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Patent-Related Flexibilities in Multilateral Treaties and their
Importance for Developing Countries and LDCs – the TRIPS Agreement
Thu-Lang TRAN WASESCHASenior Counsellor, Intellectual Property Division
WTO Secretariat
Tran Wasescha- May 2013
Second WIPO Inter-Regional Meeting on South-South Cooperation on Patents, Trademarks, Geographical
Indications, Industrial Designs and EnforcementWIPO-Ministry of Foreign Affairs-ASRT
Cairo, 6-8 May 2013
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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
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TRIPS and the IP Universe
Paris
IPIC
ParisBerne
IPIC Rome
FTAs (bilateral or regional)
TRIPS
WIPO treaties, etc.
National laws
Regional legislation
EU, OAPI, ARIPO, 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)
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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”
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Rights and obligations – patents (non exhaustive examples)
Art.27.1: Patentable subject matter
Art.29: Patent application
if granted
Art.28: Rights conferred
Exclusions permitted: Art.27.2 + 3
Requirements: novelty, inventive step and industrial applicability + disclosure
Exceptions and limitations: Art. 30 + 31
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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”)
TRIPS: general
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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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• 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)
Some TRIPS patent flexibilities (1)
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• 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]
Some TRIPS patent flexibilities (2)
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• 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
Some TRIPS flexibilities (3)
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Transitional periodsDeveloped countries
DCs & economies in transition
DCs: Additional for DCs (pharma)
LDCs(general(Art. 66.1)
LDCs (pharma & test data)
1 year(1995-1996)
5 years(2000)
Another 5 years(2005)
11 years2006
11 years2006
7.5 years(1 July 2013)
Doha TRIPS-Public health:1 January 2016(pharma & test data)
Currrent negotiations for a 2nd extension
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Flexibility example - Exhaustion
Country B
[Regime irrelevant]
ARV Drug at 5 USD/dose
Country C
international exhaustion
ARV Drug at 10 USD/dose
Country A
national exhaustion
ARV drug at 30 USD/dose
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• 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
Balance of rights and obligations (1)
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• Rightholders – competitor – Safeguards for both
– R&D is important for technology progress
– Accessibility to products; the special case of pharmaceuticals
– Consumers‘ role
Balance of rights and obligations (2)
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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)
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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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Right holder
Competitor Consumer
Balance of interests – the "virtuous triangle"
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• 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
Remarks
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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)
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