WORLD TRADE  
ORGANIZATION  IP/C/W/434 
26 November 2004 
 (04-5145) 
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 from the United States  
  
 The following communication, dated 24 November 2004, is being circulated as the request of the Delegation of the United States. 
 
_______________ 
 
 
I. INTRODUCTION  
1. The purpose of this paper is to permit progr ess in current discussions under agenda items 
pursuant to paragraphs 12 and 19 of the Doha Ministerial Declaration.  It attempts to identify common 
ground where it exists, to provide more focus and structure to the discussions, and to help reduce 
differences in order to resolve concerns that  have been expressed by various delegations. 
2. In conjunction with paragra ph 12, paragraph 19 of the Doha  Ministerial Mandate clearly 
directs the "TRIPS Council, in pursuing its work  programme … to examine the …relationship 
between TRIPS Agreement and the CBD, protection of  traditional knowledge, and folklore".  Some 
Members have expressed concerns about the difficu lty in implementing both agreements and that 
there may be a conflict between these agreements.  Advancing various reasons, some delegations have 
proposed new disclosure requirements in patent appli cations regarding:  (i) disclosure of the source 
and country of origin of the biological resource  and of the traditional knowledge used in the 
invention;  (ii) evidence of prior informed con sent through approval of authorities under the relevant 
national regime;  and (iii) evidence of fair and e quitable benefit-sharing u nder the relevant national 
regime.
1   
3. On the other hand, the United States is one of a number of Members that see no conflict 
between the TRIPS Agreement and the CBD and that  consider that these agreements can and should 
be implemented in a mutually supportive manner.  As discussed in previous  US submissions, while 
the objectives of these two agreements are distinct, they do not conflict.2  Moreover, the United States 
views with the utmost caution any proposals that would add uncertainties in patent rights that may undermine the role of the delicately balanced patent  system in its primary purpose of encouraging 
innovation, technological progress and economic development.  
                                                     
 
1 See, Bolivia, Brazil, Cuba, Dominican Republic , Ecuador, India, Peru , Thailand, Venezuela, 
IP/C/W/403. 
2 See United States, IP/C/W/257. IP/C/W/434 
Page 2  
 
 4. In an effort to help achieve progress in the discussions in the TRIPS Council, this paper sets 
out the concerns of the United States with regard to proposed new patent disclosure requirements, as 
well as our view of what mechanisms may be e ffective for achieving objectives widely shared by 
Members.  A closer study of these widely shared objectives suggests that implementation of effective 
national laws that directly address the relevant goals is the most effective way to proceed.   
II. SHARED OBJECTIVES 
5. Based on recent discussions in the TRIPS Council aimed at fulfilling the Doha Ministerial 
mandate, and written contributions s ubmitted in that context, Members appear to share several broad 
policy objectives.  These objectives include:  (1) en suring authorized access to genetic resources, 
i.e., that prior informed consent is obtained;  (2 ) achieving equitable sharing of the benefits arising 
from the use of traditional knowledge  and genetic resources;  and (3) preventing the issuance of 
erroneously issued patents.     
6. The United States supports these objectives and has consistently encouraged and supported 
the equitable sharing of benefits arising from the utilization of traditional knowledge and practices of 
indigenous and local communities.  However, based on experience, our view is that the most effective 
means to achieve the stated objectives is through tailored, national solutions to meet practical 
concerns and actual needs.  The introduction of new patent disclosure requirements will not achieve 
these important objectives and may have significant negative consequences.
3 
III. EXAMINING THE OBJECTIVES:  NEW PATENT DISCLOSURE REQUIREMENTS 
ARE NOT THE ANSWER 
A. PRIOR INFORMED CONSENT AND MISAPPROPRIATION  
7. New patent disclosure requirements will not work to guarantee that prior informed consent 
was obtained.   It must be recognized that it is the relevant prior consent agreement itself (usually 
constituting a contract between two entities), and not  a disclosure in a patent application, that 
manifests prior informed consent.  A researcher or  collector needs to know where to go, who to 
contact and which persons are authorized to grant appr oval in order to receive prior informed consent.  
A completely separate, transparent mechanism needs to be established outside the patent system that 
implements these criteria regardless of any disclosure made in a patent application.  If the goal is to 
ensure authorized access based on pr ior informed consent, only contr actual obligations that establish 
the rights and obligations of the entities involved prior to any access to genetic resources can ensure 
prior informed consent is achieved. 
8. In this light, a new disclosure requirement in  the patent system also will not prevent 
misappropriation.  Those with intent of acting in bad faith will not be  deterred by disclosure 
requirements.  Furthermore, a transparent prior inform ed consent regime is needed to ensure that the 
vast majority of researchers and/or collectors can conduct their research and activities in an 
appropriate manner.  Some proponents of new pate nt disclosure requirements have suggested that 
"misappropriation has mainly taken the form of obtaining patents in, mostly, developed Members 
inconsistently with the will of the custodian communities".4  However, misappropriation, in the 
context of these discussions, relates to the imprope r collection and/or use of genetic resources or 
traditional knowledge.  The act of patenting, per se , does not amount to misappropriation.  Indeed, 
                                                      
