Journal of Intellectual Property Rights

Vol 6 Janu aIY 2001 pp 1-17

IPR Issues in Biotechnology in the Context of

Developing Countries and India*

Prasanta K Ghosh! and Terala V Ramanaiah

Department 0/ Biotechnology, MiJlistry 0/ Science & Technology
CGO Complex, Lodi Road, New Delhi 110003

(Received 27 July 2000)

Intellectual Property Rights (IPR) on inventions in biotechnology may become a

controversial topic of discussion in the coming years, as such inventions cut across
issues related to science an d technology policies , ethics and economics. These issues
are directly related with the complexities of international trade. India would have to
be in conform ity with the provisions of World Trade Organization (WTO) on IPI( in
biotechnology inventions. 1l1is would requ ire amending the present Indian Patents
Act as also enacting provisions for th e protect ion of plant varieties, besides ensuring
the protection of biological goods linked with geographical indications. The position
of many developi ng coun tries wou ld be similar to India. The future years wo uld
witness how the developing countri es would deal with th e definiti ons of patentable
microorgan isms, protection of other living substances, distinctions between discov-
eri es and invention , ethical issu es in biological inventions, and in the provisions for
making deposits [or patentable biological materials. Genetic resources are the prop-
erties of the sovereign States to which they are indigenous. future accessions of such
resources wo uld require co nsent from th e Slates. The Convention on Biological
Diversity (CI3D) promulgates ensuring conservation and sustainable use of biological
diversity, and fair and equitable sharing of benefits from their utilization. Supply and
exchange of biological materials are expecled to move across the national bound aries
through the material transfer agreements on the basis of authorized, mutually agreed
terms among States, and subject to authorized prior consent. Consequently, access
legislation and access authori ty for genetic materials of States would be in the making
for all the CBD member countries.

'Views expressed in the paper are those of th e authors and they do not necessarily ex pr~ss the view of th~
organization to which the authors belong.
!ColTesponding author: e. mail address: pkghosh@dbl.nic. in/ gprasa ota@hot:mail. col1l
2 J INTELLEC PROP RIGHTS, J ANIJA1~Y 200 1
IPR and their protection in biotechnology
through patenting or through other interna-
tionally acceptable laws is presently a sub-
ject matter of discussion at the nation al and
inte rnational circles. Several issues are in-
deed complex. The laws of protection of
biotechnological inve ntions in diffe re nt
countries are differe nt and are not yet uni-
form. Mem ber countries of WTO are to
amend th eir IPR laws to be in co nfo rmity
with th e minimum provisions co ntain ed in
the Trade- Related Intell ectu al Prope rty
Rights (fRIPS) of WTO within a specified
period. The inventions in biotec hnol ogy cut
across issues related to science and techn ol-
ogy policies, ethics and economics, besid es
politics of internation al trad e. Interesting ly,
the expectations of the world co mmunity
from biotechnology are increasing fast. So-
cieties are conce ntrating on th e accrual of
th e potential and th e realizable benefits from
its applications in different facets of usage.
Prese ntly, th e major areas of use have been
th e manufacture of th e therapeutic recomb i-
nant products and the diag nostic devices in
med ical and pharmaceutical sector; the ge-
netically modified (GM) seeds of diverse
properties in agriculture; cl eaner method s of
production of complex fermentation based
mol ecules for indu strial use; and efficient
containment of polluted environment by th e
use of microbial and oth ers livin g biological
consortia. Th e technology would evolve fur-
ther in the coming years to register its use
in many other areas prese ntly unknown.
Public Interest Areas and Indian
Government Initiatives in
Biotechnology
Cost effective solutions to general public
hea lth problems would reduce health-care
costs; th ey would also contribute to society's
having more h ealthy peopl e at a g ive n time.
Bacterial, viral and parasitic diseases pres-
ently contribute to major morbidity an d mor-
tality in Ind ia. With th e rise in stress and
strain in people e manating from rapid indu s-
trial ization, inc reased popul ation growth
and decreased amenities for human h ealth ,
th ere h as also been a signifIcant ri se in sys-
temic ailments such as cardiovascular di s-
eases, diabetes, arthritis, vital orga n fa ilure
and certain types of cancer. In many of th ese
areas, solu tions fo r protection or prolongi ng
life are in sight through biotec h so lu tions.
These includ e developm e nt of vaccin es, fa-
cilities for medical diag nosis followed by
th erapy in complex probl e ms, developm en t
of hum a n-body-co mpatibl e orga ns in an i-
mals, xe notransplantations, developin g nu-
tritious and micro-ingredients e nriched food
and food supplements for childre n and aged
people, clearin g up th e polluted effl uents
a nd naturalizing ope n su rroundings that
have bee n degraded by inCl-eased hum an
activities. In agriculture, of th e various meth-
ods of in creasing production, th e productiv-
ity rise per unit of land use would be most
sig nifica nt in th e coming years. GM seeds
and pla nt cultivars are expected to contrib-
ute sign ifica ntly to raising th e agricultural
production in th e coming years. GM seeds
have al so great potential for producing Ilu tri-
tious food, the technology of which is in the
developm e ntal stage globally.
Th ere is a sb-on g public perception th at pri-
vatization of intell ectual properti es may have
negative impact in all developing countries
on th eir health-care sector followed by con-
cern in regional food security. The food se-
curi ty issue emanates from the control of
productive seeds used in agriculture by mul-
tin ational companies through IPR, accruing
throL!gh th eir high e r capabilities in re-
search. Towards these two e nd s partic u-
larly, efforts should be made by India, bein g
 GHOSH AND RAMANAIAH : IPR ISSU ES IN I3IOTEC HNOLOGY ...
th e found er memb er of WTO 1 to shape th e
Indian policies to be consistent with th e pro-
visions of WTO and yet avail of maximum
opportunities for th e people of th e country in
global trad e-related aspects. As India is also
a sig natory to CBD 2, it should e nsure fair
and equitable sharing of th e benefits ari sin g
from th e use of its biodiversity. It should
furth e r adop t m ea ns for acc ruin g a nd
achi eving th e rights of its indigenous and
traditional people through newer means of
IPR legislation for technology transfer in
th ese areas. Th e policies to be adopted
would have to e nsure co nservation as well as
sustain abl e use of reso urces besid es ensur-
ing th eir fair and equitable sh arin g, in ord er
to be consistent with th e provision s of CBD .
Use of genetic biodivers ity sh ould result in
th e generation of intellectu al properties that
should be exploi ted in ord er to provide reve-
nu es to th e country .
