) has typically been carried out through laws relating
to the regulation of access to and conservation of biodiversity (such as in the
Costa Rican and Indian laws analysed above313). The complex interrelationship
between national measures to implement the CBD’s objectives and the IP
dimension of TK protection raises broader questions that continue to be explored
in international policy processes:
– What scope of TK should be covered by IP aspects of protection, and how

should these aspects be integrated or coordinated with the broader sweep
of work on preservation, respect, promotion and sustainable use, linked to
genetic resources? (The work of the CBD on Article 8(j) acknowledges, for
example, the work of the WIPO IGC ‘on the intellectual property aspects
308 CBD COP Decision VIII/5 B.1.

309 See in particular the possible elements listed in annex, CBD COP Decision VII/16 H.
310 See the draft elements prepared by the CBD Executive Secretary, document UNEP/CBD/
WG8J/4/8.
311 CBD COP Decision VIII/5 B (5).
312 Decision VII/16 F.
313 See Sec. III.1.II.1(c)(ee) supra.
of sui generis systems for the protection of traditional knowledge against
misappropriation and misuse’.314)
– How should the holistic local context of protection of TK be linked to the
production of global public goods such as conservation of biodiversity and
the socially beneficial sustainable use of TK?
– Does this provision provide a legal, or at least doctrinal, basis for a right
on the part of indigenous and local communities to exercise prior informed
consent over the use of TK,315 further to the entitlement to equitable
benefits from its use that is explicitly provided for? To what extent can this
provision be construed as creating a right over TK as such?
– How should the preservation impulse – potentially entailing the documen-
tation and other recordal of TK – be reconciled with widespread anxiety
that fixing of TK in more accessible form will simply lead to its
appropriation and use by others,316 contrary to the interests and intention of
its holders?317
(d) WTO TRIPS Council
The increasing move towards recognition of TK and related interests of

developing countries has prompted several recalibrations of the international IP
policy environment. Perhaps the most striking has been the evolution of the
review of Article 27(3)(b) of the WTO TRIPS Agreement, which was scheduled
for 1999.318 This review was originally conceived as an opportunity to reconsider
certain exceptions to patentable subject matter in the life sciences with the
prospect of reducing or removing those exceptions. As 1999 approached, the
multilateral political environment regarding TRIPS and the patent system had
already begun to evolve, and the character of the review changed altogether to
become a wide-ranging debate over the interplay between TRIPS and the CBD,319
a review of patentable subject matter with proposals to convert optional
exceptions for patents on certain biological subject matter into mandatory
exclusions, and consideration of distinct, sui generis protection of TK and
314 CBD COP Decision VIII/5, E (6).

315 While it is often frequently assumed that the CBD creates such a right of PIC, it is not
explicitly provided for, and the principle was first expounded in relation to TK as such in an
international context in the draft WIPO IGC provisions discussed above.
316 Cf. Dutfield,(fn. 8 supra), p. 37, observing that documentation of TK should be undertaken in
conjunction with Art. 8(j), so that TK holders are not ‘coerced or tricked into making their
traditional knowledge public and should be fully informed of the IPR-related and other
consequences of doing so’.
317 See for example, the draft technical guidelines and threat analysis, note 309 supra.
318 See in general Dutfield, ‘TRIPS-Related Aspects of Traditional Knowledge’, [2001] Case W.
Res. J. Int’l L., Vol. 33, 275 et seq.
319 For a review of discussions, see document IP/C/W/368/Rev. 1 (8 February 2006), Relationship
Between the TRIPS Agreement and the Convention on Biological Diversity Summary of Issues
Raised and Points Made, Note by the Secretariat.
folklore, alternative means of protecting plant variety rights and extended
disclosure obligations in patent law to strengthen obligations regarding inventions
based on TK or genetic resources. A manifest political turning point was the
Declaration320 establishing the Doha round of trade negotiations, which recog-
nized the relationship between TRIPS and the CBD and the protection of TK and
folklore as TRIPS implementation issues. That political step acknowledged a
reframing of the debate that was already well established in practice by then.
Subsequent proposals have accordingly been couched in terms of the Doha
mandate on implementation, most notably a proposal to revise TRIPS itself321 the
focus of current negotiations in the WTO on TK issues. This amendment
(proposed Article 29bis) would strengthen defensive protection of TK that is
associated with biological resources322 by requiring WTO Members to oblige
patent applicants to disclose the country providing such associated TK, and the
country of origin ‘as known after reasonable inquiry’ and to provide ‘evidence of
compliance with the applicable legal requirements in the providing country for
prior informed consent for access and fair and equitable benefit-sharing arising
from the commercial or other utilization’ of such associated TK. For its part,
Norway has proposed amending TRIPS to require disclosure of the country of
origin of TK only (and not such additional information as PIC and benefit-sharing
arrangements), but would broaden the scope of the TK concerned beyond any link
with the CBD as such:
An equivalent disclosure obligation should apply where the claimed

invention relates to or applies TK, even where the TK is not directly
linked to genetic resources. The CBD only applies to TK linked to
genetic resources. However, a general obligation to disclose any tradi-
tional knowledge upon which an invention is based would help to
prevent patents being wrongfully granted.323
320 ‘Final Declaration’, Fourth Ministerial Conference, Doha, Qatar, (20 November 2001),
WT/MIN(01)/DEC/1.
321 In particular see the proposed new text for an Art. 29bis in document WT/GC/W/564/Rev. 2,
TN/C/W/41/Rev. 2, IP/C/W/474 (5 July 2006), Doha Work Programme – the Outstanding
Implementation Issue on the Relationship between the TRIPS Agreement and the Convention
on Biological Diversity, Communication from Brazil, China, Colombia, Cuba, India, Pakistan,
Peru, Thailand and Tanzania.
322 The proposal also provides for the defensive protection of biological resources as such, but the
current discussion only addresses the TK aspect; see Chapter III.2.IV.1 on Genetic Resources
for consideration of that aspect of the proposal.
323 WT/GC/W/566 TN/C/W/42 IP/C/W/473 (14 June 2006), The Relationship between the TRIPS
Agreement, the Convention on Biological Diversity and the Protection of Traditional
Knowledge: Amending the TRIPS Agreement to Introduce An Obligation To Disclose The
Origin Of Genetic Resources And Traditional Knowledge In Patent Applications, Communi-
cation from Norway.
Earlier proposals had been submitted calling in general terms for positive
protection of TK, in particular in proposing that the failed Seattle Ministerial
Conference in 1999 should extend the negotiating mandate of a new round to
cover TK protection. But these have not since evolved into such specific textual
proposals to amend TRIPS as are on the table for defensive protection through a
sui generis patent disclosure requirement. For instance, several Latin American
countries proposed during the preparations for Seattle that a future round should:
carry out studies, in collaboration with other relevant international

organizations, in order to make recommendations on the most appropri-
ate means of recognizing and protecting traditional knowledge as the
subject matter of intellectual property rights [and on the basis of such
recommendations] initiate negotiations with a view to establishing a
multilateral legal framework that will grant effective protection to the
expressions and manifestations of traditional knowledge,
envisaged to form one part of the outcome of the trade negotiations.324
Similarly, Venezuela proposed a mandatory
system for the protection of intellectual property, with an ethical and
economic content, applicable to the traditional knowledge of local and
indigenous communities, together with recognition of the need to define
the rights of collective holders.325
These proposals did not mature into a specific negotiating mandate or a formal
proposed to amend TRIPS, but the TRIPS Council has conducted an extensive
debate on protection of TK since that time. A recent Secretariat document326
summarizes TRIPS Council debate on TK between 1999 and 2006, covering the
protection of TK in general, patents on TK, and consent and benefit sharing issues,
referring to the implementation mandate of the Doha Ministerial Declaration327
and noting that the debate had focussed much more on TK than on folklore. It
remarked, however, that certain proposals had defined TK in such a way as to
include folklore, so that one proposal includes ‘cultural expressions’ as an element
of TK,328 and another refers to protection of ‘designs, music and other art forms
324 Preparations for the 1999 Ministerial Conference: Proposal on Protection of the Intellectual
Property Rights Relating to the Traditional Knowledge of Local and Indigenous Communities,
WT/GC/W/362 (12 October 1999).
325 Preparations for the 1999 Ministerial Conference: Proposals Regarding the TRIPS Agreement,
para. 9(a)(ii) of the Geneva Ministerial Declaration, WT/GC/W/282 (6 August 1999).
326 IP/C/W/370/Rev. 1 (9 March 2006), The Protection of Traditional Knowledge and Folklore:
Summary of Issues Raised and Points Made, Note by the Secretariat (Revision).
327 WT/MIN(01)/DEC/1.
328 Bolivia, Colombia, Ecuador, Nicaragua and Peru, IP/C/W/165.
generated by traditional communities’.329 This summary illustrates the diversity of
views still on whether international action is required to protect TK and what
forum should address it; on the protection of traditional knowledge and folklore.
The principal concerns driving the debate are characterized as concern over
‘granting of patents or other IPRs covering [TK] to persons other than those
indigenous peoples or communities who have originated and legitimately control
the [TK]’ and concern that TK ‘is being used without the authorization of the
indigenous peoples or communities who have originated and legitimately control
it and without proper sharing of the benefits that accrue from such use’. The
rationales for international action to address these concerns are cited as: common
economic interest, equity, food security, culture, environment, development,
coherence of international and national law, and the trans-boundary use of TK.
The African Group has proposed that the TRIPS Council adopt a decision on
TK as an outcome of its review of Article 27.3(b):330 a draft decision includes
elements on definition of TK (which would include folklore), rights conferred
under protection, TK documentation, and institutional arrangements within the
WTO, including a new body to address TK and genetic resources. By this
proposal, TK would be recognized and protected as ‘a category of intellectual
property rights.’ The declaration would grant any local community or traditional
practitioner rights (i) concerning respect for ‘will and decisions’ on commercial-
ization of TK; (ii) ‘respect and honour of any sanctity’ attached to their TK; (iii)
prior and informed consent for any access and any intended use of TK; (iv) full
remuneration; (v) prevention of third parties from ‘using, offering for sale, selling,
exporting, and importing, their knowledge and any article or product in which
their knowledge is input’ The Declaration would also strengthen recognition of
TK ‘in any form or at any stage’ as defeating novelty and inventiveness for patents
and originality for copyright, and would preclude patents where TK ‘has been a
lead to the invention’ or an invention ‘has derived at any stage’ from TK, unless
CBD access requirements have been fulfilled.
TRIPS Council debate has also explored the rationale for sui generis
protection of TK, without as yet producing an elaborated framework for such
protection: positive property rights over TK have been argued to be essential for
fairness and equity331 and to ensure erga omnes protection,332 instead of limiting
protection to the privity of contract. Elements of sui generis protection proposed
in the TRIPS Council include: defining TK333 and clarifying its scope;334
329 Australia, IP/C/W/310.

330 Taking Forward The Review Of Article 27.3(b) of the TRIPS Agreement, Joint Communication
from the African Group, IP/C/W/404 (26 June 2003). A draft decision on traditional
knowledge is included as annex to document IP/C/W/404.
331 Brazil, IP/C/W/228; Indonesia, IP/C/M/32, para. 134.
332 Brazil, IP/C/W/228, para. 34.
333 E.g. African Group, IP/C/W/404; Bolivia, Colombia, Ecuador, Nicaragua and Peru, IP/C/W/
165.
334 E.g. Thailand, IP/C/W/36/Add.1, para. 218.
delineation of the rights of TK holders,335 along the lines of the rights held by
patent owners as defined in TRIPS;336 and registration mechanisms.337
The TRIPS Council debate has therefore comprehensively analysed a wide
range of issues relating to the positive and defensive protection of TK, within
existing and sui generis forms of IP protection; and within the framework
established by CBD and beyond it. The most concrete materials to emerge from
this debate are the joint proposal for a distinct disclosure requirement in patent
law, and the African Group’s proposal for a WTO declaration on TK. Debate still
continues on the exact nature of the current ‘implementation’ mandate – whether
this relates to simple review of implementation of TRIPS text as it currently
stands, or whether it provides a basis for amendments such as the proposed new
Article 29 bis. Given the negotiating dynamics of the WTO, these questions are
likely to be resolved only as part of a broader package deal addressing clusters of
issues and interests. As for TRIPS itself, any such outcome, if agreed, would
probably leave considerable latitude (or ‘flexibility’) for WTO Members to
interpret and apply the provisions, including key terms such as ‘traditional
knowledge’, in the light of their national laws, their legal heritage and the
prevailing policy environment at the national level. Other policy processes, such
as the work of the CBD and the WIPO IGC on these related questions may also
provide interpretative context for any TRIPS outcome.
(e) Customary Law in International Instruments
Again, following the strong emphasis laid on this question by TK holders, the
recognition of customary law is a key preoccupation in the debate over
international norms and standards for protection of TK. For instance, the CBD
COP has taken note of
the request by the Permanent Forum on Indigenous Issues to the Ad Hoc

Open-ended Inter-Sessional Working Group on Article 8(j) and Related
Provisions to advance its mandate to develop mechanisms for effective
sui generis systems of protection based on customary laws of indigenous
peoples.338
It has also reviewed the development of ‘Elements of an ethical code of conduct

to ensure respect for the cultural and intellectual heritage of indigenous and local
communities relevant to the conservation and sustainable use of biological
diversity’ which may include ‘incorporation of customary law and practices’.339
335 African Group, IP/C/W/404; Indonesia, IP/C/M/32, para. 134.

336 TRIPS, Art. 28.
337 India, IP/C/W/198.
338 CBD Conference of Parties, Decision VIII/5, ‘Article 8(j) and related provisions’, UNEP/
CBD/COP/8/31, Curitiba, 20–31 March 2006.
339 CBD Conference of Parties, Decision VIII/5, ‘Article 8(j) and related provisions’, UNEP/
CBD/COP/8/31, Curitiba, 20–31 March 2006.
The draft objectives and principles for the protection of TK under consideration
in the WIPO IGC340 also address the customary law angle under several aspects:
According to the Policy Objectives, the protection of TK should
respect and facilitate the continuing customary use, development,

exchange and transmission of traditional knowledge by and between
traditional knowledge holders; and support and augment customary
custodianship of knowledge and associated genetic resources, and
promote the continued development of traditional knowledge systems
[policy objective (iv)] and contribute to the preservation and safeguard-
ing of traditional knowledge and the appropriate balance of customary
and other means for their development, preservation and transmission,
and promote the conservation, maintenance, application and wider use
of traditional knowledge, in accordance with relevant customary
practices, norms, laws and understandings of traditional knowledge
holders, for the primary and direct benefit of traditional knowledge
holders in particular, and for the benefit of humanity in general;
(objective (vii));
The general guiding principles that set directions for the attainment of the
objectives include respect for customary use and transmission of TK and
recognition of the specific characteristics of TK;
In clarifying the principles for protection of TK against misappropriation
(Article 1), the provisions propose that
application, interpretation and enforcement of protection . . . including
determination of equitable sharing and distribution of benefits, should
be guided, as far as possible and appropriate, by respect for the
customary practices, norms, laws and understandings of the holder of
the knowledge, including the spiritual, sacred or ceremonial charac-
teristics of the traditional origin of the knowledge.
In later seeking to clarify the principles that should apply to equitable benefit
sharing arising from the use of TK (Article 6), the provisions indicate that
‘[c]ustomary laws within communities may play an important role’.
Article 4 suggests what TK in particular should be protectable, and suggests
that protection should be available for TK which is integral to the cultural
identity of an indigenous or traditional community or people which is
recognized as holding the knowledge through a form of custodianship,
340 See draft WIPO TK provisions, fn. 2 supra, analysed in general in Sec. III 1. (a) supra.
guardianship, collective ownership or cultural responsibility. This relation-
ship may be expressed formally or informally by customary or traditional
practices, protocols or laws.
In seeking to define who should be the beneficiaries of protection, Article 5
suggests that entitlements ‘should, as far as possible and appropriate, take
account of the customary protocols, understandings, laws and practices of
these communities and peoples;’
In setting out appropriate limitations and exceptions, Article 8 suggests that
TK protection ‘should not adversely affect . . . the continued availability of
[TK] for the customary practice, exchange, use and transmission of [TK] by
traditional knowledge holders;’
Following preparatory work on this issue,341 the United Nations Permanent Forum
on Indigenous Issues appointed a Special Rapporteur,342 Professor Dodson, to
undertake preliminary work a study on the recognition of customary laws ‘in
international and national standards addressing traditional knowledge’, which
resulted in a concept paper for the Forum to review at its sixth session.343 This
paper recommended that the Forum ‘should commission a study, under its
mandate to prepare and disseminate information, to determine whether there
ought to be a shift in the focus on the protection of indigenous traditional
knowledge away from intellectual property law to protection via customary law,
and if so, how this should occur. The study should consider how indigenous
traditional knowledge could be protected at an international level by utilizing
customary law, including the extent to which customary law should be reflected,
thereby providing guidance to States and subsequently protection at national and
regional levels. The study would also include an analysis of indigenous customary
law as a potential sui generis system for protecting indigenous traditional
knowledge’.344
(f) UN Declaration on the Rights of Indigenous Peoples
Building on the general human rights framework established by, for instance, the
International Covenant on Economic, Social and Cultural Rights,345 a more
specific recent development on the normative plane, linking protection of TK to
the collective human rights of indigenous peoples, was the adoption by the Human
Rights Council in 2006, after many years of negotiation, of the United Nations
341 See the recommendations of ‘International Technical Workshop on Indigenous Traditional

Knowledge’ (E/C.19/2006/2, para. 41).
342 Report of the United Nations Permanent Forum on Indigenous Issues, Fifth session, May
2006, E/2006/43, E/C.19/2006/11, para. 172.
343 Report of the Secretariat on Indigenous traditional knowledge, E/C.19/2007/10 (20 March
2007).
344 Ibid., at p. 9.
345 See Sec. III.1.II.2(c) supra.
Declaration on the Rights of Indigenous Peoples, since adopted by the United
Nations General Assembly.346 The Declaration requires States inter alia to
‘provide effective mechanisms for prevention of, and redress for . . . any action
which has the aim or effect of depriving [indigenous peoples] of their integrity as
distinct peoples, or of their cultural values or ethnic identities’.347 It also
acknowledges their ‘right to maintain, control, protect and develop their cultural
heritage, traditional knowledge and traditional cultural expressions’.348 While this
Declaration remains at the level of non-binding law, it provides a basic doctrinal
framework for the protection of TK as a means of conserving the distinct cultural
identity of indigenous peoples – in effect, their ‘collective personality.’ The
Declaration may situate protection of TK against misappropriation and misuse in
the context of giving effect to a right to control and protect TK. One consistent
element in working conceptions and definitions of TK is the requirement for some
form of linkage with the collective self-identity of the indigenous or local
community that holds the knowledge. Thus attempts to find a workable definition
of TK forge a link with emerging recognition of the rights of indigenous
communities as such. Hence some degree of respect, recognition and protection of
the integrity of TK and knowledge systems may form part of the recognition and
respect of the integrity of indigenous peoples ‘as distinct peoples’ or ‘of their
cultural values or ethnic identities’.
2. Draft Sui Generis Models at the Regional Level
Regional models currently under development include the Draft Framework for
an African Instrument on the Protection of Traditional Knowledge being prepared
by the African Regional Intellectual Property Organization (ARIPO) and the
Organisation Africaine de la Propriété Intellectuelle (OAPI); and the Draft Legal
Instrument for SAARC Countries on Protection of Traditional Knowledge,
approved by the 2006 Summit of the South Asian Association for Regional
Cooperation (SAARC) as a basis for further work in SAARC. In both cases, the
benchmark established by the draft WIPO TK provisions349 was used as textual
input, and was adapted to the legal and cultural context of the regions concerned.
These texts remain draft materials within their respective policy development
processes, but may in time provide practical insight into how general principles
elaborated at the international level may be tailored and adapted for regions which
share common cultural and legal heritage.
346 Fn. 42 supra.

347 Ibid., Art. 8(2)(a).
348 Ibid., Art. 31.1.
349 See draft WIPO TK provisions, fn. 2 supra, analysed in general in Sec. III 1. (a) supra.
IV. CONCLUSIONS
The notion of ‘protection’ that should be applied to TK is at least as controversial

and unsettled as the very definition or conception of the nature of TK itself. While
flexible and diverse in its potential forms, ‘intellectual property’ protection in es-
sence concerns the creation of rights that entitle the TK holder to prevent third par-
ties from undertaking certain uses of their TK. As they have often been
characterized, IP mechanisms essentially implement a right of TK holders to say
‘no’ to certain defined uses of their TK: this is distinct from specific use rights, such
as positive use rights recognized under customary law, or custodial responsibilities.
Stemming from the right to say ‘no’ is the entitlement to set conditions for certain
defined uses – conditions that may have a moral or material character, ranging from
a right of acknowledgement or to object to derogatory uses, to an equitable financial
share or culturally appropriate non-financial benefits. Still more broadly, IP mecha-
nisms are one form among others of ensuring the ‘moral and material benefits’ pro-
vided for under human rights law,350 a notion that has recently been broadened to
embrace the collective entitlements of indigenous peoples.351 The essential choice
regarding ‘protection’ is often characterized as a stark choice between (i) IP protec-
tion of specific aspects of TK that are readily appropriated against certain illicit
forms of use by third parties external to the original community – echoing the ‘illicit
exploitation & other prejudicial actions’ that was the focus of earlier steps to protect
expressions of folklore352 or (ii) protection conceived in a fully holistic manner,
combining conservation and promotion within the original context and physical en-
vironment (invoking links with rights and custodial responsibilities over ancestral
lands353).
IP mechanisms cannot and do not supplant a more holistic approach to
recognizing and reinforcing TK systems which entails (i) strengthening custodial
systems and the traditional practices in which they are embedded, (ii) promoting
the positive use and sharing of knowledge both within and beyond the community,
consistently with customary law and protocols, and consistently with the values
and interests of the community, (iii) safeguarding and documenting both elements
of TK and the knowledge systems and customary law that give context to TK, and
(iv) recognizing customary use rights. IP mechanisms – and their inherently
limited focus — therefore have to be understood within this far broader ‘holistic’
context. It is a category error to critique IP as not being holistic – rather the
question is to understand how IP fits within an holistic approach.
The debate over TK protection, over the appropriate legal and administrative
mechanisms for protection, and over the role of IP forms of protection within an
holistic response to growing calls for greater respect, recognition and safeguard-
ing of TK systems, epitomizes a broader set of tensions and dilemmas for
350 E.g. International Covenant on Economic, Social and Cultural Rights, Sec. III.1.II.2(c) supra.
351 See draft declaration on rights of indigenous peoples, Sec. III.1.III.1(f) supra.
352 WIPO UNESCO Model Provisions, note 5 supra.
353 See Philippines Law, discussed in Sec. III.1.II.1(c)(ee) supra.
indigenous and other traditional and local communities faced with social,
economic, demographic, cultural and environmental pressures. These concerns go
the heart of:
– The very collective cultural, social and legal personality of communities,

and the apparent (but often illusory) tension between sustaining an
‘authentic’ character and responding to the changing environment
– Establishing appropriate objectives for policy and legal measures –
whether to emphasize preservation of traditional forms of generation,
maintenance and transmission of knowledge within the community,
including the customary social and legal context; whether to focus on
preservation of items of TK as such, potentially shorn of their traditional
context; whether to promote the broader use of TK for its general social
utility; or whether to defend against misuse and misappropriation of TK by
third parties, including through patent grant in foreign jurisdictions; and
– Moving beyond the false dichotomies and presumed conflicts that may
arise in the perception of these diverse objectives, to find genuinely
mutually supportive means of pursuing them all.
Broadly, the dilemma lies between the recognition of the privacy of TK systems
– the need for the undisturbed integrity of traditional modes of knowing and of
sharing knowledge – and the legitimate exploitation of TK as a form of knowledge
resource, to serve as the basis for the more equitable engagement of traditional
communities in the global knowledge economy. Should protection seek to
preserve cultural integrity and collective personality; or should it form the basis
of ensuring that the custodian community’s and its members’ engagement with
external commercial partners occurs on the community’s terms? Or can IP be used
to achieve an optimal balance, based on the principles of self-determination,
between due protection of the private sphere – those aspects of collective identity
that are reserved for the community itself – and the public face – ensuring due
recognition of source and due financial or other equitable compensation for the
use and application of TK beyond the community, but with the community’s
consent?
Within the more limited compass of intellectual property, these same broader
dilemmas – and these false dichotomies – are apparent in the choices between:
– Making more extensive use of the established system of IP rights – patents,

undisclosed information, distinctive signs – with the prospect either of
validating certain assumptions of value and legitimacy of innovation and
protectable distinctiveness embedded in the current practice, and reducing
pressure for normative development;
– Promoting adapted and extended forms of established IP protection,
leading to an adaptation and a reapplication of established modes and
principles of protection, to render them more suitable to the interests
identified in the debate about TK and IP: for instance, greater recognition
of the right to collective personality, cumulative and shared modes of
intergenerational innovation, and immaterial injuries such as cultural or
spiritual harm; and
– The elaboration of truly sui generis forms of protection, leading to the
dilemma of whether sui generis protection should essentially confine itself
to the IP dimension, concentrating on those acts of third parties that should
in some way be constrained or prevented by TK holders, or whether it
should achieve far broader policy goals, in reinforcing communities’ legal
identity, promoting holistic protection linked to the physical environment,
and preserving the local epistemological, spiritual, environmental, social
and cultural context that sustains traditional knowledge systems and
renders them fully intelligible and sustainable.
Given the limited policy bandwidth on TK issues and limited political opportu-
nities for reform of IP law and policy, the analogous dilemma for policymakers
concerns:
– whether to focus on modest but achievable reforms in the current law and
practice of IP;
– whether to aim for radical reforms that entail not merely re-centring the
working norms of the IP system but also making significant developments
in the recognition of the very legal personality of indigenous communities
at the level of international and national law, and forging new or newly
effective norms providing for self-determination of indigenous peoples,
cultural heritage, territorial rights, and human rights; or
– whether to seek compromised goals along the spectrum between these two
extremes.
Already significant operational reforms have been introduced into the patent sys-
tem, which do give genuine, practical recognition of TK at the heart of the system –
reform of the IPC, development of the PCT minimum documentation, enhanced
disclosure mechanisms introduced in some national laws and proposed internation-
ally – but these positive steps arguably have simply accentuated the question of how
the fundamental interests of an indigenous community in one country are effec-
tively served by enhanced patent quality and the refusal or revocation of patents
making use of their TK in a foreign jurisdiction, and what more needs to be achieved
at the international and national levels to directly promote the interests of TK hold-
ers. One persistent, nagging need is conceptually very simple, and politically undra-
matic – but practically extraordinarily important and an enormous systemic
challenge – that of providing sustained, culturally appropriate and effective support
for community-level capacity building, so that the interests of indigenous and local
communities are not addressed through abstracted or academic analysis, political
advocacy or broad-brush legislation, but by consultation and practical choices ini-
tiated within, by and for the TK holding communities themselves.
The full array of sui generis and other TK-related legal and policy initiatives
reviewed in this chapter should put paid to the idea that TK protection is an
abstract, academic or merely political domain. The protection of TK has entered
the IP policy mainstream, and is a central, practical focus of IP policymakers in
many countries: it is genuinely a conventional element of the law and practice of
IP, even thought the debate has at times difficulty in catching up with this fact. The
patent system has, in a relatively short space of time, begun to grapple with the
fact that TK is not antique, lacking in utility or terminally ‘prior art’: it is the
natural expression of living innovation systems worthy of recognition alongside
those forms of innovation formerly exclusively recognized within the patent
system. Pioneering countries have helped to establish both the broad principles
that are shared within TK protection regimes, and the necessary regulatory
diversity that allows protection to respond to the remarkably localized character-
istics of TK and the systems, community structures and customary law and
practices that sustain it. Yet the national initiatives to protect TK in a sui generis
manner retain a certain exploratory or experimental quality, underscoring the need
for continuing coordination at the regional and international levels.
For policymakers, the challenges concern not merely the functioning and the
cultural and operational assumptions of the current IP system, but also the
boundaries of the system as such, and its proper interaction with other, related
elements of domestic law and policy and public international law. The debate over
suitable recognition of TK within the IP system has therefore prefigured and
exemplified more general contemporary questions about the integration of IP law
and policy within a broader, more diverse and more contested policy environment.
At a time of de facto if not juridical globalization of the patent system, some
practical questions concerning TK and patents – what prior art should be routinely
examined in the processing of patent applications, how to construct the ‘person
skilled in the art’ as the benchmark for the assessment of the inventiveness or
non-obviousness of a claimed invention, what level of disclosure of a claimed
invention is adequate to support a claim for patent protection – end up
paradoxically to be the most far reaching, because they address the principal
doctrinal issues at the core of the patent system – what is the technological and
epistemological base that a patentable invention is meant to contribute to,
according to whose technological knowledge and epistemological framework can
a claimed invention be considered truly inventive, and who is the notional reader
of a patent disclosure – for a TK-based invention, is the ‘person skilled in the art’
a pharmacologist in Basel, a traditional healer in Rwanda, or a culturally diverse
amalgam of these two?
One legal trend emerging both from the policy debate and from the array of
legislative initiatives in this field is a clear entitlement to prior informed consent
to access and subsequent use of TK. At one level, this is the same classical ‘unfair
competition’ doctrinal root that has in other fields led to the future evolution of a
broader category of IP right, recalling the growth of protection of trade secrets,
geographical indications, trademarks and other distinctive aspects of personality
that find their roots in the law of unfair competition, passing off and related tort
law. This entitlement to exercise prior informed consent as a condition of access
also has the flavour of contract law: the TK holder as gatekeeper, with an
entitlement to enter into contractual arrangements governing the terms of access.
This approach does have inherent limitations, which will doubtless drive policy
demand for distinct forms of TK protection – just as the common law tort of
passing off gave rise over time to the functionally more manageable system of
registered trademarks, and the PIC-style approach to the suppression of bootleg-
ging gave rise over time to the recognition of performers rights.354 The limitations
of the PIC or bilateral contractual approach are clear, and prefigured by the
evolution of IP in other fields.
One such limitation concerns negotiating and informational asymmetries,
which leave TK holders typically in a weaker position than the users of TK who
have better access to legal expertise and to analytical capacity needed to
determine the potential value of TK (compare the issues concerning the
negotiating position of individual performers in the evolution of performers’
rights, and the call for broader safeguards of equity than can be delivered simply
through the conclusion of bilateral agreements). According to one critical account
concerning solutions based on private contractual agreements between the
provider of the genetic resource and associated TK, and the prospective user of
that resource and knowledge:
Given the asymmetry of the power relationship between the two parties,
there can be little doubt about what the inevitable outcome would be.
However carefully any model contract is drafted, however ardently such
contracts try to correct the huge imbalance between the provider and the
user, such an approach simply cannot lead to anything even remotely
resembling a fair and equitable regime. Laws regulating private contrac-
tual relationships, combined with carefully crafted model contracts
cannot, therefore be the solution.355
Benchmarking or ‘safety net’ standards, such as the guaranteed minimum

standards in the Peruvian sui generis law, may overcome these misgivings, but on
an international scale, this line of analysis leads some to the conclusion that:
a solution can only be found in a legally binding universal instrument

which balances the rights of IP holders against a concomitant obligation
on their part to submit to clearly defined, mandatory requirements
relating to GR and associated TK.356
354 See the analysis of this development in Antony Taubman, ‘Nobility of Interpretation: Equity,
Retrospectivity, and Collectivity in Implementing New Norms For Performer’s Rights’,
(2005) 12 Journal of Intellectual Property Law 351.
355 Report of the Seventh Session of the WIPO IGC, WIPO/GRTKF/IC/7/15, para. 175.
356 Ibid.
A further limitation concerns privity of contract and the difficulty in establishing
binding commitments on downstream users of TK. It is rarely the case that the
first extra-community person to access TK is the one who derives full commercial,
technological or industrial benefit from the TK: that would be the exception rather
than the rule. The key distinction between a contractual obligation and a true
property right is that the latter is erga omnes, or ‘binding on the world’.357 The call
for sui generis protection arises in part from the perceived need to restrain the use
of such TK by third parties who are not bound by any contractual or fiduciary
relations to the TK holders, and who do not infringe conventional IP rights: while
some forms of protection span the gap between bilateral contractual or fiduciary
obligations, and true erga omnes obligations (such as the recognition in the
footnote to Article 39 of TRIPS of the need not recklessly to make use of
undisclosed information when one is not the agent responsible for breaching
confidentiality), the continuing requirement to prove an unbroken nexus in the
provenance of TK creates a particular burden for TK holders when their TK is
used for commercial gain by others at the extreme other end of a long chain of
provenance.
The ultimate challenge concerns fully recognizing the collective identity of
indigenous and local communities under national and international law, and
resolving the dilemma whether to consider the due protection of TK as simply the
next agenda item in the development of intellectual property law, or whether to
address all aspects of indigenous and local communities’ needs for respect of their
collective identities – whether construed legally or culturally, acknowledgment
and practical recognition of the cultural, intellectual and jurisprudential distinc-
tiveness of the communities, and forms of protection, preservation and promotion
that in one sweep address the full holistic context of traditional knowledge
systems embedded in the way of life and world views of communities and the
environment that helps shape and define their identities.
Current policy debates over TK and IP have constituted a searching
reappraisal of the core principles of IP. The TK debate has loosened doctrinal
constraints and confounded misconceptions over the nature of IP as a public
policy tool on the part of proponent and critic alike. ‘IP protection’ need not be
inherently at odds with needs and expectations of indigenous or traditional
communities. Its defining characteristic is not commodification as such, but rather
the empowerment to say ‘no’ to the use of protected materials and a codification
of others’ responsibilities towards the custodians of protected knowledge and
traditional forms of expression, recalling that ‘ “intellectual property” shades off
into surrounding forms of civil liability’.358 Ultimately, we need guidance on how
to fulfil our responsibilities, a clear law of liability, concerning TK and towards
357 See for example, Thomas Cottier & Marion Panizzon, ‘Legal Perspectives on Traditional
Knowledge: The Case for Intellectual Property Protection’, in International Public Goods and
Transfer of Technology Under a Globalized Intellectual Property Regime, Keith E. Maskus
and J. H. Reichman (ed.), (2005).
358 W.R. Cornish, Intellectual Property, (1999), p. 761, cited in document WIPO/GRTKF/IC/7/5
(20 August 2004).
the cultural, intellectual and legal community systems that sustain TK. This would
not resolve all the challenges confronting communities who seek to maintain the
vibrancy of their knowledge systems and cultural heritage, and the integrity of
their collective identities. ‘IP protection’ in its essential form is not a stand-alone
solution; but no effective, holistic approach can be built upon the doctrinaire
rejection of this kind of legal mechanism. A steady portfolio of practical
experience and legislative initiatives at the national and regional levels have
moved TK protection from the abstract and the academic to the mainstream of IP
law, policy and practice; the question remains, however, what overarching
principles and legal mechanisms should in principle and can in practice be
established at the fully international level.
The endeavour to forge distinct, sui generis protection of TK at the
international level faces a fundamental paradox. To be a legitimate policy and
legal initiative, any protection mechanism needs to give broader meaning and
effect to norms, values and knowledge systems that are intrinsically, irreducibly
local in character, and that rely on the original community context for their full
significance. A pre-emptive international sui generis model for IP protection risks
homogenizing the subject matter of protection,359 and eliminating the distinctive
local characteristics of TK. Rather than a single sui generis approach, a more
pluralistic approach may be required – suorum genorum protection, which would
provide at the international level a network of mutual recognition of heteroge-
neous knowledge traditions integrated with customary law, under the aegis of a
general set of core legal principles. Practical experience and extensive debate
together show that international processes can usefully concentrate on the
articulation and definition of general principles and legal norms, and building
functional linkages between divergent national sui generis systems. By contrast,
seeking to codify numerous customary legal, social and cultural practices into one
single homogenized conception of TK may radically miss the point – globalizing
what is irreducibly, inherently and distinctively local.
359 See for example, Four Directions Council, Forests, Indigenous Peoples and Biodiversity,
Submission to the Secretariat for the CBD (1996): Any attempt to devise uniform guidelines
for the recognition and protection of indigenous peoples’ knowledge runs the risk of
collapsing this rich jurisprudential diversity into a single ‘model’ that will not fit the values,
conceptions or laws of any indigenous society.
Section 2
Genetic Resources
Antony Taubman*
I. INTRODUCTION
1. Unity in Biological Diversity? The Challenges of Regulating

Genetic Resources
Much of the law and policy of genetic resources (GR) has little, directly, to do
with intellectual property (IP); unlike other topics in this volume, genetic
resources are not the specific subject of IP protection, even in the most radically
reformed conception of what ‘intellectual property’ is or should be: genetic
resources are tangible, physical matter – the phenotype that serves at once as an
expression of the genotype and as a physical medium for transmission of genetic
information; the genetic resource is not the gene as such.1 Yet there is a major
* Contributing in a personal capacity; no views expressed should be attributed to WIPO, its

Secretariat or its Member States.
1 A gene is not, essentially, viewed as a physical entity, but rather ‘the units of heredity which
. . . may be regarded as the controlling agents in the expression of single phenotypic
characters ’(Oxford English Dictionary Online, second edition, 1999). Despite the common
assumption that an individual gene is represented by a specific DNA sequence in a defined
location on the chromosome, a trend has been identified towards again seeing a gene strictly
as a unit of information (with its functionality potentially distributed in complex ways across
the chromosome, with one ‘gene’s’ functionality not being mapped one-to-one to a single
S. von Lewinski (ed.), Indigenous Heritage and Intellectual Property, 181–292.

