WORLD TRADE  
ORGANIZATION  IP/C/W/449 
10 June 2005 
 
 (05-2428) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
ARTICLE 27.3(B), RELATIONSHIP BETWEEN THE TRIPS AGREEMENT 
AND THE CBD, AND THE PROTECTION OF TRADITIONAL 
KNOWLEDGE AND FOLKLORE 
 
Communication by the United States  
  
 The following communication, dated 8 June 2005, is being circulated at the request of the 
Delegation of the United States. 
 
 
_______________ 
 
I. INTRODUCTION 
1. The purpose of this paper, building upon the previous communication from the United States 
(IP/C/W/434), is to continue to facilitate discussi ons under agenda items pursuant to paragraphs 12 
and 19 of the Doha Ministerial Declaration.  In conjunction with paragraph 12, paragraph 19 of the 
Doha Ministerial Mandate directs the TRIPS Counc il to examine the relationship between the TRIPS 
Agreement and the CBD, protection of traditional knowledge, and folklore.  This paper further 
focuses on the mandate, responds to various claims a nd proposals put forward by other Members, and 
attempts to identify more precisely the areas of agreement and disagreement among Members. 
2. In response to the last US communication (IP/C/W/434), the delegations of Brazil and India 
submitted a further discussion paper (IP/C/W/443) c ontaining "technical observations" on the issues 
raised in the US submission.  The United States we lcomes this submission and the extent to which it 
reflects the willingness of Members to engage in discussion on IP/C/W/434 and to begin to focus on 
shared objectives of Members and how to achieve t hose objectives.  Focusing on shared objectives, as 
well as relevant national experiences, can assi st progress by identifying common ground where it 
exists as well as identifying differences among Members. 
II. GENERAL COMMENTS ON THE DOHA MANDATE TO EXAMINE THE 
RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CBD 
3. The United States is one of several Members that see no conflict between the TRIPS 
Agreement and the Convention on Biological Diversity  (CBD) and consider that these agreements can 
and should be implemented in a mutually supporti ve manner.  The United States has previously set 
forth a comprehensive analysis of the obligations of the provisions of the CBD most frequently cited 
as related to the provisions of the TRIPS Agreement.
1 
                                                      
1 See United States, IP/C/W/257. IP/C/W/449 
Page 2  
 
4. In examining the relationship between TRIPS and the CBD, it is worth recalling that the CBD 
does not require, or even mention, patent disclos ure requirements.  The CBD calls upon Parties to 
condition access to genetic resources on prior inform ed consent, and to encourage the equitable 
sharing of benefits arising from the utilization of ge netic resources, upon mutually agreed terms.  The 
CBD does not require countries to modify their patent laws in any way. 
5. The CBD does have a mandate to elaborate and negotiate an international regime on access to 
genetic resources and benefit sharing.  One out come of the CBD process has been the Bonn 
Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits.  After 
CBD parties gain experience from the implementation of the Bonn Guidelines, they will have a better 
understanding on how to promote prior informed consent, access to genetic resources and related 
traditional knowledge, and equitable benefit sharing. 
6. US government agencies, not just US-based companie s, collect genetic resources in the field.  
As the United States has described in previous co mmunications to the TRIPS Council, agencies such 
as the National Park Service, the National Cancer In stitute, the National Institutes of Health, and the 
Agricultural Research Service of the Department of  Agriculture all have adopted measures tailored to 
fit their specific sector's needs that are consistent with the CBD principles of prior informed consent 
and benefit sharing on mutually agreed terms.
2  These US guidelines are practical, effective and not 
burdensome, and operate outside of the intellectua l property system.  The US government has also 
provided information to private US entities on in situ  genetic resources collection, consistent with the 
Bonn Guidelines.3 
7. Although not a Party to the CBD, the United St ates is nevertheless taking positive steps to 
promote and encourage prior informed consent and e quitable sharing of benefits on mutually agreed 
terms, two of the objectives Members have raised in  the TRIPS Council.  As we have stated on prior 
occasions, we consider that discussions in the TR IPS Council could benefit significantly if other 
Members could provide information on how they  are implementing programs to achieve these 
objectives. 
III. GENERAL COMMENTS ON PROPOSAL  FOR NEW PATENT DISCLOSURE 
REQUIREMENTS 
8. Brazil and India have correctly recognized that  "any system that introduces uncertainties and 
imbalances into the patent system may be detr imental to technological progress in general and the 
protection of inventions in particular".4  We fully agree and emphasize that this concern underlies our 
view that the TRIPS Council ought to exercise the utmost caution in considering any proposals that 
may do so.  Nonetheless, the authors of IP/C/W/443 assert that the proposal for new patent disclosure 
requirements5 would establish certainty in these matters "b y establishing clear internationally agreed 
rules on disclosure", will help to ensure the "legitimac y of the patent system" and would help fulfil the 
objectives of the TRIPS Agreement in Article 7.  We  disagree.  As noted in IP/C/W/434, there are 
many troubling questions with resp ect to patent disclosure requirements proposed that would lead to 
significant uncertainties.6  Besides the potential detrimental effect on technological progress, this 
uncertainty would also undermine the sharing of  benefits of such use, as explained below. 
                                                      