Rea li zin g th e pote nti als of bi otechn ology
and its relevance to th e needs of th e people,
th e Gov e rnm e nt of Indi a, pa rti c ul a rl y
through th e Department of Biotechn ology
(DBn of th e Ministly ofScie nce & T echn ol-
ogy, have put strong emph asis on th e devel-
opm ent in all facets of biotechn ology by
allocating fund s for th e generation of skill ed
manpower, setting up of expensive R&D in-
frastru cture, providin g R&D supports for so-
phisticated research in all th e relevant areas,
supporting e ntrepreneurs for setting up
biotech industries through statutOlY proce-
dures and by formul ating policies conducive
to th e faster public and private sector invest-
me nts in biotechnology in th e country. Th e
DBT had spent~ Rs 8.01 billion during the
period 1987-88 to 1997-98 for th e develop-
me nt of a\l aspects of biotechnology in th e
country. Th e expenditure on 1~& D out of thi s
was 65.7%, that for infrastru cture and in stitu-
tional developme nt was 25.6%, while on th e
human resource developme nt it was 8.7%.
Expenditure during th e sa me period by all
oth er agencies including th e private sector
was about Rs 0.35 billion . Th e total expendi-
ture by th e country on biotech developm e nt
was th erefore about Rs 8.36 billion, which is
consid ered sizeabl e, compared to the expe n-
diture made in this area by many oth er de-
veloping countries.
Unprotected Intellectual Property
Protection of invention s throug h pate nting
or through oth er suitabl e method s is consid-
ered to be important in strum e nts for inn ova-
tio n a nd indu s tr ial d eve lopm e nt. Th e
segments, namely th e governm ent, the in-
du stlY, th e R&D in stitutes includin g th e uni-
versities, th e political syste m and th e public
are to work togeth er to assist any countIy to
frame laws relating to th e protection of in-
du stri al property to strike a balance betwee n
privatization of invention s to reward th e in-
ventors, and concurre ntly to provid e protec-
ti on to public inte rest fac tors whi c h in
certain situ ation s should be of paramoun t
importance and should take domin ance over
inve ntors'interest. All inventions cann ot be
or should not be protected du e to various
reaso ns such as strategic consid erations (in-
vention related to countries' defence, etc.)
or du e to oth er reaso ns such as tho se areas
which are contralY to morale or ethics (in-
vention related to hum an body, cru elty to
animals , etc.) . Reaso ns for categori zation of
such areas vaIyfrom country to co untlY, and
cann ot be universalized . Moreover, coun-
tri es usually make differe nt degrees of di s-
tin c tion s b e tw ee n di sc ov e ri es a nd
inve ntions. Generally, all countries exclud e
from patenting, th e di scoveries of scientific
th eori es and laws, methods of peIiorming
mental acts, all kinds of magic, mere discov-
ery of natural products and processes, pro-
4 J INTELLEC PROP RI GHTS, JANUA RY 2001
duction of new substances by using essen-
tially biolog ical processes, aesth etic crea-
tion s, carrying on or peJiorm ing busin ess by
variou s complex but innovative methods,
and us ually all nove] processes th e applica-
tion s of which produce better or econ omi-
ca lly mor e valuabl e livin g obj ec t s .
Presently, during th e last 18 years or so,
som e countri es have includ ed patenting of
many of th e earlier exclud ed patentable in-
vention such as pate ntin g of microorgan-
is ms, animals and plants. Th e scopes of
eth ics and morale have also been narrowed
down con sid erably. Not all co untries have
yet taken a un iform position, althoug h mi-
croorgani sms are c urre ntly patentabl e in
ma ny co un tries, plant vari eti es are patent-
able or protectable under sui generis sys-
tems and anim als are patentabl e in so me
countri es. Th e source materi als for many
bio tec h inv e ntion s a r e th e g e n e tic r e-
sou rces, which had been freely availabl e to
countries before the introduction of CBD.
M a ny s uch m ateri als h ad fr ee ly mov ed
across th e coun tri es in th e past. Th e ir pos-
session by countri es th at are non-indige-
nou s to such materials is neither illegal no r
can laws be enac ted to bring th em retrospec-
tively und er th e principles of sovereig nty .
wro and Transition Period for
Enactment
With th e introduction and adoption of th e
provision s of th e WTO in April 1994, sig na-
tory co untri es had agreed to e nact th e provi-
sion s of WTO within a period of tim e (5 to
10 years from 1 Janu ary 1995) so as to en-
abl e th e world communi ty to harmoni ze the
IPR protection laws. Th e developing co un-
tries, which do no tcun-ently provid e product
patenting as in India, will have an addi tional
tran sition period of 5 years to apply these
provision s .
Minimum Provision for IPR
Protection under wro and
Existing Indian Laws
Th e seven areas of IPR und er TRIPS are
tra dema rk s, trad e secr ets, indu s tr ial de-
signs, copyrig hts, integrated c ircui ts, geo-
graph ical indications and patents. In th e
fi rst six areas, Indian laws, regul ation s, ad-
mini s trative procedures and judic ial sys-
tems are consistent and are at par with th e
rest of th e world; th e norm s of enforcement
and protecti on propo sed in VITO ar e in con-
fo rmity with the Indian system. In th e last
area, namely in issues related to patents ,
Indian laws are , however, sub stantia lly dif-
fere nt from th e provision s of WT O 1n th e
fo llowing way: 4
(i) WTO provid es product pate nts in all
branch es of technology while Indian
patents system do es not provid e prod-
uct patents in drugs, foo d and ch e mi-
ca ls, but provid es o nl y p rocess
patents.
(i j) WTO would g rant patent for any in-
ve ntio n (wh e th er produ cts or proc-
esses) in a ll fie ld s of tec h no lo gy
provid ed th ey are new, involve an in-
ventive step (non-obviou s) and are ca-
p ab le of indu s tri a l a ppli ca ti o n s
(u seful), but provid e fl exibility for ex-
clusion from patentability in areas like:
(i) diag nostic, th erapeu tic and s urgica l
methods for th e treatm e nt of humans
and animals; (ii) plants; (iii) an imals;
an d (iv) essenti ally biolog ica l proc-
esses for th e productio n of pl ants or
a nimals.
WTO, however, provid es patents on
microorganism s, and microbiological
processes. In contrast, Indian pa te nt
laws do not allow patenting of any life
 GHOSH AND RAMANAIAH : IPR ISSUES IN BIOTECHNOLOGY ...
form; however, patents based on mi-
crobial processes are permitted.
