WORLD TRADE  
ORGANIZATION  IP/C/W/442 
18 March 2005 
 
 (05-1126) 
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 – ELEMENTS OF THE OBLIGATION TO DISCLOSE EVIDENCE 
OF BENEFIT-SHARING UNDER THE RELEVANT NATIONAL REGIME 
 
Submission from Bolivia, Brazil, Colombia, Cuba, Dominican Republic  
Ecuador, India, Peru and Thailand  
 
 
 The following communication, dated 4 March 2005, is being circulated at the request of the 
delegations of Bolivia, Brazil, Colombia, Cuba , Dominican Republic, Ecuador, India, Peru and 
Thailand.  It was circulated as an advan ce copy for the Council's March 2005 meeting. 
 
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I. INTRODUCTION 
1. By a communication dated 2 March 2004 the dele gations of Bolivia, Brazil, Cuba, Ecuador, 
India, Peru, Thailand and Venezuela submitted a Checklist of Issues on the relation 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  Communications elaborating 
on the first and the second of the three sets of issues identified in the Checklist i.e. elements of the 
disclosure of source and country of origin of biol ogical resources and/or traditional knowledge used in 
inventions, and elements of the obligation to discl ose evidence of prior info rmed consent under the 
relevant regime, were circulated in the TRIPS Council as IP/C/W/429/Rev.1 and IP/C/W/438 
respectively. 
2. This communication elaborates on the third 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 earlier submissions. 
A. WHAT SHOULD BE THE MEANING OF EVIDENCE OF BENEFIT -SHARING UNDER THE RELEVANT 
NATIONAL REGIME ? 
3. The disclosure of evidence of benefit-sharing aris ing out of the utilization of genetic resources 
and/or traditional knowledge in inve ntions, as contemplated, is aimed at  not only ensuring that there is 
benefit-sharing per se  but that sharing of benefits is fair and equitable among the parties, taking into 
account the circumstances of each particular case.  Th e provision of evidence of benefit-sharing will 
therefore include evidence that th ere was sharing of the benefits arising out of the utilization of the 
                                                      
1 See IP/C/W/420 and IP/C/W/420/Add. 1. IP/C/W/442 
Page 2  
 
 genetic resources and/or traditional knowledge in the invention and that the shares of benefits that 
accrued to the source and country of origin and/or  local/indigenous community, where applicable, was 
equitable and fair in the circumstances.  While it has been argued that there may be no straight-forward way of determining the equitable and fair sh aring of benefits, in the very least there are a 
number of factors that could be used to make this determination.  These include, among others: 
• assuming that there was sufficient prior informed  consent, that the sharing of benefits 
or an arrangement for future sharing of be nefits is premised upon mutually agreed 
terms in the context of Article 15(7) of the CBD.  Mutually agreed terms generally 
cover elements relating to the conditions, obligations, procedures, types, timing, distribution and mechanisms of the benefits shared;  and 
 
• that there is a reporting obligation on issues relating to patenting or commercialisation 
especially where future benefit-sharing is contemplated.  
 
4. In this regard, given that the CBD recognizes th e rights of states to prescribe the conditions of 
access to the genetic resources that are under their s overeign jurisdiction, it is expected that the 
prevalent laws and practices of the countries of origin of the genetic resources and/or associated 
traditional knowledge should provide the framework w ithin which to determine the terms of fair and 
equitable benefit-sharing. 
5. Some have argued that requiring patent applicants  to disclose evidence of benefit-sharing, as 
well as the origin of genetic resources and ev idence of prior informed consent, cannot, per se , transfer 
benefits.
2  Mechanisms for benefit-sharing, it has been  suggested, should be established at the national 
level.  It should be pointed out, however, that a requi rement for patent applicants to disclose evidence 
of benefit-sharing and prior informed consent would not be intended as a replacement for or 
alternative to national access and benefit-sharing re gimes.  On the contrary, it is intended that a 
requirement of disclosure of evidence of benefit-sharing would operate, in effect, as a vital supplementary measure and a necessary incentive for pa tent applicants to comply with the prevalent 
laws and practices of the countries of origin of  the genetic resources and/or associated traditional 
knowledge, in accordance with the objectives and norms of the CBD.  
6. In this regard, bio-prospectors, researchers a nd other prospective pate nt applicants who are 
committed to accessing biological resources and associated traditional knowledge in a fully lawful manner would have nothing to fear from disclosure requirements relating to benefit-sharing and prior 
informed consent.  The disclosure requirement shoul d not be found cumbersome in the least, given 
that such a requirement would do little other than ask of  patent applicants that they supply information 
to the effect that the laws of the countries of origin  of the genetic resources have been fully complied 
with. 
7. On the other hand, as has been pointed out in previous submissions, bio-piracy is a global 
problem and, more often than not, involves the acqui sition of material in one country and the seeking 
of a patent over that material, or over inventions deriving from or involving that material, in another 
country.  Hence, while national level a ccess and benefit-sharing regimes and/or sui generis  systems 
for the protection of traditional knowledge associated with biological resources are currently being developed in several countries, such national regim es or systems by themselves could not be sufficient 
to protect and fully preserve biological materials and/or associated traditional knowledge.  For example, the ability of patent offices and other au thorities in a national jurisdiction to prevent bio-
piracy, as well as to enforce prior informed c onsent and benefit-sharing mechanisms, does not 
ipso facto  lead to similar actions in respect of patent applications in other countries. 
                                                     