3 By "new patent disclosure requirements," this paper refers to the proposed new requirements 
regarding source and/or origin, evidence of PIC, and evidence of equitable benefit-sharing that have been proposed by Members in the course of TRIPS Council sessions. 
4 African Group, IP/C/W/404.  IP/C/W/434 
 Page 3 
 
 
 patent rights can be an effective tool, in conjunc tion with a benefit-sharing agreement, to transfer 
benefits.  
B. BENEFIT -SHARING  
9. Nor will a new disclosure requirement in the patent  system ensure that benefits are equitably 
shared with the provider of the traditional knowledge  or genetic resources.  The proposed new patent 
disclosure requirements, per se , cannot transfer benefits, as such a requirement would merely convey 
the information requested but would have no mechanis m to transfer benefits between parties.  If the 
country of origin of the relevant traditional kn owledge or genetic resour ces has no benefit-sharing 
infrastructure in place for the use of the traditiona l knowledge and/or genetic resources, there still 
would not be any compensation to the custodians of the relevant knowledge or resource even if a 
patent relating to these materials were identified.   A mechanism to transfer benefits must be 
established.    
10. Indeed, 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 commercia lize the knowledge or resources disclosed 
without 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 commercia lize 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 en tered into a valid benefit-sharing agreement 
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 revocati on of a patent due to litigation by a third 
party not affiliated with a tr aditional knowledge or genetic resources holder, this could 
actually upset the pre-existing benefit-sharing agreement. 
 
11. Moreover, a new patent disclosure requirement would fail to address benefit-sharing resulting 
from commercialization that occurs outside the patent system.  New patent disclosure requirements will be meaningless when products derived from or based on traditional knowledge or genetic 
resources are commercialized, but not patented.  There are many ways of protecting ideas that lead to commercialization, including trade secret and unfair co mpetition laws.  In such cases, benefits would 
likely not flow to the relevant communities unless a domestic access and benefit-sharing framework is 
first put in place to facilitate a contractual arrange ment that would lead to benefit-sharing.   
C. P
REVENTING ERRONEOUSLY GRANTED PATENTS  
12. Another objective raised by the proponents of disclosure requirements is that of preventing 
erroneously granted patents.  Some  have even suggested that they view a disclosure of source and/or 
origin as "critical for ascertaining inventorship" a nd capable of enabling a better assessment by patent 
examiners of novelty and inventive step.5  Indeed, these are laudable goals.  The proposed new patent 
                                                      