(iii) WTO requires protection of plant va-
rieties eith er by patents or by an effec-
tive sui generis sys t e m or by a ny
combination th ereof, while at present
there is no system for protection of
plant varieties in India.
(iv) WTO provides 20 years unifo rm dura-
tion for coverage of patent life for all
patents while Indian system provides 7
years for drugs, food and chemicals
and 14 years fo r others.
(v) The burd en of proof in case of infringe-
ment in WTO is substa ntially on the
alleged individu al who infringes while
in Indian system it is on th e plaintiff.
(vi) WTO do es not permit discrimination
between imported and domestic prod-
ucts while accord in g to the Indian law,
importation does not amount to work-
ing of the patent.
(vii) WTO requires providing same advan-
tage, favour, privilege or immunity
granted by a memb er country to the
nationals of any other memb er co un-
try.
(viii) Compulsory licensing is permitted on
merits of each case in WTO, and the
hold er of pate nt will have to be heard ,
but Indian law provides compulsory
licensing in the case of food, pharma-
ceuticals and chemical sector. Inter-
pretation of Indian law implies that
compulsory licensi ng would be freely
available in these sectors.
Convention on Biological Diversity
In accordance with th e provisions of CBD,
the States (sovereig n countries) have rights
over their natural resources and they have
the authority to determine access to their
5
ge netic resources. Article 15 and Article 16
of CBD contain conditions for access to ge-
netic resources, and conditions for access to
an d tran sfer of technology respectively. Ac-
cess to and sharing of biolog ical diversity are
dealt within th e documents of CBD on mu-
tually agreed terms and are subject to prior
inform ed consent, but would be subj ect to
national legislation. Consequently, access
to genetic resources has to proceed by nego-
tiations and it has to decide the form in
which the benefits are to be accrued to the
donor country. Sovereign countri es or na-
tional governments are required to take leg-
islative, administrative or policy measures to
achi eve "access to and transfer of technol-
ogy" between th e recipient and suppli er, for
genetic resources. Obviously such policy
measures would have to deal with private
sector also, as technologies are expected to
be developed more within the ambit of pri-
vate sector than th e public sector. In comply-
ing with these provisions of CBD th erefore,
every sovereign country needs to id entify an
official body that has the au th ority to grant
access to its genetic resources and furth er,
that body has to devise a mechanism for
providing consent. Such m ec hani s m s
would have to be co mpatible so that the
rec ipient country and the provider country
can co me closer for easing the developm ent
of tech nologi es by using natural genetic bio-
diversity, which in its natural form is not
protectable as intellectual property through
th e provisions of IPR. Natural genetic biodi-
versity is not protectable as intellectual prop-
erty of individuals by its mere possession,
under the provisions of IPR of any co untry.
Discussion
The issues before the co untry include th e
stand that would have to be taken on the
di stin ction s between discoveries and inven-
6 J INTELLEC PImp RIGHTS, JANUARY 2001
tions in biological area, the definitions and
the scope of patentable microorganisms, the
scope of patentability or protection of other
living beings like the plants and th e animals,
the conditions of deposition connected with
the patentable inventions involving living en-
tities including viruses, bacteria, fungi, plas-
mids, genes, stretches of polynucleotide
sequences of useful properties, plants, ani-
mal s etc. In many of these issues, the stand
of the wro is also not clear; WTO has not
made any definite recommendations in most
of these facets, and the subject matter is left
to specu lations and conj ectures. The CBD
document has not provided defi nite guide-
lin es for access and exchange of biological
m ater ials among States. Consequently,
CBD Member States would have to frame
their access legislation and would create
th eir biological materials access authority.
Such authorities of States would have to
promulgate terms that e nsure conservation
and sustainable use of biological diversity on
one hand, and fair and equitabl e sharing of
be nefits from their utilization among mem-
ber countries on the other hand.
India is a country, which is philosophically
wedded to the concept of making knowledge
a public property. This has been reflected in
the Indian way of life where th e authors
responsible for many ancient creations and
knowledge have not claimed their owner-
ship or even authorship. This philosophy
has don e well to the country in the long run
by enabling access to such creations and
knowledge to all without discrimination.
Even in the recent times during the last 40
years, while th e whole of industrialized
cou ntri es were busy in the protection and
privatization of inve ntions in the area of liv-
ing objects/substances such as the protec-
tion of plant varieties, patenting of
microorganisms an d animals, such steps
were generally not accepted by th e develop-
ing countries including India. But th ese po-
sitions did not prevent growth in prosp erity
in developing countries, though they were
slower (for various reasons). India, for exam-
ple, was able to increase its food grain pro-
duction significantly by about four times
from the 1953-1954 level by scientifically de-
veloping more productive pla nt cultivars in-
cluding vari et ies a nd hybrids, and by
adopting dwarf plants of wheat and rice in
Ind ian cultivation. The global milk produc-
tion became the highest in India by th e adop-
tion of sc ie ntific t ech niques for the
improveme nt of milching animals. Even in
th e drugs and pharmaceuticals area th ere
had been impressive progress both in the
production of bulk drugs and finish ed for-
mu lations; India becam e the strongest
among th e developing countries in having a
large local base of basic production of the
largest number of bulk drugs. The country
adopted such strategies as to bring in great-
est competitiveness in the market place that
resulted in India's having the lowest prices
of pharmaceutical formulations in the world.
But with th e advancement in th e techn ologi-
cal capabilities resulting in increased indus-
trialization and with changes in international
situations, many countries came together
and became members of WTO, thereby re-
instating their commitments to the IPR as
contained in the documents of \VTO. WTO
encourages privatization of knowledge . T he
prevailing Indian philosophy and practice in
society is just opposite to privatization of
knowledge. Therefore, consistent with In-
dian culture, efforts have been mad e to cre-
ate more room from within the provisions of
WTO to enable India to keep inventions in
biology more in the public domain.
 GHOSH AND RAMANAlAH : IPR ISSUES IN I3IOTECHNOLOGY ...
Microorganisms
TRIPS would require the protection of mi-
croorganisms. T he present Indian Patents
Act does not allow the patenting of any li fe
form; this act will now be modified to extend
its scope to incl ud e the patenting of patent-
able microorganism s.
Microorganisms as per the classical defini-
tions are organisms too small to be visible to
the naked eye; organ isms includ e all th e
living entities, which may be a single cell or
a group of differe ntiated but interd epe nd e nt
cell s. Microorganisms includ e viru ses, bac-
teria, actinomycetes, yeast, fungi and proto-
zoa.
