RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/51 
20 September 2006 
 
 (06-4470) 
Council for Trade-Related Aspects 
of Intellectual Property Rights   
 
  
MINUTES OF MEETING 
 
Held in the Centre Willia m Rappard on 14-15 June 2006
 
 
Chairman:  Ambassador C. Trevor Clarke (Barbados) 
  
 The present document contains the record of  the discussion which took place during the 
TRIPS Council meeting held on 14-15 June 2006. 
  Subjects discussed
         P a g e  n o s .  
 
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2  
B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ..............................................................3  
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) .....................................................................4  
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY .............................................................................................................4  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ...................................................4  
F. NON-VIOLATION AND SITUATION COMPLAINTS ......................................................................27  
G. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 ......................27  
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................28  
I. TECHNICAL COOPERATION AND CAPACITY BUILDING .............................................................29  
J. ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS – COMMUNICATION FROM THE 
EUROPEAN COMMUNITIES ........................................................................................................30  
K. INFORMATION ON RELEVANT DEVELOPMENTS . .......................................................................34  
L. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............35  
M. OTHER BUSINESS ......................................................................................................................35  
 IP/C/M/51 
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  1. In proposing the agenda for adoption, the Chairman
 said that item J on "Enforcement of 
Intellectual Property Rights – Communication from the European Communities" had been put on the proposed agenda at the written request of the delegation of the European Communities, dated 
10 May 2006.  He proposed that the Council adopt the agenda as proposed. 
2. The Council so agreed
. 
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
3. The Chairman  informed the Council that, since its meeting in March, the Council had 
received a number of supplements and updates to earlie r notifications of laws and regulations notified 
under Article 63.2 of the Agreement.  Finland had provided a complete update to its notification of 
laws and regulations, including its  responses to the Checklist of I ssues on Enforcement;  Japan had 
notified an updated text of the Japanese Pate nt Law and certain other regulations;  the 
Kyrgyz Republic had notified a number of main dedicated and other intellectual property laws and 
regulations;  Qatar had notified its laws on trade secret s and layout-designs of integrated circuits;  and 
Sweden had notified amendments to its In ternational Copyright Regulation.  The 
European Communities had notified a regulation on compulsory licensing of patents relating to the 
manufacture of pharmaceutical products for export to  countries with public health problems.  These 
notifications were being circulated in the IP/N/1 /- series of documents.  He urged those Members 
whose initial notifications remained incomplete to submit the outstanding material without delay, and 
reminded other Members of their obligation to notif y any subsequent amendments of their laws and 
regulations without delay after their entry into for ce.  In particular, he reminded those Members who 
had made any changes to their laws and/or regula tions to implement the decision on "Implementation 
of Paragraph 6 of the Doha Declaration on the TR IPS Agreement and Public Health" and who had not 
yet notified such changes to the Council to do so. 
4. With regard to notifications of contact points under Article 69, he said that, since the 
Council's meeting in March, an update to a cont act point notified earlier had been received from 
Slovenia.  This notification had been circul ated in document IP/N/3/Rev.9/Add.2.  To 
date, 121 Members had notified c ontact points under Article 69. 
5. The representative of the European Communities  said that Regulation (EC) No 816/2006 on 
compulsory licensing of patents relating to the manu facture of pharmaceutical products for export to 
countries with public health problems had been  published in the Official Journal of the 
European Union on 9 June 2006, and that it would enter into force on 29 June 2006.  With this Regulation, the European Communities had created a legal basis for the granting of compulsory 
licences for export purposes, as foreseen in the WT O General Council Decisions of 30 August 2003 
and 6 December 2005.  He hoped that this Regul ation would contribute to making key medicines 
more easily available to countries not dis posing of sufficient production capacities in the 
pharmaceutical sector.   
6. The aim of the Regulation was to transpose the WTO General Council Decisions faithfully 
and completely, without any restrictions or unnecess ary burdens.  It contained provisions preventing 
the re-import of products exported under a compulsory licence.  Like a contractual licence, a compulsory licence created a contractual bond betw een the patent holder and the licensee, with the 
sole but important difference that the will of the patent holder was substituted by a decision of the 
public authority.  The Regulation set out in detail the obligations of the licensee towards the patent 
holder. 
7. The Council took 
note of the statements made.  IP/C/M/51 
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  B. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
(i) Follow-up to reviews already undertaken  
8. The Chairman  said that, with regard to the reviews of national implementing legislation that 
had been initiated at the Council's meetings sin ce April 2001, eight reviews still remained on the 
Council's agenda.  These reviews concerned Cuba;  Fiji;  Grenada;  Mauritius;  Saint Kitts and Nevis;  
Saint Vincent and the Grenadines;  Suriname;  and Sw aziland.  As requested by the Council at its last 
meeting, the Secretariat had written to the delegatio ns in question to remind them of the outstanding 
questions. 
9. The Secretariat had received a communication from Suriname, in which it had indicated that 
its Draft Law on Industrial Property was still with Parliament for appr oval.  A draft law on copyright 
had been prepared, and it was still working on a draft law on neighbouring rights.  Consequently, 
Suriname had indicated that it was still not in a pos ition to provide responses to the questions posed to 
it in the context of the review, and that it wished to  ensure that it would make every effort to submit 
all the outstanding material befo re the Council's next meeting. 
10. The representative of Mauritius  said that the lateness in provi ding the information was due to 
the fact that the Government was trying to brin g in a number of amendmen ts in various laws.  
Furthermore, there had been some reorganization, namely that the Ministry of Art and Culture had 
taken charge of the Copyright Unit.  His delegation u ndertook to do its best to provide the information 
within a short span of time. 
11. The representative of Cuba  said that the information her de legation had provided earlier to the 
Council on its responses was still current.  The respon ses had not been sent yet, since four pieces of 
legislation were still being drafted.  They were on a list of priorities and had to be approved by the 
government authorities.  It was not yet possible to provide information regarding the date on which 
this legislation would be approve d, but she hoped that the matter would be solved in the second half 
of the year. 
12. The representative of Fiji  said that his delegation had contacted the capital concerning the 
outstanding questions.  It had assured him that the responses would be forthcoming in the very near 
future, hopefully before the Council's next meeting. 
13. The Chairman  said that a number of questions had al so been raised with regard to the 
implementing legislation of certa in Members whose reviews had al ready been deleted from the 
Council's agenda on the understanding that any dele gation should feel free to revert to any matter 
stemming from the review at any time.  These Members were Domi nica, Gabon, Ghana and Guyana.  
As requested by the Council at its last meeting, th e Secretariat had also written to these delegations to 
remind them of the outstanding questions. 
14. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
(ii) Arrangements for the review of national  implementing legislation of Saudi Arabia 
15. The Chairman  recalled that, at its last meeting, the Council had agreed that it would take up 
the review of TRIPS implementing legislation of Saudi Arabia, a newly acceded Member, at its first meeting in 2007, and that it would come back to th e arrangements for this review, in particular the 
deadline for questions and responses, at the present meeting.  As requested by the Council, the 
Secretariat had been in contact with the delegation of  Saudi Arabia to draw its attention to the TRIPS 
obligations relating to the notifica tion of implementing legislation. IP/C/M/51 
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  16. The representative of Saudi Arabia
 said that the notification of Saudi Arabia's IPR laws and 
regulations was under preparation and that it would be submitted to the TRIPS Council soon, not later 
than the end of July. 
17. The Chairman  said that the Council's first meeting in 2007 had not yet been scheduled, but 
that he expected it to take place, as usual, in Febr uary or early March.  Using this approximate date, 
and in accordance with the standard procedures for th e review of legislation, he proposed that the 
Council set the following target dates for the submis sion of questions and answers in this review: 
- questions should be submitted to Saudi Ar abia, with a copy to the Secretariat, 
by 27 November 2006;  and 
- responses to questions posed within that deadline should be submitted 
by 8 January 2007. 
18. The Council so agreed . 
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
19. The Chairman  recalled that, at its last meeting, the Council had agreed to maintain its present 
method of work on these matters at this stage, and to keep this method under review to assess whether 
any change might prove appropriate in the light of developments.  As suggested by the Chairman, the 
Council continued its past practice of discussing these three agenda items together, on the basis of the contributions by Members. 
20. In addition to recording the discussions in the formal session of the Council, the minutes 
below on these items also reflect, as agreed to by the Council, additional points made by certain delegations in the informal consultations he ld on the TRIPS Agreement and the CBD as an 
outstanding implementation issue by Deputy Directo r-General, Rufus Yerxa, on 6 and 14 June 2006.  
21. He recalled that two new documents had been presented to the Council's March meeting:  one 
from the United States, (IP/C/W/469);  and anot her from Cuba, Ecuador, India, Sri Lanka and 
Thailand, which had been made available as an advance copy.  Since the meeting, Bolivia had 
requested to be added to the list of co-sponsors.  This addition had been made to the document before 
its circulation as document IP/C/W/470.  As these two documents had been made available just prior 
to that meeting, some delegations had indicated th at they intended to make further comments on them 
at the present meeting.  The Council had received two new communications, one from Japan, 
(IP/C/W/472);  and another from Norway (IP/C/W/473, WT/GC/W/566 and TN/C/W/42). 
22. Introducing document IP/C/W/472, the representative of Japan
 said that the communication 
contained in its annex had also been submitte d to the WIPO Intergovernmental Committee on 
Intellectual Property and Genetic Resources, Tr aditional Knowledge and Folklore (IGC).  The 
document consisted of four parts:  the relationshi p between the Convention on Biological Diversity 
(CBD) and the patent system;  efforts made by Japan in pursuing the objectives of the CBD;  the 
establishment of databases on genetic resources or  traditional knowledge to prevent erroneously 
granted patents; and the study of the disclosure re quirement.  He said that the CBD and the patent 
system were complementary to each other.  The pate nt system conferred protection to inventions that 
met the stipulated criteria rather than to matters that existed in the public domain, such as traditional  IP/C/M/51 
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  knowledge or genetic resources.  The patent syst em thus provided an important incentive for 
innovation and technology transfer, and should not be changed on acc ount of the provisions of the 
CBD.   
23. As a party to the CBD, Japan had been actively in volved in pursuing its objectives.  Japan had 
established "Biotechnological Strategies" and "G uidelines on Access to Genetic Resources for Users 
in Japan" to encourage private companies and resea rchers to comply with the CBD and the Bonn 
Guidelines on Access to Genetic Resources and Fair a nd Equitable Sharing of the Benefits Arising out 
of their Utilization (the Bonn Guidelines).  The Japanese Bioindustry Association (JBA) had 
conducted training programmes to promote the CBD.   The National Institute of Technology and 
Evaluation (NITE), a biological resource centre in Japan, had been promoting joint research projects 
with other Asian countries in compliance with th e CBD requirements of access and benefit sharing 
and prior informed consent.  
24. Japan shared some Members' concerns on erroneous ly granted patents.  It was his delegation's 
view that building databases of genetic resources  and traditional knowledge that would be easily 
accessible to examiners would be effe ctive to prevent such a problem.   In the paper it was suggested 
that a summary, written in a language that mo st examiners could understand, be attached to 
documents written in indigenous languages.  This w ould enable patent examiners to utilize databases 
on a one-stop-research basis.   
25. Regarding the requirement of disclosure of origin , prior informed consent or benefit sharing, 
he said that this requirement would not help to prevent erroneously granted patents, because patent 
examiners had to research technical information with  respect to novelty and inventive step regardless 
of the country of origin or source.   
26. Introducing document IP/C/W/473, the representative of Norway  said that he believed there 
was a consensus between WTO Members that the TRIPS Agreement and the CBD could and should 
be implemented in a mutually supportive manner.   His delegation had iden tified no inconsistency 
between the two treaties, but believed that inte raction between the two would be enhanced by 
introducing an obligation in the TRIPS Agreement to disclose the origin of genetic resources and 
traditional knowledge.  Such a disclosure obligatio n would facilitate the enforcement of Members' 
rights over their genetic resources that were the subj ect of a patent application, and would make the 
CBD provisions on prior informed consent and benefit sharing more effective.  Furthermore, he said 
that the disclosure obligation should go beyond the scope of the CBD;  that is, it should also apply to traditional knowledge which was not directly linked to genetic resources.  Such a requirement could 
also help the examination of the novelty and inventiv e step of the invention, thus helping to prevent 
the issuance of erroneous patents.   
27. The disclosure obligation should be based on certain  key principles.  First, patent applicants 
should be obliged to disclose information on the s upplier country of genetic  resources and traditional 
knowledge - and the country of origin, if known a nd different from the supplier country - in their 
applications.  If the national law of the supplier co untry or country of origin required consent for 
access to genetic resources or tr aditional knowledge, the disclosure ob ligation should also encompass 
a duty to state whether such consent had been given.   If the country of origin was unknown, that fact 
should be disclosed.  Second, the disclosure obligation should apply to all patent applications at the 
international, regional, and national levels.  An  identical disclosure requirement should thus be 
reflected in other international instruments, such as WIPO treaties or regional or bilateral agreements.  
Third, if the applicant was unable or refused to give information, the application should not be 
allowed to proceed.  At the application stage, non-co mpliance with this obligation should be treated as 
a breach of a formal requirement so that the a pplication should not be processed until the required 
information had been submitted.   IP/C/M/51 
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  28. Fourth, if a breach of the disclosure obligation was discovered only after the patent had been 
granted, it should not in itself affect the validity of  the patent.  Such a breach should be subject to 
appropriate and effective sanctions outside the patent system, for example criminal or administrative 
penalties.  Upholding post-grant patent prot ection despite non-compliance with the disclosure 
obligation was important to avoid creating unnecessary  uncertainty in the patent system.  Revoking a 
patent as a consequence of non-compliance with th e disclosure obligation would not benefit those 
who considered themselves to be entitled to share the benefits ar ising from the invention because 
patent revocation would negate the exclusive rights from which benefits could be derived.  Yet, a 
patent could be revoked if the subs tantive patentability criteria had not been met.  Fifth, in order to 
increase transparency, a simple notification system should be introduced under which patent offices 
would send all declarations of origin that they  received to the CBD Clearing-House Mechanism.  
Furthermore, he said that such a disclosure obliga tion would be most appropriate in a new provision 
following Article 29 of the TRIPS Agreement.  
29. In conclusion, he said that his delegation s upported the amendment of the TRIPS Agreement 
to introduce an obligation to di sclose the source and origin of genetic resources and traditional 
knowledge in patent applications.  His delegation was ready to engage in text-based negotiations with 
a view to adopting such an amendment as soon as possible.   
30. The representative of India
 requested that the communication from Brazil, China, Cuba, 
India, Pakistan, Peru, Thailand and Tanzania to  the General Council and the Trade Negotiations 
Committee, circulated as document WT/GC/W/564/Rev.1 and TN/C/W/41/Rev.1, also be circulated as a TRIPS Council working document.
1  He drew the attention of the Japanese delegation to the 
several contributions made by developing count ries which he said refuted the course of action 
suggested by Japan.   
31. He said that Norway's proposal showed its r ecognition of the development dimension of the 
disclosure issue, which was in accordance with the instructions contained in paragraph 3 of the 
airgram convening the meeting.  His delegation was ready to engage in text-based negotiations based 
on all proposals on the disclosure requirement in th e TRIPS Council or other bodies of the WTO.  He 
said that, being put forward by a developed country , the proposal showed growing convergence on the 
need for mutual supportiveness of the TRIPS Ag reement and the CBD, and on a TRIPS amendment 
being the appropriate solution for the end of July 2006.  The proposal recognized the need for a substantive obligation on patent applicants to di sclose the source and country of origin of genetic 
resources and traditional knowledge, evidence of prior informed consent and benefit sharing.  The 
failure to comply with such an obligation woul d be punished.  It also recognized the need for 
consultations to develop a te xt for further negotiations. 
32. Turning to the US submission (IP/C/W/469), he said that he appreciated the continued US 
engagement on these issues.  He said that he was ha ppy to note that, despite not having ratified the 
CBD, the United States shared the objectives of the CBD and was ready to take steps to implement 
such objectives at the national level.  He said that  the US had asserted that the absence of provisions 
against misappropriation in the TRIPS Agreement di d not indicate conflict with the CBD, that it was 
not the lack of safeguards in the Agreement that led to erroneous patents but the lack of national 
systems to regulate the use of genetic resources, an d that the disclosure proposal would create legal 
uncertainty and other negative consequences.  He  responded that the absence of such provisions 
against misappropriation in the Agreement promoted  the grant of patents based on genetic resources 
and associated traditional knowledge without recogniz ing the CBD objectives, highlighting the urgent 
need for action towards mutual supportiveness of the two instruments in line with the instructions 
contained in Article 16.4 of the CBD.  Unless the CBD objectives were integrated within the patent 
                                                     