© 2008 Kluwer Law International BV, The Netherlands.
182 Antony Taubman
international debate over genetic resources and intellectual property. Numerous
policy and legislative initiatives at the national and regional levels address the
linkage between genetic resources and IP. And many indigenous and local
communities view genetic resources as integral to their cultural and intellectual
heritage, to their ways of life, their relationship with the physical environment and
their world views, and hence to their very cultural identity as communities.
Communities therefore have questioned or outright rejected attempts to segment
their complex, diverse and subtle collective inheritance into artificial categories
for the convenience of the conventional IP system.
In a wide-ranging, often politicized set of debates, the neat, nuanced
distinctions in the mind of the legal analyst – such as between property rights over
a physical specimen of a bacterium, and the intangible property rights over an
invention derived from access to the genetic material contained in that specimen
– can appear out of touch and irrelevant to the broader political and cultural
divergences that dominate the debate. Distinct legal and policy frameworks
develop their own cultures and own dialects, making a comprehensive and
inclusive approach all the more challenging. Yet such seemingly technical or
legalistic distinctions can, in themselves, help to shape a clearer, fairer and more
inclusive international framework. Failure at least to analyse the consequences of
these distinctions, and to analyse the interaction between competing claims of
ownership and control that operate at these distinct levels, can certainly obscure
and frustrate the dynamics of policy processes that seek such resolutions.
This chapter therefore explores the foundations of the continuing debate over
IP and genetic resources in order to establish a neutral, synoptic perspective for
reviewing the diverse (and at times volatile) developments as IP protection
touches on public policy questions concerning the governance of genetic
resources. The following examples exhibit this trend at the international level:
– Intellectual property matters, and in particular the patenting of claimed

inventions derived from plant genetic resources, were a long-running and
contentious issue in the lengthy negotiations within the Food and Agricul-
tural Organization (FAO) on the development of the International Treaty
on Plant Genetic Resources for Food and Agriculture ITPGRFA,2 and this
remains a sensitive and closely monitored issue in the implementation of
the Treaty;
physical location or sequence); see e.g. Pearson, Helen, ‘Genetics: What is a gene?’ Nature
441, p. 398–401 (25 May 2006): ‘Information, it seems, is parceled out along chromosomes
in a much more complex way than was originally supposed’ (at p. 399).
2 Food and Agricultural Organisation, International Treaty on Plant Genetic Resources for Food
and Agriculture (adopted by the FAO Conference on 3 November 2001, entry into force 29
June 2004).
Genetic Resources 183
– One of the very few formal proposals to revise the WTO TRIPS
Agreement3 since its entry into force in 1995 concerns not the strength-
ening or further elaboration of positive obligations to protect conventional
IP , but rather the proposed creation of a formal new requirement
concerning the source and origin of biological resources used in the
invention and other aspects of the legal circumstances concerning the
provenance of biological resources, which would amount to a significant
recalibration of the equitable and legal basis for obtaining a patent in the
biological sciences;4
– The issue of GR was raised in the preparations for and the Diplomatic
Conference to conclude the 2000 Patent Law Treaty, which ostensibly dealt
with patent formalities, but the broader policy context required
acknowledgement of developing countries’ concerns about GR issues,
3 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

4 Communication from Brazil, China, Colombia, Cuba, India, Pakistan, Peru, Thailand and Tan-
zania, ‘Doha Work Programme – The Outstanding Implementation Issue on the Relationship
Between the TRIPS Agreement and the Convention on Biological Diversity’,WT/GC/W/564/
Rev.2, TN/C/W/41/Rev.2, IP/C/W/474 (5 July 2006), proposing a new Art. 29 bis, as follows:
Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge.
1. For the purposes of establishing a mutually supportive relationship between this
Agreement and the Convention on Biological Diversity, in implementing their
obligations, Members shall have regard to the objectives and principles of this
Agreement and the objectives of the Convention on Biological Diversity.
2. Where the subject matter of a patent application concerns, is derived from or
developed with biological resources and/or associated traditional knowledge, Mem-
bers shall require applicants to disclose the country providing the resources and/or
associated traditional knowledge, from whom in the providing country they were
obtained, and, as known after reasonable inquiry, the country of origin. Members shall
also require that applicants provide information including evidence of compliance
with the applicable legal requirements in the providing country for prior informed
consent for access and fair and equitable benefit-sharing arising from the commercial
or other utilization of such resources and/or associated traditional knowledge.
3. Members shall require applicants or patentees to supplement and to correct the
information including evidence provided under paragraph 2 of this Article in light of
new information of which they become aware.
4. Members shall publish the information disclosed in accordance with paragraphs 2 and
3 of this Article jointly with the application or grant, whichever is made first. Where
an applicant or patentee provides further information required under paragraph 3 after
publication, the additional information shall also be published without undue delay.
5. Members shall put in place effective enforcement procedures so as to ensure
compliance with the obligations set out in paragraphs 2 and 3 of this Article. In
particular, Members shall ensure that administrative and/or judicial authorities have
the authority to prevent the further processing of an application or the grant of a patent
and to revoke, subject to the provisions of Article 32 of this Agreement, or render
unenforceable a patent when the applicant has, knowingly or with reasonable grounds
to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or
provided false or fraudulent information.
184 Antony Taubman
leading to undertakings to take up this issue in a systematic way at a policy
level;5
– The Conference of Parties (COP) of the Convention on Biological
Diversity (CBD),6 a multilateral environmental agreement, has undertaken
extensive debate on patent law issues relating to equitable benefit-sharing
from the use of GR, and to guide this work has commissioned detailed
studies on patent law matters from a sister United Nations body, the World
Intellectual Property Organization (WIPO);7
– Concerns over patenting of derivatives from samples of pathogenic viruses
led to debate concerning the current structures for sharing viruses for
research and virus development within the World Health Organization, and
assertions on the part of some countries of sovereignty over wild strains of
viruses of avian influenza viewed as genetic resources, in the light of their
commercial application in vaccine production;8
– Several international policy processes9 debate the legal status of genetic
resources obtained in the high seas and the international seabed, beyond
national jurisdiction, as such resources gain increasing scientific and
commercial significance, spurring a debate over the implications of patents
on inventions derived from such genetic resources;10
– A similar debate is unfolding11 concerning the commercial exploitation,
using the patent system, of extremophile genetic resources found in
5 During the Diplomatic Conference for the Adoption of the Patent Law Treaty (11 May to 2
June 2000), the Director General of WIPO held consultations on the question of formalities
relating to the issue of genetic resources, leading to an agreed statement read out to the
Conference which stated, inter alia: ‘Member State discussions concerning genetic resources
will continue at WIPO. The format of such discussions will be left to the Director General’s
discretion, in consultation with WIPO Member States’.
6 Convention on Biological Diversity (Rio de Janeiro, 5 June 1992).
7 See for example CBD COP documents UNEP/CBD/COP/7/6 and UNEP/CBD/COP/8/INF/7.
8 ‘WHO High-Level Technical Meeting on Responsible Practices for Sharing Avian Influenza
Viruses and Resulting Benefits’, (Jakarta, Indonesia, 26–27 March 2007), and the ‘Jakarta
Declaration of the Health Ministers of affected and other related countries’ (28 March 2007);
see also WHA60.28 Decision on Agenda item 12.1: ‘Pandemic influenza preparedness:
sharing of influenza viruses and access to vaccines and other benefits’ (23 May 2007).
9 United Nations ‘Open-ended Informal Consultative Process on Oceans and the Law of the
Sea, Eighth meeting’ (25--29 June 2007); ‘Ad Hoc Open-ended Informal Working Group of
the United Nations General Assembly to study issues relating to the conservation and
sustainable use of marine biodiversity beyond areas of national jurisdiction’ (13—17 February
2006); see UNEP/CBD/SBSTTA/8/INF/3/Rev. 1.
10 Salvatore Arico and Charlotte Salpin, UNU-IAS Report: Bioprospecting of Genetic Resources
in the Deep Seabed: Scientific, Legal and Policy Aspects (2005).
11 Inter alia in the Scientific Committee on Antarctic Research (SCAR), the Committee for
Environmental Protection (CEP), and the Antarctic Treaty Consultative Meeting (ATCM) (see
most recently ATCM XXX (2007) documents WP 36, Biological Prospecting in the Antarctic
Treaty Area – Scoping for Regulatory Framework by the Netherlands, Belgium and France
and IP 67, Biological Prospecting in Antarctica: Review, Update and Proposed Tool to
Support a Way Forward’ by UNEP). See also CBD itself.
Antarctica, raising intractable questions about ownership, sovereignty and
common heritage of humanity.12
2. The New Legal and Policy Environment for Genetic

Resources
As the patent system is increasingly used to appropriate value from the

downstream use of genetic resources, indigenous and local communities and other
custodians of genetic resources have responded by asserting their custodial
responsibilities and equitable interests over such downstream exploitation of the
resources they have custody over. The patenting process has become the cynosure
of concerns about inequitable distribution of benefits from the technological and
industrial exploitation of genetic resources, the very transparency of the patent
system leading it to serve as a means of monitoring broader trends and as a visible
and accessible point of pressure in seeking to bolster legal safeguards that
equitable returns will go back to the custodians of GR. Perhaps most strikingly for
the IP policymaker, these concerns have led to challenges of the very legal and
equitable basis for one’s entitlement to apply for and to hold a patent. The legal
circumstances of access to and use of GR may induce a recalibration of this basic
area of patent law, broadening the equitable basis of the tenure of a patent.13
Indigenous communities frequently stress that their heritage of genetic
resources should be viewed holistically, of a piece with their knowledge and belief
systems:
Maori, as with indigenous peoples elsewhere, do not necessarily consider

that their language, art forms, images or designs etc can be regarded
separately from the culture and knowledge base underpinning the TK
and the resources associated with that knowledge.14
Legal acknowledgement and practical recognition of indigenous communities’

rights over genetic resources has been linked to concerns over the integrity of their
collective cultural identities15 and indeed their rights to self determination:
12 Dagmar Lohan and Sam Johnston, UNU-IAS Report: The International Regime for
Bioprospecting Existing Policies and Emerging Issues for Antarctica, (Tokyo, 2004).
13 See, especially, the proposal for a revision of TRIPS, set out in fn. 4 supra.
14 Circulation of Comments Received on Documents WIPO/GRTKF/IC/9/4 and WIPO/GRTKF/
IC/9/5: Addendum, WIPO/GRTKF/IC/10/INF/2 Add.3 (30 November 2006), at Annex, p. 34
(Peer Review Report by Maui Solomon).
15 For example, under the Panamanian biodiversity regime, ‘any application for access to areas
used by indigenous communities as sacred, religious or similar sites, which had spiritual value
and whose preservation was essential to their cultural identity . . . would be rejected’, WIPO
Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional
186 Antony Taubman
indigenous peoples regarded their knowledge and natural resources as
springing out from a spiritual, cultural and sometimes religious connec-
tion between the people and its land, and whereas this spiritual link was
unique to indigenous peoples . . . To deprive indigenous peoples of their
genetic resources, traditional knowledge and folklore constituted a
violation of those peoples’ fundamental rights to self-determination16
At the level of emerging international norms, the United Nations Declaration on

the Rights of Indigenous Peoples17 articulates the right of indigenous peoples ‘to
maintain, control, protect and develop their cultural heritage, traditional knowl-
edge and traditional cultural expressions, as well as the manifestations of their
sciences, technologies and cultures’ and this is taken to include ‘human and
genetic resources’ and seeds. Indigenous peoples are accorded the ‘right to
maintain, control, protect and develop their intellectual property over such
cultural heritage, traditional knowledge, and traditional cultural expressions’.18
States are required, in conjunction with indigenous peoples, ‘to take effective
measures to recognize and protect the exercise of these rights’.19
A number of national laws20 and several regional laws21 or models22 deal
integrally with genetic resources and IP and traditional knowledge (TK) gover-
nance issues. Some laws also link TK, genetic resources and folklore directly to
the recognition of indigenous and other community rights as such. For instance,
the Indigenous Peoples’ Rights Act of the Philippines accords Indigenous Peoples
the right to control and protect
their sciences, technologies and cultural manifestations, including human

and other genetic resources, seeds, including derivatives of these
resources, traditional medicines and heath practices, vital medicinal
plants, animals and minerals, indigenous knowledge systems and prac-
tices, knowledge of the properties of fauna and flora, oral traditions,
literature, designs, and visual and performing arts.23
Knowledge and Folklore (IGC), Report of the Second Session, WIPO/GRTKF/IC/10/7 Prov 2
(25 April 2007), p. 113 (Statement by the Delegation of Panama).
16 WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Tradi-
tional Knowledge and Folklore (IGC), Report of the Second Session, WIPO/GRTKF/IC/2/16
(14 December 2002), p. 23 (Statement by the representative of the Saami Council).
17 Adopted by the Human Rights Council by Resolution 2006/2 and by the United Nations
General Assembly in 2007.
18 Art. 31.1.
19 Art. 31.2.
20 For example, Biodiversity Law, Law No. 7788 of the Legislative Assembly of the Republic
of Costa Rica; Indian Biological Diversity Act of 2002.
21 Andean Community Decision 391: Common Regime on Access To Genetic Resources.
and Breeders, and for the Regulation of Access to Biological Resources of 2000.
23 Sec. 34, Indigenous Peoples’ Rights Act of the Philippines.
Equally, commentators have called for new forms of legal recognition of the rights
and interests of indigenous and other local communities that would combine
conventional intellectual property with traditional resource rights24 and commu-
nity resource rights.25
So the complexity and controversy of the linkage between GR and IP are
perhaps inevitable: indeed, controversy can ensue from the very identification and
isolation of ‘genetic resources’ as a distinct subject of analysis and debate. Even
before contemplating the tangled IP dimension, the general field of genetic
resources already represents both a broad and diverse subject of law and
regulation, and the subject of a wide range of commercial, industrial, scientific
and cultural practices, that in turn touch on further fields of regulation including
the environment, bio-safety, health, indigenous affairs, human rights, bioethics,
research policy and marine resources. It is an increasingly complex and
multifaceted policy challenge to bridge between forms of regulation of genetic
resources, on the one hand, and the technology-driven evolution of the actual
forms, structures and practical applications of genetic materials, on the other: and
the complexity and breadth both of the regulatory environment and of the
technological landscape continue to accelerate. New players enter the debate even
as long-standing disagreements between established interests remain unresolved
and contentious. Distinct regulatory communities, used to operating within a
well-established framework, are called on to respond to a much broader range of
interest groups and value systems: for example, opposition to the grant of patents
comes no longer only from commercial rivals operating in the same jurisdiction,
but from indigenous communities, environmental groups and other civil society
actors who may be based in foreign countries and who raise grounds of opposition
that invoke human rights, ethics and public international law in ways that seek to
stretch the bounds of established patent law and situate it within a broader policy,
legal and ultimately cultural context.
3. Valuing Genetic Resources
(a) Genetic Resources as a Public Good
The very diversity of genetic resources is itself acknowledged as an inherent

international public good, the direct subject of public international law: the CBD,
which establishes a broad international legal framework governing genetic
resources, describes Contracting Parties as ‘[c]onscious of the intrinsic value of
biological diversity’. Biological diversity is defined (in Article 2) as:
24 Darrell Posey, ‘Traditional Resource Rights: International Instruments for Protection and
Compensation for Indigenous Peoples and Local Communities’. (Gland, Switzerland) : IUCN,
the World Conservation Union (1996).
25 See Gibson, Community Resources (Ashgate, London, 2005).
188 Antony Taubman
variability among living organisms from all sources including, inter alia,
terrestrial, marine and other aquatic ecosystems and the ecological
complexes of which they are part; this includes diversity within species,
between species and of ecosystems.
The CBD provides an authoritative definition of ‘genetic resources’, but in very

general terms, as ‘genetic material of actual or potential value’;26 in turn it defines
‘genetic material’ as ‘any material of plant, animal, microbial or other origin
containing functional units of heredity’. A generous reading of this definition
would see it extend to all forms of microbial, plant and animal life, and other
DNA and RNA constructs, such as viruses. It took a subsequent decision of the
CBD COP to clarify that the reader and author of this very chapter were not
themselves genetic resources (since they do constitute biological material con-
taining functional genes, and they can presumably be taken to have ‘actual or
potential value’).27 The related concept of ‘biological resources’ is much broader,
covering ‘genetic resources, organisms or parts thereof, populations, or any other
biotic component of ecosystems with actual or potential use or value for
humanity’, but by definition need not contain functional units of heredity. The
subsequent conclusion of the ITPGRFA within the FAO was explicitly framed to
complement the CBD;28 together, they establish the basic legal framework for
access and use of much of the world’s genetic resources. Thus the FAO ITPGR
defines ‘plant genetic resources for food and agriculture’ in terms complementary
to the CBD as ‘any genetic material of plant origin of actual or potential value for
food and agriculture’, where genetic material is ‘any material of plant origin,
including reproductive and vegetative propagating material, containing functional
units of heredity’.29
(b) Diverse Value Systems and Genetic Resources
By these definitions, what sets a genetic resource apart from mere genetic material
is this notion of ‘value’. A tremendous debate arises about that ‘value’: when the
26 CBD, Art. 1.
27 CBD COP Decision II/11 ‘Access to Genetic Resources’, which provides that ‘human genetic
resources are not included within the framework of the Convention’ (UNEP/CBD/COP/2/19,
at p. 22); in an IP context, see also Disclosure of Origin or Source of Genetic Resources and
Associated Traditional Knowledge in Patent Applications, document submitted by the
European Community and its Member States, WIPO/GRTKF/IC/8/11 (17 May 2005).
Similarly, Andean Community Decision 391: Common Regime on Access to Genetic
Resources (Art. 4) excludes from its scope ‘human genetic resources and their by-products’.
28 Art. 1 of the ITPGRFA provides that ‘The objectives of this Treaty are the conservation and
sustainable use of plant genetic resources for food and agriculture and the fair and equitable
sharing of the benefits arising out of their use, in harmony with the Convention on Biological
Diversity, for sustainable agriculture and food security. These objectives will be attained by
closely linking this Treaty to the Food and Agriculture Organization of the United Nations and
to the Convention on Biological Diversity’.
29 Art. 2, ITPGRFA.
actual or potential value of genetic resources is captured in the course of
downstream exploitation, the principle established under the CBD requires that
such benefits be shared back upstream, in an equitable manner. But how to predict,
objectively assess, practically realize that value, when its potential may be at best
a highly speculative matter? According to what sense of ‘equity’ should the
benefits be distributed, and how broad an axiological palette to draw on in
considering ‘value’ – should value be assessed beyond the simple exchange value
of the biological materials that serve as a simple substrate or physical medium for
the genetic value – recalling that the diversity of genetic resources is established
as an inherent public good? Or is value to be assessed in economic terms, as though
assessing the economic potential of any resource, comparable to a vein of ore?
A major report prepared by the United Nations Environment Program,
Cultural and Spiritual Values of Biodiversity, observes that
[p]lacing a monetary value on species and ecosystems may be a useful

exercise by which to integrate the cost of using and conserving
biodiversity into the current global economic system, but it will never be
possible to comprehend the true value of life in such a system.30
It observes that
[r]espect for biological diversity implied respect for human diversity . . .

It is the concern of many people that biodiversity must be appreciated in
terms of human diversity, because different cultures and people from
different walks of life perceive and apprehend biodiversity in different
ways as a consequence of their distinct heritages and experiences.31
This leads, indeed, to a re-evaluation of the ‘prevailing philosophical approach’ of

‘separation of spirit from matter’.32
The concept of ‘value’ and the diverse cultural perceptions of the value of GR
recur as a theme throughout this chapter, as they are central to the understanding,
and perhaps the resolution, of the legal and policy issues that arise from the
interaction of GR and IP. The central concern of many participants in the
cross-cutting debates is to ensure that their values, and value systems, are more
fully respected by other actors, so that indigenous communities seek greater
recognition for the spiritual and cultural values of genetic resources, and scientific
researchers seek recognition for their contribution to the production of public
knowledge goods using genetic resources. Resolution of these concerns entails
addressing several interlocking concerns:
30 UNEP, Cultural and Spiritual Values of Biodiversity, (Nairobi, 1999) xi (Foreword by Klaus
Töpfer, Executive Director, UNEP).
31 Ibid.
32 Ibid.
190 Antony Taubman
– The diversity of value systems logically precedes the legal distinctions
between forms of control, custodianship and ownership of tangible and
intangible property associated with GR: ideas of property and custodian-
ship are expressions of certain cultural values and ways of seeing GR;
– The appropriation of value through the application of IP, especially patents,
over downstream use of GR has been a flashpoint in the debate, leading to
disputes over the legitimacy of particular patents, over the equities of this
appropriation of derived value, and over embedded values and cultural
assumptions within the patent system.
– Legal obligations over the sharing of benefits from patented technologies
derived from genetic resources has led to a widespread debate about how
patents should and should not function as means for the generation and
allocation of such appropriated value.
– Yet the non-rivalrousness of genetic resources, compared to other forms of
resources, provides surprising accommodation of different value systems –
so that the cultural and environmental integrity of source communities may
be sustained even if derivatives of genetic material are extracted and
commercialized elsewhere (unlike other rivalrous natural resources which
can either be industrially exploited or kept integrally intact, but not both);
however, perceived injustice or inequity in the distribution of benefits from
use of genetic resources creates legal and political pressure to impose
constraints on access to and use of genetic resources.
The IP system, and patents in particular, have been brought to the centre of this
debate because IP is seen (rightly or otherwise) as the principal instrument of
capturing the actual or potential value of genetic resources, and as a means of
realizing, sharing (equitably or otherwise) or asserting private rights (reasonably
or unreasonably) over, the latent value extracted from genetic resources. Patents
and plant variety protection have also been questioned as serving interests and
making assumptions about privileged and valued forms of knowledge and
knowledge creation, that are inherently at odds with the values and interests of
traditional communities and other custodians of genetic resources and their in situ
environment.
(c) Biotechnology Patents as Means of Realizing Value
The CBD defines biotechnology in very broad terms, as ‘any technological

application that uses biological systems, living organisms, or derivatives thereof,
to make or modify products or processes for specific use’. Recent developments
in biotechnology have simply accelerated and accentuated forms of innovation
and technological development that date back to pre-history: biotechnology is the
deliberate harnessing of the chemical processes of life for utilitarian ends,
including those as fundamental to human well-being as food, health and a safe
environment.
The tools of biotechnology have therefore long been valued for their genetic
structure, and have been used as genetic resources. Historical examples range from
the close protection by military force of cloves and cinnamons as major economic
resources in the Dutch East Indies33 to the use of penicillium roqueforti bacterium in
the production of Roquefort cheese,34 and the careful regulation of this genetic re-
source as a means of safeguarding commercial advantage. It is no novelty for the
economic and industrial value of genetic resources to be recognized, applied, and
protected as the source of commercial benefit: in an oft-cited case, Louis Pasteur re-
ceived a patent35 in 1873 for a method of purifying yeast for use in making beer, for
the yeast derived by that method, and for the apparatus used to purify the yeast, on
the basis of the significant improvement to beer-making technology through puri-
fied yeast that was disclosed in the patent document.
But modern biotechnology has meant that the innovation and technological
development has reached into the very genetic makeup of biological matter. This
technological development – the capacity to manipulate the structure of nucleic
acid and to bypass natural barriers to reproduction and recombination – is indeed
exactly what is used to distinguish modern biotechnology in the Cartagena
Protocol on Biosafety,36 which defines it as:
the application of: (a) In vitro nucleic acid techniques, including

recombinant deoxyribonucleic acid (DNA) and direct injection of
nucleic acid into cells or organelles, or (b) Fusion of cells beyond the
taxonomic family, that overcome natural physiological reproductive or
recombination barriers and that are not techniques used in traditional
breeding and selection.37
The use of genetic resources as feed-stocks for modern biotechnology has created
a complex tangle of claims over rights, entitlements and expectations of access,
ownership, custody, recognition and reward. Within this intricate debate, this
chapter reviews the relationship between GR and the IP system. It does not fully
address the governance and regulation of GR in itself. Accordingly, the conscious
focus is on the IP aspects of a much broader policy environment, and there is no
attempt to explore or expound in detail the elaborate international, regional and
national frameworks that govern genetic resources in the context of conservation
of biological diversity, human rights including indigenous peoples’ rights, food
security, and innovation policy. This is not because these broader frameworks are
not of fundamental legal, policy and developmental importance, but because of
the evident need for greater clarity about the specific IP aspect of these broad areas
33 Jack Turner, Spice: The History of a Temptation, (London, 2004), passim.

34 Stipulated, for example, in the application for GI protection for ‘Roquefort’ under EC
Regulation 2081/92.
35 Improvement in Brewing Beer and Ale Pasteurization (US Patent 135,245).
36 Cartagena Protocol on Biosafety to the Convention on Biological Diversity (adopted in
Montreal on 29 January 2000, entered into force on 11 September 2003).
37 Art. 3.
192 Antony Taubman
of public international law and policy – precisely because of the immense
importance of clear and effective rules in this area. Equally, however, a focus on
the IP aspects cannot be taken in isolation of this wider context – to the contrary,
the tangle of issues surrounding the interplay between patents and genetic
resources exemplifies the general trend towards reevaluating and resituating the
patent system within a public policy context, since it serves as a microcosm or test
case of many current policy and overall systemic challenges for the patent system:
– the legitimate scope of patentable subject matter;

– the ethical and moral dimension of patenting;
– access to medicines and the link with a patentee’s obligations to the public;
– the fit scope of exceptions for research, farming, and the exercise of
overlapping IP;
– the expanding prior art base and patent quality; and
– the effectiveness of the patent system in practice in achieving to the policy
goals ascribed to it in principle.
II. FINDINGS AT THE FACTUAL LEVEL
1. The Framework for Factual Findings: Genetic Diversity

and Modern Biotechnology
(a) The Empirical Framework for Review of Genetic Resources
This section reviews the factual background of the interaction between GR and IP.
In doing so, it does not attempt to give a comprehensive account of the full range
of social, technological, political and regulatory developments that frame the
current array of legal and policy processes. Genetic resources find applications,
and spur regulatory responses, in many different technological and policy fields:
the conservation and remediation of the environment, agriculture and food
processing, human, animal and plant health, biochemical engineering and its
industrial applications, and emerging technologies that challenge all regulatory
frameworks such as transgenic modifications and nanotechnology. The regulatory
environment spans issues as diverse as indigenous land rights, constitutional
issues, the protection of the environment, public health, bioethics, law of the sea,
and innovation policy. Internationally, genetic resources have arguably emerged
as a bargaining chip in negotiations over the terms of trade in knowledge
resources, and have begun to influence perceived substantive interests in trade
negotiations.38
38 This development is charted in Taubman, ‘Cereal Offenders: Access and Equity in Trade
Negotiations on Knowledge Resources’, in Jay Kesan (ed.), Seeds of Change: Agricultural
Biotechnology and Intellectual Property, (CABI, 2007) p. 97–131.
No comprehensive and representative overview can be attempted of this full
range of interests, technological developments and policy processes. This empiri-
cal review therefore concentrates on the characteristics of genetic resources as
such, and the technological developments that have brought these issues to the
forefront – most strikingly the emergence of technologies that have overcome the
barriers preventing sharing of genes between species that have developed over
billions of years of evolution;39 and the emergence of essentially the same
technologies that have enabled entirely new ways of extracting value from genetic
resources, and thus of new ways of valuing those resources as resources. In a
curious paradox, it was the growing capacity systematically to derive technologi-
cal benefit from the functional units of heredity embedded in biological materials
that led to their conceptualization as genetic resources in the first place. These
developments provide the factual and conceptual background to the specific legal
and policy responses that are reviewed in this chapter.
(b) Genetic Diversity and a Common Technology Platform
‘Genetic resources’ have a paradoxical quality: on the one hand, they are defined
by a single mechanism for the storage and transmission of genetic and functional
information, but they embody and express the immense diversity of life in all its
forms. Sulston sketches our genetic history as follows, highlighting the unity of
the genetic inheritance of all life forms:
We think there are 30 000 to 40 000 [genes] in the human genome – only
about twice as many as in the worm or the fruit fly. At first sight, it seems
rather surprising that there aren’t more, especially as about half the genes
in worms and flies have counterparts in the human. This immediately
illustrates the remarkable unity of life, the result of the evolutionary
process that has given rise to all life on earth from a single common
ancestor.40
Modern biotechnology exists because the single, elegant structure of DNA is

shared between all organisms (allowing also for RNA-based forms such as RNA
viruses), and functions identically. This commonality – a naturally evolved
technological platform, in effect – is at the root of the modern technologies that
have opened up both much of the enormous untapped potential of genetic
resources and the associated debate over the morality and distributional equity of
the results of this technology.
39 See Freeman Dyson, ‘Life After Darwin: The Open Software of Gene Transfer’, Technology
and Society Forum Series Podcast, New Jersey Institute of Technology, (11 November 2004).
40 John Sulston, ‘Intellectual Property and the Human Genome’, in Drahos and Mayne, (eds),
Global Intellectual Property Rights, (2002) at p. 66.
194 Antony Taubman
As a practical technology, modern transgenic biotechnology can be traced to
the creation of gene-splicing technology by the path breaking collaboration
between Herbert Boyer and Stanley Cohen in the 1970s. Cohen had introduced the
plasmid pSC10141 into the Escherichia coli (E. coli) bacterium, which conferred
resistance to the antibiotic tetracycline. Reproducing the modified bacterium
meant the inherited trait was also reproduced. So he had created a means of
transferring genes using plasmids, enabling the gene to be reproduced in the
recipient bacterium. Boyer had identified how cells locate the necessary sequence
within a long strand of DNA to produce a specific protein, determining that a
restriction enzyme, produced by bacteria to defend against certain viral organisms
(bacteriophages), cuts the DNA strand at the required sequence, producing
segments with ‘cohesive ends’ that would adhere to other DNA fragments.
The scientists then collaborated to use Cohen’s plasmid as a vector for
transferring DNA segments, cut by Boyer’s restriction enzyme, in order to create
a mechanism that reproduced or ‘cloned’ specific DNA segments. The enzyme
Eco RI cut the ring plasmid at a single location, where a gene resistant to the
antibiotic kanamycin was inserted. Descendants from this altered bacterium
acquired resistance to both tetracycline and kanamycin. Cohen and Boyer then
applied this research to other species, for instance introducing toad genes into the
bacteria, which then reproduced the same genes. The key result was to enable the
systematic insertion of genes from one species to another, overcoming normal
physiological barriers to the transfer of traits between species42 – recalling the
very definition of ‘modern biotechnology’ in the Cartagena Protocol.43
(c) Innovation through Transgressing Species Boundaries
Modern medical biotechnology was effectively launched when bacteria were

harnessed to synthesize human insulin on an industrial scale,44 using this gene
41 A bacterial plasmid is a ring of DNA, much smaller and simpler than a chromosome, found
in self-replicating bacteria, and which confer biological traits such as antibiotic resistance.
42 See US patent 42372241, which claims: A method for replicating a biologically functional
DNA, which comprises: transforming under transforming conditions compatible unicellular
organisms with biologically functional DNA to form transformants; said biologically
functional DNA prepared in vitro by the method of: (a) cleaving a viral or circular plasmid
DNA compatible with said unicellular organism to provide a first linear segment having an
intact replicon and termini of a predetermined character; (b) combining said first linear
segment with a second linear DNA segment, having at least one intact gene and foreign to said
unicellular organism and having termini ligatable to said termini of said first linear segment,
wherein at least one of said first and second linear DNA segments has a gene for a
phenotypical trait, under joining conditions where the termini of said first and second
segments join to provide a functional DNA capable of replication and transcription in said
unicellular organism; growing said unicellular organisms under appropriate nutrient condi-
tions; and isolating said transformants from parent unicellular organisms by means of said
phenotypical trait imparted by said biologically functional DNA.
44 See U.S. patent 4,704,362, Itakura et al. (3 November 1987), ‘Recombinant cloning vehicle
microbial polypeptide expression’, assigned to Genentech, Inc.
splicing technology developed by Cohen and Boyer. The very point of this
development was to enable human insulin to be produced by the E. coli bacterium,
a production process that could yield large amounts of insulin relatively cheaply,
in preference to the earlier treatment of diabetics through the injections of insulin
harvested from pigs and cattle, which was expensive, difficult to obtain, and not
identical to human insulin. Harvesting of human-produced human insulin was
clearly not an option. Thus the invention capitalized on the common genetic
mechanism shared by humans and a bacterium. The code for expressing insulin in
humans is functionally effective also when incorporated into a bacterium genome.
The ready production of human insulin resulted from advances in genetic
engineering that stemmed from Cohen and Boyer’s gene splicing technology.
Once scientists identified the human gene for making insulin, this could be cloned
using recombinant DNA techniques so that human insulin could be produced by
the bacterium. This proved a significant breakthrough for treating diabetes.
A similar analysis applied in the European Patent Office (EPO) Howard
Florey/Relaxin case,45 which concerned the patenting of the gene encoding the
naturally occurring protein relaxin, enabling the production of recombinant
relaxin through novel non-human biological processes.46 This hormone is
structurally related to insulin and was first investigated for its role in loosening the
pelvic ligaments and ripening the cervix prior to childbirth; it was subsequently
tested as a potential treatment for fibrosis, and scleroderma in particular.47 In its
natural form, it was immensely difficult to obtain in sufficient quantities for
therapeutic use or even systematic investigation – since it had, in effect, to be
harvested (with the prior informed consent of human subjects) from the minute
quantities of relaxin naturally produced within the human body. It was practically
undesirable to continue to obtain human relaxin produced by human physiology.
The availability of greater quantities of recombinant relaxin produced instead
by bacteria was therefore, in terms of Justice Hand’s classic analysis in the
Adrenaline case, ‘for every practical purpose a new thing commercially and
therapeutically’.48 A European patent49 was filed in 1983, granted in 1991 and
opposed by a coalition of green members of the European Parliament. The case
was appealed and only finally decided in 2002. The issues are analysed below. But
for the present context, it transpired in this case that the very point of the invention
was to create a non-human means of producing the hormone relaxin – despite
earlier misleading scientific analyses, based on apparent similarities with insulin,
it transpired that human relaxin (or more strictly two distinct forms of the
hormone) were significantly different from other mammalian forms, and porcine
relaxin was, for instance, therapeutically useless for humans. Thus a landmark
45 Howard Florey/Relaxin [1995] EPOR 541.

