RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/46 
11 January 2005 
 
 (05-0114) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard  
on 1-2 December 2004  
 
Chairperson:  Mr. Tony Miller (Hong Kong, China) 
 
The present document contains the record of  the discussion which took place during the 
TRIPS Council meeting held on 1-2 December 2004. 
Subjects discussed  Page nos.  
A. ELECTION OF CHAIRPERSON .......................................................................................................2  
B. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................2  
C. FOLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ALREADY 
UNDERTAKEN ..............................................................................................................................3  
D. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) .....................................................................4  
E. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY .............................................................................................................4  
F. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE ...................................................4  
G. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1..................20  
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................20  
I. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION 
ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH ..................................................................21  
J. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH  6 OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC 
HEALTH ............................................................................................................................... ......27  
K. SECOND ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ............................................28  
L. TECHNICAL COOPERATION AND CAPACITY -BUILDING ............................................................29  
M. REQUEST FROM MALDIVES FOR AN EXTENSION OF THE TRANSITION PERIOD UNDER 
ARTICLE  66.1  OF THE TRIPS  AGREEMENT ...............................................................................30  
N. NON-VIOLATION AND SITUATION COMPLAINTS ......................................................................30  
O. SPECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL ..............34  
P. TRANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION 
OF THE PEOPLE 'S REPUBLIC OF CHINA .....................................................................................34  IP/C/M/46 
Page 2  
 
Q.
 INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................50  
R. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............50  
S. ANNUAL REPORT TO THE GENERAL COUNCIL ..........................................................................50  
T. OTHER BUSINESS ......................................................................................................................50  
 
A. ELECTION OF CHAIRPERSON  
1. The representative of the Secretariat  recalled that, as the Council had been informed at its 
meeting in June, the former Chair of the Council had relinquished his post because of his return to his 
capital to take up new responsibilities.  At its meet ing of 20 October, the General Council had taken 
note of the consensus on a slate of names of chairper sons for certain WTO bodies.  On the basis of the 
understanding reached, he proposed that the Council for TRIPS elect Mr. Tony Miller from 
Hong Kong, China as its Chairman for the rema inder of the current term by acclamation. 
2. The Council so agreed  
B. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
3. The Chairman  drew attention to the latest Secretariat note reflecting the status of the 
notifications of laws and regula tions under Article 63.2 received from Members whose transitional 
periods under Article 65.2 or 65.3  had expired on 1 January 2000 or who had acceded to the WTO 
after that date which w as circulated as document (JOB(04)/117).  The note showed from which of the 
Members in question notifications had been received as at 3 September 2004.  Among the 
81 Members in question, there still remained th ree who had not yet submitted any notification 
concerning their implementing legislation.  These we re Papua New Guinea;  Saint Kitts and Nevis;  
and Saint Vincent and the Grenadines. 
4. Since its meeting in September, the Counc il had received a number of supplements and 
updates to earlier notifications of laws and regulati ons.  Pakistan had notified its "Trade Mark Rules 
2004";  Morocco had notified a decree relating to industrial property;  and Japan had notified its 
amended unfair competition law.  Furthermore, Bahr ain had notified its laws related to patents and 
utility models, trade secrets, and geographical indica tions, which were, for the time being, available 
only in the original language.  They would be ci rculated as soon as a version in an official WTO 
language was received.  These notifications were bei ng circulated in the IP/N/1/- series of documents. 
5. The Chairman urged those Members whose initia l notifications remained incomplete to 
submit the outstanding material without delay.  He  reminded other Members of their obligation to 
notify any subsequent amendments of their laws a nd regulations without delay after their entry into 
force. 
6. The representative of Morocco  said that his delegation had notified a decree implementing 
Morocco's industrial property law, which had been adopted.  The decree was to enter into force on 
18 December 2004.  Therefore, he requested the Secretariat to update document JOB/04/117, which 
indicated that Morocco's notification concerned partly draft laws. 
7. As regards notifications of contact points under Article 69, the Chairman  said that, since the 
Council's meeting in September, a notification of  a new contact point had been received from the 
Former Yugoslav Republic of Macedonia.  Furtherm ore, updates to contact points notified earlier had 
been received from Belgium, Bulgaria, Canada , Croatia and Madagascar (IP/N/3/Rev.8 and 
addendum 1).  There were now 121 Members who had notified contact points under Article 69.  IP/C/M/46 
 Page 3 
 
 
8. The Council took note  of the statements made. 
C. FOLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ALREADY 
UNDERTAKEN  
9. The Chairman  said that the Secretariat had update d its informal note that listed the 
outstanding material required to complete the reviews that the Council had already undertaken 
(JOB(04)/178).  The table attached to the note lis ted 15 Members whose reviews had been initiated at 
the Council's meetings since April 2001 but which remained on the Council's agenda.  The table 
referred to submissions, including both responses and follow-up questions, received by 26 November 2004. 
10. He recalled that, just prior to the Council's last  meeting, Pakistan had provided a response to 
the last outstanding question posed to it.  Since then , this response had been circulated in document 
IP/Q/PAK/1/Add.1.  He suggested that the regular re view of the legislation of Pakistan be deleted 
from the agenda, it being understood that any dele gation could revert to any matter stemming from 
this review at any time. 
11. The Council so agreed
. 
12. The Chairman  turned to the remaining 14 Members, namely Armenia;  Congo;  Cuba;  Egypt;  
Fiji;  the Former Yugoslav Republic of Macedonia;  Grenada;  Mauritius;  Qatar;  Saint Kitts and 
Nevis;  Saint Vincent and the Grenadines;  Suriname;  Swaziland;  and Zimbabwe. 
13. The representative of Egypt  said that he was coordinating with the authorities in the capital 
and that he would provide the outstandi ng responses in the very near future. 
14. The representative of  Zimbabwe  said that he would actively pursue the issue with the capital, 
but was yet not able to indicate when the information would be provided. 
15. The representative of Fiji  said she would contact her delegation in Brussels so that it could 
indicate when it would be able to prov ide responses to the outstanding questions. 
16. The Chairman  said that the Secretariat note also listed six Members whose reviews had 
already been deleted from the Council's agenda on the understanding that any delegation should feel 
free to revert to any matter stemming from the revi ew at any time.  In that connection, certain 
questions had been raised with regard to the impl ementing legislation of those countries.  Since the 
circulation of the note, China had provided respons es to all the follow-up questions posed to it by 
Japan (IP/Q/CHN/1/Add.3/Rev.1). 
17. The representative of Argentina  said that she had no new information to add to what she had 
already provided to the Council and that she di d not know when her authorities would submit the 
responses to the interested delegations and the Secretariat. 
18. The Chairman  urged the delegations concerned to pr ovide the outstanding material as soon as 
possible, so as to allow the Council to complete the follow-up to those reviews.  He suggested that the 
Council request the Secretariat to  write to those Members whose reviews were s till pending and to 
update its note on pending reviews befo re the next meeting, and that the Council revert to this matter 
at its next meeting. 
19. The Council took  note  of the statements and agreed  to proceed as suggested by the Chair . IP/C/M/46 
Page 4  
 
D. R
EVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
E. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL 
DIVERSITY  
F. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
20. The Chairman  suggested that, since the practice in th e Council's past meetings had been that 
delegates address the three agenda items together, the Council again take them up at the same time.  
He recalled that the Council had received, just pr ior to its last meeting, a submission from Bolivia, 
Brazil, India, Pakistan, Peru, Thailand and Venezu ela entitled "Elements of the Obligation to Disclose 
the Source and Country of Origin of Biological Re source and/or Traditional Knowledge Used in an 
Invention" (IP/C/W/429/Rev.1 and its addendum 1).  In concluding these agenda items at that 
meeting, the Chair had said that Members might wi sh to revert to that document at the present 
meeting, given that it had been circulated just prio r to that meeting.  Furthermore, the Council  had 
received three new submissions;  one from Switzer land entitled "Further Observations by Switzerland 
on Its Proposals Regarding the Declaration of the Source of Genetic Resources and Traditional 
Knowledge in Patent Applications (IP/C/W/433); another from the United States relating to these 
three agenda items (IP/C/W/434);  and a third from India on behalf of Bolivia , Brazil, Cuba, Ecuador, 
India, Pakistan, Peru, Thailand and Venezuela (subsequently circulated as IP/C/W/438).  
21. The Chairman recalled that, at its last meeting,  the Council had agreed that the future Chair 
would continue the consu ltations initiated by the former Chair on how future work on the three 
agenda items should be organized.  He said that, pu rsuant to this, he had held consultations on the 
matter.  However, the consultations had not yet deve loped to a point where he would have been able 
to put a set of suggestions to the Council at the present meeting. 
22. The representative of Switzerland , introducing its new submission (IP/C/W/433), said that his 
delegation had presented this submission to th e Working Group on the Reform of the Patent 
Cooperation Treaty (PCT) of WIPO in October 2004, elaborating further its proposals to amend the 
regulations under the PCT.  He recalled that the Swiss proposal was an amendment that would 
explicitly enable parties to the PCT to require pa tent applicants to disclose the source of genetic 
resources and traditional knowledge in patent appli cations.  The present submission contained further 
observations on these proposals and addressed in greater detail the formal versus  the substantive 
nature of the disclosure requirement, the optional versus  the mandatory introduction of the disclosure 
requirement in national legislation and the concep t of "source".  He said that his delegation was 
looking forward to continuing discussions on its proposals in WIPO's Working Group on Reform of 
the PCT, and was hopeful that progress on the issue c ould be made in due course.  He promised to 
keep the TRIPS Council informed about further activities of his delegation with regard to the 
proposals and any progress achieved in the Working Group on Reform of the PCT. 
23. The representative of the United States , introducing its new submission (IP/C/W/434), said 
that it was intended to assist progress in discussions pursuant to the mandate given to the TRIPS 
Council.  He said that the his delegation, like a significant number of WTO Members, saw no conflict 
between the TRIPS Agreement and the CBD and believed that the two Agreements could be 
implemented in a mutually supportive manner and that no amendment to the TRIPS Agreement was 
required.  He said that his delegation viewed w ith utmost caution any proposals that would add 
uncertainties in patent rights and could undermine th e role of the patent system in its primary 
purposes of encouraging innovation, technological progress and economic development.  Further, 
based on recent discussions in the TRIPS Council aimed at fulfilling the Doha Ministerial mandate, 
and written contributions submitted in that context,  Members appeared to share several broad policy 
objectives.  Those objectives included:  ensuring aut horized access to genetic resources, that is, that 
prior informed consent was obtained;  achieving e quitable sharing of benefits arising from use of  IP/C/M/46 
 Page 5 
 
 
traditional knowledge and genetic resources;  and preventing the issuance of erroneously issued 
patents.   
24. He said that new patent disclosure requireme nts would not work to guarantee that prior 
informed consent was obtained.  It must be re cognized that it was the relevant prior consent 
agreement itself, usually constituting a contract betw een two entities, and not a disclosure in a patent 
application that manifested prior informed consent.  A new disclo sure requirement in the patent 
system would not prevent misappropriation since tho se who had the intent to act in bad faith would 
not be deterred by disclosure requirements.  He st ated that a transparent prior informed consent 
regime was needed to ensure that a researcher or  collector knew where to go, who to contact and 
which persons were authorized to grant approval in  order to conduct his or her research and activities 
in an appropriate manner.  He said that the ex amples of misappropriation that had been cited by 
proponents of new patent disclosure requirements app eared to relate to the improper collection and/or 
use of genetic resources or traditional knowledge.  Cont rary to some assertions, he said that the act of 
patenting, per se , did not amount to misappropriation and that patent rights could be an effective tool, 
in conjunction with a benefit-sharing agreement, to transfer benefits.   
25. Similarly, a new disclosure requirement in the patent system per se  would not ensure that 
benefits were equitably shared with the provider of the traditiona l knowledge or genetic resources and 
that a mechanism to transfer benefits needed to be  established.  If a new patent disclosure requirement 
was adopted and a non-compliant disclosure was disc overed that would invalidate a patent or prevent 
a patent from being granted, any benefits from that invention would be greatly diminished.  If a patent 
were issued but later invalidated or if an appli cation were published but a patent never issued, the 
invention would have been disclosed to the public and third parties that could most likely use and 
commercialize the knowledge or resources disclosed without any obligation of sharing benefits.  
Further, if a patent were never issued and the in formation never published, th e patent applicant could 
still be able to commercialize the invention without disclosing the invention to the public and without 
any obligation to share benefits.  He added that  a new disclosure requirement could have further 
significant, unintended consequences where a patent a pplicant had entered into a valid benefit-sharing 
agreement with the custodians of the traditi onal knowledge or genetic resources but, due to 
uncertainties in the law, a disclosure could be found invalid.  He said that if, for example, there was improper disclosure that resulted in revocation of a patent due to litigation by a third party not 
affiliated with a traditional knowledge or genetic re sources holder, that would actually upset the pre-
existing benefit-sharing agreement.  A new pate nt disclosure requirement could fail to address 
benefit-sharing resulting from commercialization that occurred outside the patent system and could be 
meaningless if products derived from or based on traditional knowledge or genetic resources were 
commercialized but not patented. 
26. He said that the proposed new patent disclosure requirements would not only be ineffective in 
achieving the goal of preventing erroneously grante d patents but would also undermine an already 
overburdened patent system as none of the suggest ed new patent disclosure requirements aimed at 
ensuring compliance with patentabilit y requirements.  Information such as that indicating the country 
of origin or ex situ  collection sites would do little to ensure the ascertainment of appropriate 
inventorship, novelty or inventive step, because such information did not generally address the 
considerations underlying the requirements, such as act s of invention or the state of the relevant art. 
27. He added that new patent disclosure requireme nts would add new uncertainties in the patent 
system, particularly where the sanctions for non-co mpliance included invalidation of a patent.  That 
would create a "cloud" of uncertainty over the pate nt right by opening new avenues for litigation and 
in other ways that would undermine not only the ro le of the patent system in promoting innovation 
and technological development but al so any potential benefit-sharing. IP/C/M/46 
Page 6  
 
28. A new patent disclosure requirement could also lead to significant administrative burdens for 
the patent offices of Members.  It did not seem possible that patent examiners could make the relevant determinations with any degree of legal certainty, particularly decisi ons that involved interpretations 
of foreign laws to determine the validity of prior informed con sent or adequate benefit-sharing 
according to the custodian country's legal regime , thereby compounding the uncertainties both in 
granted patent rights and in the process of granting patents.  He added that the proponents of a new 
patent disclosure requirement had also wrongly assu med that it would be an effective monitoring 
system. 
29. Although his delegation shared many of the objec tives raised by various Members, it was not 
convinced that new disclosure requirements in patent  applications were an appropriate solution.  
Rather, the real challenge was how the objec tives could most effectively be achieved. 
30. With respect to the objective of obtaining a ppropriate access and benefit-sharing, he said the 
experience had shown that the most effective means to achieve this was through the development of 
national laws outside the patent system.  It was imperative that governments implemented laws that 
required prior informed consent from a clearly deli neated point of contact, such as the government 
and/or indigenous representatives, before a party sought to use or collect traditional knowledge or 
genetic resources.  Points of contact could incl ude the persons authorized to provide access to 
materials.  For example, countries could establish pe rmit systems that imposed civil and/or criminal 
penalties for extracting genetic resources without a permit, where such permits would serve as 
evidence of prior informed consent. 
31. Continuing, the representative of the United States said that a contract-based system could be 
used to effectively control the collection of resources  and ensure the sharing of benefits from their use 
as this could provide a great deal of flexibilit y in determining both m onetary and non-monetary 
benefit-sharing and on issues such as choice of law.   Contracts could also provide an effective 
monitoring system by requiring mandatory disclosure to appropriate authorities of any future commercial application utilizing the relevant trad itional knowledge or gene tic resource, whether 
patented or not.  A contract-based system, such as the kind described by his delegation in previous 
submissions to the TRIPS Council, could be easily ad aptable to other legal systems, and could provide 
countries the flexibility to protect their traditiona l knowledge or genetic resources without certain 
risks that they had mentioned. 
32. He noted that many Members had not yet implemented access and benefit-sharing regimes.  
He said that many proponents of disclosure re quirements did not challenge the necessity of an 
effective, contract-based, access and benefit-sharing regime but argued that patent disclosure 
requirements were needed to improve compliance wi th such mechanisms.  His delegation disagreed 
with such a policy approach as it was unnecessarily bu rdensome to the patent system.  Moreover, such 
a legal regime, if in force, could be  adequately enforced without resort to patent law requirements.  He 
said that effective enforcement re gimes for access and benefit-shari ng should be part of civil and 
criminal codes specifically designed to enforce acces s and benefit-sharing laws.  Patent law was not 
designed to regulate or enforce misconduct issues,  such as misappropriation of traditional knowledge 
or genetic resources, but to promote progress of useful arts.  He noted that restrictions could be placed 
and were placed on the use of certain inventions  to ensure safety and efficacy, to protect the 
environment or to protect domestic or national security .  He further noted that those restrictions were 
enforced outside the patent system by separate re gulatory mechanisms.  He said that the case had not 
been made as to why a contractual access and benefit-sharing system would not serve the purpose 
effectively, just as health and safety codes applie d to their spheres.  As was the case with other 
distinct regulatory systems, criminal provisions and/ or civil liability for failure to comply could be 
included in the country's laws for those few w ho took genetic resources without entering into an 
access agreement with the required party.  IP/C/M/46 
 Page 7 
 
 
33. He said that in order for the TRIPS Council to mo re fully consider the concerns raised by the 
proponents of disclosure requirements, Members c ould more fully examine national experiences with 
respect to access and benefit-sharing systems curre ntly in place in order to better understand the 
perceived shortcomings of such existing systems.  He suggested that the Council could consider the 
extensive work that continued in the Intergovern mental Committee on Intellectual Property, Genetic 
Resources and Folklore of WIPO, which had been spec ifically created to deal with many of these and 
related matters.   
34. His delegation agreed that it was important to prevent erroneously granted patents and noted 
that several tools could be, and were being, used to address such concerns.  Patent examiners world-
wide could use organized, searchable databases of  genetic resources and traditional knowledge when 
examining patent applications.  This could help in  the discovery of relevant prior art and thereby 
improve examination of patent app lications in the relevant fields.  He also said that Members could 
consider a provision, such as that used by his coun try, which required patent applicants to disclose 
any information relevant to patentability.  The info rmation was directly related to the questions of 
patentability and could help examina tion of patent applications in a manner that disclosure of source 
and/or origin of genetic resources or traditional knowledge could not. 
35. He said that implementation of post-grant opposition or re-examinati on proceedings could 
rectify the situations in which patents had been issued erroneously.  Those procedures were far less 
costly than litigation and could alert national pate nt authorities when new information was discovered 
that was relevant to the patentability of the inventio n.  He noted that a number of granted patents had 
been successfully challenged when  it was demonstrated, through opposition processes, that they 
should not have been granted.  Those included pa tents relevant to turmeric and neem in the 
United States and European patent offices.  He said  that his delegation was unaware that any of the 
perceived instances of misappropriation cited in the TRIPS Council involving a wrongful 
determination of inventorship or prior art which could not have been satisfactorily addressed by any 
means he had mentioned or that a patent disclosur e requirement for source and/or origin would have 
corrected. 
36. He said that the patent system had been and continued to be a highly effective tool for 
technological and economic developm ent and that the WTO should be wary of upsetting the delicate 
balance, particularly when it was doubtful that any suggested changes would actually achieve the 
stated objectives.  Rather than focus on propo sed new patent disclosure requirements, the TRIPS 
Council should focus with more precision on what  Members were trying to achieve, review past 
experiences and situations that prompted various concerns and consider an y appropriately tailored 
solutions.  As many of the broader objectives were widely shared, his delegation was confident that 
appropriate solutions could be reached to address the concerns of all Members. 
37. The representative of India  introduced the paper submitted by Bolivia, Brazil, Cuba, Ecuador, 
India, Pakistan, Peru, Thailand and Venezuela (IP/C /W/438).  He recalled that a group of Members, 
including the co-sponsors of the present document, had submitted a checklist of issues for facilitating 
discussion on the relationship between the TRIPS Agreement and the Convention on Biological 
Diversity (IP/C/W/420 and Add.1).  He also recalled that, at the last TRIPS Council meeting, this group had made a first submission pursuant to th e checklist entitled "Elements of the Obligation to 
Disclose the Source and Country of Origin of Biological Resources and/or Traditional Knowledge Used in an Invention" (IP/C/W/429/Rev.1).  That submission had addressed the first set of questions 
raised in the checklist.  The present submission a ddressed the second set of questions raised in the 
checklist relating to elements of the obligation to disclose evidence of prior informed consent under 
the relevant national regimes.  He said that the purpose of the present submission was to carry forward 
the process of facilitating a more focused, stru ctured and results-oriented discussion on the 
relationship between the TRIPS Agreement and the C onvention on Biological Diversity.  He said that 
the group was encouraged by the many constructiv e comments received on the first paper and noted 
that both submissions needed to be read together. IP/C/M/46 
Page 8  
 
