WORLD TRADE  
ORGANIZATION  IP/C/W/469 
13 March 2006 
 
 (06-1111) 
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 10 March 2006, is being circulated at the request of the 
Delegation of the United States. 
 
_______________ 
  
I. INTRODUCTION 
1. The purpose of this paper, building upon the pr evious two submissions from the United States 
(IP/C/W/434 and IP/C/W/449), is to continue to f acilitate discussions under agenda items pursuant to 
paragraphs 12 and 19 of the Doha Ministerial Declaration. In conjunction with paragraph 12, 
paragraph 19 of the Doha Minister ial Mandate directs the TRIPS C ouncil to examine the relationship 
between the TRIPS Agreement and the CBD, the prot ection of traditional knowledge, and folklore.  
At Hong Kong, Ministers took note of these provisions and directed the TRIPS Council to continue its 
work.
1 
2. To further develop commonly held perspectiv es and concerns and further clarify areas of 
divergence, this paper analyzes and responds to argu ments of different Members in order to reach a 
better understanding of the issues pursuant to our mandate.   In response to the most recent United States communication
2, the delegations of Bolivia, Brazil,  Colombia, India and Pakistan have 
presented a further discussion paper3 containing "technical observations" on issues raised in the 
United States submission.  The United States ap preciates the contribution of this paper as a 
meaningful way to advance discussions.  This ex change has helped to re-focus discussions on the 
crucial question of whether the various proposals made in the TRIPS Council can adequately address 
the concerns raised by meeting objectives that are widely shared in the Council.4  Rather than 
repeating analyses and arguments fully explained in  previous US submissions, this paper seeks to 
build on the previous exchanges and, more importantly, on the "fact-based" discussion being undertaken within the TRIPS Council.     
 
                                                     
 
1 WT/MIN(05)/W/3/Rev. 2, paragraph 44. 
2 IP/C/W/449. 
3 IP/C/W/459, Bolivia, Brazil, Colombia, Cuba, India and Pakistan. 
4 See IP/C/W/434, 443, 449, 459.  Shared objectives include:  (1) ensuring authorized access to genetic 
resources, i.e., that PIC is obtained; (2) achieving equ itable sharing of the benefits arising from the use of 
traditional knowledge and genetic resources;  and (3) pr eventing the issuance of erroneously issued patents. IP/C/W/469 
Page 2  
 
  II. RELATIONSHIP OF THE TRI PS AGREEMENT AND THE CBD 
3. The United States is among those Members that see no conflict between the 
TRIPS Agreement and the Convention on Biologi cal Diversity (CBD) and consider that these 
agreements can and should be impl emented in a mutually supportive  manner.  The United States has 
previously set forth a comprehensive analysis of  the obligations of those CBD provisions most 
frequently cited as related to the provisions of  the TRIPS Agreement.  The United States has 
addressed this issue in previous submissions, in cluding IP/C/W/257, IP/C/W/434 and IP/C/W/449.  
These papers not only recognize the mutually supp ortive nature of the TRIPS Agreement and the 
CBD, but also explain efforts of the United States to promote and encourage prior informed consent 
(PIC) and equitable sharing of be nefits on mutually agreed terms.
5 
4. Nonetheless, some Members continue to rai se concerns on this qu estion.  Beyond general 
arguments, document IP/C/W/459 states that th e "TRIPS Agreement … contains no effective 
provisions to protect [biological] resources and associated knowledge from misappropriation and theft" and this generates conflicts between its implementation and the CBD.
6  It is true that the 
TRIPS Agreement, as an agreement covering trade -related aspects of intellectual property, does not 
include provisions to protect genetic resources from misappropriation and theft.  However, the 
absence of such provisions does not indicate a conflict.   Rather, those acts fall outside the purview of 
the TRIPS Agreement and are appropriately the domain of a separate regulatory system.7  
5. Further, India, Brazil and other co-sponsors of the paper allege that "the lack of safeguards in 
the TRIPS context has led to a situation where … genetic resources and tr aditional knowledge are 
often erroneously dealt with as if they formed part of the public domain" and that "no consideration is 
given to the fact that genetic resources and associ ated traditional knowledge constitute a fundamental 
contribution to the attainment of the invention".8  However, it is not the "lack of safeguards" in the 
TRIPS context that creates any "erroneous" treatment of  the relevant resources, but instead the lack of 
clearly defined national systems directly regulating the use of genetic resources, particularly in the context of access and benefit-sharing (ABS) system s.  Many countries have only recently enacted 
national ABS regimes, or are still in the process of doing so.
9  The implementation and effectiveness 
of these systems should be carefully examined be fore considering new proposals, such as those 
relating to the patent system, which would likel y result in legal uncertainty and other negative 
consequences. 
III. BUILDING ON THE FACT-BASED DISCUSSION 
6. In order to build on the common perspectives and concerns identified in the past discussions 
and to reduce divergences among Members, it remain s important to focus on the intended objectives 
when discussing the mechanisms proposed.  For ex ample, the proposals of the United States have 
been criticized because, inter alia , "national ABS systems cannot prevent the grant of bad patents."10  
However, the United States proposal has never su ggested that to be the purpose of national ABS 
systems.  The US proposals regarding national ABS systems are directed to the goals of providing 
appropriate access and equitable benefit-sharing.  With respect to mistakenly granted patents, 
proposals such as use of searchable, organized data bases, disclosure of information material to 
patentability and use of post-grant opposition and/or  re-examination procedure can directly achieve 
this objective.  
                                                      
