RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/48 
15 September 2005 
 (05-4063) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
  
MINUTES OF MEETING 
 
Held in the Centre William Rappard
 
on 14-15 June 2005  
 
Chairman:  Ambassador Choi Hyuck (Korea) 
 
 
 The present document contains the record of the discussion which took place during the 
TRIPS Council meeting held on 14-15 June 2005.  Subjects discussed
 Page nos.  
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2  
B. FOLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ALREADY 
UNDERTAKEN ..............................................................................................................................2  
C. REVIEW OF THE PROVISIONS OF ARTICLE 27.3  (b) .....................................................................3  
D. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY .............................................................................................................3  
E. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ...................................................3  
F. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1..................23  
G. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................23  
H. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION 
ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH ..................................................................24  
I. FOLLOW -UP TO THE SECOND ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE 
DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ...............32  
J. TECHNICAL COOPERATION AND CAPACITY BUILDING .............................................................32  
K. REQUEST FROM MALDIVES FOR AN EXTENSION OF THE TRANSITION PERIOD UNDER 
ARTICLE  66.1  OF THE TRIPS  AGREEMENT ...............................................................................33  
L. NON-VIOLATION AND SITUATION COMPLAINTS ......................................................................34  
M. SPECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL ..............36  
N. ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS – COMMUNICATION FROM THE 
EUROPEAN COMMUNITIES ........................................................................................................36  
O. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................43  
P. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............43  
Q. OTHER BUSINESS ......................................................................................................................44  IP/C/M/48 
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A. N
OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairman  informed the Council that, since its meeting in March 2005, it had received a 
notification of laws and regulations from Papua New Guinea.  Among the Members whose 
transitional periods under Article 65. 2 or 65.3 had expired on 1 Janua ry 2000 or who had acceded to 
the WTO after that date, excluding newly acceded least-developed country Members, there still 
remained two who had not yet submitted any notific ation concerning their implementing legislation, 
namely Saint Kitts and Nevis;  and Saint Vincent and the Grenadines.  The Council had also received 
a number of supplements and updates to earlier notif ications of laws and regulations.  Belize had 
notified three administrative instructions relating to trademarks, patents and industrial designs, and 
provided a list of certain relevant  "other laws";  Germany had notified a Law Reforming the Law 
Concerning Industrial Designs;  India had notified its  Patent (Amendment) Act, 2005, its Patent Rules 
of 2003 and 2005, as well as Government Notifications  containing a list of convention countries and 
authorized depository institutions;  and Canada had notified its legislation and regulations to 
implement paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.  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 force. 
2. He said that the Council had received notifi cations concerning the implementation of the 
Decision on the Implementation of Paragraph 6 of th e Doha Declaration on the TRIPS Agreement and 
Public Health from Norway, at its meeting in Se ptember 2004, and now from Canada and India.  He 
reminded other Members that might have adopted laws  or regulations to implement this Decision to 
notify such measures to the Council. 
3. As regards notifications of contact points under Article 69, he said that, since the Council's 
meeting in March, updates to contact points notifie d earlier had been received from Paraguay, Turkey 
and the Bolivarian Republic of Venezuela.  These no tifications were being circulated in addenda to 
document IP/N/3/Rev.8.  There were now 121 Members who had notified contact points under 
Article 69. 
4. The Council took note  of the information provided. 
B. FOLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ALREADY 
UNDERTAKEN  
5. The Chairman  informed the Council that, in the context of the follow-up to the 13 reviews 
that had been initiated at the Council's meetings  since April 2001 but which still remained on the 
Council's agenda, the Former Yugoslav Republic of Macedonia had provided, since the Council's last 
meeting, a response to the last outstanding follow-up  question posed to it.  This response, together 
with the responses it had provided earlier, had been circulated in document IP/Q/MKD/1.  
Furthermore, Zimbabwe had provided responses to questions posed by the European Communities, 
Japan and the United States.  These responses had been circulated together with the responses that it 
had provided earlier to the questions posed by Ca nada and Switzerland in document IP/Q/ZWE/1.  
The Chairman suggested that the regular review of the legislation of the Fo rmer Yugoslav Republic of 
Macedonia and of Zimbabwe be deleted from the agenda, it being understood that any delegation 
could revert to any matter stemming from these reviews at any time. 
6. The representative of th e European Communities , thanking Zimbabwe for its responses to the 
EC questions and supporting the Chair's sugges tion, said that his delegation would still seek 
clarifications on certain points bilatera lly with the delegation of Zimbabwe.  IP/C/M/48 
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 7. The representative of the United States , thanking Zimbabwe for its responses to the US 
questions, said that while his delegation was still reviewing the responses and might pose follow-up 
questions, it could agree with the Chair's suggestion. 
8. The Council agreed  to proceed as suggested by the Chair. 
9. The Chairman  turned to the remaining 11 Members, namely Congo;  Cuba;  Egypt;  Fiji;  
Grenada;  Mauritius;  Qatar;  Saint Kitts and Nevi s;  Saint Vincent and the Grenadines;  Suriname;  
and Swaziland. 
10. The representative of Egypt  said that his authorities were still working on responses, which 
would be provided to the Council once finalized. 
11. The representative of Cuba  said that the situation in respect of Cuba's pending legislation had 
remained the same since she had l ast time informed the Council on this  matter.  This delay was due to 
other urgent matters of security nature having taken priority.  He r delegation intended to notify the 
outstanding responses as soon as the three pending draft decree-laws were adopted by the Council of the State. 
12. 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 Memb ers were Dominica, Gabon, Ghana and Guyana. 
13. He urged the delegations con cerned to provide the outstanding material as soon as possible, 
so as to allow the Council to complete the follow-up to these reviews.  He suggested that the Council 
revert to this matter at its next meeting. 
14. The Council took note  of the statements and agreed  to proceed as suggested by the Chair. 
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  
15. The Chairman  suggested that, since the practice in th e Council's past meetings had been that 
delegates address these three agenda items together , the Council continue to discuss them together.  
He recalled that, at its meeting in Septembe r 2004, the Council had received a submission from 
Bolivia, Brazil, India, Pakistan, Peru, Thailand and Venezuela on "Elements of the Obligation to 
Disclose the Source and Country of Origin of Biological Resource and/or Traditional Knowledge 
Used in an Invention" (IP/C/W/429/Rev.1 and ad dendum 1).  Since the Council's last meeting, 
Colombia and the Dominican Republic had requested th at they be added to the list of sponsors of the 
submission;  these communications had been circulated  in addenda 2 and 3 to the document.  He also 
recalled that three new documents had been presente d to the Council's March meeting, one from Peru 
focusing on Peru's experience in fighting biopira cy through the National Commission on Prevention 
of Biopiracy (IP/C/W/441/Rev.1);  another from the delegation of Brazil on behalf of Bolivia, Brazil, 
Colombia, Cuba, the Dominican Republic, Ecua dor, India, Peru and Thailand entitled "The 
Relationship between the TRIPS Agreement and th e Convention on Biological Diversity (CBD) and 
the Protection of Traditional Knowledge – Elemen ts of the Obligation to Disclose Evidence of 
Benefit-Sharing under the Relevant National Regi me" (IP/C/W/442);  and a third from  India on 
behalf of Brazil and India containing technical  observations on issues raised in an earlier IP/C/M/48 
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 communication from the United States (IP/C/W/443).  All of these documents had been received just 
prior to that meeting and some delegations ha d said that they intended to comment on these 
submissions at the present meeting.  Furthermore, since its last meeting, the Council had received the 
following new communications:  a communicati on from Switzerland containing questions on 
proposals submitted by other Members relating to  the three agenda items (IP/C/W/446);  a 
communication from Peru on its position in relation to  the disclosure of origin and legal provenance 
(IP/C/W/447);  and a communication from the United States relating to the three agenda items (IP/C/W/449). 
16. The representative of Switzerland
 said that his delegation had submitted three 
communications on these three agenda items (IP/C/W/400/Rev.1, 423 and 433), in which it proposed 
to amend the Regulations under th e Patent Cooperation Treaty (PCT) to explicitly enable national 
patent legislation to require the declaration of  the source of genetic resources and traditional 
knowledge in patent applications if inventions were directly based on such resources or knowledge.  
It also proposed to afford patent applicants the possibility of satis fying the disclosure requirement at 
the time of filing international patent applications or later duri ng the international phase, and to 
include the declaration of the source in the international publication of patent applications.  He said 
that document IP/C/W/446 contained a list of questions with respect to the legal, technical and practical implications of the proposals made by Peru, Brazil, India, the United States, and the European Communities in order to allow the TRIPS Council to better understand Members' concerns.  He underlined the importance of the conformity of actions in the TRIPS Council with Members' obligations under other international agreements, such as the FAO's International 
Undertaking on Plant Genetic Resources, the Bonn Guidelines on Access to Genetic Resources 
and Fair and Equitable Sharing of the Benefits Arising out of their Utilization, and the CBD. 
17. The representative of Peru
 said that document IP/C/W/447 aimed at clarifying the issues with 
respect to the relationship between the TRIPS Ag reement and the CBD.  It was not a follow-up to 
document IP/C/W/441, but an effort to determine how the requirement for the disclosure of origin was 
being currently applied in the patent system at na tional, regional and multilate ral levels in order to 
highlight the challenges Members faced and the shortf alls in the patent system.  After analyzing the 
situation in detail, document IP/C/W/447 proposed  an amendment to the TRIPS Agreement which 
would solve many of the problems currently affecting not only Peru, but also a significant number of other mega bio-diverse countries.  He said that his delegation would continue contributing to the 
discussion in the TRIPS Council by reporting the progress made in the work of the National 
Commission for the Protection of Access to Peruvian Biological Diversity and to the Collective 
Knowledge of the Indigenous Peopl es.  He hoped that this could raise awareness of, and convince, 
those delegations who still faile d to comprehend the magnitude of the biopiracy problem and the 
urgency of the need to resolve this problem with in the framework of this round of negotiations in 
accordance with the mandate set out in paragraph 12 of the Doha Declaration. 
18. Document IP/C/W/447 gave details of the curre nt biopiracy problem with an approximate 
estimate of the phenomenon and an account of Peru's national experience since the entry into force of 
the CBD.  It specifically pointed out that inasmu ch as it was impossible for countries individually to 
guarantee compliance with the conditions of access to their resources and traditional knowledge, all 
countries should ensure the fulfilment of the obligati ons and responsibilities which were established in 
the CBD and incorporated into national legislation.  Intellectual property systems, in particular the 
patent system, could directly contribute to the fu lfilment of the objectives of the CBD in respect of 
access and benefit-sharing.  The document elaborated the reasons for the importance of the disclosure of origin and legal provenance as follows: first,  genetic resources and traditional knowledge had 
economic significance and thus it was necessary to  realize the possibilities of their commercial 
exploitation and industrialization;  second, there was a need to grant good patents and a need for 
complementarities between different legal regimes at the international level;  and third, there was a  IP/C/M/48 
 Page 5 
 
 
 need to respect the beliefs and rights of indigeno us peoples and to safeguard countries' interests in 
their genetic resources. 
19. In the document, Peru acknowledged that much  progress had been made in the conceptual 
discussion on the issue of the disclosure of origin and legal provenance, which had already been the 
subject of policy negotiations in different forums.  A group of countries, particularly those rich in 
biodiversity and historical suppliers of genetic resources and traditional knowledge, took the view that 
the only way to enforce the disclosure requirement  was to ensure that it was recognized by the 
authorities of the countries where most of the patent s were granted.  In other words, the disclosure 
requirement should be incorporated into the legisla tions of the United States, Japan and the European 
countries and form part of the administrative proced ures of granting patents in these countries.  As a 
first step, the disclosure requirement should be introduced into the TRIPS Agreement.  It was 
acknowledged that even if the requirement for th e disclosure of origin and legal provenance was 
recognized in the United States, Europe and Jap an, not all the problems associated with the 
unauthorized or unlawful use of resources and asso ciated traditional knowledge would be resolved.  
However, such recognition had the following imme diate positive implications:  re-establishment of 
trust-based relations between Southern countries (trad itionally considered to be suppliers of resources) 
and Northern countries (traditionally considered  to be users);  improved conditions for the 
establishment of regimes of access to genetic resour ces and protection of trad itional knowledge that 
were less authoritarian and restrictive;  elabor ation of common but differentiated commitments and 
obligations in accordance with th e basic principles of the CBD;  contribution to ensuring that good 
rights with legal certainty were granted under inte llectual property systems and, in particular, the 
patent system;  and establishment of positive syne rgies and complementarity between the CBD and 
intellectual property systems and, in particular, the TRIPS Agreement.  Peru had spared no efforts to 
bring its legislation in line with the CBD and to ensu re that the patent system functioned efficiently.  
Although Peru had done everything necessary at nationa l and regional level to combat biopiracy, the 
problem had persisted because of its universal na ture.  Part VI of document IP/C/W/447 introduced 
some countries' experiences, including those of Co sta Rica, Venezuela, Brazil, India and Norway. 
20. In Part VII of document IP/C/W/447, Peru proposed an amendment to Article 27 of the 
TRIPS Agreement in the form of a further excep tion to patentability in the following words: 
"Members may also exclude from patentability: (c) products or processes which directly or  indirectly include genetic resources 
or traditional knowledge obtained in the ab sence of compliance with international and 
national legislation on the subject, including failure to obtain the prior informed 
consent of the country of origin or the community concerned and failure to reach agreement on conditions for the fair and e quitable sharing of benefits arising from 
their use. 
Nothing in TRIPS shall prevent Member s from adopting enforcement measures in 
their domestic legislation, in accordance w ith the principles and obligations enshrined 
in the Convention on Biological Diversity." 
21. Under this exception patents should not be gran ted in cases of breach of binding rules under 
legal regimes, such as those governing access to  genetic resources and protection of traditional 
knowledge.  Peru also proposed an amendment to Article 29.1 of the TRIPS Agreement with the 
addition of a paragraph which would expressly provide: 
"Where appropriate, Members shall require  the disclosure of origin and legal 
provenance in the patent app lications to be submitted." IP/C/M/48 
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 22. Under this proposal, it would be left to countri es to define in their domestic legislation the 
penalties applicable in cases of failure to comply with this rule.  The op tions included not processing 
an application pending compliance with the proposed requirements, declaring the application to have 
lapsed if these requirements were not met duri ng the review procedure, declaring invalidity 
(remediable or otherwise), if a patent was gran ted and non-compliance was subsequently ascertained. 
23. In conclusion, he said that the sixth Ministerial Conference, to be held in Hong Kong, China 
in December 2005, should include in its agenda and subsequent Declaration an  explicit reference to 
the question of the relationship between intellect ual property and biodivers ity/traditional knowledge 
and the need to establish positive synergies betw een the TRIPS Agreement and the CBD.  These 
synergies included a recognition, in the context of the disclosure of origin and legal provenance, of 
suitable means for establishing a direct connection between intellectual property regimes and the 
regime for access to genetic resources and the protection of traditional knowledge, and for 
guaranteeing that the objectives of both regimes were sa tisfactorily fulfilled.  He hoped that a concrete 
solution would be found by the end of this round of  negotiations.  A development round could not be 
considered worthy of its name if it did not allo w developing countries to properly address their main 
concerns. 
24. The representative the United States
 said that his delegation could not support Peru's proposal 
on an amendment to the TRIPS Agreement.  Notin g Members' willingness to engage in a discussion 
with a focus on shared objectives and how to achie ve those objectives, he said that this focused 
discussion, including relevant national experiences, could assist progress by identifying common ground where it existed as well as by identifying differences among Members. 
25. He reiterated that the United States was one of several Members that saw no conflict between 
the TRIPS Agreement and the CBD and considered  that these agreements could and should be 
implemented in a mutually supportive manner, a nd therefore no amendment to the TRIPS Agreement 
was needed or warranted.  He recalled that the CBD did not require, nor even mention, patent 
disclosure requirements.  Indeed, the CBD did not requi re countries to modify their patent laws in any 
way.  Although not a party to the CBD, the Unite d States was nevertheless taking positive steps, as 
noted in its submission, to promote and encourage prior informed consent and equitable sharing of 
benefits on mutually agreed terms. 
26. With regard to prior informed consent and misappropriation, he said that although there 
remained a wide degree of disagreement, cer tain areas of common ground and understanding were 
emerging among Members.  In its previous docum ent IP/C/W/434, the United States had provided 
concrete proposals for achieving the widely sh ared objectives of ensuring authorized access, 
achieving equitable sharing of the benefits arisi ng from the use of traditional knowledge and genetic 
resources, and preventing the issuance of erroneously  granted patents.  His delegation continued to 
consider that the new patent disclosure requirements were not an appropriate solution to the concerns 
and objectives raised, and the uncertainties generated by such requirements only further convinced his 
delegation that the most effective way to ensu re the objectives of ensuring authorized access and 
equitable benefit-sharing was tailored national laws  outside the patent system that directly and 
effectively regulated the relevant conduct. 
27. He said that a number of Members, including Switzerland and New Zealand, had raised other 
concerns relating to the disclosure requirements, commenting on the desire for a monitoring system 
with respect to genetic resources and traditional kn owledge.  In his view, an effective monitoring 
system should be implemented through a domestic access and benefit-sharing regime.  A contract-
based access and benefit-sharing regime could requi re, among other things, mandatory disclosure to 
authorities of any commercial application utilizin g the relevant genetic resources or traditional 
knowledge and, therefore, could ensure monitori ng for the use of these resources or knowledge 
regardless of whether or not any commercial applicati on was related to a patent or resulted in a patent  IP/C/M/48 
 Page 7 
 
