WORLD TRADE  
ORGANIZATION  IP/C/W/438 
10 December 2004 
 
 (04-5467) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
THE RELATIONSHIP BETWEEN TH E TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOGICAL DIVERSITY (CBD) AND THE 
PROTECTION OF TRADITIONAL KNOWLEDGE-ELEMENTS 
OF THE OBLIGATION TO DISCLOSE EVIDENCE OF 
PRIOR INFORMED CONSENT UNDER THE 
RELEVANT NATIONAL REGIME 
 
 
Submission from Bolivia, Brazil, Cuba, Ecuador, I ndia, Pakistan, Peru, Thailand and Venezuela  
 
 The following communication, dated 30 November 2004, is being circulated at the request of 
the delegations of Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand and Venezuela.  It 
was circulated as an advance copy for the Council's meeting on 1-2 December 2004.  
_______________ 
 
 
I. INTRODUCTION 
1. By means of a communication, dated 2 March 2004,  the delegations of Bolivia, Brazil, Cuba, 
Ecuador, India, Peru, Thailand and Venezuela s ubmitted a Checklist of Issues on the relationship 
between the TRIPS Agreement and the Convention on Biological Diversity (CBD) with the aim of 
facilitating more focused, structured and result-oriented discussions on this issue.
1  Following the 
discussions in the Council for TRIPS meetings held  on 8 March 2004 and on 16 June 2004, at which 
some Members made useful substantive comment s on the issues included in the Checklist, the 
delegations of Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand, and Venezuela 
submitted a communication elaborating on the first of  the three sets of issues identified in the 
Checklist i.e., the disclosure of source and country of origin of biological resources and/or traditional 
knowledge used in inventions.  
2. This communication elaborates on the second elem ent of the checklist of issues as a basis for 
further discussion in the Council.  It should be noted,  however, that the elements relating to disclosure 
of origin and source of biological material used in inventions and the el ements relating to prior 
informed consent and benefit-sharing are closely interlinked.  This communication should therefore 
be read together with the submission contained in document IP/C/W/429/Rev.1. 
                                                      
1 See IP/C/W/420 and IP/C/W/420/Add.1. IP/C/W/438 
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 II. DISCLOSURE OF EVIDENCE OF PRIOR INFORMED CONSENT UNDER THE 
RELEVANT NATIONAL REGIME 
1. How would furnishing evidence of prior in formed consent facilitate achieving the 
objectives of the CBD and ensure a harmonious relationship between the CBD and the TRIPS Agreement?  Could contractual arrangements for ensuring prior informed consent and 
benefit-sharing suffice to achieve the objectives of the CBD in this regard? 
3. Article 15 of the CBD requires, in recognition of the sovereign rights of States over their 
natural resources,
2 that access to genetic resources shall be s ubject to the prior informed consent of the 
Contracting Party providing such resources, unless otherwise determined by that Party.3  The CBD 
also provides that States have the responsibility to ensure that activities within their jurisdiction or 
control do not cause damage to the environment of other States or of areas beyond the limits of 
national jurisdiction.4  In essence, these provisions are aimed at regulating, in particular, access by 
persons from outside the State that holds the genetic  resources, a task that requires cooperation and 
enforcement in third countries.  Indeed, Article 5 of the CBD recognizes cooperation of this nature, 
including through competent international organi zations, for conservation and sustainable use of 
biological diversity.  In order that this is fully supportive of innovation, intellectual property rights 
may have to be integrated into such an exercise.  Consequently, the mandatory furnishing of evidence 
of prior informed consent by patent applicants w ould facilitate the monitoring, and coupled with other 
laws, the enforcement of the requirements of Artic le 15 of the CBD.  This amounts basically to a 
transparency exercise in the form of additional info rmation in patent applica tions, an approach which 
allows a harmonious construction of  the TRIPS Agreement and the CBD. 
4. There is no doubt that today, genetic resour ces provide critical inputs for research and 
development of new products in many technological and industrial sectors.  The terms of access to 
genetic resources are therefore important considerati ons for researchers and bio-prospectors many of 
whom heavily use the patent system.  The CBD seeks, among other things, to regulate access to 
genetic resources, while ensuring their sustainable use.  While facilitated access to genetic resources 
is of importance to researchers and bio-prospectors,  prior informed consent by providers of genetic 
resources and arrangements for fair and equitable be nefit-sharing are critical issues for biodiversity 
rich countries as well as local and indigenous comm unities.  In this regard, the TRIPS Agreement and 
the implementing national legislations have a critical role to play to ensure that the researchers and 
bio-prospectors that use the patent system fulfil these requirements.  
5. Ensuring that the patent system is supportive of the objectives of the CBD, by promoting 
compliance with the access legislation in the countr ies of origin of the genetic resources, would 
contribute positively to the realization of the stat ed objectives and principles of the TRIPS Agreement. 
It has been acknowledged, in particular, that equity , which is an established principle of intellectual 
property law, dictates that a person should not be ab le to benefit from explo iting intellectual property 
rights based on genetic resources or associated knowle dge acquired in contravention of any legislation 
governing access to that material.5  The establishment of an equitable and balanced system for the 
acquisition, maintenance and enforcement of IPRs, which is inclusive of the interests of all sections of 
the society, would effectively be in line with the obj ectives enshrined in Article 7 of TRIPS.  Article 8 
of the TRIPS Agreement, furthermore, clearly rec ognizes the rights of Members to "in formulating or 
amending their laws and regulations, adopt measures necessary to protect public health and nutrition 
and to promote the public interest in sectors of vital importance to their socio-economic and 
technological development".  Finally, it should be  noted that Article 27.2 and 27.3 of the TRIPS 
                                                      
