 
  WORLD TRADE  
ORGANIZATION  IP/C/W/429 
21 September 2004 
 
 (04-3967) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
ELEMENTS OF THE OBLIGATION TO DISCLOSE THE SOURCE AND 
COUNTRY OF ORIGIN OF BIOLOGICAL RESOURCE AND/OR 
TRADITIONAL KNOWLEDGE USED IN AN INVENTION  
  
Submission from Brazil, India, Pakistan, Peru, Thailand, and Venezuela
 
   The following submission, dated 20 September 2004, is being circulated at the request of the 
Delegations of Brazil, India, Paki stan, Peru, Thailand and Venezuela. 
  
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 I. INTRODUCTION 
1. By a communication dated 2 March 2004 (hereaf ter, the Communication) the delegations of 
Bolivia, Brazil, Cuba, Ecuador, India, Peru, Thaila nd and Venezuela submitted a Checklist of Issues 
on the relation between the Agreement on Trade-Rela ted Aspects of Intellectual Property (TRIPS) and 
the Convention on Biological Diversity (CBD) with the aim of facilitating more focused, structured 
and result-oriented discussions on this issue.
1  Focussed, structured and result-oriented discussions on 
the relationship between the TRIPS Agreement and the CBD are crucial in ensuring that the TRIPS 
Council fulfils the Doha mandate to address this issue.2  The purpose of the checklist, which was 
drawn up on the basis of the issues raised by various delegations since 1999 and which took into 
account various notes prepared by the Secretariat,  especially documents IP/C/W/368 and IP/C/W/370 
was therefore to assist and expedite the process and not to limit the ambit of the discussions.   
2. At the TRIPS Council meeting held on 8 March 2004, at which the Checklist of Issues was 
first discussed, virtually all members agreed on the need for focussed and structured discussion on this 
issue.  In addition, most Members agreed that the Checklist of Issues iden tified in the Communication 
formed a good basis for further deliberations in th e Council.  In particular, many Members expressed 
the view that issues relating to disclosure of the source and country of origin of biological resource 
and/or traditional knowledge used in an inventio n were prime candidates to move the discussion 
forward and as such an area on which there were significant possibilities for convergence of views.  In 
the TRIPS Council meeting held on 16 June 2004, some Members made useful substantive comments 
on the issues included in the checklist.  This Comm unication is aimed at carrying the process forward 
by developing some of the issues relating to first of the three sets of issues identified in the checklist 
                                                      
