WORLD TRADE  
ORGANIZATION  IP/C/W/443 
18 March 2005 
 
 (05-1147) 
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 
 
TECHNICAL OBSERVATIONS ON ISSUES RAISED IN A COMMUNICATION 
BY THE UNITED STATES (IP/C/W/434) 
 
Submission from Brazil and India  
 
 
 The following submission, dated 4 March 2005, is being circulated at the request of the 
Delegations of Brazil and India.  It was circulat ed as an advance copy for the Council's March 2005 
meeting.  
_______________ 
 
 
I. INTRODUCTION 
1. By a communication dated 26 November 2004, the delegation of the United States submitted 
a proposal
1 on the relationship between the TRIPS Agreement and the Convention on Biological 
Diversity (CBD) mainly in response to the co mmunications dated 2 March 2004 (IP/C/W/420 and 
Add. 1 submitted by the delegations of Bolivia, Brazil, Cuba, Ecuador, India, Peru, Thailand and 
Venezuela) and 27 September 2004 (IP/C/W/429/Rev. 1 and Add. 1, 2 and 3 submitted by the same delegations plus the delegations of Colomb ia, Dominican Republic and Pakistan).  The 
communication of 2 March proposed a Checklist of  Issues on the relationship between the TRIPS 
Agreement and the CBD to facilitate  more focused, structured and result-oriented discussions on this 
issue.  The 27 September communication elaborated on the first of the three sets of issues identified in 
the Checklist i.e., the disclosure of source and count ry of origin of biological resources and/or 
traditional knowledge used in inventions.  A furt her communication elaborating on the second set of 
issues in the Checklist i.e. elements of the obliga tion to provide evidence of prior informed consent 
under the relevant national regime was submitted to  the December 2004 Council for TRIPS meeting.
2 
2. In its submission, the delegation of the Unite d States indicated that it hoped that its paper 
would permit progress on this issue by identifying  common ground where it ex ists and helping reduce 
differences among Members in order to resolve con cerns expressed by various delegations.  We 
welcome the submission of the United States a nd, in particular, the desire expressed by the 
United States to resolve the differe nces on this issue, as soon as po ssible, based on the Checklist of 
Issues as contained in document IP/C/W/420.  We look forward to the continued engagement by the 
                                                      
1 See WTO document IP/C/W/434. 
2 See WTO document IP/C/W/438 submitted by Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, 
Thailand and Venezuela dated 10 December 2004. IP/C/W/443 
Page 2  
 
 delegation of the United States and all other delegations in the TRI PS Council and hope that, working 
together, we can speedily come to a concrete solu tion and fulfil the Doha mandate in this regard. 
3. In its communication, the delegation of the United States expressed a number of concerns 
regarding the proposed new patent disclosure requi rements and offered an alternative approach.  
While the communication raises some important issues, we consider that it has not made a case 
against the proposed disclosure requirement.  If anything, the communication has provided evidence 
of why the proposed disclosure requirements would be the best way of achieving the objectives of ensuring that the implementation of the TRIPS Agreement does not undermine or otherwise run counter to the objectives of the CBD.  This techni cal note is aimed at addressing the issues raised by 
the delegation of the United States and elaborating on  why a patent disclosure requirement is the only 
effective means of addressing matters relating to pa tents and misappropriation of biological resources 
and/or associated traditional knowledge.  Some of  these concerns were already addressed in the 
submission contained in document IP/C/W/438, as well as in the new submission by a group of developing countries on disclosure of evidence of benefit-sharing.  Where necessary, however, we 
will reiterate the explanations a nd justification for the various el ements of the proposed regime. 
II. GENERAL OBSERVATIONS 
4. The delegation of the United States indicates in its submission that it "views with utmost 
caution any proposals that would add uncertainties to pa tents rights that may undermine the role of the 
delicately balanced patent system".
3  There is no doubt that any system that introduces uncertainties 
and imbalances in the patent system may be detr imental to technological progress in general and 
protection of inventions in particular.  However,  the proposed disclosure requirement would in fact 
introduce much needed certainty and preserve the bala nce in the patent system in consonance with the 
objectives and principles of the TRIPS Agreements enshrined in Articles 7 and 8 and the conditions 
on patent applicants that have been established by othe r relevant Articles of TRIPS.  In this regard, it 
is important to remember that facilitated access to  biological resources and/or traditional knowledge, 
as acknowledged by the United States in its submission,4 is of significant importance to researchers 
and bio-prospectors that use the patent system.  By establishing clear internationally agreed rules on 
disclosure, prior informed consent and benefit-sh aring, the proposed requirement would go a long 
way in establishing certainty in these matters and not uncertainty.  
5. Furthermore, since disclosure of source and country of origin, prior informed consent by 
providers of genetic resources and arrangements for fair and equitable benefit-sharing are issues of 
high importance for biodiversity rich countries as well as local and indigenous communities, the 
proposed system will not only ensure the legitimacy of  the patent system but will in fact preserve and 
strengthen the balance in the system.  The balan ce will be preserved by recognizing the contributions 
of Members as well as of traditi onal and local communities to innovation directly, or through the 
conservation of biological resour ces and/or traditional knowledge.  Establishing an equitable and 
balanced system for the acquisition, maintenance a nd enforcement of patent rights, which rely upon or 
are otherwise based on biological resources and/or traditional knowledge, would also help fulfil the 
objectives of the TRIPS Agreement as expressed in Article 7. 
6. The United States also suggests that the "imple mentation of effective national laws that 
directly address the relevant goals is  the most effective way to proceed".5  As with the grant and 
enjoyment of patent rights, the implementati on of national access and benefit-sharing laws and 
policies is indeed very important if an effective syst em of protection is to be established.  However,  
acknowledgement of the importance of establishing such national systems, a task which several 
                                                      