5 See, in particular, IP/C/W/257, paragraphs 3-6 of IP/C/W/434 and paragraphs 3-7 of IP/C/W/449. 
6 IP/C/W/459, paragraph 1. 
7 See IP/C/W/434, paragraph 25, patent law is not designed to regulate or enforce general misconduct 
issues, such as misappropriation of genetic resources or traditional knowledge. 
8 IP/C/W/459, paragraph 2. 
9 IP/C/W/459, paragraph 16. 
10 IP/C/W/459, paragraph 16.  IP/C/W/469 
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  7. Close consideration of the arguments made recently in the Council for TRIPS and, in 
particular, in documents IP/C/W/434, IP/C/W/443, IP/C/W/449 and IP/C/W/459, continues to lead to 
the conclusion that new patent disclosure requireme nts are not an appropriate solution to meet the 
concerns raised.  It is clear that in order to achie ve the objectives of PIC and equitable benefit sharing, 
national laws outside the patent system that direc tly and effectively regulate conduct are critical.  The 
co-sponsors of IP/C/W/459 agree that "a national ABS regime is necessary for the proper running of 
the benefit-sharing aspects of the system."11  As noted in previous submissions, the United States has 
proposed national contract-based systems to meet  the demands of achieving appropriate access and 
equitable benefit-sharing.   
8. The United States has long observed that concer ns about misappropriation arise more broadly 
than in the context of products under patent protection.  The co-sponsors recognize in IP/C/W/459 
that misappropriation "may or may not include patent  protection" and that "instances of other [i.e., 
non-patent] forms of commercialization are dealt with under national ABS regimes."12  It is unclear in 
the arguments of the demandeurs  why national ABS systems, on the one hand, are insufficient with 
respect to misappropriation that is followed by the filing of a patent application, yet, on the other 
hand, can apparently sufficiently handle all othe r forms of misappropriation which potentially have 
even greater commercial consequences.   
9. As previously proposed, it seems that a more appropriate solution for any kind of 
misappropriation would be to strengthen national re gimes outside the patent systems in order to 
address all instances of commercialization of misa ppropriated resources and/or  traditional knowledge 
that need to be addressed regardless of whether th ese instances involve patenting or not.  In order to 
better resolve this issue, the Council should cons ider national experiences regarding ABS systems, 
identify perceived problems or gaps with these ex isting systems, and proceed to discuss how these 
problems can be addressed. 
10. While it is evident that certain commonalities are emerging, it is equally clear that 
divergences remain strongly held.  The United States  supports the recent direction of the discussion in 
the TRIPS Council toward a more f act-based discussion, based on national experiences.  However, a 
close inspection of these documents highlights a number of questions. 
A. COMMERCIAL AVAILABILITY OF RESOURCES  
11. The most recent submissions by Peru13 and the Annex attached to document IP/C/W/459 help 
to identify the actual experiences that these delegations  consider to illustrate their concerns.   We 
believe further analysis of these documents is warranted. 
12. Member States may control their genetic res ources and acquire bene fits that may later 
develop from the use of those resources, including in ventions that may ultimately be patented because 
they are new, useful and involve an inventive step.  A major premise of Peru's latest submission is that 
patent applications that "(directly or indir ectly) incorporate genetic resources and traditional 
knowledge … ha[ve] been obtained illegally, irregularly or questionably, to say the least."14  It is not 
clear how the mere fact that a pending patent appli cation, or a granted patent, that refers to genetic 
resources or claims an invention that may have  some relation to these resources can lead to a 
conclusion that the genetic resources or intellectua l knowledge at issue has been obtained "illegally, 
irregularly, or questionably."   
                                                      