 
 application being filed.  Such a domestic monito ring system provided a more effective means to 
ensure the monitoring objective without th e deleterious effects on the patent system. 
28. He noted that a number of delegations had expressed concerns over the enforcement of 
national access and benefit-sharing regimes.  He said  that in the vast majority of cases, compliance 
would be facilitated through cooper ation between the holders and users of genetic resources.  In the 
rare cases where a party violated the national regi me, that party would be subject to the national 
regime's criminal and civil provisions, just as in  other regulatory areas, such as those related to 
environment, health and safety, in which governme nts had an important regulatory interest.  He 
indicated that the patent system did not condone or legitimize violations of environment, health or 
safety laws and, in the same manner, did not condone or legitimize misappropriation of genetic 
resources or traditional knowledge in violation of a country's access and benefit-sharing requirements. 
29. Turning to benefit sharing, he said that the be nefits that arose from the utilization of genetic 
resources might come from both commercial or non-co mmercial exploitation.  Even focusing only on 
the commercial context, there were benefits that flowed from utilization of traditional knowledge and 
genetic resources where no invention had been develope d to be qualified for patent protection.  For 
example, neither herbal remedies nor plant varieties might be patentable in a particular country.  In 
such cases, patent disclosure requirements would do nothing to ensure equ itable benefit-sharing, 
because those who utilized these resources never applied for a patent in the first place. 
30. He recalled that Brazil and India had clarified that their proposal for the new patent disclosure 
requirements would not substitute for, but woul d supplement national access and benefit-sharing 
regimes.  While he welcomed this clarifica tion, he did not see how Members could design the 
disclosure requirements to supplement national legisl ation that was not in place in the majority of 
Members.  He believed that establishing national access and benefit-sharing systems was essential before engaging in discussion of supplemental patent  disclosure requirements.  Furthermore, he said 
that it would seem prudent to determine areas of inadequacy based on experiences of existing national 
systems in order to more fully consider these matters. 
31. Regarding the remedy proposed by certain Member s, that is invalidation of the patent due to 
non-compliant disclosure, he said that it would dest roy or have significant negative consequences on 
the benefit being sought, rather than ensuring that the benefit would be shared with the appropriate 
party.  For example, if a third party challenged th e patent based on improper disclosure that resulted in 
revocation of a patent due to litigation by a third party not affiliated with a traditional knowledge or 
genetic resources holder, this could actually upset th e pre-existing benefit-sharing agreement.  This 
would then enable the further commercialization of the invention in the affected market by those 
having no obligation to share benefits. 
32. He said that in cases of commercialization that  did not involve patents, the authors of 
document IP/C/W/443 had recognized this concern and stated that these were concerns and issues that 
would be dealt with outside the patent system.  His delegation had long advocated a system outside 
the patent system to address all issues of comme rcialization and exploita tion regarding genetic 
resources and/or traditional knowledge.  Rather than  attempting to single out applications involving 
patents and trying to deal with them with a new patent disclosure requirement that might negatively 
affect technological development, a more appropr iate solution would be strengthening national 
regimes outside the patent systems in order to ta ke a comprehensive holistic approach and address all 
instances of commercialization of misappropriated r esources and/or traditional knowledge that needed 
to be addressed outside the patent system. 
33. He said that his delegation generally shared c oncerns over erroneously issued patents, but 
remained convinced that the disclosure requirements did not address these concerns in an appropriate 
or effective manner.  Determinations  of inventorship and prior art were generally rooted in a country's IP/C/M/48 
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 patent law.  Information regarding the country of origin or the source, i.e., country locations or ex situ  
collection sites, was not generally relevant in pate nt examination and would th erefore be of little value 
in that process.  There were more direct options that could effectively address these issues and prevent 
the grant of erroneously issued patents, incl uding the use of organized, searchable databases, 
requirements regarding information material to patentability, and the use of effective post-grant 
opposition or re-examination systems.  In add ition, post-grant oppos ition and re-examination 
proceedings also played an important role in helpin g to avoid or rectify erroneously granted patents.  
There were a number of examples where such systems had been used effectively in this area.  With 
regard to the requirement to disclose information ma terial to patentability in the United States, he said 
that information regarding source and/or country of origin was generally not material to patentability, 
and was therefore of little use in trying to remedy th e granting of erroneously issued patents.  A more 
effective approach was to focus on information material to patentability and thereby would not 
introduce new uncertainties of laws unrelated or te nuously related to the invention into the patent 
system. 
34. In conclusion, he said that document IP/C/W/443 and the recent comments made by Brazil, 
India and other Members clarified a number of common grounds among Members.  For example, 
Members seemed to agree that the act of patenting per se  was not misappropriation.  Members shared 
the views that an international disclosure requi rement alone would not work to guarantee prior 
informed consent and that national contract-based systems were essential elements of any solutions.  
They seemed to recognize the primacy of establishing national regimes and that, in the absence of any 
such regime, such disclosure requirements would be  of little or no use.  It seemed clear that the 
disagreement among Members on this issue was the narrower question of whether such a global 
disclosure requirement could be justified by its ab ility to ensure the effective operation of national 
regimes of prior informed consent, notwithsta nding its negative effects on the patent system, 
technological development and benefit sharing.  In  order to better assess and resolve issues regarding 
proposals to remedy the concerns expressed by Member s, he said that it might be helpful for those 
Members with access and benefit-sharing systems currently in place to identify the perceived 
problems, in particular with respect to monitoring and enforcement under such systems.  He said that, 
to his delegation's understanding, only a relativ ely small number of Members had established access 
and benefit-sharing systems and most of these systems had only been in effect a short time.  His delegation believed that such an a pproach would be consistent with the more fact-based approach to 
discussions that had been suggested in the past by Canada and supporte d by a number of other 
Members.  Continued focus by the TRIPS Council on the shared objectives and options available to 
achieve them would be helpful in addressing the mandate of paragraphs 12 and 19 of the Doha 
Ministerial Declaration.  Meanwhile, he said that his delegation also looked forward to the helpful 
work ongoing in the WIPO's Intergovernmental Committee on Intellectual Property and Genetic 
Resources, Traditional Knowledge and Folklore (IGC) that would continue to inform the discussion in 
the TRIPS Council. 
35. The representative of Brazil
 said that his delegation shared all the concerns expressed in 
Peru's submission and looked forward to continui ng to work with the delegation of Peru in 
negotiations on an amendment to the TRIPS Agreement.   He said that a number of submissions on the 
disclosure requirements revealed certain shared  objectives and goals.  The TRIPS Council had 
benefited from certain questions and clarifications  in these submissions and could now suggest a way 
forward in this debate. 
36. Setting out the basics of the proposal made by a number of developing c ountries, he said that 
it was the firm view of these countries that disclosur e of source and country of origin of biological 
resources, evidence of prior informed consent, and evidence of fair and equitable benefit sharing in 
patent applications would play a significant role in preventing biopiracy and misappropriation, apart 
from ensuring that all contributors to innovations we re adequately rewarded.  A mandatory disclosure 
obligation on patent applicants would, to an ex tent, operate as a self-policing provision.  This  IP/C/M/48 
 Page 9 
 
 
 approach would have a number of advantages:  firs t, it would be an additional reason why the patent 
applicant would be encouraged to comply with na tional laws on access and benefit sharing;   second, 
the onus on the patent applicant was limited to pr oviding information and evidence that was known to 
him or should have been known to him so that the administrative and cost burden on him would be 
minimal and the burden on the patent offices would be even less;  third, it would increase the capacity 
of patent offices in examining patent applications that dealt with biological resources and associated 
traditional knowledge;  and fourth, it would serve as a critical tool for biodiversity-rich countries in 
tracking down the patent applications based on biol ogical resources and related traditional knowledge 
and enable challenges to specious patents in a less burdensome manner. 
37. He said that in the absence of the requirement for the disclosure of source and country of 
origin, the aggrieved countries would only have th e option, under the relevant patent system, of 
challenging the grant of patents that did not meet the criteria of patentability in the granting country based on their own efforts to collect evidence of u se to cite as prior art.  These countries would have 
no recourse where biological resources had been used  without having obtained prior informed consent 
of the countries having the rights over su ch resources or where the access constituted 
misappropriation.  Pursuing a legal remedy under in ternational law and in multiple jurisdictions was 
complicated and expensive and was therefore not an  economically viable option for many aggrieved 
countries due to the capacity constraints faced by th em.  He further said that in cases of inventions 
based on biological resources and/or associated tr aditional knowledge, the source of origin of the 
biological resources and associated traditional know ledge was critical for ascertaining whether the 
applicant had invented what he claimed or just found the "invention" in nature or obtained it from 
traditional cultures.  This was especially importa nt when the traditional knowledge used in the 
invention was undocumented and existed in oral form or was documented in a local language.  
Disclosure of source and country of origin of th e resource and traditional knowledge would enable a 
better assessment by patent examiners of novelty and inventive step involved in the invention. 
38. He said that a fundamental premise behind the disclosure requirements was that disclosure of 
origin would enhance transparency in the c ontext of access to genetic resources and associated 
traditional knowledge.  There was no disagreement on the fact that a researcher or collector needed to 
know where to go and whom to contact.  Even where information on origin in itself might not be sufficient for assessing novelty and inventive step in an  invention, it was believed that such disclosure 
would facilitate a more thorough enquiry by patent  examiners into the state of existing traditional 
knowledge, prior art and the nature of inventive step  undertaken by patent applicants in developing 
inventions. 
39. He said that it was acknowledged that the effec tiveness of use of any information would be 
contingent on the extent to which adequate admi nistrative mechanisms were in place to enable 
effective searches by both patent applicants and patent examiners.  While the consolidation of 
databases, such as India’s Traditional Knowledge Digital Library and China’s Traditional Chinese 
Medicines Database, was a valuable tool for enabling this, it was not  sufficient in itself to cover the 
entire gamut of biological material and associated traditional knowledge.  Disclosing the source of origin would therefore be a fundamental advanc ement enabling searches that might be outside the 
scope of such established databases.  The actual implementation of such searches could be enhanced 
through better networks between designated focal points in various countries and clearing house mechanisms established at th e international level.  The fact that this needed to be done, however, did 
not dilute the need for the disclosure requirements or negate its fundamental contribution in achieving 
a better patent system.  On the contrary, it would help in achieving a more transparent and effective 
patent system, in which the number of erroneously  granted patents could be  substantially reduced. 
40. He said that several countries, mostly tho se providing biological resources, had already 
enacted laws to put in place an access and benefit- sharing regime.  These countries had also provided 
the terms for benefit sharing on a fair  and equitable basis in their domestic legislations.  However, this IP/C/M/48 
Page 10  
 
 was in itself insufficient to stop biopiracy and misappropriation of biological resources and associated 
traditional knowledge.  It did not achieve one of th e central objectives of the disclosure requirements, 
which was to stall the reward of a patent for knowledge, information or materials misappropriated 
from another country.  Regarding the concern th at the expanded disclosure requirements would 
potentially diminish the benefits of a patent, he  said that such requirements would ensure that 
proprietary rights were not granted to patent applic ants who had acted in bad faith.  The granting of 
such patents in the absence of compliance with pr ior informed consent and benefit-sharing would be 
tantamount to an unjust reward for a patent applicant.   Such a situation would seem to run counter to 
the objectives and principles of the TRIPS Agreement,  in particular those contained in Articles 7 
and 8. 
41. Regarding the legal effect of failure of meeti ng the disclosure requirements, he said that it 
would depend on whether such failure was established before or after the grant of patents.  If the 
non-compliance was established before the examination or grant of a patent, the legal effect could be 
not to process the patent application further until the submission of necessary declaration and evidence.  If it was established af ter the grant of a patent, the lega l effect should be revocation or 
invalidation of the patent.  He said that documen ts IP/C/W/429/Rev.1, IP/C/W/438, IP/C/W/442, and 
IP/C/W443 enumerated the circumstances where revoca tion or invalidation would be contemplated.  
In particular, revocation was proposed where a prope r disclosure would have led to the refusal to 
grant patent on the following grounds: lack of novelty due to the existence of prior art, insufficient, 
wrongful or no disclosure with fraudulent intention, or violation of ordre public  or morality.  
Revocation or invalidation would also be for eseen in cases where there was failure to disclose 
evidence of prior informed consent and benefit sharing with fraudulen t intention.  In such cases, the 
proposed disclosure requirements also foresaw se veral alternatives to revocation under certain 
circumstances, such as criminal and administrative sa nctions, and full or partial transfer of rights to 
the invention, which might be better suited to ensu re adequate compensation and to promote fair and 
equitable benefit sharing.  If prior informed con sent and benefit sharing had taken place, but was not 
disclosed or wrongfully disclosed, penalties could be  outside the patent system.  He said that a 
calibrated disclosure mechanism w ith adequate legal sanctions in cases of non-compliance was crucial 
to ensuring its effectiveness and de terrent effect.  In addition to revocation, he said that criminal 
and/or administrative sanctions might also apply through relevant legal procedures both within and 
outside the patent system. 
42. Turning to the definitions of the terms "bi opiracy" and "misappropriation", he said that 
"biopiracy" and "misappropriation" had been used va riously to refer to illegal and/or illegitimate acts 
with respect to the acquisition and use of genetic resources and traditional knowledge from 
developing countries.  He cited the definition of "p iracy" in Black's Law Dictionary as follows:  "The 
unauthorized and illegal re production or distribution of materials protected by copyright, patent, or 
trademark law".  He also quoted Eaton S. Dr one's understanding of piracy in his book entitled 
"A Treatise on the Law of Property in Intellectual Produc tions", as stating "The test of piracy [is] not 
whether the identical language, the same words, are used, but whethe r the substance of the production 
is unlawfully appropriated".  He said that the term "biopiracy" was in many ways similar to the term 
"piracy", and that just as the lack  of an agreed WTO definition on  the term "piracy" had not stopped 
Members from including the extensive enforcement provi sions into the TRIPS Agreement, the lack of 
definition of "biopiracy" should not be a preco ndition for the establishment of the disclosure 
requirements. 
43. Furthermore, he said that the proposed di sclosure requirements sought to prevent the 
application or grant of a patent for an inventi on, in which genetic resources and/or associated 
traditional knowledge were used without disclosure of the country of origin and source and without 
prior informed consent and equitable benefit sharing.   The requirements could ensure that contribution 
of all stakeholders to the invention were dul y acknowledged and reworded.  Genetic resources and 
traditional knowledge could be part of  a claimed invention, or a prerequisite for the development of an  IP/C/M/48 
 Page 11 
 
 
 invention, or material or information which facilita ted the development of an invention, or necessary 
background material or information for the development of an inventi on.  In addition, he questioned 
the actual deterrent effect of a system which did not provide for revocation as a possible sanction for 
failure of disclosure. 
44. In reply to the questions as to how to fulfil th e requirement for the disclosure of the country of 
origin and source and what was the relationship betw een this requirement and the FAO's International 
Treaty on Plant Genetic Resources for Food and Ag riculture, he said that the proposed disclosure 
requirement entailed the disclosure of both the countr y of origin and source which could be the same 
as or different from each other.  This requirement was in line with Article 15 of the CBD.  He noted 
the argument by some Members that the plant gene tic resources for food and agriculture covered by 
the multilateral system under the FAO's Treaty should constitute an exception to the proposed 
disclosure mechanism.  He said that his delegation was still open to considering ways to reflect these 
concerns in an eventual text. 
45. In response to Switzerland's question on the im plications of the disclosure requirements for 
the PCT and the Patent Law Treaty (PLT), he said that  the international patent system was made up of 
a number of treaties and instruments which built on each other and were generally meant to be 
complementary.  The discussion in the TRIPS Council was a discharge of the mandate given to Members under a WTO work programme.  The impl ementation of the disclosure requirements, once 
agreed and defined under the TRIPS Agreement, coul d facilitate actions elsewhere.  On the other 
hand, changes made elsewhere without the proposed  amendment to the TRIPS Agreement would not 
be sufficient to address either the mandate Member s had or the problems Members wished to address. 
46. Responding to the question on the role of patent o ffices, especially in determining the veracity 
of the information provided by patent applicants  relating to benefit-sharing and prior informed 
consent, he said that paragra phs 21 and 22 of document IP/C/W/443 had adequately addressed this 
question and that his delegation welcomed any textua l suggestions that provided more precision to the 
obligation of disclosure. 
47. The representative of India
 said that Switzerland's submission IP/C/W446 was a corollary to 
the original checklist of issues proposed by a gr oup of countries in document IP/C/W/420.  His 
delegation fully associated itself with the Braz ilian statement which had responded to the most 
important questions in the Swiss paper.  His dele gation would continue to examine the questions in 
the Swiss paper in its effort to deepen the technical work underway in the TRIPS Council to 
eventually adopt a solution to the problems of bi opiracy and misappropriation and to ensure equitable 
benefit sharing.  He supported the objectives outlin ed by Peru for work in the TRIPS Council going 
forward to the forthcoming Hong Kong Ministeria l Conference and said that his delegation would 
continue to work with Peru and other Members on the action proposed by Peru at all levels in the 
WTO. 
48. With regard to the US submission IP/C/W/449,  which responded to document IP/C/W/443, he 
said that it clarified some of the basic divergen ces between the perception of the United States with 
respect to the shared objectives and that of the majority of Members, including India and other 
co-sponsors of the papers on the disclosure issue.  Document IP/C/W/443 pointed out the anomalies 
in the contract-based approach suggested by the United States as a solution for the problems arising 
on account of biopiracy and misappropriation.  It  made progress on the shared objectives of the 
Members in examining the relationship between th e TRIPS Agreement and the CBD in accordance 
with the mandate given in paragraphs 12 and 19 of  the Doha Ministerial Declaration, which had not 
been appreciated in document IP/C/W/449.  While a few Members had stated that they did not see a 
conflict between the TRIPS Agreement and the CBD, they had remained open to discussing 
developing countries' proposals.  However, by referring to document IP/C/W/257 that had been 
submitted in June 2001, the United States had take n Members back to a stage before the Doha IP/C/M/48 
Page 12  
 