2 See Article 15(1) of the CBD. 
3 See Article 15(5) of the CBD. 
4 See Article 3 of the CBD. 
5 See IP/C/W/403.  IP/C/W/438 
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 Agreement, in setting forth several exclusions fro m patentability, address many broader societal and 
public interest concerns and objectives, such as protecting " ordre public  and morality" and avoiding 
"serious prejudice to the environment". 
6. Establishing a relationship of mutual s upportiveness and harmony between the TRIPS 
Agreement and the CBD would, therefore, enha nce the credibility of the patent system by 
contributing to the realization of the stated principl es and objectives of TRIPS itself.  In this context, 
the TRIPS Agreement and the CBD could be seen as two sides of the same system, aimed at promoting a consensual access to and sustainable use of genetic resources, whilst ensuring the fair and 
equitable sharing of the benefits arising out of  the utilization of the components of biodiversity. 
7. Arguments are advanced by some to use a sep arate law or contract law to achieve prior 
informed consent and not link the CBD obligation with the TRIPS Agreement.  However, firstly, 
there is no obligation to legislate on this issue in international law, at least not in all countries, 
particularly those which are not Members of the CBD .  Secondly, there also is no obligation to enter 
into or enforce a contract in the specific circumstances requiring pr ior informed consent.  While 
contractual arrangements may have a role to play in implementing the requirements of prior informed 
consent, and could constitute the evidence of prior informed consent, clearly such arrangements alone 
can not suffice to ensure the monitoring and enforc ement of the requirements of the CBD in third 
countries.  In effect, one could not rely on contr actual arrangements to promote the objectives of the 
CBD when Parties to a contract are of vastly une qual bargaining strengths, as would be the case when 
traditional or indigenous communities and commercial interests are involved. Contractual arrangements can only suffice if they are obligatory and enforceable.  This is what is sought to be 
achieved by requiring the furnishing of evidence of pr ior informed consent by patent applicants where 
biological material and/or associated traditional kn owledge has been used in the claimed invention. 
2. How should the evidence of prior informed  consent through approval of authorities 
under the relevant national regime be provided for? 
8. The furnishing of evidence of pr ior informed consent, as already noted, is aimed at ensuring 
that the genetic resources and/or  traditional knowledge used in an invention for which a patent is 
being sought was legally and legitimately accessed.  As with the disclosure of source and country of 
origin, it is foreseen that the requirement for furn ishing evidence of prior informed consent would be 
provided for by obligating Members to require, as a condition for acquiring patent rights, that 
applicants furnish evidence of prior informed cons ent with respect to access to genetic resources 
and/or traditional knowledge used in the invention. 
9. This requirement as well as the requirements for furnishing evidence of benefit-sharing and 
disclosing the source and country of origin of genetic resources and trad itional knowledge used in 
inventions would be fully compliant with  the ex isting relevant provisions of the TRIPS Agreement, 
including Article 62.1, as they constitute not only reasonable procedures but are in fact of significant advantage to patent applicants who use gene tic resources and traditional knowledge in their 
inventions.  The requirement will facilitate furt her and future access to those resources and will 
reduce the probability and cost of litigation on validity or entitlement to the patent.  As pointed out in 
the submission elaborating on the disclosure requirements (see IP/C/W/429/Rev.1), requiring applicants to provide information known to them or which they should r easonably know, and given 
the legitimate objectives sought to be achieved,  would not impose cumbersome or unreasonable 
burden on applicants. IP/C/W/438 
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 3. What should be the nature of obligation on the patent applicant that should satisfy the 
requirement of prior informed consent? 
10. To fulfil the requirement of furnishing evidence of  prior informed consent, the applicant will 
have a positive obligation and would therefore have  to discharge a positive burden in this regard.  
This means that the applicant will have to provi de evidence that he or she accessed the genetic 
resources and/or traditional knowledge used in the invention for which a pa tent is sought through 
approval or consent of the national authorities of the country of origin and/or the local or indigenous 
community, as applicable. 
11. It is foreseen that the applicant will be deemed to comply with the requirement of furnishing 
evidence of prior informed consent if the patent application contains and/or is accompanied by a 
declaration, in the prescribed form, indicating th at prior informed consent was obtained from the 
relevant national authorities (and local and indigenous  communities, where appli cable).  Further, the 
declaration would be accompanied, where relevant, by  the actual evidence of pr ior informed consent, 
for example, in the form of a certificate or duly certified contract between the applicant and the 
national authorities of the country of origin.  In th is regard, it should be noted that it may be possible 
that a single declaration with th e necessary evidence could be furnished to cover the requirements on 
disclosure of source and country of origin, evidence of prior informed consent as well as evidence of 
equitable benefit-sharing.  In effect, the requi rement could largely be met by having a single 
additional column in the patent applications for the applicant to declare that he or she has obtained the 
prior informed consent, and by attaching a certificat e or other instrument where such a certificate or 
other instrument has been issued by the releva nt national authorities (or the local or indigenous 
community, as appropriate).  Given the other informa tion that a patent applicant has to furnish to 
make out his case for having satisfied the patentability  criteria, this is certainly not a cumbersome 
requirement. 
4. What should be the obligation if there is no national regime in the country of origin? 
12. If a Member does not have a national access regime or competent authority to grant prior 
informed consent, it is foreseen that  the applicant will be deemed to have complied with the obligation 
by indicating in the relevant declaration that there was no national regime in the country of origin and 
that there was consent, at least, from the authority or community in charge of the location where the 
genetic resources and/or traditional knowledge was accessed. 
 
