1. CUTS International Capacity Building Training Programme on Advance IPR, WTO-Related Issues and Patent Writing April 28-May 02, 2008, Jaipur TRIPS – Article 27.3(b) Traditional Knowledge Session 10 May 02, 2008 B. K. Zutshi

2. WORK IN THE WTO ON: Review of Article 27.3(b) The Protection of Traditional Knowledge and Folklore TRIPS and CBD (will be presented separately)

3. GENERAL OVERVIEW OF THE PRESENTATION TRIPS PROVISIONS RELEVANT TO BIOTECHNOLOGY ISSUES DISCUSSED UNDER REVIEW OF 27.3 (B) TK DISCUSSIONS DOHA WORK PROGRAMME COORDINATION WITH OTHER ORGANIZATIONS TRADITIONAL KNOWLEDGE –Protection of traditional knowledge and folklore 3

4. TRIPS PROVISIONS MOST RELEVANT TO BIOTECHNOLOGY ARTICLE 27.1 – Patent availability and enjoyment ARTICLE 27.2 – Ordre public and morality exceptions ARTICLE 27.3 (b) – Plant and animal inventions ARTICLE 28 – Rights conferred on patent owners ARTICLE 29 – Conditions on patent applicants (Art. 62) – Acquisition and maintenance of IPRs 4

5. Members may not grant patents: If prevention of commercial exploitation is necessary to protect ordre public or morality, Including to protect human, animal or plant life or health Or to avoid serious prejudice to the environment Article 27.2 –ethical exceptions 5

6. PROVISIONS OF ARTICLE 27.3 (B) Members may exclude from patentability: –Plants and animals –Essentially biological processes for their production Members shall not exclude: –Micro-organisms –Non-biological and microbiological processes Members shall protect plant varieties –By patents or –By an effective sui generis system or –By any combination thereof Provisions to be reviewed 4 years after 1995 i.e. 1999 –Review began in 1999 and is still ongoing 6

7. Article 27.3(b) review IPC/W/369/Rev. 1 Patent protection; positions: To remove exceptions to patentability provided for in Article 27.3(b) To leave Article 27.3(b) as it is To clarify certain terms in Article 27.3(b), i.e. plants, animals, micro-organisms; criteria for patentability; ethical exceptions To amend Article 27.3(b) to prohibit patenting of life forms, including micro-organisms 7

8. Article 27.3(b) review IP/C/W/369/Rev. 1 Sui generis protection –For and against providing protection for plant varieties –Need for the clarification of “an effective sui generis system” –Relationship between TRIPS and UPOV 1978 and 1991 –Relationship between farmers’ rights and farmers’ privileges. 8

9. Doha Ministerial Declaration Doha Ministerial Declaration(WT/MIN(01)/DEC/1, 14 Nov. 2001) –Para. 19: “We instruct the TRIPS Council, 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... ” –Para. 12: Outstanding implementation issues 9

10. Extension: para. 12 of Doha Declaration “Work programme Implementation-Related Issues and Concerns 12.... we agree that negotiations on outstanding implementation issues shall be an integral part of the Work Programme... and that agreements reached at an early stage in these negotiations shall be treated in accordance with the provisions of paragraph 47 below. In this regard, we shall proceed as follows: (a) where we provide a specific negotiating mandate in this Declaration, the relevant implementation issues shall be addressed under that mandate; (b) the other outstanding implementation issues shall be addressed as a matter of priority by the relevant WTO bodies, which shall report to the Trade Negotiations Committee, established under paragraph 46 below, by the end of 2002 for appropriate action.” Different views on whether or not part of Doha round of negotiations 10

11. Organization of work since Doha 1.Paragraph 19 - Regular meetings of the TRIPS Council. Three separate items on the agenda of TRIPS Council since 2002 2.Paragraph 12 also took place in TRIPS Council and was reported upon to the TNC at the end of 2002. Since 2003 part of DG’s consultative process on outstanding implementation issues –Two issues: GI extension and CBD/TRIPS –strategic link 11

12. After Doha.. –The General Council’s decision on 1 August 2004 The General Council instructs the TNC, negotiating bodies and other WTO bodies to redouble their efforts to find an appropriate solution, as a priority, to outstanding implementation-related issues. –Hong Kong Ministerial Declaration on 18 December 2005 Paragraph 39 –Reiterates the above-mentioned instruction –Request the DG to intensify his consultative process on all outstanding implementation-related issues, and to report to each regular meeting of the TNC and the General Council. The General Council shall take any appropriate action no later than 31 July 2006. Paragraph 44 –The work shall continue on the basis of paragraph 19 of the Doha Declaration and the progress made in the TRIPS Council to date. The General Council shall report on its work in this regard to the next Session. 12

13. Protection of Traditional Knowledge and Folklore (1) IP/C/W/370/Rev.1 Little debate recently in the TRIPS Council –No specific provisions in TRIPS Implications –Members can protect TK under covered IPRS, where appropriate –Can introduce sui generis law to protection TK –Can implement CBD, provided there is no conflict with TRIPS »Article 8(j) of CBD: to respect, preserve, maintain knowledge, innovations as practices of indigenous and local communities and encourage the equitable sharing of benefits 13

14. The need for international action on the protection of traditional knowledge and folklore The international forum most appropriate to pursue such work: WIPO vs. WTO Defensive protection of traditional knowledge: –Definition of prior art –Databases –Opposition, re-examination, revocation –Disclosure requirement Positive protection of traditional knowledge: –Use of the existing IPRs –Disclosure requirements to ensure benefit-sharing –Contracts –Sui generis system of protection The Secretariat’s summary note IP/C/W/370/Rev.1 Protection of Traditional Knowledge and Folklore (2) 14