WORLD TRADE  
ORGANIZATION  IP/C/W/459 
18 November 2005 
 (05-5450) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
THE RELATIONSHIP BETWEEN TH E TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOGICAL DIVERSITY (CBD) AND THE 
PROTECTION OF TRADITIONAL KNOWLEDGE 
 
TECHNICAL OBSERVATIONS ON THE UNI TED STATES SUBMISSION IP/C/W449  
BY BOLIVIA, BRAZIL, COLOMBIA, CUBA, INDIA AND PAKISTAN 
 
 
 The following communication, dated 21 October 2005, is being circulated at the request of 
the Delegations of Bolivia, Brazil, Colombia, Cuba, India and Pakistan.  Colombia has been added as 
a cosponsor in accordance with its  request dated 2 November 2005. 
  
_______________ 
  
 
I. GENERAL COMMENTS ON THE DOHA MANDATE TO EXAMINE THE 
RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CBD 
A. C
ONFLICT BETWEEN TRIPS  AND THE CBD 
1. The United States, in all its submissions, has argued that there is no conflict between TRIPS 
and the CBD.  In its most recent submission, the United States in fact reiterates the same positions and arguments it put forward several years ago, in doc ument IP/C/W/257.  Comparing Article 1 of the 
CBD and Article 7 of the TRIPS, it argues that th e objectives of the two documents do not run counter 
to each other and are mutually supportive.  The Un ited States, however, focuses its analysis on an 
excessively narrow interpretation of both treaties, which does not take into account their spirit and 
objectives.  It is well accepted that the CBD does not address the resource depletion issue alone.  
Instead, it highlights this issue as a result of the extensive piracy of biological resources of the 
countries rich with genetic resources.  It is an ac cepted fact that the gene and biochemical hunt over 
the components of biological diversity is largel y driven by their use, value or the knowledge 
associated with those resources, without which bio prospecting loses much of its content.  This 
knowledge associated with the biological resources is  also a product of the human intellect, which is 
recognized under the CBD as deserving of protection.   Hence, the protection of the components of 
biodiversity and associated traditional knowledge from  bio piracy must be integrated within the 
framework of the TRIPS Agreement.  The TRIPS Ag reement as it stands today, whilst promoting the 
granting of patents to products based on genetic  resources and associated traditional knowledge, 
contains no effective provisions to protect those resources and as sociated knowledge from 
misappropriation and theft.  It is the absence of such provisions in the TRIPS Agreement that may generate conflicts between its impl ementation and that of the CBD.  On the other hand, the inclusion 
of provisions in TRIPS to protect genetic r esources and associated traditional knowledge from 
misappropriation would, in practice not only support fulfilment of the objectives of the CBD, but would also be in line with the fundamental objectives of TRIPS. IP/C/W/459 
Page 2  
 
 2. The United States opines that "the objectives of th e TRIPS Agreement as stated in Article 7, 
are the protection and enforcement of intellectual property rights in a way that (and not should, as in the text) contribute to the promotion of technological  innovation and to the transfer and dissemination 
of technology, to the mutual advantage of pr oducers and users of technology and in a manner 
conducive to social and economic welfare, and to a balance of rights and obligations".  Article 7 of 
TRIPS points to the need for a balance between  the monopoly rights granted under the intellectual 
property (IP) regime and the public interest.  It pr ovides for the benefits that should accrue to the 
society at large in return for the grant of intellectual property rights, viz. promotion of technological innovation, transfer and dissemination of technology,  social and economic welfare etc.  What the 
CBD envisions is a different system, which claims be nefit-sharing in respect of the use of genetic and 
biological resources and associated traditional knowle dge for the countries of origin and providers of 
such resources or traditional knowledge which, regre ttably, are not currently protected under TRIPS.  
The lack of safeguards against misappropriation in the TRIPS context has led to a situation where, 
under the existing IP regime, those genetic resour ces and associated traditional knowledge are often 
erroneously dealt with as if they formed part of the public domain, open to appropriation by anybody 
without any obligation to ask for permission and pay b ack the provider(s).  No consideration is given 
to the fact that genetic resources and associat ed traditional knowledge constitute fundamental 
elements of several products and processes a nd represent both an economic and intellectual 
contribution to the attainment of the invention.  The conflict thus largely relates to the issue of 
appropriation of benefits arising from the commerc ialization of products/processes that are based on 
biological material and/or traditional knowledge.  The moot point is whether the patent holder 
appropriates all the benefits arising from the co mmercialization of a product based on biological 
material and/or traditional knowledge or whether he/s he shares the benefits with the States and/or the 
traditional knowledge holders.  This underlying c onflict lifts the veil off the balance set by the  
US proposals by comparing the objectiv es of the Convention and the TRIPS. 
B. CBD
 DOES NOT REQUIRE OR MENTION PATENT DISCLOSURE REQUIREMENT  
3. The United States submits that there is no express obligation under the CBD regarding 
disclosure requirements in patent law.1  This argument of the United States has already been 
responded to in previous TRIPS Council meetings.  Not being an IP instrument, the CBD does not 
create patent disclosure requirements.  But Article 16.5 of the CBD does oblige countries to cooperate 
to ensure that patents and other IP rights do not run counter to the objectives of the CBD.  We submit 
that the Doha Development Agenda can make  a crucial contribution in this regard. 
C. COLLECTION OF GENETIC RESOURCES BY THE UNITED STATES GOVERNMENTAL AGENCIES 
CONSISTENT WITH THE CBD  PRINCIPLES OF PRIOR INFORMED CONSENT AND BENEFIT 
SHARING ON MUTUALLY AGREED TERMS  
4. The United States argues that its governmental agencies and US-based companies have been 
undertaking bioprospecting activities in a manner cons istent with the principles of prior informed 
consent (PIC) and benefit sharing;  it also affirms that its efforts have been in line with the Bonn 
Guidelines.2  Though it may be true that the United States may be taking steps internally, these steps 
are not sufficient to solve the concern of misappropr iation caused by the issue of bad patents and the 
trans-boundary nature of the problems of illegitimate  bioprospecting.  In this regard, contractual 
agreements alone cannot ensure compliance with th e principles of PIC and benefit sharing, as it is 
difficult to enforce a foreign obligation for an act that  is not prohibited in the country in which it is to 
be enforced.  It is an established fact that in en forcement of laws involving multiple jurisdictions, the 
binding nature and enforceability of foreign judgeme nts/obligations are always moot points.  The 
Yahoo! – Nazi case illustrates this point very well.  The French Jewish and anti-racist groups initiated 
                                                      