11 IP/C/W/459, paragraph 16. 
12 IP/C/W/459, paragraph 18. 
13 IP/C/W/458. 
14 IP/C/W/458, paragraph 7. IP/C/W/469 
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  13. It has been noted that many of the resources cite d by Peru and other Members in the course of 
discussions are grown in many countries throughout the world, including many of those countries in which patents are filed.
15  Further, it is noted that many r esources of Peruvian origin have been 
exported and sold as raw material for direct cons umption or industrial processing, with a view to 
immediate economic benefits.16  Peru itself acknowledges this issue as a "major problem" in looking 
at the "biological resource-genetic resource"  relationship and identifying "illegal access."17 The 
threshold question that must arise is whether these exports or the transactions concerning those 
exports were subject to the access and benefit-sharing regime of Peru.  If not, this leads to conclusion 
that it is likely that many, if not all, of the inve ntions cited have used starting materials that were 
obtained by legitimate means, e.g., through commerc ial channels, and not by illegal, irregular or 
questionable means. 
14. Additionally, a cursory review of several of th e patents listed in the Peruvian submission and 
in IP/C/W/459 reveal that the inventors of several  of these patents did in fact disclose the source 
and/or origin of the genetic resource related to the invention.  Given that many of the issued patents 
involving genetic resources cited by Peru and others do, in fact, disclose source and/or and origin of 
the biological material, it is clear that the propo sed new disclosure requirements in and of themselves 
will not attain the purported goals.   
15. Rather than advocate burdensom e remedies that will not in fact address underlying problems, 
Members should inquire as to how existing ABS sy stems deal with genetic resources exported as raw 
material for direct consumption or industrial pro cessing, or otherwise traded as commodities.  Another 
important question is whether extracts or other pr oducts isolated from such resources that may be 
exported are either exempt from national ABS system s or, at the least, exported without any notice to 
third parties of ABS requirements.  New disclos ure requirements will not address large volumes of 
resources that may be exported from countries, appa rently exempt or unregulated by national ABS 
systems that, after travelling through the normal ch annels of commerce eventually may be used as 
starting materials for research and/or innovation. 
16. Peru's concept of "bio-piracy" appears to be limited solely to the context of pending patent 
applications and granted patents.  As discussed previously, patentin g in and of itself does not amount 
to misappropriation.  The analyses presented by Pe ru may provide useful information concerning 
prior art to help understand whether or not a patent  should be (or should have been) granted in these 
cases.  However, there is nothing in those experi ences that suggests that the proposed new disclosure 
requirement for source and/or origin would ha ve been relevant to these determinations.18  A s  
discussed previously, a review of the discussions in TRIPS Council and the "turmeric case" in 
particular indicates that the opposite is true.19   
                                                      