46 The case is discussed in more detail below, in section III.2.III(b)(cc).
47 Seibold et al, Recombinant Human Relaxin in the Treatment of Scleroderma, Ann Intern Med.
2000;132:871–879.
48 Parke-Davis & Co. v. H. K. Mulford & Co., Case No.189 F. 95, 103 S.D.N.Y. [1911].
49 Europrom Patent EP 0101309, Howard Florey Institute.
196 Antony Taubman
patent law case pivoted on the newly devised capacity to produce cloned human
relaxin through genetically modified bacteria. The whole point was to avoid
harvesting relaxin from the human body, producing it through cloning unicellular
hosts. Humans were not the source of the recombinant relaxin. Thus the patent
case turned, legally and technologically, on the transfer of a distinctively human
gene sequence from consenting human subjects to single-cell bacteria – violating,
in a literal sense at least, the ‘integrity’ of the human genome and conferring a
distinctively human trait on a markedly distinct organism, but in the search,
assessed to have positive ethical qualities, for treatments for human ailments.
(d) The Policy Implications of Genetic Diversity
Comparative analysis of mammalian genomes has shown that a significant portion

of the human genome has been retained from the divergence of mammalian
species some 200 million years ago. The human genome is almost entirely shared
with other closely related mammalian species – as is often reported, it is more than
98per cent identical to the chimpanzee genome, and 97 per cent identical to that
of gorillas – yet the need to sustain the distinct integrity of the human genome is
expressed as an international norm.50 While the focus has been on the static
content and distinctiveness of the genome as such, it is the operation of a common
genetic system that produces the more perplexing challenges for policymakers.
The implications of this shared genetic system becomes all the more awkward for
legal regimes because modern biotechnology – as defined in the Cartagena
Protocol51 – is exactly that set of technologies that overcome natural physiological
reproductive or recombination barriers, and therefore transcend legal categoriza-
tion according to subjective criteria that would set the human genome apart from
plant genetic resources.
This is no longer a matter of abstract speculation. The first genetically modified
crop using human genetic material was recently approved for field trials:52 human
genes have been incorporated into rice genome so that the expresses the enzyme
lysozyme and the protein lactoferrin (which naturally occur in human saliva and
other human secretions, as well as in many natural foods).53 The genes confer on the
rice new antimicrobial and other beneficial qualities of potential benefit for infant
health and nutrition: the absence of these chemicals from infant formula may be one
reason for its relatively poor health benefits compared to breast milk. But this re-
mains a rice plant, grown and harvested as such, expressing by normal biological
processes a gene of human origin. Has this transferred genetic material ceased to be
50 ‘The Universal Declaration on the Human Genome and Human Rights’ (adopted by the
General Conference of UNESCO, (11 November 1997).
52 Ventria Bioscience; Availability of Environmental Assessment and Finding of No Significant
Impact for Field Tests of Genetically Engineered Rice Expressing Lysozyme, (28 June
2005)Federal Register: Volume 70, Number 12, 37077–37079.
53 Huang et al.,‘Expression of natural antimicrobial human lysozyme in rice grains’, (September
2002)Journal Molecular Breeding, Volume 10, Numbers 1–2, 83–94.
human, and should it be viewed as an integral component of a plant genetic re-
source? Or does the chain of provenance, reaching back to its human origin, inflect
or even determine how it should be characterized, and does the gene remain ‘hu-
man’ in character? What does this determination of its character and origin imply
for legal and ethical obligations for downstream users, and for its regulation? Does
a human’s prior informed consent constrain its use?
How such genetic material is perceived or categorized, and how it is therefore
regulated, may now have bearing on still more fundamental questions. The avian
influenza (A(H5N1)) virus is endemic in bird species: it is not readily transmis-
sible between humans, but infects humans who come into close contact with
infected birds, with highly pathogenic effect. One scenario for a future human flu
pandemic is the re-assortment of genetic material from H5N1 and from another flu
virus that is highly transmissible when the two viruses infect the same organism,
either a human or another mammal, such as swine. To enable diagnosis,
surveillance of viral evolution and patterns of infection, and development of
vaccines and other treatments for avian flu infections in humans, sharing of and
access to new strains of the virus are essential.54 This entails collecting specimens
of the virus from infected humans55 and animals56 for sharing through a
cooperative surveillance network. Several countries where H5N1 is epizootic
(epidemic in animals) have asserted sovereignty, citing the CBD, over the virus or
over specimens of the virus.57
The categorization and legal status of wild strains of the H5N1 virus may
therefore be fundamentally important in humanity’s response to evolution in the
flu virus, and its preparedness for and response to new pandemic strains of the
virus. As a virus, strains of H5N1 may not be considered living organisms in
themselves, although there is some legal guidance to the contrary.58 The virus
does, however, have ‘functional units of heredity’ as it consists of little more than
genetic material within a protein shell or capsid. This suggests it falls within the
general definition of genetic material in the CBD, whether or not it is viewed as
54 WHA60.28 Decision on Agenda item 12.1: Pandemic influenza preparedness: sharing of

influenza viruses and access to vaccines and other benefits (23 May 2007), urging Member
States ‘to continue to support, strengthen and improve the WHO Global Influenza Surveil-
lance Network and its procedures through the timely sharing of viruses or specimens with
WHO Collaborating Centres, as a foundation of public health, to ensure critical risk
assessment and response, and to aim to ensure and promote transparent, fair and equitable
sharing of benefits arising from the generation of information, diagnostics, medicines,
vaccines and other technologies’.
55 WHO, Collecting, preserving and shipping specimens for the diagnosis of avian influenza
A(H5N1) virus infection: guide for field operations, WHO/CDS/EPR/ARO/2006.1 (October
2006).
56 WHO, laboratory guidelines for the collection of animal specimens for diagnosis of influenza
infection (12 January 2005).
57 Maryn McKenna, Virus ownership claims could disrupt flu vaccine system, <www.cidrap.
umn.edu> (19 June 2007).
58 The Cartagena Protocol (fn. 36 supra) defines a living organism as ‘any biological entity
capable of transferring or replicating genetic material, including sterile organisms, viruses and
viroids’ (Art. 3(h)).
198 Antony Taubman
‘living’; to be deemed a ‘genetic resource’,59 it would need to have actual or
potential value for humanity – on the face of it, an unlikely attribute for a naturally
occurring pathogen, which is an example of genetic diversity humanity would
prima facie be better off without. Yet the level of patenting activity making use of
the virus60 suggests that it is of value to applied technology and to commerce,
even as they endeavour to find ways of containing and blunting its pathogenic
effect. Yet the virus is not collected and accessed in isolation: it is obtained from
throat swabs or blood samples61 which incorporate either human tissue or animal
biological material and which are sent in that form to internationally designated
laboratories. The legal basis of obtaining, sharing and exploiting such specimens
– of vital importance for a response against a potentially catastrophic pandemic –
may therefore depend on whether the specimen containing the virus was
considered a human genetic resource, potentially subject to bioethical and legal
claims on the part of the human subject, or an animal genetic resource, or a
stand-alone pathogen (subject also to biosafety regulation), or as part of a nation’s
sovereign heritage of genetic resources under the CBD.
2. Unity and Diversity in the Regulation of Genetic Resources
(a) Mapping Regulatory Regimes to Forms of Genetic Resources
These paradoxical characteristics of genetic materials – the common functional

core serving as a platform for the expression of the all the diversity of life – map
across to the laws and regulations that govern genetic resources considered within
distinct categories, categories that are defined according to human applications
and policy considerations, rather than the inherent structure and content of the
genetic materials. Separate legal and policy frameworks can apply to different
aspects of the very same genetic material and genetic resources, and the same
genetic resources are perceived, exploited and regulated very differently by these
distinct regimes. This is because same genetic resource may be perceived and
valued in different ways, in a highly subjective manner, as noted in the UNEP
study on cultural and spiritual values cited above.62 Yet genetic resources have the
one common biological root, they share a common functional backbone for
reproduction, for the transmission of traits and for the coding of proteins, and the
great majority of genes are shared across legal boundaries. The common genetic
mechanism forms the basis – comprises the very expression – of the genetic
diversity which is espoused as a higher-order public good: systemic unity in
genetic diversity, as it were. As the essential function of genetic material is the
59 See the discussion of the definition of ‘genetic resource’, III.2.I.3(a).

60 The number of published international patent applications referring to H5N1 or the avian flu
or influenza virus doubled between 2003 and 2005, rose nearly threefold in 2006, and at the
time of writing appears likely to double in 2007 (source: PatentScope, at <www.wipo.int/
pctdb/en>).
61 See fn. 55 and 56 supra.
same in each case, a single mechanism for preserving and transmitting informa-
tion in the one underlying code expresses all the diversity of life.
Figure 1: Mapping Genetic Resources to the Regulatory Framework

At the international level, there are significant unresolved issues about the
scope of regulation and sovereignty over genetic resources. The major tectonic
plates are clearly identified (see figure 1), but the points of interaction between
them can cause a degree of uncertainty, and the occasional tremor or even
volcanic eruption. The essential elements are set out below in Table 1. The broad
principles that can be distilled from these instruments include:
– A general trend away from the presumption of common heritage status of

genetic resources, and a clear movement towards the assertion and
recognition of national sovereignty – what Kloppenburg has termed ‘a
form of national property’.63
– Varying forms of recognition of the need for benefits from the utilization
of genetic resources to be shared equitably, but with relatively little
guidance on what constitutes the operational notion of ‘equity’ to be
followed.
– A broad principle of prior informed consent over the downstream use of
genetic resources, although accompanied with some uncertainty over the
competent authority, person or community to give such consent, and a need
63 Jack Kloppenburg, ‘First the Seed: The political economy of plant biotechnology’ (First edn.),
(Cambridge, 1988)
200 Antony Taubman
to distinguish prior informed consent under international law as an element
of national resource sovereignty, and prior informed consent of actors
recognized under national laws that give effect to such sovereignty.
– Remaining questions about the common heritage of humanity and about
distributional equities of benefits derived from access to genetic resources
that lie beyond national jurisdictions (in the open seas or the sea bed, or in
Antarctica64), and the use of other categories of genetic material, such as
pathogenic viruses.65
– Sovereignty over genetic resources does not necessarily translate into state
ownership of the specific specimens or physical material containing the
functional units of heredity – property rights and other entitlements may be
granted under or recognized consistent with national law, but are not
necessarily held by the state as such; a significant point of concern and
debate relating to national sovereignty over genetic resources is the claim
of indigenous peoples for recognition of their rights, and its potential
recognition under international law.66
Table 1: Overview of Regulatory Framework
Nature of genetic International legal and Regulatory objectives

resource/material policy context
Genetic resources – CBD and decisions of Conservation, sustain-
in situ and ex situ the CBD COP able use and equitable
benefit-sharing
Human genetic material UNESCO declarations Human dignity, integrity
on bioethics of human genome
Human rights Right to enjoy the
instruments benefits of scientific
progress
Rights of indigenous
peoples
64 To the extent that national territorial claims do not apply.

65 WHA60.28 Decision on Agenda item 12.1: ‘Pandemic influenza preparedness: sharing of
influenza viruses and access to vaccines and other benefits’ (23 May 2007).
66 See for example, the reported recommendation of Rodolfo Stavenhagen, UN Special
Rapporteur on the situation of human rights and fundamental freedoms of indigenous peoples,
that the New Zealand ‘Foreshore and Seabed Act be repealed or amended, and . . . the Crown
should engage in Treaty negotiations to recognise the inherent rights of Maori in that area’ and
that ‘there should be Constitutional reform in New Zealand to entrench the Treaty of Waitangi
and regulate the relationship between the Government and Maori’. The recommendations
were reportedly dismissed by the Government, describing the report as ‘unbalanced and a
missed opportunity.’ (Circulation of Comments Received on Documents WIPO/GRTKF/IC/
9/4 and WIPO/GRTKF/IC/9/5: Addendum, WIPO/GRTKF/IC/10/INF/2 Add.3 (30 November
2006), at Annex, p. 31 (Submission by Marc-René Ruakere ).
Animal genetic FAO and CBD Conservation, sustain-

resources able use and equitable
benefit-sharing
Plant genetic resources FAO International Conservation and
for food and agriculture Treaty sustainable use of plant
genetic resources for
food and agriculture,
and the fair and equi-
table sharing of the
benefits arising out of
their use, in harmony
with the CBD, for
sustainable agriculture
and food security.
Marine genetic UN Convention on the Regulation of access to
resources in the high Law of the Sea natural resources
seas/ocean floor beyond national
sovereignty/ common
heritage of humanity
Genetic resources in Antarctic Treaty System Antarctica as a ‘natural
Antarctica reserve, devoted to
peace and science’
(b) The Distinctness of the Human Genome
Despite the considerable actual overlap between the human genome and other
species, extraneous policy considerations have compelled a distinct approach to
genetic materials that can be characterized as ‘human’. This has provoked specific
exclusions from otherwise very general mandates, such as the CBD COP decision
clarifying that the CBD did not extend to human genetic resources, and similar
clarifications in other fora.67 Positive normative guidance has largely been at the
level of soft law, notably the International Declaration on Human Genetic Data
which provided that:
benefits resulting from the use of human genetic data, human proteomic
data or biological samples collected for medical and scientific research
should be shared with the society as a whole and the international
67 See for example, the exclusion of human genetic material from technical fact-finding activities
of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore (WIPO/GRTKF/IC/3/17).
202 Antony Taubman
community. In giving effect to this principle, benefits may take any of
the following forms: (i) special assistance to the persons and groups that
have taken part in the research; (ii) access to medical care; (iii)
provision of new diagnostics, facilities for new treatments or drugs
stemming from the research; (iv) support for health services; (v)
capacity-building facilities for research purposes; (vi) development and
strengthening of the capacity of developing countries to collect and
process human genetic data, taking into consideration their specific
problems68
Generally speaking, the human genome is a general exception to the emerging

assumption that other forms of genetic resource are essentially covered by
national sovereignty (apart from GR lying beyond any jurisdiction). The human
genome, and extracts from it, are subject to conflicting demands for greater
recognition of individual genetic privacy and a right of individual prior informed
consent over the use of genetic material, on the one hand; and an international
perspective on the human genome as the common heritage of humanity, following
the persuasive guidance of UNESCO,69 the Council of Europe,70 and the Human
Genome Organization Ethics Committee.71
The international legal and policy environment regarding human genetic
materials is therefore more diverse and complex than other forms of genetic
materials, notwithstanding the impossibility of drawing clear boundaries around
strictly human genes, particularly in their wider application in modern biotech-
nology. Yet the emerging body of soft law on bioethics also acknowledges the
linkages with the broader policy context of genetic resources:
Due regard is to be given to the interconnection between human beings

and other forms of life, to the importance of appropriate access and
utilization of biological and genetic resources, to respect for traditional
knowledge and to the role of human beings in the protection of the
environment, the biosphere and biodiversity.72
The human rights dimension – while not at all absent from other aspects of
genetic resources – is perhaps paramount in the consideration of the human
68 ‘International Declaration on Human Genetic Data’ (adopted by the UNESCO General

Conference, 2003).
69 Art. 12(a), ‘Universal Declaration on the Human Genome and Human Rights, UNESCO’,
(adopted by the UNESCO General Conference on 19 February 2003).
70 Recommendation No. 1425 on Biotechnology and Intellectual Property, Council of Europe,
(entered into force on 23 September 1999) and Recommendation No. 1468 on Biotechnolo-
gies, Council of Europe, (entered into force on 29 June 2000).
71 HUGO Ethics Committee, Statement on the Principled Conduct of Genetics Research (1996),
Human Genome Organisation, see <www.hugo-international.org>.
72 Art. 17 (Protection of the environment, the biosphere and biodiversity), Universal Declaration
on Bioethics and Human Rights (adopted by the UNESCO General Conference, 19 October
2005).
genome, stemming even from the invocation of ‘human dignity’ in the first line
of the preamble to the Universal Declaration on Human Rights,73 and the
statement in the preamble to the that human rights ‘derive from the inherent
dignity of the human person’.74 Human rights considerations are embedded in the
debate over genetic resources from many perspectives, including freedom and
equality,75 protection of privacy,76 right to share in scientific advancement and its
benefits,77 right to protection of the moral and material interests resulting from
scientific productions,78 right to health,79 and the right to property.80 The degree
of shared genetic heritage can of course be a sensitive matter in defining ethnicity
and collective social and cultural identity.
However, the increasing recognition of collective rights of indigenous
peoples as such may bring a human rights dimension to the debate over the use
of genetic materials derived from indigenous peoples, such as the controversy of
patenting materials derived from blood samples taken from the Hagahai people
of Papua New Guinea.81 Hence the United Nation Declaration on the Rights of
Indigenous Peoples calls on States to ‘provide effective mechanisms for
prevention of, and redress for . . . any action which has the aim or effect of
depriving [indigenous peoples] of their integrity as distinct peoples, or of their
cultural values or ethnic identities’82 Equally, nations with unusually high
degrees of ethnic and genetic commonality may see their common genetic
identity as a form of national resource.
Recent normative guidance is provided by the UNESCO Universal Declara-
tion on Bioethics and Human Rights. It recognizes that human beings are ‘an
integral part of the biosphere’, and provides for human dignity to be fully
73 Universal Declaration on Human Rights (UDHR), adopted and proclaimed by General

Assembly resolution 217 A (III) of 10 December 1948.
74 ‘International Covenant on Economic, Social and Cultural Rights’ (ICESCR) (adopted by
General Assembly resolution 2200A (XXI) (16 December 1966, entry into force 3 January
1976).
75 UDHR, Art. 1.
76 UDHR Art. 12.
77 ICESCR Art. 15(1)(b); UDHR Art. 27(1).
78 ICESCR, Art. 15(1)(c); UDHR Art. 27(2).
79 The right to the enjoyment of the highest attainable standard of physical and mental health,
ICESCR, Art. 12.
80 UDHR Art. 17.
81 For one highly critical account from an indigenous perspective, within an extensive literature
on this case, see Aroha Mead, Pacific Genes and Life Patents, 2007: ‘When news of the
Hagahai and Solomons patents [surfaced] it seemed incomprehensible that a foreign
government could patent DNA cells collected from Pacific indigenous people without the
informed consent of the individuals, their communities or even their national governments.
The Pacific patents were eventually challenged by the governments of Papua New Guinea and
the Solomon Islands, but the US government rejected their concerns taking the view that the
source of the DNA (and by implication the process in which they were collected) was of no
consequence’.
82 United Nations Declaration on the Rights of Indigenous Peoples, adopted by the Human
Rights Council (29 June 2006), adopted by the United Nations General Assembly (document
A/HRC/1/L.10) in 2007.
204 Antony Taubman
respected (Article 3); for privacy of personal information (Article 8); and for
sharing benefits from scientific research and its applications (including access to
quality health care) (Article 15). Claims of prior informed consent over the human
genome originate from the individual,83 but may also take on a family, collective,
ethnic, national or even universal character, depending on the way the genome is
being employed, and the degree to which common genetic characteristics are
being exploited – to what extent is ‘the’ human genome the property of all
humanity, and of each human?
Yet there is little clear guidance at the level of national law on the question
of ownership or other property rights over genes as such. The trend – which is
nonetheless contested – seems to be for no individual property rights to be
recognized over human tissue isolated in research or medical treatment,84 and a
fortiori for no property rights over genetic information derived therefrom, but
towards a stronger consent framework governing such interventions and a
gathering expectation of entitlement to some form of benefits from downstream
commercialization.85 This unsettled quality of the legal framework leads to
suggestions that there will be recurrences of ‘lawsuits seeking recovery of a
researcher’s profits from patents involving the patient’s genetic material’.86 Too
rigid a framework for medical research on human genetic material risks reducing
medical research on diseases of common concern, with implications for the right
to health. A bilateral approach to benefit-sharing would beg the question of the
rights and interests of other people who shared the genetic background that was
of interest to the researcher, given that all genetic material is ultimately sourced
to a common ancestor.
83 The World Medical Association Declaration of Helsinki on Ethical Principles for Medical
Research Involving Human Subjects (Adopted by the 18th WMA General Assembly, Helsinki,
Finland, June 1964, as amended by the 52nd WMA General Assembly, Edinburgh, Scotland,
October 2000) provides as follows: ‘In any research on human beings, each potential subject
must be adequately informed of the aims, methods, sources of funding, any possible conflicts
of interest, institutional affiliations of the researcher, the anticipated benefits and potential
risks of the study and the discomfort it may entail. The subject should be informed of the right
to abstain from participation in the study or to withdraw consent to participate at any time
without reprisal. After ensuring that the subject has understood the information, the physician
should then obtain the subject’s freely-given informed consent (para. 22 )’. The focus is
apparently on clinical benefits, and no guidance is provided, for instance, on any dispensation
of commercial benefits ensuing from research.
84 Moore v. Regents of Univ. of Cal., Case No.793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S.
936 [1991] (Supreme Court of California holding that there is no property interest in spleen
tissue removed during surgical treatment, but plaintiff had a right to be informed about
intention of developing a cell line and the commercial interests of his physicians.)
85 Greenberg v. Miami Children’s Hospital, 264 F. Supp. 2d 1064, 1067–68 (S.D. Fla. 2003)
(Canavan disease group provided tissues and financial support for the creation of a
genetic-based diagnostic process for the disease. Hospital patented gene and charged for the
test. Reportedly settled through a benefit-sharing agreement, on broad equitable grounds); see
also Kolata, G., ‘Sharing of Profits Is Debated As the Value of Tissue Rises’, New York Times,
(15 May 2000).
86 Eric Chen, ‘Who Owns the Property Rights to Your Genetic Material’, (2004) 13 U. Balt.
Intell. Prop. L.J. 1, at.2.
The human rights perspectives must therefore be seen in the round (see figure
2), rather than as a matter of weighing up which particular right or claimed
entitlement should ‘trump’ all the others in any context of use or extraction of
economic or other value from the human genome. Surrounding the specific rights
are fundamental values, such as conceptions of human dignity, reason and
conscience, equality and equity, morality, innovation and creativity, and solidarity.
Just as human rights may start with the individual person, and radiate out to the
family, community, humanity and even to the global environment, so does respect
for and rights over the human genome, as one’s genetic makeup firstly uniquely
defines one’s own distinctive identity, but also defines other linkages to family,
ethnic community, the human race, and finally the biosphere.
Figure 2: The Human Rights Dimension
3. The Interface between Intellectual Property and Genetic

Resources
In the broadest terms, genetic resources are material in character, and intellectual
property strictly protects intangible subject matter. Hence it is asserted above that
genetic resources as such are not proper subject matter for intellectual property
protection. This general observation has logical force, and maintaining this
distinction is crucial to coherent and effective law and policy. But it does not
explain how issues over genetic resources have become pivotal yet seemingly
intractable in the international law and policy of intellectual property. While IP
may not cover genetic resources as such, it is seen as one, or even the principal,
means of capturing the latent value of genetic resources, of anchoring the
functional utility of genetic resources in the market, and of defining and
structuring research partnerships of commercial, non-commercial or mixed
character.
206 Antony Taubman
The difficulty in characterizing the role of intellectual property vis-à-vis
genetic resources arises because the material that is legally categorized as a
genetic resource is at once multifaceted and polyvalent. The same physical
material is perceived in dramatically different ways, and valued not merely
differently but according to altogether different value systems. Broadly, however,
a genetic resource is physical material which is valued not for its immediate
attributes (the capacity of a seed to serve as food and to satisfy hunger, or the
capacity of a leaf to deliver phytochemicals that ease a headache), but for its
intangible information content (the seed’s capacity to pass on the information
necessary to grow a crop, or the plant’s coding for a therapeutic protein). As a
physical medium embodying valuable information, a genetic resource is often
perceived or discussed as a form of intangible property.
Put simply, by the CBD and ITPGRFA definitions, genetic resources are
‘genetic’ in the sense that they contain the basis of the reproduction and
transmission of useful traits between generations, and ‘resources’ in that they are
of value – or at least of potential value – to humanity. Genetic material is, in
essence, a superset constituting the set of genetic resources and the set of other
genetic material of no value: the latter set dwindling (for instance, the non-coding
DNA sequences spuriously dubbed ‘junk DNA’ now being found to have a critical
systemic role in the expression of genes), perhaps ultimately vanishing (as the
very diversity of genetic resources is accepted as a public good in itself87). An
ostensibly utilitarian standard is therefore used to establish the legal classification
as genetic resources as such, as against the broader category of genetic material,
but it is a standard that simply begs the question of how and when ‘value’ is to be
established.
The analysis and reconciliation of competing modes of ownership and
control, and the dispensation of benefits from this embedded value, require a
clearer grasp of the interplay between physical and intangible aspects of genetic
resources. Getting to grips with the intellectual property aspect of genetic
resources regulation and policy therefore entails reviewing the polyvalence of
genetic resources, and quite literally the diverse ways of seeing the resources.
The contemporary debate is fuelled not merely by differing assessments of
the relative value of genetic resources as knowledge resources, as against the kind
of innovation validated by the patent system, but also by differing value systems,
which variously privilege in situ biodiversity and TK systems, or modern
scientific and technological intervention. The first point of divergence is in the
very perceptions of the same knowledge resource, which are affected by cultural
and economic differences.
Rivalrous perceptions of the same ‘resource’ can exhibit the duality of the
familiar duck-rabbit figure (see figure 3)88: the same physical object is ‘seen’
either as a duck or a rabbit, and one perception cognitively excludes the other.
87 See reference to the CBD, part I.3(a), supra.

88 J.Jastrow, (1899). ‘The mind’s eye’. (1899) Popular Science Monthly, 54, 299–312; see
discussion also in Wittgenstein, Philosophical Investigations.
Bandyopadbyay and Shiva89 draw this parallel in analysing the conflict over
limestone resources in the Doon Valley, which are viewed by traditional users as
natural aquifers (seeing the interstices within the limestone as the resource) and by
miners as a quarry (viewing the mineral as the resource). This rivalrous perception
of the one physical resource gives rise to conflict over the assessment and
apportionment of its value – since extracting one form of value entails frustrating
its value (or even destroying the resource) from the other perspective. But genetic
resources share a quality with other knowledge resources that no other physical
resource can have: non-rivalrousness. Precisely because a genetic resource must
contain ‘functional units of heredity’ its value can be extracted and shared – it can
be both conserved and exploited, unlike, say, the limestone resources in the Doon
Valley.
Yet conflicting, seemingly rivalrous perceptions continue to dominate con-

sideration of genetic resources and debates over their appropriate use. Consider
the seed of the neem tree, azadirachta indica. Neem has been the subject of
extensive debate over patenting of useful products derived from it as a biological
or genetic resource, guided by the extensive background of traditional knowledge
surrounding the tree and its applications in health and agriculture.
The one seed might at the same time be seen, from different vantage points
(see Figure 4):
– as a physical thing, a chattel: as the germ of a new individual plant or as

the harvest of an existing plant;
– as a functional tool, perceived in terms of certain utilitarian applications, in
the field or in the laboratory;
– as an instance of a botanical variety defined by its phenotype;
– as the living repository of a plant’s genome;
– as an expression or embodiment of knowledge about its use and manage-
ment;
– as the distillation and embodiment of a heritage of breeding and selection;
or
89 J.Bandyopadbyay and Shiva Vandana, ‘Conflicts over Limestone Quarrying in Doon Valley’
(1985) Environmental Conservation, Vol. 12, No. 2.
208 Antony Taubman
– as a means of cultural transmission, and a component of a community’s
collective identity. As Chen has observed,90 a genetic resource may even
serve as a ‘meme’, akin to ‘tunes, ideas, catch-phrases, clothes, fashions,
ways of making pots or of building arches’.91
Figure 4: Ways of Seeing a Genetic Resource: Neem (azadirachta indica)

The way one sees the genetic resource will also influence the forms of access,
ownership, custody or control that one considers legitimate and that one views as
having primacy (see Figure 5). Hence these different modes of perception
correspond to a complex array of property rights, and other forms of ownership,
access and control that can converge on a single seed. Such rights or entitlements
differently privilege the physical, informational and cultural aspects of the seed.
Considering the essential distinctions in the law of property, between chose in
possession and chose in action, a seed is at once a chose in possession (one trades
in the seed, and enjoys possession by eating or planting it), and the subject of
various choses in action (one enjoys intangible property rights over the seed by
taking a legal action to restrain others from making certain use of it, such as
through plant variety protection). Other forms of property right also constrain its
use: in bio-prospecting, effective access to the seed is conditional on access to the
soil that yields it, and can therefore be regulated by property rights over the land
or by sovereign rights to set the terms of entry to national jurisdiction.
90 Jim Chen, Diversity and Deadlock: ‘Transcending Conventional Wisdom on the Relationship
between Biological Diversity and Intellectual Property’, (June 2001), Environmental Law
Reporter, XXXI.
91 Richard Dawkins, The Selfish Gene, (Oxford, 1976).
Figure 5: Ideas of Ownership, Control and Custodianship over Genetic Resources

Accordingly, the ways of perceiving the seed map across to different forms of
tangible and intangible property rights, and related property-like rights and
entitlements (see Table 2).
Table 2: Ways of Seeing and Conceptions of Property
The seed as physical object – ownership as personality (a distinct

chattel)
– associated with land ownership or
real property (governed by a ius
fruendi or associated with posses-
sion of land92
– covered by contractual constraints
on use after access afforded (e.g. a
material transfer agreement)
92 At least until it is harvested or prospected, ‘whatever is attached to the soil becomes part of
it . . . things such as seeds . . . which have hitherto existed as individual movable objects, lose
their identity when sown or planted in the ground and become part of the land. Similarly,
objects such as crops or fruit or trees, which are ordinarily thought of as things in themselves,
and which will become individual movable things once they are detached from the soil, are
at present part of it’ F H Lawson, The Law of Property, (Oxford, 1958).
210 Antony Taubman
– access constrained by controls on

entry to land
– access conditioned on a permit or
regulation governing prospecting of
genetic resources
– national resource sovereignty more
broadly
– national sovereignty in determining
the conditions of entry and exit to
the country concerned
– regulations on bioprospecting, bio-
safety, endangered species protec-
tion or quarantine (restricting or
condition access to the seed and
the right to remove it
Botanical variety (phenotype) – Plant variety right (if variety meets
substantive criteria)
– Plant patent (if variety meets sub-
stantive criteria)
Genetic makeup (genotype) – Patent (e.g. if seed is of inventively
transformed plant )
Embodiment of traditional knowl- – Traditional knowledge protection
edge or heritage of plantbreeding (where accorded)
– Custodial responsibilities under
customary law
– Farmers’ rights
Element of cultural heritage – Links to customary land use or
other rights based on customary
law and practice
– Association with local agricultural
products and associated branding
and regional identity
Recalling once again that genetic resources are defined in terms of their actual
or potential value, the distinct ways in which the genetic resource is perceived will
naturally influence how it is valued: indeed, axiological assumptions are embed-
ded in the very act of perception. And, in turn, the corresponding array of property
and associated claims over the seed also express parallel values and value
systems. Divergences in perception therefore correspond with divergent notions
of property interests, and are then linked to the divergent sets of values and value
systems that they express.
This analysis is necessary to establish two key observations: (i) given the
polyvalent quality of contested genetic resources – despite their apparent
non-rivalrous quality as genetic resources – some degree of conflict between
competing property rights and other claims over access, control, entitlement and
custodianship is probably inevitable for any genetic material that is seen as having
even potential ‘value’; and (ii) it may be difficult ever to resolve such differences
purely through the articulation of formal property rights (a kind of ‘conflict of
laws’ approach), and sustainable reconciliation is more likely to come at the level
of reconciling different value systems and different ideas of valuation. The
alternative is the truly unfortunate outcome of a zero-sum dispensation of benefits
derived from a non-rivalrous resource.
Accordingly, a politically sustainable and practically workable international
system of governance of genetic resources and associated knowledge resources
needs in some way to reconcile such distinct perceptions, claims and value
systems. Negotiations over distribution of benefits from knowledge resources can
exaggerate or entrench such divergences, but ultimately they do seek a practical
dispensation that bridges between different modes of perception and different
value systems. The very ambiguity and adaptability of value systems, as against
the bright line boundaries of property law, offers one pathway towards reconcili-
ation: contrasting values are more readily accommodated than conflicting prop-
erty claims.
It is difficult to fix the value of genetic resources if ‘value’ is construed in
narrow utilitarian terms as the economic exchange value. Establishing such a
value is problematic in any case, as much of the strictly commercial value in most
genetic resources is at best potential, rather than actual, value, and entails
predicting the outcome of latent possibilities for downstream exploitation of the
resource, an inherently speculative benchmark for valuation closer to a venture
capital model than, say, an estimate of the economic value of an oil reserve. Even
so, establishing value at the point of access is a critical concern for the effective
and equitable operation of legal mechanisms for prior informed consent and
equitable benefit-sharing. By virtue of their very definition (they contain ‘func-
tional units of heredity’) and the non-excludability of genetic resources as a
knowledge resource, one single act of access can entail an irreversible appropria-
tion of the full economic or commercial value of genetic material as a knowledge
resource (unlike poaching or inequitable exploitation of conventional natural
resources, which can be halted or renegotiated without loss of the residual
economic value of the resource).
This characteristic of genetic resources leads to claims they have been
‘stolen’ or ‘misappropriated’ even through uses which leave the original resource
virtually intact, and indeed add further to genetic diversity through genetic
modification or conventional plant breeding. Again, reconciliation may be difficult
if the exclusive focus remains on the immediate economic value of resources. But
this focus would miss a fundamental point. The legal and policy context of the
CBD accentuates more than the simple economic exchange value of ge-
netic resources: the preamble recalls ‘the ecological, genetic, social,
212 Antony Taubman
economic, scientific, educational, cultural, recreational and aesthetic values of
biological diversity and its components’. Positive acceptance of divergent
perceptions and associated value systems and property claims will facilitate robust
outcomes that are seen as legitimate and appropriate. Seeking to fix the objective
economic value simply restates the question of which form of valuation should
prevail: unless, again, the matter is resolved through a direct bilateral settlement
and mutually agreed terms, such as a material transfer agreement, which may in
turn simply have the effect of deferring the question of the consistency of
individual transactions with overarching expectations of equity and fairness. A
libertarian analysis, on the lines of Nozick,93 would suggest that no third party
(least of all a government authority) could question the distributive justice of a
bilateral agreement freely entered into. Yet many have argued that bilaterally
agreed contracts for access to GR are inherently inequitable, due to presumed
asymmetries in power and knowledge:
however carefully any model contract is drafted, however ardently such

contracts try to correct the huge imbalance between the provider and the
user, such an approach simply cannot lead to anything even remotely
resembling a fair and equitable regime.94
The complex of values surrounding a knowledge resource is richer than the

conventional zero-sum analysis, or duelling claims of exclusivity, and therefore
opens up important opportunities for constructive partnerships in the use of
knowledge resources. Conventionally, the perceived value of a resource would
increase as it moves up a ‘value added’ chain that reflects the degree of human
intervention and the extent of technological transformation of the resource from
its naturally occurring form. This can be illustrated by the degree of transforma-
tion of a plant resource, as human intervention increases with each step and the
targeting of the latent technological value of the resource becomes ever more
precise:
– Maintenance of natural biodiversity in situ;

– Ex situ collections of genetic resources and the conduct of essential
botanical enquiry (such as plant taxonomy), without significant extraction
of physical material;
– Sustainable foraging and traditional usage of naturally occurring resources,
and conservation through the application of traditional ecological knowl-
edge;
– Development of new resources through traditional selection; and then
through more targeted forms of systematic or ‘scientific’ breeding;
– Plant breeding through mutagenesis, the deliberate induction of mutation
by technological intervention; and
93 R. Nozick, Anarchy, State and Utopia (Oxford: Blackwell 1974).

94 WIPO/GRTKF/IC/5/15, at p. 175.
– Creation of transgenic organisms, synthetic compounds or industrial
processes using the functional units of heredity extracted or derived from
GR.
Figure 6: Adding Value?