38. He stated that the present submission addr essed five issues:  the first dealt with how 
furnishing evidence of prior informed consent woul d facilitate achievement of the objectives of the 
CBD and would specifically facilitate the monitoring , and along with other laws, the enforcement of 
the provisions of the CBD.  The objectives and princi ples of the TRIPS Agreement justified the need 
for evidence of prior informed consent to be ava ilable in the patent system, thus establishing a 
mutually-supportive and harmonious relationship between the CBD and the TRIPS Agreement.  The 
submission also explained why contractual arrange ments by themselves would not suffice since there 
was no obligation to legislate on the issue of prior in formed consent in international law, particularly 
for Members not party to the CBD.  While contract ual arrangements could have a role to play, the 
lack of an obligation to enter into or enforce a contract in the first inst ance made these insufficient 
both due to the unequal bargaining strength of the parties to a contract as well as due to the need for 
enforcement of such contracts outside the country  of origin of the biological resource and/or 
associated traditional knowledge. 
39. The second and third issues dealt with how the evidence of prior informed consent should be 
provided for.  He said that the submission recommend ed that this be done by obligating Members to 
require evidence of prior informed consent as a condition for acquiring patent rights.  Such 
requirements would not only be fully compliant with the TRIPS Agreement, but would be of 
significant advantage to patent applicants by f acilitating future access and reducing costs.  The 
submission recommended further that such an obligati on be discharged by a declaration in the patent 
application accompanied, where relevant, with the ev idence of prior informed consent, for example in 
the form of a certificate issued by a relevant nationa l authority.  He said that assuming that a patent 
applicant adhered to the law applicable to his ac tivities, he would not find it cumbersome to simply 
fill up another column in his application form and attach a certificate that he already possessed.  The 
fourth issue dealt with the situation where there w as no national prior informed consent regime in the 
country of origin.  He said that in such a situation, the applicant would simply state the fact and in cases where consent had been nevertheless obtained from  the authority or community in charge of the 
location where he had accessed the resource and/or tr aditional knowledge,  inform of such consent. 
40. The final part of the submission dealt with the legal effect of not providing evidence of prior 
informed consent.  At the stage of processing of the patent application, the legal effect could be that 
the processing of the application would be delayed until the necessary declaration and evidence of 
prior informed consent reached the authorities.  He said that the type of time-limits that could be 
introduced and the penalties that would ensue before the application would be deemed to have been 
withdrawn could be discussed further.  However, di scovery of the failure to have provided evidence 
of prior informed consent once the patent had been granted would involve revocation of the patents.  
Outside the patent system, other administrative, civil or criminal sanctions could also follow.  He said 
that the co-sponsors of the paper were ready to discuss how such legal effects could be further 
developed and whether judicial review as a mech anism to implement those concepts could be 
explored.  He said that conceptually the objectiv e was that deterrent, compensatory and equitable 
consequences should flow from any non-adherence to  the obligation to obtain prior informed consent 
or furnish evidence thereof. 
41. Turning to other submissions, the representative of India noted the usefulness of documents 
IP/C/W/433 and IP/C/W/434 and said that his dele gation would provide detailed comments on these 
at the next TRIPS Council meeting.  He said that th e characterisation of the ultimate objective of the 
group of developing countries as "new patent disclos ure requirements" connoted a disconnect with the 
existing disclosure requirements in the TRIPS Agreem ent and this was not the case.  He said that it 
was necessary to clarify which of the stated a nd commonly agreed objectives were addressed by the 
existing disclosure provisions and how they could be changed so as to address the balance of 
objectives.  He said that, for the group, an overarchi ng objective was to ensure certainty that their 
genetic resources were not misappropriated and that  their traditional knowle dge and art were not 
usurped.  IP/C/M/46 
 Page 9 
 
 
42. Addressing concerns raised in the paper from the United States (IP/C/W/434), particularly in 
its paragraph 10, he said that there was an inextr icable link between the objectives of the disclosure 
requirement and that of prior informed consent and access and benefit-sharing.  For example, in addressing the prior informed consent issue, the propo sal of the group ensured that the act of patenting 
did not encourage misappropriation, thus making it an  effective tool to arrest misappropriation.  
Similarly, in addressing the benefit-sharing objectiv e, the proposal was a means to avoid monopolies 
being created where none were envisaged in the patent  system, thus allowing the market forces to play 
their role.  He stated that existing disclosure requi rements already helped in preventing bad patents by 
providing means for examiners to investigate issu es like inventorship, nove lty and non-obviousness, 
areas clearly within their mandate in any patent sy stem.  He said that what was being suggested was 
additional to what already existed in the TRIPS Agreement.  He disagreed with the assertion in 
document IP/C/W/434 that national systems could and should take care of the objectives.  His 
delegation had already stated that the post-grant oppo sition or re-examination proceedings were costly 
and had pointed out that there had been misa ppropriation cases addressed under the existing patent 
regime through tortuous, costly, long winded, pos t-grant revocation proceedings during which time 
the true right holders of genetic resources or traditional knowledge continued to suffer. 
43. The representative of th e European Communities
 recalled that, at the last meeting, his 
delegation had informed the Council that it was worki ng internally on the issue of disclosure of origin 
of genetic resources and traditional knowledge in pate nt applications.  He reported that his delegation 
would submit effective, balanced and realistic proposals for the introduction, at the global level, of a 
disclosure system to WIPO by the end of the year, as had been announced at the WIPO General 
Assemblies in September 2004.  He said that this proposal built on the concept paper that had been 
submitted to the TRIPS Council in September 2002 and would be characterized by the principle that 
disclosure in patent applications of the country of  origin of genetic resources should be a mandatory 
requirement and not an option.  Further, the di sclosure requirement should apply to all national, 
regional and international patent applications a nd the system envisaged should be as simple as 
possible and not lead to unnecessary administrative bu rdens for patent offices and applicants.  He said 
that his delegation would keep the Coun cil informed of any new developments. 
44. Commenting on document IP/C/W/434, he said that his delegation like that of the 
United States, believed that there was no conflict between the TRIPS Agreement and the CBD and that both instruments could be, and should be, im plemented in a mutually-supportive manner.  His 
delegation supported the three broad policy objectives highlighted in the document and said that his 
delegation could support several other ideas.  For example his delegation be lieved that sound national 
regulations on access and benefit-sharing were esse ntial to guarantee legal certainty for all parties 
involved in order to protect the rights of providers of genetic resources.  In this respect contractual 
arrangements also had an important role to play. 
45. He said that while the introduction of new patent disclosure requirements was certainly not 
the only solution to achieve the stated objectives, it was a tool that could contribute to a solution along 
with other elements.  He underst ood the concerns in document IP/C/W /434 with regard to the possible 
negative impact that the introduction of patent di sclosure requirements c ould have on the patent 
system as a whole and believed, like the United States,  that the patent system should continue to be a 
highly effective tool for technological and economic development.  The view of his delegation was 
that the introduction of patent disclosure require ments would not necessarily be burdensome to the 
patent system, to patent offices or to applicants.  He said that in the proposal his delegation was 
working on, the patent applicant would be require d to declare the country of origin of genetic 
resources if the applicant was aware of it and that no additional research on the applicant's part would 
be required.  The patent office would not be re quired to make any assessment on the content of the 
disclosed information and its role would be limited to examining wh ether the formal requirements had 
been fulfilled and whether the applicant who decl ared that the invention was based on genetic 
resources had subsequently disclosed the information.   In order to facilitate the monitoring of the 
respect of any benefit-sharing arrangements, patent  offices would be required to notify the disclosed IP/C/M/46 
Page 10  
 
information to a centralized body.  The introduction of such measures, should not lead to unnecessary 
administrative burdens for the patent offices. 
46. In  his delegation's view, issues relating to disclosure of source and origin were prime 
candidates to move the discussion forward and cons tituted an area where there were possibilities for 
convergence of views.  He said that document IP/C /W/429/Rev.1 had raised relevant points on which 
his delegation could comment without prejudice to th e outcome of his delegation's internal reflection 
on the issue and to his delegation's position in a possible formal negotiation process in the WTO or 
elsewhere.  He said that his delegation consider ed that a disclosure requirement, provided it was 
properly calibrated, would positively contribute to the mutual supportiveness between the intellectual 
property systems and access and benefit-sharing re gimes.  He said it would help the countries 
providing access to genetic resources to monitor comp liance with access and benefit-sharing rules as 
well as with the contractual arrangements between  providers and users of genetic resources as 
facilitated by information received through foreign patent offices.  It would increase confidence 
among bio-collectors, whether private enterprises or research centres, and biodiversity-rich countries and indigenous communities and would generate le ss complex or burdensome and more effective 
access and benefit-sharing regimes, thus creating a win-win situation for both providers and assessors.  
It would help prevent inappropriate patenting of genetic resources or traditional knowledge by 
allowing patent offices to establish prior art more  accurately by making more focused searches and 
would act as a strong incentive for patent applican ts to comply with domestic rules on access and 
benefit-sharing, where they exist, and/or contractual arrangements. 
47. It was the view of his delegation that to trigge r the disclosure obligation, the genetic resource 
had to form part of the claimed invention or have  been necessary for the development resulting in the 
invention.  In other words, the invention would not have been made without the genetic resource.  He 
said that the proposal in document IP/C/W/429/Rev.1 that any use would be sufficient to trigger the 
disclosure obligation, even cases of incidental use, went too far.  Regarding the administrative and 
cost burdens, he said that document IP/C/W/429/Rev.1 stated that the applicant should have at least 
employed all reasonable measures to determine the or igin of the material.  It was the view of his 
delegation that it could be burdensome for the applican t if he had to carry out further research.  He 
noted that document IP/C/W/429/Rev.1 did not examine the possible impact of the disclosure obligation on the patent office and that it would be interesting to know what the envisaged role of the 
patent offices would be.  For example, how woul d they verify whether the patent applicant had 
obtained the relevant material in a way compatible  with access and benefit-sharing and prior informed 
consent rules?  He said that it was the view of his delegation that the role of patent offices should be 
limited to the strict minimum.  He said that the a pplicant should be requested to provide all reasonably 
available evidence of the source or origin of the genetic resource or traditional knowledge and it 
should be up to those who wished to contest such di sclosure in an administrative procedure or before 
a court to provide proof of the contrary, in accord ance with the usual rules of law on the burden of 
proof. 
48. Regarding the nature of the obligation, he said that the interest of the distinction between 
substantive and formal requirements lay in the co nsequences of non-respect of that obligation.  
Regarding the legal effect of wrongful disclosure or non-disclosure, he noted that several proposals 
had been made, ranging from far-reaching sanctions with in the patent system to sanctions outside the 
ambit of patent law.  His delegation's view was th at a requirement could only be effective if its non-
respect gave rise to sanctions but that, at this stag e, it believed that such sanctions should lie outside 
the ambit of patent law using, for example, civil or administrative sanctions. 
49. Regarding the manner in which the proposed obligation of disclosure of source or origin 
should be introduced in the TRIPS Agreement, he sa id that at the present stage his delegation had no 
views on the issue.  However, if the possibility of inserting a disclosure obligation in the TRIPS 
Agreement were envisaged, such an obligation had to  be properly calibrated.  As to how and where 
such a requirement could fit in the TRIPS Agreement,  he said that this was a technical issue which his  IP/C/M/46 
 Page 11 
 
 
delegation did not consider to be  important at the present stage since the answer would depend upon 
what was agreed on in substance. 
50. The representative of Peru  said that the requirement of prior informed consent accepted by all 
Members would enable Members to ensure compliance with the requirements of Article 15 of the CBD and would also ensure transparency in the ad ministrative procedures for the grant of a patent.  
Thus, it would ensure that patents were being obtai ned legally and ensure legitimate access to genetic 
resources and/or traditional knowledge being used in a new invention.  He said that the submission by 
the United States, laying out specific common objectiv es to be pursued in the Council, demonstrated 
good progress in continuing the debate even though ther e were no new arguments in the paper.  He 
said that his delegation did not understand why, as stated in paragraph 3 of the document, national 
laws were stated to be the best way of guarant eeing access and benefit-sharing.  He pointed out that 
his country had one of the most progressive legislations dating back to 2002, but his country was suffering from cases of bio-piracy and that, in the absence of international obligations, it would be 
very difficult for the problem to be addressed.  Hi s delegation did not believe that contracts could 
solve the problems with respect to bio-piracy as th ese were between private individuals and if illegal 
acts of bio-piracy were carried out, he did not thi nk that such individuals w ould sit down to negotiate 
and sign a contract with those who held tr aditional knowledge or genetic resources.  
51. With respect to paragraph 11 of IP/C/W/434 that rules outside the patent system on 
commercial confidentiality and competition may help, he  said that while marketing of a product could 
be monitored and controlled by these rules, it had nothing to do with the patent system per se .  The 
disclosure requirement under the patent system was in tended to ensure that if one knew of the origin 
of a given resource, failure to disclose would not meet the various requirements for the granting of a 
patent.  Further, he noted that from Part V onwar ds, the United States had presented various options 
which would prevent the granting of erroneous pa tents, including the existence of organized 
databases, information on patent ability and post-grant opposition or re-examination procedures.  He 
pointed out that Peru had databases and carried out searches and shared all possible information 
before a patent was granted, but  that did not solve the problem.  Further, in various cases of 
misappropriation in Peru, they had used administ rative measures such as post-grant opposition or 
re-examination of certain patent applications  but found such administrative measures were 
burdensome.  It was also very difficult for the hol ders of genetic resources and traditional knowledge 
in developing countries to go to different jurisd ictions and ask for opposition because the costs were 
high.  He said that there could be a much lower burde n if there was an obligation to declare the origin.  
Regarding the suggestion by the United States that disclosure would not prevent misappropriation, he 
noted that if all applicants respected their duties a nd obligations, this would be the case.  He said that 
Members were trying to improve the current system  and the requirement of disclosure would help in 
improving what was available and guarantee a better system which would make it more difficult for 
those involved in acts of misappropriation and benefit the victims of such acts. 
52. The representative of Korea
 said that his delegation believed that there was little possibility 
for conflict between the TRIPS Agreement and the CBD and that these could be implemented in a 
mutually supportive way.  Implementation at the national level was the most important element in 
ensuring the effective functioning of the two legal in struments.  Consideration of the issue in the 
TRIPS Council should take into account work in othe r relevant international organizations, such as 
WIPO, in order to avoid unnecessary duplication of work. 
53. Regarding the submission by the group of developing countries in IP/C/W/429/Rev.1, his 
delegation was not convinced that there was any n eed to amend the TRIPS Agreement at present to 
provide for the requirement of disclosure of the s ource and country of origin of genetic resources or 
traditional knowledge.  Such a requirement would not  ensure that the CBD was implemented in an 
effective way.  In many cases inventions that had utilized biological or genetic resources and 
traditional knowledge were from more than one coun try of source and it was therefore difficult for 
patent authorities to verify the authenticity of info rmation provided.  Efforts by patent authorities to IP/C/M/46 
Page 12  
 
verify the information would impose a great amount  of administrative and financial burden.  The 
TRIPS Agreement already had provisions that allo wed Members to take measures in accordance with 
the CBD and Articles 29 and 62.1 have been mentione d in this context.  His delegation supported both 
the United States and Swiss submissions.   
54. The representative of Canada 
said that the relationship between the  TRIPS Agreement  and the 
Convention on Biological Diversity , as well as the protection of traditional knowledge and folklore, 
were of clear importance to hi s delegation.  His delegation be lieved that Members' renewed 
commitment to paragraphs 12 and 19 of the D oha Declaration in the July 2004 Framework 
Agreement, as well as recent discussions in WI PO's Intergovernmental Committee on Genetic 
Resources, Traditional Knowledge and Folklore (IGC) , demonstrated that other WTO Members also 
shared that view.  The importance of preventing misappropriation in the collection and/or use of 
genetic resources and traditional knowledge was wi dely recognized and his delegation supported 
finding a way forward.  He said that the complex nature of the issues could benefit from a more structured discussion in TRIPS Council, provided that  it did not lead to a duplication of demands on  
Members' resources.  Purposeful discussions in TR IPS Council on the issues should not supplant the 
useful, substantive work that was already ongoing at the WIPO's IGC.  Rather, the technical work 
done in the WIPO committee could continue to inform the discussion at the WTO. 
55. On the specific matter of patent disclosure, he  said that the number of proposals already on 
the table underscored that the concern about misappropriation and "bio-piracy" was widespread 
amongst both developing and devel oped countries as the issue was of importance to the many 
providers and users of genetic resources and trad itional knowledge.  He noted that the approaches 
suggested in each of the proposals were quite distin ct and that each proposal had some merit and each 
raised some concerns.  It was the view of his delegation that one way of  advancing understanding at 
the present stage, and moving beyond the political deadlock, would be for the TRIPS Council to undertake an in-depth, "diagnostic" examination based on the various disclosure proposals put 
forward.  That is, an examination of how the manda tory, voluntary and contract approaches, as well as 
any other proposals that would be submitted in the fu ture, could have addressed the high-profile, real-
world complaints about so-called "bad patents" on, for example, neem, turmeric and basmati rice.  He 
said that it would be helpful if the Members advoc ating each proposal submitted facts and evidence 
indicating how their respective proposals on patent  disclosure would have addressed or remedied 
those real world situations if their proposals had be en in place at the time.  In addition to providing 
Members with a useful basis for comparing the effectiveness of those proposals, his delegation 
considered that such a diagnostic analysis would provide the TRIPS Council with valuable, fact-based 
insights into how best to respond to common c oncerns about misappropriation and "bio-piracy". 
56. His delegation was currently undertaking a domestic  review in the area.  He pointed out that, 
at the international level, WIPO continued to work on examining the interrelation between access to 
genetic resources and disclosure requirements in inte llectual property rights' a pplications, including in 
response to an invitation from the CBD.  He said that his delegation hoped to be in a position to 
submit a paper to WIPO on the i ssue before the end of the year. 
57. The representative of Colombia 
said that her delegation supported an amendment of the 
TRIPS Agreement requiring patent applicants to disclose the origin of the genetic resources and 
provide evidence of prior informed consent and be nefit-sharing so as to avoid bio-piracy at the 
international level.  She supported document IP/C/W/429/Rev.1 that, while pointing out the 
shortcomings of the existing approach, recommended making it compulsory to disclose the source and 
country of origin of the genetic resources used in inventions.  This would make it possible to identify 
whether the patent application corresponded to a true  invention and not just a discovery by making the 
information available on genetic resources on a syst ematic basis.  Her delegation was open-minded 
about discussing the best possible way of amending the TRIPS Agreement.  She said that IP/C/W/438 
could further contribute to better structuring discu ssions in the TRIPS Council and that her delegation 
would make further comments on it in the near future.  IP/C/M/46 
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58. The representative of New Zealand said that her delegation thought it important to have 
discussions on the issues in a structured manner that would enable all suggestions or approaches to be considered.  She said that one issue where there ap peared to be scope for progress and on which work 
could be focused was disclosure.  Her delegation considered that the contract-based approach 
suggested in document IP/C/W/434 and the possibility  of disclosure in applications for patents or 
plant variety rights, as suggested by the group of developing countries, were not mutually exclusive.  
While the contractual approach could be useful th ere was certainly merit in considering additional 
mechanisms, such as disclosure, in support of CBD objectives. 
59. In response to document IP/C/W/434, her delega tion agreed that there was no direct conflict 
between the TRIPS Agreement and the CBD as it was possible to implement both instruments 
consistently.  Her delegation however saw the poten tial for a conflict and recognized that it might be 
possible to implement the two Agreements inconsis tently.  This meant that there was need for a 
discussion on the relationship between the two Agreem ents and on the various ways that they could 
be implemented in a mutually-supportive and flexib le way.  Her delegation also agreed with 
document IP/C/W/434 that disclosure in patent or plant variety rights applications alone would not 
ensure that prior informed consent was obtaine d and national access and benefit-sharing systems 
should first and foremost be established to enfor ce prior informed consent criteria and sanction any 
abuses.  She stated that her delegation did not find "b io-piracy" a useful term in relation to intellectual 
property and patenting of inventions based on genetic resources was not, in and of itself, 
misappropriation.  For the most part "misappropr iation" in the access and benefit-sharing context 
related to improper collection or use of genetic resources or traditional knowledge, not the act of 
patenting per se .  
60. She said that her delegation also saw potential me rits in some of the proposals included in 
documents IP/C/W/429/Rev.1 and IP/C/W/438 and wa s interested in considering whether and how 
disclosure through the intellectual property system  could supplement or support access and benefit-
sharing systems, including prior informed consen t requirements, in addition to the contractual 
approach and other legal or administrative sanctions .  It would be interesting to explore further how 
the existing flexibilities in the TRIPS Agreement could be used to support disclosure of origin in the 
patent system.  Disclosure in patent or plant vari ety rights applications was not a solution in itself as 
intellectual property could only play a modest  supporting role, perhaps in monitoring and 
transparency in relation to benefit-sharing and prior informed consent.  In regard to the proposals on 
enforcement of prior informed c onsent and access and benefit-sharing, the view of her delegation was 
that this was not the role of the intellectual pr operty system and such proposals would not necessarily 
achieve the intended objectives. 
61. She said that WIPO's IGC had a very important ro le to play in the process and that, while her 
delegation was willing to explore the issue in the WTO context, Members should be careful and avoid 
unnecessary duplication and try and take full advantag e of valuable work of WIPO's IGC.  Her 
delegation supported the proposal by Canada of an in -depth diagnostic approach as a way to assist the 
development of the various proposals on the table. 
62. The representative of Australia 
said that his delegation saw no conflict between the TRIPS 
Agreement and the CBD and said that the two Agreements could be implemented in a mutually supportive manner.  He said that his delegation shared the three objectiv es outlined in document 
IP/C/W/434 and thought it was useful to approach  the questions from the perspective of shared 
objectives.  He noted that there were differences be tween delegations on the issues but that there were 
also points of agreement that needed to be recogni zed.  He noted that there had been difficulties in 
coming to a common understanding on the nature of the problems to which certain amendments to the TRIPS Agreement had been proposed as solutions.  He pointed out that one way of coming to a 
shared understanding of the problems would be by taking a closer look at real-life experiences of 
countries that had tried to implement disclosure syst ems.  The practical focus would help in achieving 
progress on the issue by establishing where there were real problems and how best to address them.  IP/C/M/46 
Page 14  
 
