WORLD TRADE  
ORGANIZATION  IP/C/W/446 
30 May 2005 
 
 (05-2182) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
THE RELATIONSHIP BETWEEN THE TRI PS AGREEMENT AND THE CONVENTION 
ON BIOLOGICAL DIVERSITY (CBD) AND THE PROTECTION OF TRADITIONAL 
KNOWLEDGE AND FOLKLORE AND TH E REVIEW OF IMPLEMENTATION 
OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1 
 
Communication from Switzerland  
  
 The following communication, dated 27 May 2005, is being circulated at the request of the 
Delegation of Switzerland. 
  
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 I. INTRODUCTION 
1. Paragraph 19 of the Doha Ministerial Declar ation mandates the TRIPS Council, in pursuing 
its work programme, to examine, inter alia , the relationship between the TRIPS Agreement and the 
Convention on Biological Diversity, the protection of traditional knowledge a nd folklore, and other 
relevant new developments raised by members pursu ant to Article 71.1.  According to this mandate, 
the TRIPS Council has discussed relevant issues un der these three agenda items.  Several members 
have submitted a number of communications to the TRIPS Council regarding these agenda items.
1  
Some of these communications contain proposals on how to address issues arising in the context of access and benefit sharing with regard to gene tic resources and traditional knowledge and the IPR 
system. 
2. Switzerland presented three communications on its proposals on the declaration of the source 
it submitted to WIPO's Working Group on PCT Reform.
2  These proposals would explicitly enable 
the national patent legislation to require patent app licants to declare the source of genetic resources 
and traditional knowledge in patent a pplications, if an invention is directly based on these resources or 
this knowledge.  Furthermore, these proposals would a fford applicants the possibility of satisfying this 
requirement at the time of filing an international pa tent application or late r during the international 
phase. 
3. The present communication by Switzerland contains a list of questions on the proposals of 
other members as referred to above.  The questions  endeavor to clarify certain points of these 
proposals and to thus allow the Council to better un derstand the concerns addressed and to evaluate 
solutions suggested.  Switzerland, which has pa rticipated actively and constructively in the 
discussions of the TRIPS Council on these agenda item s, hopes to contribute with this communication 
                                                      
1 See documents IP/C/W/420, IP/C/W/429/Rev.1, IP/C/W/434, IP/C/W/438, IP/C/W/441, IP/C/W/442, 
and IP/C/W/443. 
2 See documents IP/C/W/400/Rev.1, IP/C/W/423 and IP/C/W/433. IP/C/W/446 
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 to the learning process of the Council regarding the legal, technical and practical implications of the 
relevant issues and proposals. 
II. QUESTIONS REGARDING COMMUNICATIONS BY A GROUP OF DEVELOPING 
COUNTRIES
3, BY PERU4, AND BY BRAZIL AND INDIA5 
A. GENERAL QUESTIONS  
1. How do these members define the terms "biopiracy"6 and "misappropriation"7? 
2. In the context of the proposed requirements, th e proposals refer to the "country of origin":  
What is the definition of this term?  How does the country of origin relate to traditional knowledge?  
How would the focus on the "country of origin" be in  line with Article 15 of the CBD, which, in the 
context of access and benefit sharing, refers to th e "Contracting Party provid ing genetic resources"?  
What if patent applicants access genetic resources fr om a source different to the country of origin?  
Are plant genetic resources for food and agriculture under the International Treaty of FAO, due to the 
reference to the "country of origin,"8 excluded from the proposed disclosure requirement? 
3. Why do the proposals refer to "biological resources"9 and "biological material"10 instead of 
"genetic resources," that is, the terminology used in the CBD, the Bonn Guidelines and the 
International Treaty of FAO in the context of access and benefit sharing? 
4. Would the proposals have implications on WIPO's PCT and PLT? 
5. The proposals require the patent applicant to provide evidence  of fair and equitable benefit 
sharing.11 
• How can the patent applicant fulfill this requirement in practice?  When would the 
evidence provided be considered to be sufficient? 
 
• Would it be necessary for the patent granting authorities to determine the veracity of 
the information provided by the patent app licant and, if so, how could they carry out 
this task? 
 6. What circumstances would justify the proposed sanctions of the revocation of the patent
12 or 
the full or partial transfer of the rights to the invention?13 
                                                      
3 See documents IP/C/W/420, IP/C/W/429/Rev.1, IP/C/W/438, and IP/C/W/442. 
4 See document IP/C/W/441. 
5 See document IP/C/W/443. 
6 See, e.g., documents IP/C/W/420, para. 1; IP/C/W/429/Rev.1, paras. 3 and 17; IP/C/W/441, para. 4; 
IP/C/W/442, para. 7. 
7 See, e.g., document IP/C/W/443, paras. 3 and 24. 
8 The International Treaty of FAO establishes a Multilateral System of access and benefit sharing; 
accordingly, this treaty is based on a multilateral appr oach, not a bilateral approach involving individual 
countries as is the case for the CBD.  Furthermore, the International Treaty does not refer to "countries of 
origin," but to "centre of origin" and "centre of crop diversity" (see preambular para. 7 and Articles 2 and 9.1). 
9 See, e.g., document IP/C/W/429/Rev.1, para. 2. 
10 See, e.g., document IP/C/W/438, pp. 1, 2 and 3 
11 This is partly acknowledged in para. 22 of docum ent IP/C/W/443, according to which "[t]he patent  
office will need to take decisions based on these documents only when the validity of a patent is challenger in the pre- or post-grant opposition or revocation proceedings." 
12 See document IP/C/W/438, para. 15.  IP/C/W/446 
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 B. PROPOSED OBLIGATION TO DISCLOSE THE SOURCE AND COUNTRY OF ORIGIN OF THE 
BIOLOGICAL RESOURCES AND /OR TRADITIONAL KNOWLEDGE USED IN AN INVENTION14 
7. What is the definition of the term "source"?  Ho w does this term differ from the term "country 
of origin"? 
8. Would patent applicants be required to disclose the "source" and the "country of origin" or 
could they disclose either one  of them to fulfill the proposed disclosure requirement? 
C. PROPOSED OBLIGATION TO DISCLOSE EVIDENCE  OF PRIOR INFORMED CONSENT UNDER THE 
RELEVANT NATIONAL REGIME15 
9. "[T]he applicant will have to provide evidence of that he or  she accessed the genetic resources 
and/or the traditional knowledge used in the inve ntion for which a patent is sought through approval 
or consent of the national authorities of the count ry of origin and/or the local or indigenous 
community, as applicable."16 
• How can the patent applicant fulfill this requirement in practice?  When would the 
evidence provided be considered to be sufficient? 
 