2 See, e.g., United States, IP/C/W/341 and IP/C/W/393. 
3 See http://www.state.gov /g/oes/rls/or/25962.htm. 
4 Brazil and India, IP/C/W/443, paragraph 4. 
5 Similarly as IP/C/W/434, the term "new patent disclosure requirements" in this paper refers to the 
proposed new requirements regarding disclosure of source and/or origin, evidence of prior informed consent, and evidence of equitable benefit-sharing that have been proposed by Members in the course of TRIPS Council 
sessions. 
6 See, e.g., IP/C/W/434, footnote 7.  IP/C/W/449 
 Page 3 
 
 
9. The recent submission by Peru and statements by  other Members give an incorrect impression 
that the patent system is experiencing some kind of  crisis.  While patent offices around the world do 
face significant work load burdens, the patent system , in fact, works quite well.  As discussed further 
below, erroneously granted patents are the rare excep tion rather than the rule.  Peru's submission also 
raised concerns regarding the "l egitimacy" of the patent system,7 and Peru has stated that "the 
legitimacy of the IP system is in dispute, and that  will remain the case as long as bad patents continue 
to be granted and the system continues to be used to legitimize unjust and unfair situations".8  While 
noting these concerns and perceptions, after further c onsideration, as set forth below, the IP system 
generally, and the patent system in particular, do not in any way legitimize misappropriation.  
Moreover, patents, when coupled with a benefit-shar ing regime, can be an e ffective tool for benefit 
sharing.  Situations involving misappropriation can  be remedied through effective application and 
adequate enforcement of access and benefit-shari ng regimes that directly regulate inappropriate 
behaviour. 
IV. PROPOSED OPTIONS FOR ACHIEVING APPROPRIATE ACCESS, EQUITABLE 
BENEFIT SHARING, AND PREVENTING ERRONEOUSLY GRANTED PATENTS 
10. In document IP/C/W/434, the United States pr ovides concrete proposals for achieving the 
widely shared objectives of (1) ensuring authorized access, i.e. prior informed consent, (2) achieving 
equitable sharing of the benefits arising from th e use of traditional knowledge and genetic resources, 
and (3) preventing the issuance of erroneously granted patents.9  To avoid duplication, those proposals 
will not be repeated here. 
11. After further analysis of the observations made in IP/C/W/434 and IP/C/W/443, it appears 
that certain areas of common ground and understa nding are emerging among Members.  Nonetheless, 
there remains a wide degree of disagreement.  In our view, a close reading of these two documents, among other recent contributions made in TRIPS Counc il, continues to lead to the conclusion that 
new patent disclosure requirements are not an approp riate solution to the concerns raised, and only 
further convinces us that the most effective way to  ensure the objectives of ensuring prior informed 
consent and equitable benefit sharing is tailored, national laws outside the patent system that directly 
and effectively regulate the relevant conduct. 
12. The reference to "national laws" does not im ply that international norms have no relevance 
nor that the solutions proposed are not internati onal in character, as has been alleged by some.  Indeed, 
appropriate international guidelines, such as the Bonn Guidelines and guidance from the 
Intergovernmental Committee on Genetic Resource s, Traditional Knowledge and Folklore at the 
World Intellectual Property Organization (WIPO),  which address issues of appropriate access and 
benefit sharing outside the patent system, may be  of significant relevance and can be helpful to 
Members in achieving objectives.  Furthermore, a na tional contract-based system can be international 
in its outlook and may contain, inter alia , choice of forum, choice of law, or international arbitration 
provisions relevant to cross-boundary dispute or enforcement issues. 
V. SPECIFIC OBSERVATIONS ON ACHIEVING WIDELY SHARED OBJECTIVES 
A. 
PRIOR INFORMED CONSENT AND MISAPPROPRIATION  
13. Brazil and India have conceded that "an in ternational disclosure requirement alone will not 
work to guarantee prior informed consent".10  This appears to be a significant clarification of common 
                                                      