 Ministerial Conference.  He pointed out that docum ent IP/C/W/257 had missed a number of aspects of 
the obligations under the CBD, which had been clearly  identified in Part II of document IP/C/W/403. 
49. Commenting on the US argument that the CBD neither required nor even mentioned the 
disclosure requirements, he said that the CBD was not an intellectual property agreement and 
therefore did not create an obligation on the disclosure requirements.  However, Article 16.5 of the 
CBD obliged countries to cooperate to ensure that pa tents and other intellectual property rights did not 
run counter to the objectives of the CBD.  Furthe rmore, he said that although the United States had 
elaborated the positive steps it was taking to promot e two objectives of the CBD at the national level, 
none of this informed Members how these steps res ponded to their concerns relating to erroneously 
granted patents and transboundary implications.  His delegation,  on the other hand, had given 
examples in Part C of document IP/C/W/356 of  erroneously granted patents whose commercial 
exploitation went against the objectives of the CBD and also the arguments regarding unenforceability 
of national level access, prior informed consent a nd benefit-sharing regimes in respect of patents 
granted abroad.  
50. He said that his delegation was puzzled by  the US disagreement with the assertion in 
document IP/C/W/443 of the certainty established into  the patent system by the disclosure proposal.  
He said that the questions contained in footnot e 7 of document IP/C/W/434 amounted to a misreading 
of developing countries' proposals.  If a patent sh ould not have been granted in the first place, as 
happened in the cases of turmeric and neem patents,  the eventual revocation remedied the uncertainty 
of the existing patent system through a tortuous and costly route, particularly for developing 
countries.  The disclosure requirements remedied th is uncertainty.  He said that the concern about 
undue burden on patent applicants had been fu lly addressed in documents IP/C/W/429/Rev.1, 
IP/C/W/438 and IP/C/W/442.  The burden was to discl ose what was, or in any case should have been, 
known to him.  The disclosure requirements would only discourage applicants applying for erroneous 
patents.  The availability of information on the prior art would be an incentive to innovation and 
investment.  It would further ensu re that rewards of such innovation and investment, financial as well 
as intellectual, were shared equitably by a ll stakeholders leading to such innovation. 
51. Furthermore, he did not know the basis of the assertion in document IP/C/W/449 that 
erroneously granted patents were th e rare exception rather than the rule.  His delegation did not know 
the ratio of erroneously granted patents since, as a developing country, it did not have the capacity to 
go through the thousands of patents granted on inventi ons that used biological material and associated 
traditional knowledge and to  take the costly next steps to get them revoked.  The disclosure 
requirements addressed this inequity at its root. 
52. He said that Part IV of document IP/C/W/449 converged the US position, that international 
guidelines coupled with appropriate contract-based national laws containing dispute or enforcement 
provisions could address cross boundary issues, with th at of developing countries.  This showed that 
the United States shared the difficulties in having na tional laws alone as a solution to the problem as 
was pointed out in India's proposals, and admitted th at if only national systems were in place, many 
other steps were needed to be taken to meet th e shared objectives.  Further, the United States was 
recommending a theoretical national contract-based system with "an international outlook", that 
suggested use of different forums or international provisions dealing with practice of a State responsibility mandated in the TRIPS Agreement a nd the CBD.  He said that it was clear to his 
delegation that there was no need for different foru ms when Members had one in the WTO.  Further, 
there was no merit in relegating a State responsib ility issue to private international law through 
arbitration procedures that bound Members only when th ey agreed to them, particularly when there 
were equity issues that needed to be addressed.  The way forward,  therefore, was to introduce the 
disclosure requirements in the TRIPS Agreement in  order to deliver on Members' mandate in the 
WTO.  However, his delegation did not suggest that the action outside the WTO not complement the 
action within, but asked the TRIPS Council to address wh at was within its reach.  Further, he said that  IP/C/M/48 
 Page 13 
 
 
 it would be naive to suggest the Bonn Guidelines be a part of the solution while Decision VI/24 of the 
6th Conference of Parties of the CBD itself recognized the guidelines as a useful first step to an 
evolutionary process in the implementation of the CBD.  Regarding the work at the WIPO's IGC, 
which went beyond the remit of the TRIPS Council, he said that his delegation was not aware of any 
outcome or expected outcome which could replace the disclosure requirements as a solution. 
53. With regard to the US observation on its version of the widely shared objectives, he said that 
it started with twisting document IP/C/W/443 to estab lish the primacy of national regimes in meeting 
these objectives.  While recognizing their role , document IP/C/W/443 established that national 
regimes alone were inadequate to solve the proble m, unless accompanied by an internationally agreed 
disclosure provision in the patent system.  In response to the analogy of access and benefit-sharing 
regimes with the United States' health or safety regulations, he said that the case for reconciling trade 
agreements with such regulations had already been made in the WTO through the Agreement on 
Technical Barriers to Trade and the Agreement on the Application of Sanitary and Phytosanitary 
Measures.  Furthermore, he said that his delega tion was not aware of any national regulation in the 
United States where restrictions were placed on th e use of patent rights acquired erroneously, and 
much less on the use of patent rights acquired w ithout respecting the oblig ations under the CBD, 
except through costly revocation pro ceedings within the patent system. 
54. In reply to the US concern that the proposal in document IP/C/W/443 would destroy the 
benefit sharing being sought, he said that his group' s proposal had two components:  first, it did not 
promote the acquisition of patent rights on existing biological material or associated traditional 
knowledge, and intended to prevent monopolies so th at all who had access to  these materials and 
knowledge could serve the market place;  second, it en sured that where the use of such material or 
knowledge was a pre-requisite to ac quisition of patent rights, benefits from their commercialization 
should be equitably shared.  Three examples given in footnote 20 of the US paper supported India's 
proposal on the need for an international recogn ition of national regimes on prior informed consent 
and equitable benefit sharing. 
55. Contesting the US statement that information regarding the source and country of origin 
would not be relevant for determ ining novelty and inventiveness, he said that the turmeric and neem 
revocations bore testimony to such relevance and also to the costliness of such opposition 
proceedings.  He said that the US assertion that the requirement to disclose information material to 
patentability did not include the disclosure requireme nts as suggested by his delegation as it was not 
material to patentability, was contradicted by the f acts of the turmeric opposition.  The applicant for 
patent 5401504, on the filing date  (28 October 1996), had acknowle dged, but not disclosed the 
teaching about healing properties of turmeric.  The United States Patent and Trademark Office 
(USPTO) had not taken the next step of checking th ese teachings, and had granted a patent.  The same 
and more teachings had to be pr ovided in the opposition proceedings, and had become the basis of 
revocation on 21 April 1998 on the ground of lack of novelty and non-obviousness.  The information 
hidden by the applicant was material to the pate ntability and would have been provided by him had 
there been the disclosure requirement in the US patent system. 
56. He said that the US approach to the issue was not only misplaced and missed the point of the 
proposals by developing countries, but also ignored the development dimension of the discussion and urged developing countries to take unworkable, cost ly, burdensome and iniquitous routes to address 
the disclosure issue.  This not being an acceptabl e option for his and othe r delegations, he urged 
Members to continue the discussion with a view to  eventually agreeing to an outcome around the 
proposal made by India and other developing  countries. 
57. In response to the suggestion made by Cana da that Members would benefit from certain 
national experiences, he introduced two landmark cases in which bad patents had been successfully 
challenged.  The first case was the US patent 5401504,  which had been granted for use of  turmeric in IP/C/M/48 
Page 14  
 
 wound healing.  The patent disclosed the use of tu rmeric to enhance the healing process of chronic 
and acute wounds.  The claimed subject-matte r was the use of "turmeric powder and its 
administration" in oral as well as topical form for advancing wound healing.  The prior art indicated in the patent application referred to the traditional use of turmeric for healing various wounds and varied 
medicinal uses of turmeric in powde r form as well as a paste.  The scope of the patent was the use of 
turmeric at the site of an injury and/or its oral intake to enhance the healing of wounds.  The patentees 
claimed they had developed the invention based on the hypothesis that turmeric might have important 
antioxidant, antibacterial and anti-inflammatory properties when applied topically or given orally.  They claimed that they had offered an alternativ e to conventional therapy of using turmeric.  To 
buttress their claims, they described two experime nts and two case histories where the turmeric 
treatment was effective.  The ma in claim was rest ricted to "promoting healing of a wound through 
administration of an effective amount of turmeric" a nd the dependent claims we re restricted to ulcer 
or surgical wounds.  In short,  the patent appli cation claimed a new inven tion that was advancement 
over what was known about the healing effect of turm eric.  The prior art, as available on the date of 
filing (28 October 1996), was not fully indicated by th e applicant.  Nor did the USPTO try to find the 
state of the art on using turmeric for healing prop erties as on that date.  Thus, while the patent 
acknowledged some teaching about h ealing properties of turmeric, it was claimed that prior art 
disclosed only the use of ointments, paste, etc. 
58. In challenging this patent, the Government of India had made efforts to collect 32 references, 
including some that were more than one hundred year s old, that had given a clear picture of the prior 
art as on that date.  In other words, the traditional knowledge of turmeric, ev en in terms of printed 
publications and literature in other languages, was far more comprehensive an d advanced than what 
had been claimed in the patent.  In fact the comb ined teaching of these references was far ahead of 
what was claimed to be the invention in the patent ap plication itself.  All the claims were then rejected 
by the USPTO as they were obvious in light of the c itations provided.  The patentee had tried to argue 
that powder and paste had different physical properties, but the examiner had not accepted the 
contentions of the patentee and the rejection was ma de final.  Subsequently the patentee tried to 
restrict the invention to ‘non-healing surgical wounds’ based on the two case histories and wanted the amended claim to be allowed.  The examiner had rejected all claims including the amended ones and 
pointed out that using turmeric for healing of su rgical wounds was an old technique.  With the re-
examination certificate issued on 21 April 1998, the matter came to an end as all claims of the turmeric patent stood rejected.  The representative of  India believed that in the absence of a uniform 
and coherent approach to prior art across countri es, the disclosure requirements alone could ensure 
that patents like the one granted on wound heali ng properties of turmeric were not granted. 
59. The second case was the patent on insecticidal pr operties of neem oil.  In March 2005, the 
Boards of Appeal of the European Patent Offi ce had upheld the decision taken in 2000 to revoke a 
patent granted to W.R. Grace and the US Department  of Agriculture on a method for controlling fungi 
on plants by the aid of a hydrophobic extracted neem oil (patent number EP0436257).  The patent had 
been revoked since the claims were not novel in view of the public prior use, which had taken place in 
India.  Neem (Azadirachta indica), also known as Indi an lilac, was native to India, but was also found 
elsewhere and had multiple uses in many cultures.  In  India, neem had been used for various purposes 
and extracts from the plant had been used as pesticid es, medicine and fertilizer.  Fungicidal effect of 
hydrophobic extracts of neem seeds had been known and used for centuries on a wide scale in India 
both in traditional Indian systems of medicine to cure dermatological diseases and in traditional 
Indian agricultural practices to protect crops agains t fungal infections.  Since this traditional Indian 
knowledge had been in public use for centuries, it w ould seem that the patent application in question 
lacked two basic statutory requirements for the gran t of patent, namely, novelty and inventive step.  
The process of revocation of the neem patent ha d been brought to a conclusion by the EPO one 
decade after it had been first challenged, giving an  opportunity to the patent holder to retain his 
exclusive right on an unpatentable material for su ch a long period.  The revocation had been made  IP/C/M/48 
 Page 15 
 
 
 possible with the resources garnered by two non-gove rnmental organizations and one member of the 
European Parliament. 
60. He said that although misappropriation of tr aditional knowledge through the grant of bad 
patents was a well-acknowledged problem, challenges for the revocation of these patents had been 
made only in very few cases.  In the two above -mentioned cases, the challenges could be sustained 
owing to the engagement of the government in the first case and a consortium of non-governmental 
organizations in the second case.  It was quite evid ent therefore that some patents were granted 
without an adequately detailed ex amination and the process of ex amination could be strengthened 
through the introduction of the disclosure requireme nts.  The disclosure requirements alone would 
provide an effective solution to the problem of misappropriation. 
61. The representative of Thailand  said that his delegation attached importance to this issue and 
that biopiracy problems could not be solved without pressing for an international mandatory obligation by amending the TRIPS Agreement.  Re cognizing the need for the WTO Members to 
pursue their consultations and negotiations acco rding to the objective outlined in document 
IP/C/W/447, he said that these important issues should be included in the July outcome and WTO 
Members should be able to find a solution to th is issue at the Hong Kong Ministerial Conference 
according to the mandate given at Doha. 
62. The representative of the European Communities
 recalled that, at the Council's March 
meeting, his delegation had presented an outline of th e EC proposal on disclosure of origin or source 
of genetic resources and associated traditional knowle dge in patent applications.  He informed the 
Council that the proposal had been formally presen ted to WIPO in document WIPO/GRTKF/IC/8/11 
at the eighth Session of WIPO's IGC.  The European Communities considered that a binding 
disclosure requirement should be introduced and this should be applied to all patent applications.  In other words, the disclosure requirement should be implemented in a legally binding and universal manner.  He said that his delegation remained fully committed to the ongoing work on this issue in WIPO and was ready to move forwar d and have a focused discussion on this issue in 
the WTO in accordance with the manda te given by the Ministers at Doha. 
63. Commenting on document IP/C/W/442, he said that his delegation saw some serious 
problems with the introduction of a system wherei n patent applicants were required to provide 
evidence of fair and equitable benefit sharing a nd wherein patent offices were to judge whether a 
foreign country's legislation on access and benefit shar ing had been complied with.  It was the country 
of origin and/or a court of law or an arbitrator who could judge whether benefit sharing had been fair 
and equitable.  It seemed difficult fo r patent offices to carry out this task in practice.  It was unclear 
to his delegation what role pate nt offices should play and what documentation patent applicants 
should provide.  He wondered wh ether it was the patent applican ts who should provide documents 
on the origin of genetic resources, evidence of prior informed consent and evidence of benefit 
sharing and/or mutually agreed terms.  He noted that in cases where there were no national regimes, 
and as far as his delegation knew many countries were  in this position, patent applicants would face 
legal uncertainty in the country of origin and potential bio-prospectors would have to give up their activities since it would be impossi ble for them to fulfil the di sclosure requirements of prior 
informed consent and benefit shar ing when applying for a patent. 
64. Regarding the legal effect of not providing eviden ce of fair and equitable benefit sharing, his 
delegation was not in favour of revo cation of patents.  He said that the only way to make the system 
work would be to have national authorities deliver an internationally recognized certificate which 
would provide evidence of the origin, prior informed consent and benefit sharing in one document.  Since the negotiation on benefit sharing was at an early stage in the framework of the CBD, it was 
difficult, if not impossible, fo r patent offices to assess sufficiency of the documents presented to IP/C/M/48 
Page 16  
 
 them on the basis of relevant national laws.  Therefore, his delegation was not in a position to 
support the developing countries' proposal on disclosure of evidence of benefit sharing.   
65. Turning to Switzerland's submission IP/C/W/446, he said that his delegation was interested in 
the developing countries' responses to the list of ques tions in the submission, especially to question 10 
as to how prior informed consent could be obtai ned when the countries concerned did not have a 
national, transparent and consultative process in place.  The questions on the US proposal seemed to 
go to the heart of the matter, which was that whil e developing countries were seeking an instrument 
for the enforcement of their legitim ate national legislations across different jurisdictions, the US 
approach did not seem to respond to this need despit e the fact that the United States had agreed at 
the World Summit on Sustainable Development (WSSD) to the negotiation of an international 
regime on access and benefit sharing under the CBD.   He indicated that the European Communities 
recognized the concerns of developing countries and wanted practical and realistic tools which were satisfactory to all Members. 
66. Responding to Switzerland's questions on the EC proposal, he said that various options could 
be considered regarding the amendment to th e PCT and PLT, including the ones mentioned by 
Switzerland in its proposal to WIPO.  The Europ ean Communities had used the concept of "country 
of origin" found in Article 2 of the CBD which defined it as "the country which possesses those 
genetic resources in in-situ  conditions".  He recognized that this did not reflect the wider concept of 
"country providing the genetic resources" as mentioned in Article 15 of the CBD and said that in practice the concept of "country providing the ge netic resources" included the country which was or 
was not the country of origin.  Taking this into account, the European Communities had proposed 
that when the country of origin  was not known, it be possible to provide the "source" which could 
include the "country providing the genetic resource s".  The EC focus on th e country of origin was 
logical as benefit sharing should, whenever poss ible, first of all accrue to the country which 
possessed the genetic resources in situ  under its sovereign rights.  He further clarified that it was 
patent applicants who should judge whether the country of origin was known to them or not. 
67. The representative of Nigeria
 recalled that the African Gr oup had submitted several proposals 
on the three issues and expressed their concerns, such as the need to clarify the issue of patentability 
of live forms, the need to protect farmers' rights to seeds, genetic resources, traditional knowledge and 
traditional practices in developing countries, and th e need to provide for obligations that required 
Members to prohibit and prevent misappropriation of genetic resources and traditional knowledge.  
He thought that all these could be done through the requirement for disclosure of source of genetic 
resources and traditional knowledge a nd a demonstration of compliance w ith applicable regulations of 
the country of origin.  As a way of taking forward the process, the African Group was working on responses to the questions raised on its earlier s ubmission IP/C/W/404.  The Group believed that the 
way forward of making the Doha Development Agenda a reality was to address the concerns raised in 
its proposal. 
68. The representative of Korea
 said that there was little possibility of conflict between the 
TRIPS Agreement and the CBD and the two instru ments could be implemented in a mutually 
supportive manner.  He said that his delegation was carefully studying the various suggestions to 
address the problem of biopiracy, but it was not clear  whether the solution should be found primarily 
in the patent system.  He said that introduci ng the disclosure requirements as a condition for granting 
patents might impose undue burden on both patent app licants and patent authorities.  His delegation 
was particularly concerned about the implications of  denial or revocation of patents on the grounds of 
non-compliance with the disclosure requirements.  However, his delegation remained open to any 
suggestions to address the biopiracy problem and looked forward to continued constructive 
discussions not only in the TRIPS Council, but also in other international forums such as the WIPO.  IP/C/M/48 
 Page 17 
 