1 IP/C/W/449 paragraph 4. 
2 IP/C/W/449 paragraph 6.  IP/C/W/459 
 Page 3 
 
 
 legal action against the California-based Yahoo! web portal when the latter allowed Nazi memorabilia 
(items such as SS daggers, swastikas, photos of d eath camp victims, replic as of Zyklon B poison gas 
canisters etc.) to be sold on its US auction pages.3  As the French laws bar the display or sale of racist 
materials, the French court ordered that French in ternet surfers should be denied access to US pages 
hosting the auction.  Though Yahoo! banned the sale of hate-related items from all the sites, it 
challenged the decision on the ground that the offend ing sites were aimed primarily at the American 
market and were therefore protected by the US freedom of speech laws.  Subsequently, the US 
Federal Court ruled that Yahoo! was not bound to ta ilor its non-French sites to French laws.  This 
clearly demonstrates the difficulty of enforcing fo reign judgements based on contractual obligations 
in the United States that are not expressly regulated in the United States though legislation.  There is 
no law enacted by the United States to date to en sure that non-compliance with the CBD obligations 
by US nationals in other countries can be remedied under US jurisdiction.  The existing system allows 
patents to be claimed at the USPTO for inventio ns relating to genetic resources and associated 
traditional knowledge without any concern for access and bio prospection rules in the countries of 
origin of those resources and knowledge. 
II. GENERAL COMMENTS ON PROPOSALS FOR NEW PATENT DISCLOSURE 
REQUIREMENTS 
5. The United States argues that the proposed disclos ure of origin requirement would lead to 
uncertainty.4  It cites examples where the resource is indi genous to one country, but freely available in 
several other countries;  the degree of relationshi p between the claimed inve ntion and the relevant 
genetic resources or traditional know ledge;  and whether the national courts or national IP offices 
would have to interpret other nations' laws etc.  This cloud of uncertainty, in the view of the  
United States, would be potentially detrimental to innovation and technological development, the 
economic incentives of the patent system and bene fit sharing under the ABS regime.  Such arguments, 
however, are based on a misreading of the proposed di sclosure of origin requirement.  There are three 
types of disclosure requirements proposed.  They are:  (1) disclosure of source and country of origin 
of the genetic materials and associated traditi onal knowledge used in developing the invention 
claimed in the patent application;  (2) disclosure of  the evidence of prior info rmed consent;  and (3) 
disclosure of the evidence of a benefit-sharing agreement.  As is evident, these disclosure 
requirements are intended to achieve different yet interrelated objectives of the CBD.  The US 
submission tries to read these requirements toge ther, which creates confusion.  Such unnecessary 
confusion cannot be a basis to avoid internationall y binding solutions to the very real problems of 
misappropriation and bio piracy. 
6. It is clear from the proposals that the disclosure of source and country of origin is primarily 
aimed at preventing the grant of bad patents that do not fulfil the patentability criteria of novelty and/or inventive step.  Introducing such a require ment in the TRIPS Agreement would not lead to 
uncertainty but to greater legal certainty, as it would ensure that the patent system does not issue bad 
patents.  This is evident from the number of cases that have come up before the USPTO and the EPO.
5  
It is much better for the patent system to preven t the issue of bad patents rather than to take a 
laissez-faire attitude that would shift on to societ y and aggrieved third-par ties the burden of revoking 
such bad patents after they have been issued.  The procedure for revocation of patents is more 
expensive and burdensome than mere ly requiring patent applicants to disclose the source and country 
of origin of the genetic resources and associated  traditional knowledge.  The frequent revocation of 
                                                      
