. /.  WORLD TRADE  
ORGANIZATION  IP/C/W/420 
2 March 2004  
 
(04-0927) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND 
THE CONVENTION ON BIOLOGICAL DIVERSITY (CBD) 
 
CHECKLIST OF ISSUES 
 
 
Submission from Brazil, Cuba, Ecuador, India, Peru, Thailand and Venezuela  
  
 The following submission, dated 26 February 2004,  is being circulated at the request of the 
Delegations of Brazil, Cuba, Ecuador, India, Peru, Thailand and Venezuela. 
 
_______________ 
 
 
I. INTRODUCTION 
 Discussions on the relationship between the Agreement on Trade-Related Aspects of 
Intellectual Property Rights (TRIPS) and the Conven tion on Biological Diversity (CBD) and how to 
ensure their mutual supportiveness have been ta king place in the Council for TRIPS since 1999.  
Specific issues have arisen within the discussion of the relationship between the TRIPS Agreement 
and the CBD.  One of the major concerns expressed is that the TRIPS Agreement allows the granting 
of patents for inventions that use genetic ma terial and associated knowledge without requiring 
compliance with the provisions of the CBD.   To the extent that bio-piracy is today accepted as a major 
problem, the challenge is to determine what measur es need to be taken within the framework of the 
TRIPS Agreement to prevent misappropriation and to support the objectives and implementation of 
the CBD.  
 More than 25 communications and papers have  been submitted by Members on the subject to 
date.  While discussions have continued in the Co uncil for TRIPS following the mandate given to the 
Council in Doha,
1 significant work remains to be done in or der to find a satisfactory solution.  This 
checklist of the issues has been prep ared in order to facilitate more  focused, structured and result 
oriented discussions.  
 
 The purpose of the checklist is therefore to assi st and expedite the process and not to limit the 
ambit of the discussions.  The checklist should be c onsidered open for Members to raise and address 
any additional elements that are of significant con cern to them.  The checklist has been drawn up on 
the basis of the issues raised and points made by  various delegations in their communications and 
statements to the Council for TRIPS since 1999 and, in  particular, in the post-Doha period.  Account 
has also been taken of the various notes prepared by  the Secretariat, especially documents IP/C/W/368 
and IP/C/W/370, both dated 8 August 2002. 
                                                      
1 See paragraphs 12 and 19 read together with paragraph 47 of the Doha Ministerial Declaration 
(WT/MIN(01)/DEC/1). 
 IP/C/W/420 
Page 2  
 
II. CHECKLIST OF ISSUES 
1. Disclosure of source and country of origin of the biological resource and of the 
traditional knowledge used in the invention 
• How would an obligation for disclosure of country and source of origin of biological resource 
and associated traditional knowledge used in an  invention help in better examination of 
patents and in preventing cases of bad patents? 
 
• What is the meaning of disclosure of source and country of origin of biological resource and 
of the traditional knowledge used in the invention? 
 
• What would be the legal effect of wrongful disclosure or non-disclosure? 
 
• On whom should the burden of proof lie? 
 
• In what manner should the proposed obligation of disclosure of source and country of origin 
and associated traditional knowledge be in troduced in the TRIPS Agreement? 
 
2. Disclosure of evidence of prior informed consent under the relevant national regime 
• How would furnishing the above evidence fac ilitate achieving the objec tives of the CBD of 
ensuring prior informed consent and harmoni ous relationship between the CBD and the 
TRIPS Agreement? Could contractual arrangeme nts for ensuring prior informed consent and 
benefit-sharing suffice to achieve the ob jectives of the CBD in this regard? 
 
• How should the evidence of prior informed c onsent through approval of authorities under the 
relevant national regi me be provided for? 
 
• What should be the nature of obligation on the patent applicant that should satisfy the 
requirement of prior informed consent? 
 
• What should be the obligation if there is no national regime in the country of origin? 
 
• What should be the legal effect of not providi ng evidence of prior informed consent through 
approval of authorities under th e relevant national regime? 
 
3. Disclosure of evidence of benefit sharing under the relevant national regime 
• What should be the meaning of evidence of benefit sharing under the relevant national 
regime? 
 
• When is this evidence to be intr oduced by the patent applicant? 
 
• What should be the obligation if there is no rele vant national regime in the country of origin? 
 
• What should be the legal effect of not providing  evidence of fair and equitable benefit sharing 
under the relevant national regime? 
  
__________