 
 69. The representative of Canada  said that his delegation recognized the importance of preventing 
biopiracy and misappropriation of genetic resources and traditional know ledge, as well as of promoting 
a balanced patent system that benefited both patent  applicants and the public interest.  By improving the 
quality of patents granted and having common standa rds for patentability, the patent system could 
become more transparent and accessible to all segments of society.  A balanced approach encompassing 
existing flexibilities allowed for efficient functioning of a modern patent system.  He said that there 
seemed to be a convergence of views on this.  His de legation looked for technical expertise, as found in 
the WIPO, to advance work in this area. 
70. He said that it remained to be determined by Members whether patent disclosure would 
necessarily contribute to ensuring prior informed consent and equitable benefit sharing.  His 
delegation had closely followed the discussion from the beginning and carefull y reviewed all proposals 
submitted on this issue and believed that each pr oposal might have some merit while raising some 
concerns.  His delegation joined other Members who had expressed the wish to learn more about the 
effectiveness of the disclo sure mechanisms in countri es already having such procedures and alternative 
modes to achieve efficient access and benefit sharing. 
71. He recalled that, at a previous meeting of th e Council, his delegation had asked those who had 
proposed solutions to submit facts and evidence indicating how their respective proposals on the 
disclosure requirements would have been addressed or remedied those real world situations if their proposals had been in place at the time.  His delega tion continued to believe that this would provide 
the Council with valuable and fact-based insights in to how best to respond to common concerns about 
misappropriation.  As part of this effort, Canada  had begun work on the possible positive and negative 
implications of disclosure for us ers and providers of ge netic resources, incl uding patent offices, 
researchers, industry, local citizens , and civil society, etc.  He info rmed the Council that the issue of 
disclosure would be among a number of key issues to be discussed at a forthcoming domestic workshop 
that would engage stakeholders and experts in Canada on the broa d set of genetic resources and 
intellectual property issues. 
72. He said that his delegation agreed with some Members, such as Brazil, India and the United 
States, that the introduction of uncertainties and imbalances into the patent system would be 
detrimental to technological progress.  Members need ed to consider whether any solutions retained 
could create administrative and financial burdens for pa tent offices and researchers.  In evaluating the 
actual impact of the aforementioned burdens, it see med of importance to determine approximately 
how many patent applications per year could invol ve patent disclosure rega rding genetic resources 
and/or associated traditional knowledge, if such an obligation were to be introduced.  This would 
allow the impact of any disclosure regime to be a ppropriately assessed given each country's situation. 
73. Noting the contribution of Peru in document IP/C /W/447, he said that considering the lack of 
consensus among the WTO Members regarding the pr oposed obligation of disclosure of genetic 
resources and/or traditional knowledge, his delegatio n believed that it was premature for Canada to 
discuss any proposal that would suggest particular  wording of eventual amendments to the TRIPS 
Agreement. 
74. He informed the Council that Canada was activ ely supporting further research and analysis on 
the issue of the misappropriation of genetic resource s through an informal consortium of international 
organizations, which sought, through case studies a nd interviews with national authorities, a better 
and objective articulation of the issue.  In the re gard, his delegation shared many of the questions 
raised by Switzerland in its document IP/C/W/446.  His delegation t hought that it was not possible to 
come to an agreement without first clarifying many of these questions, such as what the extent of the 
burden was, and what the obligatio n would be in the case of plants that existed transnationally.  
Finally, he sought a clarification on Brazil's definiti on of the term "biopiracy" as to whether it implied 
Brazil's intention to limit the proposed rights only to developing countries. IP/C/M/48 
Page 18  
 
 75. The representative of Japan
 said that there was no conflict between the TRIPS Agreement and 
the CBD and that the two agreements co-existed in  a mutually supportive manner.  Therefore, there 
was no need to amend the TRIPS Agreement and the objectives of the CBD could be implemented by establishing national systems.  He said that, in or der to have a sound, operative and certain patent 
system, patent offices needed an explanation wh y the source or origin of genetic resources, 
evidence of prior informed  consent or evidence of benefit shar ing should be disclosed in patent 
applications.  At this stage of the discussions, it  was not relevant whether or not such information 
was known or should have been known to patent applicants.  Even without the disclosure of such information, patent examiners could still under stand and examine inventions and judge their 
patentability.  The disclosure of evidence of prior informed consent or benefit sharing would be a 
disincentive to patents applicants because such in formation could be kept secret and not disclosed.  
He also said that the discussion on the disclosure requirements should be mainly conducted in the WIPO's IGC where the participants had appropriate knowledge and the duplication of work should be 
avoided. 
76. Commenting on the US submission IP/C/W/449, he said that his delegation supported its 
general direction.  As suggested by the United States, Members should not forget that the CBD itself 
did not require to amend the patent system.  If th e purpose in disclosing source or origin, evidence of 
prior informed consent and evidence of benefit shar ing were to prevent bad patents, Members should 
establish a comprehensive database or introduce a mechanism for the third parties to be involved 
easily in the process of patenting, including through post-grant opposition.  He also said that, in order 
to pursue the objectives of the CBD, Members should fi rst consider the mechanism in the context of 
the CBD.  He encouraged those who had implem ented some national systems or programmes to 
achieve the objectives of the CBD to provi de information on this to the Council. 
77. Turning to Peru's submission IP/C/W/441, he said that it referred to several Japanese patent 
applications whose subject-matter allegedly used bi ological resources originating in Peru.  He noted 
that this document was one of the efforts which Peru  had made to identify possible cases of biopiracy.  
After a preliminary check of these Japanese patent a pplications, he said that there seemed not to be 
any biopiracy as the genetic resources referred to in  the document were widely cultivated worldwide, 
including in Japan. 
78. The representative of New Zealand
 said that his delegation was open to considering the idea 
that the disclosure requirements might have a role  in supporting the objectives of the CBD and 
furthering the objectives of Articles 7 and 8 of the TRIPS Agreement.  Regarding Switzerland's 
submission IP/C/W/446, he said that his delegati on supported efforts to clarify certain aspects of 
Members' concerns.  The paper identified a number of important issues on definitions of certain key 
terms, such as "country of origin" and "genetic r esources".  His delegation was of the view that the 
CBD and the TRIPS Agreement could be implemented in a mutually supportive manner and that the 
questions raised by Switzerland highlighted the importance of keeping firmly in mind the consistency 
between these two international obligations. 
79. Turing to the US paper IP/C/W449, he said that the paper highlighted the points of 
convergence and divergence among Members.  The debate in the Council reflected a growing 
consensus that any role played by the internati onal intellectual property system would be a supporting 
role.  In other words, it was national systems rather  than the international intellectual property system 
which should be the primary mechanism for delivering the objectives of the CBD.  The question was 
whether the international intellectual property syst em should have a supporting role and if so, what 
shape it should take.  The US paper identified a key divergence as to whether the patent system should 
be justified as a means of supporting national access and benefit-sharing systems.  He noted that 
paragraph 17 of the US paper referred to Ne w Zealand as a Member that had acknowledged the 
possible role of the disclosure of country of orig in and/or source in monitoring the use of genetic 
resources.  He said that New Zealand's views on this issue were not fixed.  His delegation was  IP/C/M/48 
 Page 19 
 
 
 conscious of the obligations under the CBD and thought that the intellectual property system might 
play a supporting role to national systems designed to achieve the objectives of the CBD.  He stressed 
that effective and well-enforced national access and benefit-sharing regi mes were of primary 
importance in dealing with the issue of misappr opriation and that without national regimes the 
intellectual property system alone could not play even a supporting role.  He therefore supported a 
fact-based approach to consider existing natio nal regimes as suggested by the United States, 
Switzerland and Canada. 
80. In conclusion, he said that his delegation was interested in Members' national experiences on 
how patent applications involving access of gene tic resources had been examined and how the 
existing disclosure requirements had operated in pr actice.  These experiences would help the Council 
develop a closer understanding of the size and natu re of the overall problem so as to consider an 
appropriate solution.  His delegation was also inte rested in knowing more about the contract-based 
approach presented by the United States, in particular its intern ational dimension. 
81. The representative of Norway  informed the Council that the Norwegian Patent Act had 
been amended in 2004 in order to further the objectives of the CBD.  The amendment had been 
notified to the TRIPS Council.  Under the new provi sions, patent applications concerning biological 
materials shall include information on the country of  origin.  Should the national legislation of the 
providing country so require, information on whethe r prior informed consent had been given shall 
also be submitted.  However, these provisions did not  apply to international pa tent applications.  The 
obligation to provide information sh all be without prejudice to the processing of patent applications.  
Nevertheless, a failure to provide  correct information was liable to a penalty in accordance with 
Section 166 of the General Civil Panel Code, which concerned giving false testimony in writing to a 
public authority.  She further informed the Council that the Norwegian policy on this issue was being 
reviewed and she would submit definitive views a nd national experiences when the internal review 
was completed. 
82. The representative of Malaysia  said that her delegation was inte rested in the questions raised 
by Switzerland in its paper IP/C/W/446 and answers to these questions.  She raised a further question 
to the group of developing countries whether th ere would be any possible conflict between the 
country of origin and source.  In other words, if patent applications disclosed the source, but not the 
country of origin, whether the latter could claim benefit sharing and how the possible conflict could 
be resolved.  In addition, she asked who would be  qualified to determine fa ir and equitable benefit 
sharing, how the authorities would determine that the benefit-sharing was fair and equitable, and 
whether a mutually agreed benefit-sharing agreemen t would be a more appropriate way to proceed on 
this issue.  Referring to Peru's proposal for an amendment to Article 29.1 of the TRIPS Agreement, 
she sought to clarify whether this proposal repr esented Peru's position on the disclosure requirements 
and whether the nature of the proposed disclosure requirements was mandatory or not.  She also 
sought a clarification from the US delegation on how contractual systems could work as a link 
between the TRIPS Agreement and the CBD. 
83. The representative of Bolivia  said that her delegation shared the views expressed by Peru in 
its submission IP/C/W/447.  She said that the issue of  disclosure of origin was a priority and should be 
included in the July meeting and in the Hong Kong decl aration at the end of this year.  Her delegation 
would like to pursue consultations in order to achie ve this goal.  She also supported the statements 
made by Brazil and India that some Members did not have resources to request the revocation of 
patents from misappropriation under current intell ectual property systems or other proposals which 
did not consider their concerns.  She hoped the deadlines cited by India would be taken into consideration by the Council. 
84. The representative of Australia
 said that the issue of relationship between the TRIPS 
Agreement and the CBD was of key importance to hi s delegation, which had been doing a lot of work IP/C/M/48 
Page 20  
 
 at the national level in recent years.  As one of the world's mega bio-diverse countries with a strong 
intellectual property system and commitment to an  innovative bio-technology sector, his delegation 
could contribute to the discussion on this issue in the TRIPS Council.  In the view of his delegation, 
the starting point was that there was no problem in the relationship between the TRIPS Agreement 
and the CBD and even if there were to be problems identified, it was not necessarily the case that the 
answers lay only in the patent system.  However, he  indicated that his delegation was not closed to a 
discussion of this issue. 
85. He said that Switzerland's submission IP/C/W /446 had brought out some helpful questions, 
some of which were similar to the ones raised by his delegation at the previous TRIPS Council 
meeting, such as questions 5 and 9 regarding the im plications of the disclosure requirements for both 
patent applicants and intellectual property offices.  It  was clear to his delegation that greater clarity on 
these definitional issues would assist the Council in ta king the issue forward and his delegation looked 
forward to further discussion with the proponents of th ese issues.  Turning to the cost implications of 
the proposals on the table, which had been raised by Australia and the United States, he said that it 
was an important issue and a discussion on it could not be avoided. 
86. He said that his delegation shared the view of  the United States that there was no conflict 
between the TRIPS Agreement and the CBD, and that  there was no crisis in the existing patent 
system.  However, this did not mean that the patent  system could not be made to work better and that 
a discussion of concerns raised, particularly by developing countries, was not warranted.  He asked 
for more factual illustrations from the United Stat es on how post-grant opposition and re-examination 
proceedings helped to avoid erroneously granted patents. 
87. As regards Peru's paper IP/C/W/447, he took no te of the proposals for the international and 
regional negotiating agenda contained in Section VII of the paper.  He said that the paper provided 
Members with factual information and that his dele gation would support the continuation of this fact-
based approach.  He indicated that while the em phasis in the paper was on the three major patent 
offices, Members should remain mindful of the imp acts that any proposals might have on all patent 
offices. 
88. Responding to Canada's question,  the representative of Brazil
 said that his delegation and 
other developing countries, who were the propone nts of the disclosure requirements, had never 
suggested that only genetic resources found in de veloping countries be covered by the proposed 
disclosure mechanism.  He had indicated that mo st existing biodiversity was found in developing 
countries and thus developing countries had been th e main victims of biopiracy.  In the same way, 
although the words "biopiracy" and "misappropriation" had been used in the past to refer to illegal 
acts that had victimized developing countries, this was meant to be a definition of the term "biopiracy", but merely as a statement of fact.  He said that it was never his delegation's intention to 
suggest that only developing countries would or  should benefit from the disclosure mechanism. 
89. The representative of Chinese Taipei
 said that, before the Council could decide on a solution 
to the three issues, it was most important for Memb ers to clarify how to resolve practical problems 
present in the proposals on the table.  In this re gard, her delegation generally shared the views 
presented by Switzerland in its paper IP/C/W/446.  In order to further understand the disclosure 
requirements, she said that the first step should be to  clarify the scope of the country of origin and the 
source.  In her view, the demandeurs  of the disclosure requirements had not yet come up with 
concrete and workable definitions  and terminologies.  For example, what should be disclosed by 
patent applicants if the genetic resources could be legally purchased in the market of several 
countries.  As a second step, she said that more attention should be devoted to the relationship 
between genetic resources and inventions.  Sin ce resources and knowledge were multifarious and 
patent applications were sometimes comprised of di fferent raw materials, certain terms used, such as 
"derived from", "used in" and "best in", had specifi c legal implications in terms of the scope of  IP/C/M/48 
 Page 21 
 
 
 disclosure.  In conclusion, she emphasized the importance of establishing a balance between the 
prevention of biopiracy and the development of technology. 
90. The representative of Peru  agreed with the statements made by the delegations of Brazil and 
India regarding the need to amend the TRIPS Agreem ent.  He said that it was clear to his delegation 
that there was a convergence of opinions among the ma jority of Members on the need to include the 
disclosure of origin in the TRIPS Agreement and that the contract-based approach proposed by the 
United States had not received any support.  He urged the delegations of Australia, Canada and 
New Zealand, which were still in the process of exam ination and consultation on this issue, to review 
Peru's experience and to take into account the co sts and benefits for both the private sector and 
indigenous communities and peoples. 
91. Regarding the argument that WIPO's IGC would be  the most appropriate forum to tackle this 
issue, he said that the Council had the same exper tise as the IGC in terms of delegations.  The last 
IGC meeting had ended up with a weak declarati on on the possibility of continuing its work and the 
future of the IGC would not be decided until the WI PO General Assembly in September 2005.  On the 
other hand, WTO Members had a clear mandate to ne gotiate this issue in a ccordance with the Doha 
Declaration. 
92. With respect to the relationship between th e TRIPS Agreement and the CBD, some Members 
believed that the agreements were complementary and could be implemented in a mutually supportive 
way.  He said that, based on its observation of  the negotiations of the Convention on Cultural 
Diversity in UNESCO, his delega tion apprehended that the terms "complementary" or "mutually 
supportive" could have the effect of making two agre ements neutral to each other and this should not 
be allowed to happen in the Council.   He reiterated that although some  countries had been seeking to 
implement the CBD in their national or regional legislation, this was not enough unless there was an effective change in the patent system, that is , an amendment to Articles 27 and 29 of the TRIPS 
Agreement. 
93. Responding to Malaysia's question on the nature of the proposed disclosure requirements, he 
said that they should be mandatory at the internationa l level.  Regarding the definitions of "biopiracy" 
and "misappropriation", he said that although ther e was no universal definition, Peru's Law on 
Protection of Access to Peruvian Biological Dive rsity and to the Collective Knowledge of the 
Indigenous Peoples (Law No. 2821 6) defined biopiracy as "unauthorized access to and use of 
biological resources or traditional knowledge of the indigenous peoples by third parties without 
compensation and without necessary authorization, an d in contravention of the principles established 
in the Convention on Biological Diversity and the existing rules on the subject.  Such appropriation 
may occur in the course of physical inspection, through ownership rights in products incorporating 
such illegally obtained elements or, in some cases, through the invocation of such rights".  
"Misappropriation" had more ge neral meaning in Spanish ( apropiación indebida – "improper 
appropriation"), including the exercise of others' ri ghts.  On a website at www.biopirateria.org there 
was another definition according to which it was "illegal or unauthorized access to and use of 
biodiversity components (mainly genetic and bi ological resources) and associated traditional 
knowledge, as part of development and research processes and application of biotechnology.  It is also 
associated to innovations protected by intellectual property rights (especially patents) and that incorporate these components or indigenous knowledge  obtained direct or indirectly without prior 
consent of or authorization from their owners". 
94. Commenting on paragraph 9 of document IP/C/W /449, which noted Peru's concern on the 
legitimacy of the patent system, he clarified that th e exact words used by his delegation were "it must 
be borne in mind that the legitimacy of the IP syst em is in dispute, and that will remain the case as 
long as bad patents continue to be granted and the system continues to be used to legitimize unjust 
and unfair situations".  He said that the Peruvian Government advocated the protection of intellectual IP/C/M/48 
Page 22  
 