3 See para 2 of the submission, supra note 1. 
4 See para 8 of the submission, supra note 1. 
5 See para 4 of the submission,  supra note 1.  IP/C/W/443 
 Page 3 
 
 
 countries have already undertaken or are currently  undertaking, does not in anyway provide a basis 
for rejecting the establishment of an international system to support and fac ilitate the implementation 
of the national systems.  Such an approach would be akin to arguing that in order to ensure the 
effective operation of the patent system, for exampl e, only national patent laws are needed and not 
international agreements such as the TRIPS Agreement.  
7. Clearly, both national and international mechan isms are critical in ensuring the mutual 
supportiveness of the implementation of the CBD and the TRIPS Agreement.  Bio-piracy and the related issues being addressed in these discussions  are issues with a significant international 
dimension needing international solutions and enfor cement.  As pointed out in document IP/C/W/438: 
"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.
6  In essence, these 
provisions are aimed at regulating, in pa rticular, 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 comp etent international organizations, for 
conservation and sustainable use of biological diversity."
7 
 WTO is a competent organization on matters rela ting to bio-piracy and the issuance of patents 
with respect to inventions that have relied upon and/or used biological resources and/or associated 
traditional knowledge.  III. SPECIFIC OBSERVATIONS 
A. P
RIOR INFORMED CONSENT AND MISAPPROPRIATION  
8. On this issue, document IP/C/W/434 argues that "new8 patent disclosure requirements will not 
work to guarantee that prior informed consent w as obtained" and that "a completely separate, 
transparent mechanism need s to be established outside the patent system".9  An international 
disclosure requirement alone will not work to guara ntee prior informed consent just like a national 
regime alone will not work.  The proposed mandatory , global disclosure requirement is not envisaged 
as a stand-alone system, but as a vital measure and incentive that would support and ensure the effective operation of national regimes for prior info rmed consent.  Consequently, while contractual 
arrangements may have a role to play in implemen ting the requirements of prior informed consent, 
and could constitute the evidence of prior informed  consent under the proposed system, clearly such 
arrangements alone cannot suffice to ensure the m onitoring and enforcement of these requirements in 
third countries.  Contractual arrangements or simila r mechanisms in national laws can only suffice if 
they are obligatory and enforceable across borders. 
9. The United States also argues that "a transparent prior informed consent regime is needed to 
ensure that… researchers and/or collectors can conduct their research activities in an appropriate 
manner" and that "those with intent of acting in bad faith will not be  deterred by disclosure 
                                                     