The increasing degree of human intervention at each stage would conven-
tionally be construed as ‘adding value’ to the raw resource used as feedstock to
innovation. However, other conceptions of ‘value’ would turn on its head this
already simplistic value hierarchy. Some traditional, consumer and civil society
voices in the genetic resource debate express increasing levels of unease and
resistance with each step up this ‘value added’ ladder – the claims of misappro-
priation are more pronounced, as are concerns that environmental, cultural and
ethical value may be in fact lost (see Figure 6). More generally, the greater the
utilitarian or commercial benefit that is extracted, the higher rises the threshold for
equity in sharing those benefits. These value systems are therefore typically seen
to be at odds, and this tension drives conflicting claims to property rights and other
entitlements to exclude illegitimate behaviour, and different conceptions of the
public domain.
Yet the policy framework defined by the CBD suggests that a zero-sum trade-
off between value systems may not be sustainable. Actual values are rarely so
neatly defined and structured as to lend themselves to this kind of precise
counterpoint. The CBD views the active utilization of GR as integral to an holistic
framework for the conservation of biological diversity. As noted, unlike other
natural resources (even biological resources as such), most GR (apart from
exceedingly rare resources) have the distinctive quality of lending themselves to
conservation in situ and technological and industrial exploitation ex situ at the
same time – precisely because they do, by definition, contain the functional units
214 Antony Taubman
of heredity. The very quality that makes access to GR such a sensitive issue – a
single sample can be sufficient to realize the full technological potential value of
a genetic resource, so one act of access can lead to the full appropriation of that
value – also means that the goals of conservation and exploitation need not be in
conflict (as they would typically be for other resources, such as the Doon Valley
aquifer), but can support one another. Access and utilization in accord with prior
informed consent and equitable benefit sharing can create incentives for in situ
conservation by generating benefits from exploitation of the resource ex situ. This
confounds the notions of exclusivity and possession that characterize property and
related tort law: ‘misappropriation’ of a genetic resource is seen as a kind of
conversion or unauthorized taking, but which does not necessarily deprive the
owner or custodian of possession of the physical resource.
On the one hand, benefit-sharing under the CBD necessarily entails the
exploitation of the resources – including as feed-stocks for biotechnological
research and commercial exploitation of the outcomes of biotechnology –
provided overarching safeguards of fairness and equity are complied with. Article
19 provides for ‘the effective participation in biotechnological research activities
by those Contracting Parties, especially developing countries, which provide the
GR for such research, and where feasible in such Contracting Parties’ and ‘priority
access on a fair and equitable basis by Contracting Parties, especially developing
countries, to the results and benefits arising from biotechnologies based upon
genetic resources provided by those Contracting Parties’. Reflecting the scope for
bartering within this general normative framework, access to results and benefits
from such biotechnological derivations, ‘shall be on mutually agreed terms’.
Conservation does not exclude such utilization of the resources, by the very
objectives of the CBD, suggesting that the assertion of contrasting value sets and
interests equally need not be zero-sum.
Hence, the CBD creates an expectation – indeed imposes obligations –
concerning the fair and equitable sharing of benefits from biotechnological
developments based on GR provided by biodiversity-rich countries and the right
of prior informed consent, but it also leaves latitude for the terms of access and
sharing of benefits to be negotiated and mutually agreed under the broad
obligation that arrangements be equitable. This requires a clearer framework for
setting equitable terms – equitable in legal and conceptual terms, in terms of
procedural fairness of the bargaining process, and in terms of distributional equity
– that should reach across cultural differences and diverse value systems, and
yield a shared conception of practical equity. The absence of such positive
normative guidance, and the current high levels of activity in patenting biotech-
nological innovations, are perhaps the key drivers of concern that patents may
serve more as a means of misappropriation than as a means of structuring
equitable benefit-sharing arrangements.
The actual scale and policy implications of the rate of appropriation and the
scale of inequitable misappropriation of the value of genetic resources through the
IP system remain keenly contested.95 But even the range of reforms to patent law
and practice that are proposed, ranging from procedural improvements to
significant new treaty language, are testament to the general acceptance that
significant levels of misappropriation are not inherently or inevitably built into the
patenting process. To the contrary, the CBD does appear to contemplate the active
patenting of biotechnological innovations based on accessed GR, provided that
this is consistent with prior informed consent and any specific terms that are
agreed between resource providers and users, and a fortiori is consistent with
equitable sharing of benefits from the utilization of the resources (in the light of
the CBD’s objectives).
For instance, the Bonn Guidelines established under the CBD provide for
joint ownership of such derivative patents as one form of non-financial benefit-
sharing.96 The FAO ITPGRFA rules out the claim by recipients of plant genetic
resources of ‘any intellectual property or other rights that limit the facilitated
access to the plant genetic resources for food and agriculture, or their genetic parts
or components, in the form received from the Multilateral System’97 but requires
equitable benefit-sharing arrangements when a recipient ‘commercializes a
product that is a plant genetic resource for food and agriculture and that
incorporates material accessed from the Multilateral System’98 unless the ‘product
is available without restriction to others for further research and breeding’,99 when
an equitable payment is only encouraged; thus the mandatory aspect of benefit-
sharing pivots on a presumption that derivative products will be subject to
restrictions such as intellectual property since this triggers the requirement for
equitable remuneration.
Modern genomics has led to a further revaluation of genetic resources. The
raw genetic information implicit within biological material – the simple sequenc-
ing of genes and other basic information about the bare ordering of base pairs in
DNA has formed the cynosure both of policy debate and of actual patenting
activity. The maturing science of genomics has since highlighted the limited value
– in both scientific and economic terms – of such bare information,
95 See the contrasting views expressed in WTO TRIPS Council documents on the implications
of patenting activity in this area, for example: IP/C/W/438: The Relationship between the
TRIPS Agreement and the CBD and the Protection of Traditional Knowledge-Elements of the
Obligation to Disclose Evidence of Prior Informed Consent under the Relevant National
Regime, submitted by Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand and
Venezuela; IP/C/W/434: The Relationship between the TRIPS Agreement and the CBD and the
Protection of Traditional Knowledge, submitted by the United States; IP/C/W449: The
Relationship Between The TRIPS Agreement and the CBD and the Protection Of Traditional
Knowledge, submitted by the United States, IP/C/W/459: The Relationship Between The
TRIPS Agreement and the CBD and the Protection Of Traditional Knowledge, Technical
Observations On The United States Submission IP/C/W449 by Bolivia, Brazil, Colombia,
Cuba, India And Pakistan.
96 See discussion of Bonn Guidelines infra at 2.IV.2.
97 ITPGRFA, Art. 12.
98 Ibid.
99 Ibid.
216 Antony Taubman
which is reducible to a string of four letters. The genomic turn entails the
increasing understanding of the function of genetic information within a regula-
tory system, that determines when and how certain genes are expressed. The
diversity of life cannot, therefore, be simply mapped across to the genetic
sequence as such, but rather the manner in which the genome functions as a
system.
This more sophisticated and nuanced understanding of the practical function-
ing of individual genes within a genome has considerable ramifications for the
valuation of genetic resources and for the related question of the disclosed utility
of claimed inventions that are derived from genetic material. An application for a
patent that claims a gene as such, without being linked to a specific utility, is likely
both to run into difficulties under patent law, as failing to disclose a useful new
contribution to technological know-how, and to attract the censure of critics, who
point to the limited value to society of the simple identification of a gene, in such
a way that may inhibit the actual extraction of practical value from the genome:
Intellectual property on a gene should be confined strictly to an

application that is being actively pursued – to an inventive step.
Someone else may want to work on an alternative application and so
need to have access to the gene as well . . . So ideally all the discovery
part of genes – the sequence, the functions, everything – needs to be kept
pre-competitive and free of property rights . . . The most valuable appli-
cations for a gene come much later than the first easy ones, so this is not
just a matter of principle but has extremely important consequences.100
In short, the approach taken to valuation of genetic resources has always been
influenced by technological change. The rise of modern biotechnology has seen a
concomitant rise in the potential value attached to genetic resources as the
physical media that carry genetic information. The act of patenting has come to be
seen in the policy debate as the definitive act of appropriating this value from
genetic resources, leading to a call for more equitable sharing of benefits from
such patents. Yet the value of such patents has increasingly been questioned –
value in both economic/commercial and scientific/technological terms. The true
extraction of value will increasingly arise from the understanding of the
functioning of genetic components within the genome construed as a system of
regulation of genetic expression. At the same time, the determination of genetic
sequences has evolved from a cutting edge laboratory skill to a routine automated
process. Developments in technology and scientific understanding continue
therefore to recalibrate both the assessment of the value of genetic resources, and
the equities of the allocation of that value.
100 Sulston, fn. 40 supra, p. 71–72.

III. EXISTING LEGAL PROVISIONS RELEVANT TO GENETIC
RESOURCES
1. Genetic Resources as the Subject of Intellectual Property
The foregoing discussion suggests that complexities inevitably arise when

considering the factual interaction between the concept of genetic resources and
intellectual property (IP) as a legal and policy system, due to the multiple ways
of seeing, valuing and asserting legal claims over the one polyvalent resource. Yet,
as a starting point, genetic resources per se are not the subject of IP protection, and
are not regulated directly by IP rights. Recalling that the CBD defines genetic
resources as certain material of actual or potential value,101 it is clear that these
resources are essentially material, and are not intangible subject matter in
themselves. One cannot therefore obtain or assert IP rights over genetic resources
qua genetic resources, any more than the author’s or publisher’s intangible
copyright over the words you are reading determines the ownership of or physical
control over the material book that someone has purchased and that you are
holding.
Of course a genetic resource is a physical medium that carries valuable
genetic information – the ‘functional units of heredity’ that define it as a GR.
Property rights give physical control over access to the information contained in
the GR (as well as to the land or territory it is present on), but that is not the same
thing as property rights that have the information content as their direct subject
matter. This is why the assertion of rights to control access to physical specimens
of GR are so prominent in the debate about equitable benefit sharing: this form of
control based on restriction of physical access can be exercised through the grant
of a visa to enter the country, the grant of permission to enter the land on which
the GR is found, or the use of a material transfer agreement or an access permit
to bind the recipient of a physical specimen to make use of its information
component in a particular manner (including obligations relating to intellectual
property potentially derived from the physical specimen). The conditions for
access to GR in US National Parks102 provide that ‘no specimens (including
materials) may be collected unless authorized on the Scientific Research and
Collecting permit’103 and that ‘collected specimens that are not consumed in
analysis or discarded after scientific analysis remain Federal property . . .
[b]ecause specimens are Federal property, they shall not be destroyed or discarded
without prior NPS authorization’.104 Further, the rules prohibit selling or other-
wise transferring the collected specimens to third parties, a rule presumably
101 CBD, Art. 2.

102 General Conditions For Scientific Research And Collecting Permit, United States Department
of the Interior, National Park Service,, reproduced in Access to Genetic Resources Regime of
the United States National Parks, document WIPO/GRTKF/IC/4/13 (6 December 2002),
Annex, p. 12.
103 Ibid. para. 6.
104 Ibid. p. 13.
218 Antony Taubman
enforceable through a mix of property rights over the specimens and direct
obligations under the access permit.
By contrast, patents are granted over inventions as intangible concepts, and
they are not property rights over physical goods or chattels that embody those
inventions, or are used in those inventions. Genetic resources, as again just noted,
are defined as ‘containing functional units of heredity’, but they are not the same
thing, conceptually or legally, as such genetic functions that they contain.
However, should these functions be deployed in a novel and inventive fashion,
they may form part of a patentable invention; such a patent, however, is not a form
of ownership of the genetic resources that contributed to or otherwise were used
in the development of the claimed invention. In other words, IP mechanisms may
well have a critical role in the process of realization of the ‘actual or potential
value’ making use of functional units of heredity that distinguishes a genetic
resource from mere biological materials. But this does not mean that they are
property rights over the physical specimens, which can separately be bought and
sold and otherwise assigned as physical property. Ownership of the physical
specimen is distinct from ownership of the derived intellectual property: thus,
again, in the U.S. National Parks example, a ‘benefit-sharing agreement would
identify the allocation of ownership in any inventions made, and the other rights
and obligations of the parties’.105 It may stipulate reporting requirements
including ‘notification of the development of any invention based upon research
using research specimens collected in the parks and identification of the contract
in any patent application claiming an invention developed as a result of the
research on collected specimens or other materials’.106
While the nuance here can seem very fine, it is not an easy way out, however,
nor a legal quibble or semantic sleight of hand, to remove genetic resources as
such from the scope of IP ownership. Rather, it provides an entry point for a much
richer and appropriately diverse analytical approach than is afforded by the elision
of genetic resources into IP subject matter. Especially, it illustrates how ownership
of GR as physical property and other legal means of exercising control over
physical access over GR can be used to leverage control over downstream uses of
the GR, control that may reach into the ownership and exercise of intangible
property rights – IP rights – over inventions that gain benefit from the functional
content of the GR. The distinction is an important one, too, when considering the
validity of a patent that claims genetic material as an invention (such as a
particular organism or a gene), as it is the character of the claimed invention as a
contribution to applicable knowledge, rather than the accuracy of a scientific
observation about external facts, that needs to be assessed.
A further necessary distinction is that between the subject matter of protection
(such as an ‘invention’, a ‘plant variety’, or ‘undisclosed information’) and the
rights conferred under protection (such as the right to prevent third parties from
certain uses of a patented genetic trait, or from commercializing a plant variety
105 Ibid. p. 10.

106 Ibid.
essentially derived from a protected variety.) It has become customary in the
debate over genetic resources and IP to use the term ‘IP rights’ synecdochically for
the more general concept of ‘IP’. In general discussion, little of substance may
pivot on this conflation of concepts, and indeed little ontological distinction may
be drawn between the property itself and the bundle of rights attached to it,
especially when the property is itself intangible. But in an operational context, and
especially in the context of examining possible modes of technology transfer, it
takes on more significance. Accordingly, this chapter distinguishes IP as such
from the legal rights stemming from ownership of IP, and only uses the term ‘IP
right’ in the latter context; thus a patent, as a form of IP, is distinguished from the
specific exclusive rights conferred by title in the patent: this is important from the
point of view of technology transfer as so much hinges on how rights connected
to certain IP are exercised (or waived, explicitly or implicitly). Critics of current
IP systems have suggested terms such as ‘intellectual monopoly privilege’ in place
of ‘intellectual property’,107 so as to avoid reifying intangible subject matter as
property.108 In practice, most forms of IP are currently dealt with (assigned,
bequeathed, capitalized, valued) as other forms of intangible property such as
choices in action; but even if such contrarian approach were taken, it would still
be helpful to distinguish between the grant of a ‘privilege’ as such and the rights
it confers (to exclude certain defined acts by third parties), given the enormous
practical implications of the way the legal right to exclude third parties is
implemented.109
This distinction is extremely important when considering goverance of
genetic resources. For example, in some jurisdictions, a patent may be granted
107 Greg Martin, Corinna Sorenson and Thomas Faunce, ‘Balancing intellectual monopoly
privileges and the need for essential medicines’, (12 June 2007) Global Health 2007; 3: 4.
108 For an alternative view, see Brigitte Andersen, (2004) ‘Intellectual Property Right’ Or
‘Intellectual Monopoly Privilege’: Which One Should Patent Analysts Focus On? School Of
Management And Organizational Psychology Working Paper, (Birkbeck, University of
London, January 2004) arguing that from the ‘economic principle or definition point of view,
patents are not monopolies but merely competitive properties of exclusive rights’ although an
exclusive right in practice may confer a monopoly.
109 Lest this distinction be seen as abstract or abstruse, the importance of this distinction in
relation to genetic resources issues was apparent in the oral argument in the US Supreme
Court case JEM Supply v. Pioneer Hi-Bred International. Case No.(99-1996) 534 U.S. 124
[2001]. The counsel (Johnston) for the petitioners conducted a somewhat confused exchange
with the bench, directly contradicting Chief Justice Rehnquist, when he appeared to conflate
the idea of subject matter protected by a plant or utility patent, with the scope of the rights
conferred on the right holder, or the difference between ‘the attributes protected’ under various
forms of plant variety and patent protection, and the ‘rights conferred’ by protection, such as
rights to restrain research and the planting of farm-saved seed. (Rehnquist CJ: ‘The rights
conferred by the statute you’re referring to [plant variety protection] are somewhat different
than the patent statute, aren’t they? Johnson: I do not – no, that is not correct, Mr. Chief
Justice . . . Souter J: Then isn’t the answer to the Chief Justice’s question yes, there is a
difference in the rights which are conveyed by 101 and by a PVP license, respectively?
Johnson: Yes, Justice Souter. Rehnquist CJ: Well, then why didn’t you answer me that way in
the first place? Johnson: I – Mr. Chief Justice, because I misapprehended the nature of the
question and I thought that you were asking about the attributes – the attributes protected’.).
220 Antony Taubman
claiming a seed as embodiment of a protected invention (recalling that this does
not confer property rights over any seed as a physical object). Such patents have
sparked considerable debate over the impact on farmers, from at least two
perspectives: (i) the farmer’s right to use farm-saved seed in future crops;110 and
(ii) the implications of patented genetic material from neighbouring farms
becoming incorporated in a crop, so that the crop itself becomes a means of
manufacturing the patented seed.111 For instance, JEM Supply v. Pioneer Hi-Bred
International112 pivoted on the distinction between protection of a plant variety as
such under sui generis legislation113 and protection of an invention as such under
the conventional utility patent law.114 Yet the underlying issue in this case
concerned the legitimate scope for exceptions to rights to control downstream use
of IP protected seeds, especially the farmer’s right to replant farm-saved seed. The
core policy issue was not whether the seed should be construed as an invention
and as fit subject matter for a patent as a form of intangible property. It concerns
the legitimate scope of and exceptions to the exclusive rights granted under the
patent, and the distinct rights granted under different forms of IP protection – sui
generis plant variety protection is argued by its proponents to be a better fit for
that subject matter on the basis that such protection should not constrain the
legitimate use of farm-saved seed.115 By contract, the ostensibly higher inventive
threshold for obtaining a patent is used to justify greater exclusivity in the rights
under the patent ‘[b]ecause of the more stringent requirements, utility patent
holders receive greater rights of exclusion than holders of a PVP certificate. Most
notably, there are no exemptions for research or saving seed under a utility
patent’.116 Despite this policy linkage between the grant of intangible property
title and the nature of rights attached to that property, the distinction is important
to maintain. For instance, the EU Biotech Directive,117 while clearly permitting
the patenting of seeds, includes a specific defence or exclusion from patent rights
to allow farmers to plant farm saved seeds.118 On the other hand, the Schmeiser
case in Canada concerned the exercise of patent rights that in effect
110 See JEM Supply v. Pioneer Hi-Bred International, fn. 109 supra.
111 The scenario in Monsanto Canada Inc. v. Schmeiser, [2004] Case No. 1 S.C.R. 902, 2004 SCC
34; see amidst a dense literature R. Burrell and S. Hubicki, ‘Patent Law and Genetic Drift:
Schmeiser v. Monsanto Canada Inc’, (2005) 7(3) Environmental Law Review pp. 282–289.
112 Fn. 107 supra.
113 Plant Variety Protection Act (PVPA), 7 U.S.C. § 2321 et seq.)
114 35 U.S.C. § 101.
115 For instance, UPOV 1991 (see III.2.III.3.(a)(dd) infra) expressly allows members to exclude
from the scope of the breeder’s right the option of allowing farmers to propagate seed saved
from their own harvest, so-called ‘farm-saved seed’.
116 JEM Supply v. Pioneer Hi-Bred International. (99-1996) Case No. 534 U.S. 124 [2001], at p.
12
117 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal
Protection of Biotechnological Inventions, 1998 O.J. (L 213) 13 (‘EU Biotech Directive’).
118 Art. 11, EU Biotech Directive; implemented for instance in Art. 60(5)(g) of the UK Patents
Act (1977, as amended in 2000), which provides for an obligation for farmers to pay equitable
remuneration to the patent holder, an obligation from which ‘small farmers’ are exempt.
covered genetically modified seeds, even though under Canadian law plants or
seeds as such are not patentable, and ‘[e]veryone agrees that Monsanto did not
claim protection for the genetically modified plant itself, but rather for the genes
and the modified cells that make up the plant’.119 Again, the case pivoted on a
clear distinction between the object of property, and the rights that flow from that
property.120
Moreover, some forms of IP law, systems and practical mechanism that are
relevant to the use and commercial exploitation of genetic resources do not
involve the grant or exercise of distinct property titles as such – such as
non-disclosure or confidentiality agreements, measures against unfair competi-
tion, and the use of public domain patent information (including technology
subject to patent rights in some national jurisdictions but not in others).
Accordingly, the term ‘IP mechanisms’ can be more appropriate for general
analysis and discussion, instead of the more specific term ‘IP rights’.
2. Overview of Current Questions
The review of the international state of play regarding IP and genetic resources
can be summarized in the following series of questions. The discussion in
following sections seeks to set these questions in their international and national
contexts, drawing on diverse practical experience and choices made by legislators
and other policymakers, but without seeking to prejudge the ‘correct’ answers to
these complex questions raised. The core questions include:
– When do legitimate IP titles overlap or conflict with other forms of

property, custodial responsibilities, entitlements and interests that are
associated with genetic resources? How should such conflicts or forms of
interaction be dealt with, through formal legal mechanisms, through
administrative initiative, or through practical negotiation? How do the
rights to control third party behaviour under these different forms of
property interact or conflict?
– What derivatives or functional aspects of genetic resources can form
legitimate subject matter for patents? How is the relationship between
invention and genetic content structured under patent law? When a patent
claims genetic content as an invention – say, a particular nucleotide
sequence, coding for a specified protein – to what extent can this be
considered patenting the genetic resource as such?
– How do the circumstances of acquisition and utilization of genetic
resources as feedstocks for research and development modify or determine
the entitlement to apply for or to hold a patent, or the manner in which
119 Monsanto Canada Inc. v. Schmeiser, [2004] 1 S.C.R. 902, 2004 SCC 34, at p. 18.
120 For instance, again highlighting the importance of this distinction, the appellant (Schmeiser)
argued ‘that the subject matter claimed in the patent is unpatentable. While acknowledging
that Monsanto claims protection only over a gene and a cell, Schmeiser contends that the
result of extending such protection is to restrict use of a plant and a seed’. (at p. 20).
222 Antony Taubman
resultant patents are exercised and enforced? What forms of linkage or
legal leverage exist, ranging from equitable and ownership interests, to
rights to revoke or transfer granted patents? How can or should patents
operate in the equitable distribution of benefits from the utilization of
genetic resources?
– What specific measures are required under patent law and other IP law to
deal with concerns over genetic resources – such as specific exceptions to
IP rights for the re-use of farm-saved seed121 or seed that has acquired
patented traits through normal genetic transfer122 and compulsory cross-
licensing between different IP titles123
– In reviewing the broader legal and ethical framework governing genetic
resources, and considering how to advance the policy objectives it frames,
what forms of exercising IP mechanisms (including the exercise of rights
flowing from IP titles) that control uses of genetic resources are desirable
from the broader policy and economic perspectives, legitimate from a
political perspective, right from an ethical perspective, and compliant with
the law (such as laws concerning anti-competitive licensing and other
abuses of IP rights)?
3. Intellectual Property Instruments
(aa) International IP Law in Context
IP protection relating to genetic resources is not a recent consequence of the

emergence of modern biotechnology. Life sciences innovations – such as
Pasteur’s improved beer-making yeast124 – were patented in the 19th century. The
1883 Paris Convention explicitly extends industrial property protection to
agricultural science and natural products.125 The recent rapid uptake of the patent
system by life sciences innovators has simply accentuated long-standing IP policy
issues that have arisen when biological materials serve as feed-stocks to
innovation, in particular:
– Can an isolated gene sequence or synthesized protein be considered

patentably ‘novel’ if it is chemically identical to a nucleotide sequence or
protein that already exists in nature?
121 William Lesser, ‘The Impacts of Seed Patents’, (January 1987)North Central Journal of
Agricultural Economics, Vol. 9, No. 1, 37–48.
122 See Schmeiser fn. 111 supra and JEM fn. 116 supra .
123 EU Biotech Directive, fn. 125 supra.
124 Improvement in Brewing Beer and Ale Pasteurization (US Patent 135,245).
125 Paris Convention, Art. 1.
– When is it a ‘mere discovery’ and when is it a true invention to isolate a
compound or derive information about an existing natural compound, such
as a nucleotide sequence?
– When is it obvious, and when is it truly inventive, to create a new form or
derivative of a known compound – such as polymorphs or salts; when is it
obvious or inventive to identify new therapeutic properties or to develop
new dosage forms of known pharmaceuticals?
– How to resolve moral and bioethical issues provoked by ‘patenting life’ –
when do these issues concern the technology itself, ownership of exclusive
patent rights over isolated chemical structures such as nucleotide se-
quences, or how those exclusive rights are exercised, and to what ends?
What does it mean to patent living organisms? What distinctions can and
should be made between higher and lower life forms?
– More generally, what is different – from a legal, regulatory, ethical point of
view – about the chemistry of life – genes and the proteins they code for?
Is DNA ‘just’ a chemical compound or something more?
Established patent jurisdictions such as the United States, Japan, the European
Patent Office and the European Union126 have over many years progressively
developed and continue to evolve answers to these questions. While the broad
principles may endure, they are challenged and adapted afresh with each wave of
technological development in the life sciences. However, the use of the estab-
lished IP system is internationalizing and broadening in scope – with many new
players, applicants, opponents, critics and beneficiaries who differ geographically,
culturally, across levels of economic development more than ever before, and as
new actors (public institutions, public-private partnerships) develop a proportion-
ately higher stake in the system. The debate over genetic resources and IP simply
accentuates this trend, the vigorous uptake of genetic inputs in life sciences
research having created entire new communities of stakeholders, building
pressure to revisit such questions, and possibly to answer them in different ways,
from a richer cultural and moral palette.
The patent system has evolved as a set of legal principles through contesta-
tion over such issues. Its fundamental role is to promote the production of public
goods by creating exclusive private rights: purposefully creating public benefit by
excluding material from the public domain. Patents entitle their owners to exclude
third parties from the use of the claimed invention, in order to create an incentive
structure for the development and practical implementation of a valuable
invention, and to induce the inventor to instruct the public in sufficient detail how
to carry out the invention. The constant challenge, reaching back to the very roots
of the patent system, is how systematically and objectively to set the appropriate
boundary around the material that should be kept from the public domain in order
to yield the expected public benefit, without fencing off legitimate parts of the
public domain.
126 EU Biotech Directive, fn. 125 supra, Art. 5.2.

224 Antony Taubman
A basic premise of patent law is that all fields of technology should be treated
consistently or without discrimination.127 Moreover, a TRIPS dispute case has
clarified the distinction between differential and discriminatory treatment of life
sciences patents: discrimination would have ‘differentially disadvantageous con-
sequences’, so that ‘those differential effects are found to be wrong or unjustifi-
able’.128 Further there are important exceptions to this principle – there is an
entitlement, for instance, to discriminate against inventions that run contrary to
morality. And life sciences innovation inevitably calls for specific, highly tailored
forms of regulatory intervention, that cover the inputs to research (e.g. access
regulations on in situ biodiversity and other prior informed consent regulations),
the process of research (ethics and bio-safety) and the outcomes of research
(regulation of genetically modified organisms, pharmaceuticals and agricultural
chemicals). Thus some form of differential treatment of patents on life sciences
innovation is inevitable, and can be seen in the law of patents in several forms:
– scope of protection (e.g. the possible per se exclusion of animals from

patentability);129
– morality and ordre public exceptions to patentable subject matter (e.g. for
genetically modified mammals);
– exceptions to the reach of patent rights (such as ‘Bolar’ exceptions for
steps required for regulatory approval130) the development of compulsory
licensing between the scope of research exceptions and the use of research
tools), and other forms of interaction with the regulation of pharmaceuti-
cals and agricultural chemicals;
– rules governing IP management in the public interest for public-funded life
sciences innovation;
– compulsory licensing and government use provisions, notably the tailored
system for pharmaceuticals established through the Doha process;131
– forms of disclosure of technological information related to the inven-
tion, notably the deposit of microorganisms for the purposes of patent
procedure;132
127 TRIPS Art. 27.

128 Canada – Patent Protection of Pharmaceutical Products, WT/DS114/R, at 171.
129 TRIPS Art. 27. 3(b).
130 Canada – Patent Protection of Pharmaceutical Products [2000] Case No.WTO WT/DS114/R;
see also Merck KGaA v. Integra Lifesciences I, Ltd., Case No.545 US 193 [2005].
131 WTO Ministerial Conference Doha, 9–14 November 2001, ‘Declaration on the TRIPS
Agreement and Public Health’ (adopted on 14 November 2001), WT/MIN(01)/DEC/2; WTO
General Council, Amendment of the TRIPS Agreement, Decision of 6 December 2005,
WT/L/641 (8 December 2005).
132 A distinct international system is established under the Budapest Treaty for the mutual
recognition of deposit of microorganisms for patent purposes; see section (cc) infra.
– proposals to require inventors who make use of genetic resources and
traditional knowledge to disclose source, origin and aspects of legal
provenance.133
So life sciences innovation is in principle treated without discrimination as any

other field of technology, but is regulated differentially. Deposit of microorgan-
isms under the Budapest system134 shows how differential treatment can be
required to maintain a non-discriminatory balance: a core principle of patent law
is that the invention should be disclosed sufficiently for third parties to carry it out
without further experimentation. For inventions that rely upon distinctive micro-
organisms, paper disclosure of the invention may be insufficient and access to the
actual microorganism may be necessary. Thus many national patent laws
specifically recognize the deposit of microorganisms under this system. Specific
approaches tailored to the life sciences include the international standard135 for
listings of nucleotide and amino acid sequences, recognizing the unique charac-
teristics of this aspect of disclosing an invention and the public interest in ensuring
uniform access to nucleotide data.
(bb) The TRIPS Agreement
As a key source of substantive patent law at the international level – for instance,
formally establishing at the international level the key patentability criteria, and
creating positive obligations to protect certain areas of biotechnology-related
subject matter – TRIPS takes its place within a complex of international rules that
represent a collective endeavour to determine what legal exclusions from the
public domain of knowledge are needed to advance the public interest; and what
forms of differential treatment of life sciences technologies are consistent with the
nondiscriminatory application of broader patent principles.
TRIPS requires patents to be available under national law for any inventions,
whether products or processes, in all fields of technology, provided that they are
new (novel), involve an inventive step (non-obvious) and are capable of industrial
application (useful). Patents are to be available and patent rights enjoyable
without discrimination as to place of invention, field of technology, and whether
imported or locally produced.136 Patents may be excluded on inventions, if their
commercial exploitation would jeopardize ordre public or morality, including
human, animal or plant life or health.137 TRIPS also allows for exclusion from
patent law of diagnostic, therapeutic and surgical methods for the treatment of
133 India, Brazil, and others, ‘The relationship between the TRIPS agreement and the Convention
on Biological Diversity (CBD) and the protection of traditional knowledge – elements of the
obligation to disclose evidence of benefit-sharing under the relevant national regime’, WTO
document IP/C/W/442 (18 March 2005).
134 See Sec.(cc) infra.
135 See WIPO Standard ST.25.
136 TRIPS Art. 27.1.
226 Antony Taubman
humans or animals, as well as plants and animals other than micro-organisms, and
essentially biological processes for the production of plants or animals other than
non-biological and microbiological processes.138
International rules, in particular TRIPS, are most often viewed as a constraint
on national policymaking, as a reduction of legislative choice, and as an enforced
convergence of national laws, which promotes the trade interests of IP owners,
and establishing a degree of efficiency, fairness and predictability within the
international patent system. For instance, it is now effectively mandatory to make
patents available for inventions that constitute microorganisms and microbiologi-
cal processes, and for a period of (at least) 20 years, in both cases contrary to the
past autonomous policy choices of many countries.139 This TRIPS requirement to
render patentable certain forms of biological invention is the essence of the
critique, voiced by many developing countries but contested by others, that TRIPS
is in tension with the CBD:
The TRIPS Agreement as it stands today, whilst promoting the granting

of patents to products based on genetic resources and associated
traditional knowledge, contains no effective provisions to protect those
resources and associated knowledge from misappropriation and theft. It
is the absence of such provisions in the TRIPS Agreement that may
generate conflicts between its implementation and that of the CBD.140
The WTO Secretariat has identified three sets of views concerning the
relationship between TRIPS and the CBD:
– there is inherent conflict between the two instruments, and the TRIPS
Agreement needs to be amended to remove such conflict;
– there is no conflict between the two Agreements and governments can
implement the two in a mutually supportive way through national
measures;
– there is no inherent conflict but there is or could be a potential for conflict
depending on the way that the Agreements are implemented, and there is

139 See for example, a reference document from the TRIPS negotiations, Uruguay Round - Group
Of Negotiations On Goods - Negotiating Group On Trade-Related Aspects Of Intellectual
Property Rights, Including Trade In Counterfeit Goods - Existence, Scope And Form Of
Generally Internationally Accepted And Applied Standards/Norms For The Protection Of
Intellectual Property, Note Prepared by the International Bureau of WIPO, MTN.GNG/NG11/
W/24 (5 May 1988).
140 IP/C/W/459: The Relationship Between The TRIPS Agreement and the CBD and the
Protection Of Traditional Knowledge, Technical Observations On The United States Submis-
sion IP/C/W449 by Bolivia, Brazil, Colombia, Cuba, India And Pakistan, 1.
a need for, or at least a case for, international action to ensure that the two
Agreements are implemented in a mutually supportive manner.141
The main reasons put forward to support the view of inherent conflict were
identified as:
by requiring that certain genetic material be patentable or protected by

sui generis plant variety rights and by not preventing the patenting of
other genetic material, [TRIPS] provides for the appropriation of such
genetic resources by private parties in a way that is inconsistent with the
sovereign rights of countries over their genetic resources as provided for
in the CBD; and [TRIPS] provides for the patenting or other intellectual
property protection of genetic material without ensuring that the provi-
sions of the CBD, including those relating to prior informed consent and
benefit sharing, are respected.
And the views that there is no conflict are reportedly based on the
observations that TRIPS and the CBD:
have different objects and purposes and deal with different subject-
matter; the granting of patent rights over inventions that use genetic
material does not prevent compliance with the provisions of the CBD
regarding the sovereign right of countries over their genetic resources,
prior informed consent and benefit sharing; no specific examples of
conflict have been cited.142
TRIPS nominally harmonized patent law around the three core patentability
criteria (novelty, non-obviousness/inventive step, and utility/industrial applicabil-
ity)143 but in doing so simply recorded the actual practice of all existing patent sys-
tems, in effect documenting the past convergence of views on the kind of exclusions
from the public domain of technology would best advance the public interest.144 It
left no guidance on substantive legal questions raised by these general principles,
such as the range of background knowledge (‘prior art’) considered relevant in as-
sessing novelty, how to assess when a claimed invention is obvious to the relevant
person skilled in the art, and what test for utility is required, such as to ensure a pat-
ented nucleotide sequence is a legitimate invention.
Thus, in setting an agreed general standard that leaves substantive questions
open, TRIPS effectively permits policy flexibility on these key aspects of the
141 The Relationship Between the TRIPS Agreement and the Convention on Biological Diversity:
Summary of Issues Raised and Points Made, Note by the Secretariat (IP/C/W/368, 8 August
2002).
142 Ibid.
143 TRIPS, Art. 27(1).
144 In the Anglo-American legal tradition, this utilitarian framework can be traced back to at least
the 1623 Statue of Monopolies passed by the English Parliament.
228 Antony Taubman
patent system. TRIPS also explicitly provides for flexibility on patentable subject
matter and a priori exclusions from patentability.145 Perhaps, with greater
implications for genetic resources issues, TRIPS requires that patents be available
‘for any inventions, whether products or processes, in all fields of technology’,146
and positively requires that patents be available for inventions involving micro-
organisms and microbiological processes for the production of plants or animals;
plants and animals and essentially biological processes for their production may,
optionally, be excluded from patentability.147 This mandatory coverage of some
biological subject matter has raised concerns that TRIPS encourages or even
requires the granting of patents covering genetic material in its natural state. The
WTO Secretariat summarizes:
A concern has been expressed that the TRIPS obligation to provide

patent protection for micro-organisms could mean the patenting of a
range of genetic materials in their natural state. It has been argued that
some Members define inventions to include discovery of naturally
occurring matter and that this has led to patents on life forms found in
their natural state . . . [a further concern is expressed about] the granting
of patents in respect of genetic material that has been merely isolated
from nature and not otherwise modified. In this connection, the view has
been expressed that for a micro-organism to be patentable in a way that
would avoid conflict with the CBD, it should have undergone some
genetic modification at the hands of man.148
Reported responses to these concerns include that:
granting of patents on inventions which use genetic resources does not

stand in the way of the fulfilment of the provisions of the CBD relating
to the sovereign right of countries over access to genetic resources in
their territories and prior informed consent as a condition of such access;
holding a patent on isolated or modified genetic materials does not
amount to ownership of genetic materials themselves, nor does it provide
property rights with regard to the source from which the original material
was obtained. A patent on an isolated, identified and modified gene
provides the patentee only with the ability to prevent others from
producing, marketing and using the modified gene. The source from
which the gene was taken would be unaffected by the patent; [and] life
forms in their natural state would not satisfy the criteria for patentability
in the TRIPS Agreement. However, if the subject-matter of a patent has
involved sufficient human intervention, such as production by means of
145 TRIPS, Art. 27(2) and 27(3).