Ordinari ly microorganisms do not include
va ri ous tumours fo rmin g ce ll lin es and
monoclonals and th ese are not natural or-
ga nisms but are produced und er abnormal
stress conditions or under human interve n-
tions. Moreover, most of th e transform ed
cell lines and all the monoclonals are derived
from cell s/tissues of ve rtebrates. Verte-
brates are not co nsidered as mi croorga n-
isms. Therefore, one view co uld be that
whi le considering the amb it of microorgan-
isms the cells an d the tissu es of high er life
forms including vertebrates and non-verte-
brates may be kept out from within its scope.
From th is point of view, th e microorganis ms
would be th e organisms of lower liie form
wh ich ca nn ot be differentiated by naked eye,
that are self- repli cable entities or which rep-
licate via a ho st organism. Microorganisms
would include viruses, sub-viral agents, plas-
mid s, and bacteria including cyanobacteria,
actinomycetes, yeast, fungi and protozoa.
T hey wou ld not include cell lin es ofvertebra l
or other cell lin es origi nating from high er
life forms. They wou ld not also includ e
monoclonals derived from vertebrates.
7
The other view on the microorganisms may
be to include all microbial e ntities that have
self-replicating capacities. Such a definition
wou ld include th e cell lines obtained from
high er li fe fo rm s, including the monoclonals
derived from vertebral cell lin es. In terest-
ingly, such a definition wou ld includ e even
th e plants and animals as microorganisms
up to the ti me the embryos are dividing and
moving towards th e developme nt and differ-
entiation into specific organs, but are small
e nough to be visible to th e naked eye, pro-
vided that the stages up to wh ich th ey may
be so nam ed cou ld be mad e stable by some
method s. Unnatural vertebral cell lin es are
however esse ntially stab le cell lin es. In es-
sence, this view would deny th e exclusions
avai labl e to countri es for th e pate ntin g of
an im a ls and plants und er Article 27 of
TRIPS.
It is suggested therefore that countries
cou ld keep the core issue of defining micro-
organisms away from the scope ofTRlPS in
future discussions of wrO . The defi nition s
cou ld be handl ed in the national laws.
Many countri es have co ns idered natu rally
occurri ng microorgani sms as non -pate nt-
able. But presently the developed countries
including the European Un ion, Japa n and
USA have started sharin g the view that if
naturally occu rrin g substances in cluding
microorganisms are isolated for th e first
tim e in a form or purity that did not occur in
nature, if they were id entifi ed distinctly and
ifth ey had indu strial applications. th en these
wou ld be the s u bj ect matter of paten ts. The
demarcation of the products of nature and
the inventive steps leading to innovative
products not fo und in nature has been de-
molished in such a treatment. Such a treat-
ment of naturally occurrin g su bsta nces do es
not distinguish between "discoveIY" and "in-
vention". Th erefore, instead of imposing
 8 J INTELLEC PROP RIGHTS, JANUARY 200 1
such a treatment on other States, it would be
wiser to hold that it should be left to coun-
tries on how they would like to treat natu-
rally occurring substances. This view is
co nsistent with TRIPS.
Within th e ambit of the provision s of WTO,
th e patentabl e micro orga ni sms cou ld be
considered to be those lhat have been pro-
duced by hum an interventions, where th e
interventio ns are non-obvious and furth er
that they do nol involve an essentially bio-
logica l process. Such mi c roorga ni sms
would no doubt satisfy th e criteria of novelty,
inventive steps and usefuln ess or indu strial
appli cation s. Such patentable microorgan-
is ms may includ e th e transgenic viruses,
sub-viral particl es, plasmids, bacteria, acti-
nomycetes, yeast, fungi, a nd parasites.
They wou ld not include the tumour forming
cell lin es and the monoclonals derived from
vertebrate cell lin e or other cell lin es origi-
nating from hig her life forms.
T h e excl usion criteria for th e purpose of
patenting mentioned to defin e patentable
microo rga nis ms would be helpful to th e de-
veloping co untri es to build innovation s
based on many usefu l cell lin es, which cou ld
be kept in th e public domain by such treat-
ments. Once a microorgani sm is patented,
it would not be publicly available with in th e
protected period, without exploi ting the pat-
e nt.
Naturally Occurring Substan ces
The present Indian Patents Act does not
allow patenting of products per se. Product
patenting is a part of the req uireme nt of
TRIPS. Paten table products mu st satisfy the
criteria of patenting, however.
Natural products isolated from nature are
generally co nsid ered to be th e products of
nature; th eir isolation, id entification, charac-
terizatio n, ind exing and finding their uses
includ ing new use are considered as discov-
eries. There could be arguments in thi s con -
text ra ng ing from how countries would loo k
atth e m from th e simplest case of their "mere
possessio n" to th e co mpl ex steps of applyi ng
hum an ingenuity to isolate th em in pu re
forms that did not exist in nature. Th ere are
no gu idelin es in the docum ents of TRIPS on
treating these issues. Therefore, when eve r
member countries would be adapting to th e
flo or limits of conformi ty of the prov isions of
TRIPS in th e ir national patent laws, it is fo r
them to decid e how they would be looking
at naturally occurring substances. As ar-
g ued earlier, if it is accepted hat th ere: is
wisdom in keeping th e national patents laws
more public fri e ndly, decisions co uld b e
taken to treat all the naturally occurring su b-
stances, howsoever iso lated or processed, to
be kept outside the purview of patentin g on
the arg um ents that such products are mere
di scoveries. All natural products such as
prote ins, g ly co -prote in s, lipid s, p hos-
phol ipids , fats and oils, carboh ydrates, si m-
pl e chemicals, agro-ch e mical s, g la ndul ar
products, bota ni ca l pes tici des, po lyn u-
c leotid e seq ue nces, natu ra ll y occurring
genes, all naturally occurrin g DNAs a nd
RNAs cou ld thu s be kept out of patenting in
countri es' own patentin g laws. Th is position
is con sistent with the provisions of TRIPS.
Plants and Plant Varieties
Th e Indian Patents Act does no t permi t the
patentin g of eith er plants or plant vari eties.
The provisions of TRIPS req uire tha t pl ant
varieties need to be protected e ith er by pa t-
enting or by a sui generis method or by a
co mbin ation of both, but countri es could
keep plants ou tsid e the purview of patenting.
Patents on plants arc obtainable in certa in
developed countri es like USA, J apa n and
 GHOSH AND RAMANAIAII : IPR ISSUES IN BIOTECHNOLOGY ...
Australia und er certain conditi ons. But the
patent laws in Europe exclude plant vari eties
fro m patenting; indeed plant varieti es are
protected by sui generis method .
