Thu-Lang TRAN WASESCHA Senior Counsellor , Intellectual Property Division WTO Secretariat

1. 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

2. 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

3. TRIPS and the IP Universe National laws TRIPS FTAs (bilateral or regional) Berne Paris Paris Regional legislation EU, OAPI, ARIPO, etc. IPIC IPIC Rome WIPO treaties, etc.

4. 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)

5. 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 General remarks (1)

6. 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 General remarks (2)

7. 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”

8. 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

9. 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”)

10. 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 Patents in general

11. 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)

12. Some TRIPS patent flexibilities (2) • Exceptions to rights • Research exemption • Regulatory exception (orso-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]

13. 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

14. Transitional periods

15. Country A Country B Rightholder Rightholder Country C Retailer Retailer Wholesaler Wholesaler Rightholder Retailer Wholesaler Consumer Consumer ARV drug at 30 USD/dose ARV Drug at 5 USD/dose Consumer [Regime irrelevant] ARV Drug at 10 USD/dose national exhaustion international exhaustion Flexibility example - Exhaustion

16. 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 (orso-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

17. 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

18. 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)

19. 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

20. Balance of interests – the "virtuous triangle" Right holder Competitor Consumer

21. 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

22. 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)

23. Consult our website www.wto.org Other questions to: thu-lang.tranwasescha@wto.org; tel.: +41 22 739 57 05; # 3024