 
1 Subsequently circulated as document WT/GC/W/564/Rev.2, TN/C/W/41/Rev.2 and IP/C/W/474, 
with the addition of Colombia as a co-sponsor.    IP/C/M/51 
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  system, these two instruments would run counter to  each other.  The objective of ongoing efforts was 
to establish adequate procedural norms within th e TRIPS Agreement to prevent bad patents, to 
prohibit misappropriation, and to ensure that the pr ivate rights created through the Agreement did not 
trump the benefit-sharing mechanisms set up by gove rnments in implementing their CBD obligations.   
33. Article 29 of the Agreement stipulated certain  minimum procedural requirements before the 
grant of patents.  Developing countries were de manding that these procedures be supportive of the 
objectives of the CBD.  These demands were in cons onance with Article 7 of the Agreement, which 
called for the protection of intellectual property ri ghts in a manner conducive to enhancing social and 
economic welfare.  He further said that one of the aims of the disclosure re quirements was to ensure 
that patents were only granted over those invent ions which fulfilled the criteria of novelty and 
inventive step.  Such requirements gave useful para meters of existing prior ar t that would help patent 
offices to establish inventiveness.  This objective could be achieved only th rough incorporating the 
disclosure requirements in the Agreement, and not through domestic contract-based access and benefit-sharing regimes, as they only governed th e conditions of access and benefit sharing.  The 
disclosure requirement would also help patent offi ces identify the holder of genetic resources or the 
country of origin and ensure that th e knowledge was not misappropriated.   
34. Other solutions, such as searchable orga nized databases, post-grant opposition and 
re-examination procedures as suggested by the United States, were costly, inadequate and ineffective 
considering the unique nature of inventions b ased on genetic resources and associated traditional 
knowledge.  Further, given that holders of gene tic resources and traditional knowledge were highly 
dispersed, organized databases were not probable in th e short term.  Therefore, this was an impractical 
suggestion.  In any case, oral traditional knowledge could not be included in databases in the short 
term.  Post-grant opposition and re -examination proceedings were ti me consuming and unaffordable 
for the poor and disadvantaged resource holders.   
35. He said that he appreciated the US acceptan ce of a requirement to disclose information 
material to patentability.  An international disclosur e obligation would be material to patentability and 
would help patent examiners in their search of pr ior art, and would prevent bad patents by adding to 
existing searchable databases.  It would give useful  hints to the patent office in ascertaining novelty 
and non-obviousness and indicate the country which n eeded to benefit from the commercialization of 
genetic resources.  It was important to trace the true existing knowledge taken from the holder of 
traditional knowledge in order to establish the inven tive step and ensure that bad patents were not 
issued.  This would also ensure that due credit a nd benefits were given to such holders in cases where 
the new invention was based on the information prov ided by them.  Thus the disclosure requirement 
was an effective way to ensure the mutual suppor tiveness of the TRIPS Agreement and the CBD as it 
provided a means to prevent misappropriation through patents granted without ensuring benefits to the 
providing country.   
36. There might be different ways in which misa ppropriation of genetic resources and associated 
traditional knowledge took place.  When there was misappropriation through pa tenting, bypassing the 
domestic access and benefit-sharing law, it was not possible to provide effective remedies through 
domestic law to prevent the abuse of the patent sy stem when the use of such resources or knowledge 
took place beyond the borders of the providing country.   Remedies should be found within the patent 
system of the country which had issued such a patent.  The national system could not remedy such patents even through the terms of a contract a nd the only solution was to introduce the disclosure 
requirements at the international level.   
37. Regarding the enforcement of national access and benefit-sharing provisions, he recalled that 
his delegation had illustrated the challenges through the " Yahoo!-Nazi " case in document IP/C/W/459.  
This case suggested that unless there was an in ternational mandate, a country would have no 
obligation to enforce the terms of a contract or a decision upholding such terms when it was against IP/C/M/51 
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  its domestic laws and public policy.  This clear ly showed that unless domestic access and benefit-
sharing regimes were under an umbrella of an intern ational obligation, the international character and 
outlook of the national regimes would not help  to achieve the desired enforcement.   
38. With regard to the US statement that the discl osure requirement could not be justified by its 
primary aim of preventing bad patents, he said that, if the source and country of origin were disclosed, 
the patent office could process the patent application on the presumption that the access obtained from 
the country of origin was legal.  This requirement would ensure the flow of benefits to the providing 
country, thereby recognizing its proprietary rights  over genetic resources and associated traditional 
knowledge. 
39. Responding to the US argument that patent examiners might or might not seek additional 
information based on the "hints" provided by the disclosure requirements in light of their negative 
consequences, he said that once an international oblig ation was created, each country would take steps 
to improve its examination system.  Thus, the discl osure requirements would prove to be sufficient to 
deal with the core concerns of developing countri es.  It would facilitate the compatibility of the 
TRIPS Agreement with the CBD and add to the st rength, credibility and certainty of the patent 
system.  On the other hand, domestic contract systems, unenforceable in many ways, could not 
achieve the efficacy of the disclosure requirements.  
40. The representative of Chinese Taipei
 said that his delegation had not yet decided its position 
on the CBD issue.  He posed the following questions to the co-sponsors of document 
WT/GC/W/564/Rev.1 regarding the draft amendment:  whether the co-sponsors suggested that WTO Members not party to the CBD should comply with it;  what the definitions of the terms "biological 
resources", "traditional knowledge", "derived from" , and "developed with" were;  who the provider 
would be if, for example, the applicant bought a potato in the domestic market and with whom the patent applicant would have to share benefits;  wh ether the obligation to supplement and correct the 
information, as required by the third paragraph of draft Article 29 bis, would exist both before and 
after the patent was granted;  what would ha ppen if Members did not have provisions on 
unenforceability of patents in their patent systems;  and if a
 third party would seek the cancellation of 
a patent after finding falsely disclosed information in  a patent specification, should the patent office 
allow the patentee to correct the information or rev oke the patent directly?  He said that since there 
was no international body or mechanism to verify the information disclosed by th e patent applicant, it 
would be a great burden on patent examiners to revi ew the fulfilment of the disclosure requirement.  
There should be a balanced mechan ism to ensure that the owner of genetic resources and traditional 
knowledge received the benefits arising from the use of such resources and knowledge, that the 
inventor had the incentive to make innovations, and th at the patent system had legal certainty without 
undue burdens on both patent examiners and patent a pplicants.  In conclusion, he said that Chinese 
Taipei was in the process of formulating its own access and benefit sharing regime and was therefore 
interested in knowing about other Member s' national experiences in this regard. 
41. The representative of Sri Lanka  said that the work in the WTO on the relationship between 
the TRIPS Agreement and the CBD had reached an advanced stage.  His delegation supported the 
disclosure proposals put forward by a group of deve loping countries and the European Communities, 
and was in favour of commencing text-based ne gotiations to amend the TRIPS Agreement.  
42. The representative of Brazil  supported the request made by India that document 
WT/GC/W/564/Rev.1 and TN/C/W/41/Rev.1 be circul ated as a TRIPS Council document.  He said 
that the proposed amendment of the TRIPS Agre ement was supported by the broad majority of 
developing countries.  It was fully compatible with the Doha mandate and would be an essential 
outcome of the Doha Development Round.  He said that the amendment had to be understood to be 
pro-intellectual property, as its objective was not to  destroy, water down or encumber the intellectual 
property system in the TRIPS Agreement.  Instea d, it sought to make the system more robust in  IP/C/M/51 
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  general and better suited to the moral principl es on which intellectual property protection should 
stand.  Its objective was also to reduce the margin for misappropriation of biol ogical resources and/or 
associated traditional knowledge.  He said that im moral conduct should not be rewarded, and that 
patents should not be granted to in ventions which were obtained thr ough dishonest practices.  He said 
that the amendment would show that the internati onal intellectual property system was responsive to 
the particular needs and concerns of developing countries, in particular the mega-biodiverse ones 
among them.  It would also make the patent syst em stronger by making the monitoring of dishonest 
practices viable and enforceable internationally.  The amendment was compatible with the evolving 
nature of science and technology, especially biotechnology.   
43. He further said that his delegation's position and responses to the technical questions posed by 
other Members could be found in documents IP/C/W/420,  429, 438, 442, 443 and 459.  In view of the 
length of the time devoted to technical discussions and exchange of views, the time was ripe for moving beyond general statements into text-based negotiations, which would give effect to the 
instruction given to Members by Ministers.   
44. He said that the disclosure requirements would not pose additional burdens for patent 
applicants and should not be considered as a new f ourth patentability criterion.  Non-compliance with 
the disclosure requirements would produce the propor tional effect of preventing patent examination 
from proceeding.  It could also constitute a gr ound for invalidation and re vocation of patents.  
Members would be called upon to ensure effective en forcement procedures.  Publishing the disclosed 
information would allow Members to track and enforce their rights over biological resources and traditional knowledge.  It would be in line with  other measures which had the aim of providing 
transparency within the international patent system.   
45. He said that the establishment of databases, as suggested by Japan, fo r widespread use by 
patent examiners and interested Members, w ould lead to the misappropriation of traditional 
knowledge in the absence of mandatory disclosure requi rements.  Thus, it would not meet the interests 
of those who tried to find a solution within the pa tent system to safeguard their legitimate interests 
over traditional knowledge and those who wished to safeguard, through the intellectual property 
system, their sovereign rights over biological resources under the CBD.   
46. He said that Norway's proposal and the proposal by the developing countries converged at 
several points, such as in the perception that th e mutual supportiveness of the TRIPS Agreement and 
the CBD could be enhanced by an amendment to  the TRIPS Agreement;  the need for text-based 
negotiations and the mandatory nature of disclosur e requirement.  According to him, the suggestion 
that traditional knowledge by itself be the object of  a disclosure requirement seemed to go beyond the 
developing countries' proposal, and he was intere sted in knowing how this would apply.   
47. With respect to the US proposal on the nationa l contract-based approach, he said that this 
approach would not provide legal certainty to tho se combating biopiracy because national legislations 
varied and the private nature of the contract woul d not create international obligations.  The approach 
was also costly, burdensome, time-consuming and ineffective to tackle biopiracy and would not 
address the international dimension of the problem .  Therefore, it was outside the scope of the 
Members' mandate, which was to look at the interf ace between the CBD and the TRIPS Agreement.   
48. The draft amendment of the TRIPS Agreemen t contained in document WT/GC/W/564/Rev.1 
attempted to translate a negotiating objective of  the Doha Round into treaty language.  Among the 
outstanding implementation issues, the issue of misappropriation of biological resources and 
associated traditional knowledge or biopiracy had the clearest and broadest suppo rt of the developing 
countries as a whole, and had matured both politically and technically to the extent that the 
proponents found themselves not only in a position to respond to all technical questions put forth by 
other Members but also in a position to propose a concre te text.  The efforts to arrive at a concerted IP/C/M/51 
Page 10  
 
  position regarding language for an amendment hi ghlighted the political and economic importance 
developing countries had attributed to the issue.  This  was part of the balance that could be brought to 
bear on the intellectual property system so that developing countries' concerns could be addressed 
through a solution that would be ingrained in the intellectual property system.  Developing countries 
were demanding a system which provided protection to  countries that were recognized by the CBD as 
the sovereign owners of their biological resour ces and to communities that were the holders of 
associated traditional knowledge.  The issue of mi sappropriation was not different in the area of 
copyright or patent protection.  The draft amendmen t was in line with other demands for adjusting to 
the ever changing nature of science and technology, such as the protection of broadcasting signals in 
new digital media or the WIPO Internet treaties of 1996.   
49. He said that some Members believed that th e CBD issue was not part of the negotiating 
mandate of the Doha Round, which in his view was not supportive of Members' common objective of 
achieving a development-oriented round.  The Round should fulfil the expectations of the majority of 
developing countries and take their views,  needs and requirements into account.   
50. Regarding Switzerland's proposal, he said that it had been put forth in the WIPO Working 
Group on Reform of the Patent Co-operation Treaty,  the IGC and the TRIPS Council.  In his view, 
Members should focus their attention on a single forum, and the most appropriate forum was the 
WTO.  Regarding Australia's concern about the po tential misuse of the disclosure requirements by 
lawyers, he said that these requirements provi ded an easier solution to the problem of 
misappropriation than the contract-based approach, which might cause a higher risk of misuse.   
51. He said that he had responded to 17 questions posed earlier by Members regarding the draft 
amendment of the TRIPS Agreement, and requested the Secretariat to circulate the responses as a 
TRIPS Council document
2  Regarding a question from Switzerland about the disclosure of 
information, he said that there was a clear need to  disclose the country providing the resource as well 
as the source, and that the requirement to disclose the country of origin would be subject to the 
condition of "reasonable inquiry".  Disclosing only the source without indicating the providing 
country would not achieve the objectives of the amendm ent.  For example, the indication of source as 
a laboratory of a multinational company would give no clue about who had provided the resource.  As 
the CBD gave the definitions of both "country of  origin" and "the providing country", disclosing 
information on both of them was an essential requis ite for the patent system to become supportive of 
the CBD.  Disclosure of information on the providi ng country and country of origin would address the 
international dimension of the misappropriation issue;  that is, patent rights might be conferred in a 
country which was different from the country where the resource was obtained.   
52. Regarding a question from the EC and the Ph ilippines as to why the term "biological 
resources" had been used instead of "genetic resour ces", he said that the CBD recognized that states 
had the sovereign right to exploit their own r esources, in accordance with the Charter of the 
United Nations and the principles of international law.  Thus, the power enjoyed by states was not 
limited to the regulation of genetic resources.  Ac cordingly, Article 15 of the CBD, which addressed 
access to genetic resources, should not be interpre ted as preventing states from regulating access and 
benefit sharing relating to biological resources.  Furthermore, the use of the term "biological 
resources", which was broader than the term "gene tic resources", was intended to ensure that all 
possible cases of biopiracy were covered and to  keep pace with technological developments, 
especially with respect to biotechnology.  The term  "biological resources" was similar to the term 
"biological material" used in the preambular pa ragraph 27 of the European Directive on the Legal 
Protection of Biotechnological Inventions (Directiv e No. 98/44/EC), which was defined in Article 2 
of the Directive.  He further said that once Memb ers had reached an agreement on the amendment, the 
definition of the term should be unive rsal and binding on all Members.   
                                                      