7 See Peru, IP/C/W/441. 
8 IP/C/W/441, paragraph 3. 
9 IP/C/W/434. 
10 IP/C/W/443, paragraph 8. IP/C/W/449 
Page 4  
 
ground among Members that can help refine the discussion on the precise nature of the objectives of such a disclosure requirement.
11  
14. In noting that their proposed global patent disclosure requirement is "not envisaged to be a 
stand alone system, but as a vital measure and in centive that would support and ensure the effective 
operation national regimes for prior informed consent",12 the authors of IP/C/W/443 appear to 
recognize that, in the absence of any such national regime, such disclosure requirements would be of 
little or no utility.  This position therefore recogni zes the primacy of establishing such regimes, while 
making clear that the disagreement among Members on this issue is the narrower question of whether 
such a global disclosure requirement can be justified by its ability to "ensure the effective operation of 
national regimes of prior informed consent", notwith standing its negative effect s on the patent system, 
technological development and benefit sharing. 
15. As a general matter, the authors of IP/C/W /443 appear to broadly dismiss the utility of a 
contract-based system that ensures prior informed consent and equitable benefit sharing by claiming 
that a "fragmented nation-to-nation system" cannot  achieve our objectives as such a system would 
entail "high transaction costs and would hence be difficult to implement".  The authors of IP/C/W/443 
assert that "[contractual] arrangements alone cannot suffice to ensure the monitoring and enforcement 
of these requirements in third countries.  Contractua l obligations or similar mechanisms in national 
laws can only suffice if they are obligator y and enforceable across national borders".13  Further, it is 
alleged that "national requiremen ts can do little to address the transnational character of the problem 
of misappropriation and bio-piracy".14 
16. However, a contract-based system need not en tail high transaction costs if implemented in an 
effective and systematic manner, e.g., by providi ng clear points of contact and setting forth clear 
statements of agreement to minimize disputes.15  In addition, a contract-based access and benefit 
sharing, with appropriate monitoring and enforcem ent would help to centralize monitoring and would 
not be a "fragmented" system.  As noted above, a contract-based system can be international in its 
outlook and may contain, inter alia , choice of forum, choice of law, or international arbitration 
provisions relevant to cross-boundary dispute or enforcement issues. 
1. Monitoring System 
17. Beyond the claims set out in document IP/C /W/443, a number of Members have raised other 
concerns in discussions relating to the proposed  disclosure requirements providing a potential 
monitoring system with respect to genetic resour ces and traditional knowledge.  Delegations such as 
Switzerland, the European Communities and New Zeala nd have also asserted that there may be a role 
for the disclosure of country of origin and/or source in monitoring the use of genetic resources.16 
                                                      