He said that his delegation was interested in knowin g more about the experiences of countries that had 
implemented the disclosure system to find out how effective these systems were, whether or not there had been particular problems or successes and what users and owners of kno wledge thought of the 
system.   
63. He informed the Council that his country was still in the process of implementing an access 
and benefit-sharing regime, including an inte rgovernmental agreement on genetic resources 
management, for controlling access to and the use of genetic resources on commonwealth lands and 
waters.  This system included measures to ensure that any benefits arising from the use of such 
resources would be equitably shared.  He said that  his delegation took seriously the need to prevent 
the issuance of erroneous patents and, to this end,  Australia had recently amended its Patents Act to 
increase the information available to the Commission er of Patents regarding the patentability of an 
invention.  He said that the amendments required a pplicants to provide the results of searches carried 
out by or on behalf of foreign patent offices in relation to corresponding appl ications.  That change 
was one of a number of amendments that had been  made domestically to try to ensure as far as 
possible that the Australian Patent Office only grante d patents for inventions that met the patentability 
requirements.  
64. His delegation noted that some useful work had been done in WIPO on the recognition of 
traditional knowledge and genetic r esources in the patent system.  The WIPO Secretariat had received 
over 50 responses to a questionnaire it had issu ed on the matter which could provide useful 
information on existing measures for identifying re levant traditional knowledge  and genetic resources, 
thereby helping to prevent patent offices from granti ng erroneous patents.  He said that the work in 
the IGC continued to be central to the overall way in  which work would be taken forward, particularly 
given its technical nature. 
65.  Regarding document IP/C/W/429/Rev.1, he sai d that it was not clear to his delegation how 
linking the introduction of a mandatory disclosure re quirement with the possible effects of wrongful 
disclosure, as outlined in paragra ph 13, would address the problem of  bio-piracy.  He said that, as 
Canada had suggested, it would be helpful if an ill ustration of how such a provision would work in a 
specific instance, for example in th e case of the neem tree were provide d.  Referring to paragraph 5 of 
document IP/C/W/429/Rev.1, he questioned how the me thod of disclosure outlined in the paper would 
prevent the system from suffering from cost problems, pa rticularly in the resolution of disputes arising 
under such a system.  Further, referring to paragra phs 8 and 10 of the same document, he asked the 
co-sponsors to clarify whether the standard of pr oof would be a subjective one, that is what the 
patentee knew, or an objective test, that is what the patentee ought to have known. 
66. He said that the national experiences so far indicated that there was no one-size-fits-all 
solution to the various problems associated with ac cess and benefit-sharing of genetic resources.  He 
said that his delegation was not closed to a discussion of the role that the patent system could play as 
part of a possible solution, but that there were also other approaches equally deserving of attention 
and all options needed to be taken into account. 
67. The representative of Kenya 
associated his delegation with the statement made by India on 
behalf of the group of developing countries a nd those made by other delegations in support of 
document IP/C/W/438.  He said that his delegati on believed that the CBD and the TRIPS Agreement 
should be mutually-supportive, especially when it came to implementation of the two agreements.  
His delegation was advocating a system that would guarantee benefit-sharing between patent holders 
and owners of genetic resources used in patents under an enforceable legal framework such as the 
TRIPS Agreement.  He said that such a system w ould guarantee that a patent office could refuse to 
grant a patent if the disclosure requirements were  not complied with at the time of making the 
application.  Such a system w ould guarantee that a patent grante d could be revoked on the ground that 
disclosure requirements had not been not met at the filing of the application.  He said that contracts 
could not substitute such a system because the greater  majority of owners of genetic resources were  IP/C/M/46 
 Page 15 
 
 
not aware of the benefits of their resources, let alone of the patent system.  It was the view of his delegation that governments had an obligation to protect owners of genetic resources by availing 
themselves of systems that would guarantee such protection. 
68. He observed that in the patent system there w as no need to ascertain the authenticity of all 
information that was provided as part of the disclosure requirement during the filing of the 
application.  In case the information was not accura te and a patent was granted based on information 
available at the time of filing, the patent system allowed for revocation of that patent on the ground 
that the information was not accurate.  That deterre d applicants from providing inaccurate information 
because they risked the patent being revoked after grant. 
69. The representative of China 
said that his delegation supported and associated itself with the 
joint proposal (IP/C/W/429/Rev.1) and believed that th e elements mentioned in the proposal could be 
a good basis for future discussions.  He said that his delegation endorsed the proposal that where there 
was failure to meet the disclosur e requirements, the patent appli cation should be deemed withdrawn 
or rejected and any patents already granted should be invalidated.  He noted that the proposals in document IP/C/W/429/Rev.1 provided specific sugg estions on how to implement the disclosure 
requirements that his delegation supported and calle d on other Members to establish their own access 
and benefit-sharing system after fully evaluating th eir specific needs as this would facilitate further 
discussions and eventually the conclusion  of relevant international rules.  
70. Regarding the discussion on the relationship be tween the TRIPS Agreement and the CBD, he 
said that Members should focus not only the positive ro le of biotech developm ent and its intellectual 
property protection, but also on the protection of bi odiversity itself.  It was necessary to amend the 
TRIPS Agreement to support the CBD because it did not  adequately consider principles of national 
sovereignty, prior informed consent and access and benefit-sharing as provided for in the CBD.  He 
said that the international commun ity should focus more on countries with abundant biodiversity and 
establish reasonable and balanced mechanisms. 
71. The representative of Chinese Taipei
 said that her delegation appreciated the constructive 
suggestions made so far on the review of the provi sions of Article 27.3 (b) and said that, even though 
there were differences in approach, the concepts were helpful and could be developed further when 
Members reflected on the possible mechanism to im plement such concepts.  Regarding document 
IP/C/W/429/Rev.1 she sought clarification of the crit erion of "insufficient, wrongful or no disclosure" 
where legal effects were proposed in paragraph 12 of the document.  She questioned how the 
examiner would evaluate whether or not the requi rement had been met where the applicant had not 
provided any information on the disclosure of source and/ or country of origin of biological resources.  
She noted that a number of Members already requi red such disclosure and expressed the need for 
sharing of experiences in this regard.  Finally, sh e noted the Swiss proposal to amend the regulations 
of the Patent Cooperation Treaty (PCT) of WIPO and pointed out that not all WTO Members were 
Contracting Parties in WIPO and questioned how such WTO Members would implement an 
agreement or decision concluded in WIPO. 
72. The representative of Norway said that the contributions from United States, Switzerland, and 
the two papers from the group of developing coun tries were useful contributions on which her 
delegation would comment in detail at  the next TRIPS Council meeting.  
73. The representative of Switzerland  said that the declaration of the source of genetic resources 
and traditional knowledge in patent applications as pr oposed by his delegation, in the context of the 
work of WIPO's PCT reform group, would allow States that were party to a contract on access and 
benefit-sharing to verify whether the other cont racting party was complying with its obligations 
arising under that contract.  This would not only f acilitate and support the enforcement of contractual 
obligations but would also allow verification of whether prior informed consent of the country 
providing the genetic resources had been obtained, a nd whether  provision had been made for fair and IP/C/M/46 
Page 16  
 
equitable benefit-sharing.  The Swiss proposal w as intended not only to increase transparency in the 
context of access and benefit-sharing but also to build trust among the various actors involved.  He 
pointed out that, should patent applicants additi onally be required to provide evidence of prior 
informed consent and fair and equ itable benefit-sharing in patent a pplications, they would have to 
submit double and triple the amount of information th at would bring little advantage to the contracting 
parties of the contract regulating access and benefit- sharing.  Furthermore, a number of practical and 
legal problems would arise, which he said were addr essed in greater detail in paragraphs 13-19 of his 
delegation's submission, IP/C/W/400/Rev.1 
74. Commenting on IP/C/W/429/Rev.1, he said that it was the view of his delegation that it 
should be left up to the national legislator to deci de whether such a requirement would be introduced 
in the national patent legislation or not.  That opt ional nature of the disclosure requirement had been 
chosen because of the great divergence in the vi ews on transparency measures, and because the 
discussions on disclosure requirements at the interna tional level have not brought any final results.  
Such a requirement would allow the national govern ments and the international community to gain 
experience, without prejudice to further internationa l efforts.  He pointed out that his delegation was 
proposing a formal disclosure requirement and that  the current provisions of the TRIPS Agreement 
were flexible enough to allow its introduction.  He  noted that paragraphs 12 and 13 of document 
IP/C/W/429/Rev.1 addressed the possible legal effects of failure to disclose or wrongful disclosure of the source in patent applications disc overed either prior to or after the gr ant of a patent.  In the view of 
his delegation, the sanctions currently allowed fo r under the PCT and the PLT could apply to such 
cases.  With regard to the sanctions called for in paragraph 13 of document IP/C/W/429/Rev.1, his 
delegation held the view that those legal effects were already possible under current patent legislation.  
He referred Members to paragraphs 24 to 26 of document IP/C/W/423 for a more detailed analysis of 
the possible sanctions for failure to disclose or wr ongful disclosure of the source advocated by his 
delegation. 
75. Commenting on IP/C/W/434, he said that the issues of access and benefit-sharing could not 
be fully resolved through a contract-based approach  alone.  This applied in particular to cases where 
no contract on access and benefit-sharing was conc luded and to cases of trans-boundary use of genetic 
resources and traditional knowledge.  A ccordingly, contracts alone could not deter those with intent to 
act in bad faith.  He pointed out further that Artic le 15, in paragraphs 4 and 7, of the CBD required 
access and benefit-sharing to be on mutually agreed  terms, which would generally be laid down in 
contracts.  Thus his delegation di d not challenge the contract-based  approach.  However, measures 
increasing transparency, in particular the disclos ure of source as Switzerland proposed, could further 
facilitate the operation of the system.  Requiring the disclosure of source in patent applications was 
only one measure among a large number of other mostly non-intellectual property measures which could assist access and benefit-sharing.  While disclos ing the source in patent applications would not 
be sufficient to resolve all issues,  in combination with those other measures it presented a simple and 
effective measure to help access and benefit-shar ing.  His delegation shared the view of the 
United States that post-grant opposition or re-examina tion of granted patents had been used in cases 
such as the neem tree and clearly showed that th e patent system worked well.  In such cases, 
disclosing the source of genetic resources or trad itional knowledge would, ho wever, have simplified 
the task of those intending to oppose such patents or to request their re-examination. 
76. In order to further improve the effectiveness and facilitate the operation of the disclosure 
requirement, his delegation proposed that patent offices transmit the information disclosed to the 
national authority of the country competent to re ceive such information.  The list of competent 
national authorities could be maintained by WIPO, in close cooperation with the CBD.  By making 
the list available on the internet, patent offices woul d have easy access to it and could, without much 
administrative burden or cost, provide the competent national authority with the information.  He said 
that, contrary to what was stated in IP/C/W/ 434, the proposal was not made because his delegation 
recognized the shortcomings of the disclosure of th e source requirement.  He said that his delegation 
agreed with the United States that it would be be neficial to the Council's discussion on the issues  IP/C/M/46 
 Page 17 
 
 
mentioned in paragraph 19 of the Doha Declara tion, if, by examining national experiences with 
respect to access and benefit-sharing systems curre ntly in place, the Council could gain thorough 
understanding of the problems and shortcomi ngs that proponents faced in practice.  
77. The representative of Japan  said that although disclosure of origin of genetic resources was 
one of the issues being discussed, the discussions shou ld not be limited only to that issue under these 
agenda items.  It was the view of his delegation that the checklist approach in document IP/C/W/420 
was not the best because the scope of the list was not  broad enough to cover all concerns.  The most 
appropriate forum to deal with the issues was the IGC of WIPO.  Under the patent system, there were 
reasons why disclosure was necessary in patent a pplications, either as a formal or substantive 
requirement, as these were directly related to evaluate  the patentability of invention or useful for prior 
art searches in the course of examination.  He said that information not related to the grant of patents 
was not required to be disclosed.  His delegation saw no reason why disclosure of origin of genetic 
resources was necessary in a patent application fo r the grant of a patent.  Even without such 
disclosure, examiners could examine an applicatio n to determine patentability.  He said that his 
delegation shared many of the views put forward by  the United States and supported the proposal by 
Canada to have an in-depth diagnostic approach. 
78. The representative of Brazil  said that the WTO remained the best-placed, neutral and 
appropriate forum to address the issues under the ag enda item.  His delegation associated itself with 
the statement delivered by India on behalf of a nu mber of developing countries, including his own, 
introducing document IP/C/W/438.  He said that th e position of his delegation regarding the first and 
second issues listed in the checklist were set out both in submission IP/C/W/429/Rev.1 and 
IP/C/W/438.  He said that the two submissions by  the group of developing countries on the first two 
issues in the checklist provided responses to the points raised in the submissions of the United States 
and Switzerland. 
79. With respect to IP/C/W/434, he said that his delegation was concerned that many of the 
comments contained on the proposed disclosure requir ements seemed to be based on assumptions that 
betrayed a diagnosis of the situation that did not do full justice to the nature of the bio-piracy problem 
and, in some cases, were based on an apparent mi sunderstanding of the nature and the intentions 
behind the proposals made by his delegation and the group of developing countries.  He contested the 
assertion made in paragraph 6 of the US submission that national measures alone would constitute the 
most effective means to address problems of bio-pi racy and misappropriation of genetic resources and 
associated traditional knowledge.  The suggestion w as problematic because it was widely recognized 
that bio-piracy was an international problem whic h could not be resolved by way of national means 
alone.  He said that international measures were  needed to address the problem as pointed out in 
submissions, including IP/C/W/429/Rev.1.  
80. With respect to references made to the issues of prior informed consent and benefit-sharing in 
document IP/C/W/434, he said that it should be bor ne in mind what role the TRIPS Council, and the 
WTO more generally, could be expected to perform in discussing the issue in light of its mandate.  
His delegation did not think it was up to the TRIPS Council or its Members to prescribe to parties to 
the CBD, who have sovereign rights over their ge netic resources, how they should implement their 
national access and benefit-sharing regimes.  He said that Members who were interested in and committed to discussions on access and benefit-sharing per se  should join the CBD and engage 
constructively in discussions taking place in that forum on, for example, the establishment of an 
international regime on access and benefit-sharing.  The role of the TRIPS Council was to consider 
how it could be ensured that the TRIPS Agreement made its contribution in promoting a harmonious 
and mutually supportive relationship between the pate nt system and the CBD.  His delegation's view 
was that the proposed mandatory disclosure of origin would make a significant, positive contribution to filling a perceived normative gap that allowed for bio-piracy to continue unabated, thereby 
rectifying a glaring inequity of the international patent system that allowed patent applicants for 
inventions derived from genetic r esources to be rewarded for violating national access laws in the IP/C/M/46 
Page 18  
 
countries of origin of those resources.  He said th at to argue that measures to effectively address 
bio-piracy should be pursued separately from the pa tent system, as suggested by the United States, 
seemed to miss the point.  
81. He said that IP/C/W/434 also contained misunderstandings as to how the proposed disclosure 
requirements would relate to arrangements for fair  and equitable benefit-sharing.  The proposed 
disclosure requirements were not intended to replace measures on access and benefit-sharing per se  
but to offer an effective incentive for patent applican ts to comply with prior informed consent and fair 
and equitable benefit-sharing.  Applicants with  good intentions committed to lawfully accessing 
genetic resources of mega-diverse countries would ha ve nothing to fear from the proposed disclosure 
requirement.  His delegation did not understand the continued resistance to the group's proposals.  He 
recognized the importance of the establishment of  national access and benefit-sharing regimes to 
implement the CBD and pointed out that his delega tion and a number of other countries already had 
those regimes.  However, for reasons pointed out in previous discussions and in the new submissions, 
his delegation believed that relying solely on such national regimes would not be enough to 
effectively prevent bio-piracy and that a mandatory  disclosure of origin requirement would constitute 
a necessary complementary measure.   
82. He pointed out that suggestions had been ma de on how disclosure of origin and prior 
informed consent requirements could operate in r espect of countries that had not yet established 
national access and benefit-sharing regimes.  He said that his delegation did not agree with the assertion that disclosure requirements would add uncertainty to the patent system and said that the proposal was intended to provide greater certainty and predictability in the patent system for all 
stakeholders in promoting the sustainable use of the components of biodiversity.  The current patent 
system did not provide that level of certainty for all stakeholders, particularly those from the mega-diverse countries and indigenous and local communiti es in those countries who had been victimized 
by the misappropriation of their knowledge and r esources.  A mandatory disclosure requirement 
would constitute an important conf idence building measure, that woul d help restore the trust of all 
stakeholders in the patent system.  It would provi de greater clarity and predictability and could even 
help the facilitated access to biological resour ces and associated traditional knowledge which bio 
prospectors and researchers were interested in.  On the other hand, he said that a malfunctioning patent system that condoned misappropr iation was deleterious to innovation. 
83. On the issue of possible administrative burden, he pointed out that the disclosure proposal 
was entirely reasonable given the nature of the seri ous problems that were sought to be addressed as 
well as the need to ensure that the international intellectual property system, particularly the patent 
system, was balanced and equitable and took on board the concerns of all stakeholders.  He said that 
the fact that the patent system was presently perceived by some as over-burdened was no testimony to its effectiveness or relevance to the objectives of promoting innovation.  On the contrary, evidence 
suggested that the patent system today was not f unctioning well.  There were incentives for applicants 
to file applications relating to "questionable inventions" and anecdotes on this had proliferated.  His 
delegation's view was that a more rigorous patent syst em that did not allow for the grant of patents for 
inventions of questionable merit was important to ensure its robustness, sustainability and relevance 
to the pursuit of the actual objectives of the intellect ual property system, which was, to a large degree, 
what the proposal by developing countries on discl osure of origin was meant to accomplish.  He 
stated that the objectives and principles of the TRIP S Agreement were clearly stated in its Articles 7 
and 8 and needed to be materialized through the proposals on a mandatory disclosure requirement of 
origin and prior informed consent requirements.   His delegation therefore did not understand the 
suggestions contained in document IP/C/W/434 that  characterized the proposals of the developing 
countries as an attempt to misuse the patent system  for the pursuit of objectives not linked to the 
patent system.  IP/C/M/46 
 Page 19 
 