2 Subsequently circulated as document IP/C/W/475.  IP/C/M/51 
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  53. Regarding another question from the EC and the Philippines about who would decide the 
fulfilment of "reasonable inquiry" as contemplat ed under paragraph 2 of the draft Article 29bis and 
what "reasonable inquiry" meant, he said that "r easonable inquiry" was similar to the expressions  
"reasonable efforts", "reasonable ground to know",  and "reasonable steps under the circumstances" 
used in Articles 34, 37 and 39 of the TRIPS Agreem ent and in Members' national legislations.  The 
applicant would initially determine how to satisfy this requirement, which was generally understood 
to mean due diligence.  The role of patent offices would be limited, in principle, to confirming that 
patent applications disclosed information in the prescribed form.   
54. He responded to several other questions posed by the EC.  As to how the three triggers 
referred to in the draft amendment - that is, "con cerns", "derived from" and "developed with" - would 
work or what they would mean in practice, he said that the three triggers sought to encompass 
relevant situations in which biological resources and/or associ ated traditional knowledge had 
contributed to an invention, while providing the margin of flexibility for national competent 
authorities where the patent would be sought to deci de whether or not the applicant had complied with 
the rule.  The term "concerns" referred to cases where a predominant or s ubstantial part of an 
invention incorporated genetic resources.  This usage would be similar to Article 3.1 of the 
EC Directive.  The term "developed with" meant th at an invention might not necessarily incorporate a 
genetic resource but the resource and/or associated  traditional knowledge might be critical in the 
development of the invention.  This would be the case particularly with respect to traditional 
knowledge as it might be rarely incorporated in the claimed invention but where the knowledge was 
indispensable in the development of  the invention.  The term "der ived from" was intended to cover 
derivative inventions.  It also appeared in Article 8.1 of the EC Directive referring to propagation or 
multiplication from original biological material.   
55. With respect to whether the word "including" in the second sentence of paragraphs 2 and 3 of 
the draft Article 29 bis meant that there were additional require ments other than the evidence of prior 
informed consent and access and benefit shar ing, he replied in the negative.   
56. About the meaning of the term "associated traditiona l knowledge", he said that the proponents 
of the draft amendment intended to give the ordinary  meaning to this term.  The word "associated" 
was prefixed to traditional knowledge in order to r estrict the disclosure requirements to the traditional 
knowledge that had relevance to the biological resources used in developing the invention or 
concerning the subject-matter of the invention.  In other words, not all forms of traditional knowledge 
were covered by the proposed disclosure requirements.   
57. About the method of publishing the disclosed info rmation, he said that it would be at the 
discretion of each Member.  The information should  be published simultaneously with the patent 
application or the granting of the patent, whichever wa s first, in the same or a separate document.  The 
supplementary or corrected information require d under paragraph 3 of the draft Article 29 bis would 
be published separately. 
58. Regarding questions from the EC and Ch inese Taipei concerning the concept of 
"unenforceable" used in paragraph 5 of the draft Article 29 bis, he said that unenforceability was 
presented as an alternative to the revocation of pa tents.  Thus, a patent holder who had failed to 
comply with the disclosure requirements would not be entitled to go to court to enforce his rights.  This was similar to the principle under the common la w that the persons with "unclean hands" could 
not go to a court to demand equity.  For example, if a patent holder di d not pay the patent renewal fee, 
he could not go to court to enforce his patent rights.   
59. With respect to New Zealand's question on why the substance of the draft text was broader 
than its title, he said that titles in the TRIPS Agreem ent, such as those of Articles 30 and 27, usually 
gave a general sense of the issue, but did not cover all the elements included under them.   IP/C/M/51 
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  60. He responded to several other questions from the Philippines and said that with regard to the 
transitional period for implementation of the draft amendment, the draft amendment was 
predominantly in the interest of developing countri es and that the problem of biopiracy had not been 
tackled adequately for ten years since the entry into  force of the TRIPS Agreement.  Thus, the period 
between the adoption of the amendment and its rati fication would be sufficient to allow countries to 
make the necessary changes in th eir laws.  This would exclude LDCs, whose general transitional 
period had been extended to mid-2013 under the TRIPS Agreement, with possible additional 
extensions.  
61. As to whether a declaration of the providing  country and the source, together with a 
declaration that the providing countries did not ha ve prior informed consent and access and benefit-
sharing regimes, would suffice, he said that pa tent applicants should present the evidence of 
compliance with the applicable legal requirements in  the providing country.  If the providing country 
did not have such requirements, a declaration to this  effect would suffice.  He said that patent offices 
would not have to assess the validity of such declar ations.  It would work based on the prima facie 
assumption that the declaration had been provided co rrectly and in good faith.  However, the patent 
applicant would still be required to disclose the pr oviding country, from whom in that country the 
biological resource and/or associated traditional know ledge had been obtained,  and, after reasonable 
inquiry, the country of origin.   
62. Regarding another question about the application of the disclosure obligation, he said that it 
would apply only to patent applications that were submitted after Members' assumption of the 
obligation under the draft amendment.  As to the meaning of "with reasonable grounds to know" used 
in paragraph 5 of the draft amendment, he said th at the phrase was a widely used legal concept and 
could be found in many legislative provisions, su ch as Articles 44 and 45 of the TRIPS Agreement.  
Paragraph 1 of Article 44 provided, inter alia, that Members were not obliged to accord such 
authority in respect of protected subject-matter acqui red or ordered by a person prior to knowing or 
having reasonable grounds to know that dealing in su ch subject-matter would entail the infringement 
of an intellectual property right.  Similar language was used in pa ragraph 1 of Article 45 regarding 
damages.  The words in para graph 5 of the draft Article 29bis  would have a similar meaning to that in 
Articles 44 and 45.  The knowledge of the patent a pplicant, the resource available to him, and normal 
business and scientific practices that he would be ex pected to know should be taken into account.  For 
example, if there was an access and benefit-shari ng law in the providing country, the patent applicant 
would be reasonably expected to know  this law and its requirement.  It  also implied that the applicant 
was expected to exercise ordinary due d iligence and not be reckless or careless.  
63. As to whether Members could impose fees on pate nt applicants to cover the costs associated 
with the disclosure obligation, he said that it was anticipated that the disclosure obligation would not impose undue burdens and costs on patent applicants, pate nt holders or patent offices.  For this reason, 
unless demonstrated otherwise, it was not foreseen th at additional fees would need to be charged to 
cover the costs.  However, where a Member consid ered it relevant, it could take this obligation, 
together with any other considerations, into account in setting fees.  In essence, the intention of the 
proponents of the disclosure requirements was to l eave this issue to the discretion of Members, 
subject to other rules in the TRIPS Agreement or ot her treaties, such as the Patent Cooperation Treaty. 
64.
 He responded to several other questions from Chin ese Taipei.  As to whether paragraph 1 of 
the draft Article 29 bis meant that a Member not party to the CBD would have to comply with CBD 
requirements, he said that paragraph 1 indicated  broad objectives that would be served by the 
proposed TRIPS amendment.  Once introduced into the TRIPS Agreement, the disclosure 
requirements would be a TRIPS and not a CBD obl igation, notwithstanding the sought objective of 
mutual supportiveness between the two treaties.  The amendment would not bind non-CBD parties to 
the provisions of the CBD, as the disclosure obliga tions would be acquired ex clusively under and in 
accordance with the TRIPS Agreement.  This was normal practice, particularly in the case of the  IP/C/M/51 
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  TRIPS Agreement, which had transposed several pr ovisions contained in othe r international treaties 
into the realm of the WTO.  Reference in th e TRIPS Agreement to provisions taken from the 
Paris Convention or other WIPO treaties did not mean that non-WIPO members were obliged to 
comply with WIPO obligations. 
65. As to whether the requirement for correction of  information applied only to the pre-grant 
period or to the post-grant period as well, he said th at the requirement would apply to both the pre- 
and post-grant periods as both the words "applican t" and "patentee" were used in the draft 
amendment.  Since the failure to comply with the disclosure obligation could prevent the further 
processing of patent applications or result in the revocation of patents, the flexibility for submitting 
additional information would benefit the patent applicant or the patent ee.  Therefore, there should be a 
continuing opportunity for providing supplemental or corrected information.   
66. As to with whom benefit-shari ng contracts should be negotiated an d the benefits be shared, he 
said that this was up to each WTO Member and that  the draft amendment did not intend to impose a 
uniform approach on WTO Members. 
67. In conclusion, he said that the mandate given by Ministers provided a basis for negotiations 
on all outstanding implementation issues, including the CBD.  It did not exclude an amendment to the 
TRIPS Agreement as an outcome of the Doha Round.  
68. The representative of Kenya  supported the proposal for an amendment of the 
TRIPS Agreement to introduce an obligation to disclo se the country of origin of genetic resources and 
traditional knowledge in patent applications.  Such  a disclosure obligation should form part of the 
formal requirements of patent a pplications.  Disclosure requirement s, especially as proposed by 
Norway, would not be burdensome to patent offi ces or patent applicants.  It was the national 
competent authorities, and not patent offices, that would verify the conditions of the acquisition of genetic resources and associated traditional knowledge.   The patent office would only check whether 
the formal requirements had been fulfilled.  The pa tent applicant should submit the information that 
was best known to him.   
69. The representative of Bolivia
 said that the amendment of the TRIPS Agreement would 
contribute to the success of the Doha Round.  Hi s delegation was interested in promoting the 
defensive protection of genetic resources and trad itional knowledge and equitable distribution of the 
benefits derived from the use of traditional knowledge.  
70. The representative of Turkey  expressed his delegation's preparedness for text-based 
negotiations.  He said that Norway's proposal incl uded useful elements for text-based negotiations.  
His delegation attached equal importance to all outstanding implementation issues and expected 
significant movement before July 2006.  He sup ported the introduction of a disclosure requirement 
into the TRIPS Agreement, but said that such an  exercise should preserve the balance within the 
patent system.  He was concerned that the cancella tion of patents as a lega l effect of non-compliance 
with the disclosure requirements might introduce uncertainties into the patent system.   
71. The representative of the Philippines  said that Members should preserve the legal certainty in 
the patent system and keep the burden on patent o ffices and users at a reasonable level.  Nevertheless, 
this policy consideration had to be balanced agai nst the equally compelling need to address the unfair 
exploitation of biological and genetic resources and associated traditional knowledge.  This need was 
demonstrated by the Philippines' national experien ce in the last ten years.  As early as 1995, the 
Philippines had passed "Guidelines Establishing a Regulatory Framework for the Prospecting of 
Biological and Genetic Resources", building on wh ich it had also passed the "Indigenous People’s 
Rights Act" in 1997.  Thereafter, the "Traditiona l and Alternative Medicines Act" and the "Wildlife 
Resources Conservation and Protection Act" had entere d into force.  Despite all these laws, biopiracy IP/C/M/51 
Page 14  
 
  and the inequitable exploitation of genetic and biological resources had continued unabated and 
unchecked. 
72. He said that, although most Members conceded that the TRIPS Agreement and the CBD were 
mutually supportive and that there was no conflict between these two Agreements, they arrived at 
different conclusions.  From the perspective of de veloping Members, it was time to use the patent 
system to combat biopiracy.  The draft amendment constituted a solid and reasonable basis for 
Members' collective engagement with a view to finding a resolution to the problem of biopiracy.   
73. He posed the following questions to the proponents of the draft amendment:  whether the 
proponents would consider an  additional implementation period as the draft Article 29 bis would 
require domestic legislative action;  whether the scope  of "biological resources" was broader than that 
of "genetic resources";  what the meanings of "reasonable inquiry" and "with reasonable grounds to 
know" were;  whether a mere declaration by patent a pplicants that the providing country did not have 
prior informed consent and access and benefit-shar ing regimes would be considered as compliance 
with the disclosure requirement;  whether the disclos ure requirements would apply retroactively to the 
patentee who had been granted the patent before  the adoption of the amendment;  and whether 
Members could impose fees as might be necessary to cover the cost of publishing additional 
information.   
74. The representative of Switzerland
 said that, while his delegation was not a demandeur  in the 
CBD issue, it saw a legitimate concern for the di sclosure of source to be addressed in the patent 
regime, and accordingly had put forward a proposal on how this could be done at the international 
level in an effective and timely manner.   
75. He then posed the following follow-up ques tions to the responses the co-sponsors had 
provided in document IP/C/W/470.  He noted that  paragraph 2 of the document stated that the 
fundamental conflict between the TRIPS Agreement and the CBD was the failure of the former to 
recognize the private intellectual property rights in volved in traditional knowledge, which was owned 
collectively.  As the TRIPS Agreement did not exclude traditional knowledge from the scope of 
intellectual property rights, he asked for a detaile d explanation on the perceived conflict between the 
CBD and the TRIPS Agreement. 
76. According to the definitions of "country of orig in" and "source" in paragraphs 3 and 4 of the 
document, he asked that, for example, if a patent  applicant had accessed a rubber tree in Thailand, 
which originated in Brazil, which country would the a pplicant have to declare as the country of origin:  
the country where the genetic resource originated  immediately or the country where the genetic 
resource originated historically?  If the historic count ry of origin should be declared, he said that this 
might result in uncertainty when it was unknown.  
77. As the definition of biological resources in paragraph 5 of document IP/C/W470 
encompassed not only genetic resources of plants and animals but those of human beings, he asked 
whether the disclosure requirements would apply to  human beings as well, and if so, what the 
reasoning behind that would be and whether such application would create a new conflict with the 
provisions of the CBD, since Decision II/11 of the CBD's Conference of Parties explicitly excluded human genetic resources from the scope of application of the CBD.  
78. As paragraph 6 of document IP/C/W/470 for esaw that the veracity of the document 
concerning prior informed consent could be cha llenged during opposition or  revocation proceedings 
due to fraud or the obtaining of information fro m the wrong person, that the parties should seek 
recourse under the domestic law, and that the finding s of the domestic authorities would be binding on 
patent offices, he sought clarification on the m eanings of "parties", "domestic law" and "domestic 
authorities" referred to.  If the "domestic authorities" meant the authority in the providing country, he  IP/C/M/51 
 Page 15 
 