3See http://www.guardian.co.uk/international/story/0,3604,893642,00.html : also see 
http://www.theinquirer.net/?article=21207 ,  
http://www.cyber-rights.org/documents/yahoo_y a.pdfp://www.vnunet.com/personal-computer-
world/news/2042963/yahoo-backs-nazi-case ,    
4 IP/C/W/449 paragraph 8 and IP/C/W/434 footnote 7. 
5 A sample list of cases attached at Annex.  IP/C/W/459 
Page 4  
 
 patents would surely create more uncertainty for the patent system and prevent technological 
innovation and the facilitated flow of  information that may be of great importance to bioprospecting 
and the biotechnological industry.  The disclosure of  origin obligation, on the other hand, would only 
require reasonable efforts on the part of patent appl icants to obtain the relevant information.  Since 
such information would normally be part of a larg er batch of information collected by the patent 
applicant for filing an application, it is not correct to argue that disclosure of origin would constitute 
an additional and/or burdensome obligation.  
7. The United States puts forward that erroneously granted patents are rare exceptions rather 
than the rule,
6 but the high rate of erroneously grante d patents on inventions involving biological 
resources and associated traditional knowledge tells the other side of the story.  In any case, there is 
no case for doing nothing to prevent issuance of ba d patents when our inte rnational obligations 
demand it and the adverse effect is primarily on de veloping country stakeholders.  In all the above 
situations, we can see that the new disclosure requ irement, being crucial in the determination of 
novelty and inventive step, can effectively remedy the problem of issuance of such bad patents 
involving genetic resources and associated traditiona l knowledge.  In other words, it would act as a 
crucial factor in the determination of the patent ability of biotechnological inventions.  As has also 
been pointed out previously,7 disclosure of origin will be releva nt in helping patent examiners to 
determine whether the claimed invention constitutes an invention that is excluded from patentability 
under Article 27, paragraphs 2 a nd 3 of TRIPS; would serve as part of a process to systematize 
available information of biological resources and traditional knowledge that will continuously build 
the prior art information available to patent exam iners and the general public; and will be useful in 
cases relating to challenges to patent grants or di sputes on inventorship or entitlement to a claimed 
invention as well as infringement cases. 
8. The mandatory requirement of disclosure of s ource and country of origin would solve the 
problem raised by the United States regarding gene tic resources that may be indigenous to one 
country but freely available in different countries.  In such cases, the source would be the country 
from where the applicant received the genetic material  and the country of origin is the country to 
which the genetic resource is indi genous.  It is not clear how the patent office would be forced to 
interpret the law of other countries in such cases. 
9. It is also not correct to argue that the other two disclosure requirements would create 
uncertainties and additional burdens for the patent of fice.  The obligation is only to produce evidence 
issued by the legally recognized authority of the country where access to the relevant material and 
information takes place.  The same applies to the case of the benefit-sharing agreement.  Disputes 
would not arise if this is obtained based on the requirements of the law of the country.  Only in cases 
where the applicant committed fraud could there be a dispute.  The raising of disputes during the opposition proceeding for failure to satisfy the requireme nts of the patent law is not new to the patent 
office.  In such cases, parties would provide adequa te and convincing evidence to the patent office to 
establish their claims.  The job of the patent office is only to evaluate such evidence and decide the 
claim.  The patent office is not expected to interpret the content of these documents but only to 
ascertain, through the claims and counterclaims, wh ether such evidence has been provided where a 
national regime requires such evidence.  It is diffi cult to appreciate how interpretation of foreign law 
is involved in such cases. 
                                                     
 
6 IP/C/W/449 paragraph 9. 
7 IP/C/W429/Rev.1.  IP/C/W/459 
 Page 5 
 
 
 III. PROPOSED OPTIONS FOR ACHIEVING APPROPRIATE ACCESS, BENEFIT 
SHARING, AND PREVENTING ERRONEOUSLY GRANTED PATENTS. 
10. The United States proposes many options to achieve the objectives of the CBD8 and provides 
that a contract-based national regime with an inte rnational outlook, supplemen ted by the guidelines of 
international instruments would be an ideal one.  Th e CBD system, as it exists now, is in line with the 
proposition of the United States i.e. "CBD  supplemented by the Bonn Guidelines."9  Despite this, the 
number of bad patents and instances of misappropr iation are increasing and the objectives of PIC and 
benefit sharing are not often met.  Since the problem is the issue of bad patents and failure to respect 
the rights and obligations of holders of the traditio nal knowledge on the basis of which the patent is 
issued, as well as the rights of the countries of origin  of the genetic resources, the solution must also 
be based on patent law and, in particular, the TRIPS Agreement.  Since the contribution of the 
custodians and holders of the genetic resources and associated traditional knowledge is not recognized 
and is clearly manifested in the misappropriation of the knowledge, a TRIPS-based solution is only 
just and reasonable.  The new disclosure requireme nt can bring to a great extent uniformity and 
certainty in relation to these concerns.  A contract-based system, howsoever perfect it may be, cannot 
ensure the effectiveness and mandatory enforcement at  the international level.  There is, therefore, a 
need for a binding international disclosure requireme nt regarding the source and country of origin (to 
deal with bad patents) and evidence of PIC and be nefit sharing (to promote PIC and benefit sharing) 
under the TRIPS Agreement to enforce national norms.  There is no need for opting for a multiple-forum solution or international arbitration wh en there can be a "one-stop shop" at the WTO.  
In any case, we are committed to resolve this problem  in the Doha Development Agenda as part of 
our mandate, and we are obliged to do so to th e extent that the TRIPS Agreement requires any 
interpretation to fulfil this mandate.  Arguing othe rwise would tantamount to shifting a component of 
the Doha mandate to outside the WTO, a propos ition that may not be acceptable in other areas of 
negotiations. 
IV. SPECIFIC OBJECTIVES ON ACHIEVING WIDELY SHARED OBJECTIVES 
A. PIC
 AND MISAPPROPRIATION  
11. The United States argues that the submissions of India and Brazil that the new disclosure 
requirement would not be a stand-alone system, ma kes it clear that, in the absence of a national 
regime, the new disclosure requirement would be of little or no utility and so the primacy is to establish national regimes.
10  It is submitted that this line of  argument does not take into account the 
aim of the proposed requirement of disclosing the s ource and country of origin.  This requirement is 
to ensure that misappropriation of genetic res ources and associated traditional knowledge is not 
encouraged through grant of patents on inventions  relating to genetic resources without recognizing 
the contributions of the holders of traditional know ledge.  Given the different nature of the prior art 
and inventive step involved in cases of genetic r esources and traditional knowledge associated with 
them, disclosure of source and country of origin can  surely help the patent office to request more 
information from the patent applicant during examinat ion of the application to ensure that bad patents 
are not issued.  This can surely  prevent bio piracy and misappropr iation of traditional knowledge by 
the patent applicant.  This is clearly one of the objectives of the CBD and this can be achieved only if 
changes are introduced in the global regime govern ing the patent law and not through national access 
legislation alone.  This also adds to the certainty and legitimacy of the patent system.  The disclosure 
requirement is also not as costly as the contr act-based system envisaged by the United States. 
                                                      