 
84. He said that document IP/C/W/434 also referred to the possibility that the proposed disclosure 
mechanism could bring unintended consequences that would run contrary to the purported objectives.  
He pointed out that his delegation was sensitive to th e issue and that the proposed system would put in 
place a mechanism that was carefully calibrated and would not bring unintende d consequences.  With 
respect to the issue of the legal effects, the group was ready to discuss and further elaborate on these 
in the future.  He said that his delegation also  disagreed that the options suggested by the 
United States would effectively address the issues be fore the TRIPS Council.  With respect to the 
three basic points addressed by Switzerland, he said th at answers had been prov ided in the submission 
by the group of developing countries. 
85. He said that the assertions that the intellect ual property system had been a power tool for 
economic growth and that the patent system put in place through the TRIPS Agreement was beneficial 
to developing countries could not stand in the face of  serious empirical tests and that, at present, there 
was no known statistical empirical evidence that would support these assertions.  On the contrary, the evidence pointed in the opposite direction that, in fact, the patent system and the TRIPS Agreement 
had been beneficial for the developed countries and had not brought any of the purported benefits to 
developing countries.  He said that the TRIPS Agre ement should be an agreement for all countries and 
that the developing country proponents of the discl osure proposal wanted to see the patent system 
work well for all stakeholders in an equitable manner. 
86. The representative of Indonesia
 said that his country was important in terms of global 
diversity because it was one of the ten mega-diverse countries.  He said that biodiversity referred to 
all aspects of life support systems, which in cluded the social, economic and environmental 
dimensions, knowledge systems, ethics and the relati onship between the various aspects.  His country 
was rich in traditional knowledge as there were tr aditional communities throughout Indonesia.  Those 
valuable aspects should be wisely exploited for th e benefit of the communities and the state, with 
sustainable use of the environment for future generations.  Thus, his delegation supported the 
proposed obligation of disclosure of relevant trad itional knowledge and genetic  resources in patent 
applications. 
87. The representative of Turkey said that his delegation, like others, was concerned about 
misappropriation of genetic resources, traditional know ledge and folklore.  The discussions needed to 
be focused on eliminating those concerns and be based on real cases.  There was need to strike a 
delicate balance so as not to unreasonably in crease the workload of the patent offices. 
88. The representative of Hong Kong, China  said that IP/C/W/434 focused on how best to 
achieve the shared objectives among Members and some  of the concerns of the United States were 
whether the disclosure requirement could help prev ent misappropriation, and about the administrative 
burden or cost of such a system.  She said that even though a disclosure system may not completely 
preclude misappropriation, it could help monitor and ensure compliance with obtaining of informed 
consent and benefit-sharing.  Her delegation looked forward to a better understanding of the 
implications of the various proposals from different Members and also to a sharing of Members' 
experiences with national disclosure requirements. 
89. The representative of Sri Lanka  said that his delegation supported the submission from the 
group of developing countries cont ained in document IP/C/W/438 a nd that he would present detailed 
comments at a later date. 
90. The Chairman observed that there had been useful di scussions, that there were several new 
and substantive submissions and a number of u seful and constructive contributions, including 
suggestions and counter suggestions for a more structured discussion on some of the issues and 
approaches.  The Chair said he would reflect on tho se matters and would contin ue his consultations on 
how future work on the three agenda items should be organized. IP/C/M/46 
Page 20  
 
91. The Council took note
 of the statements made and agreed  to proceed as suggested by the 
Chair. 
G. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 
92. No statements were made under this  agenda item.  The Council agreed  to revert to the matter 
at its next meeting. 
H. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
93. 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. 
94. The representative of the European Communities  said that his delegation attached great 
importance to this agenda item and that there was a need to move forward in finding a more focused 
and structured way to continue work on it.  R ecalling that, at the Council's meeting in June, his 
delegation had encouraged the Chair to reflect on the possibility of presenting an options paper which 
would help delegations to move forward, he wo ndered whether the Chair could indicate how he 
intended to pursue the matter. 
95. The representative of Australia  said that, at present, her delegation was not pushing the Chair 
to present an options paper but would not stand in the way of this.  Once more procedurally embedded 
in the other work on GIs under way outside the TR IPS Council, her delegati on would have a better 
understanding on where it would want to take this ag enda item.  If the Chair were to proceed with 
some kind of process, Members should be involve d in consultations from a very early stage. 
96.  The representative of Switzerland , associated himself with the European Communities' 
statement, reiterated the importance that he attach ed to this agenda item and the subject-matter 
covered by it.  Also his delegation saw a need to move forward in a more focused and structured way 
and encouraged the Chair to consult with Members on how that could be done.  One idea was to base 
the work on the updated Secretariat summary note in document IP/C/W/253/Rev.1, which summarized the information provided by Members in response to a checklist of the way they were 
providing protection for geographical indications.  The Council had already earlier agreed on this way 
of structuring discussions and work along those lines had been started last year, but, given other priorities, progress had not yet been made on the work. 
97. The representative of the United States
 said that it was important to have Members' 
participation in the future work on the item and th at his delegation would be happy to be involved in 
any consultations that the Chair might undertake in the near future. 
98. The representative of Romania  said that her delegation was very  interested in the subject of 
geographical indications and therefore associated itself with the interventions by the European Communities and Switzerland. 
99. The Chairman
 said that he would continue to reflect on the matter.  He said that he had not 
yet come to a view on whether it was appropriate at this time to enter into consultations but, if he 
came to such a conclusion, he would be in t ouch with all Members interested in the subject. 
100. The Council took note  of the statements made.  IP/C/M/46 
 Page 21 
 
 
I. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE 
TRIPS  AGREEMENT AND PUBLIC HEALTH  
101. The Chairman  recalled that, at its meeting in June, the Council had agreed to continue its 
work pursuant to paragraph 11 of the General Counc il decision on "Implementation of Paragraph 6 of 
the Doha Declaration on the TRIPS Agreement and Public Health" (hereinafter referred to as "the 
Decision") on the preparation of an amendment to the TRIPS Agreement with a view to the TRIPS 
Council making a recommendation by the end of Ma rch 2005 so that the General Council could 
conclude its work on the amendment at its first me eting thereafter.  He drew attention to a new 
communication received from the delegation of Nigeria, on behalf of the African Group, which contained a proposal for amending Article 31 of th e TRIPS Agreement (subsequently circulated as 
document IP/C/W/437). 
102. He also recalled that, as had b een agreed at the Council's meetin g in September, he had held 
consultations on the action to be taken pursuant to paragraph 11 of the Decision.  At an informal 
consultation held the day before, many delegations had presented their initial reactions to the proposal 
by the African Group.  The general view expressed by many delegations had been that it would be 
useful for him to hold informal consultations in various formats prior to the Council's next meeting 
with a view to carrying the work forward expe ditiously so as to meet the March time-frame. 
103. The representative of Barbados
 informed the Council that the Commonwealth Secretariat, 
together with the ACP Geneva Office and th e AITIC, had hosted a workshop on the Decision on 
12-14 October 2004.  The discussions at the wo rkshop had been based on national case studies from 
Bangladesh, Barbados, India, Kenya, Mauritius, Sout h Africa, Tanzania and Uganda that had been 
commissioned by the Commonwealth Secretariat.  So me of the issues considered at the workshop 
included registration and granting of marketing approvals for generics produced under compulsory 
licences;  the legislation and institutional framewo rk that could be adopted by exporting countries, 
such as Canada and Norway, which had capacity to produce pharmaceutical products, as well as by countries interested in importing those products;  and how to benefit from the Decision with respect to 
the production and imports of pharma ceutical products on a regional basis.  She said that the report of 
the workshop would be sent to the WTO Secretaria t on behalf of the three sponsoring organizations.  
Her delegation looked forward to ha ving an exchange of views on the implementation of the findings 
and recommendations contained in the report at the next Council meeting. 
104. The representative of Kenya
 associated himself with the statement made by Barbados. 
105. Introducing document IP/C/W/437, the representative of Nigeria , speaking on behalf of the 
African Group, recalled that Members had agr eed that the amendment would be based, where 
appropriate, on the Decision.  In this regard, the appropriateness of particular elements should be 
understood to refer to those elements in the D ecision that were necessary to ensure that the 
amendment is legally predictable, secure and economically and socially  sustainable.  He said that the 
proposal by the African Group was aimed at providi ng the basis for such an amendment.  It was 
proposed to amend Article 31 of the TRIPS Agreem ent by adding a second paragraph to the Article, 
so that the current text of Article 31 would beco me Article 31, paragraph 1 and the amendment text 
would become Article 31, paragraph 2.  The proposed amendment would be based on the Decision with modifications, as appropriate. 
106. It was proposed to eliminate a number of provisions in the Decision that were redundant in 
the context of an amendment or where their purpo se would otherwise be served by existing provisions 
of the TRIPS Agreement, such as the provisions  on compulsory licences or enforcement.  For 
consistency and clarity, the actual text of th e amendment had been modified, including the 
arrangement of paragraphs to fit into the TRIPS Agr eement.  He also noted that the footnote would be 
renumbered as appropriate to follow th e numbering of the TRIPS Agreement. IP/C/M/46 
Page 22  
 
107. He further explained that the Preamble of the Decision had been eliminated because it was 
only meant to provide the context for the Decision.  Also, the last sentence of paragraph 1(b) had been 
eliminated because it represented fl exibility like other provisions contai ned in the TRIPS Agreement.  
Similarly, the second paragraph was also eliminated since the elements contained therein were those 
relating to the conditions for the use of the Deci sion whose purpose would be served by other existing 
provisions of the TRIPS Agreement, such as the prov isions on enforcement and those contained in the 
current Article 31.  For example, on the specification of quantities, the patent holder would be informed and the legal validity of the licence was subject to judicial review or review by any other independent authority as contained in  paragraphs (i) and (j) of Article  31 of the TRIPS Agreement.   
108. With regard to paragraph 4 re lating to re-exportation, the prop osal had adequately addressed 
the matter under its sub-paragraph (d).  Similarly,  the provision contained in paragraph 8 of the 
Decision was not necessary once the amendment came into force as this paragraph was only applicable to waivers as required by Article IX:4 of the Marrakesh Agreement Establishing the WTO.  
The Annex to the Decision had been eliminated, since it established a self-selection criterion and did not add any value.  This was evident from the fact that any Member notifying the intention to use the 
system would clearly and explicitly indicate  that it lacked manufacturing capacity.   
109. He concluded that the proposal presented a vi able basis for undertaking the amendment as 
foreseen in paragraph 11 of the Decision.  He not ed that the proposal was not meant to re-open 
discussion on the Decision but was aimed at taking the process forward in a constructive manner.  He said that his delegation would be willing to engage with Members with a view to concluding the 
process in an expeditious manner. 
110. The representative of Korea
 said that the African Group paper provided a very useful starting 
point for substantive work on this issue.  His de legation would carefully consider the submission and 
come back with more substantive comments at a la ter stage.  Reiterating the position of his delegation 
on this issue, he said that the amendment process should be a technical exercise that did not reopen the substantive or the legal issues of the package that was reached on 30 August 2003.  He said that 
his delegation supported the suggestion to hold inform al consultations and hoped that the amendment 
exercise would be completed by March 2005. 
111. The representative of Cuba
 said that the African Group proposal was the first working 
document offering viable alternativ es in the amendment process, without prejudice to other possible 
positions.  She said that a solution should be based on discussions between Members and that the core 
issues should be dealt with from a technical standpoi nt.  The Council should go beyond a mere literal 
transposition of the provisions of the Decision in to the Agreement and should discuss the various 
concerns expressed by the different categories of Members.  She said that during the informal consultations, an appropriate balance of membership  should be observed in order to achieve wording 
for this provision based on the needs and concerns of all Members. 
112. The representative of Argentina
 said that the African Group submission represented an 
important step in order to move forward in the amendment process.  She said that her delegation 
would be ready to look into it with an open mi nd and in a positive manner.  She hoped that the 
submission would serve a good basis to move forwar d and reach a conclusion by the date that the 
Council had set. She supported the proposal to hold informal consultations before the next Council 
meeting. 
113. The representative of India  noted that the submission by Nigeria, on behalf of the African 
Group, was the first contribution on substantive aspects for discussion on this agenda item and 
supported the suggestion of having info rmal consultations on this matter.  IP/C/M/46 
 Page 23 
 
 
114. The representative of th e European Communities  said that his delegation was not yet in a 
position to make substantive comments on the African  Group proposal.  On a preliminary basis, he 
said that the Decision had been the result of long  negotiations and constituted a delicate balance of 
rights and obligations whose integr ity should be preserved.  The Decision could already be effectively 
used by Members.  He reiterated his delegati on's position that the amendment process should be a 
purely technical exercise, faithfully transposi ng the Decision into TRIPS language without any 
re-opening of substance.  He noted that the African  paper took a different approach, eliminating some 
provisions of the Decision and redrafting others.  Th is, in his view, was not a promising way forward 
and his delegation would make further comments at a later stage.  He supported the proposal to 
undertake informal consultations to enable the TRIPS Council to meet the March 2005 deadline. 
115. The representative of the Philippines  said that the African Group's long-awaited proposal was 
a good basis for taking the work on the amendment fo rward.  It appeared to be a simple and clear 
adaptation of the basic elements of the Decision th at had eliminated what was surplusage of language 
in the Decision while, at the same time, maintain ing the fundamental elements and substance. 
Therefore, contrary to what others had indicated in their preliminary remarks, the integrity of the 
Decision was by no means compromised by the propo sal from the African Group.  He said that the 
proposal addressed concerns that his delegation ha d often expressed in relation to the obligations 
imposed on importing Members with respect to pr eventing the re-exportation or unlawful importation 
into their territories of the products covered by the Decision.  He also found that it provided a more appropriate provision to address the issue of remuneration.  It also rectified provisions in the Decision which might not have lent themselves to an exped itious use of the Decision.  He looked forward to 
participating in the consultations as constructively as possible. 
116. The representative of the United States
 expressed the support of his delegation for the 
proposal to undertake informal consultations on this  matter and said that the United States remained 
fully committed to reach an agreement on the amen dment by the March 2005 deadline.  He said that 
his delegation continued to believe , as did many other delegations, that substantive issues should not 
be re-opened and that the amendment process should be  a purely technical exercise.  He reiterated that 
it was essential that this amendment preserve th e entire agreement that had been reached in 
August 2003 and needed to include an express refe rence to both the Decision and the Chairman's 
statement.   
117. Referring to the submission by the African Gr oup, he said that his delegation would need 
more time to fully consider it.  However, upon an  initial review, he had c oncerns over the apparent 
absence of several provisions of the General Council Decision text, the apparent re-wording of other 
provisions and the lack of reference to the Chairman's  statement.  He expressed interest in learning 
why the African Group believed that including the entirety of the provisions would impede the faithful implementation of the August 2003 solution, particularly in light of the statement of the representative of Nigeria that it was not the Group's in tention to re-open the August 2003 solution.  As 
the European Communities had stated earlier, the so lution had been the result of long negotiations and 
reflected an important and delicate balance.  What  might seem like surplusage to some delegations 
was essential to others.  The Chairman's statem ent was an essential part of the agreement of 
30 August 2003 as there would have been no agreement w ithout it.  There was no basis to suggest that 
the concerns that were addressed by the Chairman's  statement would not arise in the context of 
adopting the amendment.  If the intention was to  have a pick-and-choose approach, it might only 
delay the adoption of the amendment, calling into ques tion the March deadline and, in this context, he 
wondered what objectives would possibly be accomplished by such an approach. 
118. The representative of Japan
 said that his delegation intended to check whether the African 
Group proposal properly reflected the Decision and th e Statement, and that he would make comments 
on it at the next opportunity.  He supported the pr oposal to conduct informal consultations on this 
issue and said that Japan looked forward to pa rticipating in the session of consultations in a 
constructive manner. IP/C/M/46 
Page 24  
 
119. The representative of Kenya
 pointed out that the proposal of the African Group was based on 
paragraph 11 of the Decision and that it did not  deviate from it.  The African Group had taken from 
the Decision what had been appropriate to include  in the TRIPS Agreement, without disturbing the 
equilibrium.  The TRIPS Agreement set the minimu m standards, and the Group had not seen the sense 
in disturbing that part of the equilibrium.  Be sides, the amendment would be part of the TRIPS 
Agreement, and there should be no risk that the amendment could somehow be interpreted as 
eliminating the application of pr eviously existing provisions.   
120. Addressing Members who had said that the proposal  did not contain some provisions of the 
Decision, he asked them to see whether these provisi ons would make sense if they were inserted in 
the TRIPS Agreement.  For example, he asked if it would make sense to include the preambular 
paragraphs of the Decision in the Agreement.  He explained that the preamble was basically meant to 
provide the context for the Decision and did not cont ain any substantive issues.  Besides, the TRIPS 
Agreement itself had introductory paragraphs as its pr eamble.  Similarly, paragraph 8 of the Decision 
was based on annual reviews of waivers and was not a pplicable to the permanent solution.  The last 
part of paragraph 1(b) dealing with Members that might voluntary not use the system or that might 
use the system only in limited circumstances, introduced  a flexibility.  Just like with other flexibilities 
under the TRIPS Agreement, Members were free to choose whether to use the flexibility or not and 
there was no need for prior declarations and it was fo r this reason that this part of the paragraph had 
been left out of the proposal.  He said that para graph 9 simply reaffirmed the rights that Members 
already had and did not confer any new rights.  Clearly, paragraph 11 of the Decision, was aimed at providing a roadmap towards the amendment and th erefore it had to be left out.  Some other 
provisions had been left out, for example on enfo rcement, because these were already in the TRIPS 
Agreement.   
121. Regarding the Chairman's statement, he said ther e was a need to clarify that the Statement had 
not been intended to be made part of the amendment.   He said that the Group did not believe that the 
statement formed part of the amendment because it w ould negate the solution itself as mandated in the 
Doha Declaration on TRIPS and Public Health.  Th e Declaration had foreseen two problems: one was 
lack of manufacturing capacity in developing and least-developed countries and the other was the inability to make use of compulsory licensing.  The Chairman's statement did not encourage 
technology transfer, which went against the prin ciples and objectives of the TRIPS Agreement.  
Therefore, the African Group wished to have a sy stem that encouraged technology transfer to 
developing and least-developed countries so that they could make effective use of compulsory 
licences.  Moreover, the Chairman's statement had al ready served its purpose of allaying the fears of 
some pharmaceutical companies at that time and there had been many other important statements made at the time, such as the one by the Sout h African delegation which had been crucial in 
galvanizing the consensus.  He said that the African Group was ready to  engage in informal 
consultations and hoped that the deadline could be met. 
122. The representative of Brazil 
said that, upon a first reading of the African Group's proposal, it 
seemed to be a constructive one and a positive cont ribution to the debate, wh ich he hoped would help 
to make progress in the negotiations on an amendm ent to the TRIPS Agreement in accordance with 
the mandate of paragraph 11 of the 30 August De cision.  He supported the proposal to undertake 
further informal consultations on the amendment an d said that his delegation would be available to 
contribute positively. 
123. The representative of Sri Lanka  said that, as a country that did not have domestic 
manufacturing capacity for pharmaceutical products, Sr i Lanka attached a great importance to this 
agenda item.  He regretted that his delegation w as not able to provide substantive comments on the 
African Group proposal at this stage and said it w ould do so during the informal consultations.    IP/C/M/46 
 Page 25 
 