 
  asked how it could rule on the validity of a pa tent granted in other countries, and how this 
extra-territorial application of the law of the country  of origin in the patent-granting country could be 
justified.  He further asked how the authorities in the providing country would find out about the patent granted in other countries.   
79. Regarding the sanctions suggested in paragra ph 13 of the document, he asked whether these 
sanctions would be imposed in combination or altern atively, and, if alternatively, who would decide 
which sanction would apply in a certain case and ba sed on what grounds.  He also asked whether the 
applicability of the sanctions would requir e fraudulent intention or negligence.   
80. With regard to paragraph 16 on the implicati ons for the WIPO PCT and PLT, he asked what 
these implications would be;  how these implications would be introduced into the PCT and PLT,  
whether there was a need for amendment of the tw o treaties, and if so, what provisions would be 
affected.  Regarding the integration of the disclos ure requirements into the FAO International Treaty 
on Plant Genetic Resources for Food and Agriculture  wherever applicable, he noted that the 
FAO Treaty neither applied the concept of prior info rmed consent nor the concept of the country of 
origin.   
81. The representative of Korea
 said that there was little possibility of conflict between the 
TRIPS Agreement and the CBD and that these two instruments could be implemented in a mutually supportive manner.  While recognizing the importa nce of preventing biopiracy and misappropriation 
of genetic resources, his delegation thought th at introducing a new requirement into the 
TRIPS Agreement was not an appropriate solution.  He said that case studies would help to identify 
problems Members faced and to reduce gaps in Member s' understanding of this issue.  Therefore, his 
delegation would continue to engage in fact-based discussion on th is issue.  Regarding the protection 
of traditional knowledge and folklore, he said that it would be desirable to follow up the discussion in 
the WIPO IGC in order to avoid duplication.  It was also preferable to establish databases on 
traditional knowledge as suggested by Japan. 
82. The representative of Colombia
 said that Members should prevent the granting of patents to 
inventors who had not complied with the minimu m requirements for legitimate access to genetic 
resources and associated traditional knowledge in th e country of origin.  The TRIPS Agreement did 
not lay down any formal requirements on legitimate  access, which, to some extent, promoted 
biopiracy.  The Doha and Hong Kong Ministerial Conferences had given Members the mandate to take necessary action in order to find a solution to th is issue.  The appropriate solution would be to set 
up procedural rules in the TRIPS Agreement.  He re quested the Secretariat to add his delegation to the 
list of co-sponsors of document WT/GC/W/564/Rev.1.   
83. The representative of Thailand
 said that biopiracy and misappr opriation of genetic resources 
and traditional knowledge had been of great concern to  his delegation.  As a co-sponsor of document 
WT/GC/W/564/Rev.1, his delegation believed that  the draft amendment would strengthen the 
protection of traditional knowledge.  He said th at, although the intellectual property system was 
costly, difficult and burdensome for developing countries, especially small and poor developing 
countries, none of them had suggested abolishing th e system.  Intellectual property rights should be 
based on fair and equitable principles, which aime d at benefiting producers, inventors, owners and 
consumers as a whole.  The current intellectual pr operty system did not extend protection to genetic 
resources and traditional knowledge, wh ich would encourage biopiracy a nd hurt developing countries.  
The issue was thus part of the development dimens ion of the Doha Development Agenda.  The burden 
resulting from the disclosure requirements was minimal, compared to that of the intellectual property 
system.  He said that Norway's proposal showed an important convergence among Members, and that 
it was time for Members to move to text-based negotiations. IP/C/M/51 
Page 16  
 
  84. The representative of China
 supported text-based negotiations on the relationship between the 
CBD and the TRIPS Agreement because of the grow ing convergence among Members on this issue.  
He believed that document WT/GC/W/564/Rev.1 would serve as a good basis for the focused exchange of views towards a concrete solution. 
85. He welcomed Norway's support of the amendm ent of the TRIPS Agreement to introduce a 
mandatory disclosure obligation in patent app lications, although he had reservations on the 
effectiveness of sanctions outside the patent system .  He encouraged Norway to clarify this point. 
86. With respect to Japan's proposal, he associat ed himself with the position of the Indian 
delegation that databases did not seem to be an adequate solution in addressing the concerns that 
related to the misappropriation of biological resources and erroneously granted patents. 
87. The representative of Japan
 clarified that the purpose of creating databases was to prevent 
erroneously granted patents.  Technical issues on th e establishment of such databases, such as how to 
ensure that databases would be used by patent offices in an appropriate way, should be further 
discussed in the WIPO IGC.  He further clarifie d that the collection of information on genetic 
resources and traditional knowledge should respect customary law or willingness of local 
communities.   
88. The representative of Canada  said that access and benefit sharing was a broad-ranging policy 
issue that involved many levels of government in Canada.  Some Canadian stakeholders had also 
become engaged, particularly in the environmental,  forestry and national resources sectors.  The issue 
of developing a consistent, c oherent and effective national acce ss and benefit-sharing policy was 
important for Canada.  While Ca nada might not be a mega-diverse country, it had significant 
biological diversity resulting from the variety of regional climates and ecosystems and numerous and 
diverse aboriginal groups.  Consequently, Canada was a provider of many unique genetic resources 
and associated traditional knowledge including plants, en zymes, soil, microbes and marine organisms.  
Meanwhile, she said that Canada's strong resear ch capacity and knowledge-based economy also 
meant that it was a significant user of genetic r esources and traditional know ledge from other parts of 
the world.  This duality of roles, combined with a complex jurisdictional structure, created the central 
challenge for Canada in managi ng its genetic resources and traditi onal knowledge.  Meeting this 
challenge was key to its ongoing national access a nd benefit-sharing policy development process. 
89. She informed the Council that a Federal Pr ovincial Territorial (FPT) Working Group on 
access and benefit sharing had been established in Se ptember 2004 and given th e task of preparing a 
policy scoping paper and a companion national stra tegy for domestic engageme nt of governments, 
aboriginal peoples and stakeholders.  These two doc uments had been prepared by the FPT Working 
Group and approved for release by FPT Ministers r esponsible for Forests, Wildlife, Endangered 
Species and Fisheries and Aquaculture on 5 October 2005 .  Since then, Canadian federal officials had 
been working in partnership with their provincial a nd territorial counterparts to, on the one hand, raise 
awareness about access and benefit sharing and gather information on provincial and territorial 
perspectives on access and benefit sharing and, on  the other hand, discuss possible policy and 
legislative implications and options at the provi ncial and territorial levels, since it was these 
jurisdictions that had legislative responsibility in Ca nada for protecting biodivers ity.  As part of this 
awareness-raising and information-gathering ex ercise, a series of FPT Workshops on access and 
benefit sharing had been organized in 2005- 2006.  These workshops had focused on access and 
benefit sharing and agriculture, forest genetic resources, the science and technology agenda, and the 
North.  The workshops had also been used as a ve hicle through which to engage  and inform a range of 
interested Canadian stakeholders on domestic and international developments regarding access and 
benefit sharing.  Participants had included scientis ts, academics, some industries, aboriginal and NGO 
representatives.  Stakeholders had also been enc ouraged to express their views on a wide range of 
issues related to access and benefit sharing, includin g legal consistency with existing legislation at  IP/C/M/51 
 Page 17 
 
 
  federal and provincial levels, ex isting resource management practices, existing access and benefit-
sharing mechanisms in pla ce in research institutions, ex-situ  collections, industry, intellectual property 
issues and a general reflection on environmental, economic, social and legal opportunities and 
challenges associated with access and benefit sharing. 
90. She further said that Canada had made considerable progress over the past several years in 
engaging stakeholders across the country.  But th is was not a simple task and plenty of work 
remained.  For example, one of the biggest hurdles it had yet to get over was the complexity of the issue, the wide and sometimes contradictory range of perspectives often held within sectors or among 
the same stakeholders group.  Her delegation remain ed of the view that early engagement of as many 
groups as possible was essential for successful acce ss and benefit-sharing policy development and 
effective implementation. 
91. With respect to Japan's proposal on databases,  she said that her delegation was keenly 
interested in ensuring that the pa tent system was coherent, consiste nt and that quality patents were 
issued nationally and internationally.  Generally, Canada was in favour of initiatives which facilitated 
and were relevant to the task of patent examiners engaged in the task of determining the patentability 
of inventions.  Japan's submission had correctly id entified an important problem in many developing 
and developed countries' patent offices.  When engaged in prior art searches to determine the 
patentability of given inve ntions, some patent examiners did not have access to databases that could 
provide evidence that a given invention lacked either novelty or an inventive step.  It was extremely difficult these days even for a skilled patent examiner  to investigate all evidence of prior art in a 
particular field.  Even after an examiner had revi ewed all the available patent literature, databases of 
technical reports and authoritative science journals, it was still possible that he or she might have 
missed identifying prior art that was only documen ted in age-old manuscripts available in local 
languages, such as the "neem" and "turmeric" cases,  or that was only passed on by word of mouth 
among generations of traditional k nowledge custodians.  Consequently, Japan's suggestion to consider 
the development of a comprehens ive "one-stop-shop" database re lated to genetic resources and 
traditional knowledge that could be accessible by exam iners worldwide appeared to be an idea worthy 
of further technical examination.  Given WIPO's expertise and capacity in the area of databases, Canada considered that this technical examination would be best done in WIPO rather than the WTO 
or other multilateral forums.  She further said that  her delegation recognized that there might be 
significant, logistical and privacy issues involved with creating a global all-inclusive database for 
genetic resources and associated traditional know ledge.  For that reason,  Canada would support 
focusing first on initiatives which interlink exis ting and future prior art databases through common 
access protocols. 
92. In conclusion, she said that as part of the f act-based discussion her delegation had engaged in, 
patent examiners' perspective on the disclosure de bate was important to reach a proper understanding 
of the practicality and feasibility of introducing th e disclosure requirements for genetic resources in 
the patent granting process.  Canada had e nquired among its own patent examiners, who had 
identified a number of factors that had to be addresse d to fully grasp all the practical ramifications of 
the proposed disclosure requirements, as the overall co sts and benefits of the disclosure requirements 
from the broader policy context should be consider ed.  These factors included information about the 
originating organism in current applications and patents;  prior art searches and common 
nomenclature;  classification schemes identifying wh ether patents contained a claim to genetic or 
biological materials;  and means to verify the accura cy of the source of origin of material as identified 
by the applicant.  Her delegation would appreci ate any guidance other Members could provide on 
these factors. 
93. 
Another representative of Canada said that the disclosure proposal had not been the sole focus 
of the consultations held by the DDG.  Rather, a number of different proposals had been discussed 
and merited further consideration.  Th e draft amendment contained in document IP/C/M/51 
Page 18  
 
  WT/GC/W/564/Rev.2 made three assumptions which Ca nada neither agreed with, nor found to be 
fully reflective of the ongoing discussions.  Fi rst, not all Members had accepted the case for 
amendment to the TRIPS Agreement as being suffici ently substantiated and thus her delegation did 
not agree to proceed to negotiations.  Second, not all Members had agreed to overlook the fact that 
there was no mandate to launch negotiations on any intellectual property-related implementation 
issues during the Doha Round.  Third, not all Memb ers were of the view that the TRIPS Agreement 
and the CBD were not mutually supportive agreements .  In fact, her delegation continued to be of the 
view that the TRIPS Agreement and the CBD were  already mutually supportive, and that their 
objectives and principles could be reasonably implem ented in a consistent fashion by countries 
without amending either agreement.  Conseque ntly, Canada considered the draft Article 29 bis to be 
redundant.   
94. The disclosure requirements would not solve the problem facing Members.  She wondered 
whether this was the appropriate time for Member s to consider moving be yond the Doha mandate.  
While a number of Members had suggested this as an option, there were also other options that could 
reasonably be considered under the umbrella of "any appropriate action".  Her delegation was 
committed to fact-based discussions, particularly on national access and benefit-sharing systems, 
which would assist in finding appr opriate solutions to prevent err oneously granted patents and to 
improve compliance with access and benefit-sharing agreements.   
95. She said that the approach presented by Norw ay suggesting text-based negotiations went 
beyond the Members' mandate as they had not yet ag reed on appropriate action to be taken on the 
CBD issue.  As her delegation was currently evalua ting the various disclosure proposals, it could learn 
much about practicality, feasibility and costs of the introduction of the disclosure requirements from 
other countries that had implemented it in their na tional legislation, such as Germany, Belgium, 
Sweden, Denmark, Norway, Brazil and India.  A preliminary observation of these initiatives indicated 
that the subject-matter to be disclosed varied.  The expression privileged in international discussions 
was "genetic resources", but "genetic material",  "biological resources" as well as "genetic or 
biological heritage" were also referred to.  She had expressed her delegation's concerns over the costs 
and benefits to patent offices, the assessment of compliance, the trigger for such disclosure, and the 
checkpoints for access and benefit sharing.  She had noted that the disclosure requirement was one of 
many potential tools with which Members could address the principles and aims of emerging access and benefit-sharing policies at inte rnational and national levels.   
96. The representative of Australia
 said that Australia was a mega-diverse country with possibly 
the world's highest level of endemic genetic resourc es, much of which had yet to be characterized.  
Australia also had an indigenous community which had accumulated tr aditional knowledge over 
thousands of years of interaction with the Australia n continent.  At the same time, Australia was a 
developed country with a burgeoning biotechnology industry and a large agriculture sector, as well as 
large agricultural and environmental research se ctors which were reliant on access to genetic 
resources.  For these reasons, Australia had a stro ng interest in facilitating research, encouraging 
innovation and capturing the benefits from that innovation, ensuring that Australia was able to exercise appropriate control over these resources and en suring that the benefits from such access were 
equitably shared.  To do this successfully, the rights of all stakeholders had to be balanced so that 
research and innovation prospered a nd so that owners of genetic resources and traditional knowledge 
were respected and obtained appropria te benefits from any outcomes.   
97. These were precisely the factors that had infl uenced the development of Australia's own 
access and benefit-sharing regime under the Envir onment Protection and Biodiversity Conservation 
Act of 1999.  The Regulations under the Act had come into force only on 1 December 2005 and were 
based on the Bonn Guidelines.  The Regulations  established a contract-based permit system to 
manage the access and distribution of benefits deri ved from native genetic and biochemical resources.  
In a nutshell, to gain access to the material, one n eeded to obtain a permit from the Minister for the  IP/C/M/51 
 Page 19 
 