15 See, e.g., IP/C/M/48, paragraph 77.  Statement of Ja pan that genetic resources referred to in Peruvian 
submission IP/C/W/441 were widely cultivat ed worldwide, including in Japan.   
16 IP/C/W/458. 
17 IP/C/W/458, paragraph 23. 
18 See IP/C/W/434, paragraph 13.  Disclosure of so urce and/or origin has little or no relevance to 
novelty or inventive step in the usual sense.  
19 IP/C/M/49, paragraph 102. Statement of the Unite d States regarding US Patent 5,401, 504, entitled 
"Use of Turmeric in Wound Healing."  The patent application was filed by two Indian nationals working at the 
University of Mississippi Medical Center in Jackson, MS , and identified India as the country of origin.  As 
would typically be the case, that information was not relevant to the determination of patentability in the case 
and the patent was granted. After grant, a reexamination was filed in this case during which additional prior art 
that was not found by the patent examiner was cited.  The prior art led to the subsequent cancellation of all the claims in the case.  The time from the request for reexamination until the issuance of the reexamination 
certification declaring that all claims  had been cancelled was 18 months.  IP/C/W/469 
 Page 5 
 
 
  17. The proposed new disclosure requirements woul d not have addressed these past perceived 
instances of misappropriation.  In the absence of  evidence to support the assertion that these new 
proposed disclosure requirements would achieve their intended outcomes, it is all the more 
problematic for Members to consider such requirement s in light of the disincentives they are likely to 
have on innovation.  The patent system is a critical incentive mechanism for promoting the research 
and development of new inventions of legally obtained or accessed material.  This is what ultimately 
results in new inventions that enhance living co nditions, including life-saving medicines, higher crop 
yields, and better treatments for diseases.  All Members have a stake in encouraging, not discouraging, this process. 
B. 
PRIOR INFORMED CONSENT AND MISAPPROPRIATION :  ENFORCEMENT ISSUES  
18. There appears to be agreement among Members that national access and benefit-sharing 
systems are, at least, an essential component of any system that would address PIC and equitable 
benefit sharing on mutually agreed terms. 
19. However, concerns continue to be raised re garding enforcement of national ABS provisions.  
Brazil, India et al. raise the so-called "Yahoo !-Nazi" case as apparently illustrating challenges of 
trans-boundary enforcement.  This case involved a publicly accessible website selling items which 
were banned by criminal law in one jurisdiction but where the sale was a constitutionally-protected act in another jurisdiction.
20  It is clear from the facts described that the case at issue did not involve a 
party, either private or government body, from one jurisdiction attempting to enforce mutually agreed 
obligations in another jurisdiction.  Further, it s hould be noted that contract law, including provisions 
to deal with cross-boundary enforcement, is widely accep ted in most jurisdictions.  In that light, it is 
clear that this case has minimal, if any, relevan ce to the question of providing effective enforcement 
in the context of proposals made by the United States. 
20. The proposals made by the United States have cl arified that a national contract-based system 
can be adequately enforced outside of patent law requirements.  Such contract-based systems can be 
part of civil and criminal codes specifically desi gned to enforce access and benefit-sharing laws.  
Furthermore, these contract-based systems can be international in character and may contain, inter 
alia, choice of forum, choice of law, or internationa l arbitration provisions relevant to cross-boundary 
dispute or enforcement issues.  Such mechanis ms are widely used in international business 
transactions and can function to enforce mutu ally agreed terms between the parties.  
C. PREVENTING ERRONEOUSLY GRANTED PATENTS  
21. The United States appreciates the clarification that the proposed disclosure of source and 
country of origin requirement is primarily aime d at preventing the grant of so-called "bad" or 
mistakenly granted patents.21  The United States agrees with the st atement that "it is much better for 
the patent system to prevent the issue of bad patent s than to take a laissez-faire attitude that would 
shift on to society and aggrieved third parties the burden of revoking such patents"22 and has 
presented a number of proposals directly aimed at  achieving the goal of preventing erroneously 
granted patents.  Accordingly, the main question of disagreement is whether the proposed disclosure 
                                                      