 
124. The representative of Switzerland  said that the African Group pa per was a concrete proposal 
on implementation and would help focus consultations.  His delega tion would offer its comments as 
soon as possible.  He reiterated the Swiss pos ition that the work on the amendment should be 
concluded before the deadline of March 2005.  He emphasized that any solution would have to 
faithfully reflect the entirety of the substance of th e solution found and agreed  to by the membership 
on 30 August 2003.  He recalled th at this solution was the result of a long and difficult negotiation 
and represented a delicate balance.  What remained to be done was for the Council to find a form to 
technically transpose the solutio n found into the TRIPS Agreemen t in the most expeditious and 
efficient manner.  For reasons of expeditiousn ess and efficiency, Switzerland favoured the footnote 
approach for the implementation as a solution, as it was a simple and straightforward one, allowing by 
way of reference to incorporate the 5-page long text of the Decision into the TRIPS Agreement 
without upsetting the structure of the Agreement or prejudicing its readability or comprehensibility.   
125. The solution of 30 August 2003 included the Deci sion or the so-called "Motta text" and the 
Statement of the Chairman of the General C ouncil which had enabled the breakthrough for a 
consensus on the solution.  The contents of the stat ement, as read by the Chairman, had been made 
with the collective understanding and agreement of the Membership and was therefore to be clearly 
distinguished from other statements that were made  on the 30 August 2003 by individual delegations.  
The Chairman's statement therefore needed to be ad equately reflected in the implementation solution. 
His delegation agreed that this needed to be done in  a manner that would not change the legal status or 
the relationship that the Decision and the accompanying statement had had on the day of the adoption of the solution.  
126. He supported the proposal to continue inform al consultations and expressed willingness to 
contribute actively and constructively to this process. 
127. The representative of Turkey
 said that his delegation was in favour of an amendment which 
would be of a technical nature, the aim of which s hould be to transpose the Decision into the text of 
the TRIPS Agreement.  In his view, this exerci se should not alter the ri ghts and obligations of 
Members stemming from the TRIPS Agreement and WTO obligations in general.  He said that his 
delegation would comment on the African Group's contribution later.  He also signalled his 
delegation's willingness to participate cons tructively in the consultation process. 
128. The representative of Malaysia  said that the African Group had provided a substantive 
contribution which would assist in focusing the di scussions on the amendment.  The proposal aimed 
at containing elements of the Decision without re-opening discussions on substance and yet other 
delegations had raised the issue of the Chairman's statement which was not reflected in the Decision.  
Her delegation saw the need for further consultatio ns that would allow the Council to conclude the 
exercise by March 2005. 
129. The representative of Norway  said that her delegation was not able to make any substantive 
comments on the African Group proposal but that they would like to do so during the proposed 
consultations.  She reiterated that her delegation saw this process as a technical exercise in 
implementing the Decision and that it was open to any form that could be used to keep the substance 
intact. 
130. The representative of Canada  said that his delegation would revert to the African Group 
proposal in future meetings.  He said that the solu tion that had been reached in August 2003 had been 
the product of many months of intensive negotia tions and reflected a very difficult and delicate 
balance among the interests of different WTO Member s.  No delegation had been entirely happy with 
the outcome of those negotiations, but everybody had agreed on the basis of consensus to a solution 
which included the General Council Decision and a Stat ement by the Chair on the interpretation of the 
Decision.  He agreed with the comments made by the delegation of Switzerland about the status of the 
Chairman's statement.  He reminded the Council of the third sentence of the Chairman's statement, IP/C/M/46 
Page 26  
 
which placed on record that the statement repr esented several key shared understandings among 
Members regarding the Decision and the way in whic h it would be interpreted and implemented.  At 
the time this had been adopted by the Genera l Council, no delegation had objected to it.   
131. Agreeing that the system put into place in Augus t 2003 was already in effect, he encouraged 
all WTO Members to take the necessary steps to implem ent and use it.  In the view of his delegation, 
it was not the time to reopen and renegotiate any asp ect of the entirety of th e solution that had been 
agreed to at that time.  Therefore, the amendmen t process should be a technical exercise to faithfully 
transpose the entirety of the solution found into  the TRIPS Agreement.  His delegation looked 
forward to working intensively, including in info rmal consultations, in order to meet the March 
deadline. 
132. The representative of the Chinese Taipei
 said that his delegation was not able to comment on 
the substance of the African Group proposal.  Howeve r, he noted that some language used in the 
proposal was different from that in the Decision such as in the paragraph of the definition of eligible 
importing Members.  He said that his delegation su pported the proposal on informal consultations.  
He reiterated that his delegation viewed the amendment as a technical exercise that should be 
completed by the end of March 2005. 
133. The representative of Nigeria , responding to the intervention of Chinese Taipei regarding the 
paragraph on eligibility, said that the African Gr oup believed that this pa ragraph had already been 
taken care of by Article 31(b) and (c) of the current  TRIPS Agreement.  He reassured the Council that 
the Group was ready and willing to engage construc tively in the informal consultations to be 
undertaken. 
134. The representative of China  said that his delegation thought that the African Group's proposal 
was constructive and positive and that its elements could be the basis for future negotiations.  He 
supported the proposal to undertake informal consultations in order to meet the deadline. 
135. The representative of Hong Kong, China , noting that the concrete proposal made by the 
African Group would provide useful input to facilitate further discussion, said that his delegation 
would provide comments on its substantive content at a later stage.  He reiterated that his delegation 
viewed the amendment exercise as a purely t echnical one, transposing the Decision into an 
amendment without any reopening of the substan tive issues.  He supported the proposal to hold 
informal consultations in order to meet the dead line that the TRIPS Council had set for itself.   
136. The representative of Peru  hoped that the African Group proposal would serve as basis for a 
speedy and appropriate solution.  He supported the convening of informal consultations to speed up 
the process. 
137. The representative of Australia  recalled her delegation's positi on that the amendment process 
should be maintained as a technical exercise that transposed the agre ement that had been reached in 
its entirety.  She also stated that her delegati on looked forward to participating in the informal 
consultations. 
138. The representative of Colombia  said that the African Group has made an important 
contribution and that her delega tion would give its comments in due course. She supported the 
proposal of holding consultations with a vi ew to finalizing the process by March 2005. 
139. The representative of New Zealand  said that the African Group proposal was a useful 
contribution on which to focus the efforts of the Coun cil.  Her delegation was very open to ideas as to 
how the Decision might be faithfully reflected in th e TRIPS Agreement and agreed that it should be a 
technical exercise that led to an outcome that faithfully reflected the solution both in terms of  IP/C/M/46 
 Page 27 
 
 
substance and status.  She express ed her delegation's commitment to the process and interest in the 
informal consultations. 
140. The representative of the European Communities  informed the Council that, on 29 October 
2004, the European Commission had adopted a proposal for a regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical  products for export to certain countries with 
public health problems.  The main objective of this proposal was to create a legal basis, at European 
Union level, to enable the authorities to grant compulsory licences for the production and export of 
pharmaceuticals to eligible developing and least-dev eloped countries.  The proposal was based on the 
Decision and avoided introducing new conditions or restrictions, in par ticular with regard to the scope 
of products and diseases.  It established the conditi ons for the application and grant of compulsory 
licences which reflected those found in voluntary licen sing agreements.  In particular, the proposal 
imposed clear conditions upon the compulsory licensee with regard to acts covered by the licence, the 
identification of the medicines manufactured unde r the licence and the countries to which these 
products would be exported.  In addition, compulsory licences were non-exclusive and non-
assignable.  The proposal envisaged equitable remunera tion to the patentee.  In order to prevent trade 
diversion, the proposal specified that the re-im portation of pharmaceuticals manufactured under the 
regulation should be treated as counterfeit goods.  
141. The initiative of the European Commission was th e starting point of the legislative process 
within the European Union, invo lving the European Union Council and the European Parliament.  He 
hoped that the legislative process would develop expe ditiously so that this new mechanism could be 
operational as soon as possible.  He encouraged other WTO Members to im plement the Decision and 
recalled that the European Union had made two written communications to the TRIPS Council in 
which it had offered its support for the implementati on of the Doha Declaration and in which it had 
called upon all the technical assistance providers to in tegrate the health dimens ion into their technical 
assistance programmes. 
142. The representative of the Philippines
 said that, in relation to the Chairman's statement which 
accompanied the Decision of 30 August 2003, his delegati on had made it clear at that time that it saw 
a difference between the Chairman's statement wh ich provided the interpretative context, and the 
Decision itself.  On previous occasions, several delegations, including Argentina, had made the 
distinction between these two elements which other delegations had supported.  He recalled that his 
delegation had made a statement at the TRIPS Council meeting that had adopted the 30 August 
Decision in which it had provided its  understanding of the Chairman's statement.  In that respect, it 
provided interpretative context to what  had been accepted as the Decision. 
143. The representative of Thailand  expressed the interest of his de legation in partic ipating in the 
consultations suggested by the Chairman. 
144. The Chairman  suggested that he hold intensive consu ltations in various formats prior to the 
Council's next meeting with a view to carrying fo rward the work expeditiously so as to meet the 
March 2005 time-frame. 
145. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
J. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH  6 
OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
146. The Chairman  recalled that paragraph 8 of the Deci sion on the Implementation of Paragraph 6 
of the Doha Declaration on the TRIPS Agreement a nd Public Health provided that the Council for 
TRIPS should review annually the functioning of the system set out in the Decision with a view to 
ensuring its effective operation and should annuall y report on its operation to the General Council.  IP/C/M/46 
Page 28  
 
Furthermore, the paragraph provided that this review should be deemed to fulfil the review 
requirements of Article IX:4 of the WTO Agreement. 
147. The representative of Canada
 said that his country had passed legislation relating to the 
Decision in May 2004.  The draft regulations to br ing Canada's legislation into effect had been  
published for public record and comment on 2 Oc tober 2004.  The 75-day period announced for 
comment would end soon, and he hope d that the regulations and the le gislation would come into force 
some time in early 2005. 
148. The representative of Switzerland  said that it was important to hear about Members' national 
implementation of the paragraph 6 Decision.  In this  regard, he recalled that Canada and Norway had 
already announced that they had adopted implemen ting legislation as exporting countries and that the 
European Communities had provided information on  the preparation of similar legislation.  
Switzerland was preparing, in the context of th e revision of its Patent Law, a proposal on the 
implementation of the paragraph 6 solution.  Switz erland had been confident in initiating this work 
based on the WTO waiver Decision currently in place,  without waiting for the outcome of the efforts 
to incorporate it in the TRIPS Agreement, trus ting, however, that these efforts would leave the 
substance of that Decision intact.  All substan tive elements of the Decision would be faithfully 
reflected in this legislation, including effectiv e and deterrent measures to avoid such pharmaceuticals 
being diverted to other ma rkets for commercial purposes. 
149. Switzerland had opted out of the paragraph 6 so lution as an importing country, but intended 
to provide the possibility of compulsory licen sing of patented pharmaceuticals for exportation 
purposes, in order to assist countries without, or with  insufficient, manufacturing capacity that needed 
to address a public health problem such as HIV/AIDS , tuberculosis or malaria.  Rather than seeing 
compulsory licensing in the forefront as a solu tion to improve access to medicines in needy 
developing countries, he believed that negotiations w ith the right holders of patented pharmaceuticals 
needed in these countries promised a swifter and a more suitable solution to  affordable prices.  
Nevertheless, Switzerland had responded to the concerns of Members most interested in the 
paragraph 6 issue by joining the consensus on the paragraph 6 Decision and was willing to follow suit 
at the national level.  The Swiss delegation was in terested in hearing about national implementation 
efforts also from those Members which had made the case for the high degree of urgency for this 
solution throughout the negotiation pr ocess at the multilateral level. 
150. Turning to the TRIPS Council's report to the Ge neral Council foreseen in paragraph 8 of the 
Decision, the Chairman  said that, in anticipation of this, th e Secretariat had prepared a draft cover 
note to this report which was available outside th e room.  The draft cover page contained factual 
information on the use of the system establis hed under the Decision and on the work on the 
preparation of an amendment to the TRIPS Agreemen t pursuant to paragraph 11 of the Decision.  He 
suggested that the Council agree on the contents of the draft cover note and that the part of the minutes of the meeting reflecting the discussion held  under this agenda item be attached to it. 
151. The Council so agreed
. 
K. SECOND ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION 
OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
152. The Chairman  recalled that, at its meeting in February 2003, the Council had adopted a 
decision on the "Implementation of Article 66.2 of  the TRIPS Agreement".  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 to provide 
new detailed reports every third year and, in the intervening years, provide updates to their most 
recent reports.  These reports were to be submitted prior to the last Council meeting scheduled for the 
year in question.    IP/C/M/46 
 Page 29 
 
 
153. The Council had taken up its firs t annual review of developed country Members' reports on 
their implementation of Article 66.2 of the TRIPS Ag reement at its meeting in November 2003.  At its 
meeting in June, the Council had agreed to request  developed country Members to submit updates to 
the reports they had provided in 2003 on actions they had taken or planned in pursuance of their 
commitments for the present meeting.  On 13 Ju ly 2004, the Secretariat had issued airgram 
WTO/AIR/2360 to remind developed country Members of this request. 
154. To date, the Council had received updated info rmation from the following developed country 
Members:  New Zealand;  Japan;  Switzerland;  the European Communities and certain member 
States (the Czech Republic, Denmark, Finland, Fran ce, Germany, Ireland, Italy, the Netherlands, the 
Slovak Republic, Spain, and Sweden);  Canada a nd the United States.  The resulting documentation 
was being circulated in document IP/C/W/431 and addenda. 
155. He recalled that, with regard to the purpose a nd conduct of the review of this information, 
paragraph 2 of the Decision on the Implementation of Article 66.2 of the TRIPS Agreement explained 
that the annual review meetings should provide Me mbers with an opportunity to pose questions in 
relation to the information submitted and request a dditional information; discuss the effectiveness of 
the incentives provided in promoting and encouragin g technology transfer to least-developed country 
Members in order to enable them to create a sound and viable technological base;  and consider any 
points relating to the operation of the reporting procedure established by the Decision. 
156. He urged those developed country Members that had not yet provided reports to do so.  Given 
that some of the information had been received only very recently, and most of it was, so far, 
available only in its original language, he said that it was his intention to provide a further 
opportunity, at the Council's next meeting, for Members to make comments on the information 
submitted for this meeting that they might  not yet have been able to study. 
157. The Council took note  of the information provided and agreed  to proceed as suggested by the 
Chair. 
L. TECHNICAL COOPERATION AND CAPACITY -BUILDING  
 (i) Annual updates on technical cooperation activities  
158. The Chairman  recalled that the Council had held its a nnual review of technical cooperation at 
its meeting in September.  At that meeting, the Chair had said that Members would be provided with a 
further opportunity to make comments on the information submitted for the September meeting that they might not yet have been able to study.  In addition to the material submitted for the September 
meeting, the Council had received certain additio nal material.  The European Communities had 
supplemented its earlier report on the technical coope ration activities by it and its member States by 
submitting contributions prepared by the Office fo r Harmonization in the Internal Market and the 
European Patent Office (IP/C/W/426/Add.5/Suppl .1).  Furthermore, the Council had received 
information on TRIPS related tec hnical cooperation activities from Australia (subsequently circulated 
as document IP/C/W/426/Add.6), as well as from the International Union for the Protection of New 
Varieties of Plants (IP/C/W/424/Add.3). 
(ii) Joint Initiative
 
159. The Chairman  recalled that, on 14 June 2001, the WI PO 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. IP/C/M/46 
Page 30  
 
160. The representative of the WTO Secretariat
 referred to two activities foreseen for the 
upcoming months that fell under the Joint Initiative,  namely a national seminar in Niger to be 
organized jointly with WIPO later in December, a nd a national seminar in Lesotho to be held in 
January 2005.  The WTO had received a number of requests from Pacific island countries, including LDC Members and countries in the process of acceding to the WTO.  With a view to responding to 
these requests, the WTO was organizing, together w ith the Pacific Islands Forum Secretariat, a sub-
regional workshop on the TRIPS Agreement that woul d take place in Fiji at the end of January 2005. 
161. One of the major programmes of technical coope ration that the WTO had undertaken in 2004 
in favour of developing and least-developed coun tries generally was the organization of seven 
regional workshops on certain topical issues in rega rd to intellectual property.  Since the Council's 
meeting in September, three more such regional workshops had taken place:  one, organized jointly 
with WIPO, in Moldova for the countries of the Cent ral and Eastern Europe, the Central Asia and the 
Caucasus;  another in Saint Lucia for the Caribbean, co-organized with  the Institute for the Integration 
of Latin America and the Caribbean (INTAL) and th e Caribbean Regional Machinery;  and the third 
in the Dominican Republic for the Latin American count ries, also co-organized with INTAL.  The last 
of these workshops would be held the following w eek in the United Arab Emirates for the Arab 
Countries. 
162. He thanked the host countries and the co-org anizers, as well as the Geneva-based delegates 
and the staff members of WIPO and WHO, who had kindly accepted to speak at these events.   
163. On behalf of her organization and her colleagues, the representative of WIPO
 thanked the 
Government of Moldova for its ex cellent preparation and hospitality,  and said that she looked forward 
to the national workshop to be held in Niger. 
164. The Council took note  of the statements made. 
M. REQUEST FROM MALDIVES FOR AN EXTENSION OF THE TRANSITION PERIOD UNDER 
ARTICLE  66.1  OF THE TRIPS  AGREEMENT  
165. The Chairman  recalled that, at its meeting in Sept ember, the Council had had before it a 
request from the Maldives for an extension of the transition period under Ar ticle 66.1 of the TRIPS 
Agreement (IP/C/W/425).  The Council had agreed that consultations be held on this request, and that 
the arrangements for these be coor dinated between the Chair of the TRIPS Council and the Chair of 
the CTD. 
166. Since then, the delegation of the Maldives had not  been able to attend the meetings of the 
CTD and there had therefore not yet been an opportuni ty to organize consultations on this matter.  At 
the meeting of the CTD held on 26 November, the Ch air of that body had informed Members that the 
Maldives was working on a plan to  achieve a smooth transition to developing country status.  The 
CTD had agreed to revert to this matter at its  next meeting on 22 February 2005, at which the 
delegation of the Maldives was expected to attend and to present its transition plan.  
167. The Chairman suggested that the Council conti nue to proceed as agreed at its meeting in 
September. 
168. The Council so agreed . 
N. NON-VIOLATION AND SITUATION COMPLAINTS  
169. 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  IP/C/M/46 
 Page 31 
 
 
on Implementation-Related Issues and Concerns was ex tended up to the Sixth Ministerial Conference.  
At its last meeting, the TRIPS Council had consid ered what action it should take pursuant to this 
Decision.  The Council had agreed that the item on non-violation and situation complaints be put on 
the agenda of the present meeting, and that the S ecretariat be requested to update its earlier summary 
note, circulated in June 2002 as document IP/C /W/349, on the points raised in the Council's 
substantive discussion of this matter so far.  Since then, this update had been circulated as document 
IP/C/W/349/Rev.1. 
170. The representative of Peru  thanked the Secretariat for the update, which, like the original 
summary note, was objective and factual, giving a very good summary of what had happened in the past discussions on non-violation and situation compla ints held in line with Article 64 of the TRIPS 
Agreement and the Doha Declaration.  Since the No te contained an objective report, it depicted the 
positions expressed by delegations in the Council, but  it did not mention the numbers of delegations 
that supported each of the different positions.  He said that there was a vast majority, basically 
consensus-minus-one, which was of the view that this  type of complaint shoul d not be applicable to 
the TRIPS Agreement.  The arguments supporting th is position had been discussed at length in many 
meetings of the Council's meetings, and they ha d been clearly presented in document IP/C/W/385 
submitted by a number of developing c ountries.  Given this, there was very little left to be said.  This 
type of complaint was relevant to a different type of  situation in an entirely different context than the 
one of TRIPS. 
171. The present situation resembled the story where a sheep had got lost, while the rest of the 
flock remained together.  In this case, the job of the shepherd was to try a nd find the lost sheep and 
bring it back to the flock, convincing it of the ri ght path to take.  Once this matter had been solved, 
there would be more certainty on how to better appl y the intellectual property system and more time 
to find effective solutions to more substantive and important problems. 
172. The representative of Canada
 said that he was pleased that this item was back on the agenda.  
Canada had been active since the Uruguay R ound in focusing the TRIPS Council on the mandated 
examination of the scope and modalities of non-viola tion and situation complaints, or non-violation 
nullification and impairment (NVNI).  His delegation ha d examined this issue in detail in its capital, 
spoken about it to many colleagues at the WTO,  and submitted several de tailed communications on 
the subject.  Throughout this examination, his de legation had consistently  expressed concern that 
transplanting this type of remedy into the TRI PS environment would introduce into the Agreement a 
measure of uncertainty, resulting ultimately in constraints in domestic policy-making beyond what 
Members agreed to when they negotiated the TRIPS Agreement. 
173. His delegation had arrived at this view from the basic premise that the TRIPS Agreement was 
a sui generis agreement among trade agreements;  and that, as such, a remedy that had been designed 
to deal principally with issues arising in market a ccess agreements was not suitable for application in 
the context of an agreement that dealt with the creation of minimum standards.  There remained 
considerable disagreement among Members to the a ppropriateness of this remedy and, as Peru had 
also noted, he believed there was a near consensu s around the view that non-violation and situation 
complaints should not apply to TRIPS.  
174. In that light, he encouraged those few delega tions who supported the application of NVNI in 
the TRIPS Agreement to better elaborate their ra tionale for advocating this potentially important 
change in the balance of rights and obligations in th e TRIPS Agreement.  It was clear, after all, that 
because NVNI had not so far applied in TRIPS, agreeing to apply it now would shift the balance 
WTO Members had maintained since the Uruguay Round.   In Canada's view, the onus was therefore 
now on those few delegations to explain why the Co uncil should agree to change that status quo.  He 
concluded by expressing his hope that in future m eetings Members could arrive at the consensus 
required to fulfil the respon sibility under Article 64. IP/C/M/46 
Page 32  
 