 
6 See Article 3 of the CBD. 
7 See para 3 of the submission, supra note 2. 
8 It is presumed that by charact erizing the proposed disclosure sy stem as "new", the United States 
considers that existing provisions of  the TRIPS Agreement permit Members to require of patent applicants the 
disclosure of the source and country of origin of bi ological resource and/or associated traditional knowledge 
used in an invention.  However, what is needed for the effective prevention of bio-piracy and misappropriation are mandatory provisions, not permissive ones. 
9 See para 7 of the submission by the United States, supra note 1. IP/C/W/443 
Page 4  
 
 requirements".
10  It is further argued that "the act of patenting per se , does not amount to 
misappropriation".  As already noted, the propos ed disclosure requirements constitute a core 
component of international efforts to ensure a tr ansparent regime that, wh ile allowing for access by 
researchers and/or collectors to biological res ources, ensures compliance with national regimes 
relating to prior informed consent and benefit-shari ng.  Such transparency and predictability cannot be 
established through a fragmented nation-to-nation system but only through an internationally 
established and enforced system.  How can myriad  separate and different national systems with no 
common denominator regulate the relationships be tween entities, persons and activities taking place 
in different countries? 
10. Regarding the deterrence aspect of the disclosure proposal in respect of those actors intent on 
acting in bad faith, while it is true that the discl osure requirement by itself will not deter them, the 
legal consequences of the failure to comply w ith the disclosure requirements of the proposed 
international regime can, if properly calibrated,  deter those bent on ac ting in bad faith.  In this regard, 
documents IP/C/W/429/Rev.1 and IP/C/W/438 elabor ate on several possible legal consequences for 
non-compliance, the nature of which will depend on whether one is dealing with a formal or 
substantive component of the disclosure and on whether it is at the level of pre- or post-grant.  The 
legal effects proposed in the above-mentioned documents include non-processing of the patent 
application, revocation of the patent, full or partial transfer of the rights to the invention, narrowing of 
the scope of the claims, and imposition of criminal, civil and/or administrative penalties.  
11. However, we recognize that these sanctions ma y be insufficient to have the full deterrence 
value that is desired.  In this regard, we welc ome additional proposals by any delegation aimed at 
strengthening the sanctions for failure to comply w ith the proposed disclosure requirement in order to 
ensure that such sanctions provide sufficient deterrence. 
12. Finally, with respect to whether patenting per se  could constitute misappropriation, it is 
important to note that no suggestion has been made that the act of patenting per se  would constitute 
misappropriation under the proposed disclosure regime.  It is the act of applying for a patent or 
patenting an invention where, biological resour ces and/or traditional knowledge is used, among 
others: to form part of the claimed invention; dur ing the process of developing the claimed invention; 
as a necessary prerequisite for the development of th e invention; to facilitate the development of the 
invention; and/or as necessary background material for the development of the invention, without 
obtaining the prior informed consent of the Member  or relevant authorities of the Member in which 
the biological resources and/or traditional knowledge are obtained and without providing for equitable 
benefit-sharing, that constitutes a serious form of  misappropriation.  Moreover, it is clear that the 
system of patenting per se  being followed in many cases today resu lts in bad or questionable patents.  
The reason for that happening is insufficient discl osure of the details of the existing knowledge and 
the inadequacy of the existing patent system to ch eck the relevant details.  The proposed disclosure 
condition would surely contribute to preventing the issue of bad and questionable patents. 
B. BENEFIT -SHARING  
13. Document IP/C/W/434 argues that the proposed disclosure requirement per se cannot transfer 
benefits, as such a requirement would merely c onvey the information required but would have no 
mechanism to transfer benefits between parties.  As already noted, the proposed obligation to disclose 
evidence of prior informed consent and benefit-sh aring under the TRIPS Agreement is not intended as 
a stand-alone system but as a system that would su pplement and ensure the effective enforcement of 
national regimes.  Consequently, it is not the international obligations per se that will transfer benefits 
but the proposed system coupled with the relevant  national regimes.  Moreover, given the enormous 
number of patents granted worldwide, the disclosure requirement will facilitate the monitoring of 
                                                      