 
  Environment or his delegate and to provide evidence of a benefit-sharing agreement with the owner or 
manager of the biological resource.  The legislation clear ly set out the criteria that needed to be met.   
98. In addition, Australia was in the process of de veloping a model contract as a guide to assist 
the parties when developing a benefit-sharing agreem ent.  It would not be mandatory, but aimed to 
provide assistance and incorporate best practice ex amples from similar agreements worldwide.  The 
model contract was designed to address one of the main critiques of the contract-based system, i.e. 
that indigenous communities and other owners of  genetic resources and traditional knowledge were 
not in a position to negotiate effectively.  Overall, the purpose of this legislation was to give investors 
in the industry confidence and security when committi ng to large and sustained investment in research 
and development whilst also ensuring that Aust ralia's genetic resources were used in an 
environmentally sustainable manner, on mutually agr eed terms with prior informed consent and with 
an equitable return for Australia.   
99. There was not necessarily a relationship between Australia's access and benefit-sharing 
regime and its intellectual property or  patent regimes.  Parties could include terms in the contract that 
stipulated that if the resources were commercialized including through a patent, certain benefits would 
flow.  This recognized that many uses could be made of genetic resources and traditional knowledge 
outside the patent system and that biopiracy coul d occur outside the patent system.  The issue of 
biopiracy, therefore, should be addressed at the access phase.  As the contract system was still new, a 
number of licences were under negotiation, but none ha d been completed yet.  It was still too early to 
assess the system, but it was going well in terms of de livering real benefits to genetic resource and 
traditional knowledge owners. 
100. He said that his delegation had proposed focusing Members' attention on access and 
benefit-sharing regimes.  It was interested in hear ing from other Members the details of the practical 
problems that they had experienced in implementi ng and operating their regimes.  Referring to the 
statements made by the Philippines that its nationa l access and benefit-sharing regime had not worked 
adequately in the prevention of biopiracy, and ther efore it supported using the patent system as a 
solution to biopiracy, he said that there were many po ssible reasons for this unfortunate experience.  It 
was vital to examine the nature of the problems e xperienced by Members, the reasons why they had 
occurred and what was the most appropriate solution. 
101. Another representative of Australia said that it remained unclear to her delegation how the 
disclosure requirement itself would have prevented th e granting of patents in the turmeric and other 
cases that had been discussed in the TRIPS Council .  The argument for the disclosure requirements 
seemed to be that patent applicants would be less  likely to lie when confronted with an explicit 
disclosure requirement or that an explicit disclosur e requirement would provide patent examiners with 
additional clues in determining prior art.  Howe ver, her delegation believe d that such arguments 
would not justify an amendment of the TRIPS Agre ement or other international patent treaties.  
Instead, her delegation saw value in pursuing more pr actical ways to prevent the granting of erroneous 
patents, such as the database system proposed by Japan.  In addition, she wondered whether it was 
appropriate for the TRIPS Agreement to enforce th e objectives of prior informed consent and benefit 
sharing provided by other international agreemen ts.  She expressed her concern over the uncertainty 
that the disclosure requirement would engender in the patent system, given that many Members had 
not yet established access and benefit-sharing regi mes.  Invalidating patents because of non-
compliance with access and benefit-sharing regimes th at might not exist or were unclear would put at 
risk the integrity of the patent system with impli cations for the ability to share benefits.  She also 
expressed concern over the burden imposed on patent  offices by the disclosure requirements.   
102. In conclusion, she reiterated her de legation's approach to this issu e:  first, a clear examination 
of the problem, second, development of options for solutions, and third, negotiations.  Accordingly, 
he believed that it was premature a nd inappropriate to move to negotia tions at this stage.  Members IP/C/M/51 
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  could not amend the TRIPS Agreement unless they had identified the problem with national access 
and benefit-sharing regimes.  Therefore, Member s should start with technical discussion to identify 
the problem, and then develop proposals for options for an appropriate solution, and then move to negotiations on those options.  Many  safeguards and balances had been  built into the patent system, 
and when Members considered a new measure, they  should ensure that the measure was capable of 
meeting its objectives while preven ting adverse consequences.   
103. The representative of the United States
 said that her delegation was one of several Members 
that did not see a conflict between the TRIPS Agr eement and the CBD, and considered that these two 
agreements could and should be  implemented in a mutually supportive manner, and that no 
amendment to the TRIPS Agreement was needed or  warranted.  Nonetheless, she recognized that 
there remained a wide divergence of views among Members on this issue, including advocacy of a 
variety of approaches.  In light of this, it was premature to engage in a text-based discussion.  
Document WT/GC/W/564/Rev.1 might help to elabor ate the conceptual position of its co-sponsors, 
but it could not be a basis for the Council's future wo rk.  The future work shou ld continue with fact-
based discussion, which should include examination of  existing access and benefit-sharing regimes, as 
it appeared to be directly related to perceptions  of what constituted "misappropriation".  It would 
facilitate progress in this area and would continue  to clarify points of disagreement while reducing 
differences among Members. 
104. The US proposal on national access and benefit-sh aring systems was directed to the goal of 
providing appropriate access and equ itable benefit sharing.  With respect to mistakenly granted 
patents, the proposals on use of searchable organized databases, disclosure of information material to 
patentability, and use of post-grant opposition and/ or re-examination procedures could directly 
achieve this objective.  Her dele gation had closely reviewed the arguments made by the proponents of 
the disclosure requirements and continued to believe  that the disclosure requirements were not an 
appropriate solution to meet the concerns raised.  She further said that there seemed to be universal 
recognition in the TRIPS Council that at least a national access and benefit-sharing regime was 
necessary for the proper running of the benefit-shari ng aspects of any such system.  Thus, it was clear 
that in order to achieve the objectives of prior informed consent and equitable benefit sharing, 
national laws outside the patent system that dire ctly and effectively regulated such conduct were 
critical.  Her delegation had long observed that c oncerns about misappropriation arose more broadly 
than in the context of products under the patent protection.  Many countries had only recently enacted 
or were in the process of enacting national acces s and benefit-sharing systems.  Focusing on 
mechanisms to strengthen national re gimes outside the patent system in order to address all instances 
of commercialization of misappropriated resources a nd/or traditional knowledge  that needed to be 
addressed regardless of whether these instances invol ve patenting or not, led to a more comprehensive 
and appropriate solution to the purported problems and issues.  It was unclear in the arguments of the 
proponents of the disclosure requirements why na tional access and benefit-sharing systems were 
insufficient with respect to misappropriation that w as followed by the filing of a patent application, 
although it could sufficiently handle all other form s of misappropriation which potentially had even 
greater commercial consequences. 
105. She said that in order to better understand perceived instances of misappropriation, the 
TRIPS Council should continue its consideration of fact-based examples and examine national 
experiences regarding access and benefit-sharing system s to identify perceived problems with or gaps 
in these existing systems.  It was not clear how the mere fact that a pending patent application or a 
granted patent that referred to genetic resources or claimed an invention that might have some relation 
to genetic resources could lead to a conclusion that  the genetic resource or traditional knowledge at 
issue had been obtained illegally, irregularly or quest ionably, especially given the availability of such 
resources commercially.  Many of the resources cited by some Members in the course of discussions 
were grown in many countries throughout the wo rld and further many such resources had been 
exported and sold as raw materials for direct cons umption or industrial processing with a view to  IP/C/M/51 
 Page 21 
 
 
  immediate economic benefits.  Whether these expor ts were subject to national access and benefit-
sharing regimes in Members needed to be explored.   
106. She said that a cursory review of several of the patents listed in recent submissions as 
evidence of biopiracy or misappropriation revealed that the inventors of these patents had in fact 
disclosed the source and/or origin of the genetic res ources related to the inventions.  Given that fact, it 
was clear that the proposed new disclosure requireme nts, in and of themselves, would not attain the 
purported goals.  Rather than advocate burdensom e remedies that would not address underlying 
problems, Members should enquire as to how existin g access and benefit-sharing systems dealt with 
genetic resources, for example, whether, if genetic resources were exported as raw material for direct 
consumption or industrial processing or otherwise traded as commodities, this might impact upon 
perceptions of illegal and otherwise wrongful beha viour.  In her view, the disclosure requirements 
would not address large volumes of resources that might be exported from countries apparently 
exempted or unregulated by national access and bene fit-sharing systems that, after travelling through 
the normal channels of commerce might eventually be  used as starting materials for research and/or 
innovation.  In the absence of evidence to support the assertion that the disclosure requirements would 
achieve their intended outcomes, it was problematic for Members to consider such requirements in 
light of the disincentives they were likely to have on innovation.  She further said that the patent system was a critical incentive mechanism for prom oting research and developm ent of new inventions 
of legally obtained or accessed material.  This was what ultimately resulted in new inventions that 
enhanced living conditions, including life saving medi cines, higher crop yields and better treatments 
for disease.  All Members had a stake in encouraging and not discouraging this process.   
107. She said that national contract-based systems coul d be adequately enforced outside the patent 
system.  Such contract-based systems could be part of civil and criminal codes specifically designed to enforce access and benefit-sharing laws.  Such sy stems could be international in character and 
could contain, inter alia , choice of forum, choice of law, or  international arbitration provisions 
relevant to cross boundary dispute or enforcement issues.  Such systems were widely used in 
international business transactions a nd could and did function to enfo rce the mutually agreed terms 
between parties.  Nevertheless, her delegation w as still open to further discussion on the enforcement 
issue.   
108. She said that the disclosure requirements were primarily aimed at preventing mistakenly 
granted patents.  However, due to  the tenuous relationship between sour ce and/or country of origin to 
issues relating to prior art and inventorship, it was not likely that the disclosure requirements would 
provide any helpful information to patent examiner s.  The problems cited by Peru in its recent 
document, including limited information in the Englis h language in certain patent databases, difficulty 
in finding prior art because of lack of systema tization of information and in finding documents 
relating to particular customs, were illustrative of broader concerns.  The disclosure requirements 
would have little, if any, bearing on how to alter the situation cited by Peru. 
109. She said that her delegation fully supported the Japanese proposal's goal of improving prior 
art search systems and that it had made several proposal s directly related to this goal, including use of 
organized databases of prior art.  She found the de tailed analysis provided by Japan on the turmeric 
and neem cases consistent with her delegation's an alysis of these cases, which led to the conclusion 
that the disclosure requirements could not fulf il its purported objective.  She supported further 
consideration of Japan's proposal, including the use of languages, assessment  and identification of 
compilation of the database and the notion of a "one -stop-shop" database.  She said that the ongoing 
work in WIPO could continue to inform the di scussion in the TRIPS Council in this regard.   
110.
 She said that her delegation would continue to study other examples that had been cited to 
support the premise that disclosure of source and orig in of country would be effective in preventing 
mistakenly granted patents.  The premise appeared to be inconsistent with the fact-based discussions IP/C/M/51 
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  held to date.  The proponents of the disclosure requirements appeared to assume that what was known 
about a genetic resource prior to research and develo pment was what led the inventor to the patented 
invention.  Such was not the case in many, if not most, circumstances.  Many inventions were the culmination of numerous researchers seeking a solution to a problem or the result of an unexpected finding while seeking information on an unrelated expe riment.  For example, it had taken more than 
thirty years with hundreds of millions of dollars of private sector investment to develop the 
anti-cancer medication Taxol, which had originally been  isolated from the Pacific Yew in Washington 
State in the United States.  This illustrated the real and costly efforts undertaken to develop a 
biological resource into a commercially successful product, and the risks involved in undertaking such 
research and development.  Many medicines that we re developed from plant and animal extracts were 
the result of arduous research efforts, unexpected resear ch results or trial and error experimentation.  
The patent system was designed as an incentive fo r innovators to undertake such intensive and 
expensive research and development by rewarding th em an exclusive right to exclude others from 
using the invention for a limited time.  Members s hould be wary of potentially upsetting this system 
by introducing new patent disclosure requirements. 
111. She noted that the proponents of the disclosure requirements had a presumption, without 
empirical evidence, that an invention related to a genetic resource was automatically based upon 
illegal access or misappropriation.  However, she said that many genetic resources were indeed 
commercially sold, legally obtained and independently  researched and developed into inventions.  She 
further said that the recent fact-based discussion had helped to identify some apparent common 
ground among Members, including that national ac cess and benefit-sharing systems were essential 
elements of any solution and further that Members appeared to share the concern over how to improve 
prior art search mechanisms for patent offices ar ound the world with the objective of preventing 
mistakenly granted patents.  She reiterated that he r delegation would continue to engage in the fact-
based discussion, including the analysis of the is sues, such as perceptions of illegality of access, 
genetic resources traded as commodities, the rela tionship of traded genetic resources to national 
access and benefit-sharing regimes in place, as well as  the relationship of traded genetic resources to 
starting materials that might be used for research and innovative purposes.   
112. Another representative of the United States responded to three questions posed to his 
delegation earlier by India.  As to a question ab out whether the civil and criminal penalties as 
proposed by the United States were envisioned to appl y to acts in foreign countries, and if so, how 
such laws could be enforced internationally, he said that contract-based access and benefit-sharing 
systems could be adequately enforced outside pate nt laws through civil and criminal laws.  Such 
systems could be international in character and were  easily adaptable.  Compliance with such systems 
would be facilitated by the establishment of cl ear, transparent, contract-based national access and 
benefit-sharing regimes.  While a few individuals could ignore the legal requirements, as they might 
ignore other laws or regulations, the case had not been made for why a contract-based system would 
not be effective, particularly when compared to the alternative proposal for the disclosure 
requirements, which had speculative benefits at best, yet would be likely to result in negative effects 
on the patent system and benefit sharing.  He reca lled that his delegation had described in detail its 
national experiences with the access regimes in the US  national parks and national cancer institutes.   
113. Replying to another question on the further work on international recognition of access and 
benefit-sharing systems, he said that his delegation had not requested such further work per se , but 
instead had suggested further study of national access and benefit-sharing systems, including 
identification of perceived problems or gaps in ex isting systems in order to better understand concerns 
raised.  Such study would be helpful in unders tanding perceived instances of misappropriation.  
Further questions had been raised regarding exports of genetic resources as raw material or otherwise 
as commodities that had been legally obtained.  He said that further study on these issues would help 
to clarify concerns and find appropria te resolution to these concerns.    IP/C/M/51 
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  114. Responding to a further question as to what would be the implications for patent systems if 
the disclosure requirements had been limited to a patent office simply collecting and publishing 
evidence of prior informed consent and benefit sharing and not examining or adjudicating such 
evidence, he said that the disclosure requirement s, including those requiring evidence of prior 
informed consent and equitable benefit sharing, w ould have significant negative impacts on the patent 
system.  These requirements would create, among other effects, a cloud of legal uncertainty over 
patent rights, thereby inhibiting research and development and dimini shing or eliminating potential 
benefit sharing.  He recognized that, according to  some proposals for disclosure requirements, patent 
offices might not have to examine or adjudicate eviden ce of prior informed consent or benefit sharing.  
While this might lessen the burden on patent offices with respect to the task of examining foreign 
access and benefit-sharing systems which patent ex aminers would be ill equipped to assess, a cloud 
would nonetheless remain over all gr anted patents for which this issue might be relevant.  These 
disclosure requirements would provide an additional avenue to litigation and other uncertainties that 
would undermine the role of the patent system, ev en where good faith attempts to comply had been 
made.  These potential litigation challenges impact ed negatively upon research  and development and 
innovation by creating uncertainty over a patent, whic h was a clear necessity in attracting investment 
for research and development.  Thus, such disclosur e requirements not only had the potential effect of 
undermining the technological development incentives of the patent system, but would also have a 
negative effect on any possible benefit sharing.  However, contract-based mechanisms could ensure 
appropriate access by ensuring prior informed consen t and equitable benefit sharing without upsetting 
the incentives critical in the patent system that prom ote research and development and innovation.  In 
addition, he said that Members could not make pr ogress on a solution with respect to the concern over 
misappropriation without looking at national access and benefit-sharing regimes, which went directly 
to the heart of the relationship between  the TRIPS Agreement and the CBD.   
115. The representative of New Zealand  said that New Zealand did not have a dedicated national 
access and benefit-sharing regime.  However, it had es tablished several laws to regulate access to, and 
use of, genetic resources.  There were two formal access regimes in New Zealand:  the Department of 
Conservation Concessions Regime and the Ministry of Fisheries Fishing Permit or Special Permit Regime.  In addition, access to genetic resources located on private land was subject to the landowner's consent according to common law unless th e resource in question had been specifically 
claimed by the Crown through legislation, such as the Wildlife Act.  Failure to obtain the landowner's 
consent would be considered theft.  As the agre ement with the private landowner might be informal 
and/or ad hoc, in many cases there might be no evidence of prior informed consent and benefit 
sharing.  Under the Department of Conservation Concessions Regime, an application form must be 
submitted to the Department for the taking of resources, including genetic resources, for research 
purposes.  A fishing permit or a special permit was required to access aquatic life in New Zealand waters.  The access requirement would differ depend ing on the source.  The law required consent for 
access to genetic resources, but it was not clear to bioprospectors what requirements they should fulfil 
in certain circumstances.  The consultation with private companies indicated  that the absence of an 
access and benefit-sharing regime was a disincentive to bioprospecting.  He said that national access 
and benefit-sharing regimes must be the primary me ans for addressing concerns over access to genetic 
resources.  Therefore, New Zealand had been making efforts domestically, such as national capacity building to allow for the effective engagement of indigenous groups in the debate on this issue, 
exchange of information between officials and indi genous groups about their concerns about misuse 
of traditional knowledge and benefits for indigenous economic development.   
116. He said that the introduction of a new disclos ure requirement would increase complexity 
without clear benefits.  His delegation continued to have concerns about the suitability and practicality 
of the disclosure requirements in the absence of wide spread access and benefit-sharing regimes at the 
national level.  His delegation was interested in h earing other Members' national experiences in order 
to identify problems and find appropriate solutions.   IP/C/M/51 
Page 24  
 