20 IP/C/W/459, paragraph 4.  For the purposes of argument, this paper will assume that the facts 
presented in IP/C/W/459, although taken from secondary sources, about this case are accurate.  
21 IP/C/W/439, paragraph 6. 
22 IP/C/W/459, paragraph 6. IP/C/W/469 
Page 6  
 
  of source and country of origin can be justified by  its primary aim, i.e., whether it can prevent the 
grant of mistakenly granted patents.  As we  have shown in previous documents, it cannot.
23 
22. Nonetheless, the co-sponsors of IP/C/W/459 pers ist in the argument that disclosure of source 
and/or origin is not only relevant, but "crucial".24  It is argued that "disclosure of source and country 
of origin can surely help the patent office to re quest more information from the patent applicant."25  
Later, the co-sponsors argue that disclosure of source and/or country of origin is crucial for preventing 
mistaken patents because such inform ation gives "useful hints in relation to the existing prior art and a 
way to inquire into the extent of inventiveness." 26  
23. Even if one accepted that the requirements would help in this regard, the speculative benefits 
of providing "hints" to patent examiners who ma y or may not seek additional information based on 
such hints are not a sufficient justification for these proposed new patent disclosure requirements, 
particularly when viewed in the light of the inhere nt negative effects of such requirements.  Moreover, 
due to the tenuous relationship between  source and/or country of origin to issues relating to prior art 
and inventorship, it is not likely that this proposal will provide any helpful "hints."   
24. The experience of Peru is instructive in id entifying the perceived "problems" faced in 
collecting information, but here again, it is the US proposals, not the new proposed disclosure 
requirements, that can address these problems.  The problems cited include limited information in the English language in certain pate nt information databases, problems in finding prior art because the 
available information is not "sys tematized" and difficulties in findi ng documents regarding particular 
customs, that are attributed to the customs of certain communities in Peru to transmit traditional 
knowledge orally from ge neration to generation.
27   
25. However, disclosure of source, origin, PIC or benefit sharing agreements have little, if any, 
bearing on how to alter the situations  cited by Peru.  In fact, the appl ications for several of the patents 
listed in the Peruvian submission and in IP/C/W/459  did indeed disclose the source and/or origin of 
their starting material.   
26. Peru has stated that its goal was to show that "p atents that should not be granted … are in fact 
being granted" and that this is in support of "r eview of the TRIPS Agreement" and the "need to 
improve the prior art search systems currently used  by intellectual property offices" around the world.  
This is a useful clarification.  The United States fully supports the goal of improving prior art search systems and has made proposals directly related to  this goal and we are open to more explicitly 
focusing discussion on how this can be achieved.  The options proposed by the United States, 
including, use of organized databases of prior ar t and a more general disclosure of information 
material to patentability requirement  are consistent with "systemati zing" information and would more 
directly provide the required information to patent  examiners rather than providing "hints" which 
would bear little, if any, relation to the issues under consideration. 
27. The United States has been working to improve the quality of patent examination and ensure 
that challenges regarding prior art are addressed.  As  noted previously, we fully support efforts to 
compile organized databases related to traditional kn owledge and genetic resources in order to assist 
patent examiners around the world in their search for prior art. This should help prevent the issuance 
                                                     
 
23 See, e.g., IP/C/W/434, paragraph 13, information indi cating country of origin, ex situ collection sites, 
etc., will do little to ensure ascertainment of inventorsh ip, novelty or inventive step  because such information 
does not address the considerations underlying these requirements, such as acts of invention or the state of the relevant art.   
24 IP/C/W/459, paragraph 20. 
25 IP/C/W/459, paragraph 11. 
26 IP/C/W/459, paragraph 20. 
27 IP/C/W/458, paragraph 23.  IP/C/W/469 
 Page 7 
 