175. The representative of Argentina
 was pleased to see the item back on the agenda, since this 
gave a possibility of further deba te.  Like the preceding delegations , she believed that non-violation 
complaints were inherent to agreements dealing with  trade and directly linked to market access.  As 
pointed out by the delegation from Canada, the TRIPS Agreement was a sui generis  agreement and it 
was not a market access agreement.  Therefore, she believed that the possibility of non-violation 
complaints would lead to uncertainty with respect  to the legality of governmental measures which 
could legitimately be adopted by a Member, openi ng the possibility that these measures could be 
legally challenged by other Members.  This woul d cause an imbalance in the rights and obligations 
under the TRIPS Agreement.  She recalled that docum ent IP/C/W/385, to which Peru had referred and 
which was co-sponsored by Argentina, contained a propo sal that this type of complaint be determined 
inapplicable to the TRIPS Agreement. 
176. The representative of the United States  recognized that Members had agreed to extend the 
moratorium on non-violation complaints.  This had been a significant concession on the part of the 
United States.  Nonetheless, his delegation continue d to consider that non-violation complaints were 
fully appropriate in the TRIPS context and it exp ected the moratorium to expire at the Sixth 
Ministerial Conference. 
177. The possibility of non-violation nullification a nd impairment disputes had been part of the 
GATT dispute settlement system since the beginning.  Failure to allow this possibility in connection 
with the TRIPS Agreement could invite Members to look for creative ways to avoid their TRIPS 
obligations.  In that light, neither the TRIPS text nor the GATT practice supported the contrary view.  
Furthermore, the United States considered that Ar ticle 26 of the Dispute Settlement Understanding 
provided all the necessary assurances and safeguards for Members to handle any disputes that might 
arise alleging non-violation nullifica tion and impairment under TRIPS a nd to prevent any abuse of the 
dispute settlement process. 
178. The representative of the European Communities  recalled that his delegation had already 
pointed out that it was difficult to transpose th e non-violation and situation complaint concept from 
GATT to the TRIPS Agreement.  This view was ba sed on a number of considerations.  First, such 
transposition would introduce elements into the TR IPS Agreement that might create uncertainty and 
lack of clearness.  Secondly, the objective of the Agreement was not market access or tariff 
concessions;  the TRIPS Agreement obliged Members to  put in place clearly described legislation and 
to enforce it, and any failure to comply with TR IPS obligations could be directly addressed as a 
violation of the TRIPS Agreement.  Thirdly, any behaviour that restricted market access or reduced 
benefits under tariff concessions could be a ddressed under GATT or GATS.  And finally, as a 
consequence, there seemed to be little practical scope for non-violati on and situation complaints under 
the TRIPS Agreement.  While being open to continue  discussing this issue further, he believed that 
non-violation and situation complaints should not be applicable in the TRIPS context. 
179. The representative of Australia , while being in favour of con tinuing discussions on the matter, 
said that her delegation had already shared some of its real concerns regarding the possible 
applicability of non-violation and situati on complaints to the TRIPS Agreement. 
180. The representative of Switzerland  recalled that his delegation had said at earlier Council 
meetings that it was important to take into cons ideration the fact that Article 64.1 of the TRIPS 
Agreement made the full dispute settlement mechanis m, negotiated in the Uruguay Round, applicable 
to the TRIPS Agreement, including non-violation a nd situation complaints.  The fact that Members 
had included in paragraphs 2 and 3 of Article 64 a five-year moratorium for the examination of the 
scope and modalities for such complaints in the TRIPS context seemed to confirm this. The very 
nature of a moratorium was that it was temporar y and thus the availability of such complaints 
followed after the end of the moratorium in acco rdance with the modalities agreed.  He could not see 
why the burden of proof would now have shifted on to those Members who read this Article in this 
light.  Given many Members' concerns about tran sparency and predictability and their desire to  IP/C/M/46 
 Page 33 
 
 
continue the discussion on the scope and modalities,  Members had agreed to extend the moratorium 
until the next Ministerial Conference.  He assu red the Council that his delegation was willing to 
engage in the discussion. 
181. The representative of Brazil  said that it was clear that ther e was an emerging consensus in the 
Council that non-violation and situation complaints  should not apply in the context of the TRIPS 
Agreement, a view that was supported also by hi s delegation.  He encouraged the few remaining 
Members that had not yet subscribed to this prevailin g view to do so as quickly as possible in order to 
discharge the mandate that the Council had had for some time. 
182. The representative of India  said that the discussions so far had shown that there was an 
emerging consensus that there was no occasion to appl y non-violation and situation complaints in the 
TRIPS context.  India's position a nd the reasons behind it were cont ained in document IP/C/W/385.  
He restated the principle behind this position, wh ich was that non-violation and situation complaints 
did not apply in the TRIPS context and that the moratorium, as some delegations called it, was without prejudice to Members' positions on the appl icability of non-violation and situation complaints 
in the TRIPS context.  Nevertheless, his de legation was prepared to discuss the issue. 
183. The representative of Malaysia
 welcomed the 1 August 2003 Decision to extend the 
moratorium on non-violation and situation complaints , although she wished that it had been a decision 
that had resolved this issue.  Like the vast ma jority of Members, Malaysia had serious doubts about 
the need for the application of non-violation and s ituation complaints to the TRIPS Agreement.  This 
was not necessary for the security and predictabili ty of benefits under the Agreement, since it 
contained a large number of provisions that s upported strong enforcement and implementation of 
TRIPS obligations.  In fact, the application of non- violation and situation complaints could lead to 
greater uncertainty and to an imbalance of Memb ers' rights and obligations.  She hoped that the 
Council could reach a decision in the near future on the non-applicability of such complaints to 
TRIPS. 
184. The representative of Kenya  reiterated his delegation's position that non-violation and 
situation complaints should not apply to the TRIPS Agreement. 
185. The representative of Egypt  recalled that his delegation was one of the co-sponsors of 
document IP/C/W/385.  The WTO dispute settlement  mechanism was a major contribution to the 
stability of the global economy, making the trading syst em more secure, predictable and credible.  She 
believed that non-violation complaints  in general were difficult to justify in a rules-based system and 
that their use would increase legal uncertainty and threaten the predictability and security that the 
system sought to guarantee.  Given the special nature  of the TRIPS Agreement, it was inappropriate to 
transpose into it rules that were appropriate in an agreement concerning market access and reciprocal 
concessions.  Her delegation supporte d the conclusion that the non-vi olation and situation complaints 
be made inapplicable to the TRIPS Agreement. 
186. The representative of Turkey  said that the views of his delegation had been expressed in 
document IP/C/W/191, which it had cosponsored with  several other countries.  He supported the 
statements made by other delegations, particular ly Peru, Argentina, Canada and the European 
Communities, and echoed the suggestion made by Malaysia. 
187. The representative of Hong Kong, China  said that the application of non-violation and 
situation complaints raised systemic issues, which n eeded to be discussed in detail.  She expressed her 
delegation's interest in participating in such discussions. 
188. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. IP/C/M/46 
Page 34  
 
O. S
PECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL  
189. The Chairman  said that, in its Decision on the Doha Work Programme of 1 August 2004, the 
General Council had recalled the 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 recognized the progress that had been  made so far.  As regards all those WTO bodies 
to which proposals in Category II had been referr ed, the General Council had instructed them to 
expeditiously complete the consideration of these proposals and report to the General Council, with 
clear recommendations for a decision, as s oon as possible and no later than July 2005. 
190. At its meeting of 21 September 2004, the TRIPS Council had considered what action it 
should take pursuant to this Decision in regard to  special and differential treatment.  The Council had 
agreed to request the Secretariat to summarize in an informal note the Council's work so far on the 
Category II proposals on special and differential treatment referred to in it, and to revert to the matter 
at the present meeting.  The Secretariat's summary note had been circulated in document JOB(04)/164. 
191. No statements were made under this  agenda item.  The Council agreed
 to revert to the matter 
at its next meeting. 
P. TRANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION OF THE 
PEOPLE 'S REPUBLIC OF CHINA  
192. The Chairman  recalled that paragraph 18 of Chin a's Protocol on Accession required the 
TRIPS Council to review the implementation by Ch ina of the TRIPS Agreement each year for eight 
years and report the results of such review promptly  to the General Council.  He further recalled that 
paragraph 18 required China to pr ovide relevant information, in cluding information specified in 
Annex 1A, to the TRIPS Council in advance of th e review.  He informed the Council that the 
information submitted by China to it as required unde r Annex 1A of the Protocol of Accession, dated 
26 November 2004, had been circulated in doc ument IP/C/W/436.  In addition, the Chinese 
Delegation had made available two room documen ts entitled "White Paper on Intellectual Property 
Rights Protection in China in 2003" and "Status of China's Intellectual Property Rights Protection".  
Questions and comments in connection with the tran sitional review had been submitted by Japan, the 
United States and the European Communities, which had been circulated in documents IP/C/W/430, 
432 and 435, respectively. 
193. The representative of China , briefing the Council on China's implementation of the TRIPS 
Agreement and the relevant commitments since the l ast review, said that the Chinese Government had 
always attached much importance to the protection of intellectual property rights and would fulfil its 
international commitments in a serious and positiv e manner.  Since the introduction of opening up and 
reform polices in the late 1970s, China had estab lished an advanced legislation framework, an 
administrative network and enforcement mechanism, which were sophisticatedly structured and were 
consistent with international ru les.  Moreover, China had participated in and ratified major 
international treaties and conventions on IPR protect ion.  This remarkable process, which had taken 
developed economies over 100 years, had been completed by China in around two decades.  She said that the Chinese Government was fully aware that  resolute and effective enforcement was the 
essential link for the legislation to exert its protective functions. 
194. With respect to law enforcement, she said that China's IPR protection featured both 
administrative and judicial channels which operate d in a complementary way simultaneously.  China 
had investigated and dealt with infringement cases, combated offences and protected interests of right 
holders through administrative enforcement, crim inal proceedings as well as closer cooperation 
between administrative departments, public security authorities and people's procuratorates.  IP/C/M/46 
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195. To further step up IPR protection, China's Government had set up, at a national level, an IPR 
protection working group consisting of all judi cial and administrative enforcement authorities 
involved in IPR protection.  This working group was mandated to coordinate national IPR protection 
work and supervise the handling of major violatio n cases.  The State Council had also laid out a 
year-long special campaign across the country for strengthening IPR protection commencing from 
September this year. 
196. Recognizing the legitimate concerns and interest s in IPR protection of foreign companies and 
entities operating in China, the Chinese Government  had institutionalized a coordinating mechanism 
for regular communication and exchange with fore ign enterprises and trade associations.  This 
mechanism had recently been expanded to include representatives of foreign commercial chambers in 
China to better attune to comment s and opinions from representatives of a broader range of interests 
in a timely manner.  These concerned foreign parti es had played a positive role in cooperating with 
enforcing authorities by reporting infringing acts and making suggestions and also by jointly promoting the protection of IPR.  These policies and measures were in line with the specific situation 
of China and had achieved concrete results.   
197. During a special IPR protection campaign in the first half of this year, which mobilized 
several authorities concerned, industrial and commerc ial authorities had investigated and dealt with 
4,036 trademark infringement cases with a total fine  of nearly 30 million RMB.  12,000 copyright 
enforcement personnel had inspected over 8,000 so ftware and audiovisual product dealers and had 
confiscated over 1.5 million pirated discs.  In  this respect, she referred to the Xiushui  market in the 
city of Beijing, as an example.  This market had been a place renowned for fake goods, especially 
clothes, and had almost became a sign of Beijing.  In the transitional review of last year, some 
Members had raised questions concerning this particul ar market.  Nevertheless, if one went to that 
market now, one would find that things had cha nged dramatically.  On 20 July 2004, the Beijing 
Administration of Industry and Commerce had publis hed a decree banning all clothes and accessory 
markets from selling commodities bearing 25 trademarks such as Prada, Burberry etc.  Vendors 
continuing to sell such commodities would be i nvestigated as suspected trademark infringers.  
Vendors with repeated offences would be evicted fr om the market and vendors suspected of criminal 
activities would be transferred to the judicial aut horities for investigation.  This measure indicated 
China's strong commitment to comb ating IPR offences and a serious regard to Members' concerns and 
at the same time served as a testimony to e nhanced competence and accumulated experience. 
198. China's IPR protection was getting more systematic  in terms of organization, more extensive 
in terms of territory, more regular in terms of time and more institutionalized in terns of enforcement.  
She pointed out that IPR protection was not a passive response to fu lfil China's accession 
commitments, but that it responded to an increasi ng need to build a sound trade and investment 
environment, promote scientific and technical i nnovation and to speed up economical development of 
China.  She said that China's G overnment spared no effort in establishing a strong and effective IPR 
protection system, which was in the interest of bot h China and other Members.  However, the Chinese 
Government hoped that Members could understand that, given that China had started  building its IPR 
protection only 20 years ago, it still had a long wa y to go before it could have a highly advanced 
protection system.  Lastly, she said, Members should view the IPR situation of China from a developmental perspective and should continue to provide support and assistance for China's 
painstaking efforts to improve IPR protection. 
199. She said that China had prepared two documents  for this meeting, namely: "White Paper on 
Intellectual Property Rights Protection in China in 2003" and "Status of China's Intellectual Property 
Rights Protection" which had been made available as informal room documents.  She expressed her 
hope that these documents could put together th e big picture for Members and help them better 
understand the measures and achievements of Chin a on IPR protection.  Although the communication 
from the European Communities had reached the Chinese delegation only three working days before IP/C/M/46 
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the review, as a cooperative gesture, China ha d provided answers to the European Communities' 
questions. 
200. In answering the specific questions from Member s, the representative of China first took up 
the general issues.  With regard to on-line appli cation and information disclosure, he said that the 
office of the national working group on intellectual property protection was set up in the Ministry of 
Commerce, namely MOFCOM.  Its website at ip r.mofcom.gov.cn provided a great deal of 
information on IPR protection in China. 
201. He said that the e-filing of patent applica tions was in a trial operation phase.  Patent 
examination deadlines and public info rmation such as published patent applications, patent rights and 
the register on layout-designs were available on th e website of the State Intellectual Property Office 
("SIPO") at www.sipo.gov.cn. 
202. The Trademark Office had already realized on- line trademark publication and had publicized 
all the opposition decisions on the website of the State Administration for Industry and Commerce 
("SAIC").  At present, China was making efforts to speed up the automation process of trademark 
registration.  In China, the acquisition of patent  and trademark rights was subject to a registration 
procedure, while the copyright subsisted when a work was created, without prior examination by a 
governmental agency.  Accordingly there was no plan concerning on-line applications for or 
examination deadlines on copyright protection.  He sa id that the on-line application and search system 
for registration of IPR protection of the General Administration of Customs of China ("GCA"), had 
come into use in September 2004.  Anyone could br owse information on all registered IPRs in the 
GCA website at www.customs.gov.cn/ipr/ipr2001c/d efault.asp.  The detailed information of a 
registered IPR contained the name of the registered holder, name of the product, type and the content 
of the right etc., by the registration system.  The right holder could submit his application for a 
registration on-line, find out the process of veri fication for IPR in the GCA and managing or 
maintaining its registration information. 
203. According to China's Copyright Law, works by a foreigner may be protected under an 
agreement concluded between China and the country or Member to which he belonged or under an 
international treaty, to which both Members were pa rties, even if they had not obtained marketing 
approval.  For instance, in 2004, the National Copy right Administration of the People's Republic of 
China ("NCAC"), at the right owners' request, had undertaken special measures to confiscate pirated 
audio-visual products of the US film "Shrek 2", wh ich had not yet gained access to China's market at 
that time.  The relevant Articles stipulating punish ment were Articles 5, 10, 21 and 25 in the Law on 
Unfair Competition. 
204. Regarding changes in polices or restrictions on representation of intellectual property rights, 
he said that there had been no change in the rules on the qualification of patent agents.  Pursuant to the 
regulations on patent representations issued by the State Council in 1991, law firms seeking to 
practise patent representation were required to have at  least three attorneys at law with patent agent 
qualifications and approved by SIPO .  China had not so far established any special requirement in 
respect of copyright representation.  The representativ e also suggested that the legal consultant firms 
should be asked for help regarding useful informat ion for foreign right holders to lodge complaints 
directly to Chinese officials. 
205. Regarding legislation and the judicial interp retation, he said that the enactment of a 
systematic and universal civil code had always been an important legislative task for China.  In the 
ninth National People's Congress ("NPC"), a draft civil code had been filed and reviewed while in the 
tenth NPC the enactment of a civil code had been de emed an extremely important task.  However, the 
universality and complexity of issues concerning civil codes made it difficult to tell the exact time for promulgation.  Moreover, as China's economy and so ciety developed, some detailed articles of the  IP/C/M/46 
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draft civil code would need further rectification a nd modification.  More research ought to be done to 
find out how and what to do with the modification.   
206. As to judicial interpretation regarding IP th at were currently planned for enactment or 
revision, the Supreme People's Court and the S upreme People's Procuratorate had discussed the 
"Judicial Interpretation and Application of the La ws dealing with Criminal Offences of IPR" 
(hereinafter the "Interpretation"), which would be promulgated soon.  In drafting the Criminal 
Interpretation to IPR, the Supreme Court and th e Supreme Procuratorate had solicited the comments 
and questions from the standing committee of the NPC, public securities court, procuratorates, 
administrative bodies for enforcement and the academy. Moreover, comments and the 
recommendations from enterprises, chambers and asso ciations of the US, EU and Japan had been  
duly considered.  After the comments and questions  had been summarized, the Interpretation would 
carry out clearer and more definite standards fo r verdicts and lower the threshold for criminal 
acquisition.  When the new Interpretation took e ffect, the provisions of the relevant judicial 
documents that were inconsistent with the new Interpretation would automatically be nullified. 
207. The Anti-Monopoly Law was on the legislative agenda of the tenth NPC.  Since the 
organization of the State Council in 2003, the Mini stry of Commerce was responsible for checking 
monopolies.  Therefore, it had the mission of drafting Anti-Monopoly Law, which had been the mission of the former state economy and the trade committee. 
208. Based on the legislative research and sufficient discussion, MOFCOM had completed the 
draft of the Anti-Monopoly Law and had submitted it to the State Council in March 2004.  The draft 
contained articles regulating monopoly agreements, abuse of dominant market status, large scale 
concentration of enterprises, authority and legal du ties.  Due to China's situation, the draft also 
included the articles regulating administrative monopo lies and abuse of intellectual property.  After 
the deliberation of the State Council's legislative affairs office, the draft of Anti-Monopoly Law 
would be submitted to the State Council.  If the St ate Council approved, the draft would be submitted 
to the standing committee of the NPC for further deliberations. 
209. Regarding the amendment of the Law to Count er Unfair Competition, since 1998 SAIC had 
already done a lot of research about the amendmen t of the law to counter unfair competition and was 
now starting to draft the amendment. 
210. The regulations on the protection of the right of communication through information network, 
mentioned in Article 58 of China's Copyright Law, had been brought into the 2005 legislative agenda 
of the State Council.  Currently, this task was carried out in an orderly way. 
211. He said that China consistently attached great importance to public participation in 
legislation.  Article 5 of the Law on Legislation,  which had come into effect on 1 January 2000, 
stipulated that legislation should embody people's will, develop socialist democracy and protect the 
people's right to participate in legislation through various ways. 
212. On 22 March 2004, the State Council had publishe d the guidelines for implementation of the 
promotion of legitimate administrative activities, am ong which paragraph 16 had stipulated that "the 
present way of legislation by the government s hould be changed and the government should extend 
public participation into governmental legislatio n.  Legislators, juristic enforcers and law 
professionals should communicate with each othe r and thus a professional consultation and a 
reasoning system should be established.  In drafti ng laws, regulations, rules and documents as a basis 
for administrative management, the government should solicit comments through various channels, 
such as hearing, documentation, symposium, discussion or publishing the draft.  The will of the 
majority was to be respected and people's own good should be embodied.  Af ter drafts of laws, 
regulations, rules and documents as a basis for administrative management are passed, they should be IP/C/M/46 
Page 38  
 
published in a governmental gazette, popular newspa pers and governmental websites.  Citizens, 
cooperations and the corporate body should ha ve easy access to the governmental gazette". 
213. Regarding questions on patents, in 2003, the number of patent applications filed by US 
applicants had been 12,221, while the number of  Chinese applicants had been 251,238, among which 
56,769 had been for inventions, 127,842 for utility models, while 86,627 had been for industrial 
designs.  The statistics relevant to foreign applicatio ns in China was available in SIPO's annual report.  
The report could be browsed on the SIPO website.  SIPO did not collect and compile data on foreign 
patent applications by types.  No work was done  on examination duration of foreign applications 
alone. 
214. Pursuant to Article 23 and 45 of the Patent La w, any entities or individuals, including foreign 
nationals, could request a patent right to be declar ed invalid on the grounds that the patent for design 
was identical or similar to any design before the date  of filing.  In addition, pursuant to rule 79 and 
rule 86 of the implementing regulations of the Chinese Patent Law, where there was a dispute over the ownership of patent rights, the parties concerned could request administrative authority for patent 
affairs to mediate or institute legal proceedings w ith a People's Court.  Where a People's Court or an 
administrative authority held that the ownership of the patent right should belong to the plaintiff, the 
plaintiff could request SIPO to make a registration of change in ownership of the patent right by 
producing an effective judgement or decision. 
215. As for legal protection for layout-designs of in tegrated circuits, the regulations on protection 
of layout-designs of integrated circuits and its  implementing rules had been promulgated and had 
come into effect a long time ago.  The Supreme Pe ople's Court had also formulated a notice on trial of 
cases concerning layout-designs of integrated circu its, which provided the legal basis on the way of 
relief to protect the layout-designs of integrated ci rcuits.  Up to the present, there had not been any 
lawsuit on layout-designs of integrated circuits a nd SIPO had not received any request for settlement 
on disputes relating to them. 
216. A State Food and Drug Administration (SFDA) was now conducting an investigation into the 
linkage between patent approval and drug approval processes.  As for measures taken to protect 
undisclosed data, pursuant to paragraph 2 of Article  35 of the Implementation Rules on the Drug Law, 
the SFDA would not approve an application that  was based on other applications' undisclosed 
experimental data.  Pursuant to  Article 14 of the Methods on Ad ministration of Registration for 
Drugs, applicants should make a commitment that all the data to be provided had been obtained by 
themselves, when an application for drugs registra tion was submitted.  Pursuant to Article 21 of the 
Method on Administration of Registration for Drugs, proof of legitimacy of source would be needed 
for submission of application for drugs registration if  the data had been obtained abroad.  Pursuant to 
Article 22 of the Method on Administration of Re gistration for Drugs, the SFDA had reserved the 
right to request the applicant to re-experiment, to pr ove that the data had been obtained by himself.  
Pursuant to Article 52, during the verifying period  of approval for new drugs, technical requirements 
for new drugs would not be lowered even if the dr ug had already entered into the foreign market.  
That was to say there would be no dependence on data.  The SFDA was obliged to keep secret only 
the experimental data which had been obtained by the applicant alone.  Punishment would be 
exercised pursuant to Article 72 for the leakage of unreleased experimental data.  Pursuant to paragraph 3 of Article 35 of the Implementation Rules on the Drug Law, the SFDA would accept 
applications concerned when public interests were i nvolved or measures had been taken to ensure that 
the data would not be used fo r unjustified commercial purpose. 
217. One of SIPO's key tasks was to tackle examin ation backlogs.  After adoption of measures 
such as recruiting a large number of examiners on a continuous basis, updating the automation system 
and optimising the examination process etc., the averag e period of examination for patent applications 
for inventions by SIPO in 2003 had been 30 months., while from January to July in 2004, the average  IP/C/M/46 
 Page 39 
 
