RESTRICTED  WORLD TRADE  
ORGANIZATION  IP/C/M/49 
31 January 2006 
 (06-0444) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard on 25-26 and 28 October,  
29 November and 6 December 2005  
 
Chairman: Ambassador Choi Hyuck (Korea) 
  
 The present document contains the record of  the discussion which took place during the 
TRIPS Council meeting held on 25-26 and 28 October, 29 November and 6 December 2005. 
  Subjects discussed
 Page nos.  
A. N OTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT .........................................................3 
B. F OLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ALREADY 
UNDERTAKEN ..............................................................................................................................3  
C. T RANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION 
OF THE PEOPLE 'S REPUBLIC OF CHINA ........................................................................................4 
D. R EVIEW OF THE PROVISIONS OF ARTICLE 27.3  (B) ...................................................................12 
E. R ELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY ...........................................................................................................12 
F. P ROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE .................................................12 
G. D ECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION 
ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH ..................................................................34 
H. R EVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF 
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC 
HEALTH ............................................................................................................................... ......41 
I. N ON-VIOLATION AND SITUATION COMPLAINTS .......................................................................42 
J. T RANSITION PERIOD FOR LEAST -DEVELOPED COUNTRIES ;  REQUEST FOR EXTENSION ..........45 
K. S PECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL ..............52 
L. R EVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1..................53 
M. R EVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON 
GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 ...............................................................53 
N. T HIRD ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT ............................................54 
O. T ECHNICAL COOPERATION AND CAPACITY -BUILDING ............................................................55 IP/C/M/49 
Page 2  
 
P. E
NFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS – COMMUNICATION FROM THE 
EUROPEAN COMMUNITIES ........................................................................................................57 
Q. I NFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO ..............................61 
R. O BSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS ...............61 
S. A NNUAL REPORT TO THE GENERAL COUNCIL ..........................................................................62 
T. O THER BUSINESS ......................................................................................................................63 
 