146 TRIPS, Art. 27(1).
147 TRIPS, Art. 27(3).
148 IP/C/W/368, 5.
a technical process or isolation or purification, and if the isolated or
purified subject is not of a previously recognized existence, then it is
capable of constituting an invention.149
How these distinctions and concerns have been addressed under national and
regional laws is covered below.
These contested views concerning the interrelation between TRIPS and the
CBD is symptomatic of a broader discourse, sparked by the re-valuation of
genetic resources precipitated by developments in the life sciences.150 The
perception that developed countries have vastly increased their capacity to derive
value and benefit from genetic materials largely originating in developing
countries has triggered an intense debate over the equities of the patent system as
currently configured. This has led to calls to recalibrate the equitable balance
within the patent system, and has reshaped the dynamics of patent law and policy
in the international arena.
Most strikingly at present, this has led to proposals to rewrite international
patent law standards151 to make it mandatory to disclose genetic resources and
traditional knowledge used in the course of developing an invention. In some
formulations the obligation is extended to require evidence of the legal circum-
stances of source or origin of such TK and GR (documenting that prior informed
consent was obtained for its use in the invention, and equitable benefit-sharing
arrangements were entered into). Actual national laws have been amended along
these lines in a number of significant economies, creating a distinctive new
requirement for those seeking patent protection for life sciences inventions. A
divisive debate continues internationally over the appropriate scope, if any, and
effectiveness of such disclosure requirements, but they are emerging as a matter
of national practice in a number of jurisdictions. This issue exemplifies the
centrifugal trend in national responses to the two paradoxes of life sciences patent
policymaking, especially the question of how to reconcile differential treatment of
specific technological areas with the broader goal of nondiscriminatory imple-
mentation of the basic principles of patent law: how differential treatment may
sustain an overall equitable balance.
(cc) The Budapest Treaty
An existing sui generis disclosure requirement relevant to genetic resources is that

recognized under the Budapest Treaty on the International Recognition of the
Deposit of Micro-organisms for Purposes of Patent Procedure (the Budapest
Treaty). Concluded in 1977, the Treaty deals with the scenario in which a
149 IP/C/W/368, 5.
150 See the discussion in Taubman, ‘Cereal offenders: access and equity in trade negotiations on
knowledge resources’, in J. Kesan (ed.), Agricultural Biotechnology and Intellectual Prop-
erty: Seeds of Change (2007), from which some of this discussion is drawn.
230 Antony Taubman
microorganism cannot be fully described in a patent document to achieve the
necessary level of disclosure and practical enablement that is essential for the
validity of a patent. In such cases, under the patent law of many countries, a
physical sample of a microorganism may be deposited for the purposes of patent
procedures. The Budapest Treaty creates an international network for the
recognition of such deposits. Under the Treaty, where a national patent system
allows or requires an applicant to deposit actual samples of microorganisms for
the purposes of patent procedure, that the Contracting Party must recognize the
deposit of a micro-organism with any prescribed International Depositary
Authority (IDA) as being sufficient for patent procedure under the national law.
IDAs are typically public scientific institutions with established culture collec-
tions, and with the capacity to maintain collections of microorganisms and other
related materials (as at 1 March 2006, 37 IDAs were notified under the Treaty).
The deposit must be recognized whether or not the IDA is within or beyond the
jurisdiction of that country, thus obviating the need for multiple deposits in
multiple jurisdictions. The system also reflects the practical and bio-safety issues
that would arise if patent offices were called on to maintain deposits of
microorganisms, and the transit of microorganisms to multiple countries.
The practice under this system has extended from microorganisms as such to
biological material more generally. For example, in accordance with EPC Rule 28
if an invention involves the use of or concerns biological material and

this biological material is not available to the public and cannot be
described in such a manner as to enable the invention to be carried out
by a person skilled in the art, reference needs to be made to the deposit
of this biological material.
The Budapest system exemplifies how technology-specific interventions
may be necessary to ensure a balanced and non-discriminatory approach
to the effective implementation of patent law principles – in this case, the
requirement that the invention be fully and effectively disclosed for a
patent to be valid, when documentary disclosure is inadequate to achieve
this. It also represents a form of close practical interaction between the
ex situ conservation of genetic resources and the patent system, and the
thin conceptual line that can lie between a genetic resource conceived as
such and an invention.
(dd) Plant Breeders’ Rights
As discussed above, one way of looking at a plant is as an exemplar of a botanical

variety – the plant perceived as a phenotype. Sui generis ‘plant breeder’s rights’
(PBR) or ‘plant variety rights’ (PVR) are the established form of the intangible
property right corresponding to that way of seeing and valuing the plant,
conferring a form of limited ownership over a variety of plant as such. The
International Convention for the Protection of New Varieties of Plants (the UPOV
Convention) sets out a widely followed152 international legal framework estab-
lishing an agreed set of general standards for PBR, that can be flexibly adapted
and applied at the national level. Hence national laws give effect to similar broad
principles and interact with other countries’ systems, allowing for a high degree
of technical cooperation, but laws are tailored to serve the legal environment and
domestic interests of each country. TRIPS requires the plant varieties be protected
by an effective sui generis system, by patents or by both: UPOV is generally not
viewed as a mandatory choice of sui generis system, but is very widely applied
even by countries that do not adhere to UPOV legally. During the conclusions of
the Uruguay negotiations, the Director General of GATT commented that WTO
Members
have been left greater flexibility in meeting their obligations in this area
than would have been entailed had there been a specific reference to
UPOV. In practice, many countries will, nonetheless, wish to profit from
the experience that has been gained under UPOV and tailor their systems
to it;153
an observation since borne out in practice, with an increasing degree of adherence

– de jure and de facto – among WTO Members to the UPOV system.
The subject matter is the plant variety as such, which is the lowest level of
taxonomy within the plant kingdom, being a distinct group of plants within a
species.154 By contrast, a plant ‘species’, the next hierarchy in the classification,
includes plants that may differ from one another, but are capable of interbreeding.
Plant breeding develops new varieties by intervening in the genetic makeup of
plants, through selection, hybridization, genetic engineering and mutation, to fix
desirable traits in a stable form for successive generations. The UPOV standards
accord protection to a new variety that is distinct155 from existing varieties,
152 As at 18 June 2007, 64 countries had adhered to the UPOV Convention; reportedly a number
of other countries maintain systems that are de facto compatible with the UPOV system even
if not compliant de jure (the suggestion that this may reflect a continuing preference among
some countries for the standards of the now closed 1978 Act of the UPOV Convention is made
in an extensive literature about the differences between the 1978 and 1991 Acts, an issue
which is not surveyed here).
153 See Sutherland, Peter, ‘Seeds of Doubt: Assurance on “Farmers” Privilege’, Times of India,
(15 March 1994).
154 UPOV 1991 defines a ‘variety’ as a plant grouping within a single botanical taxon of the
lowest known rank, which grouping, irrespective of whether the conditions for the grant of a
breeder’s right are fully met, can be: defined by the expression of the characteristics resulting
from a given genotype or combination of genotypes; distinguished from any other plant
grouping by the expression of at least one of the said characteristics; and considered as a unit
with regard to its suitability for being propagated unchanged.
155 Under the 1991 Act of the UPOV Convention a protectable variety must be ‘clearly
distinguishable from any other variety whose existence is a matter of common knowledge at
the time of the filing of the application’ (Art. 7). The UPOV Guidelines cite plant
characteristics such as leaf shape, stem length, and plant colour to determine if the difference
between varieties is ‘clear and consistent’. Distinctness is the main criterion to determine the
232 Antony Taubman
uniform156 and stable.157 National offices cooperate extensively on field tests of
varieties against these standards, guided by established UPOV principles and
detailed technical guidelines, achieving a degree of technical cooperation and
consistency of approach that contrasts with the more diffuse patent system.
Of all IP rights, plant breeding is the most closely intertwined with genetic
resources, especially plant genetic resources for food and agriculture: all the main
food crops are not wild strains but the product of many generations of selective
breeding. Plant breeding programs continue to produce new varieties that help
respond to the challenges of making agriculture sustainable, securing future food
supplies for a growing population on dwindling agricultural lands, and dealing
with environmental change. To the extent that society expects private interests to
undertake the development of new varieties as a form of public good, a means of
appropriately engaging those private interest is required to channel resources into
plant breeding, and to ensure the benefits of the new varieties are available to the
public on reasonable terms, including for plant breeding – in other words for
continuing use of these varieties in turn as genetic resources and as feed-stocks for
further breeding: the same balance between exclusivity and access that lies at the
heart of the patent system, but calibrated in a distinct manner.
As a sui generis system tied to a distinct set of genetic resources and a distinct
mode of innovation, PBR have a firm imprint of the specific context of plant
breeding. This sui generis character is manifest, for instance, in a relatively ‘thin’
horizontal layer of exclusive rights, compared to patent rights which may reach
through the innovation process to control downstream use. The rights under a
PBR system are tied to the degree of breeding involved in producing an eligible
new variety, as a commercial product in itself, rather than as an economically
valuable feedstock for further plant-breeding: explicit exclusions apply to acts
done for private, non-commercial and experimental purposes, and acts done for
the purpose of breeding other varieties (‘breeder’s exemption’). A limited optional
exception may be used to permit farmers to save seed for future crops (‘the
farmer’s privilege’158), which many countries employ. There is a direct structural
analogue with the notion of benefit-sharing under the ITPGRFA, in which there is
an effective option between making a derivative product available for research or
scope of plant breeders’ rights over subjects that are closely related to another protected
variety; see CBD, Second Conference of the Parties, Doc. UNEP/CBD/COP/2/17, 6 October
1995, para. 18.
156 According to the 1991 Act of the UPOV Convention a variety ‘shall be deemed to be uniform
if, subject to the variation that may be expected from the particular features of its propagation,
it is sufficiently uniform in its relevant characteristics’. According to the UPOV Guidelines,
the variation shown by a variety must be ‘as limited as necessary to permit accurate
description and assessment of distinctness and to ensure stability’ (Art. 8).
157 According to the 1991 Act of the UPOV Convention a plant variety is stable if ‘its relevant
characteristics remain unchanged after repeated propagation or, in the case of a particular
cycle of propagation, at the end of each such cycle’ (Art. 9).
158 Art. 15(ii) of the UPOV Convention 1991 allows ‘farmers to use for propagating purposes, on
their own holdings, the product of the harvest which they have obtained by planting, on their
own holdings, the protected variety or [an essentially derived variety]’.
breeding, or making a financial contribution to compensate for lack of such
availability.
The exclusive rights conferred therefore have little ‘reach through’ effect, and
centre on the use of the protected species for commercial propagation. This leads
to a further characteristic: a form of ‘commons’ or ‘open source’ structure in
which the common stock of improved plant varieties is in principle available for
the use of all other plant breeders, again structurally similar to the multilateral
benefit-sharing arrangement under the ITPGRFA. In other words, the exclusive
rights are linked to the value extracted from the resource (the protected variety)
from its commercial propagation, and not from its value as a feedstock for
derivative innovation. Hence PBRs differ significantly from patents in restricting
the exclusive rights conferred to one particular slice of potential use of the
protected subject matter. Protected varieties are also denominated in a distinct
manner, in effect to make them ready for genericization at the end of the period
of protection – a distinguishing denomination of the variety, distinct for example
from the breeder’s trademark, that will continue to denote that variety when it
becomes commercially free for all to use – a practical recognition of the branding
and market access issues that arise when an improved plant variety is returned to
the common pool.
Two developments between the 1978 and 1991 acts of the UPOV Convention
had the effect of ‘thickening’ somewhat this relatively thin layer of protection.
This revision of the conception of the proper scope of plant breeders’ rights is an
interesting case study in how technological and commercial changes alter the
perceptions of fairness and equity, especially when new technologies extract value
in new ways from genetic resources: the conception of equity in the dispensation
of benefits is not inert or fixed, but is highly responsive to the perceived impact
of new forms of business practice and the possibilities created by new biotech-
nologies.
In one development, the scope of protection was adjusted to broaden the base
of legitimate commercialization by the plant breeder. This stemmed once again
from the distinctive quality of genetic resources, and their non-excludability once
a single act of access takes place. Under UPOV 1978, the breeder’s right did not
extend beyond the propagating material to the results of planting that material, in
particular the harvesting of the resulting crop. Hence an orchardist could
propagate a full orchard over many seasons from the acquisition of a single tree,
potentially denying the original breeder an equitable return from a single
transaction in selling the original propagating material. Technological develop-
ments greatly facilitated the rapid reproduction of plants, again meaning that
much more commercial value could be extracted following a single legitimate
access to the original plant variety. Accordingly, UPOV 1991 extended to the
breeder the right to authorize production or reproduction; propagation; sale;
selling or other marketing; exporting; importing; or stocking for any of these
purposes in relation to the protected variety, whereas the scope of protection is
limited under UPOV 1978 to production for the purpose of commercial market-
ing. UPOV 1991 also creates certain qualified rights over harvested material
234 Antony Taubman
obtained through unauthorized use of propagating material, when the breeder has
not had reasonable opportunity to exercise their right in relation to the propagating
material. Since the 1978 Act restricted rights to production of the seed for sale,
offer for sale and other commercialization,159 this implicitly allowed the farmers’
privilege as an entitlement to retain seed for planting in later seasons. While the
1991 Act responded to perceptions of a changing commercial context by
extending PBR to cover production or reproduction of propagated or harvested
material;160 this in turn created the need for an explicit recognition of the farmer’s
privilege,161 so as to retain an overall equitable balance from the point of view of
these key users of plant genetic resources.
A similar development, explicitly driven by technological change, broadened
the right from the protected variety as such to further varieties ‘essentially
derived’ from it. Under the standards of the UPOV 1978, a breeder had no legal
interest in the downstream use of a protected variety by plant breeders. Rights
were exhausted once a subsequent variation was introduced into the variety. This
development provides a further instance of how technological change, and in
particular advances in biotechnology, lead to pressure to recalibrate the equitable
balance, the sense of what is fair in the downstream distribution of value extracted
from genetic material. According to one account:
These rules have with certain exceptions worked well in practice and
have been reaffirmed in the 1991 Act. However, the rules did not prevent
a person finding a mutation within a plant variety (such mutations are
quite frequent in some species), or selecting some other minor variant
from within a variety, from claiming protection for the mutant or variant
with no authorization from or recognition of the contribution to the final
result of the original breeder. The lack of recognition of the contribution
of the original breeder in such circumstances was generally considered to
be unfair. Modern biotechnology has greatly increased the likelihood of
such unfairness; it may take 15 years to develop a new variety but a mere
three months to modify it by adding a gene in the laboratory. Under the
1978 Act, the addition of a single gene could enable the biotechnologist
responsible for the modification to claim protection for the modified
variety without recognizing any obligation to the original breeder. The
1991 Diplomatic Conference considered that this situation could be a
disincentive to the continued pursuit of classical plant breeding. The
concept of essential derivation embodied in Article 14(5) of the 1991 Act
is designed to ensure that the Convention continues to provide an
adequate incentive for plant breeding. Under that Article, a variety which
159 Art. 5(i) of the UPOV Convention 1978.

160 Art. 14(i), UPOV Convention 1991.
161 The 1991 Act of the UPOV Convention establishes the standard of permitting ‘farmers to use
for propagating purposes, on their own holdings, the product of the harvest which they have
obtained by planting, on their own holdings, the protected variety or [an essentially derived
variety]’. (Art. 15(ii)).
is essentially derived from a protected variety and which fulfils the
normal protection criteria of novelty, distinctness, uniformity and stabil-
ity, may be the subject of protection but cannot be exploited without the
authorization of the breeder of the protected variety.162
A plant variety is considered to be ‘essentially derived’ if it retains ‘virtually the

whole genetic structure of the earlier variety’; thus the plant variety remains open
for subsequent breeding and the introduction of variations, but the breeder’s
authorization is only required if the case that the resulting variety is considered
essentially derived. This can be seen as a distinctive choice in the equitable
dispensation of value, firstly in sustaining an open framework for downstream
development, but reserving for the breeder a broader scope of exclusivity as a
direct response to an enhanced technological capacity to extract further value
from a protected variety. Relatively little practical experience with this provision
has since been reported. The concept of essential derivation has also found its way
into defensive protection of other forms of IP: the Biodiversity law of Costa Rica
excludes from ‘patents, trade secrets, plant breeders’ rights, sui generis commu-
nity intellectual rights and farmers’ rights’ inventions that are ‘essentially derived
from certain traditional cultural or biological knowledge’ (Art.78); and other
proposals to deny patents for inventions essentially derived from based traditional
or indigenous knowledge, products or processes.163
Plant variety rights recognize the specific innovation context of plant
breeding programs, and remain a central means of managing the allocation of
value that is added through innovative human intervention in the development of
plant genetic resources. Yet, as recent revisions to breeders’ rights have exempli-
fied, this form of innovation now functions within a much broader technological
framework, particularly with the introduction of targeted gene technologies, but
also on a broader policy plane. The acknowledgement of past human ingenuity
over many generations in breeding the world’s staple food crops has led, for
instance, to recognition of the complementary concept of ‘farmer’s rights’. Thus
the Contracting Parties to the FAO International Treaty:
recognize the enormous contribution that the local and indigenous

communities and farmers of all regions of the world, particularly those
in the centres of origin and crop diversity, have made and will continue
to make for the conservation and development of plant genetic resources
which constitute the basis of food and agriculture production throughout
the world.164
162 Cited in Taubman et al, ‘Intellectual Property and Biotechnology: A Training Handbook’,
Module Seven Plant Breeder’s Rights (7.6 The nature of the Plant Breeder’s Right), at 7–13,
(2002), available at <www.dfat.gov.au/publications/biotech/index.html>.
163 India, IP/C/M/25, para. 70.
164 ITPGRFA, Art. 9.1.
236 Antony Taubman
The Treaty specifies farmers’ rights to be implemented at the national level,
addressing protection of traditional knowledge, equitable participation in sharing
benefits, and participation in decision making on conservation and sustainable use
of plant genetic resources for food and agriculture.165
(b) Regional and National Levels
The following sections focus on aspects of national and regional IP laws relevant
to the debate over genetic resources. Subsequently, the chapter reviews –
essentially from an IP point of view – those laws that govern genetic resources
directly,166 but no attempt is made to review the full scope of such laws which
would be more properly reserved for another volume; as this chapter has argued,
the regulation of genetic resources extends well beyond even the most liberal or
opportunistic conception of intellectual property as such. However, articulating
and clarifying the linkage between genetic resources or biodiversity regulation on
the one hand and the law of patents – both concerning one’s entitlement to a
patent on an invention derived from genetic resources, and the patentability of
such a claimed invention – has been a priority for national legislators in many
countries.
Accordingly, this section first reviews some relevant aspects of national
patent laws, then turns to an overview of sui generis laws, such as biodiversity
legislation, which have direct bearing on the interplay between the regulation of
genetic resources and the recognition and exercise of IP rights, particularly
patents.
(aa) The Distinction between ‘Naturally Occurring’ and ‘Isolated’

Genetic Material
One consistent concern with life science patenting, with direct bearing on the
status of genetic resources, has been the legitimacy of patents on ‘naturally
occurring’ materials. When is it legitimate to seek a patent for newly identified or
characterized, isolated, purified or synthesized chemical forms that correspond to
those already existing in nature? Contemporary concerns over patenting of genetic
materials are a new chapter in a long-running debate. Patenting of isolates or
purified forms of genetic materials, provided a specific new utility is identified,
has a long history. Early in the twentieth century, beriberi – a major cause of death
in Asia – was a major public health crisis at the time. Suzuki isolated a naturally-
occurring substance from rice bran (aberic acid, later called thiamine or Vitamin
B1), which prevented the disease. This was the first vitamin to be isolated and to
be directly linked to the cure of a major disease. In 1911, Suzuki was granted a
received Japanese patent 20785 for isolated aberic acid.
165 ITPGRFA, Art. 9.2.

166 See III.2.III.4(b) infra.
In the same period, a landmark US case helped to distil the conceptual issues
that continue to dominate in the gene patenting debate of today. Judge Hand
upheld a patent on isolated adrenalin granted to Takamine because the fact of its
isolation was a new state of affairs which was potentially useful in a practical
sense in enabling therapeutic use of adrenaline. He observed:
even if it were merely an extracted product without change, there is no

rule that such products are not patentable. Takamine was the first to make
[adrenaline] available for any use by removing it from the other
gland-tissue in which it was found, and, while it is of course possible
logically to call this a purification of the principle, it became for every
practical purpose a new thing commercially and therapeutically. That
was a good ground for a patent.167
This case underscores the distinction between a patent on a naturally occurring

compound as such, and a patent on its artificially extracted and isolated form, for
which specific utility has been identified. Plainly, a patent claim for adrenalin in
its natural state, within the human suprarenal gland, would be invalid for want of
novelty; equally, it lacks practical utility (the point of Takamine’s invention was
to make adrenaline available for clinical use, not to characterize its operation
within the suprarenal gland). The same general issue arises today, when the debate
centres on how a naturally occurring nucleotide sequence may legitimately be
viewed as an invention, and when it is a simple discovery of the workings of
nature. There is a degree of convergence on this question, despite the inevitable
divergences in national and regional patent law, focusing on the same insight by
Justice Hand: the isolation of a gene sequence must deliver a new state of affairs
of practical utility to humanity, and should not simply amount to the discovery
that a certain nucleotide sequence exists in nature.168
This line of legal development leaves its impression in the EU Biotech
Directive169 which stipulates that ‘the human body and the simple discovery of
one of its elements, including a sequence or partial sequence of a gene’ is not
patentable but that:
[a]n element isolated from the human body or otherwise produced by

means of a technical process, including the sequence or partial sequence
of a gene, may constitute a patentable invention, even if the structure of
that element is identical to that of a natural element.170
167 Parke-Davis & Co. v. H. K. Mulford & Co., Case No.189 F. 95, 103 (S.D.N.Y. 1911).
168 See for example Amgen, Inc. v. Chugai Pharmaceutical Co. 927 F.2d 1200, 1206 [Fed. Cir.
1991].
169 Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection
of Biotechnological Inventions, (entered into force on 6 July 1998).
170 EU Biotech Directive, Art. 5.2.
238 Antony Taubman
Yet a patent is awarded for an invention, not for a bare chemical structure per se,
even if it is newly disclosed, and so there must be clear, practical utility associated
with the newly identified or isolated gene sequence. Hence in the EU a bare
nucleic acid sequence is not patentable without its function being indicated.171 If
a gene sequence is used to produce a protein, the protein and its function must be
identified. If the nucleotide sequence has a different function, such as transcription
promoter activity, that should be indicated.
Similarly, in 2001 the US Patent Office issued Utility Examination Guide-
lines172 that required a patent on an isolated gene to demonstrate ‘specific,
substantial, and credible’ utility. There is now an emerging global practice,
including in leading developing countries such as Brazil, China and India, of
allowing patents on gene sequences provided that they are genuinely new,
inventive and have clear utility or usefulness: this idea is built into the very
concept of ‘invention’ in many jurisdictions, where it is conceived as a specified
solution to a technical problem, not as a scientific insight. For instance, current
Indian practice may deem identifying a human gene as a ‘simple discovery’, not
a patentable invention, ruled out by the legislative bar on patents on ‘the human
body, at the various stages of its formation and development, and the simple
discovery of one of its elements’173
Debate continues over when is it a legitimate invention, and when is it a
routine adaptation of known technology, to produce purified or newly isolated
substances, including gene sequences. Typically, in established patent systems,
such claimed inventions have been assessed case by case, in the light of the
technological background. The changing technological background will quickly
render obvious the once inventive in a relatively short space of time. For instance,
the Nuffield Council on Bioethics has questioned the relevance for patentability of
the distinction between naturally occurring genetic materials and those that have
been purified and isolated, suggesting that patent offices had assumed that
knowledge of the structure of a genetic sequence (and its uses) can only be
obtained by creating an artificial, purified form of the sequence,174 but that, that
even once true, gene sequencing is undertaken by bio-informatics techniques and
may no longer involve the actual isolation and purification of a gene as such.175
(bb) Valuing the Pathway from the Genetic Resource to the

Product or Valuing the Product?
Further, while the creation of a newly synthesized genetic material may be

considered inherently patentable, this does not mean that even an inventive means
of creating that material, gives the inventor a right over the synthesized form as
171 EU Biotech Directive, Recital 23.

172 Utility Examination Guidelines, 66 Fed. Reg. 1092, 1098 (5 January 2001).
173 Indian Patent Law, s.3j.
174 Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), Nuffield Council on
Bioethics, London, see <www.nuffieldbioethics.org> 27–28.
175 Ibid., p. 28.
such: a distinction may be drawn between a patent over an inventive pathway to
the outcome, and a patent over the outcome as such. An early landmark decision
concerning modern gene technologies, Biogen v. Medeva,176 made this distinction
clear. The case concerned ‘an artificially constructed molecule of DNA carrying
a genetic code which, when introduced into a suitable host cell, will cause that cell
to make antigens of the virus hepatitis B’. The technology in this patent enabled
the production of antigens for hepatitis B for use in diagnostic tests and
vaccination. At the time of the invention, in 1978, researchers had actively sought
synthesized hepatitis B antigens. It was already known that hepatitis B was
produced by a particle (the ‘Dane particle’) containing a circular DNA molecule
(a plasmid), which had two antigens, one at its surface and one at its core. There
were three possible ways to obtain the antigens: purification from natural Dane
particles, chemical synthesis, and recombinant DNA technology. The third option,
which the inventor chose, required finding the genes that coded for the antigens,
and inserting these into a host cell which would express the antigen genes in a
form that would allow for ready production of large quantities of the antigen. The
approach taken was considered ‘inventive’ in 1978 given the state of knowledge
of molecular biology at that time.
Biologists distinguish two basic types of cells in organisms – the eukaryotic
and the prokaryotic. Eukaryotic cells are more complex and have a distinct
nucleus (these are the cells of plants and animals). Prokaryotic cells have a
simpler structure, lacking any distinct nucleus and other complex structures (these
are the cells of simple organisms such as bacteria). The decision held that the
inventive concept was the notion that the antigen could be produced by creating
large fragments of the genomic hepatitis B DNA, and then using the pBR322
vector to introduce these fragments into the E.coli bacterium: ‘the idea of trying
to express unsequenced eukaryotic DNA in a prokaryotic host’. The invention
avoided the need to determine the actual genetic sequence of the whole hepatitis
B virus. However, the main claim was to recombinant HBV antigen, and was not
limited to the particular method chosen.
The House of Lords held that this claim was not sufficiently supported by the
disclosure of the patent. It was inevitable in a young science that scientists would
achieve for the first time dramatically new things such as cloning the HBV
antigen, and
[t]hose who followed, even by different routes, could have greater

confidence by reason of the initial success, but this was not enough to
justify a monopoly over the whole field. Care was needed not to stifle
further research and healthy competition by allowing the first person who
had found a way of achieving an obviously desirable goal to monopolise
every other way of doing so . . . The technical contribution to the art
disclosed [in the patent] consisted in showing that – despite the
uncertainties which then existed over the DNA of the Dane particle –
176 Biogen Inc. v. Medeva Plc [1997] R.P.C. 1, HL.

240 Antony Taubman
known recombinant techniques could be used to make HBV antigens in
a prokaryotic host cell. This did not justify a claim to a monopoly of any
recombinant method of making the antigens. The claimed invention was
too broad. Its excessive breadth was due, not to the inability of the
teaching to produce all the promised results, but to the fact that the same
results could be produced by different means which owed nothing to the
invention. It did not establish any new principle which other would have
to follow to achieve the same results.
Accordingly, if another person had cloned HBV antigen through another method
– such as sequencing the Dane particle DNA – this would have fallen within the
scope of the patent, even though the patent would provide no real guidance to that
person.
(cc) Overview of the Issues in Patenting Genetic Material
While focused on human genetic material, rather than the mainstream of

CBD-related or plant genetic resources, the Howard Florey/Relaxin case177 in the
European Patent Office178 provides an exemplary study of the issues involved in
the extraction of utilitarian benefit from genetic materials. At the same time, it
highlights how the established principles of patentability are adapted and applied
to valuable, but potentially controversial, new technologies. As discussed earlier,
the EPO considered the opposition lodged to a patent179 for a synthesized DNA
sequence that coded for a human H2-preprorelaxin, functionally equivalent to
naturally occurring H2-relaxin. It was derived from human tissue obtained, with
consent, during childbirth. This enabled the production of clinical quantities of
relaxin for therapeutic use (which could not be feasibly harvested in its natural
state). This hormone is structurally related to insulin, which led to certain false
assumptions about its structure in the common general knowledge, reinforcing the
non-obviousness in patent terms of the eventual derivation of its sequence with a
defined function. It was first investigated for its role in loosening the pelvic
ligaments and ripening the cervix prior to childbirth, with potential application in
treating difficult births. This line of investigation failed when problems arose in
finding a stable and effective means of delivery. Relaxin was subsequently tested
as a potential treatment for fibrosis, and scleroderma in particular.180
At the first instance, the EPO Opposition Division observed:
to find a substance freely occurring in nature is a mere discovery and

therefore unpatentable. However, if a substance found in nature has first
177 Howard Florey/Relaxin [1995] EPOR 541.

178 Also discussed above in Part II.1(c).
179 Patent EP 0101309, Howard Florey Institute.
180 Seibold et al, ‘Recombinant Human Relaxin in the Treatment of Scleroderma’, Ann Intern
Med. (2000);132:871–879.
to be isolated from its surroundings and a process for obtaining it is
developed, that process is patentable. Moreover, if this substance can
properly be characterised by its structure and it is new in the absolute
sense of having no previously recognised existence, then the substance
per se may be patentable.181
In its natural form, it was immensely difficult to obtain in sufficient quantities for
therapeutic use or even systematic investigation, and the availability of recombi-
nant, synthetic relaxin was, in Justice Hand’s phrase from the Adrenaline case,
‘for every practical purpose a new thing commercially and therapeutically’.182
The Opposition Division’s decision reviewed the grounds of opposition in a
manner that provides a comprehensive analysis of the legal issues arising in the
patenting of gene sequences derived from human subject. The opponents charged
that the patent was not novel, since as the gene encoding Relaxin had always been
present in human body, but it was held that even naturally occurring substances
isolated for the first time with no previously recognized existence were patentable.
Against the claim that the patent had no inventive step or was obvious, since
conventional techniques had been used to isolate the gene sequence, it was held
that the very existence of the substance in the form disclosed was a surprise, and
confounded expectations about the nature of Relaxin. The method alone used to
achieve the invention was not enough to determine obviousness. The opponents
likened the claimed invention to a ‘mere discovery’ such as patenting the moon or
a new animal found in a remote area. The Opposition Division agreed that it was
an unpatentable discovery to find a substance freely occurring in nature, and
would not be patentable, but took the view that it was not a mere discovery to
newly isolate and characterize a substance; a further distinction was that the
invention was a solution to an established technical problem (creating therapeutic
supplies of relaxin). On whether the invention was contrary to morality and indeed
an offence to human dignity in isolating a gene from tissue, using pregnancy for
a technical, profit-oriented process, the decision held that the general public would
not view the invention as too abhorrent for a patent to be granted, and that the
tissue had been donated with consent within framework of gynaecological
operations. Many life-saving substances had been isolated in a similar manner,
and were patented and welcomed by the public. Bioethics standards approved the
use for other purposes of parts of the human body removed during an intervention.
Against the claims that patenting human genes amounted to a form of
‘modern slavery’ entailing dismemberment of women and their piecemeal sale to
commercial enterprises, and that patenting human genes amounted to the
intrinsically immoral patenting of human life, the decision took the view that there
was no slavery: a patent on DNA encoding H2 Relaxin does not create rights over
181 Howard Florey/Relaxin [1995] EPOR 541, Ibid, 548.

242 Antony Taubman
individual human beings, and the invention achieved the opposite of dismember-
ment: to the contrary, the whole point – the technical problem solved – was to
avoid harvesting Relaxin from the human body, producing it instead through
cloning unicellular hosts rather than humans. Patenting a ‘human gene has nothing
to do with the patenting of human life’, and there was no moral distinction
discerned between patenting a gene and other substances found in the human
body, such as adrenaline. The reasoning in the decision may or may not attract the
approval of all commentators,183 but it certainly set out key distinctions that help
illuminate the complex relationship between the material origins of an invention
and the invention as such.
(dd) Defensive Measures in National and Regional Patent Law
Defensive protection of genetic resources can be defined as legal measures taken

to prohibit the patenting of genetic material considered inappropriate or illegiti-
mate subject matter for a patent, and practical measures taken to reduce the
likelihood that actual patenting outcomes will include granted patents on
illegitimate subject matter.
One such legal measure is the exclusion of certain categories of generic
material from patentable subject matter. However, some patent law instruments
stipulate that biotechnology is not inherently different from any other technology,
providing for instance that an invention is not unpatentable merely because it is
biological in character;184 further, that the isolation of biological material may be
an invention even if the material previously occurred in nature,185 provided it
meets the conventional patentability criteria.186
183 See the review of these issues in Australian Law Reform Commission, Issues Paper on Gene
Patenting and Human Health, 2003, citing for example, T Claes, ‘Cultural Background of the
Ethical and Social Debate about Biotechnology’ in S. Sterckx (ed.), Biotechnology, Patents
and Morality (Ashgate, Aldershot, 2000) pp. 179, 182. T. Schrecker and others, Ethical Issues
Associated with the Patenting of Higher Life Forms (1997), Westminster Institute for Ethics
and Human Values McGill Centre for Medicine Ethics and Law, Montreal, at
<www.strategis.ic.gc.ca/pics/ip/schrecef.pdf>; D. Keays, ‘Patenting DNA and Amino Acid
Sequences: An Australian Perspective’ (1999) 7 Health Law Journal 69, 76.
184 For example, Schedule A2, para. 1, Patents Act 1977, United Kingdom (providing that an
invention shall not be considered unpatentable solely on the grounds that it concerns ‘a
product consisting of or containing biological material’).
185 For example, EU Directive 98/44 on the Legal Protection of Biotechnology Inventions: Art.
3.2.
186 For example, EU Directive 98/44 on the Legal Protection of Biotechnology Inventions: Art.
3.1.
(1) A Priori Exclusions
Some countries provide specific statutory exclusions of certain forms of biological

and genetic material from patentable subject matter. For example, Andean
Community Decision 486 excludes as an invention ‘[a]ny living thing, either
complete or partial, as found in nature, natural biological processes, and biological
material, as existing in nature, or able to be separated, including the genome or
germ plasm of any living thing’ (Article 15(b)). The African model law provides
that ‘[p]atents over life forms and biological processes are not recognized and
cannot be applied for’.187 At the national level, examples include exclusions under
Panamanian law of ‘biological material as it is found in nature’188 and under
Brazilian law ‘all or part of natural living beings and biological materials found
in nature, or isolated therefrom, including the genome or germ plasm of any
natural living being and the natural biological processes’.189
Reflecting the distinct ethical status accorded to the human genome, several
patent laws distinctly single out the human body as being specifically unpatent-
able,190 but leave open the possibility of patenting constituents of the human
genome (such as specific human genes, subject to utility and ethical standards).
The EU Biotech Directive singles out elements of the human genome, stipulating
that the ‘human body, at the various stages of its formation and development, and
the simple discovery of one of its elements, including the sequence or partial
sequence of a gene, cannot constitute patentable inventions’.191 However, in
clarifying the boundary around patentable material, it clarifies that an:
element isolated from the human body or otherwise produced by means

of a technical process, including the sequence or partial sequence of a
gene, may constitute a patentable invention, even if the structure of that
element is identical to that of a natural element,192
provided that there is disclosure of the ‘industrial application of a sequence or a

partial sequence of a gene’.193 Under national law within the EU, France recently
defined the scope of patentable subject matter to preclude the human body and the
simple discovery of one of its elements, in the terms of the EU Biotech Directive,
but also ruled as inherently unpatentable ‘total or partial sequences of a gene as
187 Art. 9, of the OAU Model Law.

188 Panama, Industrial Property Law 35, Art. 15 (iii).
189 Industrial Property Law – Law No 9.279, of 14 May 1996, Art. 10(ix).
190 For example, New Zealand, Section 2 of the Patents Act 1953; Australia, Subsection 18(2) of
the Patents Act 1990 (excluding ‘human beings and the biological processes for their
generation’).
191 EU Directive 98/44 on the Legal Protection of Biotechnology Inventions: Art. 5.1.
244 Antony Taubman
such’.194 It stipulates that a patent is only available for ‘an invention constituting
a technical application of a function of an element of the human body’ and ‘shall
cover the element of the human body only to the extent necessary to the
realization and the exploitation of this particular use, which must be disclosed . . .
in a concrete and precise manner’.195 Similarly, German law was amended with
effect in 2005 to remove the possibility of patenting naturally occurring human
gene sequences per se, by requiring that the claim itself should include the
disclosed use for the gene if the invention is a sequence or partial sequence of a
gene which is identical to a natural sequence.196 Other patent laws go further to
exclude human genetic material in broader terms, such as Panama’s exclusion of
‘the living matter that makes up the human body’ 197
Other legal systems have set borders around higher life forms, such as
multicellular organisms. Canada’s Supreme Court198 ruled against the patentabil-
ity of higher life forms on the basis that they do not constitute a ‘manufacture’ or
‘composition of matter’, the term used to define ‘invention’ in the patent law.199
The majority decision (notably drawn from the civil law tradition) argued that
patent law did recognize a distinction between higher and lower life forms, citing
the TRIPS Agreement, but cautioned against drawing a line between humans and
animals, since ‘the patenting of all plants and animals, and not just human beings,
raises several concerns that are not appropriately dealt with in the Patent Act’ 200
and ‘a judicially crafted exception from patentability for human beings does not
adequately address issues such as what defines a human being and whether parts
of the human body as opposed to the entire person would be patentable’.201 The
dissenting opinion took the view that ‘altering every single cell in the body of an
animal which does not in this altered form exist in nature, by human modification
of “the genetic material of which it is composed”, is an inventive “composition of
matter’.”202
Ultimately, as this Canadian case-law illustrates, difficulties arise in drawing
boundaries around human genes as such (influencing the majority’s conclusion
that policy considerations dictate that the line should rather drawn between higher
and lower life forms), noting the ‘increasingly blurred line between human beings
and other higher life forms’203 and citing an intervener:
194 Art. L611-18 of the Intellectual Property Code, inserted by Act No. 2004–800 of 6 August
2004, Art. 17a II, Offıcial Journal of 7 August 2004, at 18(d).
195 Ibid.
196 German Patent Act, §1(a)(4).
197 Panama—Industrial Property Law 35, Art. 15(iv).
198 Harvard College v. Canada (Commissioner of Patents), [2002] Case No.4 S.C.R. 45, 2002
SCC 76.
199 Patent Act, R.S.C. 1985, s. 2.
200 Harvard College v. Canada (Commissioner of Patents), [2002] Case No. 4 S.C.R. 45, 2002
SCC 76, para. 206.
201 Ibid.
202 Ibid., at para. 8.
203 Ibid., at para. 68.
The pig receives human genes. The human receives pig organs. Where
does the pig end and the human begin? How much DNA does it take
before one becomes the other? The answer to these questions, once
ridiculous and offensive, may now just be a matter of degree.204
As advances in technological capability205 and greater understanding of the

natural flow of genes between species (horizontal gene transfer206) expose the
inherent flaws in such genetic essentialism,207 and the imprecision and uncertainty
of outcomes through the exercise of such a priori exclusions,208 the focus of the
debate and of international norm-setting proposals has moved towards a concen-
tration on the origin or source of genetic material, rather than its essential
qualities. The same gene sequence may, after all, be derived from and included in
different life forms, and the legal framework will differ depending on its source –
both in terms of the kind of life form it is isolated from, and the jurisdiction where
the source material was located. In other words, taking up a key theme of this
chapter, the actual or potential value of a genetic resource is linked not to the
inherent genetic structure as such and the information the resource contains, but
rather the manner and legal circumstances in which the material resource is
accessed.
(2) Conditional Exclusions
This focus on the circumstances and legitimacy of access to GR, rather than the
inherent utilitarian value of the resources, finds a clear regulatory imprint in the
movement towards legal measures that create positive obligations on patent
applicants to make certain disclosures, or in effect to guarantee or to prove certain
legal states of affairs, in relation to genetic resources used in the development of
a claimed invention – so called disclosure requirements (many, but not all, overlap
with similar provisions regarding traditional knowledge.)209 Such defensive
measures no longer function as objective, circumscribed rules on patentability of
the claimed invention as such – they do not directly concern the inventive quality
or inherent patentability of the invention, but rather amount to regulation of the
manner in which the source materials required for the invention are obtained, and
204 Animal Alliance of Canada, ibid, para. 180.