• Would it be necessary for the patent granting authorities to determine the veracity of 
the information provided by the patent app licant and, if so, how could they carry out 
this task? 
 10. Who would decide whether the prior informed consent of local and indigenous communities 
is necessary? How would this procedure be carried out in practice? 
D. P
ROPOSED OBLIGATION TO DISCLOSE EVIDENCE  OF BENEFIT SHARING UNDER THE RELEVANT 
NATIONAL REGIME17 
11. The proposals require the patent applicant to su bmit evidence that the sharing of benefits was 
"equitable and fair in the circumstances."18 
• How can the required evidence that the sharing of benefits is "equitable and fair in the 
circumstances" be established by the patent applicant?  Are the two factors mentioned 
in the proposals19 appropriate to make this determin ation, especially when considering 
the various possible forms of benefits?20 
 
• Would the national legislation of the country of origin also be applicable to traditional 
knowledge,21 or would it be up to the indigenous and local community to determine 
whether the sharing of benefits is "e quitable and fair in the circumstances"? 
 
                                                                                                                                                                     
13 See document IP/C/W/442, para. 14. 
14 See document IP/C/W/429/Rev.1. 
15 See document IP/C/W/438. 
16 See document IP/C/W/438, para. 10. 
17 See document IP/C/W/442. 
18 See document IP/C/W/442, para. 3. 
19 See document IP/C/W/442, para. 3. 
20 See also Appendix II of the Bonn Guidelines. 
21 According to the proposals, "it is  expected that the prevalent laws and practices of the countries of 
origin of the genetic resources and/or associated tr aditional knowledge should provide the framework within 
which to determine the terms of fair and equitable benefit sharing" (see document IP/C/W/442, para. 4). IP/C/W/446 
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 • Who will determine whether the shares of be nefits are "equitable and fair in the 
circumstances"?  Would any such determina tion by entities other that the contracting 
parties to the contract on access and benefit sharing be in line with the contractual autonomy foreseen in the CBD with re gard to access and benefit sharing? 
 
• It is proposed to require the patent appli cant to indicate how the national authority and 
community, where applicable, would enforce an  arrangement to ensure future sharing 
of benefits without having to resort to expensive litigation.
22 How could the patent 
applicant fulfill this obligation in practice? 
 
III. QUESTIONS RE. COMMUNICATION BY THE UNITED STATES23 
1. In the view of the United States, tailored, nati onal solutions are the most effective means to 
achieve the objectives of (1) ensuring authorized acc ess to genetic resources;  (2) fair and equitable 
benefit sharing, and (3) preventing the issuance of erroneously issued patents.24  Furthermore, a 
"contract-based system can be used to effectivel y control the collection of resources and ensure the 
sharing of benefits from their use."25 
• How would a purely national approach address problems arising with regard to trans-
boundary access and benefit sharing, that is, cases where genetic resources and 
traditional knowledge are used outside the scope  of application of the national solutions 
advanced by the United States? 
 
• How would a purely contractual approach address cases where no contract on access 
and benefit sharing has been concluded betw een the provider and the user of genetic 
resources and traditional knowledge?26 
 
• How would the proposed approach take into account the generally long-term nature of 
research and development activiti es involving genetic resources? 
 
IV. QUESTIONS RE. PROPOSALS BY EURO PEAN COMMUNITY AND ITS MEMBER 
STATES TO WIPO27 
1. The EU and its member States propose to amend the PCT and the PLT. 
• Would the treaty text or the regulations be amended? 
 
• What is the wording of the provisions proposed to be amended? 
                                                      
22 See document IP/C/W/442, para. 10. 
23 See document IP/C/W/434. 
24 See IP/C/W/434, paras. 5-6. 
25 See IP/C/W/434, para. 20. 
26 This question also applies to the proposals in document IP/C/W/257, as summarized in para. 22 of 
document IP/C/W/434:  "The paper suggested that, inter alias , contracts authorizing collection of genetic 
materials include provisions requiring reporting and benefit sharing and that parties to such access agreements 
be obliged to notify the appropriate authorities in the event an invention was developed using genetic materials collected under the contract." 
27 See document "Disclosure of origin or source of genetic resources and associated traditional 
knowledge in patent applications," available at <http://www.wipo.int/tk/en/genetic/proposals/ 
european_community.pdf> 
  IP/C/W/446 
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 2. The EU and its member States propose to require pa tent applicants to declare "the country of 
origin." 
• What is the definition of the term "country of origin"? 
 
• How would the focus of the proposals on the "country of origin" be in line with Article 
15 of the CBD? 
 
3. The proposals require patent applicants, in case the country of origin of genetic resources is 
unknown to the patent applicant, to declare the s ource of genetic resources.  Who decides whether the 
country of origin is unknown to the patent applicant? 
 
 
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