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

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.

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

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

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)

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

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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Consult our website www.wto.org

Other questions to: thu-lang.tranwasescha@wto.org;

tel.: +41 22 739 57 05; # 3024