  117. The representative of the European Communities
, commenting on the communication 
submitted by the group of developi ng countries (IP/C/W/470), said that his delegation could go along 
with the distinction between "country of origin" an d "source of the genetic resource" made in that 
document.  Article 2 of the CBD defined "country  of origin" as the country which possessed those 
genetic resources in in situ  conditions, that is conditions wher e genetic resources existed within 
ecosystems and natural habitats, and, in the case of domesticated or cultivated species, in the 
surroundings where they had developed their distinctiv e properties.  The term "source" referred to any 
source from which the applicant had acquired the gene tic resource other than the country of origin, 
such as a research centre, a gene bank or a bota nical garden.  However, while the co-sponsors of 
document IP/C/W/470 suggested that the applicant di sclose both the country of origin and the source, 
his delegation believed that the applicant should disc lose the country of origin if he was aware of it 
without being obliged to undertake further resear ch.  If the country of origin was unknown, the 
applicant should disclose the source of the genetic resource to which the inventor had had physical 
access and which was still known to him.   
118. Regarding the incorporation of traditional knowledg e in the definition of country of origin, he 
said that as traditional knowledge was not defined in the CBD and as there was no commonly agreed 
meaning of it, a further in-depth discussion on this issue was needed. 
119. Regarding the use of the terms "biological res ources" and "biological material" instead of 
"genetic resources", he did not agree with the stat ement that these terms would be interchangeable.  
He said that Article 15.7 of the CBD laid down that access and benefit-sharing objectives must be met with regard to genetic resources.  Article 2 of th e CBD defined genetic resources as genetic material 
of actual or potential value.  Article 15 of the CBD did not apply to biological resources.  "Biological 
resources" was broader than "genetic resources" and was defined to include genetic resources, 
organisms or parts thereof, populations, or any ot her biotic component of ecosystems with actual or 
potential use or value for humanity.  Broadening th e scope to biological resources would mean that 
any component of ecosystems with actual or pot ential value could be subject to the disclosure 
requirements.  This would introduce further uncertainty  to both patent applicants and patent offices.  
Therefore, he suggested retaining the term "genetic  resources" as referred to in Article 15.7 of the 
CBD. 
120. Regarding the obligation to discl ose evidence of prior informed consent and benefit sharing, 
he said that many countries had not yet adopted le gislation on access and benefit sharing and were 
therefore not in a position to deliver certificates.  Even in some countries where such legislation 
existed, difficulties with implementing the legislatio n had been reported.  Those who were the most 
advanced in domestic policy-making should share thei r experience with other Members.  The patent 
system should not be used to verify compliance with national access and benefit-sharing regimes. 
121. With respect to document IP/C/W/469, submitted by the United States, he agreed that national 
contract-based access and benefit-sharing systems were essential elements of any solution.  He also 
agreed that remedies to prevent erroneously gr anted patents should include the use of organized 
databases, information material to patentability and the use of post-grant op position or re-examination 
systems alternatives to litigation.  However, hi s delegation considered that the requirement of 
disclosure of the country of origin or source of th e genetic resource used in an invention would be 
helpful to patent offices, provided it was properly calibrated.  It w ould help to establish novelty by 
making searches focused and thus prevent the mi sappropriation of genetic resources and related 
traditional knowledge.  The introduction of the discl osure requirement was not, and should not be, the 
only solution to fulfil the CBD objectives, but it coul d contribute to the other solutions, such as 
contractual arrangements.  He agreed to conti nue considering national e xperiences regarding access 
and benefit-sharing systems, identifying perceived problems or gaps with these existing systems, and 
proceeding to discuss how these problems could be addr essed.  However, he said that this should not 
prevent Members from continuing discussions on the disclosure requirement.  IP/C/M/51 
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  122. Regarding document IP/C/W/473 from Norway, he  noted several simila rities between it and 
the EC proposal to WIPO, including that the disclosure obligation should apply to all patent applications at internati onal, regional and national le vels;  that the legal effect of non-compliance with 
the obligation should be outside the patent system;  and that a simple notification system should be 
introduced under which patent offices would send decl arations of origin they received to the CBD 
Clearing-House Mechanism.  However, the Norweg ian proposal deviated from the EC proposal on 
several points, including that the disclosure oblig ation should apply to a ll traditional knowledge and 
not only to traditional knowledge which was directly li nked to genetic resources;  that the scope of the 
disclosure requirement should not be limited to s ource and/or origin of genetic resources but should 
also include the information on prior informed co nsent;  and that the TRIPS Agreement should be 
amended to incorporate such requirements.  
123. Regarding document IP/C/W/472 from Japan, he sai d that the relevant work undertaken in 
WIPO should be taken into account, where appropriate , by the TRIPS Council, in order to avoid the 
duplication of efforts.   
124. The representative of the Philippines
 expressed his delegation's willingness to share its 
national experience with other Members.  Howeve r, he doubted the usefulness of discussion of 
Members' national experience, considering the time c onstraints.  He said that because of the absence 
of the disclosure requirements in most Member s' patent systems, Members could not find a 
comparative benchmark to test the effectiveness of the disclosure requirements.  While looking at a 
great diversity of Members' national experiences,  Members should examine whether the disclosure 
requirements could be either alternatives or co mplements to national access and benefit-sharing 
regimes.  Text-based negotiations would provid e Members with an opportunity to discuss the 
practical, legal and policy implications of the discl osure requirements.  He said that, as indicated by 
the delegations of Brazil and India, the disclosure requirements would be only an additional formal 
requirement, which would not constitute  a disincentive to innovation.   
125. The representative of India  said that it had taken the Indian Government seven years to set out 
its national legislation on access and benefit sharing.   The legislation might function well at home, but 
could not solve problem of transboundary use of ge netic resources and traditional knowledge.  Hence, 
his delegation had put forward the disclosure prop osal in the TRIPS Council, from which national 
access and benefit-sharing system could benefit.  He  said that Australia's national experience showed 
that a contract-based solution might not work, give n the unequal negotiating power of the aboriginal 
communities and bioprospectors.  Also, the voluntary nature of the contract itself determined that it 
would not work effectively.  He said that the ai m of the disclosure proposal was not to cover the 
entirety of the range of systems presented by New Z ealand.  Instead, it only pr oposed a solution in the 
patent system.   
126. He further said that the discussion in the TRIPS Council had shown increasing support for an 
amendment to the TRIPS Agreement in order to insert the minimally burdensome disclosure 
requirements.  Concerns and questions raised by Members had been largely addressed.  Even those 
who had expressed opposition to the amendment had s hown that they had benefit-sharing systems 
domestically, but some of them admitted to possible inequity between the mutually agreeing parties in 
those access and benefit-sharing systems.  For this gr oup, the next step could be the consideration of 
the draft text with a view to using the proposed amendment to address some of these equity issues.  
The outcome of these negotiations would be a key component in the fulfilment of the development 
dimension of the Doha Round.   
127. The representative of Brazil  said that defining prior art might help to improve patent quality, 
but did not address the issue of the relationship between the TRIPS Agreement and the CBD.  This 
was because the improvement of prior art search es would not achieve a supportiveness of the CBD 
objectives.  While it was interesting to discuss the patent quality and possible changes to prior art IP/C/M/51 
Page 26  
 