 
period had been further reduced to 28 months.  Otherwise, SIPO had no statistics on the average 
period of examination in specific technical fields.   
218. Regarding the protection of plant varieties, there was no specific plan to implement the 
UPOV 1991 Act.  China had always been increasing the number of new varieties of plants under protection and expanding the scope of  new varieties of plants under protection.  This list of newly 
added varieties was available to the public on the webs ite of the Ministry of Agricultural and the State 
Forestry Administration. 
219. Regarding the prevention of misappropriated a pplications, pursuant to Article 23 and 45 of 
the Patent Law, any entity or individual including fo reign nationals, could request a patent right to be 
declared invalid.  In addition, pursuant to rule 79 and rule 86 of the implementing regulations of the 
Chinese Patent Law, where there had been a dispute over the ownership of patent rights, the parties 
concerned could request the administrative authority for patent affairs to mediate or institute legal 
proceedings with the People's Court. 
220. Regarding the improvement of  licensing regul ations, Articles 24 and 25 of the Regulation on 
the Administration of Import and Export Technology  were reasonable and did not contradict the 
TRIPS Agreement.  Article 28.2 of the TRIPS Agr eement provided that patent owners should also 
have the right to assign or transfer by succession a pa tent and to conclude licensing contracts.  This 
provision granted the right of licensing patents to the pa tent owner.  However, it did not mean that the 
licensor did not need to undertake any obligation a nd that he could license the patent without any 
restriction.  As the transferor held the technol ogy and should know the ownership and the capacity of 
the technology, it conformed to the principle of equity that the transferor was required to guarantee his 
legitimate ownership over the tec hnology provided and to guarantee th at the technology provided was 
capable of obtaining the contracted goal.  It was also consistent with the principle of tort law that the 
transferor should bear tort liability if the transferee  infringed legitimate rights and interests of others 
due to use of technology according to the contract.  The laws on transfer of technology in many 
countries had similar provisions, so the said provisions  conformed to the international usage and did 
not impose unreasonable restriction to the honest and bona fide transferor. 
221. Turning to protection of trademarks and ente rprise names, he first took up the issue of 
pending opposition and cancellation proceedings at the Trademark Office and their respective pendency.  Currently, the Trademark Office of China had over 2,100 pending cancellation 
proceedings involving registered trademarks that ha d not been used for over three years and that the 
pendency was about one year.  The office had 29,000 pending opposition proceedings and, in 
2002-2003, the average pendency had been about two years.  China was now revising its examination 
guidelines and would publish them after the revision. 
222. Regarding the related goods and services in trad emarks examination, the Office had adopted 
the concept of similar goods and services in this process.  When examiners made a substantive 
examination on prior trademark rights, they made  cross examination on similar goods or services in 
different classes.  In determining whether they we re similar goods or services, factors as the purpose, 
function and sales channel of the goods or ser vices would be taken  into consideration. 
223. Turning to the determination of well-known mark s, he said that, for the People's Court, the 
recognition of well-known trademarks was essentially the determination of the facts of the case which 
was a constituent part of jurisdiction exercised by the People's Court.  The decisions made by the People's Court to determine a well-known trademar k was in conformity with the international 
conventions.  The Interpretation by the Supreme Peop le's Court of the Application of Laws Dealing 
with Cases Concerning Dissension on Internet Domain  Name and the Interpretation by the Supreme 
People's Court to the Application of Laws De aling with Civil Cases Concerning Dissension on 
Trademark Rights made clear regulations on the issues above.  According to statistics, since the 
amendment of the Trademark Law, Chinese courts had determined 17 well-known cases, three of IP/C/M/46 
Page 40  
 
which concerned foreign brands.  According to Article 22 of the Interpretation by the Supreme 
People's Court on the Application of Laws Dea ling with Civil Cases Concerning Dissension on 
Trademark Rights, the recognition of well-known trad emarks should be based on the rules made in 
Article 14 of the Trademark Law.  The People's Cour t would not verify the trademark when one party 
of the previous applied to protect a well-known trad emark that had been determined by the concerned 
administrative authorities or by the People's Cour t, if the other party had no dissension on the well-
known trademark concerned.  If the other party submitted its dissension, the People's Court would 
make a re-verification according to Article 14 of the Trademark Law. 
224. The Customs of China had no right to dete rmine a well-known trademark if Courts or 
authorities of the SAIC had already determined a we ll-known trademark.  On a request to the Customs 
to help enforcement, the Custom s would assist in enforcement. 
225. There had not been a commonly accepted practice in the recognition of well-known 
trademarks.  However, the revised Trademark Law and its subsequent regul ations made clear and 
detailed prescriptions on this matter, which were comp letely in conformity with the requirement of the 
TRIPS Agreement.  Therefore, pursuant to these regulations, two factors would be taken as the 
standard for recognition of well-known trademarks wh en authorities of public security were dealing 
with the concerning criminal cases.  First, pursuant to the provisions on the determination and protection for well-known marks by the SAIC and the Interpretation by the Supreme People's Court to 
the Application for Laws Dealing with Civil Cases Concerning Dissensions on Trademark Rights, the status of well-known trademarks should have been  granted by the authorities of the SAIC or 
determined by the People's Court.  Second, pursuant  to Article 213-215 of the Criminal Law, a well-
known trademark in the sense of the Criminal Law s hould be registered in the Trademark Bureau in 
China. 
226. Turning to the protection of geographical indicati ons ("GIs"), he said that the AQSIQ System 
of GI protection and the system of GI protection established by the China's Trademark Office in the 
form of collective and certification trademark were  different intellectual property rights protection 
measures and that applicants could chose either of the two systems voluntarily for GI protection. 
227. The State Council had endowed AQSIQ with both the function of general administration and 
law enforcement.  AQSIQ had enforced GI protecti on for registered GIs (PDOs) in the light of the 
Law on the Quality of Products, the Law on Standa rdisation, the Regulations on the Product of 
Destination of Origin and a compulsory national standard entitled "The General Specifications on 
Product of Destination of Origin".  Supervision and spot checks as well as other law enforcement 
measures had been taken against counterfeiting of such domestic GIs as Chinese Longjing tea, 
Shaoxing  wine and Longkou Vermicelli.  Sanctions were  taken against the counterfeiting of Cognac 
wine in China. 
228. In the light of the Law on the Quality of Products, quality and a technical supervision 
agencies could impose punishment on counterfeiting GI  products, while consumers could impose civil 
liabilities on the misfeasor only in the light of the Law on the Quality of Products, and the Law on the 
Protection of Consumers' Rights. 
229. The application for protection under the GI system of AQSIQ had been carried out on a 
voluntary basis.  Applicants already possessing a tr ademark, certification or collective mark could 
also apply for GI protection under the GI system of AQSIQ voluntarily. 
230. AQSIQ would follow an active and pragmatic a pproach to strengthen the communication and 
the cooperation on GI protection with other countries.   Based on consensus between the two parties, 
AQSIQ and the Ministry of Productive Activities of Italy had signed a memorandum on bilateral 
cooperation regarding GI protection with a view to  enhanced information exchanges and technical 
cooperation between the two parties.  IP/C/M/46 
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231. The representative of China said that, since last year's transitional review, there had been no 
new rules on the protection of enterprise names.  Ever since joining the Paris Convention, China had 
been strictly observing the principle of nationa l treatment providing equal protection for domestic 
companies' trademarks and marks registered in Chin a by foreign companies.  He said that the saying 
that "foreign enterprises in China did not enjoy the same protection for their well-known marks as 
domestic enterprises in China" did not have any factual grounds.  Since the implementation of 
provisions on determination and the protection of well-known marks on 1 June 2003, the Trademark 
Office and the Trademark Review and Adjudication Bo ard had totally determined the status of 153 
well-known marks, among which 24 were from abroad , 12 from the US, 12 from other Members.  He 
said that if the registrant of a well-known mark need ed a competent authority to determine his mark as 
well-known based upon the provision of Article 13 of the Trademark Law, he or she should, in line 
with Article 14 of the Trademark Law and the re levant provisions on th e determination and the 
protection for well-known marks, submit written evid ence which he or she believed could prove that 
his or her mark was well-known.  Moreover, ther e was no uniform requirement for the content or 
formats of written documents.  He said that recentl y a court in Tianjin had determined the Japanese 
mark YAMAHA as a well-known mark in a civil case ruling.   
232. Turning to copyright issues, the representative of China sai d that, according to China's 
Copyright Law, copyright protection was the same even for works appearing in different media.  
Thus, whether distributed as hard publications or co mmunicated as soft Internet content, all of them 
could be protected under the Copyright Law.  At  present, China was actively working on increasing 
the personnel involved in copyright enforcement.   
233. In the Notice on 2004 Special Control Action of fighting against software piracy,  the NCAC 
had explicitly demanded that the administration of enterprises' commercial use of software should be 
strengthened and that the enterprises which installed,  or used pirated software in their computer 
system or which installed software beyond the sc ope prescribed in the purchaser's sale contract, 
should mend their act within a specific time.  Othe rwise they would be severely punished by the 
operation of law.  Consequently, in case of using pirated software by a commercial institute, the 
copyright administrative department may impose pena lty without a prior judgement of whether the act 
impaired public rights and interests or not.  Accord ing to China's Copyright Law the use of pirated 
software in a Internet cafe was an infringing act, wh ich was also prohibited by law.  The "temporary 
reproduction" issue was being studied by the Chin ese Government at present and would be properly 
dealt with in the Measures for the Protection fo r the Right of Communication through Information 
Network, which had been brought into the 2005 legislative agenda of the State Council.   
234. Where an ISP did not remove the relevant cont ent regardless of a copyright owner's notice or 
knowing that the Internet content provider infringe d another copyright through network and where 
this omission impaired public rights or interests, the ISP should be liable for administrative infringement.  The National Copyright Administration NCAC and the Ministry of Information 
Industries were drafting the Administrative Measures on the Protection of the Rights to 
Communication through Information Network, in wh ich the administrative procedure of notice-and-
take-down would probably be incl uded to reduce network piracy.  It was expected that these 
departmental rules would be issued by the end of 20 04.  According to China's laws and regulations, as 
well as future Administrative Measures on the Protection of the Right of Communication through Information Network, which was still in draft, the Mi nistry of Information Industries had the authority 
to revoke ISPs' business licences.   
235. He said that, undoubtedly, China was cautious  as well as active about the accession to the two 
new treaties, the WIPO Copyright Treaty ("WC T") and WIPO Performances and Phonograms Treaty 
("WPPT") and China had made great efforts for th is goal.  The Administrative Measures on the 
Protection of the Right of Communication through Information Network was being drafted by the 
NCA and the Ministry of Information Industries and would be issued by the end of this year.  In IP/C/M/46 
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addition to effectively implementing the two new treaties to which China would accede, the State 
Council had brought these measures into  its 2005 legislative agenda.   
236. It was known that the obligation regarding the removal and alteration of electronic rights' 
management information ("RMI") stemmed not from the TRIPS Agreement but from the WCT and 
WPPT.  Nevertheless, this problem was being actively taken into account.  Currently, the State 
Council was doing the legislation planning on these ma tters so that the protection of RMI would be 
properly dealt with. 
237. Regarding the payment of royalties for copyright the NCAC and the State Administration of 
Radio, Film and Television were working on broadcasting payment measures.  At present, the task 
was in the process of investigation, study and drafting.   
238. In respect of retroaction, he said that Article 9 of the Implementing Measures on Copyright 
Administrative Penalty entirely conformed with th e Article 29 of the Law on Administrative Penalty, 
which prescribed "Where an illegal act is not di scovered within two years of its commission, 
administrative penalty shall no longer be imposed, excep t as otherwise prescribed by law.  The period 
of time prescribed in the preceding paragraph sh all be counted from the date the illegal act is 
committed;  if the act is of continuing or continuous nature, it shall be counted from the date the act is 
terminated".  Therefore, the prescription of admini strative penalty was different from that of civil 
procedure.  The latter was counted from the date on which the injured party had known or should have 
known the infringement of its rights, while the form er was counted from the date on which the illegal 
act had been committed or terminated.   
239. Regarding some further copyright questions, he said that China had recently indicated that it 
would join the 1996 WIPO Internet treaties, the WCT and WPPT, but neither had it indicated joining 
before 2005, nor had it intended to complete a draf t for the Internet-related implementing rules before 
the end of 2004.  According to the Copyright Law of China, the measures on the protection of the right of communication through information netw ork had been brought into its 2005 legislative 
agenda. He said that currently this task w as being carried out in an orderly way.   
240. Regarding the protection of sound record producers' rights, he said that the Chinese copyright 
legislation was totally consistent with the TRIPS Agreement and that China would provide the rules 
on collecting societies to Members concerned once these were ratified. 
241. Turning to the issue of enforcement, he said th at the State Council had promulgated a special 
action plan for the protection of IPRs this year a nd SAIC had issued its action plan for the campaign 
of exclusive trademark rights protection in June . All these plans were being made available on the 
website of the state office of the IPR working group at ipr.movcom.gov.cn or on the website of SAIC.  
One may also refer to the NCAC's Implementing Plan on Special Action for the Protection of IPRs of September 2004, which would be available at www.ncac.gov.cn.   
242. Regarding the case numbers of administrative enforcement, according to statistics, in 2003 
and in the first half of 2004, the people's courts at various levels throughout China had completed 
trials of 220 cases of fake registered trademarks, 85 cases of selling commodities with fake registered 
trademarks, 167 cases of illegal production and sale of registered trademarks, 22 of copyright 
infringement, 4 cases of selling copyright infring ing duplicates and 69 cases of commercial secret 
infringement.  
243. The statistics in 2003 showed that 37,489 la w-breaking cases of various kinds had been 
handled by Administrations for Industry and Commer ce ("AICs") at all levels throughout the country, 
among which there had been 11,001 general tradem ark offences and 26,488 trademark infringement 
and counterfeiting cases.  Besides, 84,755,000 pieces or sets of illegal representations of trademarks 
had been seized and/or removed.  15,597 mould plates and other tools directly used for the  IP/C/M/46 
 Page 43 
 
 
infringements had been confiscated and 5,754.92 tons  of infringing goods had been destroyed.  The 
fine had totalled 242m RMB and 52 persons involved in 45 cases had been transferred to judicial 
organs for criminal liability.   
244. In the first three quarters of 2004, 13,922 law- breaking cases of various kinds had been dealt 
with, among which there had been 3,407 genera l trademark offences and 10,515 trademark 
infringement and counterfeiting cases.  In addition, 12,232,900 pieces and sets of illegal 
representations of trademarks had been seized and/ or removed.  16,894 mould plates and other tools 
directly used for the infringements had been confi scated and 10,952 tons of infringing goods had been 
destroyed.  The total value involved had reached 452m RMB, the fine had amounted to 99m RMB and 16 persons involved in 14 cases ha d been transferred to judicial organs for criminal liability.  In 
2003, SIPO at various levels th roughout China had accepted 1,527 patent dispute cases among which 
1,237 cases had been completed.   
245. Further, in the enforcement against producing and selling fake commodities and infringing 
IPRs, the Supreme People's Procuratorate this year  had required a particul ar supervision by the 
People's Procuratorate at various levels over crim inal cases of this kind.  From January to 
October 2004, the People's Procuratorate at various levels had approved the arrest of 2,118 criminal 
suspects involved in the production and sale of fake commodities and prosecuted 1,522 of them.  There had also been approval of the arrest of 483 criminal suspects and the prosecution of 488 
involved in other IPR infringements.  70 more cases had been marked as priority cases by the Supreme People's Procuratorate, either monitored dir ectly by itself or required to be monitored by the 
High People's Procuratorate at the provincial level.  In the first three quarters of 2004, 6,275 unfair 
competition cases on the infringement of IPR had been i nvestigated into and dealt with by AICs at all 
levels throughout the country.  The total value involved had been 385.61m RMB, among which 6.94m 
had been confiscated and 35.58m had been the fine.   
246. In 2003 the copyright administrative departments at all levels had accepted 23,013 cases and 
had settled 22,429 of them.  21,032 cases had resulte d in penalty.  1,173 cases had led to mediation 
and 224 had been removed to judicial department s.  In the same year, the local copyright 
administrative department had captured 67.97m of  various kinds of pirated products, including 
24.75m pirated books, 1.78m pirated periodicals, 26. 45m pirated audiovisual products, 6.62m pirated 
electronic publications, 7.22m pirated soft ware and 1.14m other pirated products. 
247. He said that China had always attached great importance to IPR protection and fighting IPR 
infringement and that China was also prepared to coope rate with other Members, either in the bilateral 
or the multilateral legal framework.  He said that for criminal actions, the foreign affairs bureau of the 
Supreme People's Court coordinated the contacts wi th foreign members and the hearing of the IPR-
related cases was undertaken by the third civil court of the Supreme People's Court.  At present, the National Copyright Administration (NCAC) had established a good relationship of interactive 
cooperation with BSA, MPA, IFPI, Customs of Hong  Kong SAR and MPIA.  As China believed that 
striking piracy was an unshirkable international duty for the governments of all Members, including 
developed Members, China was ready to continu ously consult and coopera te with the relevant 
departments of other governments in this respect, so as to jointly crack down on piracy.   
248. With respect to patents according to Article 57 and 68 of the Patent Law, he said that 
administrative enforcement was to be carried out by  the administration responsible for patent-related 
work.  Therefore, there was no mechanism for c oordinated action with foreign governments.   
249. On the customs enforcement front, the Ch inese Customs authorities and the Customs 
authorities in Hong Kong, China had established an excellent cooperation relationship, which 
included joint enforcement action, information ex change, investigation assistance, personnel training 
etc. The Chinese customs authorities enjoyed good cooperation with the Asean-Pacific Regional Intelligence Liason Offices ("RILOs") of the Worl d Customs Organization ("WCO") in respect of IP/C/M/46 
Page 44  
 