8 IP/C/W/434. 
9 There exists no recommendation fr om the WIPO IGC on the matter. 
10 IP/C/W/449 paragraph 14. IP/C/W/459 
Page 6  
 
 12. Disclosure of source and country of origin also  facilitates realization of the CBD objectives of 
PIC and benefit sharing.  Production of the evidence of PIC and benefit sharing along with the patent 
application are proposed specifically to achieve this.  It is in this context that the proposal from India 
and Brazil emphasized the need for national systems to support the international obligation in this 
regard.  Thus, it is incorrect to state that the object of the new disclosure requirement of source and 
country of origin is of "little or no utility" if national regimes on PIC and benefit sharing are not in 
place.  Even in the absence of a national ABS regime, disclosure of source and country of origin could surely help prevent bio piracy and misappropriatio n of traditional knowledge associated with genetic 
resources by preventing the issue of bad patents.  Additionally, in the cases where national ABS 
regimes have been established, disclosure ensures th at the requirements of these national regimes are 
met by bio-prospectors. 
13. The options contained in a contract-based sy stem as proposed by the United States, viz. 
choice of forum, choice of law, international ar bitration provisions governing transboundary issues, 
enforcement issues etc., are concerns of privat e international law.  Since the problem of 
misappropriation of genetic resources and associat ed traditional knowledge is a truly global one, 
requiring international intergovernmental norms, solutions-based on private international law are 
inadequate.  It is submitted by the United States that  a contract-based system "can be international in 
its outlook" with "provisions relevant to cross- boundary dispute or enforcement issues".  The  
United States is thus admitting to the limitations of  relying solely on national systems, and is agreeing 
that additional steps need to be taken to rectify the limitations of the existing regime.  Clearly, the best 
and most effective way to address the shortcomings of the existing system is through the 
establishment of an internationally binding obligation rather than the simple use of private 
international law principles within the national re gime.  This binding international obligation can 
easily be achieved by integrating it within TRIPS oblig ations.  It is this aspect that India and Brazil 
emphasize when arguing for a binding requirement of disclosure of evidence of PIC and benefit 
sharing in the patent application.  
1. Monitoring System 
14. The United States also opines that a contract -based ABS regime can be an effective 
monitoring system by mandating disclosure of any commercial application utilizing the resources or 
traditional knowledge.
11  It is to be noted that in the case of genetic and biological resources, 
monitoring is a very difficult task and may not be technically feasible especially when it leaves the country of origin
12 due to the nature of the product being purloined.  One of the major uses of genetic 
resource and traditional knowledge associated with it takes place through the patent system.  The 
patent system acts as an incentive to the comm ercial use of genetic resources and associated 
knowledge by creating a private monopoly over goods which are either public or owned by civil 
society rather than corporate interests who are able to prevent abuse.  The objective of a disclosure of 
source and country of origin mechanism in the pate nt system is the prevention of misappropriation of 
knowledge by preventing the grant of bad monopolies.  So a solution within the patent system for 
monitoring the use of genetic resources and associated  knowledge is more a ppropriate and effective 
than a fragmented private stakeholder-based contractual system. 
2. Enforcement of ABS Systems  
15. The United States equates disclosure of origin, as well as evidence of PIC and benefit sharing, 
with separate regulatory measures in the areas of health, environment and other matters.  It is 
submitted by the United States that like the national regulatory measures enacted in those areas, PIC 
                                                      
11 IP/C/W/449 paragraph 18. 
12 Glowka, "The Next Rosy Periwinkle Won't be Free:  Emerging Legislative Framework to Implement 
Article 15", Environmental Policy and Law , 27/6 (1997) p.445.  IP/C/W/459 
 Page 7 
 