  searches, it would not bring a solution to the misappropriation of biological resources on an 
international scale.   
128. Regarding the legality of use of  genetic resources mentioned by the United States, he said that 
this issue had not been addressed in the draft amen dment.  The disclosure requirements would provide 
a tool for monitoring and tracking information regard ing the use of biological material and traditional 
knowledge.  If there was misappropriation of biol ogical resources and traditional knowledge, the 
patent application would not be further processed or the granted patent might be revoked.  Patent 
offices would not judge the legality of the purchase of or access to a particular biological resource.  The disclosure requirement had no bearing on exports of biological resources.   
129. Regarding the national contract-based approach, he said that a number of Members would be 
required to adjust their civil or criminal codes, which would not provide an incentive to innovation but 
would facilitate biopiracy on an international scale be cause of the great diversity of national regimes.  
The amendment would improve incentives to innovati on.  National experiences, although interesting, 
did not have a direct bearing on Members' ma ndate to examine the relationship between the 
TRIPS Agreement and the CBD.  Moreover, negotia tions in the WTO were not usually based on a 
fact-based examination of national experiences.  He recalled that the TRIPS negotiations had not 
taken into account, nor been conditi oned upon, any examination of na tional experiences.  Therefore, 
Members should not limit their work to fact-based discussion or divert their attention to national experiences.  The TRIPS Council was a forum for Members to negotiate internationally binding 
treaties.  
130. In conclusion, he said that as a great number of Members had made substantive comments on 
the proposal for amendment of the TRIPS Agreement,  the time was ripe to move towards text-based 
negotiations.   
131. The representative of Australia
 could not share the conclusion reached by India that the 
Australian model contract was not effective in addressing the misappropriation of genetic resources 
and traditional knowledge.  He said that Australia  had long experience in relation to access and 
benefit sharing on copyright issues, such as the co llective management of copyright in relation to 
indigenous images.  The images created by Aust ralia's indigenous popula tion were popular both in 
Australia and overseas.  Initially, Australia had encountered the problem of not only commercial 
misuse and inequitable distribution of rewards stem ming from the commercial use of such images, but 
also of a deeply religious and sp iritual sentiment of abuse of the indigenous communities as a result of 
unregulated access to the images.  In that context, Australia had worked very closely with a range of 
stakeholders, including primarily the indigenous co mmunities.  Based on international best practices, 
Australia had developed a range of model cont racts, which had been successful in empowering 
indigenous control and access and benefit sharing in re lation to copyright issues, and, in particular 
control over indigenous images.  He agreed with th e delegation of India that the model contract alone 
might not be enough to address the problem.  Hence, Australia had invested heavily in a wide ranging 
education programme with the indigenous communiti es to make them aware of their rights and the 
dangers of uncontrolled access to their images.  This had led to a dramatic increase in the confidence 
of these indigenous groups in dealing with people who wished to use their images.  As a result, 
Australia's indigenous groups were quite competent ne gotiators, and drove a hard bargain.  In relation 
to copyright management, there was a good framework  for identifying what appropriate bargains 
might look like.  The indigenous groups were conf ident and aware of the issues compared to the 
former situation where often they had refused to  negotiate at all.  They objected to broader 
distribution of these images on spiritual or religio us grounds as they were inappropriate for such 
purposes.  This had been a good practical solution to the access and benefit sharing issue.  He further 
said that the exchange of national experiences might help Members introduce good model access and 
benefit-sharing regimes.    IP/C/M/51 
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  132. The representative of UNCTAD  said that in response to a request made by the CBD 
Secretariat to UNCTAD to examine issues related to disclosure of origin requirements in intellectual 
property applications, UNCTAD had commissioned Jos hua Sarnoff and Carlos Correa to prepare a 
paper entitled "Analysis of Options for Implementing Disclosure of Origin Requirements in Intellectual Property Applications".  He indicated that the views expressed in the paper were those of 
the authors and did not necessarily reflect those of the UNCTAD Secretariat.  The study identified a 
need for an international system of mandatory di sclosure of origin requirements and set out the 
possible features of such a system.  It addressed questions of terminology and scope, before discussing issues including choices for model provisi ons on disclosure requirements and the choice of 
treaty regime in which to adopt requirements.  Optio ns relating to substantive and procedural triggers 
for disclosure requirements were examined, and the authors also considered incentives for the 
enforcement of such obligations.  In addition, th e paper looked at practical issues related to the 
enforcement of disclosure requirements within existin g treaties, and analyzed intellectual property law 
issues raised by the use of international certificates of  origin.  The study's authors argued that a system 
of mandatory disclosure of origin requirements coul d be an effective way to contribute to goals of 
deterring the misappropriation of genetic resources, strengthening the intellectual property system and 
promoting the fair sharing of benefits derived from the use of genetic resources and associated 
traditional knowledge. 
133. The representative of India
 said that the paper introduced by UNCTAD was useful as it 
contained material on the definition and terminol ogy issues which Members would eventually need 
when they would develop a text for the amendment to the TRIPS Agreement.   
134. The representative of the United States  said that the paper represented the opinion of the two 
authors who had long been known as supporters of the disclosure requirements.  However, Members 
were still far from any consensus on this issue and hi s delegation was of the view that the disclosure 
requirements were not an appropriate solution.  He indicated that the paper could be an informative 
document for delegations, but must be understood in its appropriate context.  He hoped that UNCTAD 
would commission studies on alternatives to the discl osure requirements, which would be helpful for 
Members in their future discussion.   
135. The Council took note  of the statements made under these three agenda items and agreed  to 
revert to them at its next meeting.   
F. NON-VIOLATION AND SITUATION COMPLAINTS  
136. The Chairman  recalled that paragraph 45 of the Hong Kong Ministerial Declaration directed 
the TRIPS Council to continue its examination of th e scope and modalities for complaints of the types 
provided for under subparagraphs  1(b) and 1(c) of Article XXIII of GATT 1994 and make 
recommendations to its next Session.  It was agreed  that, in the meantime, Members would not initiate 
such complaints under the TRIPS Agreement.   
137. He further recalled that, at its meeting in Marc h 2006, the Council had agreed to keep this 
item on the agenda as a regular item so as to allow Members who had new thinking to share it, and 
also enable the Council to consider improved ways of organizing its work on this matter. 
138. The Council agreed  to revert to the matter at its next meeting. 
G. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1 
139. No statements were made  under this agenda item. 
140. The Council agreed  to revert to the matter at its next meeting. IP/C/M/51 
Page 28  
 
  H. R
EVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
141. The Chairman  recalled that Article 24.2 provided th at the Council should keep under review 
the application of the provisions of the GI Section of  the Agreement.  As agreed by the Council at its 
meeting in March 2006, he had he ld consultations on how the Council should organize its future 
work.  In the light of these consultations, it seemed that Members still needed more time to reflect on 
the matter.  He therefore suggested that he hold  further consultations on the matter and that the 
Council revert to this matter at its next meeting. 
142. In addition to recording the discussions in the formal session of the Council, the minutes 
below on this item also reflect, as agreed to by  the Council, additional points made by certain 
delegations at an informal meeti ng of the Council held on 14 July 2006. 
143. The representative of the European Communities  said that his delegation attached great 
importance to this issue and felt that there was a need  to move forward on this matter in order to find a 
more focused and structured way to continue the work that this Council had already started.  In 
previous discussions, several ideas had been floated on how to carry this work forward, including his 
delegation's suggestion for an options paper.  He  was open to examining any proposal on how to 
structure future work and considered that two elemen ts were essential for doing so.  First, one should 
concentrate on the examination of the appli cation of the TRIPS provisions on geographical 
indications, as stated in Article 24.2, and not on im plementing legislation.  A substantial exercise had 
already been carried out with regard to nationa l implementing legislation, which should not be 
replicated under this item.  Such a review was not  foreseen specifically for geographical indications 
and it would be extremely resource intensive, and w as not carried out in respect of any other section 
of the Agreement.  Secondly, one should take adva ntage to the maximum exte nt possible of the work 
done so far, in particular of the replies to the checklist of questions and the Secretariat's summary 
paper (IP/C/W/253/Rev.1).  The summary paper alr eady contained many of the elements mentioned 
by delegations, such as how Members applied their obligations and a list of practical examples of GI 
protection. 
144. Any agenda for future work could, for exampl e, be based on the different sections of the 
summary paper:  overview of the means of protection available;  definition and criteria for recognition;  procedures for recognition;  eligible authorized users and monitoring; protection against 
improper use;  and enforcement and relationship wi th trademarks.  Such an approach would allow 
Members to comment on the summary paper, and al so provide any necessary updates.  It would be 
helpful to draw general lessons fro m Members' replies to the checklist in a structured manner, making 
sure that the approach was of a general nature and not focused on the way Members had implemented 
their specific obligations on geographical indications .  This would allow Members to benefit from the 
wealth of information that had b een submitted so far by Members and processed by the Secretariat.  
All Members could gain from exchanging views an d information on their experience in protecting 
geographical indications.  In particular, many Me mbers that had only relatively recently established 
TRIPS-compliant GI protection systems would benefit from it. 
145. He suggested that an annotated  agenda, based on the headings and the contents of document 
IP/C/W/253/Rev.1, be circulated by the Chair, so as to allow Members to con tinue with this process. 
146. The representative of the United States
 said that, during past discussions under this item, his 
delegation had indicated its belief that the Council should follow the proposal made by Australia to 
walk through the provisions on geographical indicati ons paragraph by paragra ph.  His delegation was 
particularly interested to see how countries had ensu red that protection was available for nationals of 
other Members to protect their geographical indica tions.  A closer look at the details of domestic 
implementation of GI protection based on the "wal k through" of the provi sions would provide not  IP/C/M/51 
 Page 29 
 
 
  only the best, but also the necessary platform fo r ascertaining the benefits of protection and the 
implementation problems countries had faced.  He expr essed an interest in attending any consultations 
that the Chair might choose to have on this matter. 
147. The representative of Australia , echoing the comments made by the United States, referred to 
document IP/C/W/211, submitted by his delegation in 2000.  Australia's preferred approach continued 
to be to go through all of the provisions of th e Agreement relating to geographical indications. 
148. The representative of Switzerland  said that his delegation attached great importance to this 
agenda item and thus to a structured and focused review under it.  The discussion should be structured 
according to the headings of the updated summary note of the Secretariat (document IP/C/W/253/Rev.1) on the information provided by Members in response to the checklist on the way 
they had provided protection for geographical indicati ons at the national level.  The question of which 
of these headings would be discussed in the next me eting should be determined by the Council or by 
the Chair in advance of that meeting and confirmed in a circular letter by the Secretariat so that 
Members would be able to prepare their interventions  or submissions effectiv ely in a timely manner.  
Members that had not yet provided information in response to the Secretariat's checklist should be 
encouraged to do so.  The more information that was available, th e more meaningful this review 
would be. 
149. The Council took note
 of the statements made and agreed  to proceed as suggested by the 
Chair. 
I. TECHNICAL COOPERATION AND CAPACITY BUILDING  
(i) Annual Updates on Technical Cooperation Activities   
150. Turning to the arrangements for the annual review of technical cooperation, the Chairman  
recalled that the Council had traditionally undertaken  such a review each autumn.  He therefore 
suggested that the Council hold its annual review  of technical cooperation at its next meeting 
scheduled for 25-26 October.  Accordingly, he s uggested that the Council once more invite developed 
country Members to supply information on th eir activities pursuant to Article 67 of the 
TRIPS Agreement.  Other Members who also made available technical cooperation were encouraged 
to share information on these activities if they so wished.  He also suggested that the Council once 
more invite those intergovernmental organizations that had observer status in the TRIPS Council to 
provide information on their activities of relevan ce and that the WTO Secretariat might also be 
instructed to report on its activities.  Furthermore,  he suggested that the Council might request that 
this information be made available by 29 Septembe r, i.e. approximately three weeks prior to the 
Council's next meeting, in order to allow its  timely circulation before that meeting. 
151. The Council so agreed . 
(ii) Other matters 
152. The representative of the Secretariat  said that, while the Secretariat would report more fully 
on its TRIPS-related technical cooperation activities to  the next session of the Council, he wished to 
take this opportunity to inform the Council in re gard to the follow-up by the Secretariat to the 
provisions on enhanced technical cooperation in the TRIPS Council Decision of 29 November 2005 
on the extension of the transition period for least -developed country Members.  He recalled that 
paragraph 2 of the Decision provided that "with a vi ew to facilitating targeted technical and financial 
cooperation programmes, all the le ast-developed country Members will provide to the Council for 
TRIPS, preferably by the 1 January 2008, as much information as possible on their individual priority 
needs for technical and financial cooperation in order to assist them taking steps necessary to IP/C/M/51 
Page 30  
 
  implement the TRIPS Agreement".  Paragraph 3 of  the Decision concerned technical and financial 
cooperation to be provided by developed country  Members and paragraph 4 technical assistance and 
capacity building by the WTO in cooperation with WIPO and other interna tional organizations.  
Paragraph 4 provided that "[i]n order to assist least-developed country Members to draw up the 
information to be presented in accordance with para graph 2, and with a view to making technical 
assistance and capacity building as effective an opera tion as possible, the WTO shall seek to enhance 
its cooperation with the World Intellectual Property Or ganization and with other relevant international 
organizations". 
153. The Secretariat had received requests fro m ten least-developed countries for national 
workshops this year, which it welcomed.  Two of these had already been undertaken and the 
remaining eight were scheduled for the second half of the year.  The Secretariat was suggesting to 
each of these countries that the workshops should include components geared towards the type of 
needs assessment foreseen in paragraph 2 of the D ecision, and this could include a separate meeting 
with key officials for this purpose. 
154. He also informed the Council that, in respon se to paragraph 4 of the Decision and based on 
the WIPO-WTO Cooperation Agreement of 1995 and also the Joint Initiative on Technical 
Cooperation in Favour of LDCs by the Directors-Ge neral of the two Organizations, it was envisaged 
that the eight remaining workshops this year would either be organized jointly with WIPO or that 
WIPO would provide a resource person.  He expresse d his appreciation of the contribution that WIPO 
was willing to make in this regard. 
155. The WTO Secretariat had reached its capacity  limits as far as workshops for LDCs in 2006 
were concerned.  However, he urged interested  LDCs to include a workshop in their technical 
cooperation requests for 2007 and to give the Secretar iat as much notice as possible in this regard in 
the light of the provisions of the Decision.  WIPO had also agreed to support these activities next year 
and had further indicated that it would take into account the needs assessments foreseen in 
paragraph 2 of the Decision in its own technical cooperation activities in favour of LDCs wherever 
feasible. 
156. The Council took note
 of the information provided. 
J. ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS – COMMUNICATION FROM THE 
EUROPEAN COMMUNITIES  
157. The Chairman  said that this item had been put on the Council's proposed agenda at the request 
of the delegation of the European Communities, da ted 10 May 2006.  He reca lled that the Council had 
discussed this topic at its three last meetings  on the basis of three communications from the 
European Communities (IP/C/W/448, 468 and 471).  At the last meeting, some delegations had 
indicated that they wished to comment on these pape rs, in particular the latest one focusing on border 
measures that had been made available just prior to that meeting. 
158. The representative of the European Communities  said that his dele gation had launched a 
debate in the TRIPS Council more than a year ago on the worrying status of IP enforcement 
worldwide and the negative consequences of piracy  and counterfeiting, including for the health and 
safety of citizens and the economic viability of co mpanies and right holders.  Several Members had 
supported this initiative, expressing similar concerns  and the willingness to continue the discussion in 
the Council.  The issue was also being debated in other forums such as G8, Interpol, the OECD, the 
WCO, WIPO and the WHO.  However, these interna tional organizations lacked a clear, coherent and 
effective set of rules as contained in Part 3 of the TRIPS Agreement.  IP/C/M/51 
 Page 31 
 
