Second WIPO Inter-Regional Meeting on South-South

Cooperation on Patents, Trademarks, Geographical

Indications, Industrial Designs and Enforcement
WIPO-Ministry of Foreign Affairs-ASRT
Cairo, 6-8 May 2013

Patent-Related Flexibilities in
Multilateral Treaties and their
Importance for Developing Countries
and LDCs – the TRIPS Agreement
Thu-Lang TRAN WASESCHA
Senior Counsellor, Intellectual Property Division
WTO Secretariat

Tran Wasescha- May 2013

 Outline

• The TRIPS (Trade-Related Aspects of

Intellectual Property Rights) Agreement in the
Intellectual Property (IP) universe
• TRIPS Patent flexibilities: a few examples
• TRIPS Balance of rights and obligations: a few
examples
• Some final remarks
 TRIPS and the IP Universe
National laws

TRIPS FTAs
(bilateral
or
Berne
Regional Paris Paris regional)
legislation
EU, OAPI,
ARIPO,
etc.

IPIC Rome
IPIC

WIPO treaties, etc.

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 The WTO in a nutshell
• Presently 159 Members. Some 97 % of trade in
goods and services (altogether)
• Multidisciplinary complex mechanism of
negotiations, trade-offs across the board
• The “multilateral” character of WTO agreements
(vs. Pluri-lateral)
• “Single undertaking”
• Dispute settlement system (DS)
 General remarks (1)

• Patents in the Uruguay Round: area of IP where

the discussion on pros and cons of IP protection has
been most emotional and difficult. Delicate
balance struck
– within Section 5; and
– within the TRIPS Agreement.
– within the UR single package
• Flexibilities
• So-called “constructive ambiguity”
• Policy space
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 General remarks (2)

• Flexibility. What is “flexibility”?

– Policy Space
• Defining policy orientation
• Implementation Space
– Constitutional rules
– Legislative systems
– National interests but also a need for coherence and
attraction of FDIs

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 TRIPS – balance of interests
• Paris, Berne Conventions. Balance of interests
already carefully negotiated. Incorporation of
WIPO’s basic conventions
• TRIPS: Plus certain elements or re-affirmations or
clarifications
• Balance of interests  negotiation of flexibilities,
e.g. exhaustion of rights, patentability,
compulsory licensing
• ”Flexibilities” and “constructive ambiguity”
 Rights and obligations – patents (non
exhaustive examples)
Art.27.1: Patentable
subject matter Exclusions permitted:
Art.27.2 + 3
Requirements: novelty,
Art.29: Patent application inventive step and
industrial applicability +
disclosure
if granted
Art.28: Rights conferred Exceptions and
limitations: Art. 30 + 31
 TRIPS: general
Minimum level of protection!
• Subject to transitional arrangements for
certain Members
• Freedom to go beyond this level: national
laws, regional legislation, bilateral and
multilateral agreements
• "Shall" provisions
• But flexibility in "may" provisions + obligations
tempered provisions (“shall have the
authority”)

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 Patents in general
• Area of IP where the discussion on pros and cons of
IP protection has been most emotional and difficult.
Delicate balance within Section 5, within the other
TRIPS parts
• But have we really invented the wheel with TRIPS?
The Paris Convention and its modernity
– TRIPS preamble; Article 7: especially focused on patents;
“Modern” dimension of this article
– Article 8

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 Some TRIPS patent flexibilities (1)
• Freedom to determine the appropriate method
of implementing TRIPS (Art.1.1)
• Exhaustion of rights (Art. 6); usefulness for DS
• Article 8 (Doha on TRIPS-Public health)
• Exclusions from patentability (Art. 27)
– The "may" provisions
• Exclusive rights = 20 years temporary
“monopoly”?: NOT a blank check (see
pharmaceuticals)