5 IP/C/W/403. IP/C/W/434 
Page 4  
 
 disclosure requirements, however, will be ineff ective in achieving this objective and will only 
complicate an already overburdened patent system.   
13. First, none of the suggested new patent discl osure requirements aim to ensure compliance 
with patentability requirements such as proper inve ntorship, novelty or inventive step.  Second, 
disclosure of source and/or origin can be expressed in wide variety of ways.
6  Information indicating 
country of origin, ex situ  collection sites, etc., would do little to ensure ascertainment of appropriate 
inventorship, novelty or inventive step, because such information does not generally address the 
considerations underlying these requirements, such as acts of invention or the state of the relevant art.   
D. ADDITIONAL CONCERNS REGARDING NEW PATENT DISCLOSURE REQUIREMENTS  
1. Adding uncertainty to the Patent System 
14. Furthermore, new patent disclosure requirement s would add new uncertainties in the patent 
system.7 Particularly where the sanctions for non-comp liance include invalidation of a patent, this 
would create a "cloud" of uncertainty over the pate nt right by opening a new avenue for litigation and 
other uncertainties that would undermine the role of the patent system in promoting innovation and technological development.   This could have  negative effects on the economic development 
incentives that patents provide.
8  These uncertainties would likely also undermine any potential 
benefit-sharing.    
2. Administrative Burdens 
15. Moreover, new patent disclosure requirements may also lead to significant administrative 
burdens for the patent offices of Me mbers that would in turn create additional costs, particularly with 
respect to those requirements that would demand comp liance with foreign laws.  A patent office is not 
positioned to examine documentation, unilaterally provided by applican ts, in response to requirements 
such as those proposed regarding source and/or origin , prior informed consent,  or evidence of benefit-
sharing.  To implement an appropriate standard of review within the patent system for these matters 
would create significant new administrative burdens and substantial new costs, including training and 
system development, for the patent offices of a ll Members. Furthermore, even with the added 
resources and costs, it does not seem possible that pa tent examiners could make such determinations 
with any degree of legal certainty, particularly deci sions involving interpretati ons of foreign laws to 
determine the validity of prior informed consen t or adequate benefit-sharing according to the 
custodian country's legal regime, thereby compounding  the uncertainties both in granted patent rights 
and in the process of granting patents.  Courts and other authorities of those jurisdictions providing 
                                                      
6 See Switzerland, IP/C/W/400/Rev.1. 
7 These new patent disclosure requirements would generally be requirements untested to a great extent 
at the national level, leading to significant legal uncer tainty, for which at least one proposed sanction is the 
revocation of the patent right.  Concerns include, inter alia , situations in which the resource is indigenous to one 
country, but freely available in several other countries, the degree of relationship between the claimed invention 
and the relevant genetic resource or traditional knowledg e, and whether national courts or national intellectual 
property offices would have to interpret other nation's laws.  This would also lead to undue burdens on those applicants seeking to comply with such requirements, which, in turn, may discourage applicants from seeking 
protection and may thereby act as a disi ncentive to innovation and investment. 
8 The patent system is designed to promote innovation and provides significant economic development 
incentives.  See e.g., Kamil Idris  "Intellectual Property:  A Power Tool for Economic Growth," describing a 
number of ways in which patents can stimulate economic development, including: (1) patent information 
facilitates technology transfer and inve stments, (2) patents encourage R&D at  universities and research centres, 
(3) patents are catalysts of new technologies and businesses, and (4) businesses use patents in licensing, joint 
ventures and other revenue generating transactions.  IP/C/W/434 
 Page 5 
 