 property rights and sought to promote innova tion and creation throughout the country.  The 
Government also devoted large amounts of money to combating biopiracy.  He thought that an 
appropriate intellectual property system should protect  the interests of both intellectual property right 
holders and the owners of genetic resources and traditional knowledge.  Thus, his delegation had 
never doubted the legitimacy of the patent system, bu t questioned how to make the system more fair 
in cases of access to genetic re courses and traditional knowledge.  He urged the United States to 
present its national experiences regarding the prom otion of prior informed consent and benefit 
sharing. 
95. The representative of the United States
 said that the US submission focused on Members' 
mandate of examining the relati onship between the TRIPS Agreemen t and CBD, responded to various 
claims and proposals put forward by Members and attempted to identify the areas of agreement and 
disagreement among Members.  The document full y explained concrete proposals that addressed 
concerns raised by Members without the negative effects on the patent system and benefit sharing 
inherent in the proposed disclosure requirements.   He looked forward to further discussion on 
Members' national experiences and the US pate nt system at the Council's next meeting. 
96. The representative of Colombia  said that his delegation was still examining the proposal for 
the amendment to the TRIPS Agreement.  He urged the United States to further explain and illustrate 
its experience on the prevention of illegitimate us e of genetic resources and traditional knowledge 
through a contract-based system. 
97. The representative of India  said that the mandate in paragraph 12 of the Doha Declaration 
referred to outstanding implementation issues whic h were contained in JO B(01)152/Rev.1 and that 
there were a number of proposals relating to the disclosure requirements in paragraph 10 of that 
document.  Responding to EC concerns on the role  of patent offices, evidence of prior informed 
access and benefit sharing, he said that documents  IP/C/W/429/Rev.l, IP/C/W/438 and IP/C/W/442 
had addressed these concerns and that the Counc il's work could proceed, irrespective of the 
development of  "certificate of origin" or national regimes.  The three documents indicated that the 
burden on patent applicants would be minimal.  In  reply to Canada's concern on the implications of 
the proposed disclosure requirements, he said that  some regions and countries had been seeking to 
implement these requirements, such as the ANDE AN Communities, the Organization of African 
Unity, Brazil, Costa Rica, India, the Philippines, Belgium, and Norway.  In response to Japan's 
statement that source of origin was not important for patentability and that disclosure requirements 
would be a disincentive to patent applicants, he  said that the patent system should establish an 
inherent balance between inventors' disclosure ob ligation and their exclusive patent rights.  The 
disclosure was necessary for patent examiners to determine patentability of an invention and for a 
person skilled in the art to carry out the invention.   Responding to Malaysia's question as to how the 
disclosure system would operate, he  said that there would be no pr esumption of a conflict between the 
country of origin and the source and that benefit sharing would be a matter to be addressed primarily 
by national laws in providing  countries.  Na tional authorities implementing such laws would 
determine what was equitable and fair in accordance  with the CBD.  He informed the Council that a 
New Delhi Ministerial Declaration of Like Minded Mega-Diverse Countries on Access and Benefit Sharing had been agreed on 21 January 2005 and the objectives of the proposed  international regime 
were contained in paragraph 3 of the Annex to this  Declaration.  Regarding Chinese Taipei's concerns 
on legally purchased resources, he confirmed that any material or knowledge that was obtained in 
compliance with national regimes on prior informed  consent and benefit sharing were legitimate 
under the proposed disclosure system. 
98. The Council took note
 of the statements made and agreed  to revert to these three agenda items 
at its next meeting.  IP/C/M/48 
 Page 23 
 
 
 F. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 
99. No statements were made under this  agenda item.  The Council agreed  to revert to the matter 
at it's next meeting. 
G. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
100. The Chairman  recalled that Article 24.2 provided th at the Council should keep under review 
the application of the provisions of the geogr aphical indications section of the Agreement. 
101. The representative of Australia  said that his delegation regarded the review under Article 24.2 
as a useful process that allowed Members to ex amine the ways in which other Members had 
implemented their TRIPS obligations and this was pa rticularly important in an area as complex as 
GIs.  It was against this background that his dele gation wished to draw Members' attention to the 
outcome of the dispute in which Australia had challenged the EC regime for protecting GIs for 
agricultural products and foodstuffs and that had been adopted by the DSB on 20 April 2005. 
102. The panel's report had confirmed that the EC regime was inconsistent with the European 
Communities' existing WTO obligations and Australia c onsidered that this fact needed to be properly 
noted and recorded in the context of the Article  24.2 review.  Although the European Communities 
claimed that the system put in place by the TRI PS Agreement was, among other things, insufficient 
and discriminatory, it was the European Comm unities' own system for implementing its GI 
obligations which had been shown to be insufficien t and discriminatory and thus in breach of the its 
fundamental WTO obligations to treat imported pr oducts and foreign nationals no less favourably 
than it treated its own products and nationals. 
103. Although it was at the European Communities' discretion how it would implement the panel's 
findings, it could be expected that it would have to  amend its legislation and, as was evident from the 
period of almost a year until the 3 April 2006 that it had requested to make th e necessary changes, this 
would clearly take some time.  The fact that th e Member with the most advanced system for the 
recognition and protection of GIs in the world needed one year to bring its system into conformity 
with a basic WTO principle such as national treatment raised serious concerns about how long it 
would take Members to implement the types of oblig ations that were being proposed by the European 
Communities in the context of the negotiations on the wines and spirits register.  Her delegation 
would return to this issue in the Special Session of the TRIPS Council. 
104. The representative of the European Communities  said that the panel had to the largest extent 
possible vindicated the EC approach to GIs, particul arly as regards the relationship with trademarks.  
The panel had also identified a number of areas in which the EC legislation needed clarification 
regarding the need to treat foreign applications fo r GI registration in the same manner as applications 
that came from or related to GIs whose area of produc tion was within the EC territory.  The fact that 
the European Communities had recently  received the first application for registration of a GI relating 
to an area outside the European Union, "Colombian  Coffee",  gave it an opportunity to demonstrate in 
practice that foreign applications would be pro cessed and reviewed under the same conditions as any 
EC application without being subject to a verificati on of the conditions of reciprocity and equivalence, 
as the European Communities had already argued duri ng the panel proceedings.  This would show for 
the record that the EC system w as indeed the most advanced and probably the most robust system and 
was certainly equipped to handle non-EU GIs. 
105. The representative of the United States  said that the DSB's recommendations and rulings in 
the GI case were instructive in two senses.  Firs t, they helped clarify Members' current TRIPS 
Agreement obligations with respect to GIs, part icularly as concerned national treatment and the IP/C/M/48 
Page 24  
 
 obligation to respect the rights of trademark owne rs.  Secondly, the recommendations and rulings 
called into question the need for or the wisdom of  new disciplines with respect to GIs.  If even 
developed country Members with a long history of  GI protection had difficulty implementing their 
current obligations, Members had to ask themselve s about the consequences and risks of taking on 
additional obligations.  These recommendations and ruli ngs further suggested that to the extent that 
there were problems with the protection of GIs, th ese problems might be the result not of insufficient 
disciplines, but of insufficient implementation of those disciplines. 
106. The representative of Colombia
 thanked the European Communities for the reference to 
Colombian Coffee and said that the Colombian coffee producers had decided to request the registration of this GI in the European Commun ities on the basis of an assessment of this brand's 
prospects in the European market.  His delegation would be awaiting results and following the process 
carefully. 
107. The representative of Australia
 said she had wanted to underline that the very advanced 
system of GI protection in the European Commun ities was not WTO consistent.  She said that the 
Colombian Coffee trademark was protected in Australia and was owned by the same Colombian 
authorities that had been referred to. 
108. The Council took note  of the statements made and agreed  to revert to this matter at its next 
meeting. 
H. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE 
TRIPS  AGREEMENT AND PUBLIC HEALTH  
109. The Chairman  informed delegations that, as had be en agreed at the Council's open-ended 
informal meeting on 23 May, he had reported to th e General Council, at its meeting on 26 May, that 
the preparation of an amendment to the TRIPS Ag reement pursuant to paragraph 11 of the General 
Council decision on the "Implementation of Paragr aph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health" (hereinafter referre d to as "the Decision") continued to be actively 
under consideration in the TRIPS Council.  Howeve r, more time was necessary before the Council 
was in a position to make a recommendation, and that the Council would revert to this matter at its 
present meeting. 
110. He recalled that, at the open-ended consultation of  23 May, he had shared with delegations his 
assessment of the situation regarding the preparation of an amendment in the light of the consultations 
he had held.  At that time, there had not been a great deal of discussion about how to find a way forward and some delegations had indicated that they wished to reflect further before reacting.  Since 
then, he had continued his consulta tions in various formats on this matter.  However, they had not 
yielded any new thinking for him to share with dele gations.  Some African delegations had referred to 
the Declaration adopted by the African Union Conf erence of Trade Ministers in Cairo the previous 
week, which called for "urgent attention" to be gi ven to the amendment of the TRIPS Agreement to 
incorporate the Decision.  These delegations had expressed the hope that the Council could complete 
its work on the amendment before the summer break. 
111. He had not detected any objection to his sugges tion that he continue his consultations on this 
matter with a view to agreeing on a recommendati on as soon as possible, having regard to the hope 
expressed by some delegations that this be done before the summer break.  He added that, however, 
he needed the active cooperation and flexibility of  all delegations for this to be possible. 
112. The representative of Canada
 said that his delegation had moved quickly to introduce 
domestic legislation implementing the Decision.  National legislation had come into force on 
14 May 2005.  The delay between the adoption of the legislation and its coming into force had partly  IP/C/M/48 
 Page 25 
 
 
 been due to the fact that accompanying regulations  had had to be drafted, which had involved a public 
consultation process.  The implementation of the Decision in Canada had required amendments to both the Patent Act and the Food and Drugs Act, a nd to their corresponding regulations.  Although no 
consolidated versions of the am ended Acts had been published ye t, his delegation had decided to 
notify the amending legislation and re gulations to the WTO in early June 2005.  He recalled that the 
Canadian legislation was based on the Decision and the accompanying Chairman's Statement and was 
limited to the export of products manufactured under a compulsory licence, in conformity with the Decision.  It thus had no application for the Canadian market. 
113. He welcomed the fact that other exporter count ries were working to amend their legislation 
and that some importer countries had started to review  their legislation to make sure there were no 
barriers to the import of drugs under this regime.  This demonstrated that his delegation was not the 
only Member to consider that the Decision provided  sufficient legal certainty to allow countries to 
modify their legislation and encouraged other Memb ers to do so.  He considered that the amendment 
process should be a technical exercise reflec ting the agreement WTO Members reached in 
August 2003 without re-opening or re-negotiating subs tantive issues.  The De cision was a tool that 
had allowed his delegation to estab lish a legal framework for the export of drugs, but it would not in 
itself provide medicines to those in need.  More  efforts were needed at the practical level. 
114. His delegation wanted to see the initiative work and was prepared to continue to work with 
other countries and to hold discussions with them to promote a better understandi ng of its regime.  His 
delegation stood ready to provide information to inte rested developing countries as to how to use the 
regime.  He restated that this legislation was onl y one part of a broader commitment to address public 
health and development issues.  It would co mpliment the work that his delegation was doing 
internationally to address those issues. 
115. A second representative from Canada provided Me mbers with a more detailed overview of 
his delegation's national regime which established tw o new forms of government authority.  The first 
was the authority to grant a licence to export a generic version of a patented product to a country 
suffering from public health problems that was unabl e to manufacture its own such products.  The 
second authority was to conduct the same health a nd safety review of these products as applied to 
products destined for domestic consumption.  He ad ded that specific funding had been allocated to 
create a special expedited queue, so that these drugs  were not subject to the same backlog as those 
subject to the domestic review process. 
116. He noted that his Government had also either s ubstantially reduced or waived most, if not all, 
of the user fees which would otherwise apply to bo th the patent office's review of the compulsory 
licence application and the health and safety review.  His delegation had made every effort to ensure 
that the application process was as simple and streamlined as possible, and to minimize the 
obligations imposed on countries wishing to ava il themselves of the regime and import licensed 
products.  The only truly substantive act required of  an importing country was to notify the WTO of 
its intention in this regard and to identify the na me of the product, the quantity sought and to specify 
the patent status of the product in  that country, either that there w as no patent covering the product, or 
that there was a patent and the Government intende d to grant a compulsory licence to import.  The 
generic pharmaceutical manufacturer, whose responsib ility it was to apply for a compulsory licence, 
had to first seek a voluntary licence from the patent  right holder, on reasonable terms and conditions, 
as required by Article 31(b) of the TRIPS Agreement.  Once a compulsory licence was granted, 
assuming the voluntary licence had been denied, the ge neric manufacturer had to pay royalties to the 
patentee.  The amount was calculated on the basis of the importing country's rank on the United Nations' human development index,  and the monetary value of the supply contract.  Based on the 
countries that were currently eligible to import under his delegation's regime, such royalties could 
range from approximately 0.02 per cent to 3.6 per cent. IP/C/M/48 
Page 26  
 
 117. He noted that the regime contained a number  of measures aimed at minimizing the potential 
for diversion of licensed products, including the require ment that all such products be distinctively 
marked and labelled, and in the case of solid or dosag e forms such as capsules or tablets, distinctively 
coloured and imprinted with the simple "XCL".  Generic manufacturers holding compulsory licences 
to export would be required to establish a website disclosing the particulars of the licence and the 
drug.  They also had to provide an export notice to the patent office, the importing country and the 
patentee within 15 days of shipping each batch of  a product to an eligible importing country.  The 
legislation also provided for the termination of a compulsory licence if the products were re-exported 
in a manner contrary to the Decision, or shipped to  an unauthorized country other than in transit. 
118. He informed Members that a compulsory li cence granted under the regime was valid for a 
period of two years, renewable for two additional y ears if the original authorized quantity had not 
been shipped in full upon expiry of the initial two-year term. 
119. In keeping with the Chairman's Statement not to use the Decision for commercial or industrial 
purposes, he indicated that the holder of a compulso ry licence who charged more than 25 per cent of 
the price of a brand-named product in Canada was s ubject to a legal challenge at the instance of the 
patentee on the grounds that the licence had prove d predominantly commercial as opposed to 
humanitarian in nature.  In the event that the pa tentee was successful in challenging the right of the 
licensee, various remedies would apply, including the delivery of stockpiled drugs to the country that 
was seeking to import them, and the payment of damages to the patentee. 
120. He clarified that third parties, such as NGO s, could also purchase drugs under the regime, 
with the permission of the importing country.  Cert ain NGOs were already in advanced discussions 
with generic manufacturers in Canada for the pur chase of a fixed-dose combination used to treat 
HIV/AIDS, which the Government wa s in the process of adding to the list of eligible drugs under the 
regime. 
121. The representative of India
 said that India's Patent Act ha d been amended in April 2005 to 
further clarify its legislation to ensure that drugs ma de locally continued to be available at affordable 
prices to all citizens in India and other developing co untries, particularly least-developed countries, in 
conformity with the Decision.  The recent amendmen ts to the patent law and rules had been notified 
to the WTO and were available as documents IP/N/1/I ND/D/2 to D/5.  He highlighted two changes in 
the law which were particularly relevant for the discussions on the TRIPS Agreement and public 
health.  First, the new Section 92( a) of the Patents Act enabled the manufacture for export of generic 
versions of patented pharmaceu tical products to countries with no or insufficient manufacturing 
capacity, thus using the flexibility provided for in  the Decision.  His delegation hoped that this 
provision would be useful for other developing countr ies, and in particular least-developed countries, 
as it imposed minimal requirements on the recipient c ountries.  Second, Section 90(1) of the Patents 
Act had been amended to clarify that prod ucts made under compulsory licences, granted 
predominantly for the supply of the domestic ma rket, could also be exported.  Thus, while 
Section 92(a) incorporated the flexibilities provide d in the Decision to manufacture specifically and 
only for export, the standard compulsory licences coul d also be used to satisfy export demands where 
those occurred next to domestic demands. 
122. The representative of Korea  said that his delegation remained committed to the amendment of 
the TRIPS Agreement reflecting the Decision.  He expressed disappointment that the target date of 
March 2005 had not been met and hoped that the pro cess would be completed soon.  His delegation 
maintained the view that the amendment should be a technical exercise that  neither re-opened the 
substance of the Decision nor changed the legal status  of the Chairman's Statement. In particular, the 
voluntary commitment that the so- called "partial opt-out" Members, including Korea, had made, 
should not be turned into a legal obligation.  IP/C/M/48 
 Page 27 
 
