1. ato2461 INTELLECTUAL PROPERTY AND DEVELOPMENT Presentation by Adrian Otten Director, Intellectual Property Division, WTO Secretariat Panel Discussion 7 June 2005, New York

2. ato2462 TRIPS Agreement rBased on a recognition of the legitimate interest of countries in the way their IP is protected in other countries. r And the desirability of a functioning international rule of law in relations between countries in this area. r Respects the need for balance in national IP systems between the interests of producers and users of intellectual property, and the need for flexibility so that countries can fine-tune this balance in the light of their development needs. r Negotiated as part of the Uruguay Round of trade negotiations.

3. ato2463 Balance and Flexibility in the TRIPS Agreement (1) Objectives - Article 7  The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

4. ato2464 Balance and Flexibility in the TRIPS Agreement (2)  Article 8 – Principles  Exceptions to protectable subject-matter  Exceptions to rights  Compulsory licensing  Exhaustion and parallel imports  Measures against anti-competitive practices  Transition periods

5. ato2465 Debate about the Balance and Scope for Flexibility in the TRIPS Agreement  Different views about whether balance found in the TRIPS Agreement is optimal  Manifestations in ongoing work of the WTO -TRIPS and public health -Biotechnology/biodiversity/traditional knowledge, in particular the relation between the TRIPS Agreement and the Convention on Biological Diversity -Geographical indications

6. ato2466 TRIPS and Public Health (1) Doha Declaration on the TRIPS Agreement and Public Health, 2001 rThe Declaration, while reaffirming TRIPS commitments, recognizes right of WTO Members to use the flexibilities provided for in the TRIPS Agreement to the full, clarifies them where appropriate, and agrees that they should be interpreted in a way supportive of public health. rExtends transition period for pharmaceuticals for LDCs to 1.1.2016 rPara. 6 instructed the TRIPS Council to find, before the end of 2002, an expeditious solution to the problem of WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector in making effective use of compulsory licensing under TRIPS.

7. ato2467 TRIPS and Public Health (2) Para. 6 Doha: What was the problem? rMembers can issue compulsory licences for importation as well as for domestic production. rThe problem was whether sources of supply from generic producers in other countries to meet such demand will be available, particularly in the light of the provision of Article 31(f) of the TRIPS Agreement (“predominantly for the supply of the domestic market of the Member”).

8. ato2468 TRIPS and Public Health (3) Decision on Implementation of Para. 6, August 2003 rThe Decision takes form of waivers (with amendment foreseen) r3 waivers granted: rof 31(f) to exporting Members subject to conditions on transparency and safeguards against diversion; rof 31(h) to importing Members provided remuneration paid in exporting Member on same products; rof 31(f) to any LDC or developing country part of RTA where at least half LDCs.

9. ato2469 TRIPS and Public Health (4) Chairman’s statement at time of adoption of the Decision rStatement represents several key shared understandings of Members. rSystem should be used in good faith to protect public health and not to pursue industrial or commercial policy objectives. rAll reasonable measures should be taken to prevent diversion. rExpeditious review in TRIPS Council and good offices of the Director-General or Chair of the TRIPS Council. r44 Members opt-out fully or partially as importers (33+11).

10. ato24610 TRIPS and Public Health (5) Turning the waiver Decision into an amendment rWaivers remain in force until replaced by an amendment. rIssues: rcontent – amendment to be “based, where appropriate,” on the waiver Decision; rlegal form; rTiming.

11. ato24611 The TRIPS Agreement and the Convention on Biological Diversity (1) Doha Work Programme rPara. 19 - Doha Ministerial Declaration: “We instruct the Council for TRIPS, in pursuing its work programme including under the review of Article 27.3(b), the review of the implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this Declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by Members pursuant to Article 71.1. In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.”

12. ato24612 The TRIPS Agreement and the Convention on Biological Diversity (2) Disclosure Proposal of Developing Countries Amend TRIPS Agreement to make obligatory disclosure by patent applicant of: rThe source and country of origin of biological resources and traditional knowledge used in the invention. rEvidence of prior informed consent. rEvidence of fair and equitable benefit sharing. In their view, essential for balanced outcome to Doha Development Agenda negotiations.

13. ato24613 The TRIPS Agreement and the Convention on Biological Diversity (3) Positions of other delegations -Willingness to envisage some rules on disclosure of origin or source; - National solutions using legislation on access and benefit sharing and contracts sufficient and no need to involve the patent system -Mind not closed -Role of WTO and WIPO -Relationship with the Round

14. ato24614 Geographical Indications (1) Three Initiatives rNegotiations on the establishment of a multilateral system of notification and registration of geographical indications for wines and spirits (Article 24.3 + Doha). rIssues related to the extension of the protection of geographical indications provided for in Article 23 to products other than wines and spirit. rProposals in Agriculture negotiations for “clawback” of use of certain GIs.

15. ato24615 Geographical Indications (2) Legal Effects of GI register: Three Proposals rRegister in form of a searchable database, to be consulted when participating Members take national decision on GI protection. rMore far-reaching legal effects and opposition mechanism (if no opposition, presumption – or more – that GI not fall under an exception to protection which could have been ground for opposition). rSome legal effects consequent on a registration (presumption of ownership, compliance with GI definition and protection in country of origin). No opposition mechanism.

16. ato24616 Geographical Indications (3) Participation in GI Register: Two main positions rLegal effects in all WTO Members (“multilateral” system) rLegal effects mandatory only in those opting to participate in the system (“eligible for protection in those Members participating in the system”).

17. ato24617 Geographical Indications (4) Extension rPara. 18, 2 nd sentence of Doha Declaration: “We note that issues related to the extension of the protection of geographical indications provided for in Article 23 to products other than wines and spirits will be addressed in the Council for TRIPS pursuant to paragraph 12 of this Declaration.” rDifferent views on whether part of Round. rDifferent views on merits.