In Eu rope, the plant variety protection has
been g iven a separate legal system of prolec-
tion, common ly known as Plant Variety
Rights or Plant Breeders' Rights. Such
rights origin ated from and through th e e n-
actm ent of th e Inte rnational Union for th e
Protection of N ew Varieties of P lants
(UPOV). Th e UPOV has presently memb er-
ship of 43 States, and many countries for
protecting plant vari eties have accepted its
1978 version. However, UPOV had come
out with its 1991 version that cam e inlo force
from April 1998. Many countri es had not yet
ratifi ed th e 1991 version ofUPOV. Th e 1978
version of UPOV dealt with th e Plant Breed-
ers' Rig hts for co mm ercia l marketing of the
reprodu ctive parts of th e protected pl ant va-
ri eti es . Th e researchers as well as th e plant
breeders could use such protec ted va ri eti es
as study materials for further research , and
th e resulting new vari eti es developed from
th e protec te d va ri e ti es did not r e quir e
authori zation for th e sub sequ e nt breeders
or th e researchers to utilize th e m for co m-
merc ial gain s. T hese rig hts had been with -
drawn in 1991 version of UPOV. furth er,
th e 1978 vers ion of UPOV provid ed th e farm-
ers' rights to save seeds in accordan ce with
th eir tradition al prac tices . Thi s rig ht had
al so been s ubstan tially curtailed in th e 199 1
version of UPOV, on the g round s that farm-
saved seeds could form a sizeable part of the
annual use of seeds of protected vari eti es;
th erefore if farm ers were allowed to save
seeds, the saved portion wouid collectively
form a s ub stanti al quantum th at would result
in loss in revenu e of the own e r of lh e pro-
tected vari ety. Th e 1991 UPOV allows th e
9
farmers to save limited quantities of seeds
for lheir own requirements only.
T he TRIPS does not mention about or refer
to the provisions of UPOV, nor does it in cli-
cate the precise steps to be taken for protect-
in g plant varieties, except that it
promulgates that plant varieti es are to be
protected . India is not a member of th e
UPOV. India is th erefore; free to e nact its
own Plant Variety Protection (PVP) law that
would be co nsistent with the TRIPS. Whil e
framing its PVP, Indi a can draw [rom th e
provisions of UPOV, especiall y from its 1978
version . [n the new law the farm e rs' rights
as well as th e research ers' rights cou ld be
uph eld in accord ance with th e traditional
practices of th e country. Th e researc hers'
rig hts are consistent with th e provision s of
intell ectual properly principl es in any coun-
try that research could be carri ed ou t with
an y materi al, provid ed that any new mate rial
produced out of lh e utilized mate rial ~) ro­
lected or unprotec ted) is not marke ted. In
order to mark et a new material produ ced
from a protected material, lh e re may be
need to obtain th e conse nt of th e own e r
depe ndin g upo n th e IPR laws of th e States ..
As regard s farm ers' rig hts of saving seeds,
lh ese have to be co nsistent with th e tradi-
tio nal practices of th e country, on whi ch
TRIPS ca nnot have any control. India ca n,
th erefore , drafl its own PVP law th al ca n
have ad equale provi sions [o r prolec ling lh e
farm ers' rights as well as th e researc hers '
rig hls.
A plant vari ety is identifi ed by its whole
g e nom e. Th e usual criteria of prolecti on
lhrough UPOV Convenlion is availabl e to
new vari eti es of bolanical ge nera and s pe-
c ies, provided lh e vari ety is cl early di stin -
g uishabl e (D) by one or more ch aracteri stic
features [rom any other known vari ety, lh e
new vari ety is s ufficiently homoge neous or
]0 J INTELLEC PROP RIGHTS,JANUARY 2001
uniform (U) having regard to the features of
its vegetative propagation or sexual repro-
duction, and further the new variety is stabl e
(S) in its essential characteristics. This im-
plies that it should re main tru e to its descrip-
tion after r epeated propa gat ion or
reproduction or at the e nd of each cycle
where the breeders have defin ed a particular
cycl e of multiplication or r eproduction .
Popularly, these criteria are called as DUS
criteria. All memb er cou ntri es can adopt
these cr it er ia. Th e phenotypic charac-
teristics are to be id en tified, ind exed and
notified in accordance with th ese criteria.
Concurrently it would be most usefu l to in-
troduce genotypic identification s, which
wou ld no doubt includ e characteristic RFLP,
RAPD and DNA finger printing procedures
for bringing in more preciseness to id entifi-
cation. Genotypic characterization would,
however, require th e creation of enormous
infrastructure in the govern me nt laborato-
ries. A national laboratory may therefore be
designated and equipped for this purpose to
augment capacity building withi n the cou n-
try.
In India, th e Protection of Pl ant Vari eti es and
Farmers' Rights (PPVFR) Bill, 1999 was in-
trodu ced as Bill No: 123 of 1999 in th e Par-
liament. The Bill is under examination by a
Select Committee of the Parliament. The
Indian PPVFR has substantially incorpo-
rated in it th e 1978 provisions of th e UPOV;
th e criteria for the protectable plant vari eti es
are similar. The varieties that would be de-
veloped by incorporating one or a few trans-
genes by sta ndard m e thod s would be
considered as essentially derived varieties
and these would also be eligibl e for protec-
tion as "essentially derived varieti es". In
oth e r words, GM plants shall be protected as
essentially derived varieties provided th ey
satisfy th e DUS criteria. The PPVFR recog-
nizes the Research ers' rig hts as well as the
Farmers' rights, s imil ar to what was a'va il-
able in 1978 UPOv. The Bill further recog-
nizes the r ights of the Community that
contributed to th e development of a pro-
tected vari ety. The detail s of the adopted
PPVFR will be known only after the Bill is
accepted by the Parliament, and is e nac"ed.
Animals and Animal Varieties
Th e TRIPS h as provid ed ex e mption s to
countries to the protection of animals. Ani-
mal vari eti es are included within the broad
provisions of animals. Consequently, th e op-
portuni ty provid ed in the provisions ofV\~rO
should be availed of and animals includin g
animal parts like organs, tissues and cells of
animals modified to patentable invention
may be kept out of patenting, as this would
enabl e the people to use inventions in them
freely for benefits.
Interestin gly, animal breeds produced by
any cou ntry by using traditional meth ods
are not protected through any law anywh ere
in th e wo rld . Traditional methods includ e
th e biological methods of animal breeding.