 
  of mistakenly granted patents.28  Further, the United States continues to support efforts in the 
World Intellectual Property Organization (WIPO) to  ensure that prior art related to traditional 
knowledge is better integrated into the international patent system.29 
28. We continue to study the examples cited by othe r delegations, but a first review fails to show 
how the new proposed disclosure requirements rega rding source and/or country of origin would 
address the concerns raised.30  As discussed at the most recent session of the TRIPS Council, a 
detailed analysis of the facts of the turmeric ca se shows that the country of origin was indeed 
identified yet, as would commonly be the case, this information had little relevance to the matters of 
patentability at hand.31  The United States is in the course of studying other examples that have been 
cited to see if any empirical evidence can be gather ed that supports the premise that disclosure of 
source and/or origin would be effective in preventing mistakenly granted patents.   
29. With respect to the goal of preventing mistaken ly granted patents, it should be recognized that 
errors, albeit rarely, will continue to occur in an y system.  To the extent that this happens, these 
circumstances can be rectified by an effective post-grant opposition or  re-examination practice.  Some 
Members have complained that such systems are "costly" and "burdensome."32  We remain open to 
ideas from other Members on how to improve these systems short of new requirements that have little 
if any relevance to matters of patentability.  For ex ample, in recent years, the United States Patent and 
Trademark Office (USPTO) has introduced and refine d procedures to facilitate bringing prior art to 
the attention of a patent exam iner during patent examination.33  We note that to the extent that source 
and country of origin may be rele vant to patentability of inventions, this can be accomplished by a 
disclosure requirement of any information known by  the applicant to be material to patentability.34  
D. RELATIONSHIP OF GENETIC RESOURCES AND /OR TRADITIONAL KNOWLE DGE TO INVENTION   
30. The arguments of the proponents of the proposed  new disclosure requirements seem to imply 
that all biological resources automatically contain an economic and intellectual contribution worthy of 
protection.  If all biological resources automati cally contain such an economic or intellectual 
contribution, then the most appropriate system of protection, regardless of any eventual patenting or 
commercialization, should be a national contract-bas ed ABS system that permits monitoring of the 
biological resource upon access.  Yet, instead, the pr oponents argue in favour of new patent disclosure 
requirements that would have little, if any, effect  in actually protecting this purported economic and 
intellectual contribution of the biological resource.   
31. In reviewing the arguments made in IP/C/W/459, we have noted with particular interest the 
argument that "genetic resources and associated  traditional knowledge constitute fundamental 
elements of several products and pro cesses and represent both an economic and intellectual  
                                                      
28 IP/C/W/434, n. 18.  A number of initiatives are exemplary of this approach, including the China 
Traditional Chinese Medicines Database and the Indi a Traditional Knowledge Digital Library (TKDL) of 
Ayurveda.  See, e.g., the relevant website of the World Intellectual Property Organization (WIPO) at 
http://www.wipo.int/tk/en/databa ses/tkportal/index.html.  
29 See, e.g., PCT/MIA/12/6, "PCT Minimum Documentation:  Status Report" (29 November 2005).  
Annex I contains a list of traditional knowledge related periodicals added to the minimum documentation 
required to be available for searching by Internationa l Authorities under the Patent Cooperation Treaty (PCT). 
30 See, e.g., Annex of IP/C/W/459.   
31 IP/C/M/49, paragraph 102, see, infra n. 20. 
32 IP/C/W/459, paragraph 23. 
33 See 37 CFR 1.99. 
34 See, e.g., the requirement in the United States, 37 CFR 1.56(a):  Each individual associated with the 
filing and prosecution of a patent application has a duty of candour and good faith in dealing with the [United States Patent and Trademark] Office, which incl udes a duty to disclose to the Office all information 
known to that individual to be material to patentability as defined in this section.  IP/C/W/469 
Page 8  
 
