WORK IN THE WTO ON: The Relationship between TRIPS and CBD Facilitating the Participation in the Intellectual Property and Traditional Knowledge Debate in WIPO's IGC, Chateau Bossy, 22 February 2008 WORK IN THE WTO ON: The Relationship between TRIPS and CBD The Protection of Traditional Knowledge and Folklore Jayashree Watal Counsellor, Intellectual Property Division, WTO

GENERAL OVERVIEW OF THE PRESENTATION BACKGROUND ON WTO TRIPS &CBD, TK DISCUSSIONS DOHA WORK PROGRAMME BIODIVERSITY Background on TRIPS & CBD, TK discussions in the WTO, including Doha & Hong Kong Ministerial Declarations Relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) Issues, positions, proposals COORDINATION WITH OTHER ORGANIZATIONS TRADITIONAL KNOWLEDGE Protection of traditional knowledge and folklore CONCLUDING REMARKS

Background on TRIPS & CBD, TK discussions in the WTO Rio summit 1992: Traditional knowledge (TK) or relationship with the CBD not raised in the Uruguay Round negotiations (WT/CTE/W/8). Discussions on the relationship between the TRIPS Agreement and the CBD began in the WTO in the Committee on Trade and Environment in 1995 Brought into the TRIPS Council through the built-in review of Article 27.3(b) in 1999

BACKGROUND (contd.) Picked up momentum in the run up to Seattle with proposals on amending TRIPS to include TK submitted by developing country groups. No result at Seattle but was seen as important by all. Discussion continued through 2000-2001. GC Special Session on Implementation directed continued examination of the relationship between TRIPS and CBD - several papers submitted Doha work programme.

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

Extension: para. 12 of Doha Declaration “Work programme Implementation-Related Issues and Concerns ... 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

Organization of work since Doha Paragraph 19 - Regular meetings of the TRIPS Council. Three separate items on the agenda of TRIPS Council since 2002 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

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.

Relationship between TRIPS and the CBD Two issues: Whether or not there is conflict between the two Whether or not something needs to be done in the WTO on the TRIPS side to ensure mutual supportiveness If yes, what? Two widely shared aims: Avoidance of erroneous patents Securing prior informed consent and benefit sharing Importance of not unduly burdening patent offices and users of the patent system generally recognized. See Secretariat’s summary note - IP/C/W/368/Rev.1 and Corr.1

Compatibility of TRIPS and CBD and action recommended (1) 4 positions: 1. No conflict There is no legal conflict between TRIPS and CBD Both have different and non-conflicting objectives Nothing needs to be done on the TRIPS side to ensure that the two are implemented in a mutually supportive way at the national level Willing to engage constructively on the basis of widely shared objectives Ensuring authorized access and equitable benefit sharing Avoiding erroneously granted patents 2. No conflict but undecided whether international action desirable Further study is needed, including sharing of national experiences to examine pros and cons of different approaches

Compatibility of TRIPS and CBD and action recommended (2) 3. No inherent conflict, but international action desirable Both can and should be implemented in a mutually supportive way A disclosure requirement on patent applicants is needed: Amendment to TRIPS required Amendment to PCT regulations but not TRIPS Mandatory for all patent applications 4. Inherent conflict Need to reconcile CBD and TRIPS as part of the review of Article 27.3(b) by amendment to TRIPS Patents over genetic resources not compatible with sovereignty A mandatory prohibition of patents on life forms, including on microorganisms as well as a disclosure requirement in TRIPS

International action - Disclosure approach An obligation upon patent applicants using genetic resources and associated traditional knowledge in inventions to disclose at least the source and/or country of origin of such resources or knowledge Brazil et al (“Disclosure Group”), EC, Norway, Switzerland

Comparative table of the disclosure proposals Brazil, India, Peru etc. Norway EC Switzerland Amendment TRIPS Article 29bis Article 29bis ---------- PCT Regulations Elements of disclosure The country providing biological resources (BR) and/or associated traditional knowledge (TK), the provider, the country of origin if known after reasonable inquiry Evidence of compliance with national reqmts. on prior informed consent; fair & equitable benefit sharing from commercial or other use Source of GR and TK , even if unrelated to GR. Country of origin, if known Evidence of compliance with national reqmts. on prior informed consent CBD Clearing-House Mechanism country of origin, if readily known. If not, source of GR and related TK Patent offices should send information received to the country/CBD Clearing-House Mechanism source of genetic resources (GR) and TK Patent offices should send information received to the country (list of government agencies) Mandatory or optional mandatory Optional at international level, mandatory at national level

Comparative table of the disclosure proposals Brazil, India, etc. Norway EC (in WIPO) Switzerland (in WIPO) Trigger for disclosure Where invention concerns, is derived from or developed with BR and TK -------------- GR and TK: direct basis & awareness (i.e. know or have reason to know this) Where invention is directly based on or makes immediate use + physical access (GR) or is consciously derived (TK) Legal effects of non-compliance: Pre-grant - to prevent the further processing of applications or the grant of patent; - Delay of the processing of applications; - Delay of the processing of patent applications; Post-grant to revoke; to render unenforceable Including in cases of false or fraudulent info. - legal effects should be outside the ambit of patent law (civil and/or administrative sanctions). - invalidation of granted patents, if due to fraudulent intent; - Could include criminal sanctions, including fines.

Current work in the WTO on CBD as an implementation issue Recent important submissions: Text of Article 29bis by Disclosure Group (IP/C/W/474 + Addenda) – now has support of 77 developing country Members Norway (IP/C/W/473, 491) Japan’s database proposal in WIPO (IP/C/W/472, 504) to establish a database related to genetic resources and traditional knowledge, which is accessible by patent examiners in any country Older important submissions referenced in IP/C/W/368/Rev.1

Coordination with other organizations TRIPS Council calls for information on the work of other organizations and are also informed of this through Members Work in WIPO: IGC – WTO Secretariat participates as observer. Work in the CBD: Working Group on Access and Benefit Sharing – WTO Secretariat participates as observer. Work in the FAO reported upon from time to time in the TRIPS Council. UNEP, UNCTAD: reports on seminars, symposia and expert meetings Among relevant international IGOs, only FAO, WIPO, UN, UNCTAD and UPOV have observer status in the TRIPS Council. Application of CBD under consideration along with others.

Protection of Traditional Knowledge and Folklore (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

Protection of Traditional Knowledge and Folklore (2) 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