 
  159. At the Council's last meeting, his delegation had introduced a communication which was 
designed to initiate a debate on the use of customs measures specifically as a means to fight the global 
traffic of IPR infringing goods.  Customs had a prim e role to play in stopping the international 
movement of fake goods, as they were responsible for about 70% of all seizures of counterfeit goods 
globally.  Several delegations had indicated their d esire to comment on this issue.  His delegation had 
therefore requested that the item be put on the agenda  again.  Rather than being negative or consisting 
of finger-pointing, he wished that the discussions could be positive and trigger an exchange of views 
on best practices. 
160. He reiterated the request he had made at the C ouncil's previous meeting that the Secretariat be 
invited to prepare a synopsis of Members' contri butions to the Checklist of Issues on Enforcement 
(IP/C/5).  A summary of these responses would consti tute a useful element for future discussions.   
161. The representative of China  said that his delegation had already made detailed comments on 
the EC communications at the Council's last meeting.  For the reasons it had mentioned at that meeting (as recorded in paragraph 135 of document IP/C/M/50), it would be inappropriate to discuss 
these communications.  He therefore requested th at the item be removed from the Council's agenda. 
162. The representative of Brazil
 referred to his interventions at the Council's last meeting of the 
TRIPS Council, and added that, according to Article  1.1 of the TRIPS Agreement, Members were free 
to determine the appropriate method of implementin g the provisions of the Agreement within their 
own systems and practice.  He did not support th e EC proposal of searching for a coordinated 
response to enforcement, including the promotion of best practices and the monitoring of operational 
performance of national agencies in charge of comb ating counterfeiting and pi racy.  Regarding border 
measures, he failed to see the need to revise Article  51 of the Agreement, as implicitly suggested by 
the European Communities.  Article 51 already contem plated the possibility of suspending the release 
into free circulation of counterfeit and pirated good s by customs authorities at the request of right 
holders. 
163. The TRIPS Agreement had to be seen as an ag reement in its entirety.  All articles were 
relevant and should be addressed on a demand-driven basis for t hose Members seeking technical 
cooperation.  Members who wished to raise issues relating to IPR enforcement should do so under the 
existing review mechanisms in the Agreement.  Exchange of information on national laws and 
measures concerning enforcement were currently u nder discussion in other forums, such as the WIPO 
Advisory Committee on Enforcement and the WCO.  The TRIPS Council already faced important challenges relating to the outstanding implementa tion issues under the Doha Round negotiations.  His 
delegation was therefore not prepared to engage  in an in-depth discu ssion on enforcement and 
supported China's proposal not to make this i ssue a permanent agenda item for the Council. 
164. The representative of Australia
 said that it was important to take note of the EC's request that 
any discussion be positive and not involve finger-poi nting.  While he could support a discussion of 
border enforcement issues, he said that the outcome  intended by the European Communities had to be 
clarified first.  Given the resource and cost implications of any changes to border enforcement 
measures, it was important to have  a more detailed analysis of the perceived problems before coming 
to any official view.  There was also a need to  consider the extent to which these issues were 
considered in other forums, particularly in the WCO, in order to avoid duplication of work.   
165. The representative of Switzerland  supported the inclusion of IPR enforcement on the 
Council's agenda, and the EC's proposal that the Secr etariat provide a synopsis of Members' responses 
to the Checklist of Issues on Enfor cement.  The main objective should be to look at possible ways and 
means to assist Members in their efforts to im prove enforcement mechanisms while taking into 
account their specific needs, in particular those expressed by developing country Members.  Necessary assistance should be provided to Member s that experienced difficulties in implementing IP/C/M/51 
Page 32  
 
  enforcement mechanisms with a view to enha ncing the workability and efficiency of such 
mechanisms. 
166. The delegation of Argentina
 said that issues relating to enforcement could be dealt with under 
the Council's agenda item on the review pursuant to Ar ticle 63.2.  The proposal to make this issue a 
separate and permanent agenda item was not acceptable.  This would be imbalanced, focusing on the 
interests of right holders, while not taking the ob jectives in Article 7 sufficiently into account, in 
particular the contribution of IPR protection and en forcement to social and economic welfare.  She 
disagreed with the objectives of the EC initiative wh ich in her view seemed to aim at amending the 
Agreement or establishing best practices.  She also  disagreed with Switzerland, which in her view 
seemed to consider that problems with enforcem ent were limited to developing countries, since 
counterfeiting and piracy also occu rred in developed countries.   
167. The representative of the United States  supported the EC's proposal for a dialogue among 
Members on the implementation of TRIPS enforcem ent obligations and identifying solutions to 
implementation deficiencies.  It agreed with th e objective of examining the implementation of the 
TRIPS enforcement provisions in detail to unde rstand where the main problems, difficulties and 
shortcomings were.  Focusing on each of the individual sections in Part III of the Agreement would 
provide a good framework for the discussion.  He agreed with the approach of examining implementation difficulties within each Section, mechanisms to address those difficulties and a 
coordinated response at the TRIPS level through va rious tools, including the promotion of best 
practices.  He supported a discussion on border measures that would address the areas referred to in the first EC paper.  Such a discussion would be beneficial in assisting countries with enforcement 
difficulties to gain insights into how to addr ess those problems and to implement an effective 
enforcement regime under the Agreement. 
168. The representative of Chinese Taipe
i said that an effective enforcement regime would 
encourage innovation and invention, and promote the development of trade and economy.  He agreed 
with the European Communities th at an effective border enforcement regime was crucial to 
preventing IPR infringements.  It was essential th at customs authorities around the world would share 
information and experiences.  Sharing the Europ ean Communities' experiences in implementing the 
Council Regulations No.1383/2003 and No.1891/2004  concerning customs action against goods 
suspected of infringing certain IPRs would contribu te to the Council's discussions on the matter.  
169. Regarding the statistics contained in the latest  EC communication (IP/C/W/471), he noted that 
the chart showing the number of articles seized, li sted by origin of goods on page 8, identified 
Chinese Taipei as the second largest source country.  Ho wever, in the other chart on the same page on 
the number of cases by origin of goods, Chinese Ta ipei did not figure among the first seven source 
countries.  This discrepancy could be the result of  a commercial dispute between an EC company and 
a domestic company, in which case it had nothing to  do with IPR infringement and should be treated 
separately.  
170. The efforts by Chinese Taipei to protect IPRs should not be ignored or underestimated.  
According to the 2005 Annual Business Infringement Report released by IFPI, its efforts to enforce 
IPRs had significantly reduced the number of IP infringements and it was no longer among the 31 markets with a strong presence of pirated CDs.  
171. The representative of Japan
 said that counterfeiting and piracy was a serious problem with a 
global impact.  The number of infringing goods suspended by the Japanese customs had grown 
by 47.3% from 2004 to 2005.  Problems were increa sing, not only in terms of volume and region, but 
also with regard to the scope of infringed right s that varied from conventional trademarks or 
copyrights to patents and designs.  He hoped that  the discussion in the Council would address this 
problem.  IP/C/M/51 
 Page 33 
 
 
  172. The representative of Canada  reiterated its interest in a ddressing counterfeiting and piracy.  
The TRIPS Council could be an appropriate fo rum for a dialogue, which should not, however, 
duplicate discussions occurring in other internati onal organizations.  The proposed exchange of 
information and cooperation between customs author ities was also discussed at the WCO, which had 
the appropriate expertise on customs issues.  She considered that a compilation of Members' 
responses to the Checklist of Issues on Enforcement would be useful.  Her delegation had submitted 
its response in 1997, and would most likely have to update it. 
173. The representative of India  said that, while enforcement was an important issue, this was not 
the appropriate time to discuss it.  Negotiations  on some more important development issues, 
including those related to biopiracy, were goi ng on and the discussion on enforcement should be 
deferred until those negotia tions were concluded. 
174. Regarding the objectives of the EC proposal, the representative of the European Communities  
said that paragraphs 6 and 7 of document IP/C /W/468 set out the objectives and methodology that 
included the identification of difficulties and the ex amination of appropriate mechanisms to address 
those difficulties.  He restated that the aim of the initiative was a positive discussion, not finger-
pointing.   
175. He agreed with Brazil that Article 1.1 provide d for the freedom of each Member to choose the 
appropriate method of implementing the Agreement.  The initiative was not to be interpreted as an 
implicit attempt to revise Article 51, as suggested  by Brazil.  He disagreed with the Brazilian 
suggestion that this issue be discussed in WIPO , since TRIPS matters should be discussed in the 
TRIPS Council.  He noted that at the latest meeting of the WIPO Advisory Committee on 
Enforcement, Brazil had suggested not discussing this issue in WIPO, because it was already 
discussed in the TRIPS Council. 
176. He agreed with Argentina that Article 7 was an  important provision.  However, he failed to 
see how illegal activities, such as piracy, which were  often connected to organized crime or caused 
public health problems, as in the case of fake me dicines, could favour econom ic development.  The 
assumption put forward by Argentina that the European Communities aimed at changing the 
Agreement was not correct.   
177. He also agreed with India that biopiracy was an  important issue.  However, this was not the 
only form of piracy, and his delegation had therefore requested that the issue of enforcement be put on 
the agenda of the Council. 
178. The representative of Brazil  said that he had not said that the issue should not be discussed in 
the Council, since it was addressed by WIPO.  Other delegations had mentioned the need to avoid 
duplication.  His delegation had merely pointed to the fact that the WIPO Advisory Committee on Enforcement was taking care of certain issues unde r its competence regarding IPR enforcement in 
general.  Many participants ha d sent national experts to discuss concerns regarding enforcement, 
including many issues regulated by the TR IPS Agreement.  The allegation by the 
European Communities that his delegation refused to participate in that particular Committee was not 
correct.  The Executive Secretary of the Nati onal Committee on Combating Piracy had presented 
national experiences at the last meeting of the WIPO Advisory Committee on Enforcement.  Many 
different, new perspectives on measures that countries could take to combat piracy had been presented 
in WIPO, and it would be duplicative to repeat this in the Council. 
179. He said that the Council was not empowered to enforce the TRIPS Agreement as such in 
Member countries.  His delegation was strongly oppo sed to creating any diversion of functions within 
the WTO or fragmenting the competence of the disput e settlement mechanism, for example by tasking 
the TRIPS Council to examine the fu lfilment of certain TRIPS provisions in an isolated manner.  If IP/C/M/51 
Page 34  
 
  Members believed that other Members were not co mplying with the TRIPS Agreement, they could 
use the WTO dispute settlement mechanism for that purpose. 
180. The TRIPS Agreement contained many provis ions on public interest flexibilities and 
exceptions to rights that, in his view, should also be adequately enforced by Members.  Moving ahead in the direction of the EC proposal would lead to an imbalance, given that these provisions were not 
covered by the EC proposal.  This was not acceptable to his delegation. 
181. The representative of the European Communities
 said that he failed to understand how the 
objective of exchanging information on best practices could imply that, as stated by Brazil, certain Members did not apply the TRIPS Agreement properly.  With regard to the fl exibilities referred to by 
Brazil, he failed to see any link between such flex ibilities in the Agreement and criminal activities. 
182. The Chairman
 noted that the views among delegations continued to differ on this issue. 
183. The Council took note  of the statements made. 
K. INFORMATION ON RELEVANT DEVELOPMENTS .   
184. The Chairman  said that under this agenda item, info rmation had usually been provided in 
relation to new accessions to the WTO, developments  in the area of dispute settlement and, more 
recently, acceptances of the recent TRIPS Amendment.  On this occasion, he had no new 
developments to report in these areas. 
185. The representative of the European Communities  said that he wished to raise the issue of the 
compliance of the United States with the DSB rulings on IP matters.  In the case US – Section 110(5) 
Copyright Act  (WT/DS160), a WTO panel had found, in 2000, that certain provisions of this Act were 
inconsistent with the United States' obligations unde r Section 1 of Part II of the TRIPS Agreement.  
The United States had been granted one year to co mply with that ruling, i.e., until July 2001.  
However, the US Copyright Act had still not been amended.  His delegation found this situation 
worrying, from both an individual and a systemic point of view.  He posed the following three questions to the US delegation:  first, were there any specific legislative initia tives in the United States 
to bring the Copyright Act into compliance with th e TRIPS Agreement?  In other words, during the 
past five years, had the US Congress discussed any piece of legislation aimed at amending 
Section 110(5) of the US Copyright Act?  Secondl y, what specific steps wa s the US administration 
taking to ensure that the United States would brin g its Copyright Act into conformity with the 
TRIPS Agreement?  Had there been any written co mmunication to Congress that the United States 
could share with his delegation on this matter?  A nd thirdly, when did the United States expect to 
finalize its work to comply with the WTO ruling, which was adopted in July 2000? 
186. The representative of the United States
 said that, since these questions had only been raised to 
his delegation at the present meeting without prior notice, he was not in a position to give specific answers.  He took note of the questions and, cons istent with previous discussions that his delegation 
had had both in the TRIPS Council and in other forums  on this issue, it would continue to cooperate 
with the European Communities.  The United States intended to respond to these questions bilaterally, 
if that would be acceptable. 
187. The representative of the European Communities
 said that his delegation took note of the 
statement of the United States and agreed with it. 
188. The Council took note  of the statements made.  IP/C/M/51 
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  L. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
189. The Chairman  said that the list of the 17 pending requests for observer status in the 
TRIPS Council by other intergovernmental organizations was contained in document 
IP/C/W/52/Rev.11.  He recalled that the Council had discussed these pending requests at its previous meetings, but had not been able to reach consensus on any of them.  He informed the Council that the 
Executive Secretary of the Secretariat of the Conventi on on Biological Diversity, in his letter to the 
Director-General dated 1 May 2006, had drawn atte ntion to the fact that the Eighth Session of the 
CBD Conference of the Parties, at its meeting in Curitiba, Brazil in March 2006, had adopted 
decisions VII/16 and BS-III/6 to renew the applica tion for accreditation of the CBD Secretariat as an 
observer at the TRIPS Council.  This and other pending requests had been discussed at an informal 
meeting of the Council but, unfortunately, he was not in a position to report any developments in 
delegations' thinking concerning the pending requests.  Therefore, he suggested that the Council take 
note of this information and agree to revert  to this matter at its next meeting. 
190. The Council so agreed
. 
M. OTHER BUSINESS  
(i) Fourth annual review pursuant to  paragraph 2 of the decision on the 
"Implementation of Article 66.2 of the TRIPS Agreement" 
191. Turning to the arrangements for the Council's fourth review under the decision on the 
"Implementation of Article 66.2 of the TRIPS Agreement", the Chairman  recalled that paragraph 1 of 
the Decision provided that developed country Me mbers should submit reports annually on actions 
taken or planned in pursuance of their commitments under Article 66.2.  To this end, they had to 
provide new detailed reports every third year and, in  the intervening years, provide updates to their 
most recent reports.  These reports had to be submitt ed prior to the last Council meeting scheduled for 
the year in question.  Paragraph 3 of the Decision determined the information that had to be provided 
in these reports.  He recalled that the first set of  detailed annual reports un der the Decision had been 
presented to the Council's meeting in November 2003, and two sets of updates to the Council's 
meetings in December 2004 and October 2005.  Ther efore, this year, developed country Members 
should submit new detailed reports on actions taken or planned in pursuance of their commitments 
under Article 66.2 prior to the Council's end of  year meeting that had been scheduled 
for 25-26 October.  As provided in paragraph 2 of the Decision, the Council should review these 
updates at that meeting.  He therefore suggested that developed country Members be requested to 
submit new detailed reports on actions  they had taken or planned in pursuance of their commitments 
under Article 66.2 by 29 September 2006, i.e. approxim ately three weeks before the meeting, in order 
to allow their timely circulation and review  at the Council's meeting in October. 
192. The Council so agreed . 
(ii) Other Reviews 
193. The Chairman  reminded Members of certain other re views that would be on the Council's 
agenda at its next meeting in October.  As he ha d already indicated under an earlier agenda item, the 
Council would take up its annual re view of technical cooperation.  Furthermore, the Council would 
need to hold its third annual review under para graph 8 of the Decision on the Implementation of 
Paragraph 6 of the Doha Declara tion on TRIPS and Public Health, and report on its operation to the 
General Council.  Finally, the C ouncil would have on its agenda th e fifth transitional review under 
Section 18 of the Protocol on the Accession of the People's Republic of China. 
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