11 IP/C/W/443, in footnote 8, Brazil and India also assert that the United States considers existing 
provisions of the TRIPS Agreement permit Members to require patent applicants to disclose the source and/or 
country of origin.  However, the United St ates has not yet considered this issue. 
12 IP/C/W/443, paragraph 8. 
13 IP/C/W/443, paragraph 8. 
14 IP/C/W/443, paragraph 25. 
15 Some Members have also raised concerns regarding "unequal bargaining power".  However, one 
flexibility of the United States proposal is that Members may, if appropriate, regulate the terms of agreement 
through national laws or rules.  In such cases, the country of origin would determine for any cases it deems appropriate certain terms of collection without the need  for arms-length bargaining in the typical sense. 
16 See, e.g., IP/C/M/46 at paragrap h 46 (Statement of the European Communities) and at paragraph 60 
(Statement of New Zealand); s ee also Switzerland, IP/C/W/400.  IP/C/W/449 
 Page 5 
 
 
18. An effective monitoring system should provide for monitoring of the use of genetic resources or traditional knowledge at the point of access thr ough the access and benefit-sharing (ABS) system.  
A contract-based access and benefit-sharing regime can require mandatory disclosure to authorities of 
any commercial application utilizi ng the relevant genetic resour ces or traditional knowledge, and 
therefore, can ensure monitori ng for the use of these resources or knowledge regardless of the 
commercial application involved, and whether or not an y application is related to  a patent.  Therefore, 
such a system provides a more effective means to ensure the monitoring objective, without the 
deleterious effects on the patent system. 
2. Enforcement of ABS Systems 
19. Delegations have also expr essed concerns over effective enforcement of national access and 
benefit-sharing provisions, including any monitoring provisions.  In the vast majority of cases, 
compliance will be facilitated through cooperatio n between the holders, or other appropriate 
authorities, and users of the genetic resources and/or  traditional knowledge.  In the rare cases where a 
party violates the national regime, they would be su bject to criminal and civil provisions, similarly as 
with respect to other areas of misconduct, such as  breaches of environmental law, health and safety 
laws and other areas in which governments ha ve an important regulatory interest. 
20. From a broader perspective, patent rights ar e not a universal enforcement regime to regulate 
any misconduct that can arise in the development or  use of an invention. As we have observed 
previously, patent rights permit an inventor to exclude others from certain acts,
 but do not permit an 
inventor to use the invention without restriction.  Restrictions can and are placed on the use of certain 
inventions to ensure safety and efficacy (e.g. health regulations governing pharmaceutical products), 
to protect the environment (e.g. regulations gove rning emissions from automotive engines) or to 
protect domestic or national security (e.g. regulating firearms), for example.  These restrictions are 
enforced outside the patent system by separate regulatory mechanisms.17  
21. While a few individuals could ignore the lega l requirements of an access and benefit-sharing 
system, in the same way that individuals currently  may violate health or safety regulations, the case 
has not been made for why a contractual system that  would apply to the vast majority of those seeking 
access would not serve effectively, just as health, safety and other regulatory codes that are of great importance apply where appropriate.  Furthermor e, the patent system does not condone or 
"legitimize" violations of these other laws and, in the same manner, does not condone or legitimize 
misappropriation of genetic resources or traditional knowledge in violation of a country's access and 
benefit-sharing requirements.  As is done in th e case of these other distinct regulatory systems, 
criminal provisions and/or civil liab ility for failure to comply can be included in the country's laws for 
those few who might take genetic resources wit hout entering into an access and benefit-sharing 
agreement with the required party.   
B. 
BENEFIT SHARING  
22. To better understand why patent disclosure re quirements would not promote benefit sharing, 
it is important to recall that the benefits that ar ise from the utilization of genetic resources come from 
commercial or non-commercial exploitation.  Even fo cusing only on the commercial context, there are 
benefits that flow from utilization of traditional knowledge and genetic res ources whether or not any 
invention has been developed that qualifies for pate nt protection.  Neither herbal remedies nor plant 
varieties may be patentable in a particular country .  A patent disclosure requirement would do nothing 
in these cases to help enforce a country's ABS re gime, because those who utilize these resources never 
apply for a patent in the first place.   
                                                      