However, if novel animals are produced by
no n-bi ologica l, non-natura lly occu r rin g
processes such as by full genomic cloning as
is dOIl e in th e developm ent of Dolly 12 or by
touch ing th e germ cell lin es B -15, introdu c-
ing in them new genetic traits t.h e n th e re-
sulting an imal as well as the processes could
be paten table in accordance with the laws of
some countries. The transgenic onco-m ouse
developed by th e Harvard College of USA Hi
was assigned a US patent protection as th e
animals qualify all the criteria of patenting.
Following the dec isions of th e US Pate nt
Office, a European Patent was also g ranted,
but th e Animal Rights Group of Europe op-
posed the grant of such a patent; th e matLe r
is consequ e ntly sub-j udice in Europe at th e
 GHOSH AND RAM ANALAH : IPR ISSUES IN BIOTECHNOLOGY ...
present. Th e moot point in such patents
arises from ethical issues of patentin g ani-
mals, which will be discussed later on. The
take · home lesson is that developin g coun-
tries like India could keep the pate ntin g of
animals and animal varieties, how so ever
derived, outsid e th e scope of their patentin g
laws , which position is consiste nt with th e
provisions of TRIPS. It can also be arg ued
that while efficie nt animal breeds produc ed
by traditional m ethod s have made phenom e-
nal progress th e world over, th e science or
the technology appli ed to animal breedin g
has not suffered du e to lack of patenting
process in th em. It can also be stated that
non-availability of th e system of patenting or
any other method of intellectual property
protection in this area has not affected its
sc ie ntific or tech nological developm ents.
Why therefore shall a system be broug ht in
place in this area that ca n restrict th e free
ava ilability of superior animal breeds to any
country? On the contrary market forc es and
market competition should be allowed to
bloom , as such measu res ensure to the maxi-
mum th e interests of th e consumers.
Process Patents/ Innovative Reverse Engi-
neerzng
The Article 28 of TRIPS confers certa in
rig hts on its owner, according to which th e
owner can prevent third parties from mak-
in g , using, offering for sale, selling, or im-
porti ng for these purposes, th e produ ct tJl<lt
is patented. If the subject matter of th e pat-
ent is a 'process for making a produ ct', thc
owner shall have the rig ht to prevent third
parties from using th e process for the above
purposes .In accordance with Article 34 of
TRIPS the burden of proof in respect of in-
fringement of th e rights of th e owner even
for a 'product by a process' patent is on th e
alleged infringer. Th erefore, in th e ensuin g
11
patent regime of TRIPS innovative new proc-
esses would have to be developed for mak-
in g a product that is protected by a process;
unl ess th e new process is substantially inn o-
vative, it would not be easy to introduce
"products protected by a process" by other
entrepre neurs from the membe r cou ntri es
in the coming years.
Geographical Origin 0/ Biological Mate-
rials and Traditional Knowledge
Every co untry is e ndowed with natural bio-
logica l reso urc es. CBD states that technol-
ogy transfer should be carried out on term s,
which are consistent with effective protec-
tion of IPR. It furth er recognizes that pate nts
may have an influence on the impl eme nta-
tion of the provisions of CBD, and therefore
patentee should cooperate in this rega rd
subj ect to national legislatio n and intern a-
tionallaw in order to ensure that such rig hts
are supportive, and they do not run co unter
to th e obj ectives of CB D. Biological inven-
tion s are expected to draw heavily from ge-
netic resources. Con sequ ently, in ord er to
fa cilitate th e claim of individual co untries on
such genetic resources, it would be essential
to legislate that inventors would have to di s-
close in their pate nt specification th e so urce
of th e biological materials used in the inve n-
tion s. Th ese are consistent with th e prov i-
sions of TRIPS, which in its prea mbl e on
TRIPS states th e need to promote effective
a nd adequate protection of IPR and to e n-
sure that measures and procedures to e n-
force IPR do not themselv es b ec om es
batTier to legitimate trad e.
There are also situation s wh ere invention s
would emanate from traditional practices or
from established b'aditional produ cts used
locally. For exampl e, th ere are innumerabl e
local food and beverage as well as local
remedi es, which are standardized by usin g
 12 J INTELLEC PIWP RIGHTS, JANUAHY 200 1
the method s offermentation or extraction or
process in g in trad itional mann er. Docu-
me nts of invention originating from the use
of s uch materials or processes should de-
scribe in sufficient details such starti ng ma-
terials includin g th e traditional practices ,
with a view to e nab ling the governments to
take s uc h steps in futur e as would be
deemed fit to benefi t the com munities hold-
ing such knowl edge.
Further, th ere are already several trad ed
goo ds that ori gi nate from specific geo-
g raphicallocations. Such goods when mar-
keted with mark (simi lar to lab elling) or
geograph ical in dications of origin are ex-
pected to fetch better prices in th e trade
because of established goodwill of such
products. Provisions exist in Article 22 of
TRI PS to app ly geographical indi cat ion s on
s uc h goods to enable procuring premium on
them when traded . fa lse claims sho ul d be
s ubjected to prosecution and pun ishment.
Examples of biotech goods in relation to
geographical indi catio ns in Indian context
are Darjeel ing tea, basmati rice, Hydera badi
biryani, Bangali rasogulla, Mysore pal?, Gu-
jarati dholda , petlza of Mathura, Bu rd wan's
11Iehidana and sitabhog, Bo ngaon 's IWlIcha
gol/a, Bikanari bhujia, I?tung 1ymbari and do-
h!?ha jJdem of Meghalaya, Izawaigar saidall
or saibum of Manipu r, khorias,baste1Iga, gUlI -
druk, iaitenga, hajpaui, jJara-apong, suiai,
zu Jnd phatilw of Assam. There are Illan y
other such local foods of popu larity in differ-
e nt parts of Ind ia. Like In d ia, every co untry
has some such spec iali ty ite ms of agricul-
tural, natural or manufactu red goods. Tn or-
der to exploit the names of geograph ica l
in d icatio ns on goods for obta ini ng a pre-
mium, Member Countries are entitled to in -
s titute nation al laws cons iste nt with th e
provisions ofWTO to register su ch products
und er the provisions of geographical indica-
tions as intell ectual properti es, and would be
en titled to collect revenues from th e regis-
tration of such marks. Such r evenu es co l-
lected by the States can then be s pe nt for th e
upliftment of the communities from wher e
the geographical ind ications originated .
In India, the first step towards these direc-
ti ons has been taken by enacting Th e Geo-
grap hi cal Indi cat ions of Good s l ?