  contribution  to the attainment of the invention " (emphasis added). 
35  The recent submissions provided 
in the "fact-based" discussions have been helpful in illustrating percei ved concerns but also highlight 
differences among Members.  An invention, by definition, must be new and involve an inventive step.  If an invention does not meet these criteria, it is  not patentable.  The proponents appear to have 
assumed that what is known about a genetic resource prior to research and development is what leads 
the inventor to the patented inve ntion.  Such is not the case in ma ny, if not most, circumstances.  
Many inventions are the culmina tion of numerous researchers seeking a solution to a problem, or the 
result of an unexpected finding while seeki ng information on an unrelated experiment. 
32. For example, it took more than 30 years to develop the anti-cancer medication TAXOL® 
which was originally isolated from the Pacific Ye w in Washington State, USA.  This cost the 
US Government more than $32 million USD and cost Bristol-Myers Squibb (BMS) more than 
$320 million USD in ramp-up costs and investment .  Total drug investment for BMS purportedly 
approached nearly $1 billion USD.
36 This invention was developed as a result of a US National 
Cancer Institute mass-screening programme of mo re than 100,000 plant extracts and 16,000 animal 
extracts for evidence of anti-cancer activity. TAXOL ® was the only extract that showed promise and 
resulted in a commercialized drug. The researchers is olating the Pacific Yew extract had no previous 
knowledge of anti-cancer activity.  Document IP/C/W /459 overlooks the real and often costly efforts 
undertaken to develop a biological resource into  a commercially successful product, and the risks 
involved in undertaking such resear ch and development.  Many medicines that are developed from 
plant and animal extracts are a result of arduous r esearch efforts, unexpected research results or trial-
and-error experimentation.37   
33. This emphasizes that many inventions resulting from research and development of biological 
resources are a result of independent discovery and are not developed based on previous knowledge of 
properties of the biological resource.  The patent system is designed as an incentive for innovators to 
undertake such intensive and expensive research and development by rewarding an exclusive right to 
exclude others from using the invention for a limited time.  We should be very wary of potentially 
upsetting this system by introducing new patent disclosure requirements.   
34. The case of Merck Sharp and Dome (Merck) and the National Institute of Biodiversity of 
Costa Rica (INBio) is an example of the benefits of a national ABS system where, as is often the case, the economic potential of a biological resource is  unknown and may not be realized through research 
and development, yet the contract entered into be tween the user and provider resulted in dramatic 
benefits for INBio and the Costa Rican Government.
38  Under the terms of this agreement, INBio, a 
government created non-profit scientific organization provided 10,000 samples of plants, animals and 
soil to Merck with exclusive rights to research these  samples for two years and with retention rights 
for any resulting patents.  In exchange, Merck paid INBio $1 million USD upfront and provided the 
institute with training and laborat ory equipment.  Merck additionally agreed to pay royalties for any 
drugs developed from the biological samples.39  The agreement between Merck and INBio was 
successful enough that the parties extended the agreem ent at least two more times.  Although it has 
been reported that the resources screened by Merck have not been commercialized to date and have 
not led to any patentable inventions, as is typically  the case, this arrangement transferred significant 
                                                      
35 IP/C/W/459, paragraph 2. 
 36 Stephenson.  A Tale of Taxol®.  Research in Review .  Florida State University Office of Research, 
(Fall 2002).  
37 See Medical Miracles. American Chemical Society , 
http://acswebcontent.acs.org/landmarks/med ical4.html (last accessed 7 March 2006). 
38 Benefit Sharing – Experience of Costa Rica.  Paper prepared by the Government of Costa Rica for 
the Second Regional Workshop of the UNCTAD "Project on Strengthening Research and Policy Making 
Capacity on Trade and Environment in the Developing Countries."  Havana, Cuba (31 May - 3 June 2000). 
39 Coughlin Jr. M.D.  Using the Merck-INBio agr eement to clarify the C onvention on Biological 
Diversity.  Columbia Journal of Transnational Law  31(2):  337-75 (1993).  IP/C/W/469 
 Page 9 
 