1 See IP/C/W/ 420 and IP/C/W/420 Add. 1. 
2See paras. 12 and 19 read together with pa ra. 47 of the Doha Mi nisterial Declaration 
(WT/MIN(01)/DEC/1). 
 IP/C/W/429 
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 i.e., the disclosure of source and country of or igin of biological r esources and/or traditional 
knowledge used in inventions.  
II. HOW WOULD AN OBLIGATION FOR DISCLOSURE OF SOURCE AND 
COUNTRY 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? 
3. A number of cases have been documented where patents have been issued with respect to 
genetic resources and products or processes that ha ve been known and used by traditional or local 
communities for many years and even centuries. Cas es such as those relating to turmeric, Neem tree, 
Hoodia and ayahuasca have been widely publicised  and discussed.  These cases involving various 
levels of bio-piracy have raised serious questi ons about the quality of patent examination.  One 
argument that has been advanced in defence of patent examiners is that the relevant prior art was not 
available to them and there was no way of knowing that the claimed invention was in fact not a patentable invention at all.  A number of possi ble principles and mechanisms to improve patent 
examination with respect to genetic resources and traditional knowledge have been proposed mainly 
aimed at improving the availability of prior art in formation relating to these resources.  However, 
none of these mechanisms is likely to make ava ilable all prior art information while addressing 
important cultural and religious sensitivities associat ed, in particular, with  traditional knowledge.  
4. Many of these mechanisms are also voluntary and provide no guarantee that in fact patent 
examiners in different countries will consider this in formation in the prior art search.  Consequently, a 
legally binding obligation to disclose the source and country of origin of biological resource and/or 
traditional knowledge used in inven tions will guide the patent examiner s in ensuring  that all relevant 
prior art information is available to the patent exam iners.  Disclosure will also be relevant in helping 
patent examiners determine whether the claimed inve ntion constitutes an invention that is excluded 
from patentability under Article 27 pa ragraphs 2 and 3 of the TRIPS Ag reement.  Further, disclosure 
would serve as part of a process to systematise available information of biological resources and 
traditional knowledge that will c ontinuously build the prior art information available to patent 
examiners and the general public.  
5. In addition to matters relating prior art, pate ntability and exclusions to patentability, the 
disclosure requirements will also be useful in cases re lating to challenges to patent grants or disputes 
on inventorship or entitlement to a claimed inve ntion as well as infringement cases.  It has already 
been shown in the TRIPS Council that patent cha llenges involve a great cost in terms of time and 
resources, and are not a suitable option for developing countries.  Patent grant challenges, cases on 
inventorship or entitlement as well as infringement cases form an important component of processes that ensure patent quality. In this regard, it is not eworthy that disclosure requirements of various types 
are already an accepted norm in international patent law practice.  
6. Some national patent laws require patent app licants to inform the patent authorities of 
information that may be useful in assessing the valid ity of patent claims or in understanding the 
invention.  At the international level, Article  29 of the TRIPS Agreement, for example, obliges 
Members to require that patent applicants disclo se the invention in a manner sufficiently clear and 
complete for the invention to be carried out by  a person skilled in the art and may require the 
applicant to indicate the best mode to carry out th e invention known to the inventor.  That article 
further permits Members to require an applicant to provide information concerning the applicant's 
corresponding foreign applications and grants.  Th ese existing rules on disclosure of various types of 
information are meant to ensure the quality of patents that are granted as well as to ensure 
transparency.  It is clear theref ore that an obligation to disclose source and country of origin of 
biological resource and/or traditional knowledge used  in an invention would play a critical role in 
ensuring patent quality.  IP/C/W/429 
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 III. WHAT IS THE MEANING OF DISCLOSURE OF SOURCE AND COUNTRY OF 
ORIGIN OF BIOLOGICAL RESOURCE AND OF THE TRADITIONAL KNOWLEDGE USED IN THE INVENTION? 
7. A number of questions have been raised relating to the meaning of the proposed obligation to 
disclose the source and country of origin of a biol ogical resource and traditiona l knowledge used in an 
invention.  Among others, the ques tions relate to whether the oblig ation would be a substantive or 
formal requirement relating to patentability; what level of use of the resource in the invention would 
be sufficient to trigger the obligation; and, what  the administrative and cost burdens of such an 
obligation would be.  
8. The disclosure of source and country of orig in of biological resource and/or traditional 
knowledge used in an invention will have both subs tantive and formal implications. Similarly, any 
use, the disclosure of which is necessary to determ ine the existence of prior art, inventorship or 
entitlement to the claimed invention, the scope of  the claim and/or is necessary for understanding or 
carrying out the invention would be sufficient to trigge r the disclosure obligation.  In this regard, even 
where the use was only incidental, it would be sufficien t to trigger the obligation if the disclosure of 
the source and country of origin is relevant for pr ior art, inventorship or entitlement determinations, 
the scope of the claim and/or for understanding or carrying out the invention.  Among others, the uses 
that would be relevant for prior art, inventorship  or entitlement determinati ons, the determination of 
the scope of the claims and/or for understanding or  carrying out the invention could include, among 
others, where the biological resource and/or traditional knowledge is used: 
(a) to form part of the claimed invention; 
(b) during the process of developing the claimed invention; 
(c) as a necessary prerequisite for th e development of the invention; 
(d) to facilitate the development of the invention; and, 
(e) as necessary background material for the development of the invention. 
9. Suggestions have also been made to the effe ct that a disclosure obligation relating to the 
source and country of origin of biological res ources and/or traditional knowledge would impose a 
significant administrative and cost burden on patent applicants.  While there will be administrative 
implications and there may be cost implications for applicants as they are expected to at least employ 
all reasonable measures to determine the  country of origin and  source of the material to meet this 
obligation, it is not foreseen that administrative pr ocedures and costs related to meeting the obligation 
would be in any way burdensome.  As a matter of patent law practice there are a number of other 
disclosure requirements including disclosure of best mode.  As already noted, there are already a 
number of Members that require such a disclosure of source and country of origin of biological 
resources and/or traditional knowledge used in an invention.  
10. The collection and recording of the informati on necessary to meet the obligation should not 
require applicants to undertake significant add itional recording and documentation outside what 
would be done in the process of developing an invent ion even where there is no disclosure obligation. 
The only significant difference would be that from the information that is usually collected and 
recorded in the process of invention, the applicants  would have to cull out information relating to use 
of biological resource and/or traditional knowledge .  The disclosure obligation as envisaged, taking 
into account existing practice would therefore not im pose any burdensome administrative or costs on 
applicants. IP/C/W/429 
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 IV. WHAT WOULD BE THE LEGAL EFFECT OF WRONGFUL DISCLOSURE OR 
NON-DISCLOSURE? 
11. There has been significant debate on the legal e ffect on the application or granted patent in 
cases where there is insufficient, wrongful or no disclosure of the biological resource and/or traditional knowledge used in an invention.  As al ready noted, the proposed disclosure requirement 
will have both formal and substantiv e components and implications.  The nature of the legal effect of 
insufficient, wrongful or no disclosure will depend on whether one is dealing with a formal or 
substantive component of the disclosure and whethe r it is at the level of pre or post-grant.  
12. In this context, where the insufficient, wrongf ul or no disclosure is discovered before the 
examination or grant of a patent, the legal effect c ould be that the application would not be processed 
any further until the submission of the necessary disc losure declaration.  This could be accompanied 
with penalties and time limits within which th e proper disclosure should be made otherwise the 
application could be deemed withdrawn.  In essence,  the insufficient, wrongful or no disclosure of the 
source and country of origin of biological res ource and/or traditional knowledge should justify the 
non-processing of the application as it affects the determination of prior art, inventorship or 
entitlement to the claimed invention, the scope of the claim and/or whether it is necessary for 
understanding or carrying out the invention.  
13. Where the insufficient, wrongful or lack of disclosure is discovered after the grant of a patent, 
the legal effect could include: 
• Revocation of the patent where it is determined  that the proper disclosure would have led to 
the refusal to grant the patent either on the grou nds of lack of novelty due to the existence of 
prior art or on grounds of ordre public or morality and where there is fraudulent intention for 
the insufficient, wrongful or lack of disclosure.   In addition, to revocation criminal and/or 
administrative sanctions may also be imposed, for example, where the insufficient, wrongful 
or lack of disclosure amounts to a false representation; 
 