17 See IP/C/W/434, paragraph 25.  
 IP/C/W/449 
Page 6  
 
23. Brazil and India clarify that their proposal for new patent disclosure requirements will not 
substitute for but will supplement and ensure the effective enforcement of national ABS regimes.
18  
While we welcome this clarification, we do not see how we can design disclosure requirements to supplement national legislation that is not in place in  the majority of Members.  Establishing national 
access and benefit-sharing systems is essential befo re engaging in discussion of supplemental patent 
disclosure requirements.  Furthermore, it would seem prudent to determine areas of inadequacy, based 
on experiences, of existing national systems in order to more fully consider these matters. 
24. The authors of IP/C/W/443 attempt to addr ess the examples given by the United States in 
IP/C/W/434 in which benefits from an invention woul d be diminished if the patent was issued and 
later invalidated, or was never issued, and th e invention is nevertheless commercialized.
19  T h e  
authors argue that this is similar to situations in volving any other patent and is not limited to patents 
involving disclosure of the country and source of origin. 
25. However, there is a significant difference in this case, as it is the very proposal  of adding new 
disclosure requirements with the objective of ensuring benefits that would cause  the additional 
uncertainty that may lead to invalidation or other wa ys of diminishing benefits that could be shared 
from these inventions.  More simply put, the remedy proposed itself (invalidation due to non-
compliant disclosure, etc.) would destroy or ha ve significant negative consequences on the benefit 
being sought, rather than ensuring that the benefit w ould be shared with the appropriate party.  This 
would clearly fail to meet the shared objective of ensuring the equitable sharing of benefits arising the utilization of genetic resources and/or traditional knowledge.
20 
26. In response to statements in IP/C/W/434  regarding cases of commercialization that do not 
involve patents, the authors of IP/C/W/443 recognize this concern, but they state that "these are 
concerns and issues that will be dealt with outside the patent system".21  The United States has long 
advocated a system outside the patent system to address all issues of commercialization and exploitation regarding genetic resources and/or tr aditional knowledge.  Rather than attempting to 
single out applications involving patents and trying to deal with them with a new patent disclosure 
requirement that may negatively effect technological  development, a more a ppropriate solution would 
be strengthening national regimes outsi de the patent systems in order to  take a comprehensive, holistic 
approach and address all instances of commercia lization of misappropriated resources and/or 
traditional knowledge that need to be addressed  outside the patent system in any event. 
                                                     