205 See the discussion on ‘modern biotechnology’ above, section III.2.II.1.
206 See discussion above III.2.II.1(c).
207 A precise instance of the difficulty in regulating human genetic resources as such, for the
reasons discussed above, section III.2.II.2(b).
208 For instance, despite the Supreme Court decision on the patenting of a higher life form as
such, Canadian Patent 1341442 entitled ‘Transgenic Animals’ was issued on 7 October 2003,
with claims extended to a method of testing a material suspected of being a carcinogen, a
method of producing a transgenic cell culture, a method of producing a transgenic mammal,
a method of testing a material suspected of altering neo-plastic development, a somatic cell
culture derived from a transgenic non-human mammal, the use of a transgenic non-human
mammal, and several specific plasmids.
209 See III.1.II.1(c)(aa)(3)(ii).
246 Antony Taubman
the consequent equitable entitlement of the patent applicant to secure a legiti-
mately enforceable patent right. ‘Disclosure requirements’ may be simply that –
a requirement to disclose certain information – or they may in effect determine
whether a patent can legitimately be obtained, held or exercised depending on the
circumstances of access to genetic resources used in the invention. An example of
a clear substantive requirement is that of Egypt’s law, which provides that
‘[w]here the invention involves biological, plant or animal product, or traditional
medicinal, agricultural, industrial or handicraft knowledge, cultural or environ-
mental heritage, the inventor should have acquired the sources in a legitimate
manner’.210
This mechanism has long been incorporated within the Andean Community
Common Intellectual Property Regime,211 which provides that ‘the granting of
patents on inventions that have been developed on the basis of . . . [the traditional
knowledge of their indigenous, African American, or local communities] shall be
subordinated to the acquisition of that material in accordance with international,
Andean Community, and national law’. Implementing this requirement, it
stipulates that patent applications shall contain ‘a copy of the contract for access,
if the products or processes for which a patent application is being filed were
obtained or developed from genetic resources or byproducts originating in one of
the Member Countries’ and
if applicable, a copy of the document that certifies the license or

authorization to use the traditional knowledge of indigenous, African
American, or local communities in the Member Countries where the
products or processes whose protection is being requested was obtained
or developed on the basis of the knowledge originating in any one of the
Member Countries, pursuant to the provisions of Decision 391 and its
effective amendments and regulations.
The EU Biotech Directive also provides a preambular reference to the

desirability of such disclosure, illustrating that this kind of mechanism has been
under active consideration for over a decade, but in keeping with a more
circumspect European approach to this form of reinforcing practical conformity
between patent law and regulation of genetic resources, does not compel its
implementation:
whereas if an invention is based on biological material of plant or animal

origin or if it uses such material, the patent application should, where
appropriate, include information on the geographical origin of such
material, if known; whereas this is without prejudice to the processing of
210 Patent Act of Egypt (Art. 13).

211 Andean Community Common Intellectual Property Regime Decision 486.
patent applications or the validity of rights arising from granted
patents.212
The EU has since put forward a considerably more far-reaching proposal for a
binding disclosure obligation in international law.213
In line with their international proposals for strong disclosure mechanisms in
patent laws,214 key emerging patent jurisdictions in the developing world, such as
Brazil, China, India and South Africa, are in the process of implementing such
requirements, typically requiring a strong linkage between demonstrated legiti-
macy of access to genetic resources and the right to hold a patent. In 2002, India
amended its Patents Act to require disclosure of ‘the source and geographical
origin of the biological material in the specification, when used in the inven-
tion’215. India’s law on biodiversity further sets out substantive constraints,
precluding the application
for any intellectual property right by whatever name called in or outside

India for any invention based on any research or information on a
biological resource obtained from India without obtaining the previous
approval of the National Biodiversity Authority216
and the requirement that the
National Biodiversity Authority may, while granting the approval under

this section, impose benefit sharing fee or royalty or both or impose
conditions including the sharing of financial benefits arising out of the
commercial utilization of such rights. 217
South Africa’s Patent Amendment Act, 2005, provides that before acceptance of
an application, an applicant must
lodge with the registrar a statement in the prescribed manner stating

whether or not the invention for which protection is claimed is based on
or derived from an indigenous biological resource, genetic resource, or
traditional knowledge or use
212 Recital 27, Preamble, Directive 98/44/EC on the Legal Protection of Biotechnological
Inventions.
213 Document submitted by the European Community and Its Member States, Disclosure Of
Origin Or Source Of Genetic Resources And Associated Traditional Knowledge In Patent
Applications, WIPO/GRTKF/IC/8/11, (17 May 2005).
214 See in particular the proposal for a new Art. 28bis of TRIPS, fn. 4 supra.
215 Patents (Amendment) Act of 2002, amending Patents Act 1970, s. 10(4)(d)(ii)).
216 India’s Biological Diversity Act 2002, Art. 6(1).
217 Ibid., Art. 6(2)).
248 Antony Taubman
In that event, the registrar shall call upon the applicant to furnish proof ‘as to his
or her title or authority to make use of’ this material. A proposed amendment to
China’s Patent law218 provides both for a substantive requirement that
for an invention-creation, the completion of which depends on acquisi-

tion and exploitation of genetic resources, but the acquisition and
exploitation of said genetic resources are contrary to relevant laws and
regulations of the State, no patent right shall be granted219
and a procedural requirement that ‘for an invention-creation, the completion of

which depends on acquisition and exploitation of genetic resources, the applicant
shall indicate the source of said genetic resources in the description’.220
These measures can presuppose a linkage between the regulation of access
and downstream benefit-sharing of genetic resources, on the one hand, and the
procedures for granting and enforcing patents on the other; broadly they give
increasingly concrete expression to a normative aspiration that has frequently
been put in broad, even abstract terms:
[t]he principle of equity dictates that a person should not be able to

benefit from an IP right based on genetic resources or associated
knowledge acquired in contravention of any legislation governing access
to that material.221
The Indian example shows how patent law and the regulation of access to genetic
resources may evolve together. Increasingly attention is turning to how the legal
circumstances of origin of genetic resources can be systematically documented,222
which raises in turn the question of how documentation of the nature of access to
genetic resources can and should have bearing on the application for and exercise
of patents on inventions derived from those resources.
218 ‘China to Revise Patent Law’, People’s Daily, (24 November 2005); see also ‘Disclosure of
Genetic Resources’, China Daily, (3 May 2007), p. 9.
219 Art. 25, A2, Amended Patent Law, Draft.
220 Art. 26, Amended Patent Law, Draft.
221 Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and
Development Policy, (2002), p. 87.
222 T. Brendan, D. Cunningham, and K. Watanabe (2004), ‘The feasibility, practicality and cost
of a certificate of origin system for genetic resources. Preliminary results of comparative
analysis of tracking material in biological resource centres and of proposals for a certification
scheme’, United Nations University Institute of Advanced Studies, Yokohama, Japan.
Information document of the Third meeting of the Ad Hoc Open-ended Working Group on
Access and Benefit-Sharing UNEP/CBD/WG-ABS/3/INF/5.
Figure 7: The Historical Context: Genetic resources are assumed to be the

common heritage of humanity and immediately derived knowledge about the
properties of genetic material is assumed to be in the public domain. As utilitarian
value is extracted from the genetic material, some benefits are passed one step at
a time back along the chain of provenance. But the model remains open to
challenges as to its legitimacy and utility: is it equitable to ignore the claims of
the original custodians of the resource for an equitable share of the returns; and
even for strictly utilitarian grounds is there need for confidence in sustainable
incentives for the conservation of those resources as the wellspring of future
extraction of value?
4. Non-intellectual Property Instruments
(aa) Genetic Resources as National Property and the Eclipse of the

Common Heritage
The impact of technological change on the established balance of interests was

foreseen early in the era of modern biotechnologies. The capacity of modern
biotechnology to extract new forms of value from genetic resources, including
through use of the patent system, has directly induced the repudiation of the past
doctrine that held genetic resources as common heritage. Instead, as Kloppenburg
250 Antony Taubman
observed some two decades ago, genetic resources have come to be seen as ‘a
form of national property’:
as the coming decades witness the elaboration of a new regime of

production based on the manipulation of genetic information, germplasm
will become an increasingly central resource. Third World nations are
justified in their pursuit of the common heritage. But the material
consequences of the decommodification of all plant germplasm might
actually work to the detriment of the South. The real problem for the
South is not acquiring access to the elite lines of the North but
establishing control over and realizing some benefit from the appropria-
tion and utilization of its own resources. Third World nations have little
to gain from quixotic pursuit of common heritage in plant genetic
resources. But they have a great deal to gain through international
acceptance of the principle that plant genetic resources constitute a form
of national property223
This insight has in fact been borne out in the subsequent evolution of international
regimes governing genetic resources. A key turning point has been the deliberate
expression of sovereignty over genetic resources and a trend to assert various
forms of property or quasi-property rights over GR. The 1992 conclusion of the
CBD amounted to a political trade-off between a firm codification of national
sovereignty over GR and an agreement to facilitate access to genetic resources for
sustainable use, consistent with the Convention’s requirements for equitable
benefit sharing. In 1983, the FAO224 had declared plant genetic resources to be ‘a
common heritage of mankind to be preserved, and to be freely available to all for
use, for the benefit of present and future generations’. In 1989, it was made clear
that ‘the term “free access” does not mean free of charge’, that benefits from
access to such resources were ‘part of a reciprocal system’,225 and that access to
plant genetic resources was subject to recognizing ‘rights arising from the past,
present and future contributions of farmers in conserving, improving, and making
available plant genetic resources’.226 The conclusion of the ITPGRFA explicitly
stated state sovereignty over plant genetic resources as a principle in international
law, maintaining consistency on this point with the CBD, which had articulated
the principle in 1992.
The assertion of sovereignty is linked to a broader trend towards re-
evaluating and asserting control the aggregation of genetic information and
traditional know-how embedded in biological resources:
223 Jack Kloppenburg, First the Seed: The political economy of plant biotechnology (First Edn.),
(Cambridge, 1988).
224 FAO 1983, International Undertaking on Plant Genetic Resources (FAO Resolution 8/83).
225 FAO Resolution 4/89.
226 FAO Resolution 5/89.
For the first time we realize we have the wealth that everyone else wants
. . . All this time the development paradigm made us beggars and kept us
running to the government to give us something; made us keep running
to northern aid agencies to give us aid . . . We now realize we have the
capital and we have to do our own planning for development on the basis
of this living capital.227
Sovereignty over such knowledge resources has been asserted in part as a

reciprocal response to the perceived use of intellectual property law to extend
exclusive control over the knowledge resources held in the developed world. Yet
the affirmation of sovereignty does not typically aim, at least in principle, at
exclusivity over resources per se. In the key international regimes that govern GR,
the recognition of sovereignty over resources and a strengthened right to set the
terms of use are balanced by an expectation of reasonable access to the covered
resources. There is a predisposition towards appropriate forms of use as necessary
to attain broader public policy goals. Both the CBD and the FAO treaty pivot on
the expectation that GR should and will be utilized, subject to equitable
safeguards.
The exercise of sovereignty typically has the net effect of making access
conditional on equitable considerations or reciprocal benefits – these are variously
construed in terms of sharing of monetary or non-monetary benefits, access to
derivative innovations for research and breeding and other reciprocal access to
derivative knowledge resources, and other forms of contribution to broader
developmental goals. Equity considerations are also expressed in terms of
procedural fairness, for instance, in the CBD’s requirements for prior informed
consent and mutually agreed terms.
The embedded notion of ‘equity’ need not be expressed through reciprocal
claims of exclusivity: for example, under the ITPGRFA, benefit-sharing com-
prizes the exchange of information, access to and transfer of technology,
capacity-building, and the sharing of the benefits arising from commercializa-
tion.228 The obligation to share direct economic value obtained from the resources
is triggered not by property rights in the resources, but by the commercialization
of a product incorporating a resource covered by the treaty; and this is mandatory
only when access for further research and breeding is restricted,229 such as
through IP rights or potentially through technological measures or other legal
measures such as contracts, although these questions are still under development
in the context of implementation of the treaty.
227 Shiva Vandana, Late Night Live, Radio National, Australian Broadcasting Commission, (19
November 2001).
228 Art. 13.2.
229 Art. 13(d)(ii).
252 Antony Taubman
(bb) Convention on Biological Diversity
(1) Central Principles
The CBD is the central international legal instrument in the field of genetic
resources. As discussed already, it was a significant milestone in the evolution of
rights and entitlements relating to the dispensation and sharing of benefits from
genetic resources, with a firm articulation of the principle of national sovereignty
over genetic resources, and a landmark recognition of the role of local and
indigenous peoples and the custodianship of traditional knowledge as central to
the conservation of biodiversity. Again, because of the unique characteristics of
genetic resources which can at once be conserved and exploited, by virtue of the
fact that their value as resources resides in the functional hereditary units they
contain, its threefold objectives link conservation with sustainable use and a
guarantee of equitable sharing of benefits. While it naturally recurs throughout
this chapter as a leitmotif, no attempt is made to review its provisions, the
extensive body of supplementary decisions by the CBD COP, or the voluminous
secondary literature, but rather the interplay with the IP system is reviewed.
It should be noted, however, that even though the CBD espouses fundamental
principles and obligations, it does have the character of a framework convention,
and intensive work has continued since its conclusion to develop appropriate
mechanisms for its effective implementation: ‘it is still only an instrument to
guide change, and its provision leave most of the hard work of establishing
operational measures on [access and benefit-sharing] to national governments’.230
Thus the manner in which this implementation of the general principles of the
CBD is undertaken – at the national, but also at the regional and international
levels – may have far greater interaction with and impact upon the IP system than
the general provisions of the treaty itself. Much of the IP-related debate centres on
the issues already canvassed in this chapter, and has little to do with conservation
issues as such: how are genetic resources to be valued, and how should that value,
once realized, be equitably allocated; what is the role of intellectual property,
particularly patents, in realizing, distributing or misappropriating that value; and
to what extent does the grant or exercise of intellectual property rights,
particularly patents, conflict with resource sovereignty and with the threefold
objectives of the CBD, in particular through the direct patenting of genetic
resources as such. The political economy context of this debate is succinctly
expressed by one mega-diverse state as follows:
As one of its main tasks, the CBD seeks to balance the lack of
equilibrium between those who are able to use biological resources and
their components (the industrialized countries) for commercial and
industrial purposes, and those who do not have such capacities but do
230 Laird et al, ‘Creating Conditions for Equity’, in Laird (ed.) Biodiversity and Traditional
Knowledge, Earthscan, (London, 2002), at p. 418.
have the raw material, i.e. these resources and their components
(developing countries). For this purpose, the CBD establishes rules and
principles on the conditions for this access and use, and as to how the
benefits derived from such use should be shared in a fair and equitable
manner.231
The established IP system – and TRIPS in particular – has been set in counterpoint
to the CBD. TRIPS has for some served as a metonym or an emblem for one view
of how policymakers and legislators should shape the framework for knowledge
management. For instance, it has been characterized as favouring privatization of
knowledge (and knowledge resources such as genetic resources), entrenching
economic privileges centred in the developed world, and neglecting the ‘social
function’ of IP laws.232 Turning again to values, TRIPS and the broader IP system
may also be seen as embodying a set of values – the market, private interests, ex
situ exploitation as against in situ conservation, alienation of traditional knowl-
edge from its local roots – that stand in tension with the values underpinning the
policy goals of the CBD, particularly the polyvalence of biological diversity -
noting the CBD preamble’s invocation of the ‘ecological, genetic, social,
economic, scientific, educational, cultural, recreational and aesthetic values of
biological diversity and its components’. As noted above, there is a complex
debate under way concerning potential conflict between TRIPS and the CBD:
while conducted at a relatively technical legal level, it can also be viewed as a
dialogue between distinct value sets. This may, of course, entail a reconciliation
of the value sets and perceptions of interests that drive actual behaviour and actual
choices within the broad framework set by the legal instruments concerned.
Hence a full review of the interplay between the provision of the CBD and
the IP system opens up possibilities for considering the IP system in the rounds as
a flexible set of policy instruments for governments to direct the allocation of
effort in the socially beneficial exploitation of genetic resources, and as a practical
mechanism for individual actors to exert authority over their stake in the chain of
provenance of genetic resources from origin to ultimate application. To point out
these possibilities – which are doubtless at various degrees of latency and
practical realization – is not necessarily to endorse or validate the current
operational state of affairs of the IP system. Reconciliation of the CBD and the IP
system (whether or not epitomized by TRIPS as such) can entail such straight-
forwardly practical measures as directing patent examiners to take account of
established databases of genetic resources,233 or as politically and legally
231 Patents referring to Lepidium Meyenii (Maca): Responses of Peru, document WIPO/GRTKF/
IC/5/13 (12 May 2003).
232 See Sub-Commission on Human Rights resolution 2000/7, Intellectual property rights and
human rights (17 August 2000).
233 See for example, the SINGER database administered by Bioversity (formerly IPGRI) and its
potential role in patent examination (Practical Mechanisms for the Defensive Protection of
Traditional Knowledge and Genetic Resources within the Patent System, document WIPO/
254 Antony Taubman
momentous as the proposed rewriting of international patent law to build new
disclosure requirements234 that potentially redefine the basis of the entitlement to
apply for and be granted a patent.235
(2) The CBD Objectives and Intellectual Property
This complex policy and practical context provides the inevitable backdrop for a
review of the interaction between specific CBD provisions, and the principles and
practice of the IP system. This review concentrates on the following points of
interaction, with in the normative framework provided by the CBD’s objectives:
– The recognition of sovereignty over genetic resources

– The principle of prior informed consent for access to genetic resources
– The requirement for equitable sharing of benefits
– Requirements for transfer of technology
The bulk of the analytical scrutiny on the CBD, especially in its relation to the IP
system, has been on the first three of these points of interaction. However, the
CBD must also be seen as concerned with the practical exercise of technology as
well, through partnerships and structures partially mediated by the IP system.
Parties to the CBD recognize ‘that technology includes biotechnology, and that
both access to and transfer of technology . . . are essential elements for the
attainment of the objectives’236 of the CBD. Its objectives are to be carried out ‘by
appropriate access to genetic resources and by appropriate transfer of relevant
technologies, taking into account all rights over those resources and to technolo-
gies, and by appropriate funding’.237 IP, the legal regulation of IP, and the practical
exercise of IP mechanisms (including choices over how rights are exercised)
potentially have bearing on each of the CBD objectives.
For instance, technologies developed under the aegis of the IP system and
protected by it in some jurisdictions may be useful for the conservation of
biological diversity, or they may be seen as prejudicial to biodiversity (in this
regard, Article 19.3 refers to ‘living modified organism resulting from biotech-
nology that may have adverse effect on the conservation and sustainable use of
biological diversity’, as the basis for the subsequent negotiation of the Cartagena
GRTKF/IC/5/6 (14 May 2003); see also more recent proposals along these lines by Japan, the
Patent System and Genetic Resources, documents WIPO/GRTKF/IC/9/13 and WIPO/GRTKF/
IC/11/11 (25 June 2007)).
235 See Examination of Issues Relating to the Interrelation of Access to Genetic Resources and
Disclosure Requirements in Intellectual Property Rights Applications, UNEP/CBD/COP/8/
INF/7.
236 CBD, Art. 16.1.
237 CBD, Art. 1.
Protocol238). Technologies protected under and disclosed by the IP system may
contribute to the sustainable use of the components of biodiversity. And the role
of IP laws, the specific scope of IP rights and the way they are exercised, may help
determine how benefits from the utilization genetic resources are generated and
shared and how the appropriate transfer of relevant technologies is undertaken.
(i) Sovereignty over Genetic Resources

In the debate over the relationship between the CBD and the TRIPS Agreement,239
the IP system – and patents in particular – are argued to threaten or undermine the
sovereignty over resources that is a key principle in the CBD. This question
represents a specific conundrum posed by the polyvalence and the extreme
non-rivalrousness of genetic resources – one single act of access can alienate the
entire downstream value of genetic resources and undercut any subsequent efforts
of the custodial state to retain the actual and potential value. The act of seeking
intellectual property protection over derived value from the resource can therefore
be perceived as undermining sovereignty over the resource as such. On the other
hand, within a national jurisdiction, the due apportionment of private property
rights may also be seen as a legitimate exercise of sovereignty: the recognition of
sovereignty under international law is consistent with the due recognition of
private property rights under municipal law. The principal challenge arises when
private property rights are granted in one jurisdiction over intangible derivatives
from genetic resources accessed in another jurisdiction. Debate continues over the
appropriate forms of legal articulation between the exercise of sovereignty over a
genetic resource in one jurisdiction and the grant of IP rights on a derivative of
that resource in a distinct jurisdiction, when the realization or capitalization of
innate value through the IP system is claimed to misappropriate that value or
indeed the resource itself. This may be viewed from a public international law
perspective – a matter of clarifying the respective roles of the two states
concerning in the governance of the resource, or from a private international law
perspective – as a question of conflict of laws. Sustaining a clear and functional
linkage between international and national law can be difficult in this context,
since private actors rather than nation states are most likely to violate sovereignty
over genetic resources – despite claims that developed countries systematically
appropriate the genetic wealth of the mega-diverse countries. Two general
IP-related scenarios may be considered, where a genetic resource is appropriated
in violation of the sovereignty of the source country:
– the resource itself is directly patented in a foreign country, on the basis of

a presumably spurious claim of the applicant to have invented the resource
in its original form: this would appear to be the most direct form of
violation of sovereignty over the resource, since although it is unlikely to
deprive the source country of a non-rivalrous resource, it clearly reduces its

239 Set out III.3(a)(bb), supra.
256 Antony Taubman
capacity exclusively to extract its value and amounts to a form of control
over the resource in the foreign country – to use tort law as a metaphor, a
form of ‘conversion’ of the resource; and
– a patent is sought not on the resource in the form accessed, but on an
invention made possible through access to the resource: in this case, the
question turns on whether the patent applicant is directly liable, or whether
liability can be traced back to the violation of sovereignty, in such a way
that vitiates the applicant’s entitlement to apply for a patent in a foreign
jurisdiction.
Actual cases of claimed violation of sovereignty over genetic resources, while

reinforcing this broad principle as a political priority, can also pose questions
about the scope of sovereignty, its practical implementation, its retrospective
effect, and its linkage with more specific rights of access and control.
(ii) Retroactivity
A frequently cited example of violation of sovereignty and failure to share benefits
is that of the rosy periwinkle (Catharanthus roseus), which is indigenous to
Madagascar. Research in the 1950s led to the isolation of two alkaloids, vincristine
and vinblastine, which were found to be effective in treating cancer. The pharma-
ceutical company Eli Lilly successfully commercialized these compounds. This has
suggested to many critics that the benefits from this commercial activity should
flow back to Madagascar, and the case has become an exemplar in the literature on
bio-piracy.240 Yet the plant in question had been distributed around the globe since
at least the eighteenth century. It was the knowledge of local communities in Ja-
maica and in the Philippines (the latter as the result of a routine literature search)
that the plant had medicinal properties in general that led to the active screening of
the plant as part of a much broader screening program sponsored by the US National
Cancer Institute, leading to the discovery of hitherto unrecorded anti-cancer prop-
erties. Like the knowledge that guided this research was not from Madagascar, the
physical specimens of the rosy periwinkle that were used in the research were
sourced from the West Indies, where the plant is widespread.
It is clearly a legal, policy and practical challenge to follow through the full
implications of the suggestion that this research activity – no matter how lucrative
– should give rise to a claim over a share in the benefits based on an unexhausted
sovereignty over the resources, when the physical samples and associated
knowledge used are cleared sourced from locations and communities well beyond
the origins of the genetic material. The notion of perpetual sovereignty, with
retroactive effect, over genetic resources does have potentially major ramifications
and unexpected consequences: an example often cited in this context is that of
rubber, seeds of which were removed from Brazil by Henry Wickham in the
nineteenth century, ending Brazil’s lucrative monopoly over rubber production
and establishing Malaysia as a major producer.
240 R. Stone, ‘The Biodiversity Treaty: Pandora’s Box or Fair Treaty?’ (1992) Science, 256, 1624.
(iii) Diffusion of Genetic Resources and Scope of Sovereignty
Genetic resources are rarely neatly confined to one nation-state and typically span
national borders. If sovereignty is construed as reaching beyond the right to
control access to and use of specific specimens of genetic material, and is to cover
the genetic content and its inherent value as such, then the natural diffusion of
genetic resources may make it difficult for exclusivity of entitlement to be
sustained. For example, bio-prospecting in Samoa by the American ethno-botanist
Paul Cox led to the identification of the mamala tree (Homalanthus nutans) as a
traditional treatment for hepatitis. Mamala was analysed and found to be a source
of prostratin, a previously known substance. The traditional knowledge about
mamala pointed to its therapeutical qualities. In time, it was shown to be
potentially effective in treating HIV-AIDS, and methods of extracting prostratin
from mamala were patented. A generous benefit-sharing arrangement was reached
with the research sponsor, the Aids Research Alliance.241 Royalties from com-
mercialization of any AIDS treatment are earmarked for the Samoan Government,
the local villages, and descendants of the two traditional healers or taulasea who
had made use of mamala as traditional medicines. Developing countries would
also receive preferential access to any drugs resulting from this research. Even so,
this arrangement was subject to criticism and questioning of its legitimacy,242
including on the basis that mamala and related genetic resources were present
through the Pacific, and Samoa could not be recognized as having sole custody or
sovereignty, given the diffusion of the resource through the broader region.
Similarly, the neem tree is widely spread throughout South Asia and South-East
Asia, despite a strong general cultural identification with the tree in India
especially.
Arguably the only defensible true monopoly over genetic resources is that of
the right to grant or deny access to physical manifestations of the genotype, rather
than the genotype per se. Prior informed consent provides a clear mechanism for
governing access to the physical resource and then, through legally binding
obligations incurred in exchange for the grant of consent, controlling downstream
use of the genetic resource and extraction of benefits derived from the genetic
information contained within the resource.
(iv) Prior Informed Consent:

The most immediate and direct means of exercising sovereignty over genetic
resources is provided through the principle of prior informed consent, which the
CBD stipulates as being a condition of access to the resources,243 unless a
Contracting Party determines otherwise. In principle, no access to genetic
241 AIDS Research Alliance of America (ARA), ‘AIDS Research Alliance of America Announces
Landmark Agreement To Share Drug Profits With Samoan Village Healers’, Press Release (13
December 2001).
242 Peteru, Clark, ‘The Mamala Plant Patent’, in Aroha Te Pareake Mead and Steven Ratuva (eds),
Pacific Genes and Life Patents: Pacific Indigenous Experiences & Analysis of the Commodi-
fication & Ownership of Life, (2007), at p. 178.
243 Art. 15(5).
258 Antony Taubman
resources – and thus no extraction of value from the resource – can take place in
the absence of prior informed consent. This would apply a fortiori to the
undertaking of the specific utilization of genetic resources that leads to a claimed
invention and the subsequent filing of a patent application. Some national
biodiversity laws provide directly for constraints on seeking IP rights without
authorization of the national authority entrusted with the grant of prior informed
consent. Such constraints may form part of the IP law of the country concerned,
so that Egypt’s Patent Act244 provides, inter alia, that
[w]here the invention involves biological, plant or animal product, or

traditional medicinal, agricultural, industrial or handicraft knowledge,
cultural or environmental heritage, the inventor should have acquired the
sources in a legitimate manner.
However, regulation of genetic resources may also reach through to attempts to

patent derivative research in foreign jurisdictions. For example, India’s Biological
Diversity Act 2002 provides that (Article 6(1))
[n]o person shall apply for any intellectual property right by whatever
name called in or outside India for any invention based on any research
or information on a biological resource obtained from India without
obtaining the previous approval of the National Biodiversity Authority
before making such application . . . provided that if a person applies for a
patent, permission of the National Biodiversity Authority may be
obtained after the acceptance of the patent but before the sealing of the
patent by the patent authority concerned [and] provided further that the
National Biodiversity Authority shall dispose of the application for
permission made to it within a period of ninety days from the date of
receipt thereof.
It also provides (Article 6(2)) that the
National Biodiversity Authority may, while granting the approval under

this section, impose benefit sharing fee or royalty or both or impose
conditions including the sharing of financial benefits arising out of the
commercial utilization of such rights.
More generally, the Bonn Guidelines suggest that material transfer agreements
(MTAs) on genetic resources could include ‘conditions under which user [of an
accessed genetic resource] may seek intellectual property rights’.245
Such measures provide a legislative framework under national law mirroring
a provision often exerted through contract law in material transfer agreements, or
244 Art. 13.

245 UNEP/CBD/COP/6/20, decision VI/24.
research agreements, in which material is provided subject to contractual
constraints on downstream patenting activity. The legal dilemma of how to
determine the enforceability of such obligations under the domestic public law of
one country, or under a contract concluded in that country, when a patent is
applied for in a separate jurisdiction, is one of the questions that is driving some
proponents to push for mandatory disclosure of prior informed consent as a
positive condition of the entitlement to apply for, hold or enforce a patent on
derivative research making use of genetic resources. Broadly speaking, the
question is whether, and if so how, one’s breach of legal mechanisms giving effect
to prior informed consent in one country can or should taint one’s entitlement to
a patent in a separate jurisdiction.
Figure 8: Post-CBD Context: The critiques of the past dispensation of the value
extracted from genetic resources lead to an assertion of national sovereignty over
the resources and a principle of prior informed consent governing access both to
the resources as physical material and as a medium for genetic information and
to knowledge concerning the inherent value of those resources; this forms a legal
basis for asserting claims to an equitable share of downstream benefits extracted
from the resources.
(v) Equitable Benefit Sharing:

The essential shift in values and legal principle marked by the CBD is the removal
of the assumption under international law that genetic resources form part of the
common heritage of humanity, in favour of the assertion of national sovereignty;
and at the domesticlevel, the potential removal of public domain status in favour
260 Antony Taubman
of some form of prior informed consent mechanism, which may be vested in a
specific authority, a community, or other custodian recognized under national law
(contrast Figures 7 and 8). Yet there is a positive assumption in the CBD that
resources will be actively utilized – sustainable utilization is an objective of the
Convention – and states do acquire obligations to ‘endeavour to create conditions
to facilitate access to genetic resources for environmentally sound uses . . . and not
to impose restrictions that run counter to the [CBD’s] objectives [including
sustainable use]’.246
While this qualified obligation falls short of a strong obligation to put
resources at the disposal of potential users, it certainly promotes a climate of
expectation that resources will be accessible.
However, this expectation shifts the focus to the third objective of the CBD
– the equitable sharing of benefits once resources are utilized – since it has been
the lack of confidence in equitable returns from downstream use of resources that
helped to precipitate the shift towards assertion of national sovereignty and prior
informed consent in the first place. The clash in values and in policy interests can
be resolved with the recognition that confidence in the return of equitable benefits
to the origin of the genetic resources will itself foster efforts to maintain and
conserve those resources – without which, of course, the downstream processes of
extracting and applying latent value could not be sustained. In other words, in
parallel with the familiar incentive argument for IP to promote recognized forms
of innovation, a mechanism is developed to provide a positive incentive to
conserve and maintain the feed-stocks of that innovation, the genetic resources:
this provides the seed of a move away from the zero-sum paradigm that dominates
debate over IP and genetic resources.
On the other hand, the downstream recognition of the value of certain in situ
genetic resources can lead to their uncontrolled harvesting, putting in doubt their
sustainable use as required by the CBD’s second objective: at least two celebrated
examples of genetic resources with therapeutical qualities of interest to the
general public beyond the source communities have been subject to protection
against species loss: the hoodia cactus in Southern Africa247 and tongkat ali
(Eurycoma longifolia) in Malaysia.248 This is one instance where an obligation of
disclosure of source of valuable genetic resources within the patent system may
actually run counter to the CBD’s objective insofar as it relates to the conservation
of in situ biodiversity.
246 CBD Art. 15.2.

247 Hoodia gordonii is a listed species under CITES (the Convention on International Trade in
Endangered Species of Wild Fauna and Flora). See also Robyn Dixon, ‘Hoodia fever takes a
toll on rare plant’, Los Angeles Times, (26 December 2006), and Ginger Thompson, ‘Twee
Rivieren Journal; Bushmen Squeeze Money From a Humble Cactus’. New York Times,
(1 April 2003).
248 See for example, List of Protected Plants, Second Schedule [Sec. 2(1)] PART II on Protected
Plants, Sarawak Wild Life Protection Ordinance, 1998 (Chapter 26), at <www.forestry.
sarawak.gov.my>.
Hinging on the pivotal notion of ‘equity’, the question of equitable sharing of
benefits, and the role of the IP system (especially the patent system) in generating
and allocating such benefits, have therefore been the subject of extensive debate
and analysis. Few question the legitimacy of the principle in itself, which has been
widely accepted at a general level; but the interpretation and application of the
principle remains contested. Even those examples of cases which have been cited
as exemplary instances of equitable benefit-sharing have been criticized or even
suspended because of concerns about inequitable sharing of benefits.
The most frequently cited example of all equitable benefit sharing arrange-
ments is the agreement between Merck & Co., Inc. and the Instituto Nacional de
Biodiversidad (INBio) of Costa Rica,249 signed in November 1991, predating the
conclusion of the CBD itself. This agreement provided for financial and other
support to assist in the preservation of biological diversity in Costa Rica, in
exchange for access to a certain number of plant specimens collected by INBio.
Merck made an upfront payment of some USD 1.135 million, comprising
contributions to various technical, administrative, scientific and conservation
objectives. The Agreement is still cited by some critics as being inequitable250 or
inherently inappropriate,251 although ironically no positive leads were identified
by Merck252 and the agreement has reportedly significantly assisted Costa Rica to
establish a viable framework for the conservation of its valuable biological
diversity. Other examples of benefit-sharing have been criticized as being
inequitable,253 begging fundamental questions about the nature and standard of
‘equity’ that is required to meet the broad international standard articulated by the
CBD.
Two broad aspects of equity potentially arise: fairness of process (procedural
equity), and fairness of outcome (distributive equity). The CBD establishes prior
informed consent as a procedural safeguard, and equity of outcome in the form of
the requirement for equitable sharing of benefits arising from access to and
research on GR, but gives little guidance as to when the obligation to share
benefits equitably can be taken to have been exhausted. The Bonn Guidelines have
provided some further guidance on the nature of equitable benefit-sharing,
essentially in terms of appropriate procedure, but also identifying some forms of
appropriate benefits (if not the actual level required to meet distributional equity);
249 Coughlin M, ‘Using the Merck-INBio Agreement to Clarify the Convention on Biological
Diversity’ (1993) 31 Columbia Journal of Transnational Law 337.
250 Sylvia Rodriguez, ‘Bioprospecting has failed – what next? Sprouting UP’, Seedling, (GRAIN
Publications, October 2002).
251 See for example, Susan K. Sell, ‘Books, Drugs and Seeds: the Politics of Access’, Paper
prepared for the Transatlantic Consumer Dialogue, The Politics and Ideology of Intellectual
Property, (20–21 March 2006), Brussels (taking issue with the legitimacy of the bilateral
contractual approach).
252 The Agreement was renewed but concluded in 1999 with no positive leads having been
reported (Memoria INBio (Annual Report), 2004).
253 R. Wynberg ‘Rhetoric, Realism and Benefit Sharing: Use of Traditional Knowledge of Hoodia
Species in the Development of an Appetite Suppressant’. Journal of World Intellectual
Property, 7(6): 851–876.
262 Antony Taubman
the subsequent work within the CBD on a draft international regime on access and
benefit sharing may provide more specific guidance. These two developments are
discussed below.254
(vi) Transfer of Technology255

The negotiators of the CBD stressed that its objectives were to be carried out ‘by
appropriate transfer of relevant technologies, taking into account all rights . . . to
technologies’. IP rights are manifestly among the ‘rights . . . to technologies’
required to be ‘taken into account’. The three objectives are very broad in their
potential scope, and it is difficult exhaustively or exclusively to inventory tech-
nologies distinctly relevant to the conservation of biological diversity, the first ob-
jective. Of immediate interest are remote sensing technologies for use in gathering
and assessing information on biodiversity, and technologies for ex-situ conserva-
tion such as preservation and propagation technologies for ex-situ collections.
Some technologies, by contrast, may be seen as prejudicial to conservation of
biodiversity, and some national and regional patent laws provide for exclusions
from patentability of technology that cause serious prejudice to the environment.
Technologies contributing to the second objective, sustainable use of the compo-
nents of biodiversity, include technologies for screening the active properties of ge-
netic materials for possible therapeutic use or useful enzymatic activity. Finally,
intellectual property laws, as well as specific intellectual property rights and the
way they are exercised, and mechanisms concerning patent disclosure, may help
determine how benefits from the utilization of genetic resources are generated and
shared, in particular whether this is undertaken equitably or not, and how the appro-
priate transfer of relevant technologies is undertaken. 256
Analysing the kinds of technologies are relevant to the objectives of the
CBD,257 and disclosing the full landscape of patents that have bearing on their
implementation, remains an important empirical task that is still in its early
stages.258 Even so, it is clear that effective implementation of the CBD will require
technologies developed to some extent under the aegis of the IP system and
254 Sections III.2.IV.2 and III.2.IV.3 respectively.