 
 123. He noted that Korea remained committed to  the goal of facilitating the supply of essential 
medicines to developing countries at affordable pr ices.  His Government was working hard to revise 
its national laws and regulations to implement the Decision and had just completed the revision of its 
patent law.  The revised patent law would make  it possible to grant compulsory licences for the 
purpose of export to eligible Members, making it po ssible for the entire production to be exported, 
while also introducing safeguard measures as require d by the Decision.  He informed Members that 
the revised patent law had been promulgated on 31 May 2005 and would enter into force on 
1 December 2005.  The legislative process to implem ent the Decision had not yet been completed, as 
the Government was in the process of reviewing th e relevant regulations to implement the revised 
patent law.  He hoped that the process would soon be completed and that the TRIPS Council could be 
duly notified of the details of the revision. 
124. The representative of Rwanda, speaking on behalf of the African Group , thanked the 
Chairman for his efforts and also for reminding Me mbers of the African Group's position, i.e. the 
need to amend the TRIPS Agreement in accordan ce with paragraph 11 of the Decision.  The 
amendment would allow the entire WTO membership  to implement the Decision in relation to 
paragraph 6 of the Doha Declaration on the TRIP S Agreement and Public Health as mandated by 
Ministers at the Doha Ministerial Conference. 
125. He indicated that the African Union Ministers' meeting, held in Cairo from 5 to 9 June 2005, 
had called for an urgent solution.  For this matter,  the African Group continued to actively engage in 
consultations, calling upon other part ners to engage constructively by tabling their proposals on the 
amendment, which would facilitate finding common gr ound in a speedy manner.  He also encouraged 
the Chairman to pursue informal consultations with all interested Members with a view to finding an 
agreement on the amendment as soon as possible. 
126. The representative of Norway  recalled that her country had been the first one to have a fully 
operational system in place, as the Decision had already been implemented into its domestic legislation on 14 May 2004 and ente red into force on 1 June 2004.  A detailed description of the 
system together with a copy of the legislation w as set out in document IP/C /W/427.  The adopted set 
of regulations aimed at reflecting as closely as possible the content of the Decision.  It followed a tradition in the domestic legal system, where nati onal provisions relating to the implementation of 
international public law had to be interpreted in light of the inte rnational public law provisions. 
127. She believed that it was more important to get th e amendment  right than rushing into changes 
to the TRIPS Agreement.  She reiterated her delega tion's view that the transposition of the Decision 
into treaty language should be considered primarily as a technical exercise, that would not change the 
substance of the Decision itself.  Her delegation was not committed to any particular form that such 
an amendment should have.  She said that incorp oration of the Decision into the Agreement by 
reference in a footnote would not prevent it from acquiring treaty status.  Alternatively,  the 
30 August 2003 text could be annexe d to the Agreement, or changes could be made to Article 31 of 
the Agreement.  Any combination of these two fo rms would also be acceptable to her delegation. 
128. In her delegation's view, the Chairman's Statement should primarily be seen as an 
interpretative instrument.  Its inclusion in the Agre ement would change and upgra de its legal status, in 
a way that had not been foreseen in August 2003.  It followed, therefore, that her delegation could 
only agree to the re-reading of the Statement at the time of the adoption of the amendment of the 
Agreement. 
129. She said that the examples of Norway, Cana da, and others showed that nothing barred 
Members from already implementing the Decision into national legislation at the present stage.  Due 
to different legal systems, there were differences in  the domestic implementation.  She referred to the 
example of Canada which had chosen to also incl ude the Chairman's statement in its legislation, IP/C/M/48 
Page 28  
 
 whereas her country had chosen not to do so.  While her delegation supported the necessary time 
being taken to get the amendment right, it was e qually important to underline that the Decision was 
fully operational and that nothing in the presen t process should prevent Members from taking the 
necessary measures to implement it.  Against this background, she expressed concern about the lack 
of results in the ongoing process which seemed to  create uncertainty around the arrangements agreed 
upon in August 2003 after some very difficult negotiations.  Few Members had so far implemented 
the Decision.  Her delegation had the impression that many Members would await an agreement on the amendment to the TRIPS Agreement before ma king the necessary amendments to their national 
patent laws.  She, therefore, urged Members to agree on a solution.  Her delegation stood ready to 
support work towards a compromise solution.  She also indicated that, although her delegation had 
already put in place national implementing legislation,  it would be ready to adapt that legislation if 
Members were to agree on another solution in the forthcoming discussion. 
130. The representative of Uganda
, supporting to the statement made by Rwanda on behalf of the 
African Group, referred to the call by the African Mi nisters to pay urgent attention to the amendment 
of the TRIPS Agreement to incorporate the Decisi on.  His delegation remained open and committed 
to engage constructively in the discussion aimed at  a compromise ensuring a lasting solution to the 
problem of public health.  The submission of  the African Group constituted a good basis for 
converting the Decision into an amendment of the Agreement.  He called upon all Members to table 
their proposals and to engage  in a constructive debate. 
131. He welcomed initiatives undertaken by certain  Members to transpose the Decision into 
national legislation, thus ensuring that generic dr ugs could be exported to developing countries.  
However, while the paragraph 6 mechanism would he lp, it would only solve part of the problem by 
making drugs available in poor countries, but it would not enable those countries to establish local manufacturing capacities.  There had been recent ex amples in his own country, where some drugs 
used in the treatment of HIV/AIDS could not be pr oduced locally and had not been available for some 
time so that patients had died.  A lasting solution should aim at providing a predictable and stable 
supply of drugs. 
132. The representative of th e European Communities
 reaffirmed his delegation's full commitment 
to the amendment process and to the completion of  the work as soon as possible.  His delegation had 
addressed this issue in an open and constructive manne r and intended to continue working in the same 
spirit.  He confirmed that his delegation was s till discussing the submission of a proposal for an 
amendment internally, setting out technically how to transpose the Decision into an amendment of the 
TRIPS Agreement.  This proposal would reflect  his delegation's well-established position on this 
issue, according to which the process should be a technical exercise without any re-opening of 
discussions on substantive issues.  He expressed the hope  that this proposal could be submitted in the 
very near future. 
133. Providing an update on the ongoing work w ithin the European Communities on draft 
legislation implementing the Decision, he said that the internal legislative process was making good 
progress.  The Council of the European Union and the European Parliament were seeking a rapid 
adoption of the proposed legislation.  He indicated  that the European Parliament was expected to 
adopt its opinion in September 2005, which would make it possible to adopt the new legislation 
before the end of 2005. 
134. The representative of Kenya  welcomed the initiatives taken by some governments to 
accommodate the Decision in their domestic laws.  He  also looked forward to receiving the European 
Communities' proposal in the very near future.  Th is would highlight the importance of the matter and 
should enable Members to complete the work on the amendment within a very short time.  IP/C/M/48 
 Page 29 
 
 
 135. He noted that, while the European Communities considered the transposition of the Decision 
into an amendment of the Agreement to be a techni cal exercise, they had been working for a long time 
on their proposal.  This indicated that the prep aration of an amendment was not an easy task. 
136. He reminded Members that the Decision constitute d a temporary solution that would have to 
be converted into a permanent solution.  He reitera ted that the ultimate aim of the exercise should be 
to ensure that countries overcame the problem of access to medicines by establishing local 
manufacturing capacities.  This should be borne in mind when amending the Agreement. 
137. Considering the informal consultations as an im portant opportunity for delegations to clarify 
their positions in a more focused environm ent, the representative of the Philippines  welcomed the 
reports made by other delegations on the measures taken to implement the Decision at the domestic 
level.  He also noted the point made by some dele gations that the Decision was not just a temporary 
solution.  His delegation was, however, more sy mpathetic to the passionate pleas made by the 
countries at the forefront of the HIV/AIDS pandemic for a permanent and lasting solution.  This was 
only reasonable in a rules-based system like that of the WTO. 
138. He believed that further consultations were  appropriate and that Members should be 
encouraged to arrive at a mutually satisfactory r esolution taking into account the spirit and intent of 
the Decision.  The African Group proposal remained  an important basis for further discussions.  He 
urged delegations that had concerns  with that proposal to submit their own proposals in order to move 
the discussions forward. 
139. He reiterated his delegation's position that an y amendment of the TRIPS Agreement pursuant 
to the Decision should be consistent with the human itarian context in which it had been adopted, and 
should reflect the letter and spirit of the consensu s.  The negotiations should preserve the flexibilities 
that developing countries had gained from the Decision, and should bear in mind fundamental 
concerns in this process.  His delegation had alwa ys been a keen participant in these negotiations, 
both in the drafting of the Declaration on the TRIPS Agreement and Public Health, and of the 
Decision.  It had committed itself to negotiate res ponsibly and constructively,  yet constantly mindful 
of the objective of providing developing countries with the necessary policy space to implement 
trade-related aspects of national health programmes. 
140. Associating himself with the coordinator of the African Group and earlier speakers from 
Africa, the representative of Mauritius  thanked Members who had taken action at the national level to 
implement the Decision.  He welcomed the very important initiative of the Norwegian Government 
which had taken the first step a year ago to adopt  domestic legislation in order to implement the 
Decision.  He encouraged Norway to take a leadership  role and to work with the Chairman so that the 
process could be brought to a successful conclusion.   He urged Members who had expressed concerns 
about the African Group proposal, to submit their ow n proposals so that the various difficulties and 
differences could be clarified.  This would enab le Members to see what could be done to achieve 
concrete results within the set deadline. 
141. The representative of New Zealand  said that her delegation considered this to be an extremely 
important issue and would support a ll efforts to find a permanent so lution.  The exercise was and 
should remain technical in nature and the soluti on should be neutral in terms of effect on the 
substance of the Decision.  Hard work was requi red to avoid the unravelling of the Decision,  
particularly given the growing number of Members that had already amended domestic legislation in 
accordance with the terms of the Decision.  Her dele gation was prepared to be flexible and pragmatic 
about the precise form of the solution and encouraged  a greater focus on the various technical options 
available rather than returning to the substance of the solution.  She looked forward to further 
proposals, including that foresha dowed by the European Communities. IP/C/M/48 
Page 30  
 
 142. The representative of Malaysia
 welcomed the African Group proposal to further the work on 
the amendment of the TRIPS Agreement in line w ith paragraph 6 of the Doha Declaration on the 
TRIPS Agreement and Public Health.  She looked forward to a possible paper by the European 
Communities as this would lend momentum to the work on the amendment.  She noted that there were still a number of concerns regarding the cont ent and the form of the amendment, as well as the 
treatment of the Chairman's Statement.  Her dele gation encouraged the Chairman to continue his 
consultations to accelerate the process toward s a solution implementing paragraph 6 of the 
Declaration. 
143. The representative of the United States
 noted that the agreement reached on 30 August 2003 
to implement paragraph 6 of the Doha Declara tion on the TRIPS Agreement and  Public Health 
provided an important contribution, among other effo rts, to address major public health crises faced 
by those most in need.  His delegation remained  fully committed to reachin g an agreement on the 
amendment expeditiously.  It was es sential that this amendment preser ve the entire agreement reached 
in August 2003. It therefore needed to include an express reference to both the Decision and the 
Chairman's Statement. 
144. His delegation continued to belie ve that substantive issues s hould not be re-opened and the 
exercise be viewed as technical.  He recalled that this issue had been resolved by consensus among all 
Members in August 2003 after 20 months of consider able work by delegations.  He noted that his 
delegation sought only to preserve all aspects of th e agreement reached in August 2003, including the 
legal relationship between the Gene ral Council text and the Chairman's Statement, and remained open 
to how this could be best and most expeditiously accomplished. 
145. The representative of Switzerland  re-confirmed the commitment of his delegation to the 
implementation of the Decision in the TRIPS Agreemen t and to the conclusion of this work as soon as 
possible.  He recalled that the waivers of oblig ations under the TRIPS Agreement were in place and 
fully operational, independently of any future TRI PS amendment.  There were no obstacles to the use 
of a compulsory licence, under the conditions of the Decision, for the exportation of pharmaceutical 
products under patent protection to  developing countries and, in pa rticular, least-developed countries 
with insufficient or no manufacturing capacity facing public health problems. 
146. He referred to the growing number of Member s (Canada, the European  Communities, India, 
Korea, Norway and also Switzerland) which were re vising, or had already revised and put in place, 
national laws in order to quickly and faithfully implement the Decision.  This provided sufficient 
evidence that the Decision provided the necessary lega l certainty to implement permanent legislation 
at the national level, making it fully operational.  It  was at the disposal of those Members who had to 
address a situation covered by the Decision. 
147. In his delegation's view, the Council only needed to find a way of technically transposing the 
Decision into the TRIPS Agreement in the most exped itious and efficient manner.  He reiterated that 
it was vital for his delegation that the solution reflect ed the entirety of the s ubstance of the consensus 
and the solution which had been found by the membership on 30 August 2003.  Thus, only a purely 
technical amendment would faithfully translate th e consensus found, which had been achieved only 
after a very long and difficult negotiation process,  representing a delicate balance of interests of 
Members.  He recalled that his delegation had alre ady proposed the inclusion of the entirety of the 
30 August 2003 consensus in an Annex to the Agreemen t.  However, other options could be looked at 
as long as they translated the entirety of the consen sus into the Agreement.  For his delegation, the 
General Council Chairman's Statemen t made at the time of adoption of  the Decision was part of the 
consensus found on 30 August 2003 and, therefore, also formed an integral part of the solution found on that day.  Without the Statement, there would have been no solution.  Therefore, it needed to be adequately reflected in the amendment.  IP/C/M/48 
 Page 31 
 
 
 148. With regard to other concerns of importance me ntioned by some delegations in relation to the 
TRIPS Agreement and public health, he recalled th e Declaration on the TRIPS Agreement and Public 
Health of November 2001 and the flexibilities provide d by the TRIPS Agreement as mentioned in that 
Declaration.  He suggested that the Chairman con tinue informal consultations in bilateral or small 
group settings before resuming plenary discussions. 
149. The representative of Brazil  reaffirmed his delegation's commitment to this process and the 
importance for the membership to conclude this ex ercise as soon as possible.  He looked forward to 
continuing the discussions on the amendment to the TRIPS Agreement.  He reiterated that his delegation did not agree to the inclusion of the te xt of the Chairman's Statement into the amended 
Agreement as it was not a part of the Decision.  Th e proposals made by some  Members to this effect 
would be tantamount to an unwarra nted upgrading of the legal status of the Chairman's Statement, 
which would not be acceptable for his delegation.  He also recalled that the African Group proposal 
remained a good and important basis for the ongoing discussions on the text of an amendment to the Agreement. 
150. Highlighting his delegation's commitment to finalizing the work on the amendment to the 
TRIPS Agreement to give permanent effect to the solution reached in  August 2003, the representative 
of Australia
 asked Members to bear in mind that agreemen t on this issue had been reached after hard 
work and a number of Members had already implemen ted that solution or were about to do so.  The 
waiver was in place and would remain there until th e amendment was complete.  For his delegation, 
the key was to preserve this solution.  Neither th e substance of the Decision nor the relationship 
between that Decision and the Chairm an's Statement should be altered. 
151. In his view, this was no longer a political issue, but a technical matter.  It was incumbent upon 
the TRIPS Council to solve it.  The Council had both the technical know-how and the willingness to 
make such a resolution possible.  He said that the process had got off to a good start, as certain relevant technical questions to be addressed by the C ouncil had been sorted out.  He had no doubt that 
more questions could be added to this list as the discussions progressed. 
152. As regards the elements of the Decision that  would become redundant by the change in the 
legal form, he considered that the question should also be asked as to what was gained or lost by 
removing any particular element of the Decision.  In his view, as very little, if anything, would be gained, every effort should be made to preserve the D ecision in its entirety.  This would imply that it 
was left to individual Members, in using or impl ementing the Decision, to determine for themselves 
which provisions remained releva nt and which provisions were re dundant.  Members who had already 
implemented the Decision had done this with some success. 
153. He believed that it was generally accepted that the Decision would not have been reached 
without the Chairman's Statement.  The key for hi s delegation was to preserve that agreement and not 
to add to it or subtract from it in any way. 
154. Concerning the question of whether the Chairman's  Statement could be read out again at the 
time of the amendment, he noted the differing vi ews and indicated that his delegation was still 
thinking about this, the key issue being whether or not this would sufficiently meet the need to faithfully preserve the 2003 agreement.  Several ques tions would arise in this context, for example, 
whether only the Chairman's Statement would be re ad or other statements be made, whether the 
Statement would have exactly the same legal standi ng as the Statement made in 2003, and what the 
status would be of reactions to the Statement that were different to reactions made to the Statement 
in 2003. IP/C/M/48 
Page 32  
 
 155. As regards the form of the amendment, he conf irmed that it should be that which best served 
the solution to be adopted.  His delegation was flexib le on this, but added that it was keen for the issue 
to move forward, and would like to be associated in any consultations. 
156. In conclusion, the Chairman
 reiterated his suggestion to c ontinue his consultations on the 
preparation of an amendment to the TRIPS Agreemen t pursuant to paragraph 11 of the Decision with 
a view to agreeing on a recommendation as soon as possible. 
157. The Council so agreed . 
I. FOLLOW -UP TO THE SECOND ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON 
THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
158. The Chairman  informed the Council that, pursuant to  the second annual review of developed 
country Members' implementation of Article 66.2 th at the Council had taken up at its meeting in 
December 2004, the European Communities had pr ovided further information to supplement its 
earlier report.  This information concerned releva nt activities of the European Investment Bank 
(IP/C/W/431/Add.3/Suppl.1). 
159. Turning to the arrangements for the Council's third review under the decision on the 
"Implementation of Article 66.2 of the TRIPS Ag reement", he recalled that paragraph 1 of the 
Decision provided that developed country Member s should submit annually re ports on actions taken 
or planned in pursuance of their commitments under Artic le 66.2.  To this end, they were obliged 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.  The first set of detailed annual reports under the Decision had been presented to the 
Council's meeting in November 2003, and the firs t set of updates to the Council's meeting in 
December 2004.  Therefore, this year developed country Members were obliged to submit updates to 
these reports prior to the Council's end of year meet ing, that had been scheduled for 25-26 October.  
As was provided in paragraph 2 of the Decision,  the Council shall review these updates at that 
meeting. 
160. Accordingly, he suggested that developed c ountry Members be requested to submit a second 
set of updates to the reports they had provided in  2003 on actions they had taken or planned in 
pursuance of their commitments under Article 66.2 by 30  September, i.e. about three weeks before the 
meeting, in order to allow their timely circulati on and review at the Council's meeting in October. 
161. The Council so agreed . 
J. TECHNICAL COOPERATION AND CAPACITY BUILDING  
(i) Annual Updates on Technical Cooperation Activities  
162. The Chairman  suggested that, in view of the Hong Kong Ministerial Conference in 
December, the Council hold its annual review of te chnical cooperation at its meeting scheduled for 
25-26 October.  Accordingly, he suggested that  the Council once more invite developed country 
Members to supply information on their activities pur suant 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 al so suggested that the Council invite those 
intergovernmental organizations that had observer st atus in the TRIPS Council to provide information 
on their activities of relevance and that the WTO Secret ariat might also be instructed to report on its 
activities.  Furthermore, he suggested that this in formation be made available by 30 September, about  IP/C/M/48 
 Page 33 
 