10 Para 8 of the submission, supra note 1.  IP/C/W/443 
 Page 5 
 
 
 these patents by the owners of the biological mate rial and/or associated tr aditional knowledge with a 
view to check whether prior informed consent and benefit-sharing arrangements are being adhered to 
by the patent owners upon commercialization.  The Un ited States also lists some examples to argue 
that benefits from an invention would be diminished if the patent was issued and later invalidated, or 
was never issued, and the inventio n is nevertheless commercialized.11  However, the situation exists 
for all kinds of patents, and is not limited to patent s involving disclosure of the country and source of 
origin of biological materials and/or associated traditional knowledge.  In such cases, as in the case 
with any other type of patents, other legal means w ould have to be resorted to by the owners of the 
biological material and/or associated traditional knowledge to rectify the damage, for example by 
commercializing the product themselves (in case of invalidation) or competing in the market place 
with those who commercialize it (in cases of commercia lization without patent rights).  What changes 
with the grant of a patent is the grant of a lega lly enforceable monopoly to the exclusion of everyone 
else without any feasible recourse, particularly fo r developing countries and impoverished traditional 
and local communities, for a long period of time, and it is this damage that will be prevented by the 
proposed disclosure requirement. 
14. 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 
genetic resources and/or traditional knowledge in the invention and that the shares of benefits that 
accrued to the source and country of origin or loca l/indigenous community was equitable and fair in 
the circumstances.  While it has b een argued that there may be no straightforward way of determining 
the equitable and fair sharing of benefits, in the ve ry least there are a number of factors that could be 
used to make this determinati ons.  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 commercialization 
especially where future benefit-sharing is contemplated. 
 
15. Where there is no national regime, 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, but that there was benefit-sharing or an arrangement for future 
benefit-sharing, at least, with the authority or  community in charge of the location where the 
biological resources and/or trad itional knowledge were accessed. 
16. The United States in its submission also raises th e question of what would happen where there 
is no patent but there is in any case commercializatio n, that is, commercialization that occurs outside 
the patent system or commercialization by others where the patent is, for example, revoked.  These 
are all important questions and valid concerns.  Ho wever, these are concerns and issues that will be 
dealt with outside the patent system and is not a subject that the TRIPS Council can satisfactorily 
address.  The proposed disclosure requirements are aimed at addressing situations where biological 
resources and/or traditional knowledge is utilized for purposes of obtaining or otherwise exploiting 
patents.  In other words, the system is aimed at addressing patent related issues and therefore only 
constitutes one element, albeit a crucial one, of a larger national and intern ational benefit-sharing 
                                                     
 
11 See para. 10 of the US Submission, IP/C/W/434. IP/C/W/443 
Page 6  
 
 regime.  Situations falling outside the patent system  would have to be addressed within the national 
regimes in conjunction with other international ru les outside the patent system including, where 
applicable, by addressing issues relating to trade secret laws or competition laws. 
C. P
REVENTING ERRONEOUSLY GRANTED PATENTS  
17. Document IP/C/W/434 also submits that the proposed disclosure requirements will be 
ineffective in preventing erroneously granted patent s and that such a requirement would do little to 
ensure ascertainment of appropriate inventorship , novelty or inventive step.  Indeed, the mere 
disclosure of source and country of origin may not he lp ascertain inventorship etc.  However, to the 
extent that the disclosed information will help de termine whether the biological resources and/or 
traditional knowledge was used: to form part of  the claimed invention; during the process of 
developing the claimed invention;  as a necessary prer equisite for the development of the invention;  
to facilitate the development of the invention;   and/or as necessary background material and/or 
information for the development of the invention, su ch information would be relevant in determining 
the existence of prior art and the non-obviousness of the claimed invention, determining inventorship 
or entitlement to the patent, the scope of the claim and/or for understanding or carrying out the 
invention.  Indeed, the United States accepts th is premise and argues in its submission, in 
paragraph 29, that "patent examiners worldwide co uld use organized searchable databases of genetic 
resources and traditional knowledge when examining pa tent applications.  This could aid in the 
discovery of relevant prior art and thereby improve  the examination of patent applications in the 
relevant field".12  The disclosure of the country and source of origin will enable the patent examiner to 
do this job more effectively and prevent issue of bad patents. 
D. ADDITIONAL CONCERNS RAISED IN TH E SUBMISSION BY THE UNITED STATES : UNCERTAINTY , 
ADMINISTRATIVE BURDEN AND EFFECTIVENESS  
18. The submission by the United States raises a number of additional concerns in its 
communication including that the proposed disclosure requirement would "create a 'cloud' of uncertainty over the patent right", that the re quirement would lead to significant administrative 
burdens and costs, that patent examiners would be unable to determine the validity of prior informed 
consent or adequate benefit-sharing and that the sy stem would not be an effective monitoring system.  
First, with respect to uncertainty, as already explained: 
"[T]he proposed disclosure requirement would in fact introduce much needed 
certainty and preserve the balance in the patent system in consonance with the 
objectives and principles of the TRIPS Agreements enshrined in Articles 7 and 8 and 
the conditions on patent applicants that have been established by other relevant 
Articles of TRIPS.  In this regard, it is important to remember that facilitated access 
to biological resources and/or traditional knowledge, as acknowledged by the United States in its submission, is of significant importance to researchers and bio-prospectors that use the patent system.  By establishing clear internationally agreed 
rules on disclosure, prior informed con sent and benefit-sharing, the proposed 
requirement would go a long way in establishing certainty in these matters, not uncertainty."
13 
19. The question of administrative burden and cost s has already been addressed in an earlier 
communication.14  However, it is worth repeating here th at while we consider that there will be 
administrative implications and there may be cost imp lications for applicants as they are expected to 
                                                      