 
18 IP/C/W/443, paragraph 13. 
19 IP/C/W/443, paragraph 16. 
20 See IP/C/W/434, paragraph 10, where a number of  situations are examined where if such a 
requirement were adopted and a non-compliant disclosure were discovered that would invalidate a patent, or 
prevent a patent application from grant, because of a new patent disclosure requirement, any benefits from that 
invention would be greatly diminished: 
- for example, if a patent issued, but was later invalidated, or if an application were published, but 
never issued, the invention has been disclosed to the public and third parties can most likely use 
and commercialize the kn owledge or resources disclosed w ithout any obligation of sharing 
benefits; 
- further, if a patent is never issued and the information never published, the patent applicant may 
still be able to commercialize the invention without disclosing the invention to the public and 
without any obligation to share benefits; 
- a new disclosure requirement could also have further significant, unintended consequences where 
a patent applicant has entered into a valid bene fit-sharing agreem ent with the custodians of the 
traditional knowledge or genetic resources but, due to uncertainties in the law, a disclosure may be 
found invalid.  For example, if there were improper disclosure that resulted in revocation of a patent due to litigation by a third party not af filiated with a traditional knowledge or genetic 
resources holder, this could actually upset the pre-existing benef it-sharing agreement. 
21 IP/C/W/443, paragraph 16.  IP/C/W/449 
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27. In this context, it is our understanding that  only a relatively small number of Members have 
established access and benefit-sharing systems and mo st of these systems have only been in effect a 
short time.  It therefore may be helpful to the C ouncil's consideration of these issues to understand, 
from national experiences, examples of percei ved problems with existing ABS regimes, e.g., 
problems encountered or other issues with respect to existing monitoring and enforcement provisions, 
so concerns regarding monitoring and enforcement th at have been raised can be more adequately 
discussed.  The United States believes that any inte rnational effort should not be focused on new 
patent disclosure requirements but rather, on effort s to encourage the establishment of appropriate 
access and benefit-sharing systems that (1) improve  compliance by providing users with clear rules 
for collection of genetic materials, and (2) help  ensure that where uses of genetic resources or 
traditional knowledge are made, benefits are equ itably shared with the appropriate parties. 
C. PREVENTING ERRONEOUSLY GRANTED PATENTS  
28. Document IP/C/W/443 clarifies an important point of agreement that "the mere disclosure of 
source and country of origin may not help ascertain inventorship, etc".22  However, it goes on to state 
that "to the extent that the disclosed informati on will help determine whether biological resources 
and/or traditional knowledge were used [in certain circumstances"],23 it may assist examiners in 
determining these issues. 
29. Furthermore, document IP/C/W/443 refers to  issues of "bad or questionable patents"24 and 
states that these occur beca use of insufficient disclosure of the details of the existing knowledge and 
the inadequacy of the patent system to check these details.  The United States generally shares 
concerns regarding erroneously issued patents, but  we remain convinced that the proposed disclosure 
requirements do not address these concer ns in an appropriate manner. 
30. Determinations of inventorship, prior art, etc. are generally rooted in a country's patent law.  
For example, inventorship is generally based on act s of invention, while determinations of novelty 
and inventive step (obviousness) are based on the state of the relevant art.  Information regarding the 
country of origin or the source (i.e. country locati ons or ex situ collection sites) is not generally 
relevant to these considerations  and would therefore be of little value in that process.   
31. There are more direct options that can effec tively address these issues and prevent the grant of 
erroneously issued patents.  Options include the use of organized, searchable databases, requirements 
regarding information material to patentability, and the use of effective post-grant opposition or re-
examination systems.25  
32. Brazil and India point out the perceived limit ations in organized databases in protecting 
traditional knowledge and genetic resources.  One su ch complaint is that "no documentation can be 
completely comprehensive and exhaustive".26  While this may be the case, certainly such a source of 
information that directly relates to the genetic r esources and/or traditional knowledge would be more 
comprehensive than information regarding country of origin and/or source of such materials which, in 
many cases, would be of little or no relevance to th e patentability issues under consideration.  For the 
same reasons, the assertion that disclosure requi rements would assist in the effectiveness of 
opposition or re-examination pro ceedings is also unfounded. 
                                                      
22 IP/C/W/443, paragraph 17. 
23 IP/C/W/443, paragraph 17. 
24 IP/C/W/443, paragraph 12.  
25 IP/C/W/434, see paragraphs 28-32. 
26 IP/C/W/443, paragraph 28. IP/C/W/449 
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33. As noted previously, the United States considers that post-grant opposition and re-
examination proceedings play an important role in  helping to avoid or r ectify erroneously granted 
patents.  There are a number of examples where su ch systems have been u sed effectively in this 
area.
27 
34. Document IP/C/W/443 is also helpful in clarif ying that "no suggestion has been made that the 
act of patenting per se would constitute misappropriation".  However, the authors then state that "the 
act of applying for a patent or patenting an inve ntion where biological and/or traditional knowledge is 
used … without obtaining prior informed consent of the Member or relevant authorities in 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" (emphasis 
added).28  
35. In other words, it is not the act of patenting or applying for a patent, but rather the fact that 
traditional knowledge or genetic resources were acce ssed in violation of a national access regime and 
are being exploited, based on that improper access , without obtaining prior informed consent and 
without providing for equitable benefit sharing that is the cause of any potential misappropriation.  As 
noted before, it is not a patent disclosure requirement that can ensure such matters, but rather having 
in place a comprehensive and effective access a nd benefit-sharing regime that will do so. 
D. ADDITIONAL ISSUES  
36. Several other claims are made in documen t IP/C/W/443 that fail to adequately address 
concerns raised by the United States and others  concerning the proposal for patent disclosure 
requirements.  In response to concerns raised re garding the burdens on both the patent offices of 
Members and patent applicants, the authors of IP /C/W/443 state their expectation that the patent 
applicants would have to take "all reasonable measur es" to determine the country of origin but that 
"such burden would generally be s ubsumed in, or at least not be more burdensome than the usual 
burden befalling the patent applican t to make out a case for his claims  under current patent procedures 
and practices".  They note that, in the US system in particular, the requirement could be covered under 
the "information material to patentability requirement".29 
37. The United States appreciates that Brazil and India acknowledge the requirement in the 
United States to disclose information material to patentability in addressing their concerns.  However, 
as noted, the United States does not consider a requireme nt for source and/or origin to be similar to a 
requirement to disclose information material to pa tentability.  As discussed previously, information 
regarding source and/or country of or igin is generally not material to patentability, and is therefore of 
little use in trying to remedy the granting of erroneousl y issued patents.  A more effective approach in 
achieving the objectives of preventing erroneously granted patents would be one that focuses on 
information material to patentability.  One signi ficant advantage of this approach is that the 
information required is solely related to issues of patentability and thereby would not introduce new 
uncertainties of laws unrelated or tenuously rela ted to the invention into the patent system. 
38. Brazil and India go on to state that patent ex aminers would not be re quired to determine the 
validity of prior informed consent or adequacy of bene fit sharing, but then note that "the patent office 
will need to take decisions based on these documents  [prior informed consent and benefit sharing] 
only when the validity of a patent is challenged during … opposition proceedings".30 This point 
underscores the potential for a "legal cloud" over the validity of patent rights.  Many of these disclosure requirements would be new and would provi de an additional avenue  to litigation and other 
                                                     