 
 three weeks prior to the Council's next meeting, in order to allow its timely circulation before the 
meeting. 
163. The Council agreed  to proceed as suggested by the Chair. 
(ii) Joint Initiative 
164. The Chairman  recalled that, on 14 June 2001, the WIPO  and WTO Secretariats had launched 
a Joint Initiative on Technical Cooperation for L east-Developed Countries.  Since then, the WTO 
Secretariat had kept the Council informed about  the implementation of the Joint Initiative. 
165. The representative of the WTO Secretariat  said that, with regard to activities specifically 
directed towards least-developed coun tries, the Secretariat had conti nued to work with the authorities 
of the countries in question and WIPO with a view to organizing national seminars as requested by 
Lesotho and Chad.  In addition, the Secretariat ha d received a request for a national activity under the 
Technical Cooperation Plan from Mozambique which w as sought to be carried out before the end of 
the year. 
166. Regarding other activities that were not sp ecifically addressed towards least-developed 
countries but might be of considerable interest to  them, two of the regional workshops recently held 
by the Secretariat had taken place in Africa.  One had been held in Gabon in May for French-speaking 
African countries, and the other for English-speaki ng African countries would be held in Zambia in 
July.  Both these events had a focu s on topical issues before the TRI PS Council, including the issue of 
TRIPS and public health. 
167. The Secretariat was organizing a workshop on the TRIPS Agreement and public health to be 
held from 26 to 28 September 2005, the main objec tive of which was to support participants from 
developing countries with direct responsibilities fo r matters relating to the TRIPS Agreement and 
public health in the use of the paragraph 6 mechan ism.  Invitations had been sent out to developing 
country and economy in transition Members to nomina te candidates for this workshop.  The closing 
date for such nominations was 30 June 2005.  
168. The Council took note  of the information provided. 
K. REQUEST FROM MALDIVES FOR AN EXTENSION OF THE TRANSITION PERIOD UNDER 
ARTICLE  66.1  OF THE TRIPS  AGREEMENT  
169. The Chairman  recalled that, in August 2004, the Ma ldives had submitted a request for an 
extension of its transition period under Article 66.1 of the TRIPS Agreement for a further five years 
(IP/C/W/425).  This document set out in an annex the motivation of the request, as called for by Article 66.1.  He recalled that the CTD had at the sa me time discussed issues relating to the Maldives' 
graduation from its status as a least-developed c ountry.  As the Council had been informed at its 
March meeting, the United Nations' General Assemb ly had adopted a decision on 20 December 2004 
concerning the Maldives' graduation, the effect of which was that the Maldives would retain its LDC 
status until 20 December 2007.  Since the UN had ta ken that decision, the Maldives had informed the 
CTD that it wanted the UN to re-examine its positio n concerning this recent decision to graduate the 
Maldives from LDC status because of the devasta ting effects of the December tsunami on its 
economy (WT/COMTD/52). 
170. As concerned the specific request that the Ma ldives had submitted to the TRIPS Council, the 
Government of Maldives had recently clarified th at its request for an extension of the TRIPS 
transition period was intended to be independent of an y consideration with regard to the issue of its 
graduation form the UN's list of least-developed coun tries, and that the request was based solely on IP/C/M/48 
Page 34  
 
 Article 66.1.  In the light of this clarificati on provided by the Maldives and discussions between the 
Secretariat and a representative of the Maldives, th e Chairman said that it was his understanding that 
the Maldives was requesting an extension of its TRIPS transition period under Article 66.1 for the 
remainder of the period that, under the present UN De cision, it remained on the list of LDC countries, 
that is for the period of 1 January 2006 to 20 December 2007. 
171. The Chairman said that in his consultations with Members he had received positive reactions 
to the question of whether Members would be ready to agree to extend the Maldives' transition period 
under Article 66.1 until 20 December 2007 at the present meeting.  Although some delegations had 
said that the request provided fairly limited informatio n to support the request, they could consider the 
Council granting the extension on that basis, given the exceptional circumstances in the Maldives that 
were known to all delegations, na mely the devastating effects of the December tsunami on its 
economy.  The point had also been made that any decision on this matter should be without prejudice 
to how the Council would handle any future requests for an extension. 
172. In the light of this positive reaction and to fac ilitate the Council's consideration of the request, 
the Secretariat had made available a draft decision on this matter the previous day.  Since then, some 
delegations had suggested the incl usion of an additional provision in  the preamble along the following 
lines: 
"Recognizing
 the exceptional circumstances faced by the Maldives and that this 
Decision is without prejudice to future decisions of the Council for TRIPS under Article 66.1." 
The Chairman proposed that the Council adopt the draft decision with this additional preambular 
provision. 
173. The Council so agreed
.1 
L. NON-VIOLATION AND SITUATION COMPLAINTS  
174. The Chairman  recalled that the General Council decisi on of 1 August 2004 on the Doha Work 
Programme provided, under the title "Other elements of the Work Programme", that the moratorium 
on non-violation and situation compla ints covered by para graph 11.1 of the Doha Ministerial Decision 
on Implementation-Related Issues and Concerns was ex tended up to the Sixth Ministerial Conference.  
This matter had been on the agenda of the Council' s last two meetings, at which it had discussed the 
matter on the basis of, inter alia , an updated Secretariat summary note on the points raised in the 
Council's substantive discussion of this  matter so far (IP/C/W/349/Rev.1). 
175. The representative of Peru  recalled that a few years ago his delegation, together with other 
developing countries, had presented document IP/C/W/385, proposing that the TRIPS Council 
recommend to the Fifth Ministerial Conference  of the WTO in Cancún to determine that 
paragraphs 1(b) and 1(c) of Ar ticle 23 of GATT 1994 were not appli cable to the TRIPS Agreement.  
This document was supported by virtually all dele gations and it contained all the arguments necessary 
to justify that position.  In view of the importanc e of the issue, he called upon the Council to adopt a 
definite decision in Hong Kong in order to fulfil the Doha mandate.  It was his delegation's view that 
the application of non-violation a nd situation complaints was neither necessary nor desirable or even 
possible in the context of the TRIPS Agreement. 
                                                      
1 The decision on "Maldives – Extension of the Transition Period under Article 66.1 of the TRIPS 
Agreement" was subsequently circulated in document IP/C/35.  IP/C/M/48 
 Page 35 
 
 
 176. The representative of Canada  said that his delegation had been repeating its position on this 
issue since near the end of the Uruguay Round, namely that non-violation and nullification/impairment should not apply in the co ntext of the TRIPS Agreement.  His delegation 
supported the suggestion by Peru that a de finitive decision be taken at Hong Kong. 
177. The representative of Argentina
 said that his delegation, as a co-sponsor of document 
IP/C/W/385, shared the view of Peru and Canada and hoped that the Sixth Ministerial Conference 
would enable Members to broker a definitive solution. 
178. The representative of Malaysia  said that, like the other delegati ons that had s poken before, her 
delegation had made its position clear on this issue and supported the suggestion by the delegation of 
Peru.  She hoped that Members would be able to take a position regarding the applicability of the 
non-violation and situation complaints to the TRI PS Agreement and close the discussion of this issue 
at the Sixth Ministerial Conference. 
179. The representative of the United States  said that his delegation continued to consider that non-
violation complaints were fully appropriate in th e TRIPS context and expected the moratorium to 
expire at the Sixth Ministerial Conference.  In res ponse to comments that had been made at the last 
meeting of the Council, he said that the appli cation of non-violation complaints to the TRIPS 
Agreement would not and did not upset the balance of  rights and obligations in the TRIPS Agreement. 
180. It was the objective of non-violation complaints to discourage actions that evade obligations 
without directly violating them and no clear reason had been provided as to why the TRIPS 
Agreement should not benefit from this objective.  The United States remained willing to discuss how 
the non-violation remedy applied to the TRIPS Agre ement.  Specifically, Article 26 of the Dispute 
Settlement Understanding was helpfu l and important guidance for Members concerning non-violation 
disputes under TRIPS and his delegation would be in terested in focusing future discussions on this 
issue. 
181. The representative of Brazil  said that his delegation associated itself with the statement made 
by Peru and hoped that the issue could be r esolved at Hong Kong as proposed in document 
IP/C/W/385 in September 2002, which had been co-sponsored by Brazil. 
182. The representative of India  said that, as a co-sponsor of IP/C/W/385, India fully supported the 
course of action proposed by Peru. 
183. The representative of Bolivia  said that his delegation supported the previous speakers who 
had proposed that a definitive decision be taken at the next Ministerial Conference in Hong Kong that 
non-violation complaints were not a pplicable under the TRIPS Agreement. 
184. The representative of Japan  said that his delegation believed it was worth continuing to study 
and discuss the scope and modalities of non-violation complaints in the TRIPS Council in order to 
ensure the predictability of their application. 
185. The representative of the Philippines  said that his delegation shared the view of those 
delegations who had called for the closure of the i ssue of applicability of non-violation complaints 
under the TRIPS Agreement. 
186. The representative of Cuba  said that his delegation, as a co-sponsor of the proposal by Peru, 
hoped that the Ministerial Conference would find a solution to this issue. 
187. The representative of Egypt  said that her delegation s upported the recommendation and 
course of action suggested by Peru. IP/C/M/48 
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 188. The representative of the European Communities
 said that his delegation agreed with most 
other speakers that non-violation and situation compla ints were not applicable in the TRIPS context. 
189. The Council took note  of the statements made and agreed  to revert to this matter at its next 
meeting. 
M. SPECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL  
190. The Chairman  recalled that, in its Decision on the D oha Work Programme of 1 August 2004, 
the General Council had recalled Ministers' decision in Doha to review all special and differential 
treatment provisions with a view to strengthening  them and making them more precise, effective and 
operational, and had recognized the progress that ha d been made so far.  Regarding all those WTO 
bodies to which proposals in Category II had been re ferred, the General Council had instructed them 
to expeditiously complete the consideration of th ese proposals and report to the General Council, with 
clear recommendations for a decisi on, as soon as possible and no later than July 2005.  Therefore, the 
Council needed to decide, at the present meeting, on the report that it had been called upon to make to 
the General Council, including on any recommendation for a decision. 
191. This matter had been on the agenda of the Counc il meetings in December and March.  At the 
December meeting, the Council had had before it an informal Secretariat note summarizing the 
Council's work so far on the Category II proposals on sp ecial and differential treatment referred to it 
(JOB(04)/164).  He said that his understanding was that the situation, as reflected in that summary note, remained unchanged. 
192. He further recalled that agreement had been  reached in 2003 amongst participants on the 
second part of one of the proposals, concerning excl usive marketing rights.  His predecessor had, 
therefore, forwarded the agreed text to the Chair of the General Council, by means of a letter dated 
21 August 2003, for appropriate action.  This text ha d subsequently been included in the Draft Cancún 
Ministerial Text, but had not formally been adopted as there had been no substantive outcome to that 
meeting.  As regarded the other proposals, no de legation had taken them up since then, including in 
the Council's past two formal meetings. 
193. In the light of the consultations he had held on this matter, the Chairman suggested that the 
Council authorize him to report to the General Council to the effect that the TRIPS Council 
recommends that the General Council take appropri ate action concerning the text that had been 
forwarded to it by the TRIPS Chair by means of the letter dated 21 August 2003.  In addition, he 
would provide a brief factual report on what had happened with regard to the other proposals. 
194. The Council so agreed
.2 
N. ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS – COMMUNICATION FROM THE 
EUROPEAN COMMUNITIES  
195. The Chairman  recalled that the European Communities had informed the Council at its last 
meeting that it was planning to submit a communica tion on the issue of enforcement of intellectual 
property rights and wished to have the issue on the agenda of the present meeting.  Furthermore, on 
20 May 2005 it had sent a written request to the Secr etariat that the item be placed on the agenda of 
the present meeting.  The communication from the European Communities on "Enforcement of Intellectual Property Rights" had now been circulated in document IP/C/W/448. 
                                                     
 
2 The report to the General Council by the Chair on "Special and Differen tial Treatment Proposals 
Referred to the TRIPS Council" was subsequently circulated in document IP/C/36.  IP/C/M/48 
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 196. Introducing document IP/C/W/448, the re presentative of the European Communities  said that, 
since the adoption of the TRIPS Agreement in 1994 and its entry into force, noteworthy progress had 
been achieved worldwide on the protection of intell ectual property rights (IPRs).  Intellectual property 
systems had been set up or improved in accordance with international standards in a number of 
countries, where different types of rights were now  protected by law.  The European Communities, 
thus, acknowledged that most WTO Members had, in general, implemented or were in the process of 
implementing the TRIPS Agreement, including its pr ovisions related to enforcement of intellectual 
property rights.  However, in parallel with this global improvement of the legislative and regulatory 
standards, the volume and value of IPR violations, namely in the form of counterfeiting and piracy, 
had increased dramatically over the last years, to the point where it had take n on industrial proportions 
and now represented a considerable share of the gl obal economy.  Confronted with this apparent 
contradiction between the introduction of the firs t comprehensive, multilateral set of rules for IP 
enforcement and the deterioration of the levels  of piracy and counterfeiting, the European 
Communities wished the TRIPS Council to careful ly examine compliance of Members with the 
TRIPS enforcement provisions, pursuant to  Article 68 of the TRIPS Agreement. 
197. All Members should be concerned with this i ssue because, first of all, counterfeiting and 
piracy affected legitimate right holders and rights that had been acknowledged by all Members.   It 
created losses of sales, reputation and jobs and ultimately put at stake the viability of the most creative, innovative and quality-driven companies and economy actors.  But more importantly than that, potentially dangerous counterfeit goods threatened consumers' or users' health and safety.  Even 
though EU customs controls on transit goods enab led the interception of some of these dangerous 
products, consumers in the poorest countries were partic ularly exposed to their sales.  Dramatic cases 
were reported by the World Health Organiza tion (WHO) and the European Communities had 
witnessed an increase of 70 per cent of seizures of infringing goods relating to foodstuffs and drinks.  
No country could afford the circulation of danger ous goods like these in their territory.  The seizures 
of products like mineral water c ontainers, ageing products or pharmaceuticals illustrated the scale of 
the problem and should be an indicator that more attention needed to be paid to this issue.   
198. A further reason why every country, rich or poor, more or less i ndustrialized, should be 
concerned, had to do with the undeniable role th at was played by organized crime networks in the 
spread of piracy and counterfeiting.  No country co uld afford to leave an entire sector of its economy 
in the hands of criminal organizations, allowing pa rt of its industrial and commercial resources to 
become a "parallel economy".  However, until such activity would no longer be seen as a low 
risk/high profit type of crime, it would continue to sp read.  It was, therefore, also a question of public 
order, security and good governance to fight against counterfeiting and piracy. 
199. He said that effective enforcement of IPRs w as also essential to attract foreign investment, 
transfer of technology and know-how, as well as to protect local right holders in developing countries.  
It was also an indicator of good governance, internati onal credibility, of respect of the rule of law and 
of bilateral and multilateral commitments.  Last, but not least, it would encourage more domestic 
authors, inventors and investors and would c ontribute to the development of these countries. 
200. His delegation considered the TRIPS Council to be the right place to address this problem for 
the following reasons.  While it was true that coun terfeiting, as an underground activity sometimes led 
by well organized groups, was difficult to eradicate,  the theft of this kind of property was made 
attractive by the relatively low risk it involved – th e risk of being caught, jailed or fined – compared 
to expected profits from it.  The present scope of  the problem was, thus, a sign that the level of 
execution and the results of the implementation of  the IPR enforcement measures prescribed by the 
Agreement could be questione d and had to be improved. 
201. Unquestionably, the Agreement established the freedom of each Member to determine the 
appropriate method of implementing its provisions.  However, ultimat ely such implementation had to IP/C/M/48 
Page 38  
 
 allow the adequate prosecution of the objectives of the Agreement, namely those stated in 
Article 41.1, " Members...shall permit effective action against any act of infringement of intellectual 
property rights covered by this Agreement, including expeditious rem edies to prevent infringements 
and remedies which constitute a dete rrent to further infringements… ".  Hence, Members had an 
obligation to take account of the present situation a nd find ways to combat and reduce it.  Considering 
that, pursuant to Article 68 of the Agreement, the Council was to " monitor the operation of this 
Agreement and, in particular, Members' co mpliance with their obligations hereunder… ", his 
delegation submitted that deficient enforcement of IPRs was an issue that it was appropriate to 
address in the Council in the coming months and years. 
202. While being complementary to work that was being done in other forums like WIPO, the 
TRIPS Council was the most appropriate forum for a discussion of this issue.  The aim of the TRIPS 
exercise would be to understand where the main problems, difficulties and shortcomings laid by 
examining the implementation of TRIPS provisi ons on enforcement in detail, and to make 
recommendations on ways to improve the situa tion, for instance by laying down benchmarks to 
evaluate the progress made by national administrati ons towards a higher level of IP enforcement, 
suggesting best practices, etc., to ensure a full im plementation of TRIPS obligations in this field. 
203. Such an in-depth examination of the situati on would also allow to better target technical 
assistance in the IP field.  The European Commun ities was an important contributor to IP-related 
technical assistance worldwide and had, in partic ular, a number of programmes exclusively focused 
on IP, and some very fruitful cooperation with a number of WTO Members.  It was certainly possible to improve coordination with other providers, to fo cus it more carefully and to take into account the 
demands and requests of the recipient countries a nd other partners in the technical cooperation 
programmes. 
204. His delegation's main concern was that the cu rrent standard of the TRIPS Agreement would 
be fully implemented, as that would already improve  the situation.  However, even more could be 
done and the EC paper provided some examples on how  to improve the situation, e.g. procedures 
available to preserve evidence, methods used to calcu late evidence, sanctions available at the civil and 
criminal level, rights of information, the use of provisional and protective measures, as well as 
customs measures and their availability in cases of export and transit.  While these were merely 
suggestions to be discussed, the main focus of the paper was to assess the implementation of the 
instruments that were in place. 
205. He said that his delegation would like to ta ke into consideration reactions from other 
Members when making further proposals on how this issue should be discussed in the future.  His 
delegation was already working on finalizing concrete  proposals and suggestions which it intended to 
present before the next TRIPS Council meeting. 
206. The representative of Argentina
 said that the concerns about piracy and counterfeiting were 
shared by all Members.  He noted that the Eu ropean Communities had recognized the substantial 
progress that had been made across the world in pr otecting intellectual property and that the vast 
majority of Members had implemente d provisions on enforcement.  Nevertheless, in a brief analysis 
on page 2 of its paper, the European Comm unities had voiced a concern over an increase in 
infringement cases and cited a series of cases whic h touched upon areas of responsibility of other 
international organizations and customs authoriti es, for example, cases of smuggling, transport of 
hazardous materials and pharmaceutical smuggling.  It should be remembered that a series of 
conventions governed, for example, the transport of  dangerous and hazardous materials and that the 
World Health Organization was competent in the area of pharmaceutical smuggling.  The issues 
raised by the European Communities were, therefore, not questions that could be solved in the TRIPS 
Council, but were of relevance to various bodi es and organizations such as the World Customs 
Organization, which had an interest in such issues.  IP/C/M/48 
 Page 39 
 