255 The following section draws on the first draft of text prepared by the author in an official
capacity as a contribution to a joint study on this issue, The Role of Intellectual Property
Rights in Technology Transfer in the Context of the Convention on Biological Diversity: A
Technical Study, document UNEP/CBD/COP/8/INF/32 (15 February 2006), but no endorse-
ment or other linkage should be construed between that study and the present chapter.
256 For example, the agreement between the Government of Samoa and the University of
California concerning development of AIDS treatments from mamala bark provides for
preferential access to resulting technologies for the benefit of developing countries; discussed
further in section III.2.IV(a)(bb)(1).
257 Technology Transfer and Cooperation: Indicative list of technologies for conservation and
sustainable use of biological diversity, Note by the Executive Secretary, Subsidiary Body for
Scientific, Technical and Technological Advice, UNEP/CBD/SBSTTA/9/INF/13 (8 October
2003).
258 See for example, the discussion on the creation of a tailored portal for access to CBD-related
technologies, document UNEP/CBD/COP/8/INF/41 (6 March 2006).
covered by IP rights in some jurisdictions. Many technologies relevant to the
CBD’s objectives are covered by patents enforceable in at least some of the
Parties to the CBD, even though few technologies would be covered by patents
with legal effect in a majority of the fully 190 Parties. The bulk of relevant
technologies can indeed be assumed to be free of patents in many CBD Parties,
although that doesn’t mean the technology is necessarily fully available for its
most effective and efficient use, as this may require associated know-how and the
necessary infrastructure (the lack of infrastructure and capacity to exploit
technologies being, of course, one factor in decisions not to seek patents in a
country). The role of technology transfer in achieving the CBD objectives is spelt
out in a series of specific provisions, Articles 16 (Access to and Transfer of
Technology), 17 (Exchange of Information), 18 (Technical and Scientific Coop-
eration) and 19 (Handling of Biotechnology and Distribution of its Benefits).
These provisions refer explicitly to the role of IP mechanisms in several contexts
and are in general affected considerably by how IP rights are exercised and how
IP systems are deployed as a means of transferring information about new
technologies into public domains.
– Article 16, on access to and Transfer of Technology, establishes obligations

relating to ‘technologies that are relevant to the conservation and sustain-
able use of biological diversity or make use of genetic resources and do not
cause significant damage to the environment’. Technology explicitly
includes ‘biotechnology’ which in turn is defined in Article 2 to mean ‘any
technological application that uses biological systems, living organisms, or
derivatives thereof, to make or modify products or processes for specific
use’. Distinguishing between access to and transfer of technology, it
clarifies that both are considered essential to attaining the objectives of the
CBD, and the treaty obliges Parties to provide and/or facilitate both access
and transfer.
– The role of IP in relation to access may differ from its role in relation to
transfer. Transfer of technology, as a legal obligation, has been debated
extensively and is present in many international legal documents:259 as a
general expectation that not merely the benefits of technology but the
capacity effectively to implement it should pass from developed countries
to developing countries, it’s diverse characteristics, ranging from practical
capacity building and financial arrangements and incentives, to certain
legal mechanisms such as exceptions to IP, licenses on favourable terms
and transfer of ownership of relevant IP.260 The essential point, however, is
259 See UNCTAD, Compendium of International Arrangements on Transfer of Technology :

Selected Instruments: Relevant provisions in selected international arrangements pertaining
to transfer of technology (2001), UNCTAD/ITE/IPC/Misc.5; this compendium contains
almost 300 pages of international legal documents.
260 In UNCTAD, Transfer of Technology, 2001, ‘technology transfer’ is defined as ‘the process
by which commercial technology is disseminated. This takes the form of a technology transfer
transaction, which may or may not be covered by a legally binding contract, but which
264 Antony Taubman
that the capacity to use the technology should be transferred, rather than
simple knowledge of it, generally through a specific transaction between
provider and recipient.261 The term ‘access to technology’ can be used in
very similar circumstances262, but by contrast, would suggest either access
to information about the technology, or legal access in the sense of freedom
to operate.
Access to and transfer of CBD-related technology to developing
countries is required to be provided and/or facilitated under fair and most
favourable terms, including on concessional and preferential terms where
mutually agreed. IP mechanisms may be one form of structuring such
mutually agreed terms and clarifying the nature of the technology that is
to be provided or facilitated, and the precise means of transferring the
technology. IP on the technology may also be one issue affecting access
and transfer that would have to be agreed upon as part of the concessional
and preferential terms. For example, a technology may be licensed under
IP rights in a way that specially favours developing countries, or
humanitarian or non-profit purposes.
involves the communication, by the transferor, of the relevant knowledge to the recipient’. (at
p. 6) The UNCTAD draft International Code on the Transfer of Technology (1985) defines
transfer of technology as ‘the transfer of systematic knowledge for the manufacture of a
product, for the application of a process or for the rendering of a service and does not extend
to the transactions involving the mere sale or mere lease of goods’ (Art. 1.2) and cites the
following technology transactions: ‘(a) The assignment, sale and licensing of all forms of
industrial property, except for trademarks, service marks and trade names when they are not
part of transfer of technology transactions; (b) The provision of know-how and technical
expertise in the form of feasibility studies, plans, diagrams, models, instructions, guides,
formulae, basic or detailed engineering designs, specifications and equipment for training,
services involving technical advisory and managerial personnel, and personnel training; (c)
The provision of technological knowledge necessary for the installation, operation and
functioning of plant and equipment, and turnkey projects; (d) The provision of technological
knowledge necessary to acquire, install and use machinery, equipment, intermediate goods
and/or raw materials which have been acquired by purchase, lease or other means; (e) The
provision of technological contents of industrial and technical co-operation arrangements’
(Art. 1.3).
261 This notion of technology transfer should be distinguished from a related, but distinct and
more descriptive definition in innovation policy, especially in the context of disseminating
public-funded and university or institutional research to industry for the creation of practical
products: as defined in Human Genome Program, U.S. Department of Energy, Human
Genome Program Report (1997): ‘the process of converting scientific findings from research
laboratories into useful products by the commercial sector’. Technology transfer in interna-
tional legal documents such as the CBD and TRIPS has a more normative edge to it.
262 The ‘Access to Knowledge’ movement has, for example, focused not merely on copyright
issues relating to dissemination of knowledge as such and information society issues, but also
on mechanisms to promote technology transfer under the IP system. For instance, the draft
Treaty On Access To Knowledge (draft of 9 May 2005) proposes that ‘the grant of a patent
shall be conditional upon . . . a commitment to ensure enabling transfer of know-how after the
expiration of patent’ (Art. 14(c)), accessed at <www.cptech.org/a2k/a2k_treaty_ may9.pdf>.
For technology covered by patents and or other forms of IP, this access
and transfer must be ‘on terms which recognize and are consistent with the
adequate and effective protection of intellectual property rights’ (but
consistently also with paragraphs 16.3, 16.4 and 16.5). This suggests that
the terms that govern the provision of access and transfer would need to
consider the operation of relevant IP rights, and should not simply
effectively negate them.
Where technology makes use of genetic resources that were provided
by a party to the CBD, legislative, administrative or policy measures are
required with the aim of providing access to and transfer of technology
which makes use of those resources, on mutually agreed terms. This
includes technology protected by patents and other IP rights. One possible
pathway to clarifying and determining mutually agreed terms of access and
transfer of such technology would be to agree upon licenses under such IP
rights within a broader agreement as to the mechanism for providing
access to and transfer of the technology.
Parties to the CBD are required to ‘take legislative, administrative or
policy measures, as appropriate, with the aim that the private sector
facilitates access to, joint development and transfer’ of the technology
referred to in Article 16.1; this should benefit both governmental institu-
tions and the private sector of developing countries. IP laws and policies,
including policies on management of publicly funded research and laws
governing exceptions and licensing, as well as specific licensing, joint
venture, research cooperation and other technology partnership arrange-
ments that deal with IP, all potentially contribute to this goal.
This article also recognizes that patents and other IP rights may
influence the implementation of the CBD, and requires parties to ‘coop-
erate in this regard subject to national legislation and international law in
order to ensure that such rights are supportive of and do not run counter to
its objectives’. In view of its context within this article, this requirement
may point to the specific benefits of cooperation in relation to patents and
other IP rights as part of the overall framework of promotion of access to
and transfer of CBD-related technologies.
Article 17 concerns the ‘exchange of information, from all publicly available

sources, relevant to the conservation and sustainable use of biological diversity,
taking into account the special needs of developing countries’. The information
concerned includes ‘results of technical, scientific and socio-economic research,
as well as information on training and surveying programmes, specialized
knowledge, indigenous and traditional knowledge as such and in combination
with the technologies referred to in Article 16, paragraph 1’. As it follows Article
16 and is distinct from it, this article suggests that a distinction can be drawn
between the simple exchange of information as such, and the processes of access
to and transfer of technology. Patent information systems are a key source of
266 Antony Taubman
information, in the general sense of ‘exchange of information’ considered here;
their practical availability and accessibility to widespread user groups have been
transformed in the time since the CBD was concluded. Patent information systems
also play an important role in the promotion of access to and transfer of
technology, including in identifying useful or relevant technologies, determining
the identity and patterns of ownership, ascertaining legal status and territorial
reach of relevant patents and thus informing on freedom to operate for those
seeking to use this technology.
For example, Figure 9 illustrates the increase in patent activity on certain
tools relevant to the assessment and sustainable use of genetic resources, namely
the international patent applications disclosing inventions in sub-class C12Q in
the International Patent Classification (‘measuring or testing processes involving
enzymes or micro-organisms, compositions therefore, and processes of preparing
such compositions’). The most active individual participant in this field of
patenting is the University of California, which easily outstrips any commercial
player. The technology transfer policy of this institution includes the objectives ‘to
disseminate new and useful knowledge resulting from University research
through the use of the patent system’ and ‘to license patents to industry in order
to promote the development of inventions toward practical application for use by
the general public’.263
Figure 9: Recent Patent Activity

In a proposal to the WTO on technology transfer, several developing
countries noted that ‘patent applications and patent databases are important
potential sources of technological information’ and the beneficial effects of such
263 UC Technology Transfer Program, at <www.ucop.edu/ott/genresources/ttprog.html>.

tools would be enhanced by encouraging ‘patent offices to cooperate in sharing
information and regulatory standards. They could help develop databases for
some developing countries, especially those that are not available on the internet,
to make the information accessible to potential domestic users’.264
Article 18 deals with international technical and scientific cooperation in the
field of conservation and sustainable use of biological diversity. Special attention is
to be given to the development and strengthening of national capabilities, by means
of human resources development and institution building. Cooperation is also re-
quired for ‘the development and use of technologies, including indigenous and tra-
ditional technologies’ in pursuance of the CBD’s objectives. Parties to the CBD are,
subject to mutual agreement, to ‘promote the establishment of joint research
programmes and joint ventures for the development of technologies’ relevant to the
CBD’s objectives. This form of cooperation is likely to raise practical and policy
questions concerning IP management, and appropriate ways of structuring coopera-
tive research partnerships and technology development joint ventures. The overall
policy guidance lent by the CBD may help to shape specific practical structures,
partnerships and mechanisms to promote this form of cooperation.
Article 19, on Handling of Biotechnology and Distribution of its Benefits, re-
quires the effective participation in biotechnological research activities by coun-
tries, especially developing countries, which provide the genetic resources for
research. It provides for ‘priority access on a fair and equitable basis’ by those coun-
tries to ‘the results and benefits arising from biotechnologies based upon genetic re-
sources’ and that ‘access shall be on mutually agreed terms’. Similar to Articles 16
(Access to and Transfer of Technology) and 18 (Technical and scientific coopera-
tion), the practical implementation of this requirement will entail considering how
IP mechanisms are, and can be, used in structuring, managing and promoting these
kinds of technology access and cooperative research arrangements.
The implementation of the CBD provisions on access to, transfer of,
participation in, and equitably sharing benefits from genetic resources will require
forms of knowledge management that range between full public domain status,
through various forms of bilateral and non-exclusive technology pooling and
sharing arrangements, to potentially exclusive IP-based structures (such as an
exclusive licensing strategy for a patent on a pharmaceutical legitimately derived
with consent from a genetic resource, used to generate benefits in accordance with
mutually agreed benefit-sharing terms). Accordingly, rather than seeking to define
one single technology transfer vehicle or structure, it may be more productive to
consider some general characteristics of the use of IP in attaining technology
transfer and related goals under these CBD provisions.
Above all, it is not an either/or choice. IP laws and mechanisms do not
constitute a single, stand-alone form of knowledge management, necessarily to be
adopted or rejected in their entirety, or to be used to the exclusion of other forms
264 India, Pakistan and the Philippines, Steps that Might be Taken Within The Mandate of the WTO
to Increase Flows of Technology to Developing Countries, Submission to the Working Group
on Trade and Transfer of Technology, WT/WGTTT/W/10 (13 October 2005), at para. 13.
268 Antony Taubman
of knowledge management, innovation promotion and technology diffusion; they
are a set of specific legal means, normally set by statute in the context of public
policymaking, aimed at supporting the development and management of knowl-
edge in the broader public interest or at suppressing unfair or misleading
commercial practices. The resort to IP mechanisms is not, then, a choice for
exclusivity as such, or as an end in itself, or as a polar opposite to technology
sharing and collaboration. Few technological developments in the life sciences are
achieved through tightly exclusive vertically integrated product development
processes.
Further, most practical technology transfer mechanisms and other technology
partnership arrangements that make use of IP mechanisms will also touch on a
combination of other non-IP elements, ranging from capacity development and
training, to laws governing investment and legal remedies against abusive
licensing practices. According to one UNEP report, environmentally sound
technologies are not just individual technologies, but total systems which include
know-how, procedures, goods and services, and equipment as well as organiza-
tional and managerial procedures. This implies that when discussing transfer of
technologies, ‘the human resource development and local capacity-building
aspects of technology choices, including gender-relevant aspects, should also be
addressed’.265
The actual effect and operation of IP mechanisms in the access to and transfer
of technology under the CBD will depend on a concretion of a wide range of
specific choices at the level of individual institutions and firms regarding: (i)
decisions to take out or to forego IP protection in each discrete jurisdiction
concerned; (ii) choices concerning ownership and management of relevant IP
portfolios; and (iii) approaches to licensing and enforcement of IP rights,
including degrees of exclusivity and non-exclusivity (such as license arrange-
ments that give non-exclusive access to interested parties), favourable terms for
public-interest or non-commercial use, or for use in developing countries (e.g.
licensing practices such as equitable access licenses for low and medium income
countries or humanitarian licenses).
In addition, options for technology transfer may be influenced by the
approach taken in national patent laws on such issues as research exceptions, as
well as regulatory measures consistent with Article 40 of TRIPS which deal with
licensing practices or conditions which may impede the transfer and dissemina-
tion of technology.266
A key potential role for IP systems is clarifying and structuring the form of
partnerships concerning knowledge development, deployment and dissemination
– this may be one aspect of negotiation of mutually agreed terms, when these are
prescribed by the CBD in the context of transfer of technology. Thus the benefits
265 United Nations Environment Program (UNEP), ‘Transfer of Environmentally Sound Tech-
nology, Cooperation and Capacity-Building‘, 34.4, at <www.unep.org>.
266 See for example, Chapter IX (‘Voluntary Licensing’), Intellectual Property Code of the
Philippines.
or disadvantages of IP in the context of access to and transfer of technology will
not necessarily depend on binary questions of the presence or absence of IP
altogether, but the net effect of successive decisions and determinations, as well
as the impact of broader regulatory questions such as safeguards against
anti-competitive practices and abusive licensing practices.
As noted, the overwhelming bulk of IP protection for claimed inventions,
notably through the patent system, is concentrated in developed economies, with
relatively few corresponding patents in the majority of developing countries. The
principle of territoriality within the IP system means that the bulk of this material
is in the public domain in many developing countries. Practical access to
technological knowledge contained in patent documentation has increased rapidly,
but not necessarily with easy access to the legal information and advice that is
required to determine freedom to operate with information that is located in this
way.
Inappropriate patenting outcomes, where they occur, such as patenting of
already disclosed traditional knowledge related to biodiversity, or patents that are
invalid for other reasons, such as lack of novelty or inventive step, may constrain
legitimate access to and use of technology. It is difficult, both in terms of time and
money, for a concerned third party to obtain the revocation of patents that were
erroneously granted. Defensive protection measures in the patent system therefore
help sustain positive conditions for technology transfer relating to GR.
(3) Food and Agricultural Organization: International Treaty
All genetic resources have common roots and share extensive material with many
other organisms, creating the dilemmas for policymakers sketched out above. Yet
this is strikingly so for plant genetic resources for food and agriculture –
especially the food crops – where many generations of breeding and improvement
render the notion of an origin difficult to construe, let alone to legally define.
Given that modern crops are the descendents of 2x antecedents from x genera-
tions, the notion of tracing the source, say, to 210 varieties after ten generations of
breeding, and sharing benefits ‘equitably’ with all of them, becomes entirely
unworkable – and the same applies to efforts to seek authorization from each
historically identifiable source. In view, also, of the fact that very few countries
derive significant quantities of their agricultural food and other benefits from
agriculture from indigenous species, all nations can be rightly described as
‘genetically interdependent’.267 Any significant food crop will be a congeries of
gradually accumulated genetic traits, typically sourced from several continents
and over centuries or millennia. These distinctive characteristics of plant genetic
resources lend themselves especially to a multilateral structure, rather than a
267 Dan Leskien, Seeding Solutions: the Struggle for Genetic Resources, International Policy
Issues, Introduction, Doc. CBD, Fifth Conference of the Parties, UNEP/CBD/COP/5/INF/25,
(1 May 2000), p. 12.
270 Antony Taubman
complex of bilateral contractual arrangements. On the other hand, the develop-
ments discussed above have led to a strong normative pressure for national
sovereignty over genetic resources to be expressed.
Within the multilateral system and the full international legal system, the
Food and Agricultural Organization has a specific mandate for plant genetic
resources for food and agriculture which has culminated in distinctive, tailored
forms of governance and benefit-sharing, even while complementing the CBD.
FAO work on access and benefit sharing led first to a non-binding International
Undertaking on Plant Genetic Resources for Food and Agriculture,268 which
evolved after many years of negotiation into the ITPGRFA which legally
established a multilateral system for access and benefit sharing specifically
tailored for plant genetic resources for food and agriculture. The objectives invoke
the linkage with the CBD directly, aiming at
the conservation and sustainable use of plant genetic resources for food
and agriculture and the fair and equitable sharing of the benefits arising
out of their use, in harmony with the Convention on Biological Diversity,
for sustainable agriculture and food security.269
The political character of the Treaty is notable: Contracting Parties firstly
recognize the sovereign rights of States over their own plant genetic
resources for food and agriculture, including that the authority to
determine access to those resources rests with national governments and
is subject to national legislation,
but secondly, in exercising these sovereign rights over their resources,
agree to establish a multilateral system, which is efficient, effective, and

transparent, both to facilitate access to plant genetic resources for food
and agriculture, and to share, in a fair and equitable way, the benefits
arising from the utilization of these resources, on a complementary and
mutually reinforcing basis.270
Thus a multilateral pooling of resources is understood to be a coordinated act of

national sovereignty.
ITPGRFA covers an annexed list of plant genetic resources for food and
agriculture, including some 35 crop genera and 32 forage genera specifying some
70 species). This list was formally ‘established according to criteria of food
268 WIPO, Intergovernmental Committee on Intellectual Property and Genetic Resources,

Traditional Knowledge and Folklore: An Overview, Doc. WIPO/GRTKF/IC/1/3, (16 March
2001), p. 17.
269 Art. 1, ITPGRFA.
270 Art. 10.2, ITPGRFA.
security and interdependence’271 but at the same time was negotiated pragmati-
cally with a continuing vigorous assertion of national sovereignty: key food crops
such as groundnut are excluded, and there is a specific exclusion of the species
lepidium meyenii (maca), which has been the subject of a long-standing
controversy over allegations of bio-piracy in the patenting of its medicinal
properties.272
By the force of the Treaty, the Multilateral System includes ‘all plant genetic
resources for food and agriculture listed in Annex I that are under the management
and control of the Contracting Parties and in the public domain’. At the same time,
all other holders of the Annexed plant genetic resources are invited to include their
holdings in the Multilateral System, introducing a supplementary voluntary
component to the resource pooling under the system. Coverage under the
Multilateral System automatically entails expeditious access, but ‘solely for the
purpose of utilization and conservation for research, breeding and training for
food and agriculture, provided that such purpose does not include chemical,
pharmaceutical and/or other non-food/feed industrial uses’.273 Presumably, the
resource holder retains rights to negotiate bilateral terms over access for other
purposes, such as for pharmaceutical research, on the basis of ownership or
control over the physical resource as such, and the capacity to impose restrictions
on physical access. In other words, in the manner of a patent pool, access to the
covered resources is only facilitated for designated purposes in line with the
Treaty’s objectives.
In view of the overlap between rights of control over physical resources as
such and related intangible property rights, the Treaty only requires coverage of
resources that are in the public domain, and further stipulates that access and
transfer of technology shall be provided on terms which recognize and are
consistent with the adequate and effective protection of intellectual property
rights.274 Further, recipients may not claim ‘any intellectual property or other
rights that limit the facilitated access to the plant genetic resources for food and
agriculture, or their genetic parts or components, in the form received from the
Multilateral System’,275 the ‘facilitated access’ referring presumably to access to
the genetic resources covered by the system established by the Treaty This
provision represents a key inflexion in the longstanding policy debate – discussed
passim in this chapter – over patents that claim genetic content as patentable
inventions, recalling the difficulties in drawing bright lines between simple
discovery or routine analysis of ‘genetic parts and components’ and a truly
patentable invention, and between the physical material ‘in the form received’ and
the extraction of patentable technological know-how from that material, which
271 Art. 11.1, ITPGRFA .

272 See for exmple, Patents referring to Lepidium Meyenii (Maca): Responses of Peru, document
WIPO/GRTKF/IC/5/13 (12 May 2003).
273 ITPGRFA, Art. 12(3)(a).
274 ITPGRFA, Art. 12(3)(f), 13(2)(b)(iii).
275 ITPGRFA, Art. 12(3)(d)
272 Antony Taubman
may not entail physical transformation of the genetic material as such but the
isolation of useful extracts from that material.
Crucially, the emphasis lies on the potential negative impact on facilitated
access to the resources covered by the treaty, and thus on any frustration of the
objectives of facilitating access for the defined purposes of ‘utilization and
conservation for research, breeding and training for food and agriculture’, rather
than constructing ‘access’ in terms of resolving competing property claims. By
contrast, there is clearly no bar on securing intellectual property rights on
derivative material, such as PBR on new varieties resulting from the received
resources, or patents on inventively genetically transformed materials. Yet the
creation of legal or technological constraints on access to such transformed
materials – such as through IP rights – triggers the Treaty’s access and benefit
sharing obligations, now discussed.
A key design feature of the Treaty is its implementation of a specific model
of access and benefit sharing, tailored for the needs of genetic resources seen as
feedstock for agriculture and for the breeding of new crop varieties. Given the
diffuse character of plant genetic resources, and the public domain status of this
material, the bilateral structuring of benefit-sharing arrangements under the CBD
gives way to a fully multilateral network.276 Given that this approach is structured
as an exercise of sovereignty over resources, it is truly complementary to the
CBD; a decision to commit genetic resources to a multilateral pool is consistent
with the exercise of sovereignty over national resources, and could even be
formally analysed as a congeries of bilateral undertakings. Even as an instrument
that lays emphasis on bilateral structuring of access and benefit sharing arrange-
ments, the CBD would also be consistent with a multilateral approach, again
potentially chosen as a free expression of national sovereignty exercising prior
informed consent. The Treaty’s approach to access and benefit-sharing has the
elements of an ‘open source’ approach – taking this term as a general metaphor
rather than a literal description – according to which the feedstock to innovation
– the ‘source code’ – are to be freely available to all who wish to use them as an
input to the cumulative development of further materials, provided the derivative
innovations thereby produced are in turn available for further research and
breeding.
The general approach to benefit-sharing under the Treaty is founded on
agreement that ‘benefits arising from the use, including commercial, of plant
genetic resources for food and agriculture under the Multilateral System shall be
shared fairly and equitably’, through the following agreed mechanisms: ‘the
exchange of information, access to and transfer of technology, capacity-building,
and the sharing of the benefits arising from commercialization’.277 Benefit sharing
from commercialization is triggered when a product is itself a plant genetic
resource for food and agriculture and incorporates material received under the
Development Policy (London, 2002), p. 78.
277 ITPGRFA, Art. 13(2).
system. If the product is not available for others without restriction for further
research and breeding, then the original recipient is required to pay an equitable
share of benefits. Where the product is available to others, the recipient would
only be encouraged to make such a payment. The level of payment is set by the
Governing Body established under the Treaty, which may ‘also decide on the need
to exempt from such payments small farmers in developing countries and in
countries with economies in transition’.
Reflecting the general experience that perceptions over equity in benefit
sharing are liable to change, and will be influenced by actual experience in
practice, the Governing Body is also to review the levels of payment ‘with a view
to achieving fair and equitable sharing of benefits’. Within five years from the
Treaty’s entry into force, the Governing Body may also assess whether payment
should be mandatory when commercialized products are available without
restriction to others for further research and breeding.278 The ITPGRFA has now
been set into operation with the conclusion of the standard material transfer
agreement (SMTA) that governs each accession, discussed below.
(b) National and Regional Levels
Beyond the regulation of compliance with expectations on access and benefit

sharing within conventional and extended patent law instruments, sui generis and
related laws at the national level279 and regional model laws280 seek to create
regulatory linkages between the conservation and protection of GR, on the one
hand, and IP mechanisms – both conventional and sui generis TK measures – on
the other hand. This following section reviews representative examples, illustrat-
ing the range of regulatory responses to the desire for more systematic linkages.
It is futile and probably impossible to group these diverse measures together as
representing a closely interrelated body of law. The measures differ in terms of
their normative character or structure, their ostensible objectives, and their
proximity to the IP system, both conventional IP and the sui generis protection of
278 ITPGRFA Art. 13(2) sets out these detailed arrangements for benefit-sharing.
279 Brazilian Provisional Measure No. 2186–16 of 2001 Regulating Access to the Genetic
Heritage, Protection of and Access to Associated Traditional Knowledge (‘Brazilian law’);
Costa Rican Law No. 7788 of 1998 on Biodiversity (‘Costa Rican Law’); Indian Biological
Diversity Act of 2002 (‘Indian Law’); Panama Law on The Special Intellectual Property
Regime upon Collective Rights of Indigenous Communities, for the Protection of their
Cultural Identities and Traditional Knowledge (‘Panama Law’); Peruvian Law No. 27,811 of
2002 Introducing a Protection Regime for the Collective Knowledge of Indigenous Peoples
Derived from Biological Resources (‘Peruvian Law’); the Philippines Indigenous Peoples
Rights Act of 1997 (‘Philippines Law’); the Portuguese Decree Law No.118 of 2002
Establishing a Legal Regime of Registration, Conservation, Legal Custody and Transfer of
Plant Endogenous Material (‘Portuguese Law’);
and Breeders, and for the Regulation of Access to Biological Resources of 2000 (‘African
law’); and Pacific Regional Framework for the Protection of Traditional Knowledge and
Expressions of Culture (2002);
274 Antony Taubman
TK; as the discussion below suggests, they are perhaps best seen as a plurality of
responses to a general underlying instinct that a failure of essential equity requires
a response, a regulatory instinct that finds its impression in diverse forms. The
interaction between the strict regulation of access to GR, and the broader cluster
of IP-related questions takes on several aspects:
– a prescribed interface with conventional IP law, in particular constraining

the patent system in its substantive or procedural aspects;281
– overlapping rights, or overlapping regulatory mechanisms, that recognize
the integral linkage between genetic resources and certain categories of
traditional knowledge (typically characterized as associated with or related
to genetic resources, potentially broader in scope than the linkage between
knowledge and physical resource established under the CBD282)
– provision for entitlement to an equitable share of benefits from the
downstream utilization of genetic resources
The normative character of these measures range across the following:
– elaborations of mainstream patent law principles applied to genetic

material as such, or material derived from GR;
– the creation of distinct new disclosure requirements, building on or adding
to existing disclosure doctrines under patent law,283 to use the patent
system to monitor or enforce compliance with separate access and
benefit-sharing regulations concerning GR:284 debate continues as to
whether the creation of such disclosure requirements is a natural extension
or application of existing patent law principles, including the embedded
notion of ‘equity’ or equitable entitlement in patent law,285 or a pragmatic
yoking together of two distinct regulatory mechanisms altogether;
281 As discussed in sections III.2.III.3(b)(dd) above.

282 Contrast the more precise delineation of relevant TK in the CBD itself, which focuses not on
‘traditional knowledge’ but on ‘knowledge, innovations and practices of indigenous and local
communities embodying traditional lifestyles relevant for the conservation and sustainable use
of biological diversity’ (Art. 8(j)).
283 See the analysis of patent disclosure doctrines in WIPO, Technical Study On Disclosure
Requirements In Patent Systems Related To Genetic Resources And Traditional Knowledge,
(Geneva, 2004), pp. 34 et seq.
284 These measures bridge between sui generis regulation of access to GR and IP laws: see for
example the complementary measures in Andean Community Decision 391 and 486. these
measures are therefore discussed in the immediately previous section, III.2.III.3, supra.
285 For example, Brazil has stated that ‘disclosure proposals do not constitute an attempt to use
the patent system to enforce non-patent legal requirements or for the pursuit of objectives of
distinct legal mechanisms. Rather, the objectives of the disclosure proposal, as formulated by
Brazil and other developing countries, are quite germane to the patent system, as they
essentially seek to ensure that the international patent system operates in a more equitable and
balanced manner. A basic concern of most proponents of disclosure requirements is to ensure
that the patent system does not reward inequitable behavior, and, in particular, does not reward
– various forms of biodiversity legislation that implement national obliga-
tions and entitlements under the CBD – essentially, through the exercise of
sovereignty over GR, the establishment of national regimes applying the
principles of prior informed consent and equitable sharing of benefits – that
have bearing on the obtaining and exercising of IP;286
– broader systems of recognizing indigenous rights that combine elements of
TK, TCEs and genetic resources within an holistic normative frame-
work.287
Debate at the international level explores the interaction and potential systemic
conflict between the CBD and the IP system, typically as represented by TRIPS.
By contrast, national laws on GR tend to express several overlapping objectives
which may have bearing on when and how IP is obtained and exercised, generally
reflecting the objectives and principles of the CBD, either explicitly or indirectly.
The specific legislative objectives include:
– Explicitly linking the environmental goal of conservation of biological

diversity with the IP-related concept of exercising an entitlement to receive
equitable remuneration or other benefits from the use of GR, giving effect
to the ‘incentive to conserve biodiversity’ logic discussed above (a form of
IP protection to create incentives not to innovate but rather to conserve in
situ biodiversity).288
– recognition of traditional ownership or custodianship of genetic resources,
or other forms of community interest, as the basis for the assertion of rights
and interests over downstream uses of GR: for example, the Philippines
Law aims ‘to recognize, protect, and promote the rights of Indigenous
Cultural Communities and Indigenous Peoples’289
– cognate with this recognition of custodianship, strengthening or extending
recognition of customary law as the basis of ownership, custodial or other
rights and interests (such as recognition of continuing entitlement to
customary use); linking the regulation of access to genetic resources to the
attainment of core CBD objectives of conservation and sustainable use of
patent applicants for violating the laws of the countries of origin of genetic resources utilized
in developing the invention. The disclosure requirement, as proposed by Brazil and other
developing countries, would, in effect, be fully in line with existing principles and objectives
of the existing patent system, such as those enshrined in Articles 7, 8, 27.2 and 27.3 of the
TRIPS Agreement. Simply put, Brazil and other countries proposing disclosure of origin/PIC/
benefit sharing requirements believe that the patent system, in order to retain its credibility and
robustness, should not reward this kind of inequitable behavior ‘. Comments of Brazil on para.
74 of document WIPO/IP/GR/05/1, quoted in Invitation to WIPO from the Conference of
Parties of the Convention on Biological Diversity, document WO/GA/32/8 (24 August 2005),
Annex, p. 38.
286 Such as the Costa Rican and Indian laws.
287 Philippines Law fn. 280 supra.
288 p. 212, supra.
289 Philippines Law fn. 280, supra.
276 Antony Taubman
GR, and thus giving effect to the sense of ‘equity’ innate in the CBD
requirement for ‘fair and equitable sharing of the benefits’:290 for instance,
India’s biodiversity legislation provides for ‘equitable sharing of the
benefits arising out of the use of biological resources and knowledge’291
– creating specific, positive community-held rights that acknowledge the
intellectual contribution of communities to the development and conser-
vation of GR;292 for example, the Philippines law aims
to provide for a system of community intellectual rights protection
in respect of the innovative contribution of both local and indig-
enous cultural communities in the matter of development and
conservation of genetic resources and biological diversities.293
Reflecting the view that certain forms of TK at least are closely interrelated with
genetic resources, and that the access regime should accordingly regulate the two
fields together, a number of the laws typically address the two subject matters
integrally; for instance the omnibus African Union model law aims ‘to ensure the
conservation, evaluation and sustainable use of the biological resources, and
knowledge and technologies in order to maintain and improve their diversity’. The
main aim of the model law is to ensure the conservation, evaluation and
sustainable use of the biological resources, and knowledge and technologies in
order to maintain and improve their diversity. The African model law has the most
holistic approach, covering biological resources, their derivatives, ‘and commu-
nity knowledge and technologies’.294 Accordingly, it includes but does not require
a specific link with the CBD objectives of conservation and sustainable use. The
Brazilian law addresses ‘access to components of the genetic heritage’ alongside
‘access to traditional knowledge relating to the genetic heritage’; equally it
extends the CBD principle of equitable benefit sharing to this ‘associated
290 Notably the objective of ‘fair and equitable sharing of the benefits arising out of the utilization
of genetic resources’, Art. 1 CBD; and the logic of Art. 8(j) which is a mechanism for in situ
conservation, but ‘the equitable sharing of the benefits arising from the utilization of such
knowledge, innovations and practices [relevant for the conservation and sustainable use of
biological diversity]; see also Art. 16.
291 India, Biological Diversity Act of 2002.
292 Closely cognate with the conception of farmers’ rights (see discussion above on the FAO
ITPGRFA), as a form of acknowledgement of the historic and ongoing contribution of farmers
to conservation and development of the diversity of plant genetic resources.
293 Philippines Law fn. 280, supra.
294 African model law, Art.2(1)(i)-(iii); ‘community knowledge’ is defined as ‘the accumulated
knowledge that is vital for conservation and sustainable use of biological resources and/or
which is of socio-economic value, and which has been developed over the years in
indigenous/local communities’.
traditional knowledge.’295 It also provides for access to and transfer of tech-
nology296 for the conservation and use of biological diversity.
IV. DRAFT LAWS AND OTHER MODELS
1. Tailored Patent Disclosure Mechanisms for Genetic

Resources
Without doubt the most extensively discussed and debated current issue in the
field of intellectual property and genetic resources is the proposal, propounded by
a significant number of countries, for a mandatory requirement under international
law to introduce a so-called disclosure mechanism in national or regional patent
law, a requirement that would be triggered by the act of applying for a patent on
an invention that in some way makes use of genetic resources (such proposals also
generally extend to traditional knowledge, but that aspect is not discussed here).
Proposals of this nature have been tabled in several international fora:
– A group of developing countries has proposed the revision of the TRIPS

Agreement that would oblige WTO Members to introduce such a require-
ment in their national patent law.297
– CBD COP Decision VI/24 invited governments
to encourage the disclosure of the country of origin of genetic

resources in applications for intellectual property rights, where the
subject matter of the application concerns or makes use of genetic
resources in its development, as a possible contribution to tracking
compliance with prior informed consent and the mutually agreed
terms on which access to those resources was granted
and
to encourage the disclosure of the origin of relevant traditional

knowledge, innovations and practices of indigenous and local
communities relevant for the conservation and sustainable use of
biological diversity in applications for intellectual property rights,
where the subject matter of the application concerns or makes use of
such knowledge in its development.
295 Brazilian law, fn. 280 supra, Art. 1.