 
27 IP/C/W/434, paragraph 31 
28 IP/C/W/443, paragraph 12 
29 IP/C/W/443, paragraph 20   
30 IP/C/W/443, paragraph 22  IP/C/W/449 
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uncertainties that would undermine the role of the pa tent system.  Particularly where the sanction, as 
has been proposed, would be revocation of the pa tent right, this would cause undue uncertainties in 
these patent rights, even where a good faith a ttempt has been made to comply with such 
requirements.31  This would not only have the potential effect of undermining the technological 
development incentives of the patent systems, but would also have a negative effect on any benefit-
sharing that could be derived therefrom. 
VI. CONCLUSION 
39. After analyzing the recent comments from Brazil and India, as well as other Members, it 
appears that a number of points are being clarif ied and issues are becoming more focused.  For 
example, there no longer appears to be any question that, notwithstanding other significant 
differences, Members share the view that national, contract-based access and benefit-sharing systems 
are essential elements of any solution.   
40. A major point of disagreement appears to be whether the proposed new patent disclosure 
requirements are justified as a means of enforci ng national ABS systems, in light of the negative 
consequences of such requirements.  In order to  better assess and resolve issues regarding proposals to 
remedy the concerns expressed by Members, it may be helpful for those Members with ABS systems 
currently in place to identify the perceived problems,  in particular with respect to monitoring and 
enforcement provisions of such systems, so that the Council may better address these issues.  
41. Continued focus by the TRIPS Council on shared objectives and options available to achieve 
them will be helpful in addressing the mandate of  paragraphs 12 and 19 of  the Doha Ministerial 
Declaration.  Along these lines, the United States h as presented a number of concrete proposals to 
address concerns of Members.  With respect to access  and benefit sharing, we view the best approach 
to be one involving the implemen tation of national regimes for prio r informed consent and equitable 
benefit sharing that establishes clear terms and that can be enforced adequately  and effectively outside 
the patent system.  Further, when addressing issu es regarding the erroneous  granting of patents, 
Members should focus on remedies that directly a ddress that goal.  These remedies include the use of 
organized databases, information material to patent ability and the use of post- grant opposition or re-
examination systems as an alternative to litigation. 
__________ 
                                                      
31 See, e.g., WIPO/GRTK/IC/7/15, statement of Biotechnology Industry Organization (BIO) to the 
WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore, 
"Biotechnology companies had to be able to count on patent exclusivity to justify taking risks and spending money to discover and develop inventions.  A disclosure requirement that could block the grant of a patent for 
an otherwise eligible invention, or could be used to invalidate that patent, would create unacceptable risks  
(emphasis added").