 
 the genetic resources or traditional knowledge would be  more appropriately situated to examine these 
matters. 
3. Ineffectual Monitoring System 
16. Proponents of a new patent disclosure requirement also appear to wrongly assume it to be an 
effective monitoring system.  Indeed, the proposal by Switzerland for a disclosure of source 
requirement in the context of the Patent Cooperation Treaty (PCT) appears to recognize the 
shortcomings of such a disclosure of source requireme nt in noting the difficulties posed by the various 
ways that information could potentially be discl osed, such as through databases, publications or 
ex situ  collections.9  Thus, the Swiss, apparently aware of the shortcomings of a disclosure of source 
requirement, per se , go so far as to suggest that it be implem ented in conjunction with an apparently 
multilateral system of notification, in which nationa l patent offices would identify and notify points of 
contact designated to receive such information in  other governments.  This would be coordinated 
through an office at WIPO that would create a list of notified contact points for each government.10 
Notwithstanding the complexity of issues surrounding the creation of such a system, including its associated costs and effectiveness, such an appare ntly multilateral notification system still does not 
address legal uncertainties in the patent system and consequent negative effects created by a 
disclosure of source and/or origin requirement nor does it address the fact that an access and 
benefit-sharing infrastructure in a country is necessar y to enable the sharing of such benefits.   
17. In light of these concerns, the United States is not convinced that new disclosure requirements 
in patent applications are an appropriate solution.   However, the United States shares many of the 
objectives raised by various Members.   The real ch allenge is how most effectively to achieve these 
objectives.  As more fully described below, this  challenge can best be met if countries establish 
separate legal and other frameworks that will directly and effectively address these issues. 
IV. EXAMINING THE OBJECTIVES:  OPTIONS TO ACHIEVE APPROPRIATE 
ACCESS AND EQUITABLE BENEFIT-SHARING 
18. Experience shows that the most effective mean s to achieve the shared objectives of obtaining 
appropriate access and benefit-sharing is through de velopment of national laws outside the patent 
system that can more directly and effectivel y regulate conduct relevant to these issues.    
A. A
CHIEVING PRIOR INFORMED CONSENT  
19. It is imperative that governments implement laws that require prior informed consent from 
clearly delineated points of contact, such as the gove rnment and/or indigenous representatives before 
a party seeks to use or collect traditional knowledge or genetic resources.  Points of contact should 
include the persons authorized to  provide access to materials.  Fo r example, countries could establish 
permit systems that impose civil and/or criminal penalties for extracting genetic resources without a 
permit, where the permit would serve as evidence of prior informed consent. 
B. ACHIEVING EQUITABLE SHARING OF BENEFITS  
20. A contract-based system can be used to eff ectively control the collection of resources and 
ensure the sharing of benefits from their use.  C ontracts can provide a great deal of flexibility in 
determining benefit-sharing, both monetary and non-monetary.  Within the contract, a party can 
require the researcher to report regularly to the point of contact regarding progress of his research. This informs the authorities of how the relevant tr aditional knowledge or gene tic resource is being 
                                                     