296 See Art. 16 to 19 of the CBD, discussed section III.2.III.4(a)(bb)(2) supra.
278 Antony Taubman
– The draft CBD international regime currently under negotiation contains a
reference to this requirement.298
– Switzerland has tabled a proposal to amend the Patent Cooperation Treaty
Regulations ‘in order to explicitly enable the Contracting Parties of this
treaty to require patent applicants to declare the source of genetic resources
and traditional knowledge in patent applications’.299 It suggests also the
‘wording of the proposed new provisions . . . in particular the proposed new
subparagraph (g) in Rule 51bis.1 and subparagraph (vi) in Rule 4.17, is
sufficiently specific and clear to be directly implemented at the national
level’ and can therefore serve in itself as a model for national laws.300
– As noted above,301 the European Union has tabled a proposal for a
mandatory requirement ‘to disclose the country of origin or source of
genetic resources in patent applications’, which would apply to all
international, regional and national patent applications, the applicant
would be required to declare ‘the country of origin or, if unknown, the
source of the specific genetic resource to which the inventor has had
physical access and which is still known to him’ when the invention is
‘directly based on the specific genetic resources’.302
Further, at the invitation of the CBD COP, WIPO has undertaken two extensive
studies of the issue, developed through widespread consultative processes,303 and
UNCTAD has commissioned an academic study on the issue.304 The WIPO
Technical Study identified as a key issue ‘the legal basis of the disclosure
requirement in question, and its relationship with the processing of patent
applications, the grant of patents and the exercise of patent rights. This raises also
the legal and practical interaction of the disclosure requirement with other areas
of law beyond the patent system, including the law of other jurisdictions’. The
study identified the following specific legal and policy questions that remain
current in the international debate on disclosure requirements:
298 See section (ii) following.

299 See PCT/R/WG/4/13 and, with identical contents, PCT/R/WG/5/11 Rev; PCT/R/WG/6/11;
and PCT/R/WG/7/7. This proposal was recently transferred to the WIPO Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and
Folklore following the conclusion of the current phase of PCT reform: see document
WIPO/GRTKF/IC/11/10 (6 June 2007), Declaration of the Source of Genetic Resources and
Traditional Knowledge in Patent Applications: Proposals by Switzerland.
300 Comments of Switzerland on WIPO/IP/GR/05/1, reported in WO/GA/32/8 (24 August 2005).
301 See Section III.2.III.3.(b)(dd)(2), supra.
302 Document WIPO/GRTKF/IC/8/11, Disclosure of Origin or Source of Genetic Resources and
Associated Traditional Knowledge in Patent Application, submitted by the European
Communities and their Member States.
303 See UNEP/CBD/COP/7/INF/17 (Technical Study on Disclosure Requirements in Patent
Systems Related to Genetic Resources and Traditional Knowledge) and Annex to WO/GA/
32/8 (Examination of Issues Regarding the Interrelation of Access to Genetic Resources and
Disclosure Requirements in Intellectual Property Rights Applications).
304 UNEP/CBD/COP/8/INF/25 (Analysis of Options for Implementing Disclosure of Origin
Requirements in Intellectual Property Applications - Submission by UNCTAD).
– the potential role of the patent system in one country in monitor-
ing and giving effect to contracts, licenses, and regulations in
other areas of law and in other jurisdictions, and the resolution of
private international law or “choice of law” issues that arise in
interpreting and applying across jurisdictions contract obligations
and laws determining legitimacy of access and downstream use of
GR/TK;
– the nature of the disclosure obligation, in particular whether it is
essentially a transparency mechanism to assist with the monitor-
ing of compliance with non-patent laws and regulations, or
whether it incorporates [the direct enforcement of compliance
with access and benefit sharing regulations in other countries];
– the ways in which patent law and procedure can take account of
the circumstances and context of inventive activity that are
unrelated to the assessment of the invention itself and the
eligibility of the applicant to be granted a patent;
– the situations in which national authorities can impose additional
administrative, procedural or substantive legal requirements on
patent applicants, within existing international legal standards
applying to patent procedures, and the role of non-IP international
law and legal principles in this regard;
– the legal and operational distinction (to the extent one can be
drawn) between patent formalities or procedural requirements,
and substantive criteria for patentability, and ways of character-
izing the legal implications of such distinctions;
– clarification of the implications of issues such as the concept of
‘country of origin’ in relation to genetic resources covered by
multilateral access and benefit-sharing systems, differing ap-
proaches to setting and enforcing conditions for access and
benefit sharing in the context of patent disclosure requirements,
and coherence between mechanisms for recording or certifying
conditions of access and the patent system.305
Reflecting the still unsettled state of international opinion on this issue, the
further ‘examination of issues’ developed in response to a second invitation by the
CBD COP306 identified further questions relevant to genetic resources in
particular as including:
What external circumstances affect the entitlement of the applicant to

apply for and to be granted a patent, especially the circumstances
thatsurround the obtaining and use of inputs to the invention, and any
305 Annex to document WIPO/GRTKF/IC/5/11, paras 205 and 206.

306 Document WO/GA/32/8, Annex, para. 74, concluded following an Ad Hoc Intergovernmental
Meeting (WIPO/IP/GR/05/1), June 2005.
280 Antony Taubman
broader obligations that arise? . . . is the claimed invention truly new and
inventive (non-obvious), having regard to already known [genetic
resources]? . . . how can the patent system be used to monitor and
sanction compliance with laws governing access to [genetic resources]
and compliance with the terms of laws or regulations governing ABS,
mutually agreed terms, permits, licenses or other contractual obligations,
especially when these obligations arise under foreign jurisdictions? Is the
patent law the appropriate vehicle for ABS? What impact would a new
disclosure requirement have on innovation?; And are national patent
offices the appropriate bodies to enforce licences or contract-based
interests of providers of genetic resources or associated TK?
The disclosure question has been extensively analysed and debated, and
continues to be the cynosure of international debate over the relationship between
genetic resources and the patent system. The multiplicity of proposals shows a
degree of divergence on some key questions:
– What is the link between a claimed invention as such and the genetic
material used in creating it?
– Is it simply a requirement to disclose information, or is it effectively an
obligation to comply with substantive standards as the basis of a patent?
– What are the legal implications of failing to comply with the requirement?
Even so, these diverse proposals do have common underlying themes:
– they seek to forge some form of operational or legal linkages between two
distinct regulatory mechanisms, the regulation of access to genetic re-
sources and the exercise of sovereignty over those resources, on the one
hand, and the recognition of specific innovative activities through the
patent system, on the other hand;
– they seek to redefine, again in some practical or legal manner, the equitable
basis upon which a patent is granted to a person making use of genetic
resources;
– they establish a line of enquiry and scrutiny that reaches back down the
chain of provenance to either the source or the origin of genetic resources,
to an extent that has not been systematically undertaken in conventional
patent practice;
– they respond to the strongly-voiced expectation that the principles of prior
informed consent and equitable sharing of benefits do have bearing on the
patent system, and indeed that the patent system has a legitimate role in
either passively monitoring or even actively enforcing the application of
such principles.
The debate over disclosure mechanisms confront some complex questions of how
individuals are required to comply with international legal standards, and how the
different laws at the national level should be integrated, for instance, how a patent
granting authority or judicial authority in one country can base its judgment on
entitlement to hold, or to exercise, patent rights on an assessment of compliance
or otherwise with the laws of a foreign jurisdiction.
The disclosure requirement has moved in recent years from being a broad po-
litical proposal to becoming an operational element of a number of national patent
systems,307 with further amendments reported that are expected to take effect in the
near future.308 The practical experience that will soon be derived and documented
from the operationalization of this emerging – if closely contested – means of regu-
lating the extraction of value from genetic resources will likely have considerable
impact on the elaboration and acceptance of such measures at the international
plane, whichever forum is preferred to take this work forward: potential impact
range from a relatively minor addition to the paperwork in filing a patent application
to a fundamental recalibration of the equitable and legal basis on which an applicant
can legitimately seek a patent. A continuing, rich debate continues309 as to whether
(from a sceptical perspective)310 – and if so, how best (from a proponents’ perspec-
tive)311 – such a disclosure requirement can promote the attainment of the objec-
tives of the CBD, and whether its role should be directly legally to enforce those
objectives, whether it should serve a transparency and monitoring role, or both.
2. CBD Bonn Guidelines
Since the conclusion of the CBD, and the adoption of its broad principle
concerning the equitable sharing of benefits, debate has continued over how to
assess what is ‘equitable’, how the principle should be implemented, and how it
should be legally enforced, including at the international level. The proposals for
tailored disclosure requirements in patent law have, for example, been bruited as
a means of providing a legal safeguard that benefit-sharing obligations have been
met. At the same time, the COP has acknowledged the limitations of developing
countries’ capacities to give effect to their entitlements under the COP to exercise
307 For example, Brazil, India, South Africa, Sweden, and Norway; see discussion above in
Section III.2.III.3.(b)(dd)(2).
308 For example, proposed amendment to the Chinese Patent Law, .see discussion above in
Section III.2.III.3.(b)(dd)(2).
309 See for instance Note prepared by the Secretariat, ‘The TRIPS Agreement and Convention on
Biological Diversity. Summary of Issues Raised and Points Made’. IP/C/W/368/Rev.1,
(revised 8 February 2006).
310 Communication from the United States, ‘Art. 27.3(b), relationship between the TRIPS
Agreement and the CBD, and the protection of traditional knowledge and folklore’, WTO
document IP/C/W/449 (10 June 2005), and Communication from the United States, ‘Art.
27.3(B), Relationship Between the TRIPS Agreement and the CBD, and the Protection of
Traditional Knowledge and Folklore, WTO document IP/C/W/469 (13 March 2006).
311 Communication from Bolivia, Brazil, Colombia, Cuba, India and Pakistan, The Relationship
between the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the
Protection of Traditional Knowledge: Technical Observations on the United States Submis-
sion IP/C/W449 WTO document IP/C/W/459 (18 November 2005).
282 Antony Taubman
sovereignty over their genetic resources. This led to the development of the
non-binding Bonn Guidelines,312 and their adoption by the COP in 2002.313 The
Guidelines do not specify predetermined formulae on ‘equity’ in benefit-sharing,
reflecting the diversity of possible access and use scenarios and of benefit-sharing
methodologies. Rather, the Guidelines focus on the procedural aspects of equity
in benefit-sharing, seeing the sharing of benefits in terms of a process as much as
a stand-alone ‘deal’. The emphasis is on appropriate consultation mechanisms and
the involvement of all stakeholders to ensure the prior informed consent of
providers of genetic resources, and clarifying the respective roles and responsi-
bilities of users and providers. Guidance is provided on the essential elements of
mutually agreed terms, on incentives, accountability and monitoring and dispute
settlement.
The Bonn Guidelines clearly call for careful review of the IP implications of
access and benefit sharing during the establishment of mutually agreed terms,
strongly implying that the dispensation of IP derived from access should not be by
default, but should be explicitly settled during the prior informed consent process.
Thus, ‘guiding parameters in contractual agreements’ or ‘basic requirements for
mutually agreed terms’ include the use of IP relating to ‘joint research, obligation
to implement rights on inventions obtained and to provide licences by common
consent’314 and the ‘possibility of joint ownership of intellectual property rights
according to the degree of contribution’.315 Material transfer agreements should
address, under the rubric of access and benefit-sharing provisions, the question of
‘[w]hether intellectual property rights may be sought and if so under what
conditions’ and should clarify the legal situation as to the ‘[a]ssignment, transfer
or exclusion of the right to claim any property rights, including intellectual
property rights, over the genetic resources received through the material transfer
agreement’.316 The potential forms that benefit-sharing could take are identified as
including as both a monetary and a non-monetary benefit, the joint ownership of
relevant IP.317 Benefits may also include, in line with the CBD text, access to
relevant technology potentially covered by IP:
[t]ransfer to the provider of the genetic resources of knowledge and

technology under fair and most favourable terms, including on conces-
sional and preferential terms where agreed, in particular, knowledge and
technology that make use of genetic resources, including biotechnology,
312 Secretariat of the Convention on Biological Diversity, Bonn Guidelines on Access to Genetic
Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization,
2002, Montreal: Secretariat of the Convention on Biological Diversity.
313 See CBD COP Decision VII/19.
314 Bonn Guidelines, 43(c).
315 Bonn Guidelines, 43(d).
316 Bonn Guidelines, Appendix I, Suggested elements for material transfer agreements.
317 Bonn Guidelines, Appendix II, Monetary And Non- Monetary Benefits.
or that are relevant to the conservation and sustainable utilization of
biological diversity.318
The public policy context and transparency function of the IP system is also
stressed, with an invitation to CBD Contracting Parties to consider
[m]easures to encourage the disclosure of the country of origin of the

genetic resources and of the origin of traditional knowledge, innovations
and practices of indigenous and local communities in applications for
intellectual property rights319
reflecting the continuing interest in disclosure requirements in patent law as a

means of promoting or enforcing both transparency and compliance with benefit
sharing obligations. National monitoring of benefit sharing accordingly may
include surveillance of ‘applications for intellectual property rights relating to the
material supplied’.320
The Bonn Guidelines tread the pathway between a soft law instrument,
interpreting the CBD provisions on prior informed consent and benefit sharing or
at least situating them in a practical context, and capacity building – providing a
checklist of options and distilled best practice procedures for consultations on
access and benefit sharing and the development of detailed national regulations.
3. CBD International Regime
With the Bonn Guidelines recently adopted, the World Summit on Sustainable
Development321 issued a call in 2002 to
negotiate within the framework of the Convention on Biological Diver-

sity, bearing in mind the Bonn Guidelines, an international regime to
promote and safeguard the fair and equitable sharing of benefits arising
out of the utilization of genetic resources.
The CBD COP subsequently established a negotiation process, undertaken

through the Ad Hoc Open-ended Working Group on Access and Benefit-sharing,
on the elaboration of an international regime on access and benefit sharing, which
would supplement the more general requirements of the CBD, or ‘to effectively
implement the provisions of Article 15 and Article 8(j) of the Convention and the
three objectives of the Convention’.322 The COP decision amounted to a
recognition that the CBD was indeed a framework convention in need of more
318 Ibid.
319 Bonn Guidelines, 16(d)(ii).
320 Bonn Guidelines, 55.
321 Plan of Implementation adopted by the World Summit on Sustainable Development,
Johannesburg. (September 2002), para. 44 (o).
322 CBD Decision VII/19 on access and benefit-sharing.
284 Antony Taubman
detailed normative guidance for the full attainment of its objectives, although it
was not settled whether or not the regime (‘instrument/instruments’) should
constitute binding international law. The COP established terms of reference for
the negotiations, covering the process, nature, scope and elements for consider-
ation in the elaboration of the regime. The eighth COP323 requested the Working
Group ‘to continue the elaboration and negotiation of the international regime’
and instructed it to complete its work before the tenth COP, which is scheduled for
2010. A draft document, entitled International Regime on Access and Benefit-
Sharing, sets out the range of views held by Parties at the fourth meeting of the
Ad Hoc Open ended Working Group) and was submitted to the fifth meeting of the
Working Group for the purposes of continuing to elaborate and negotiate the
international regime in accordance with the COP decision, as well as, inter alia,
the following inputs for the elaboration and negotiation of an international regime:
(a) the outcomes of the group of technical experts on the certificate of
origin/source/legal provenance; (b) a progress report on the gap analysis, and the
matrix, and (c) other inputs submitted by Parties relating to access and
benefit-sharing.324 This international regime, once concluded, is expected to have
significant impact on the practical operation, and to some extent the legal basis,
of the intellectual property system as it applies to genetic resources, although as
noted above the text remains in a dynamic state and the final contours are yet to
be established.
4. FAO: Standard Material Transfer Agreement
The entry into force of the FAO ITPGRFA on 29 June 2004 triggered the treaty
requirement to develop and to agree upon a standard material transfer agreement
(SMTA) that would cover all accessions to plant genetic resources under the
multilateral system created by the treaty. The SMTA has since been negotiated by
a contact group325 and adopted by the treaty’s Governing Body,326 therefore
forging not merely a key tool required for the effective operation of the
multilateral system ‘both to facilitate access to Plant Genetic Resources for Food
and Agriculture and to share, in a fair and equitable way, the benefits arising from
the utilization of these resources, on a complementary and mutually reinforcing
basis’, but also establishing an authoritative benchmark for access and benefit-
sharing generally relating to plant genetic resources. The SMTA also provides
significant glosses on the terms of the treaty that have bearing on the use of
intellectual property rights.
For example, the Treaty criterion triggering the obligation to pay an equitable
contribution from commercialization of a derivative product, whether the product
is ‘available without restriction to others for further research and breeding’, (see
discussion on the Treaty above), is clarified to cover ‘when it is available for
323 Convened in Curitiba, Brazil, (20–31 March 2006).

324 UNEP/CBD/COP/8/31 (15 June 2006).
325 Contact Group for the Drafting of the Standard Material Transfer Agreement.
326 Governing Body of the Treaty, Resolution 1/2006 (16 June 2006).
research and breeding without any legal or contractual obligations, or technologi-
cal restrictions, that would preclude using it in the manner specified in the Treaty’.
In other words, the restrictions are not limited to intellectual property rights, but
may include other constraints, such as restrictive licensing conditions on the
product, or genetic use restriction technologies that restrict further breeding from
the product. The notion of a ‘product’ relevant to this obligation is clarified to
indicate that incorporation of introduced material may be evidenced by ‘pedigree
or notation of gene insertion’, a key practical question in monitoring compliance.
The SMTA provides that access to plant genetic resources for food and
agriculture protected by intellectual and other property rights shall be consistent
with relevant international agreements, and with relevant national laws, and that
the provider ‘shall periodically inform the Governing Body about the Material
Transfer Agreements entered into’.
The recipient is required to undertake that accessed Material ‘shall be used or
conserved only for the purposes of research, breeding and training for food and
agriculture. Such purposes shall not include chemical, pharmaceutical and/or
other non-food/feed industrial uses’ and, in line with the Treaty, that they ‘shall
not claim any intellectual property or other rights that limit the facilitated access
to the Material provided under this Agreement, or its genetic parts or components,
in the form received from the Multilateral System’.
The SMTA fixes a standard benefit-sharing royalty as ‘one point-one percent
(1.1 %) of the Sales of the Product or Products less thirty percent (30%)’ but
excepts from payment products that are ‘available without restriction’ in the terms
of the Treaty, have been purchased or obtained from another party who has
already paid the royalty or is exempt from payment, or ‘are sold or traded as a
commodity’.327 Recipients are obliged to submit an annual report setting out
relevant sales and payments due, as well as ‘information that allows for the
identification of any restrictions that have given rise to the benefit-sharing
payment’. (This may include information on relevant IP, for example.) As an
alternative, a discounted rate of 0.5 per cent is available for renewable periods of
ten years.328 This payment would be based ‘on the Sales of any Products and of
the sales of any other products that are Plant Genetic Resources for Food and
Agriculture belonging to the same crop’ as the material provided, whether or not
whether or not the product is available ‘without restriction’ in the Treaty sense.
This discounted royalty becomes closer to a general levy to support the
multilateral system, and corresponds in a concrete way to the requirement in the
Treaty that recipients be ‘encouraged’ to make payments even when not relevantly
restricting access to their products.
Apart from its operational significance, the SMTA is an important develop-
ment as it sets the most tangible and authoritative benchmark so far for what is
considered an equitable level of benefit sharing – either access to technology
resulting from the permitted use of the resources, or a royalty rate on sales at the
327 SMTA, Annex 2.

328 SMTA, Annex 3.
286 Antony Taubman
scale of 1per cent. The multilateral benefit-sharing arrangement is sui generis in
character and linked to a very specific form of downstream use of a genetic
resource, but nonetheless this may be expected to set expectations for equitable
returns from other forms of downstream use of genetic resources. Moreover, the
high rate of accessions of such genetic resources is likely to lead to many more
cases of practical benefit-sharing than has been evident under the CBD, although
the product development cycle (such as the development of a new genetically
modified crop making use of resources accessed in accordance with the SMTA)
cannot be expected to yield an eligible ‘product’ (in the terms of the Treaty) for
several years at least.
5. WIPO – Guidelines on Access and Benefit-sharing
The CBD requires that ‘[a]ccess [to genetic resources], where granted, shall be on
mutually agreed terms’.329 Mutually agreed terms are typically contracts or permit
systems that help to establish the equitable sharing of benefits from the utilization
of genetic resources. Mutually agreed terms may need to deal with IP issues – for
instance, on the dispensation of derivative IP as an aspect both of sharing of
monetary benefits, according to the CBD Bonn Guidelines (Appendix II),330 and
of sharing non-monetary benefits.331 The CBD COP has encouraged
the World Intellectual Property Organization to make rapid progress in

the development of model intellectual property clauses which may be
considered for inclusion in contractual agreements when mutually agreed
terms are under negotiation.332
Work has proceeded in the Intergovernmental Committee on Intellectual Property

and Genetic Resources, Traditional Knowledge and Folklore on this question, but
rather than concentrating on model clauses, the approach has rather been to
promote awareness of the range of choices that have been undertaken in actual or
in model mutually agreed terms, through an electronic database, and then to draw
together this range of empirical data in the form of guide practices on IP questions
for access and benefit-sharing agreements were prepared. The database itself is
increasingly used as a practical capacity building (non-normative) tool.
The most recent draft on guide practices, entitled ‘Genetic Resources: Draft
Intellectual Property Guidelines for Access and Equitable Benefit-Sharing’,333
noted
329 Art. 15.4 CBD.

330 See Items 1(j) in the catalogue of Monetary Benefits listed in Appendix II of the Bonn
Guidelines.
331 See item 2(q) of Appendix II, Bonn Guidelines.
332 See Decision VI/24C, Convention on Biological Diversity, para. 9.
333 WIPO/GRTKF/IC/7/9.
that the terms of access to genetic resources may include a requirement
not to take out IP at all on derivative research, or an obligation to consult
with the resource provider in the event of potential IP activity, and may
structure ownership and management of any agreed resultant IP in a
range of different ways, including co-ownership between access provider
and resource user and different mechanisms for ensuring access to
technology and other equitable benefits.
The WIPOIGC agreed on four principles that require the draft guidelines to:
– recognize, promote and protect all forms of formal and informal human
creativity and innovation, based on, or related to, the transferred genetic
resources;
– take into account the sectoral characteristics of genetic resources and
genetic resource policy objectives and frameworks;
– ensure the full and effective participation of all relevant stakeholders and
address process issues related to contract negotiation and the development
of IP clauses for access and benefit-sharing agreements, including TK
holders; and
– distinguish between different kinds of use of genetic resources, including
commercial, non-commercial and customary uses.
As the Bonn Guidelines illustrate, there is a continuum between soft norm-setting

and capacity building for those implementing and using national regulations on
benefit-sharing. Recalling that the requirement for equity in benefit-sharing
includes a procedural aspect – the right of prior informed consent as a form of
equitable safeguard, for instance – even the practical strengthening of capacity to
review, analyse and exercise options in the choice of benefit-sharing arrangement
has normative implications – giving effect to the ‘informed’ component of prior
consent. Nonetheless, the WIPO Draft Intellectual Property Guidelines for Access
and Equitable Benefit-Sharing need to operate within the normative space already
established by existing legal and soft-norm instruments. The guidelines therefore
appear to be directed more towards the capacity-building end of the spectrum than
towards establishing substantive norms. Even so, in working within the existing
normative framework, they received some criticism for their apparent endorsement
of the bilateral construction of benefit-sharing arrangements rather than favouring
multilateral substantive standards,334 reflecting a broader line of criticism of the
CBD framework and the Bonn Guidelines by those concerned that bilateral
deal-making may be inherently inequitable without a stronger substrate of
334 See for example WIPO Intergovernmental Committee, Report of the Seventh Session,
document WIPO/GRTKF/IC/7/15 (10 June 2005): ‘However carefully any model contract is
drafted, however ardently such contracts try to correct the huge imbalance between the
provider and the user, such an approach simply cannot lead to anything even remotely
resembling a fair and equitable regime ‘. (Delegation of India, at p. 91).
288 Antony Taubman
normative expectations as to the substantive, distributive aspect of equity – in
other words, procedural equity is considered insufficient, contrary to the libertarian
view of justice.335
V. CONCLUSIONS
The notion of ‘equity’ over the benefits from access is the quintessence of the
debate over IP and genetic resources, and is the implicit or explicit goal in the
search for legislative and other legal responses to the rapidly evolving techno-
logical capacity to extract commercial and other benefits from genetic resources.
The development of modern biotechnology, and above all the sense that its
benefits were inequitably reserved for rich countries, has arguably been the
principal motive for the formulation of genetic resources as a national asset,
subject to national sovereignty. Kloppenburg’s prediction that concerns about
inequitable distribution of benefits of and access to new technologies would lead
to genetic resources in the agricultural domain being reconceived as a ‘form of
national property’ has amply been borne out in relation to his immediate subject,
the seed. But the same development was apparent for the broader sweep of genetic
resources, such as the biodiversity that is to be conserved under the CBD: the
architecture, the normative essence, of that treaty is that the perception of
inequitable returns to the original custodians (including no benefits at all) from the
downstream extraction of value from genetic resources would negate any
incentive to conserve biodiversity in the first place and to use its components
sustainably – this logic binding together the triple objectives of the treaty.
The concept of ‘equity’ is central to the debate, but is typically invoked in
very broad terms that may simply beg the question of what test, or what standards,
are to apply. For instance, the UK Commission on IP rights simply states that the
‘principle of equity’ dictates that no one should benefit from an IP right ‘based on
genetic resources . . . acquired in contravention of any legislation governing access
to that material’.336 In practice, the bid to attain equity has taken on diverse shapes
and forms, ranging over the articulation of broad normative statements with an
aspirational hue, coercive legal mechanisms built into the patent system, and
practical capacity building measures to ensure that prior consent truly is
‘informed’.
However, two broad aspects of equity are identified: fairness of process
(procedural equity), and fairness of outcome (distributive equity). Both aspects of
equity are reflected in the international treaties reviewed in this chapter, which
establish prior informed consent (PIC) as a procedural safeguard, and equity of
outcome in the form of equitable sharing of benefits arising from access to and
research on GR. Equity is broadly an element of international law in itself, one

Development Policy, (2002), 87.
of the ‘general principles of law recognized by civilized nations’,337 and may also
serve as a guide for the application of international law.338 PIC over access to
genetic resources is arguably already an international equitable principle, as an
equitable safeguard against unfair consequences of the assumption that genetic
material has public domain status.339 Addressing the use of genetic resources in
biotechnology, the CBD requires ‘all practicable measures to promote and
advance priority access on a fair and equitable basis by Contracting Parties,
especially developing countries, to the results and benefits arising from biotech-
nologies based upon genetic resources provided by those Contracting Parties;’ this
access ‘shall be on mutually agreed terms’.340
These treaty provisions concern, in principle, the reciprocal obligations and
expectations of states as actors within the international legal system, but in
practice the attainment of this fair and equitable access has been assessed with
particular reference to patenting trends under national laws. The choice of national
authorities to grant a patent in their own jurisdiction is argued to be a violation of
a foreign nation’s sovereignty over its GR/TK; even by contrast with the WTO
TRIPS Agreement, which has been widely critiqued as a force for globalizing
intellectual property (IP) standards, there can be no more telling instance of the
globalization of IP and the multi-jurisdictional character of perceived interests in
knowledge resources than the widespread protest against the patenting in one
country of inventions derived from the genetic resources of another.
Patenting of inventions based on GR under municipal patent law has
therefore become a lightning rod for concerns over inequitable misappropriation.
The claim of misappropriation and violation of sovereignty over resources has an
international dimension, with some similarities to past international disputes over
the exploitation of resources. The patenting process may also become an equitable
fulcrum, a locus for remedying claimed inequities in access to and use of GR: this
prospect has led to specific amendments to patent law in some countries and
proposals for international patent law reform, steps which may recalibrate the
basis of an inventor’s entitlement to apply for and benefit from patent protection,
and may possibly broaden the equitable basis of patent law and extend the formal
interaction of the patent system with a broader legal, policy and ethical
environment. Ideas of equity range from the relatively technical procedural
question of whether a patent should be enforceable if it was obtained by
337 Statute of the International Court of Justice, Art. 38; See also Justice Margaret White, ‘Equity
– A General Principle of Law Recognised by Civilised Nations?’ Vol 4 No 1 QUTLJJ, at 103.
338 ‘A sharp division between law and equity, such as prevails in the administration of justice in
some States, should find no place in international jurisprudence . . . [w]hat are widely known
as principles of equity have long been considered to constitute a part of international law, and
as such they have often been applied by international tribunals’ (Separate Opinion of Hudson
J. in The Diversion of Water from the Meuse, PCIJ Rep. ser A/B, no 70 (1937), at 76–77; see
also, for example, the invocation of equity as a basis for dispute settlement in the United
Nations Convention on the Law of the Sea (1982), Art. 59.
339 See CBD, Art. 1, 3 and 15 in particular.
340 CBD, Art. 19 (‘Handling of Biotechnology and Distribution of its Benefits’), para. 2.
290 Antony Taubman
inequitable conduct, to a broader sense that the patent system should be used to
police distributive equity in the allocation of benefits derived from GR.
‘Equity is a roguish thing’,341 long questioned for its subjectivity and
unpredictability; it can be construed as a resort to value judgments over the letter
of the law. In its most general application, the ‘principle of equity’ is invoked as
an appeal to good conscience, to fairness, to privilege a broad sense of what is
right over the strict application of the law; it restores the rightness of legal process
when literal conformity with the law may offend an inherent sense of justice. One
venerable equitable maxim states that one ‘who comes to equity must come with
clean hands’.342 It has long been understood that if one is fairly to derive benefit
from the patent system, one should deal with the patent office and enforce a patent,
with clean hands; acts such as fraud on the office and other forms of misrepre-
sentation may lead to the denial or loss of a patent altogether.343 These are general
provisions, covering any patent applicant; but the suggestion has been made that
specific equitable safeguards are needed when GR/TK is used in research. It is
suggested in particular that a doctrine of fraudulent procurement or unclean hands
might compel life sciences researchers to disclose the source of GR/TK used in
developing an invention and to obtain PIC for this use of resources.344
This chapter has discussed how genetic material is defined as containing
‘functional units of heredity’.345 This same quality – the ready propagation of
genetic material – also provokes distinct and challenging issues in assessing the
equitable implications of access and extraction of value from the resources. A
single act of access to genetic material can capture the functional units of heredity
that define it as genetic; for instance, a single sample of genetic material may
enable the researcher to establish a self-sufficient cell line. The actual, potential
and perceived value of genetic resources has increased just as biotechnology
opens up new forms of utilizing resources, but it remains difficult to make an
objective assessment of the value of resources – in an economic or technological
sense – at the point and time of initial access or transfer. This is one, particularly
teasing, impact of technological advances in the life sciences – it enhances the
objective value of GR, but can influence their perceived value at a still higher rate,
and thus precipitates a recalibration of expectations of fair allocation, and in turn
the balance of legitimacy and equity in the practice of biotechnology and the
exploitation of these resources.
341 John Seldon: ‘Table Talk’, Richard Milward, (ed.) (1689), cited in J. Bartlett,‘, p. 263 (15th
ed. 1980).
342 For example Jill Martin, Hanbury and Martin: Modern Equity, (2001), p. 28.
343 For example in United States law, 37 C.F.R. 1.56 ( ‘no patent will be granted on an application
in connection with which fraud on the Office was practiced or attempted or the duty of
disclosure was violated through bad faith or intentional misconduct’); in Australian law
(Patents Act 1990, 138(d), ground for revocation include ‘that the patent was obtained by
fraud, false suggestion or misrepresentation ’).
344 Nuno Pires de Carvalho, ‘Requiring Disclosure of the Origin of Genetic Resources and Prior
Informed Consent in Patent Applications Without Infringing the TRIPS Agreement: The
Problem and the Solution,’ 2 Wash. U. J.L. & Pol’y 371 (2000), 399-400.
345 CBD Art. 2.
This impact of technology on perceived equities, and the extensive flow of
genetic resources between societies and jurisdictions, taken together make it
highly desirable to establish an international and cross-cultural dispensation that
is widely seen and accepted to be equitable. But diverse value systems and
different legal rights and interests intersect, overlap, abut and conflict, rendering
complex and elusive any form of perceived fairness and equity in the allocation
of the value appropriated through research. Source communities and individu-
als346 naturally attach high value to their GR, and this ‘value’ goes well beyond
immediate economic exchange value and technological utility; it extends to an
expectation that the inherent worth of GR be recognized, as an end in itself and
as an element of the cultural identity of a community, and the personality of an
individual.347 The call for equity in the dispensation of genetic resources therefore
reaches beyond the specific framework of law and regulation to touch on core
human rights and the essence of our genetic and cultural identities.
346 Moore v. The Regents of the University of California et al., Case No. 51 Cal. 3d 120.
347 Moore, note 346 supra.
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Traditional Knowledge and Genetic Resources

Chapter · January 2008

Ethics of IP View project

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I. FINDINGS AT THE FACTUAL LEVEL

1. Recognizing the Characteristics of Traditional Knowledge

S. von Lewinski (ed.), Indigenous Heritage and Intellectual Property, 59–180.

the content or substance of knowledge resulting from intellectual activity

In surveying the main sources of factual information regarding TK, it is important

– TK conceived of simple information drawn from a traditional source –

The current controversies over misappropriation, misuse and appropriate and

– Name and address of the custodian of TK or associated biological/genetic

21 Technical Proposals to the WIPO Intergovernmental Committee on IP and Genetic Resources,

– Clarifying and reframing IP discourse: it is noteworthy that needs and

Indigenous communities have since reinforced the understandings conveyed in

24 Representative of the Tulalip Tribes, WIPO Intergovernmental Committee on Intellectual

The increasingly powerful voice of TK-holding communities in IP policymaking

3. Terms and Definitions

(a) the choice of an appropriate term or terms;

(bb) Addressing Indigenous Knowledge in Particular

A significant choice in terminology, a matter with major policy and legal

39 See document WIPO/GRTKF/IC/9/11: Republic of South Africa: Indigenous Knowledge

(b) Subject Matter to be Covered: Characterizing Traditional

(aa) Holistic Approach

The second step identified above is to describe or characterize the nature of TK

all tradition based (i.e., generally developed on the basis of transmission

(cc) Self-Referential Aspect of Defining TK

In view also of the growing salience of TK in many public policy debates, it is

51 FAO ITPGRFA, fn. 14 supra.

(dd) The Role of a Definition of TK

Following a review of approaches taken to terminology in other areas of IP, one

(i) while illustrative or descriptive characterizations of “traditional knowl-

60 See Gibson, fn. 43 supra.

From an intellectual property policy perspective, it is necessary to be clear about

62 WIPO/GRTKF/IC/3/9, fn. 34 supra, para. 12.

The essential characteristics of traditional knowledge are its linkage with a

to the content or substance of knowledge resulting from intellectual

65 Fikentscher/Ramsauer (fn. 4 supra), p. 31.

The approach is not dispositive of what actual protection would be afforded,

(c) Scope of Legally Protected TK

69 See Draft WIPO TK provisions, fn. 2 supra, Art. 3.2.

(i) generated, preserved and transmitted in a traditional and intergenera-

These elements of a definition of protectable TK are based on the experience of

TK might be integral to the identity of an indigenous or traditional

71 Draft WIPO TK provisions, fn. 2 supra, p. 22.

4. TK and IP Protection in an Holistic Context

Clarifying ideas of ownership and custodianship – first conceptually, then legally

5. Needs and Expectations for the Protection of Traditional

76 Dutfield (fn. 58), p. 62.

– positive protection, or the creation or recognition of positive rights over

A typical – but by no means universal – experience is for TK holders first to call

(a) Positive Protection

Positive protection may entail the use of:

– IP rights (whether rights recognized under the conventional IP system or

WIPO surveys of existing forms of IP protection for TK illustrated a wide

– more effective, equitable and culturally appropriate access to existing

willful offensive use of traditional knowledge of particular moral or

(b) Defensive Protection