12 See the United States Submission, supra note 1. 
13 See para. 4 above. 
14 See the communication of 27 September 2004, supra note 10, paras. 9 and 10.  IP/C/W/443 
 Page 7 
 
 
 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 ad ministrative procedures and costs related to meeting 
the obligation would be in any way burdensome.  In any case, such a burden would generally be 
subsumed in, or at least not be more burdensome than, the usual burden befalling the patent applicant 
to make out a case for his claims under current patent procedures and practices. 
20. As a matter of patent law practice, there are a number of other disclosure requirements, 
including disclosure of best mode, and in other ju risdictions, such as the United States, a requirement 
to disclose all information materi al to patentability.  The proposed requirement is no different from 
these obligations the fulfilment of which has not been shown to impose any unnecessary burden on 
applicants.  In fact, for the US patent system, the proposed disclosure requirement should not be 
burdensome at all, as it could most likely be cove red under the 'information material to patentability' 
requirement.  The US system would only have to put in place an add itional requirement to cover prior 
informed consent and benefit-sharing.  The collec tion and recording of the information necessary to 
meet the obligation should not require applicants  to undertake significant additional recording and 
documentation outside what would be done in the process of developing an invention even where 
there is no disclosure obligation.  The disclosure obligation as envisaged, taking into account existing 
practice, would therefore not impose any burdensome administrative or other costs on applicants. 
21. With respect to determining the validity of pr ior informed consent and adequacy of benefit-
sharing, it is important to note, firstly, that no s uggestion has been made that patent examiners would 
be required to determine the validity of prior inform ed consent or the adequacy  of benefit-sharing.  
Secondly, as explained in the communications of 27 September and 10 December 2004,15 the 
obligation of patent applicants would be clear ly defined under the proposed mandatory disclosure 
system and all the patent examiner would be required to determine is that the patent applicant has met 
the defined disclosure obligation.  As noted, in the communication of 10 December, in particular:  
"It is foreseen that the applicant will be deemed to comply with the requirement of 
furnishing evidence of prior informed con sent if the patent application contains 
and/or is accompanied by a declaration, in the prescribed form, indicating that prior 
informed consent was obtained from the relevant national authorities (and local and indigenous communities, where applicable).   Further, the declaration would be 
accompanied, where relevant, by the actual evidence of prior 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 this regard, it should be noted 
that it may be possible that a single declar ation with the necessary evidence could be 
furnished to cover the requirements on di sclosure of source and country of origin, 
evidence of prior informed  consent as well as evidence of equitable benefit-
sharing."
16 
22. Consequently, the role of the patent examiner will be limited to confirming that the patent 
application contains a declaration in the prescribed  form indicating that prior informed consent was 
obtained and that benefits were shared and/or that there exists an arrangement for future 
benefit-sharing in accordance with the relevant nati onal law.  The patent office will need to take 
decisions based on these documents only when the valid ity of a patent is cha llenged in the pre- or 
post-grant opposition or revocation pr oceedings.  In such cases the patent office will have evidence 
from both the parties to the proceedings and could take a decision like any other ground on which the 
grant of a patent is opposed or revocation of a patent is requested. 
                                                      