(Registration and Protectio n) Act, 1999. The
rul es an d procedures for enacting thi s wou ld
soon be notified. Accordin g to the Act, "geo-
graph ical indications" in rela tion to goods
wou ld mea n an indication which id entifies
such goods as agric ultural goods, natural
goo ds or manufactured goods as originating
or manu factured in the territo ry of a country
or of a region or locali ty in that territory,
where a g iven quality or reputation or other
characteristics of such goo ds is essentiall y
allributab le to its geograp hical ori gi n and in
case where s uch goods are rnanufac turcd
goods one of th e activities of e ith er the pro-
du ction or of processing or production of th e
goods concern ed takes pbce in s uch a terri-
tory, region or locality, as the case may be.
Goods wo ul d mea n any agricultural, natural
or man ufactured goods or goo ds of ind ustlY
and includes foodstuff. The India n Contro l-
ler General of Patents, Des ig ns and T rade
Marks shall be th e Registrar of Geographi-
ca l In d ications. The usc of a geogra phical
indication shall be construed as a referen ce
to th e use of a prin ted or oth er visual repre-
se ntation of the geograph ical in dication.
Ethical Issues
Pate nting of invention confers rig hts on the
patent holder to prevent othe rs fr om exploit-
in g the invention fo r commercial gains. It is
a rig ht conferred by the sovere ign States to
th e owner. The State machinery gua rantees
such rig hts to the inve nto rs. Co nsequently,
 GHOSH AND RAMANAIAH : IPI< ISSUES IN BIOTECHNOLOGY ...
patenting rights are powerful rights con-
fen-ed upon the patent holders. As the States
deal with the welfare and equity of people,
all acts of States are to be ethical. Conse-
quently, the patenting laws in every country
have ethical consid erations, and inve ntions
that cu t acro ss the questions of morality are
not allowed to patent. In the existing Indian
Pate nts Act, provisions have been built in for
preventing patenting of inventions that are
contrary to public mo·rale. The European
Patent Convention (1973) in its Article 53 (a)
excludes from patenting any invention "the
publication or exploitation of which is con-
trary to morality or ordre public". All Euro-
pean countries hav e incorporated this
provision in essence in their national patent
laws. Subsequently, European Parliament
and the Council on Legal Protection of Bio-
logi ca l Inve ntion issued 18 Directive No.
98/44/EC on 6.7.1998 for patenting of bio-
logical inventions.
It is often argued that the acts o[ patenting
are ethically neutraI 19-21. Perhaps th ese ar-
gument stems from the philosophy that pat-
enting attorneys who advice inventors on
th e suitability of their inventions examine
the cases on the basis of set criteria of nov-
elty, inventive steps and usefuln ess (indus-
trial applications) only, and such criteria
have nothing to do with the ethical issues.
Some people argue that if the practice of an
invention is considered immoral by societies
then by an act of law such inventions should
be banned from patenting, and consequently
nobody would bother to patent such inven-
tions. Indeed, this is what every society does
through its governments to prevent from
patenting the inventions the exploitation of
which is contrary to morality or to the ordure
public. Unfortunately, th ere is no universa l
code of conduct that is applicable and usefu l
for every society uniformly that sets th e
baselin e of ethics and morality. In the con-
text of biological inventions, the situation
has become more complex especially for the
developing countries after Chakrabarti 2
was allowed a patent on his inve ntion of a
genetically modified Pseudomonas microor-
ganism that had an add itional plasmid incor-
porated by Chakrabarty, by virtue of which
the organism had acquired th e capacity of
metabolising a wid e range of hydrocarbons.
Th e importanc e of this patent was that living
objects that could not hith erto be patented
became patentable from this time. Societi es
took a long time to accept that this patent
was not a patent for life per se but for a living
organism that was "partially modifi ed" by
the inventive genus of human interventions.
In fact, Chakrabarty'S invention did not cre-
ate any new life but it only modified irre-
versibly a life form that did not ex ist in
nature. The modification was, however,
very powerful and the progenies of the modi-
fieci organism also inh erited th e modifi ed
properties intact. Hereafter, patenting of
complex living objects have been allowed
such as the patenting of other microorgan-
isms and hybridomas and many cell lin es
derived from high er life forms such as in-
sects, mammals, etc. US have allowed th e
patenting of an oncomouse 16, which is an
animal that can be used [or testing th e car-
cin ogenic potential of new compounds. The
ethical consid erations in th e patenting of
th ese inventions have. th erefore, changed
and living objects have not been considered
as a bar for th eir be ing patenteci. The moot
point, therefore, in th e consicferation of ethi-
cal issues from these experiences are clear
that the floor limits of ethics can change with
time and with the societal needs. Ethical
issues are, therefore, to be considered as
dynamic societal morals that can change
with tim e. However, every country at a par-
ticular time has the right to set th e floor
14 J INTELLEe PROP
lim its of ethics th at can be binding within th e
territory over a peri od of tim e. WTO is neu-
tral on setting any flo or limits of ethical is-
s ues th at are g lobally acceptable. In this
context, th erefore, it can be s tated that th e
ba selin e of morali ty s hould be drawn within
the States in accord ance with th eir social
and cultural norm s, and th ese norm s should
o nly have territorial applications.
With th e above in view, it is s tated th at for
India a philosophy based on ge neral welfar e
of h uman and an imals s houl d be co nsidered
as th e base lin e of ethics for the purpose of
pr eve ntin g in ve nti o n s fr o m pa t e n tin g.
Ma in tenance of activiti es of anim al we lfare ,
huma n dig nity an d preservatio n of natural
liv in g bi ologica l wealth are natural to human
beings. Inventio ns and activiti es, which are
co ntrary to th ese, would trade upon e thi ca l
issues. Th erefore, in vention s in areas whi ch
do not co nform to animal welfa re or which
brin g dow n hum an d ig ni ty s hould not be
consid ered to be area s that are patentabl e.
Con sequ ently, di scoveri es of any of the natu-
ral c le me nts in cl uding th e parti al or full se-
qu e nce of genes [rom hum an body s hould
not be allowed fo r pate ntin g. All inve ntions
lead ing to cru e lty of an im als with out brin g-
ing about any advantage to kn owledge or
information or weUare or med ical be nefits to
hum an or animals sh ould also not be all owed
to be patented. Simil arly, process fo r mod i-
fy in g human germ lin e, methods of deter-
minin g th e sex of h um an fo etus, use of
hum an embryos fo r organ culture and clon-
ing of hum an beings s hould also not be al-
lowed to be patented.