 
 and benefit sharing could be monitored through sep arate national regulatory authorities and that the 
patent system need not be strained for this.13  As noted above, the prevention of illegal access to 
genetic resource through regulatory measures is diffi cult given the ease with which such resources can 
be purloined.  So what is attempted through mandato ry disclosure requirement is to ensure that the 
implementation of the TRIPS Agreement and of the obligations under the CBD should take place in a 
mutually supportive manner.  As explained, this requires internationally binding legal obligations 
rather than national regulatory measures alone.  The US contract-based solution sidelines this issue.  
The United States also submits that the patent sy stem does not condone or legitimize misappropriation 
of genetic resources or traditional kn owledge in violation of domestic requirements and that as in the 
case of other regulatory requirements, inclusion of civil or criminal liability for non-compliance can 
adequately take care of the question of enforcement.   This seems to be an over simplification of the 
issue.  One of the primary justifications for the disclosure proposal as an internationally binding norm 
is precisely the realization that the effort to ge t bad patents revoked or PIC/ABS issues addressed in 
the countries of grant of patents has proven to be costly, burdensome and more complicated than what 
could be offered by the mutual harmonization of the approaches of TRIPS and CBD through the 
disclosure requirement.  
B. BENEFIT SHARING  
16. The United States observes that "establishing na tional access and benefit-sharing systems is 
essential before engaging in discussion of supplemental pa tent disclosure requirements.   Furthermore, 
it would seem prudent to determine areas of inade quacy, based on experiences, of existing national 
systems in order to more fully consider these matters."14  Of course, a national ABS regime is 
necessary for the proper running of the benefit shari ng aspects of the system.  But it is not correct to 
argue that establishment of national access systems is  a pre-requisite for discussing an international 
framework for the disclosure requirement.  There are many instances where international norms are 
set before national systems are put in place.  This is all the more true with new and emerging areas, 
including in the field of intellectual property.  An  example is the Treaty on Intellectual Property in 
Respect of Integrated Circuits (the Washingt on Treaty), which was adopted in 1989 and has never 
entered into force.  No Member states of WIPO at the time had national legislation or experience in implementing that Treaty during the negotiations of  the TRIPS Agreement, but its provisions were 
nevertheless adopted as minimum standards of protecti on within TRIPS as part of those negotiations.  
Another example is the protection of copyright in the digital environment.  The issue was internationally discussed and the so-called "WIPO Internet Treaties" (WIPO Copyright Treaty and 
WIPO Performances and Phonograms Treaty) adopte d at a Diplomatic Conference in 1996 before 
many countries, particularly developing and l east-developed countries, could even experience and 
grasp the full extent of the problem, let alone est ablish an appropriate legal framework to find 
solutions.
15  The justification for that normative effort ha d been the need to prevent violation of rights 
and misappropriation of profits.16  The international framework, once established, led to the 
introduction of national systems, including in the United States, where legislation to implement the 
"Internet Treaties" came into operation only in 2000.17  Similarly, to prevent violation of rights over 
genetic resources and associated traditional knowledge,  national regimes, howsoever effective they 
may be, can only require that PIC and benefit shar ing should be linked to the grant of access.  The 
effective enforcement of such national regimes w ill be very weak, unless they are supported by an 
international legally binding obligation.  Moreove r, such national ABS regimes cannot prevent the 
grant of bad patents involving genetic resour ces and associated traditional knowledge.  But if 
                                                      
13 IP/C/W/449 paragraph 21. 
14 IP/C/W/449 paragraph 23. 
15 See www.wipo.org/treaties/en/ip/wct/ - 26k 
  16 For a detailed discussion, see Mahaly Ficsor,  The Law of Copyright and the Internet , Oxford 
University Press, 2002. 
17 See www.copyright.gov/legislation/dmca.pdf. IP/C/W/459 
Page 8  
 
 disclosure is made obligatory at the international level, all the concerns will be properly addressed.  
So the establishment of an international obligation assumes primacy.  Furthermore, it is to be noted that many countries have already enacted national laws  for ABS and others are in the process of doing 
so. 
17. Another conclusion asserted by the United Stat es is that "the remedy proposed itself 
(invalidation due to non-compliant disclosure, et c.) would destroy or have significant negative 
consequences on the benefit being sought, rather than  ensuring that the benefit would be shared with 
the appropriate party.  This would clearly fail to meet the shared objective of ensuring the equitable 
sharing of benefits arising out of the utilizati on of genetic resources a nd/or traditional knowledge."
18  
The goal of the disclosure requirement primarily is  to prevent misappropriation of genetic resources 
and associated traditional knowledge.  Disclosure of origin, coupled with disclosure of evidence of 
benefit sharing and PIC, promotes the equitable shar ing of benefits.  When there is patent protection 
involved in the commercialization of genetic resources and associated traditional knowledge, an 
enforcement mechanism within the pa tent framework will be more eff ective in ensuring that fair and 
equitable benefit sharing takes place.  The disclosur e requirement will ensure that PIC and fair and 
equitable benefit sharing agreements are obtained in  compliance with the national law of the country 
of origin of the genetic resources.  The consequen ces of non-disclosure, such as invalidation of patent 
rights, will flow only in cases of fraudulent claims, no t bona fide ones.  The intention is to protect the 
legal rights of the custodians and holders of the knowle dge or the resources.  The nature of the benefit 
shared, the mode of its sharing etc., are concer ns to be addressed under the national regime.  For 
example, if the person providing the genetic resource s is giving only the raw material and he does not 
have any knowledge of its use value, he can claim benefit sharing for the mere supply of the 
resources.  It is a wrong notion that patent monopoly is  essential for the sharing of benefits and that if 
there is no patent, no benefits can be shared.  Furthermore, remedies for non-compliance with 
disclosure are not limited to invalidation, as they may include other possibilities, such as the full or 
partial transfer of rights. 
18. The United States also argued that  "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 appropr iate solution would be strengthening national 
regimes outside the patent systems in order to take  a comprehensive, holistic approach and address all 
instances of commercialisation of misappropriated res ources and/or traditional knowledge that need to 
be addressed outside the patent system in any event."19  It is true that misappropriation of traditional 
knowledge and genetic resources may or may not in clude patent protection.  The new patent 
disclosure requirement can only deal with situations  where there is misappropriation through patents. 
The instances of other forms of commercialization are dealt with under the national ABS regimes.  
But it is erroneous to argue that since the patent disclosure requirement does not cover all instances of 
commercialization, such a requirement is not necessary.  The fact that misappropriation may not 
always involve the granting of patents does not mean that, when patents are actually involved, 
disclosure of origin may not make a significan t contribution to preventing misappropriation. 
Moreover, when there is a patent, it is only thro ugh the disclosure requirement that we can better 
assess the novelty and inventive step in the claimed i nvention and thereby prevent the grant of patents 
to ineligible claims.  The ABS regime can do nothing in relation to the grant of bad patents.  It is 
clear, therefore, that we cannot undermine the significance of the new patent disclosure requirement 
on the ground that it does not cover all instances of commercialization. 
19. The United States believes that any international effort should not be focused on new patent 
disclosure requirements but rather, on efforts to enco urage the establishment of appropriate access and 
benefit-sharing systems that (1) improve complian ce by providing users with clear rules for collection 
                                                      