 
9 IP/C/W/400/Rev.1. 
10 IP/C/W/400/Rev.1. IP/C/W/434 
Page 6  
 
 used and keeps communication channels open.  The c ontract can also require mandatory disclosure to 
appropriate authorities of any future commercia l application utilizing the relevant traditional 
knowledge or genetic resource, wh ether patented or not.  This type of mandatory disclosure 
requirement can provide for an effective monitoring  system by ensuring a specific type of disclosure 
of the particular commercial application involved.   The contract can also specify choice of law 
provisions, so that all parties are aware of the law that will apply should disputes arise.  Contracts can 
be specifically enforced, requiring adherence to its terms; damages for breach of contract can also be 
specified, including punitive damages.  
21. It is also our understanding that many Member s have not yet implemented access and benefit-
sharing regimes.  As described in previous US submissions to TRIPS Council, the United States has 
developed contract-based systems to ensure appropriate access and benefit-sharing.   
22. In June of 2001, the United States introduced a paper
11 that described in detail the provisions 
of the CBD that might have some im plications for the TRIPS Agreement,12 and explained how those 
obligations might be implemented through the use of  a contract-based regime for access to genetic 
resources.  The paper suggested that, inter alia , contracts authorizing coll ection of genetic materials 
include provisions requiring reporting and benefit-sharing and that parties to such access agreements 
be obliged to notify the appropriate authorities in the event an invention was developed using genetic 
materials collected under the contract.    
23. In March of 2002, the United States submitted another paper13 describing in considerable 
detail the procedures used by the US National Can cer Institute in collecting genetic materials for 
screening for potential therapeutic uses related to  cancer.  Many US government agencies have 
established policies that embody the principles of appropriate access and equitable benefit-sharing.  
Further, in November of 2002, the United States submitted a paper describing the regime for access to 
genetic materials in US National Parks.14  That paper includes a detailed description of the regime, 
including the use of Scientific Research and Collecting Permits as well as Cooperative Research and 
Development Agreements.  This experience might be  helpful to other Members, particularly those 
Members that have not yet implemented such  a regime in their respective territories. 
24. The access systems described in these papers are easily adaptable to other legal systems, and 
can provide countries the flexibility to protect thei r traditional knowledge or genetic resources without 
the risks mentioned earlier of undermining the econom ic development incentives of strong intellectual 
property protection and without the risk of underm ining benefit-sharing, as discussed earlier.   
C. COMPLIANCE WITH ACCESS AND BENEFIT -SHARING REGIMES  
25. Many of the proponents of disclosure require ments do not challenge the necessity of 
effective, contract-based, access and benefit-sharing regimes.15  However, some argue that patent 
disclosure requirements are necessary, in addition to such regimes, to improve compliance with such 
mechanisms.16  The United States disagrees with such a policy approach as unnecessarily burdensome 
to the patent system.  Such a legal regime, if in fo rce, can be adequately enforced without resort to 
                                                      
11 United States, IP/C/W/257. 
12 Specifically, Articles 8(j), 15, 16 and 19. 
13 United States, IP/C/W/341. 
14 United States, IP/C/W/393. 
15 See Bolivia et al., IP/C/W/403, paragraph 18 states  that "it is acknowledge d that these mechanisms 
can and should be used, and several countries have alre ady enacted laws to put in  place an Access and Benefit-
sharing (ABS) regime."  Further, see paragraph 16 of Sw itzerland, IP/C/W/400, which notes that Article 15.7 of 
the CBD requires that sharing of bene fits arising from utilization of gene tic resources shall be on mutually 
agreed terms and that "generally, the mutually agreed terms will be laid down in a contract." 
16 IP/C/W/403.  IP/C/W/434 
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 patent law requirements.  Effective enforcement regi mes for access and benef it-sharing should be part 
of civil and criminal codes specifically designed to enforce access and benefit-sharing laws.  Such 
enforcement mechanisms can be appropriately tailored so as not have unintended, negative 
consequences on the intellectual property system.  Pa tent law was not designed to regulate or enforce 
misconduct issues, such as misappropriation of trad itional knowledge or genetic resources, but to 
promote the progress of the useful arts.  Patent ri ghts permit an inventor to exclude others from 
certain acts,17 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 governing emissions 
from automotive engines) or to protect domestic or national security (e.g., regulating firearms), for 
example.  These restrictions, notably, are enforced outside the patent system by separate regulatory 
mechanisms. 
26. While a few individuals could ignore the legal 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 and safety codes apply in their spheres.  As is done 
in the case of these other distinct regulatory system s, criminal provisions and/or civil liability for 
failure to comply can be included in the country 's laws for those few who might take genetic 
resources without entering into an access ag reement with the required party.    
27. In order for the TRIPS Council to more fully c onsider the concerns raised by the proponents 
of disclosure requirements, Members may want to  more fully examine national experiences with 
respect to access and benefit-sharing systems curre ntly in place in order to better understand the 
perceived shortcomings of such existing systems.  In  this light, the Council may also want to consider 
the extensive work that continues in the Inte rgovernmental Committee on Intellectual Property, 
Genetic Resources and Folklore of the WIPO, which was specifically created to deal with many of 
these, and related, matters. 
V. EXAMINING THE OBJECTIVES:  OPTIONS TO PREVENT THE ISSUANCE OF 
ERRONEOUSLY GRANTED PATENTS 
28. Several tools can and are being used to a ddress concerns regarding the issuance of 
erroneously granted patents.  The TRIPS Counc il may want to consider these more fully. 
A. ORGANIZED DATABASES  
29. First, patent examiners world-wide could u se 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 ex amination of patent appli cations in the relevant 
fields.18  
B. INFORMATION MATERIAL TO PATENTABILITY  
30. Furthermore, Members way wish to consider a requirement such as that  used in the United 
States for patent applicants to disclose any inform ation known by the applicant to be material to 
                                                      