Discovery and Invention
Al l findin gs in biology where a bi ological
s u bs tance or its properties already existed in
nature bu t was noticed for th e first ti me
indiv idu ally or coll ectively by hum an s hould
1~ IGH TS , JANU ARY 2001
be ter med as discovery. This s hall apply to
mi c rob es, pl ants a nd a ni ma ls in c lu din g
every s ubstance in th e m in full or in parts of
th eir development in the natural form, in th e
bi olog ical system . Natural1y occurri ng mi-
crobes, plants and anim als, naturally occur-
r ing bio c h e mi ca ls, ge n es, nu c le ic ac id
s tretches, protein s, carbohydrates, lipid s o r
co mbin ations th ereof which arc natu rally oc-
cLi lTin g , s hould be termed as products of
natu re and th ey s houl d be kept away from
intell ectua l property protecti on. Proper ties
of such s ubs tances as well as th e in ter-rela-
ti onships and fun ction s sh ould be co nsid -
ered to be fa llin g within th e preview of
natural laws , and therefore findin g th e m by
h uma n eve n for th e fi rs t tim e s hould be
co nsidered as discoveries. Inve ntion s 0 11 th e
oth er hand would be th ose fin d in gs throug h
hum a n interventi on whic h did not occur
naturally bu t could be mad e to occu r by
h um a n intervention, and th erefo re which
would satisfy th e cri teria of in tellectual prop-
erty protecti on namely being new, involvin g
inventive s teps and bein g useful or having
applicati ons . T he usefuln ess or applications
are in relation to indu strial a pp l i c ati on ~. Co n-
sequ ently, patentabl e bi ological su bsta nces
shou ld have indu strial application s at the
time when th ey are co ns id ered for protec-
tio n an d should not be base d on hypothe ti-
cal or potential future application s.
Al l process of mul tiplication and production
of an im als and pl ants by natural proc esses
suc h as crossing or sel ectio n s hould be con-
sidered as esse ntially biol ogica l process and
should not be co nsid ered as pate ntable in-
ven tion.
Deposit and Access of Biological Materi-
als
Two hidd en criteria for th e protection of IP R
consist of ad equ ate desc ription of th e inve n-
 GHOSH AND RAMANAIAH : IPR ISSUES IN BIOTECHNOLOGY ...
tion and the reproducibility of the invention
in the hands of persons reasonably skilled in
the art. In biological invention, it is not pos-
sible to adequately describe the living sub-
stance(s), nor it is possible to reproduce the
invention without the biological material (s) .
Consequently, the world community has ac-
cepted that all biological materials be depos-
ited in recognized international repositories.
In accordance with the Budapest Treaty 23,
patentable microorganisms are required to
be deposited by the inventors in designated
recognized repositories. Such provisions
are required to be legislated by the States for
all biological materials including plants, ani-
mals and multiplying substances such as
genes, plasmids, viruses, etc. as is applicable
for microorganisms. These may require the
creation of national depository set-ups and
th e building up of the necessary capabilities
in many States. Besides, States may also
become a part of the Budapest Treaty by
complying with the necessary procedures
for enabling them to have access to deposi-
tion of biological materials in designated
labs for the purposes of their IPR.
Conclusion
The protection of plant varieties to individu-
als in Europe in sixties through UPOV was
the beginning of conferring rights of living
substances / materials / objects to individu-
als. The US decision to allow Chakrabarty to
obtain a patent on his genetically modifi ed
Pseudomonas spp. was another landmark
event that started the world community to
prepare itfor accepting the patenting of com-
plex and high er life forms including hybrido-
mas, vert e bral a nd insect cell lin es,
genetically engineered plants and animals in
the developed countries. Although th e de-
veloping countries resisted to such IPR in
their own patenting laws initially, the trend
15
is fast changing. Patenting of living organ-
isms that qualify the criteria of patentibility
are being given protection through their na-
tionallaws in many developed countries and
the debate on whether living materials can
be patented is gradually being pushed to
backseats. Realizing that this compromises
ethical issue at least for higher life forms and
having regard to the fact that the research
capability of developing countries are lower
and would continue to remain so for many
years in future, it is prudent to conclude that
liberal views on patenting of living organ-
isms would mainly benefit th e developed
nations. There is wisdom in taking advan-
tage from within th e provisions of WTO to
keep out of patenting as much of inve ntion
in living objects as is possible by the devel-
oping countries within the framework of
WTO in their national patenting laws. It
would be prud ent to tackle the issue by cre-
ating conditions of strong market competi-
tion within the t erritories of States by
providing equal level pl aying grounds in
other facets and factors of production so that
only the fitter enterprises could sustain in
competition. The bargaining point of the de-
veloping countries lies in having their large
local markets, which would grow over the
years ilTespective of what laws of IPR th ey
would adapt.
Genetic resources are th e properties of th e
sovereign States to which th ey are indige-
nou s. Future accessions of such reso urces
would require consent from the States.
cnD promulgqtes ensuring conservation
and sustainable use of biological diversity,
besides fa ir and equitable sharing of be nefits
from th eir utilization . Having abundant natu-
ral resources, the developing countries have
an edge over the developed nations. It
makes good sense to create conditions of
structured but compatible mechanism of
16 J INTELLEC PROP RlGHTS, JANUARY 2001
sharing of such resources with other coun-
tries or individuals; sharing is expected to
promote finding ways of quicker exploitation
of such resources. Once the resourc es are
put to commercial use, the countries sharing
their indigenous genetic resources would be
able to receive part of th e tangible wealth
created through their exploitation. Supply
and exchange of biological materials are
therefore expected to move across the bor-
ders through the materials transfer agree-
me nts on the basis of authorized, mutually
agreed terms and subject to authorized prior
inform ed consent. Consequently, authori-
ties and legislation for th e access of biologi-
cal materials of States would be in th e
making for all the CBD Me mber countri es.
The benefits from the application of biotech-
nology are fast penetrating in to the societal
fabric of every country. Th e areas to be
demarcated as unprotectabl e in tellectual
properties in mod ern biology would become
a subject matter of discussion and it would
not be easy to come to co nsensus. IPR laws
of the Member Countries ofWTO includin g
Indi a wou ld have to be in conformity with the
provision of WTO. This wou ld r eq uir e
amending th e IPR laws of States; in many
States some laws are to be enacted fo r the
first tim e such as PVP laws and laws on
geographical indi cations. The future years
would witn ess how the developing countries
including India wou ld deal with th e issues of
patentable microorganism s , protection of
other living objects/substances, ethical is-
sues in biological inve ntion s, distinction be-
tween discoveries and invention, fanners'
privi lege, research ers' rights, co mmunity
rights, geographical indications , method s of
sharing of biological materials and in creat-
in g prov ision s for making deposits for IPR
protected biological materials.
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