 
2 See United States, IP/C/W/434.  IP/C/W/442 
 Page 3 
 
 
 8. What is needed is the establishment of an in ternational framework of protection.  Such a 
system would provide, inter alia , a procedure whereby the use of biological material and/or associated 
traditional knowledge from one country is allowed,  particularly for commercialisation and/or the 
taking out of intellectual property rights, only after the competent authority in the country of origin certifies that the source of origin has been disclo sed, and that prior informed consent and benefit-
sharing conditions have been accepted.  The pa tent system should be supportive of, and not run 
counter to, the objectives of such a framework.  The TR IPS Agreement, in effect, has a role to play in 
supporting its operation.  As in the case of disclosure of evidence of prior informed consent, requiring 
patent applicants to provide evidence of fair and equitable benefit-sharing will enhance the credibility 
of the patent system by contributing to the reali zation of the stated objectives and principles of TRIPS 
itself, as enshrined in Articles 7 and 8 of this WTO Agreement.
3 
B. WHEN IS THIS EVIDENCE TO BE INTRODUCED BY THE PATENT APPLICANT ? 
9. There have been questions raised about the poi nt when evidence of benefit-sharing should be 
introduced by the patent applicant since, it is argu ed, that the benefit-sharing could only take place 
after the grant of a patent and the commercialisation of the relevant technology.  While this may be 
true, it does not necessarily raise a problem with respect  to furnishing evidence of benefit-sharing at 
the time of applying for the grant of a patent.  In the first instance, the very fact of gaining access may 
trigger a certain level of benefit-sharing.  To j uxtapose with patent law, it is common practice that 
companies or individuals who require access to bac kground intellectual property to undertake further 
research and development may pay for the benefit of having access to such background information. 
10. More importantly, however, where the real be nefits can only arise from the patenting and 
commercialisation of the invention which utilised ge netic resources and/or traditional knowledge, the 
applicant will still have to provide evidence at the time  of the application.  The nature of the evidence 
contemplated here is evidence of the existence of an  arrangement for the fair and equitable sharing of 
any benefit that may arise out of the utilization of the resources, in accordance with the terms of the 
country of origin's national laws, regulations and practices.  It coul d also be contemplated that the 
applicant would, in providing evidence of the existen ce of an arrangement to ensure future sharing of 
benefits, have to indicate how the national au thority (and community, where applicable) would 
enforce such an arrangement without having to resort  to expensive litigation.  This is an important 
consideration because it can not always be assumed that the two parties, especially where local or 
indigenous communities are involved, would be able  to negotiate and enforce the arrangement on 
equal terms. 
C. WHAT SHOULD BE THE OBLIGATION IF THERE IS NO RELEVANT NATIONAL REGIME IN THE 
COUNTRY OF ORIGIN ? 
11. Where there is no national regime a similar appro ach to that taken for prior informed consent 
discussed in Document IP/C/W/438 would apply.  In pa rticular, it is foreseen that the applicant will be 
deemed to have complied with the obligation by indi cating in the relevant declaration that there was 
no national access and benefit-sharing regime in the c ountry of origin, but that there was, in any case, 
benefit-sharing or an arrangement for future bene fit-sharing with the authority or community in 
charge of the location where the genetic resources and/or traditional knowledge were accessed, in a 
manner that fully respects the prevalent laws, regulations and practices of the country of origin. 
                                                      
3 See IP/C/W/438. IP/C/W/442 
Page 4  
 
 D. W
HAT SHOULD BE THE LEGAL EFFE CT OF NOT PROVIDING EVIDENCE  OF FAIR AND EQUITABLE 
BENEFIT -SHARING UNDER THE RELE VANT NATIONAL REGIME ? 
12. To fulfil the requirement of furnishing evidence of  benefit-sharing, the applicant will have to 
discharge a positive obligation.  As with the disclosure of source and country of origin and evidence of prior informed consent, it is foreseen that the requirement for furnishing evidence of benefit-
sharing would be provided for by obligating Memb ers to require, as a condition for acquiring patent 
rights, that applicants furnish evidence of fair an d equitable benefit-sharing with respect to genetic 
resources and/or traditional knowledge used in the inve ntion.  The nature of the legal effect of not 
providing evidence of benefit-sharing will also depend on whether it is at the pre or post-grant stage. 
13. Where it is determined that genetic resources and/or traditional knowledge was used in an 
invention but no evidence of benefit-sharing or an  arrangement for future benefit-sharing 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 and prior informed consent, this could 
be accompanied with penalties, including criminal penalties where appropriate, and time-limits within 
which the proper declaration and evidence must be provided.  Otherwise the application could be 
deemed withdrawn.  The failure to provide ev idence of benefit-sharing should justify the non-
processing of the application.  
14. Where the failure to provide evidence of benef it-sharing is discovered after the grant of a 
patent, the legal effect could include: 
• Revocation of the patent where it is determin ed that there is fraudulent intention behind 
the failure to provide evidence of benefit-shari ng.  In addition to, or as an alternative to 
revocation, criminal and/or administrative san ctions may also be imposed, in particular, 
to ensure adequate compensation where it is  eventually determined that no benefits 
were shared or are intended to be shared; 
 
• Full or partial transfer of the rights to the inve ntion, also as an alternative to revocation, 
as a means of promoting fair and equitable benefit-sharing; 
 
• Criminal and/or civil sanctions, outside the patent system, including the possibility of 
punitive damages, where it is determined that  the patent holder in fact provided benefits 
but did not provide the evidence in the application.  
 
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