17 See, e.g. TRIPS Article 28. 
18 A number of initiatives are exemplary of this approach, including the China Traditional Chinese 
Medicines Database and the India Traditional Knowledge Di gital Library (TKDL) of Ay urveda.  See, e.g., the 
relevant web site of the World Intell ectual Property Organization (WIPO) at 
http://www.wipo.int/tk/en/data bases/tkportal/index.html. IP/C/W/434 
Page 8  
 
 patentability.
19  If the objectives are to truly to determine prior art, to ascertain inventorship and to 
prevent mistakenly granted patents, this type of requirement is directly related to achieving these 
goals, to the extent that the applicant may have su ch information.  Inventorship is included here 
because US law clearly requires that inventorship  be a requirement for entitlement to a patent.20  This 
type of information is directly related to the qu estions of patentability and can aid examination of 
patent applications in a manner that disclosure of source and/or origin of genetic resources or 
traditional knowledge cannot.  
C. POST-GRANT OPPOSITION OR RE-EXAMINATION  
31. Implementation of post-grant  opposition or re-exa mination proceedings can rectify the 
situations in which patents are issued erroneously.  These procedures are far le ss costly than litigation 
and can alert national patent authorities when new in formation is discovered th at is relevant to the 
patentability of the invention.  These procedures can directly bring information to the attention of 
patent authorities, as appropriate, in  order to address questions of pate ntability with regard to issued 
patents.  Indeed, a number of granted patent s have been successfully challenged when it was 
demonstrated through existing opposition processes that  these patents should not have been granted.  
This has included patents relevant to turmeric a nd neem in the United States and in the European 
Patent Office.21  
32. We are unaware that any of the perceived instances of misappropriation have involved a 
wrongful determination of inventorship or prior ar t that could not be satisfactorily addressed by the 
above means, or that a patent disclosure requireme nt for source and/or origin would have corrected 
this. 
VI. CONCLUSION 
33. The patent system has been and continues to be  a highly effective tool for technological and 
economic development.  The WTO should be wary of  upsetting the delicately balanced patent system, 
particularly when it is doubtful that any suggest ed changes will actually achieve their stated 
objectives. 
34. Further, it would be wrong to assume that a new disclosure requirement within the patent 
system will accomplish the objectives of ensuring access and equitable benefit-sharing, preventing 
misappropriation and preventing erroneously issued pa tents.  Rather than focusing on proposed new 
patent disclosure requirements, the TRIPS Coun cil should focus with more precision on what 
Members are trying to achieve in this area, revi ew the past experiences and situations that have 
prompted various concerns and cons ider any appropriately tailored solutions.  As many of the broad 
objectives are widely shared, we are confident that appropriate solutions can surely be reached to 
address the concerns of all Members.   
 
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19 37 CFR 1.56(a): Each individual associated with the filing and prosecution of a patent application 
has a duty of candor and good faith in dealing with th e [United States Patent and Trademark] Office, which 
includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.  
20 See 35 USC 102(f): "A person sha ll be entitled to a patent unless he did  not himself invent the 
subject matter sought to be patented". 
21 See Carlos Correa, "Traditional Knowledge and Intellectual Property: Issues and Options 
Surrounding the Protection of Traditional Knowledge", QUNO, November 2001.