 
  benefits to INBio.40   It also has been touted as a very eff ective access and benefit sharing regime that 
meets the obligations of the CBD.41 
35. These examples illustrate the actual and inhe rent risk in investing in research and 
development activities for biological resources.  Commercialization of products resulting from the 
research are the exception, not the rule, and introduc tion of new patent disclosure requirements that 
may upset the careful balance created by the patent system to promote innovation should not be 
entered into given that the analysis of such discl osure requirements results in a conclusion that they 
will not attain their purported goal.  On the othe r hand, national ABS systems have proven to be 
effective in achieving PIC, equitable sharing of be nefits and monitoring of the use of the resource, 
providing significant sharing of benefits, even wh ere no patentable inventions are developed.   
36. A national ABS system can be effectively u tilized to recoup any inherent economic or 
intellectual contribution of the genetic resource itsel f.  For example, contractual agreements entered 
into between the provider and user at the time of  access to the genetic resource can be extremely 
effective in maintaining long-term control over the use of that genetic resource or associated 
traditional knowledge as previously indicated.42  A contract-based system that provides regular 
reporting requirements on subsequent research and deve lopment of the material is by far the best way 
to trace an intangible asset, such as the "intell ectual contribution of a biological resource."  
Furthermore, while we do not see the benefit of  new disclosure requirements and are opposed to 
insertion of these requirements as part of the patent regime, we note that a contract-based system can 
be used to require contractually that the user of th e material disclose the source and country of origin, 
PIC and existence of the contract in any subsequently filed patent application. 
37. We further note that there appears to be a presumption by the proponents, without empirical 
evidence, that an invention related to a genetic  resource is automatically based upon illegal access or 
misappropriation absent concrete evidence to th e contrary.  However, as discussed above, many 
genetic resources are indeed commercially sold, le gally obtained, and inde pendently researched and 
developed into inventions.  Even  within publicly accessible international and national gene banks, 
there are many resources where the country of origin is unknown.  Even assuming  arguendo , that new 
disclosure requirements could achieve the purported goals, new patent disclosure requirements would 
be unworkable given the absence of knowledge of count ry of origin for numerous publicly available 
resources.  However, as previously stated, such new disclosure requirements create legal uncertainty 
and increased burdens on the patent system, as well as  negative effects on benefit sharing, but will not 
prevent the purported acts of misappropriation or bad patents.43  These objectives must be 
accomplished through national ABS systems upon acces s to the material initially.  These examples 
lead to the conclusion that new patent disclosure re quirements will not achieve the desired objectives 
and that incorporation of such requirements in  the patent system would stifle innovation and 
undermine the patent system.   
                                                      
40 Letter from the Biotechnology Industry Organization to Ambassador Rob Portman, US Trade 
Representative (6 December 2005). 
41 Coughlin, Jr. supra  note 39. 
42 IP/C/W/434, paragraph 20. 
43 IP/C/W/434, paragraph 26. IP/C/W/469 
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  IV. CONCLUSION 
38. The current exchange of views in the TRIPS Council concerning "shared objectives" has been 
very helpful.  The more recent fact-based approach has permitted further progress.  Both the turmeric 
case, raised by India in the TRIPS Council, as well as document IP/C/W/458 from Peru regarding its 
national experiences in confronting misappropria tion issues have established a greater clarity 
concerning the proponents' underlying concerns.   
39. A detailed analysis of these individual cases and experiences continues to lead to the 
conclusion that the newly proposed disclosure requi rements are not an appropriate solution to the 
concerns raised, and that more directly tailored so lutions, such as those proposed by the United States 
are a more effective solution.  With respect to access  and benefit sharing, we continue to consider the 
optimal approach to be one involving the implem entation of national regimes for prior informed 
consent and equitable benefit sharing that establishes clear terms and that can be enforced adequately 
and effectively outside the patent system.  When addressing issues regarding the erroneous granting of 
patents, Members should focus on remedies that di rectly address that goal.  These remedies include 
the use of organized databases, information mate rial to patentability and the use of post-grant 
opposition or re-examination systems as  an alternative to litigation. 
40. The discussion has also helped to identify co mmon ground among Members.  It has also been 
confirmed that Members agree that national, cont ract-based ABS systems are essential elements of 
any solution.  Members also appear to share th e concern about how to improve prior art search 
mechanisms for patent offices around the world with  the objective of preventing mistakenly granted 
patents. 
41. While disagreement still persists, the United Stat es will continue to engage in the discussion 
in order to directly address the concerns raised in TRIPS Council, through proposals that fully meet 
the objectives sought without the negative effects inherent in the proposed patent disclosure 
requirements.  In order to continue recent progress,  further examination of national experiences would 
be helpful.  The most recent fact-based discussions  have raised a number of issues regarding genetic 
resources, their trade as commodities, and the rela tionship of these goods to national ABS regimes in 
place, as well as the relationship of such goods to st arting materials that may be used for research or 
innovative purposes.  Analysis of these issues coul d bear greatly on perceptions of misappropriation 
and perceived solutions to the concerns raised.   
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