 
 207. He said that the EC interpretation, that Ar ticle 68 mandated the Council to focus on certain 
suggestions and initiatives which the European Comm unities had listed in para graphs 23-27 of its 
paper, would give the supervisory task mentioned in Article 68 a very  broad remit.  His delegation did 
not share such an interpretation of Article 68 as a "policing power" of the TRIPS Council and 
considered that the EC suggestion, that the Council recommend, for example, benchmarks for 
assessment purposes, went beyond the competence of the Council.  It was his delegation's view that 
the EC proposals in this context were, therefore, not appropriate and that the Council's already heavy 
agenda under this Round should not be  further burdened by an issue that did not necessarily belong in 
this forum. 
208. The representative of Brazil , while agreeing that the issue of enforcement of IPRs and 
combating piracy was an important issue, said that he had several reservations of a legal, procedural 
and conceptual nature with respect to the EC document and its proposals for work in the TRIPS 
Council.  He agreed with the delegation of Argentina that the EC proposals went beyond the 
competence of the TRIPS Council.  His delegation was aware that Article 68 mandated the Council to 
monitor the operation of the Agreement and afforded  Members the opportunity to consult on matters 
related to trade-related aspects of intellectua l property.  However, it was his delegation's 
understanding that this monitoring role was alr eady being performed through the procedures set forth 
in Article 63.1 and 63.2 of the Agreement, which we re currently dealt with under items A and B of 
the Council's agenda and there was therefore no need  for further activities of the Council relating to 
the implementation of TRIPS enforcement provisions. 
209. His delegation was particularly concerned that the Council's activities proposed by the 
European Communities, namely a detailed examina tion of Members' percei ved shortcomings in 
implementing TRIPS enforcement provisions, the layi ng down of benchmarks for Members to comply 
with, as well as the elaboration of best practices, would entail the establishment of a new prescriptive 
and de facto norm-setting role for the Council.  This would narrow the flexibilities which Members 
currently enjoyed under Article 1.1 of the Agreemen t to determine themselves how best to implement 
their obligations at the national level and could, therefore, not be justified by Article 68 of the 
Agreement.  It was his delegation's view that Article 68 should not be invoked to establish new 
"TRIPS-plus" obligations for Members in this or any other area. 
210. While acknowledging the efforts made and the le gitimacy of the concerns expressed by the 
European Communities, his delegation suggested th at the Council decline to discuss this issue and 
that the proposed new agenda item would not be in cluded in the agendas of future Council meetings, 
because the Council's agenda was already occupied with the current Doha Round and should not be 
burdened with this potentially divisive issue.  His delegation encouraged the European Communities 
to address its concerns to the WIPO Advisory Committee on Enforcement which, as the EC document 
pointed out, had a mandate for the exchange of in formation, awareness rais ing and coor dination of 
technical assistance programmes and should therefore be well equipped to address the issue. 
211. The representative of Australia  agreed that enforcement was an important issue and pointed 
out that, as discussions on the topic were also being held in other forums, it was important that any 
discussions that would be held in the TRIPS Counc il would be conducted in a focused way that would 
be useful to the Council and all its Members.  As a preliminary remark, he said that his delegation did 
not object to discussions focusing on how to address problems, shortcomings and difficulties with the current enforcement situation.  Commenting on paragraph 26 of the EC document, where the 
availability of customs measures for export and transit had been listed as an issue for special attention 
in the proposed discussions, he said that his delega tion was interested to know  whether the European 
Communities was implying a need to strengthen or  extend the legal provisions in this regard. 
212. With regard to the mention of the establis hment of benchmarks in paragraph 24, his 
delegation asked the European Communities to elabor ate further on their potential nature, as it had to IP/C/M/48 
Page 40  
 
 be recognized that effective border control alwa ys required adequate resources.  Concerning the 
important issue of technical assist ance and cooperation, he highlight ed the fact that Australia was 
actively providing assistance relating to enforcement in its region, cooperating with the WHO in the 
Western Pacific on putting in place programmes to strengthen pharmaceutical systems against corruption and to improve national capacities to de tect and eliminate counterfeit medicines in the 
Mekong basin area.  Any discussion on this issue woul d need to take into account that a number of 
Members were already active in enfo rcement on the bilateral, regional a nd multilateral levels.  He said 
that his delegation was open to further discussion on this topic in the TRIPS Council and might offer further comments on the EC paper at a later stage. 
213. The representative of Mexico
 said that his delegation agreed with the European approach and 
that he would make further comments af ter a detailed analysis of the paper. 
214. The representative of Canada  welcomed the EC paper as a useful basis for discussion and said 
that his delegation considered an in-depth examin ation and exchange of views to be beneficial.  
Canada believed that effective enforcement of IPRs w as an important issue not just with regard to the 
economic questions, but also as it related to public  health and safety as well as organized crime.  
Ongoing discussions on IP enforcement in other foru ms such as WIPO, APEC and the OECD should 
be taken into account when discussing the TRIPS Counc il's role in this area, and his delegation was 
interested in the EC views in this context.  Furthe rmore, his delegation was interested in more details 
on the specific type of work that was being proposed, what would be the basis for the TRIPS examination and recommendations, and what was the intended scope and impact .  His delegation was 
looking forward to further discussions on this topi c and would provide more comments after further 
analysis of the EC document. 
215. The representative of Cuba
 said that the issue of enforcement was not new and was already 
being discussed in WIPO. The issue of biopiracy, th at was of particular concern to developing 
countries, was being discussed in the TRIPS Council and no agreed solution had been found.  This 
situation continued to be beneficial to large inte rnational companies with a capacity to exploit the 
existing intellectual property system that benefited intellectual property right holders.  There was no 
empirical evidence to support the much-used argument that an effective intellectual property regime 
and, as part of it, effective enforcement, was essenti al in order to attract foreign investment and the 
transfer of technology and know-how.  In reality, such decisions depended on other factors which 
aimed at maximizing gains from intellectual property by limiting access to new knowledge and technology, which were not only the result of deve lopment, but also a prerequisite for it.  These 
contrived arguments had led to the strengthening of the multilateral intellectual property regime and 
resulted in more intellectual property rights for foreign right holders in developing countries. 
216. This system was distorted and unbalanced, ineffectual in preventing the undeserved granting 
of rights, too complex to access for companies from developing countries, and yet the system had to be overseen by the governments of developing countr ies in exchange for very few benefits.  At the 
same time, governments of developed countries clai med to be unable to ensure that right holders, 
usually multinational companies, fulfilled their part of the bargain, so that developing countries were 
now administering a system of essentially unilateral obligations. 
217. While her delegation was in favour of combating piracy and counterfeiting, it remained yet to 
be seen how the TRIPS Agreement, in its present fo rm, contributed to the development of, and how it 
could benefit, underprivileged so cieties by favouring collective rights over the individual rights of 
private companies.  The rights to a livelihood and de velopment, supreme and ma jority rights were just 
as important as the minority rights of intellectual property owners.  As representatives of national 
authorities, delegations could not negotiate in the in terests of private profit but had to also address 
public policy.  For that reason, her delegation belie ved that it would be inappropriate to begin an 
exercise that would further increase the rights of ri ght holders who already enjoyed privileges, while  IP/C/M/48 
 Page 41 
 
 
 there were still important obligations to fulfil and ri ght holders' contributions to be made with regard 
to the objectives of the TRIPS Agreement. 
218. The representative of Korea  welcomed the EC submission and agreed that enforcement was 
an important pillar of IP regimes.  Over the last  decade, many Members had made great efforts to 
eradicate counterfeiting and piracy but they rema ined a cause for great concern, which deserved 
Members' collective consideration.  He noted that the fight against piracy was not only a question of 
laws and regulations and the will to enforce th em, but also required a huge amount of human, 
financial and technical resources as well as close c oordination between relevant government agencies 
and the business communities.  These were not al ways readily available in all Members. 
219. It was also important to note that a large nu mber of other factors were involved in the 
working of an IPR regime, including the structure of the legal systems of the countries concerned, 
business practices, cultural traditions and public awaren ess.  Therefore, his delegation believed that no 
one-size-fits-all approach existed, but that the fi ght against counterfeiting and piracy required a long-
term holistic approach that took into account the unique situation and resource constraints of each 
country.  In this context, his delegation was looki ng forward to further deliberations on this issue. 
220. The representative of the United States  welcomed the EC submission and agreed that the 
expansion of piracy and counterfeiting facing WTO Members was a global problem that all Members 
should be concerned with.  The rising level of in tellectual property infringements, despite improving 
regulatory standards of protection, showed that legislative and regulatory frameworks were of little 
value if not supported by proper enforcement measures.  He said that, in order to stem the global rise 
in piracy, focus needed to be placed on enforcem ent of intellectual property rights and that his 
delegation was open to such discussions and would provide further comments on the EC paper at the 
next meeting. 
221. The representative of Switzerland  welcomed the EC submission and agreed that the dramatic 
surge of infringing goods, despite the TRIPS obligati ons to afford adequate and effective protection, 
highlighted that the issue of enforcement was of crucial importance to all Members.  Counterfeiting 
and piracy undermined the interests of all right ho lders, whether they were multinational companies or 
artisan manufacturers.  As the TRIPS Agreement, in  particular, recognized that enforcement was at 
the heart of any functioning IP system, the TRIPS Council was the right place to discuss the issue.  
His delegation supported putting the item on the age nda of the next meeting for an in-depth 
examination and an exchange of views th at should be well-focused and organized. 
222. The representative of the Philippines  shared the concerns of the European Communities and 
other Members concerning the social and economic costs of counterfeiting and piracy.  While noting 
the mandate of the Council in Article 68 of the TRIPS Agreement, he shared the concerns of 
Argentina and Brazil of not overstretching the scope  of this mandate.  He noted that it remained 
unclear which mechanisms the European Comm unities was envisaging in its proposal, but his 
delegation anticipated a number of serious concerns w ith the proposals so far.  Firstly, the question of 
the competence of the Council to deal with the issu es identified in the proposal was very relevant.  
Secondly, if country-specific discussions on impl ementation review were being envisaged, which 
criteria would be used to determine which countries we re to be examined and in which order?  There 
was also a need to put in place safeguards against the deterioration of the process into an unmitigated 
procedure with serious implications  for domestic law and policy, havi ng regard to Article 1.1 of the 
TRIPS Agreement.  Thirdly, in case an agreement was reached on a review or monitoring procedure, 
would there be sufficient safeguards in place against an asymmetrical application of the procedures to 
the different categories identified by the European Communities, i.e. source countries, transit countries and target countries, bearing in mind the possible configuration of these types of countries?  His delegation was looking forward to further cl arification from the European Communities on these 
issues. IP/C/M/48 
Page 42  
 
 223. The representative of Japan
, welcoming the EC submission, said that enforcement was an 
important issue and that his dele gation would make more comments on the document at the Council's 
next meeting. 
224. The representative of Chinese Taipei  said that the problem of counterfeiting deserved the 
attention of all WTO Members.  Technological developments had made the Internet a breeding 
ground for infringements and his Government had lear ned form experience that a comprehensive legal 
framework was needed to provide adequate protec tion to right holders.  His delegation was open to 
discussion and was looking forward to more detaile d explanations from the European Communities 
on this important matter. 
225. The representative of Malaysia  said that his delegation shared the general concerns regarding 
increased levels of counterfeiting and was engaged in improving its enforcement procedures under the 
TRIPS obligations.  However, he was of the view th at the difficulties encountered were less due to a 
lack of rules or guidelines, but due to a lack of resources and implementation capacity.  What was needed, therefore, was not the creation of new rul es and benchmarks but the improvement of capacity 
and resources of countries in need of strengtheni ng their enforcement infrastructures.  As such, 
technical assistance might not be within the compet ence of the WTO and, as other organizations such 
as WIPO, WCO and OECD were already working on the issue, he suggested that Members work 
actively in these Organizations and provide them with  the resources needed to help countries improve 
their enforcement capacity. 
226. The representative of India
 noted that counterfeiting and piracy were not new phenomena.  
While they deserved condemnation and necessitated countermeasures, these measures should be taken 
at the national level.  As had been pointed out by  Argentina and Brazil, there was little to discuss at 
the level of the TRIPS Council in this regard.  Given the transition periods under the Agreement, 
some obligations were only beginning to be implemen ted or would only be implemented in the future.  
It was, therefore, premature to start any regular revi ew of enforcement and, in view of the much more 
urgent issues on the agenda, the Council should not ev en begin to consider whether the tasks proposed 
by the European Communities were within its competence or not. 
227. The representative of Bolivia  said that enforcement was a concern shared by all 
Members, with particular emphasis on biopiracy in the case of Bolivia.  Joining the WTO and the 
TRIPS Agreement had been a significant step  for Bolivia who, like most developing 
countries, belonged only to a small number of intell ectual property agreements.  Therefore, countries 
like Bolivia would need more time to reflect befo re they could discuss enforcement matters, be it 
in this or other forums, in the manner proposed or in other ways to be decided upon. 
228. The representative of Venezuela  said that his delegation supported the statements made by 
Argentina, Brazil and India in considering that enfo rcement was not a relevant matter to be dealt with 
by the Council. 
229. The representative of Peru , while agreeing with the general c oncerns about piracy, shared the 
concerns raised by some other Members with rega rd to the appropriateness of the Council as a forum 
for discussing these issues.  Peru was trying to combat  piracy and establish a culture for the defence of 
intellectual property in order to st rengthen the markets and protect assets so that investment by foreign 
companies would be attracted.  Over a year ago, a new law had been passed to combat piracy which had increased the level of criminal punishment and ot her sanctions for the infringement of intellectual 
property.  A unit combating customs crimes in whic h various sectors participated had been established 
and the national institute for the defence of comp etition and intellectual property was making strong 
efforts to promote intellectual property rights.  IP/C/M/48 
 Page 43 
 
 
 230. It was his delegation's view that this effort by  Peru and other countries to protect and promote 
intellectual property rights of legitimate right owners  should be accompanied by a similar effort by all 
countries in the struggle against biopiracy, which caused incalculable damage and where there had 
been no similar response from developed countries.   These issues should be balanced and one could 
not demand commitments from others if one was not  prepared to make such commitments oneself. 
231. The representative of the European Communities  thanked Members for their comments and 
welcomed the agreement among Members that counte rfeiting and piracy constituted a problem.  It 
was very clear that the TRIPS Council was the appropriate forum to address this issue at the multilateral level and that it had a role in seeking so lutions to the problems identified, since it was at 
the WTO that the issue of IPR enfo rcement had started to be discussed.  With regard to delegations' 
concerns about a reinforcement of enforcement provi sions, he emphasized that this was not the focus 
of their paper and that most Members would be happ y with an effective implementation of the current 
provisions.  TRIPS-plus aspects, lik e customs controls for exports or  goods in transit, had only been 
listed in the paper because there was a critical mass of countries that already had such provisions in 
their laws and a discussion on their benefits could be of  interest.  It had not been the intention of his 
delegation to propose the rewriting of Chapter 3 of th e TRIPS Agreement.  He said that his delegation 
would reply to other comments at subsequent occasions. 
232. The Council took note
 of the statements made and agreed  to revert to the matter at its next 
meeting. 
O. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
233. The Chairman  informed the Council that, at its meeting on 20 April 2005, the Dispute 
Settlement Body had adopted panel reports on European Communities – Protection of Trademarks 
and Geographical Indications for Agricultural Products and Foodstuffs , complaints by the United 
States and Australia (IP/D/19/Add.2 and IP/D/25/Add.1). 
P. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
234. The Chairman  informed Members that, since its last meeting, the Council had received a 
request for observer status in the Council for TRI PS from the African, Caribbean and Pacific Group of 
States (ACP Group).  The letter from the ACP Group toge ther with its attachments had been faxed to 
Members on 27 May.  An updated list of the now 17 pending requests for observer status in the 
TRIPS Council by other intergovernmental orga nizations had been circulated in document 
IP/C/W/52/Rev.11. 
235. 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 th em.  The consultations he had held prior to this 
meeting on whether Members could agree on the new request by the ACP Group or whether there had been any developments in their thinking concerning the earlier pending requests had revealed that the 
situation remained that the Council would not be able to reach consensus on any of the pending 
requests at this point.  Therefore, he suggested that the Council agree to revert to the matter at its next 
meeting. 
236. The Council so agreed
. IP/C/M/48 
Page 44  
 
 Q. O
THER BUSINESS  
237. The Chairman  reminded the Council of certain reviews that would be on the agenda of its 
next meeting scheduled for 25 and 26 October.  The Council would hold the second annual review 
under paragraph 8 of the Decision on the Implementati on of Paragraph 6 of the Doha Declaration on 
TRIPS and Public Health and to report on its operation to the Genera l Council.  Secondly, it would 
take up its third annual review pursuant to paragr aph 2 of the Decision on the "Implementation of 
Article 66.2 of the TRIPS Agreement".  Thirdly, it  would take up its annual  review of technical 
cooperation.  Finally, it would have  on its agenda the fourth tran sitional review under Section 18 of 
the Protocol of the Accession of the People's Republic of China. 
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