18 IP/C/W/449 paragraph 25. 
19 IP/C/W/449 paragraph 26.  IP/C/W/459 
 Page 9 
 
 
 of genetic materials;  and (2) help ensure th at where uses of genetic resources or traditional 
knowledge are made, benefits are equitably shared with the appropriate parties.20  Thus the  
United States also accepts the need to establish an ABS regime with rules for strict compliance 
ensuring equitable benefit-sharing. The effective way of promoting effective compliance with such 
national regimes is to create inte rnationally binding obligations in the field, clearly spelling out the 
requirements of disclosure of source and country of origin, prior informed consent and benefit sharing 
as proposed.  Also, the various situations cited by the United States in footnote 20 of document 
IP/C/W/449 do not undermine the relevance of establis hing an international disclosure requirement.  
In fact, these examples support the need for a disclosure requirement on PIC and benefit sharing.  They show that there is a distinction between co mmercialization without a patent, where there is no 
exclusivity and public domain know ledge is exploited by all, in cluding the original owners, and 
commercialization with a patent, where despite lack  of novelty or inventiveness, a monopoly has been 
created in favour of the patent applican t and against other legitimate exploiters. 
C. P
REVENTING ERRONEOUSLY GRANTED PATENTS  
20. It is heartening that "the United States generally  shares concerns regarding erroneously issued 
patents."21  But document IP/C/W/449 refuses to accept that the proposed disclosure requirement 
would address the issue of bad patents.22  As explained by India in the TRIPS Council meeting in  
June 2005, disclosure of origin is crucial in dete rmining novelty and inventive step, giving useful 
hints in relation to the existing prior art and a way to inquire into the extent of inventiveness.  As 
noted by Brazil in its statement in the same meeting,  the patent disclosure requi rement is "…critical in 
ascertaining whether or not the applicant has invented what he claims in the patent, or has just found it 
in nature or obtained it from traditional cultures.  This is especially important when the traditional 
knowledge used in the invention is undocumented and ex ists in oral form, or is documented in a local 
language.  Disclosure of source and country of origin of the res ource and traditional knowledge would 
enable a better assessment by the patent examiner of  the novelty and the inventive step involved in the 
invention".  The role of disclosure requirement as information material to patentability in assessing 
novelty and non-obviousness is clear and the United  States accepts this as important in their 
submission.23  But in its latest submission the United States misses the point that if the disclosure 
requirement is made mandatory, the patent examin er can require the applicant during the processing 
of the application to furnish more information to ensure that patents are not issued for ineligible 
inventions.  This would signifi cantly contribute to addressing the problem of bio piracy and 
misappropriation.  The absence of details such as the ones that would have to be provided by the 
patent applicant under the proposed disclosure of orig in requirement makes the prior art search almost 
impossible and the patent office is often compelled to  issue patents for inventions that do not fulfil the 
relevant criteria.  The revocations of the turmeric and neem patents are cases in point. 
21. IP/C/W/449 also argues that determination of inventorship, prior art etc. are rooted in a 
country's patent law.  (Inventorship based on acts of  invention;  novelty and inventorship based on the 
country's relevant art).  It argues that information regarding the country of origin or the source i.e. 
country locations or ex situ  collection sites etc., is not relevant to considerations like inventorship or 
prior art and would therefore be of little value in that process.24  One of the primary aims of the 
proposed disclosure requirement is to check the i ssue of erroneously granted patent by rooting the 
patent examination on novelty and inventiveness.  In  this regard, informati on on source and country of 
origin can give useful hints in relation to the hol ders of the resources and/or the knowledge associated 
with them.  The United States does not accept the fact  that this information clearly facilitates the 
                                                      