information exchange. In recent years, quite a number of cases had been disclosed with the 
information provided by the Asean-Pacific RILOs of  the WCO.  An agreement between China and the 
EU on customs administrative mutual assistance w ould also be signed at the end of 2004, which 
would initiate the cooperation between the Customs au thorities of the two sides with respect to IPR 
protection.   
250. According to China's laws, regul ations and departmental rules,  copyright owners could seek 
relief at the enforcement department of the place where the infringer had its seat of business or its principal operative office, or where the infringement was committed or the infringing result took place.  The People's Procuratorate, at its four levels  from supreme down to the local county, internally 
had all special bodies or relatively fixed personnel to deal with IPR-related criminal cases.  He said 
that, in the Supreme People's Procuratorate, the ex amination, prosecution and appearing in court of 
IPR cases was undertaken by the pr osecution office.  The prosecution office was also responsible for 
providing coordination, guidance and personnel traini ng for the prosecution offices at various levels 
of the People's Procuratorate when dealing with cases of this kind.  The prosecution office also had an 
inter-agency meeting mechanism with the investiga ting authorities dealing with cases of this kind to 
exchange information, start crime preventi on measures and also comment on the evidence 
establishing work of the investigating authorities.  In  the People's Procuratorate at all local levels it 
was also the prosecution offices that were responsib le for the examination, prosecution and appearing 
in court for cases of this kind.  They accep ted guidance from the higher level, the People's 
Procuratorate, on application of law and criminal pena lty criteria etc. in cases of this kind and also had 
inter-agency coordinating mechanisms with the i nvestigating authorities at the same level.   
251. With regard to the issue of private investigati ng firms, he said that the Ministry of Public 
Security of China was taking active steps to consid er it.  However, there was still no new regulation 
being issued. 
252. Regarding the elimination of localism, he said that in order to fight against and eliminate local 
protectionism, the State Council had issued, on 21 Ap ril 2001, stipulations on the prevention of local 
blockades in market economy activities.  This was a special regulation fighting against local 
protectionism.  On IPR protection specifically, a special action programme on IPR protection had 
been issued by the State Council on 26 August 2004, in  which the elimination of local protectionism 
was also an important content. 
253. Turning to administrative enforcement, he said that the NCAC was the government body 
responsible for copyright administrative protectio n in the Internet environment.  Data on the 
administrative enforcement showed that, in the fi rst three quarters of 2004, 20,371 unfair competition 
cases of various kinds had been investigated and d ealt with by AICs at all levels throughout the 
country.   
254. According to the Law on Administrative Procedur e, if an administrative punishment decided 
by the enforcement department was obviously unreasonable, the People's Court could modify it by 
verdict.  According to the Law on Administra tive Procedure and Articles 44 and 56 of the 
Interpretation on Issues Concerning the Implementa tion of the Law on Administrative Procedure by 
the Supreme People's Court, the People's Court could ma ke an order or a verdict to reject the lawsuit 
or the claims of the lawsuit.   
255. According to the aforesaid law and interpretation,  all the parties of a law suit had an equal 
right to entrust a lawyer and all the evidence needed  to be shown and enquired in the court hearing.  
Evidence which had not been enquired by the opposin g party in a court hearing was never adopted for 
the grounds of deciding the case, except if the evidence involved confidential information of the 
country, commercial secrets, individual privacy or w as to be kept secret based on definite provisions 
of laws.  He said that the People's Court had to de liver the judicial documents including the verdict,  IP/C/M/46 
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order and decision to the relevant parties of the la wsuit, otherwise these judicial documents would not 
go into effect.   
256. Regarding obligations of administrative ag encies to provide written decisions with 
interpretations for their enforcement decisions, he sa id that his delegation believed that this question 
was not relevant to the IPR system and that hi s delegation was not obliged to answer it here. 
257. Regarding the degree of deference extended to administrative case decisions, he said that his 
delegation believed this question to  be about how the court made its judgement upon facts recognized 
and laws applicable in administrative enforcement.  He said that in the administrative lawsuit system 
of China, the principle of validity review of speci fic administrative behaviour was applied.  In case 
administrative behaviour needed to be carried out  upon case notes pursuant to the relevant law, the 
court practised the principle of "records exclusiv ity", that was to say that the court would not 
introduce or accept evidence beyond th e record. In other cases, the court would conduct an overall 
review on the recognition of the facts and laws ap plicable in administrative enforcement.  Under 
special circumstances, the court coul d collect evidence by authority.   
258. According to the Law on Administrative Punishment of China, the amount of fines of 
administrative punishment was prescribed by laws or administrative regulations.  Competent 
authorities of copyright administration on various levels were obliged to conduct their administration legally and were not allowed to lower or raise the amount of the fine.   
259. Turning to civil enforcement, he said that pursu ant to the Law on Civil Procedure, the period 
of first instance of civil law cases was six months , while the period of second instance of civil law 
cases was three months.  The period could be extende d and the procedure for extension would have to 
be followed.  In practice, most IPR cases could be  finished within the trial period, though some 
complicated cases could take longer time.  When circ umstances appeared for la wsuits to be suspended 
according to the law, the court would suspend the lawsuit.  The compensation amount was determined 
by the court on the basis of the principle of comp lete compensation prescribed in laws and judicial 
interpretations and of the specific case including  the reasonable amount of money paid to stop the 
infringement.  The retaining fee for lawyers, which wa s consistent with the re levant regulations, could 
be calculated in the compensation on the basis of the request of the plaintiff and the specific case.  If 
one party had dissensions on the compensation amount, he  or she could appeal to a court of a higher 
level. The court of the second instance would verify  all the requests, but in practice, hardly any 
changes were made to a compensation amount determ ined by the court of the first instance.   
260. The present Patent Law, Trademark Law and Copyright Law and corresponding judicial 
interpretations all contained regul ations concerning judicial injunctions before the lawsuit.  The 
concerned right holder could file to the court.  Af ter the court had accepted the application, it would 
actively and with caution determine whether judicial  injunctions would be im plemented.  Actually, 
statistics showed that the Chinese courts had awar ded injunctive relief to right holders in several 
hundred cases.  Courts that awarded injunctive relief be fore lawsuits were mainly those situated where 
the defendant was or where the infringement had o ccurred.  Even if some injunctions had to be 
enforced in places other than where the court was situated, the concerned court would assist in the 
enforcement.  Meanwhile, China's courts were tryi ng hard to ensure the enforcement of verdicts. 
261. Turning to criminal enforcement, he said that in  legal terms, it was possible that both civil and 
criminal IPR cases were heard by courts of the same level, but this was really rare.  According to 
Article 20 of the Law on Criminal Procedure of China,  criminal cases by foreigners were heard by the 
middle level People's Court.  Pursuant to Article 23 of the Law on Criminal Lawsuits of China, the 
upper level People's Court could, if necessary, hear  the case which should be heard by a court on a 
lower level; if the court on the lower level regard ed the case as extremely serious, it could request to 
transfer the case to an upper level People's Court. IP/C/M/46 
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262. Article 7 of the General Administration of Cu stoms Notice No. 742 of 1998 had stipulated 
that, once the People's Procuratorate thought th at there was enough evidence for a suspicion of 
smuggling and cases should be heard by the lowest le vel People's Court, the People's Porcuratorate 
could sue the case at the local intermediate Peopl e's Court according to Article 23 of the Law of 
Criminal Procedure.  This meant that it was the in termediate People's Court that would hear part of 
the IPR criminal cases concerning accusations of sm uggling.  Investigations conducted last year by 
the concerned bodies of the Supreme People's Court had shed some light on this issue.  However, 
given the complexity of responsibilities within diffe rent authorities, the issue whether the hearing 
level of IPR criminal cases should be  adjusted, required more research. 
263. Turning to customs border enforcement, he said that at present, measures taken by the 
General Administration of Customs to protect IPR included establishing more laws and regulations on 
IPR protection, training more enforcers of GC A, strengthening coopera tion with right holders, 
participating more in cooperation and communication with foreign c ounterparts, and employing more 
advanced technology to find more pirated produc ts.  All these measures had proven effective to 
prohibit exportation and impor tation of pirated goods.   
264. According to old regulations, once the consigner or the consignee of the goods apply to the 
Customs for dissension on their goods that are susp ected of piracy, the Customs could no longer 
conduct an investigation on whether the product w as pirated or not.  However, a new regulation 
stipulated that, in response to an application fro m right holders, once the Customs had found products 
suspected of piracy, the goods would be detained by the Customs, no matter whether the consigner or 
the consignee filed to the Customs for dissension.   The Customs could conduct investigations on 
whether the goods were pirated or not.  Therefore,  the enforcement by the Customs was strengthened 
while efficiency of enforcement was improved. 
265. In a passive protection mode, right holders w ould have to pay a deposit equivalent to the 
worth of the products, but in an initiative protection mode by the Customs of China, the Implementing 
Rules of GCA stipulated, firstly, that deposit equivalent  to the worth of the goods had to be paid if the 
goods were worth less then 20,000 RMB;  secondly, that  a deposit equivalent to half of the worth of 
the goods had to be paid if the goods were wo rth between 20,000 and 200,000 RMB, with the deposit 
being no less then 20,000 RMB;  thirdly, that a de posit of 100,000 RMB had to be paid if the goods 
were worth more then 200,000 RMB.  In either mode , right holders could choose to pay the deposit in 
cash or to show the Customs the insurance letter pr ovided by a bank or a financial organization other 
than a bank.   
266. According to the law, only the consigner or the consignee of the imported or the exported 
goods were subject to Customs administration.  Therefore, the Customs could not extend its jurisdiction to other companies involved in piracy.  However, in real practice, Customs would provide 
the information on the detained goods to the right holder and concerned authorities of the 
administrative enforcement.  The right holder an d the concerned authorities of the administrative 
enforcement could exercise punishment on the comp anies involved in piracy on the basis of the 
information provided by the Customs.  From 2001 to 2003, there had been altogether 5,000 cases 
where the Chinese Customs had exercised protection measures, while in 1,700 of these cases pirated 
products had been found.  The value of the confiscated products had been 198m RMB. 
267. Customs enforcement was categorized as admi nistrative enforcement.  The products had 
already been deemed by the Customs as pirate d and the Customs would exercise administrative 
punishment to the violator, including confiscating g oods and forfeiture.  Since 1996, there had been 
5,800 cases where the Customs had exercised administ rative punishment to violators.  Therefore, it 
was unnecessary for the Customs to f ile an administrative lawsuit in IP R cases.  As for civil lawsuits, 
it had to be filed by the right holder to the court.  In criminal lawsuits, as there had not been clear prescriptions on criminal obligations for piracy in exportation and importation, neither were there any 
judicial interpretations, the Customs so far had not transferred the cases for criminal obligations.      IP/C/M/46 
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268. In recent years, cooperation in IPR enforc ement between the Chinese Customs and the 
international community had been strengthened.  Statistics showed that, since 2000, by joint 
enforcement with the Customs of Hong Kong, Chin a, the Chinese Customs had dealt with more than 
200 IPR cases where the information had been provid ed by the Asean-Pacific RILO of the WCO. 
269. Regarding the cost burden for right holders for infringing products that had been stopped at 
the border, he said that it was in conformity with the present situation in China to let the right holder 
pay the storage fee and the Chinese Customs had realized that this practice was impeding IPR 
protection.  However, it had to be admitted that it was unaffordable for the g overnment to solve this 
problem.  Therefore, with the right holder unde rtaking part of the financial burden of the 
counterfeiting actions, the enforcement by competent authorities was facilitated in a sense.  The new 
regulation and its implementation stipulated clearly the investigating period and the period to deal 
with examining the product.  According to this regulation, the pendency of customs clearance would 
not be long.  Therefore, the storage fee for products  would be reduced shortly and finally right holders 
would undertake the charges concerned.  Pursuant  to the new regulation, once the suspected goods 
were determined as piracy, IPR right holders could take the storage fee and concerned charges as part 
of the fees to stop piracy which the right holder could request the violator to compensate for.  
Therefore, the right holder only paid the deposit te mporarily and could be compensated by way of 
repayment from the violator.   
270. Regarding confiscated goods, he said that if these were all to be destroyed, it would cause not 
only waste of natural resources but also environmen tal pollution.  Therefore, the Customs would sell 
such products that could be reutilized at auction to  make full use them.  Meanwhile, pirated indicators 
on a product would be erased to protect the interests of the right holder.  So far, the implementation of 
the regulation was satisfactory so that no revision to the regulation would be made. 
271. The representative of Japan  thanked the Chinese delegation for its comprehensive statement.  
He said that, at the transitional review in 2002 and 2003, his delegation had ra ised questions regarding 
the "further improvement of enforcement in judi cial procedures", "patent examination procedures", 
and other issues.  He said that his delegation appr eciated the fact that th e Chinese Government had 
made considerable efforts to improve its intellect ual property protection in response to these questions 
by, for example, drafting new judicial interp retation on criminal thresholds, and launching a 
nationwide campaign to step up its protection of intellectual property rights. 
272. He said that, in spite of such efforts, it app eared that China's intellectual property protection 
and enforcement was still insufficient in the light of  the high level of counterfeiting and piracy that 
continued to exist in China.  In document IP /C/W/430 submitted by the Japanese delegation, the 
following four issues had been recognized as hi ghly important: "active pursuit of criminal 
prosecutions", "strengthening of sanctions throu gh alteration of criminal prosecution standards", 
"pendency of patent examinations ", and "prevention of misappropria ted applications", about all of 
which the Japanese industry had serious concerns.  He  said that due to time constraints, China might 
not be able to prepare detailed responses to all th e questions immediately, but his delegation would 
greatly appreciate China's providing su ch responses through future discussion. 
273. The representative of the United States  expressed her appreciation of China's answers to 
Members' questions.  China deserved recognition for the extensive IPR-related legislative changes it 
had made at the time of accession.  The United States also appreciated China's efforts to improve its 
IPR enforcement and protection environment, includ ing the growth of China's Trademark Office and 
Patent Office and the increasing dockets of the Chin ese courts and enforcement agencies.  Under the 
leadership of Vice Premier Wu Yi, China had commi tted to address a number of problems in its IPR 
regime and to significantly reduce IPR infringement levels. She said that China had announced various action plans in this regard, only some of wh ich had been made publicly available to date. The 
United States was watching China's follow- through on these commitments closely. IP/C/M/46 
Page 48  
 
274. She said that, as China's own official reports  had noted, IPR infringement in China was 
rampant and the magnitude of IPR infringement in China was harming the interests of right holders 
not only in China but around the world. China's increasing exports of count erfeit and pirated goods 
posed dangers to consumers through out the developed and developing world.  In light of China's 
obligations under the TRIPS Agreement to provid e adequate and effective IPR enforcement, the 
United States noted a number of continuing prob lems.  Administrative enforcement was weak. 
Administrative enforcement processes typically afford ed no meaningful relief to right holders:  fines 
were non-deterrent; the decision-making process was not transparent; and too few administrative cases were referred to criminal prosecution.  As an  example of this problem, she said that while new 
border measures implemented earlier this year ha d provided for some improvements, they had 
significantly reduced the level of customs penaltie s from 300% to 30% of value.  China's civil, 
administrative and criminal enforcement systems continued to suffer from local protectionism.  She said that structural changes, such as pr oviding an immediate right of appeal to
 non-local courts or 
agencies, requiring mandatory penalties, and ins tituting mandatory sentenci ng practices would help 
address these problems.  Institutional challenges re mained.  Although China had created an expert 
civil IPR court, its criminal and administrative courts lacked the same level of expertise in IPR 
matters. 
275. In addition, she said, the United States had ser ious concerns about certain aspects of China's 
IPR legal framework, although China had done much  legislative work at the time of its WTO 
accession.  In particular, China's Criminal Law rais ed serious TRIPS issues by requiring a showing of 
profits for certain types of offences;  failing to  address commercial-scale tr afficking of infringing 
goods;  and criminalizing counterfeiting only when th e infringing mark was "identical" rather than 
confusingly similar.  She said that the United States appreciated China's commitment to issue a 
judicial interpretation by the end of this year to immediately address these issues, and was looking 
forward to its implementation. 
276. However, she said that the United States greatly  regretted that China had not released a draft 
of the long-awaited criminal judicial interpreta tion for widespread public comment.  Both the US 
Government and right holders had waited anxiously for the opportunity to comment on the draft prior 
to its final promulgation.  Last year at the TRI PS Council, China had pledged to increase transparency 
by making judicial interpretations on IPR matt ers available for public comment.  While the 
United States was pleased with the positive trend in this regard and noted the release during the 
present week of three draft civil IPR-related judicial  interpretations for public comment, nevertheless 
the drafting of this critical criminal judicial in terpretation had been opaque  with the draft being 
disclosed only to selected entities and industry associations. 
277. She said that the United States appreciated that  China had committed in the near term to 
address some of the problems highlighted above an d looked forward to real results from China's 
efforts. The coming months would be a critical peri od, particularly in the light of the issuance and 
implementation of the judicial interpretation and im plementation of the IPR action plans.  The United 
States looked forward to continuing efforts on issues  that remained of concern to both countries as 
well as to other Members, with a view towards improving the overall IPR enforcement environment in China. 
278. With respect to the specific answers provided by the Chinese delegation, she said that the 
United States appreciated very much the information provided on administrative enforcement cases.  
As a matter of clarification, she requested the Chinese delegation to confirm that, under Chinese law, 
there was no obligation requiring administrative d ecisions in IPR cases to be issued in writing. 
279. The representative of the European Communities
 thanked China for updating the TRIPS 
Council on its efforts to improve IP protection in China.  He said that his delegation was taking note with satisfaction of the progress that had been ma de so far and of positive on-going initiatives to 
tackle the problems. However, the European Co mmunities remained concerned by the level of  IP/C/M/46 
 Page 49 
 
 
counterfeiting in China and urged China to continue its efforts towards an effective IP enforcement 
system.  In this respect, his delegation was comm itted to working with the Chinese authorities to 
improve the situation.  With regard to the ques tions that had been submitted very recently by his 
delegation, he said that his delegation would apprec iate it if China could respond to them as soon as 
possible. 
280. The representative of Australia  thanked China for the very comprehensive and informative 
responses to the many questions posed to them.  He said that Australia attached particular importance 
to its bilateral cooperation with China in intell ectual property matters and was looking forward to 
continuing to work closely with China to the mutu al benefit of both countries on intellectual property 
issues.   
281. The representative of Chinese Taipei  thanked China for its statement and the information 
provided by its delegation.  Although Chinese Ta ipei had not submitted questions in writing in 
advance, his delegation shared some of the views regarding intellectual property issues mentioned by 
other delegations.  His delegation attached great importance to the transparency requirement under 
Article 63.1 of the TRIPS Agreement.  Chinese Taip ei was of the belief that transparency of 
administrative rulings as well as laws and regulations in the national system was of crucial importance 
both to local and foreign IP owners.  In this light, he wished to draw attention to the issue of well-
known marks.  According to China's recent comm unication in document IP/Q/CHN/1/Add.1, dated 
9 June 2004, the State Administration for Industr y and Commerce (SAIC) was revising the "Rules on 
the Determination and Protecti on of Well-Know Marks".  He said that his delegation would 
appreciate it if China could advise if there were any de velopments in this regard .  In addition, he was 
interested in having a list of well-known marks currently  applicable in China for reference.  He asked 
if the Chinese delegation could advise where to loca te such a list if it was publicly available on the 
Internet.  In conclusion, he said that his dele gation had noticed that China had already made good 
progress in several areas of intellectual property and would like to encourage China to continue in its 
relentless endeavour in the time ahead. 
282. In response to the remarks made by othe r delegations, the representative of China  said that, 
with regard to the written questions posed by th e European Communities on 26 November 2004, most 
of these concerns had already been covered by Ch ina's initial statement.  His delegation had given 
answers regarding the Chinese inte ntion to join the WIPO 1996 Intern et Treaties and had pointed out 
that China had never indicated that it would join  these treaties before the end of 2005 and had said 
nothing about a completion of the draft for the Inte rnet-related implementing rules before the end of 
2004.   With regard to the Copyright Law of Chin a, the measures on the protection of the right of 
communication through information networks had al ready been put onto the 2005 legislative agenda 
of the State Council and this task was currently be ing carried out in a smooth and orderly way.   
Regarding the protection of the rights of producers of sound recordings, he said that the Chinese copyright legislation was totally consistent with  the TRIPS Agreement.  Regarding the rules on 
collecting societies, he said that these would be  made available by the Chinese delegation to the 
European Communities and any other Members con cerned once the rules had been ratified.  In 
reaction to prevalent interests and requests from industries, local communities and other sectors, SAPO of China was engaging in a preliminary assessm ent of the national IP strategy.  Regarding the 
follow-up question from the delegation of the United St ates, he said that his delegation would discuss 
with experts in the capital and would hopefully be able to come back with further information. 
283. Turning to the preparation of the TRIPS Council's report to the General Council, the 
Chairman
 suggested that, given that the TRIPS Council would not have anothe r meeting before the 
General Council's next meeting scheduled for 13 and 14 December 2004, the TRIPS Council agree 
that that he, acting on his own responsibility, prepare a brief and factual report to the General Council.  
The content of the cover page to the report would be similar to that submitted by the TRIPS Council 
in 2003, and the part of the minutes of the meeti ng reflecting the discussions held under this agenda 
item would be attached.  IP/C/M/46 
Page 50  
 
284. The Council took note
 of the statements made and agreed  to proceed with the preparation of 
the report as suggested. 
Q. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
285. The Chairman  informed the Council that the Kingdom of Cambodia had become the 148th 
Member of the WTO on 13 October 2004. 
R. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
286. The Chairman  said that the list of the 16 pending requests for observer status in the TRIPS 
Council by other intergovernmental organizations wa s contained in document IP/C/W/52/Rev.10.  He  
recalled that the Council had discussed these pending re quests at its previous meetings, but had not 
been able to reach consensus on any of them.   
287. The Council agreed  to revert to the matter at its next meeting. 
S. ANNUAL REPORT TO THE GENERAL COUNCIL  
288. The Chairman  informed Members that a draft Annual Report of the Council had been 
circulated in document JOB(03)/177.   He suggested that the Secretariat would be requested to update 
the draft to reflect the discussions at the present meet ing.  This draft would be faxed to Members, who 
would have two days to comment on the updated parts of the draft report once it had been circulated 
by the Secretariat.  The Chair indicated that this short period for comments was due to the fact that the 
report had to be circulated in time for the General Council's meeting of 13-14 December. 
289. The Council agreed  to proceed as suggested by the Chairman.1 
T. OTHER BUSINESS  
290. The Chairman  suggested the Council agree on the following dates for the Council's meetings 
in 2005:  8-10 March, 14-15 June and 25-26 October 2005. 
291. The representative of Egypt  requested that the meetings be coordinated so as to avoid any 
conflict with meetings at WIPO.  The Chairman  informed the Council that the Secretariat had liaised 
with WIPO in order to avoid any fo reseeable conflict in meeting dates. 
292. The Council agreed  on the dates for the Council's meetings in 2005 as suggested by the Chair. 
__________ 
 
                                                      
1 The Annual Report (2004) of the Council for TRIPS was subsequently circulated in document 
IP/C/32.