15 Supra notes 10 and 2 respectively. 
16 See para.11 of the submission. IP/C/W/443 
Page 8  
 
 23. Finally, on the question of effectiveness of th e system.  As already pointed out, the proposed 
regime is not intended as a stand-alone mechanism.
17  However, the proposed international obligation 
for disclosure coupled with national regimes and ot her international rules such as those developed 
under the CBD or elsewhere would constitute an effective system. 
IV. OBSERVATIONS ON THE PROPOSED OPTIONS FOR ACHIEVING 
APPROPRIATE ACCESS AND EQUITABLE BENEFIT-SHARING AND 
PREVENTING BAD PATENTS 
24. In light of the concerns expressed in its submi ssion, all of which we have addressed in this 
communication, the United States in its submission also proposed an alternative mechanism outside 
the patent system as the most effective way of addressing issues related to misappropriation and bio-
piracy.  Before commenting on the proposed altern ative approach, we wish to reiterate that a 
fragmented nation-to-nation system cannot achieve ou r objectives.  Such a system would entail very 
high transaction costs and would hence be difficult to  implement.  Only through an internationally 
established and enforced system can the problems of misappropriation and bio-piracy, which have a 
significant international dimension, be effectively addressed. 
A. ACHIEVING PRIOR INFORMED CONSENT  
25. While delineated national points of contact and the establishment of permit or other national 
systems are important elements of a national regime and may be a necessary prerequisite for ensuring prior informed consent, such national requirements can do little to address the transnational character 
of the problem of misappropriation and bio-piracy. 
B. A
CHIEVING EQUITABLE BENEFIT -SHARING  
26. The limitations of a contractual system in addressing the international dimension of the issues 
under discussion have been amply demonstrated in  earlier communications and repeated here in 
paragraphs 8 to 16 above. 
C. ORGANIZED DATABASES AND INFORMATION MATERIAL TO PATENTABILITY  
27. While organized searchable databases may play, in some cases, an important role in helping 
ensure that prior art information is available to patent examiners, we do not see how such databases 
can be a substitute for the disclosure requirement.  Just like organized databases cannot achieve the 
purposes such as the one served by the requirement under United States law for patent applicants to 
disclose information material to patentability, or requirements such as for disclosing best mode, it 
cannot serve the purpose of the disclosure requirement.  More importantly, a voluntary system of searchable databases or provision of information ma terial to patentability w ill provide no guarantee 
that in fact patent examiners in different countri es will consider this information in the prior art 
search.  
28. One should also recall, furthermore, that, as h as been pointed out in previous submissions,
18 
databases in themselves have other important limitati ons as a possible tool to facilitate the protection 
of traditional knowledge.  Given the vast breadth and depth of such knowledge, no documentation 
effort can be completely comprehensive and exhaus tive of all the traditional knowledge available in a 
country.  This is particularly true when traditi onal knowledge used in a particular invention is 
undocumented, based on oral traditions or documen ted in a local language.  Moreover, in many 
                                                      
17 See paras. 6 and 7 above. 
18 See WTO document IP/C/W/403, submitted by Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, 
India, Peru, Thailand and Venezuela.  IP/C/W/443 
 Page 9 
 
 
 developing countries there are serious concerns a bout the appropriateness of use of databases for 
reasons of loss of confidentiality of the traditiona l knowledge which is not in the public domain.  
Given these limitations, it is clear that, while data bases can, in some cases, complement the purpose 
of expanded disclosure norms, they cannot substitute them. 
D. POST-GRANT OPPOSITION AND RE-EXAMINATION  
29. While pre-grant and post-grant opposition or re-examination proceedings can rectify the 
situations of erroneously granted patents, such proceedings cannot replace the need for a disclosure 
requirement.  If anything, the effectiveness of such  proceedings with respect to cases involving 
biological resources and/or trad itional knowledge will be significa ntly improved or may depend on 
the disclosure obligation.  In this regard, the disclos ure requirement as envisaged will also be useful in 
cases relating to challenges to patent grants or di sputes on inventorship or entitlement to a claimed 
invention as well as infringement cases. 
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