5. What should be the legal effect of not pr oviding evidence of prior informed consent 
through approval of authorities under the relevant national regime? 
13. There has been significant debate on the legal effect on the application or granted patent in 
cases where there is insufficient, wrongful or no disclosure of the source and country of origin of biological resources and/or traditi onal knowledge used in an inven tion as well as failure to provide 
evidence of prior informed consent.  The legal e ffect with respect to insufficient, wrongful or no 
disclosure of the source and country of origin bi ological resources and/or traditional knowledge used 
in an invention was considered in the earlier submis sion (see IP/C/W/429/Rev.1).  As indicated in that 
submission, there would be separate and additional le gal effects associated with enforcing obligations 
related to prior informed consent. 
14. The nature of the legal effect of not provid ing evidence of prior informed consent will depend 
on whether it is at the pre- or post-grant stage.  Where it is determined that genetic resource and/or 
traditional knowledge was used in an invention but  no evidence of prior informed consent has been 
furnished as required before the examination or grant of a patent, the legal effect could be that the 
application would not be processed any further un til the submission of the necessary declaration and 
evidence.  As with disclosure of source and country  of origin, this could be accompanied by penalties  IP/C/W/438 
 Page 5 
 
 
 and time-limits within which the proper declarati on and evidence must be provided otherwise the 
application could be deemed withdrawn.  The failu re to provide evidence of prior informed consent 
should justify the non-processing of the application.  
15. Where the failure to provide evidence of prio r informed consent is discovered after the grant 
of a patent, the legal effect could include: 
• Revocation of the patent.  In additi on to revocation, criminal and/or 
administrative sanctions may also follow , though outside the patent system, in 
particular, to ensure adequate compensa tion where it is eventually determined 
that no prior informed consent was obtained; 
 
• Criminal and/or civil sanctions, includ ing the possibility of punitive damages, 
could follow, again outside the patent sy stem, where it is determined that the 
patent holder in fact obtained prior informed consent but did not provide the 
evidence in the application.  
 
As noted in the submission on disclosure, we are mindful that the above-mentioned concepts will be 
further developed where Members may need to refl ect on the mechanism to implement such concepts, 
which could include judicial review, as necessary.  Wh ile a certain level of leeway may be given here 
on the exact legal effect for each infraction, each Member should nevertheless have an obligation to 
ensure that the effect of failure to provide eviden ce of prior informed consent, as with insufficient, 
wrongful or no disclosure of the source and country of  origin and benefit-sharing is effective in terms 
of its deterrent, compensatory and equity value.  
 
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