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 Some TRIPS patent flexibilities (2)
• Exceptions to rights
• Research exemption
• Regulatory exception (or so-called "Bolar exemption")
• Other limitations
– Compulsory licenses (CLs)
– Public non-commercial use – Government use
– Dependent licenses
– Confirmation by Doha Ministers of policy space
(grounds for CLs)
• [but obligation to respect conditions for granting CLs]
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 Some TRIPS flexibilities (3)
• Plant variety protection
• Enforcement of patent rights
– Takes account of specific national systems
– No need to devote additional resources
– May  provisions; shall have the authority
provisions
– Transition periods for LDCs

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 Transitional periods
Developed DCs & DCs: Additional LDCs LDCs (pharma &
countries economies in for DCs (pharma) (general test data)
transition (Art. 66.1)

1 year 5 years Another 5 years 11 years 11 years

(1995-1996) (2000) (2005) 2006 2006

7.5 years Doha TRIPS-Public

(1 July 2013) health:
1 January 2016
(pharma & test
data)

Currrent
negotiations
for a 2nd
extension
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 Flexibility example - Exhaustion

Country A
Country B

Country C

ARV drug at 30
USD/dose
ARV Drug at 5
USD/dose
national exhaustion [Regime
ARV Drug at 10 USD/dose
irrelevant]
international
exhaustion
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 Balance of rights and
obligations (1)
• Article 7
– Confirmation of Doha ministerial declaration (public health)
– Interpretation for dispute settlement cases
• Exceptions to rights
• Research exmption
• Regulatory exception (or so-called "Bolar exemption")
• Other limitations
– Compulsory licenses (CLs)
– Public non-commercial use – Government use
– Dependent licensing
– Confirmation by Doha Ministers of policy space (grounds for
compulsory licenses) but obligation to respect conditions for
granting CLs
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 Balance of rights and
obligations (2)
• Rightholders – competitor
– Safeguards for both
– R&D is important for technology progress
– Accessibility to products; the special case of
pharmaceuticals
– Consumers‘ role

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 Doha Declaration TRIPS-Public
health and Paragraph 6 System
• Doha declaration on TRIPS-Public health
• Confirmation of flexibilities and public policy
space
• Importance of R&D but also accessibility and
affordability
• Paragraph 6 system:
– Waivers (WT/L/540 and Corr.1 )
– Procotol (amendment) (WT/L/641)
 TRIPS-Public Health - Some References

• Doha Declaration on TRIPS and Public Health (WT/MIN(01)/DEC/2)

• Decision on the implementation of paragraph 6 of the Doha
Declaration on TRIPS and Public Health (WT/L/540 and Corr.1)
• Decision on an amendment to the TRIPS Agreement (Protocol)
(WT/L/641)
• Annual Review of the Functioning of the System
• Members’ laws implementing the Para.6 System:
http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm
• How to accept the Protocol Amending TRIPS:
http://www.wto.org/english/tratop_e/trips_e/accept_e.htm
• Decision on extension of transition period for LDCs with respect to
pharmaceutical products (IP/C/25)
• Decision on general extension of transition period for LDCs (IP/C/40)
- 30 June 2013, being discussed /negotiated

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 Balance of interests –
the "virtuous triangle"
Right holder

Competitor Consumer
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 Remarks

• TRIPS: first most comprehensive treaty on IP

• Balance struck (but balances are fragile)
• Pendulum effect
• Great flexibility, perhaps not always well understood
• Doha Declaration: useful to give some comfort to
certain Members
• Test for future: how the patent system is used.
Important to keep the balance between innovation-
R&D and access to medicines
• Short, Medium and Long-term visions
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 Remarks
• Patent flexibilities
• “Common sense” use of IP, of rights and obligations, of
flexibilities (e.g. patentable inventions), otherwise
“Pendulum effects”, which is not in the benefit of any
party.
• Sound and reasonable use of IP Foreign direct
investment (even if it is one pre-requisite only among
others). Other factors to tackle?
• DCs and LDCs: group of countries of hopes and
possibilities (natural resources  inventive activities
patentable inventions)
 Consult our website
www.wto.org
Other questions to:
thu-lang.tranwasescha@wto.org;
tel.: +41 22 739 57 05; # 3024

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