20 IP/C/W/449 paragraph 27. 
21 IP/C/W/449 paragraph 29. 
22 IP/C/W/449 paragraph 28 & 29 read with IP/C/W/443 paragraph 17. 
23 IP/C/W/449 paragraph 36.  
24 IP/C/W/449 paragraph 30. IP/C/W/459 
Page 10  
 
 identification of the person skilled in the art and wh ether there exists a prior use or prior publication 
of the properties of the claimed invention involvin g the resources.  This is also linked with the 
practices of a country.  Especially when the resour ce is collected from one country and is indigenous 
to another country, the information of both source and origin proves to be more helpful in assessing 
the application on the patentability criteria.  So th e United States is not correct in arguing that the 
information that would be provided under a disclosur e of origin requirement has nothing to do with 
considerations like novelty and inventiveness. 
22. The United States further argues that "the op tions of organized searchable databases, 
information material to patentability, and use of  effective post-grant and re-examination procedures"
25 
better serve the purpose of preventing the issuance of bad patents.  Assuming but not accepting that 
such systems could be effective, disclosure of source  and country of origin is also important for their 
effective use.  For example, disclosure of origin  will surely help the patent examiner to more 
effectively use the searchable databases in findi ng out the prior art and undertaking its further 
analysis.  Disclosure of origin also contribut es effectively to post-grant and re-examination 
procedures, since the disclosure would help the opp onents collect adequate information on the prior 
art and obviousness.  This is evident from the oppos ition proceedings in the neem case before the 
EPO.26  The disclosure of country of origin helped the opponents to prove the teachings in India 
during opposition proceedings  regarding the healing properties, wh ich led to the revocation of the said 
patent. 
23. The United States submitted that post-grant and re-examination procedures play an important 
role in rectifying erroneously granted patents.27  It is an established fact that despite the existence of 
such procedures, many bad patents are still issued  in relation to genetic resources and the knowledge 
associated with them.  This shows that post-gr ant and re-examination procedures alone are not 
sufficient to effectively deal with the situation.  The procedure as proposed by the United States is 
also complex, lengthy, expensive and burdensome.  In addition of being more costly and burdensome, 
post-grant re-examination and revoca tion are curative mechanisms for the ailment of the issue of bad 
patents, rather than preventive steps.  What we argue  for is an effective pro cedure to prevent the issue 
of erroneous patents, which is preferable to relyi ng on the costly post-grant rectification of mistakes 
committed by patent offices in issuing bad patents.  In  this context, the proposed disclosure system is 
an effective preventive mechanism to the increased problem of issue of bad and questionable patent 
specifically in the area of biotechnology.28  The above-mentioned post-grant and re-examination 
procedures could be truly helpful only if coupled w ith disclosure of origin, which is clearly a more 
direct, simple and cost effective measure. 
24. The United States also argues that information th at directly relates to the genetic resources 
and traditional knowledge provided by organized da tabases would be more comprehensive than 
information regarding the source and/or country of origin29 of the genetic resources, provided under a 
disclosure of origin requirement. There is no logic in this argument.  It is not possible to document the 
whole knowledge available in a country let alone in the world.  Also, the knowledge that is kept 
confidential by some communities cannot be docum ented.  Since documentation as proposed cannot 
be exhaustive and comprehensive, it cannot remedy e rroneously granted patents.  On the other hand, 
                                                      
25 IP/C/W/449 paragraph 31. 
26 For a detailed discussion, see 
http://www.womenandlife.org/WL OEen/information/globalization/neembriefmar05.html or 
http://www.ifoam.org/press/press/pdfs/Briefing_Neem.pdf 
27 IP/C/W/449 paragraph 33. 
28See US FTC Report on Patent October 2003 "To Promote Innovation: The Proper Balance of 
Competition and Patent Law and Policy". 
29 IP/C/W/449 paragraph 32.  IP/C/W/459 
 Page 11 
 
 
 the proposed disclosure requirement gives useful links  to the novelty and inven tive step in the claimed 
invention, thereby preventing the grant of bad patents. 
25. It is quite interesting to note that the United St ates concludes that "in other words, it is not the 
act of patenting or applying for patent, but rather  the fact that traditional knowledge or genetic 
resources were accessed in violation of a national acce ss 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".30  This conclusion is incorrect, 
first because erroneous patents are wrongly granted pa tents, even within the patent system.  Second, 
this conclusion also suppresses the issue of viola tion of the property rights and misappropriation of 
genetic resources and associated traditional knowledge by the granting of bad patents. 
26. In addition to the issue of benefit sharing, the CBD tries to bring out the global issue of 
misappropriation of genetic resources and associated  traditional knowledge through different means 
including granting of patents good and bad.  This is  evident from Article 16 of the CBD that mandates 
the need to use international intellectual propert y norms supportive of the objectives of CBD.  By 
using the genetic resources or the knowledge associat ed with them, many actors have been taking out 
patents, including those that do not even fulfil the criteria of novelty or inventive step.  The US 
submission fails to convince that a contract-based national system could provide solutions to these 
problems.  We submit that only a patent disclosure requirement including the evidence of PIC and benefit-sharing agreement can effectively check th e problem of misappropriation of genetic resources 
and associated traditional knowledge. 
D. A
DDITIONAL ISSUES  
27. The United States also addresses other concerns like additional burden created by the new 
patent disclosure requirement on the patent offices and the applicants.31  I t  i s  t o  b e  n o t e d  t h a t  t h e  
applicant is required to submit only information of which he is, or in any case should be, well aware.  
In most countries having national regimes, the ev idence relating to PIC and benefit sharing are 
conditions precedent for the grant of access.  So the new patent disclosure requirement does not 
impose on him/her any cost or administrative burden while proceeding for a patent.  Likewise, the 
patent office is also not asked to test the verac ity of the evidence furnished in relation to PIC or 
benefit sharing. These serve as prima facie evidence of compliance.  Disclosure of source and country 
of origin of the genetic material or associate d traditional knowledge, enhances the capacity of the 
patent office in examining the patent applica tions involving biological resources or traditional 
knowledge and serves as a critical tool in tr acking down applications involving them.32  This gives the 
patent office useful hints to enquire into the novelty and inventiveness claimed in the invention. 
28. Similarly, the United States does not consider th e "requirement for source and/or origin to be 
a requirement to disclose information material to patentability" and adds that thus it cannot remedy 
the granting of bad patents.33  As discussed earlier, this requirement  alone can deal with the problem 
of bad patents whereby the patent office can require  the applicant to furnish more information during 
the processing of the application.  It checks the gr ant of bad patents by testing them against novelty 
and inventive step, being crucial in the determination of the criteria of patentability, it is of course an 
information material to patentability. 
 