• Full or partial transfer of the rights to the invention where full disclosure would have shown 
that the another person or  community or government al agency is the invent or or part inventor 
or would otherwise be entitled to all or part of the claimed invention;  and, 
 
• Narrowing the scope of the claims where parts of  the claims are affected due to lack of 
novelty or fraudulent intention or where full di sclosure would have led to refusal to admit 
those parts of the claims.  
 
 We are mindful that the above-mentioned con cepts will be further developed where Members 
may need to reflect on the mechanism to implemen t such concepts, which could include judicial 
review, as necessary.  While 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 
insufficient, wrongful or no disclosure is effective in terms of its deterrent, compensatory and equity 
value. 
 
14. It should be noted here also that apart from th e above possible legal effects of insufficient, 
wrongful or no disclosure of the source and country of origin of biological resource and/or traditional 
knowledge used in an invention there may be separat e and additional legal effe ct related to enforcing 
obligations related to prior informed consent (PIC ) and benefit sharing (BS) which are not discussed 
here.  IP/C/W/429 
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 V. ON WHOM SHOULD THE BURDEN OF PROOF LIE? 
15. An application will be deemed to prima facie  comply with the disclosure requirement if it 
contains a declaration in a prescribed form indicating the source and country of origin of the biological resource and/or traditional knowledge used in an invention.  However, this will only cover 
the basic part of the question of burden of proof.  It is anticipated that while the submission of a 
declaration of the source and country of origin of  a biological resource and/or traditional knowledge 
used in an invention would - facie  establish compliance with the disclosure requirement, the applicant 
will be required to positively discharge a burden of proof that the genetic resource and/or traditional 
knowledge was legally and legitimately accessed and th at benefit sharing had or would take place if a 
patent is granted with respect to the invention that used the biological resource and/or traditional 
knowledge.  The issue of how the disclosure under the patent system would relate to prior informed 
consent and access and benefit sharing regimes would be  dealt with in the second and third sets of the 
issues in the Checklist of Issues. 
VI. IN WHAT MANNER SHOULD THE PROPOSED OBLIGATION OF DISCLOSURE 
OF SOURCE AND COUNTRY OF ORIGIN AND ASSOCIATED TRADITIONAL 
KNOWLEDGE BE INTRODUCED IN  THE TRIPS AGREEMENT? 
16. The obligation on applicants to disclose the s ource and country of origin of a biological 
resource and/or traditional knowledge used in an invention contemplates a positive obligation to be 
imposed on patent applicants.  A number of Memb ers already require patent applicants in their 
territories to disclose the source and country of origin of a biological resource and/or traditional knowledge used in the invention. 
17. However, bio-piracy is a global problem and mo re often than not, involves the acquisition of 
material in one country and seeking of a patent in  another country.  This means that relying on 
national measures alone is not sufficient to addr ess the bio-piracy problem.  To ensure the 
effectiveness of the contemplated obligations on the applicants, a positive and mandatory obligation 
needs to be imposed on Members to require the disclos ure by patent applicants in their territories of 
the source and country of origin of the biological  resources and/or traditional knowledge used in 
inventions.  Such a positive and mandatory obligatio n could be introduced into the TRIPS Agreement 
either by appropriately amending the existing prov isions or by introducing a new article in the 
Agreement. 
 
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