                                                      
30 IP/C/W/449 paragraph 35. 
31 IP/C/W/449 paragraph 36. 
32 Statement by Brazil in the TRIPS Council in June 2005. 
33 IP/C/W/449 paragraph 37. IP/C/W/459 
Page 12  
 
 29. Another argument extended by the United States is that "…the disclosure requirement would 
be new and would provide an additional avenue to litigation and other uncertainties that would 
undermine the role of the patent system.  Partic ularly where the sanction would be, as has been 
proposed, revocation of the patent right, this w ould cause undue uncertainties in these patent rights, 
even where a good faith attempt has been ma de to comply with such requirements."
34  It also adds the 
statement of the Biotechnology Industry Organiza tion to the WIPO Intergovernmental Committee on 
Genetic Resources, Traditional Knowledge and Folklore that patent exclusivity is justified on the risks 
and investment involved in discovering and devel oping inventions and that the proposed requirement 
and sanctions, that may block the patent of an ot herwise eligible inventi on, would create unacceptable 
risks.35  It also argues that it would have detrimen tal effects on the developmental incentives of the 
patent system and benefit sharing.  However, it is an accepted fact that an in vention is eligible for 
patent protection only if it satisfies the universally  recognized criteria of novelty, inventive step and 
industrial applicability.  An invention that lacks th ese basic elements cannot be protected under patent 
law only on the ground that there is a huge investme nt behind it.  Thus the new requirement is not 
creating any unacceptable risk, but adds to the legitim acy and certainty of the patent system that only 
the eligible inventions are protected.  The sancti ons are only affecting fraudulent claims, without any 
uncertainty as alleged and a bona fide researcher need  not worry about the same.  On benefit sharing 
also, no ambiguity is created.  It is not true that  the proposed requirements will have negative effects 
on the possible benefit sharing.  If a patent is gr anted, the benefits arising out of such monopoly 
should be shared with the resource provi ders.  It is true that if there is no patent, benefits from a patent 
cannot be claimed.  But, it does not undermine the possibility of getting benefits from 
commercialization or the grant of access itself. 
 
_______________ 
 
                                                      
34 IP/C/W/449 paragraph 38. 
35 IP/C/W/449 footnote 31.  IP/C/W/459 
 Page 13 
 
 
 ANNEX 
 
FOOTNOTE 5  - A SAMPLE LIST OF BAD PATENTS  
 
 
1. The Quinoa Case - US patent 5,304,718  
Source: Graham Dutfield, Intellectual Prope rty, Biogenetic Resources and Traditional 
Knowledge, Earth Scan, UK and USA, 2004, Chapter 5, p. 53  
2. The Enola Bean Case - US patent 5,894,079  
Source: Graham Dutfield, Intellectual Prope rty, Biogenetic Resources and Traditional 
Knowledge, Earth Scan, UK and USA, 2004, Chapter 5, p. 54 –55. 
 
3. Dupont’s Biopiracy Challenged - EP 744888, issued to Dupont Aug. 2001 
Source: "Dupont claims patent monopoly over natural maize traits", Greenpeace press release, May 29th 2001  http://www.greenpeace.org
 
 
4. Ayahuasca patent - U.S. Plant Pa tent 5,751 on June 17, 1986 
Source: Glenn M. Wiser,  PTO Rejection of the "Ayahuasca" Patent Claim: Background and 
Analysis, Center for International Environmental Law, November 1999, 
http://www.ciel.org/Biodiversity/ptorejection.html  
 
5. “Ampalaya” – Philippines - US 5484 889, JP 6501089 and EP 553357 
Source: http://lists.essential.org/pipermail/upd-discuss/2001q1/000127.html  
 
6. Turmeric Patent - US pate nt 5,40,504 on 28 March 1995 
Source: Mashelkar, R. A., Intellectual Property Rights and the Third World, Journal of Intellectual Property Rights, Vol.7, July 2002, p.317.  
 
7. The Hoodia Case - WO 9846243 
Source: Graham Dutfield, Intellectual Prope rty, Biogenetic Resources and Traditional 
Knowledge, Earth Scan, UK and USA, 2004, Chapter 5, p.52  
8. Toxin of the Amazon frog Epipedobates tricolor 
Source: http://www.metu.edu.tr/~mengu/biopiracy_mengu_odev.pdf
 
 
9. Maca 
Source : http://fletcher.tufts.edu/research/2003/MaliniGoel.pdf   
 
10. Patent for composition of bringal, Karela, Jamun and Gurmar  - US patent 5,900,240 
 
11. Patent for Arhar or Pigeon pea or Caja nus – US patents 6,410,596 and 6,541,522 
 
12. Patents for Pepper – US patents 5,536,506, 5,744,161 and 5,972,382 
 
13. Patent for Amla - US patent 5,529,778  
 
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