  IP/C/M/49 
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A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
1. The Chairman  informed the Council that, since its meeting in June, it had received a number 
of supplements and updates to earlier notifications of laws and regulations notified under Article 63.2 
of the Agreement.  Japan had no tified an amended Customs Tariff La w and a number of "other laws 
and regulations";  Hong Kong, China had notified r ecent amendments to its intellectual property laws 
and regulations;  Korea had notified amendments to its Trademark Act;  Belize had notified its 
Trademarks (Electronic Filing) Administrative Instru ctions;  and Sweden had notified amendments to 
its copyright, patent and plant breeder's rights laws .  These notifications were being circulated in the 
IP/N/1/- series of documents.  He urged tho se Members whose initial notifications remained 
incomplete to submit the outstanding material w ithout delay, and reminded other Members of their 
obligation to notify any subsequent amendments of th eir laws and regulations without delay after their 
entry into force. 
2. The Council took note  of the information provided. 
B. FOLLOW -UP TO REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION ALREADY 
UNDERTAKEN  
3. The Chairman  informed the Council that, in the context of the follow-up to the 11 reviews 
that had been initiated at the Council's meetings  since April 2001 but which still remained on the 
Council's agenda, Egypt had provided, since the C ouncil's last meeting, responses to all outstanding 
question posed to it.  These responses, together w ith the responses it had provided earlier, had been 
circulated in document IP/Q/EGY/1.  The Chairm an suggested that the regular review of the 
legislation of Egypt be deleted from the agenda, it being understood that an y delegation could revert 
to any matter stemming from the review at any time. 
4. The representative of Switzerland , thanking Egypt for the responses to the Swiss questions, 
noted that some of these responses were new res ponses replacing previous answers from Egypt.  
While his delegation was still reviewing these ne w responses and would pose follow-up questions 
where necessary, it could agree with the Chair's suggestion.  
5. The representative of the United States , thanking Egypt for its responses to the US questions, 
said that while his delegation was still reviewing the responses and might pose follow-up questions, it 
could agree with the Chair's suggestion. 
6. The Council agreed  to proceed as suggested by the Chair. 
7. The Chairman  further informed the Council that  Congo had provided responses to 
outstanding questions, which had not yet been ci rculated to Members but were available as an 
advance copy of document IP/Q/COG/1/Add.1.  Also Qatar had provided responses to outstanding 
questions, which would be circulated shortly after some necessary clarifications.  The remaining eight 
Members with outstanding questions were Cuba;  Fiji;  Grenada;  Mauritius;  Saint Kitts and Nevis;  
Saint Vincent and the Grenadines;  Suriname;  and Swaziland. 
8. He said that a number of questions had also been raised with regard to the implementing 
legislation of certain Members whose reviews had already been deleted from the Council's agenda on 
the understanding that any delegation should feel fr ee to revert to any matter stemming from the 
review at any time.  These Members were Dominica, Gabon, Ghana and Guyana. 
9. He urged the delegations con cerned to provide the outstanding material as soon as possible, 
so as to allow the Council to complete the follow-up to these reviews.  He suggested that the Council 
revert to this matter at its next meeting. IP/C/M/49 
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10. The Council took note
 of the information provided and agreed  to proceed as suggested by the 
Chair. 
C. TRANSITIONAL REVIEW UNDER SECTION 18 OF THE PROTOCOL ON THE ACCESSION OF THE 
PEOPLE 'S REPUBLIC OF CHINA  
11. 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 pursuant to the requirement, dated 24 October 2005, had been 
circulated as an advance copy of document IP/C /W/460.  In addition, the Chinese delegation had 
made available as a room document a "White Pape r" entitled "New Progress in China's Protection of 
Intellectual Property Rights".  Questions and comment s in connection with the transitional review had 
been submitted by the European Communities, Japan and the United  States (documents IP/C/W/450, 
451, 453 and 453/Add.1, respectively).  
12. The representative of China , briefing the Council on China's implementation of the TRIPS 
Agreement and the relevant commitments since its last review, said that China had taken only two 
decades to establish an advanced intellectual prope rty legislation framework, administrative network 
and enforcement mechanism, including the ratificatio n of major international treaties and conventions 
for IPR protection.  On average, this had take n developed economies over one hundred years to build 
up.  Without the consistent efforts of the Chinese Government, it would have been impossible to fulfil 
this mighty task in such an efficient and effective way.  China was fully awar e that transparency and 
enforcement were essential to put the functions of a well-built IP legal system into full play.  The 
Chinese Government had set up a national level IPR protection working group consisting of all 
judicial and administrative enforcement authorities involved in IPR protection.  With concrete results achieved since August 2005, a one-year-long special campaign across the country for strengthened 
IPR protection had been further extended by the State Council to the end of this year.   
13. Recognizing the legitimate concerns and the e normous interest of foreign governments and 
companies in China's IPR protection, the Chinese Government had built a new mechanism for regular 
communication and consultation with foreign-invested  enterprises and trade associations, as well as 
with the governments of the Members concerned.  He said that China had always attached great 
importance to the protection of intellectual prope rty rights and had fulfilled its international 
commitments in a serious and positive manner.  IPR protection was not a passive response to fulfil 
China's accession commitments, but  resulted from an intrinsic need to foster a sound environment for 
trade, investment and R&D in China, which would help to keep the rapid economic development of 
China more sustainable.  China spared no effort in establishing a strong and effective IPR protection 
system which was in the interest of both China a nd other WTO Members.  However, given the long 
journey to go before China could have a highly a dvanced IP protection system, as mentioned in the 
beginning of the statement, China hoped that Members would view the IPR situation of China from a more developmental and realistic perspective a nd continue their support and assistance during the 
process of improvement. 
14. He said that, prior to the meeting, China had prepared a document containing the information 
requested by Annex 1A of China's Acc ession Protocol (IP/C/W/460), and also the 2005 White Paper 
on the New Progress in China's Protection of Intellectual Property Rights , which had been made 
available as a room document.  He hoped that these  documents would put together a complete picture 
for Members to better understand the measures a nd achievements of China on IPR protection. 
15. Turning to the responses to the written questions  received from some Members, he said that 
there were three important cross-cutting issues regard ing these questions.  First, for all the statistical  IP/C/M/49 
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data falling within China's WTO obligations, he requested Members to refer to the information 
provided under Annex lA prior to this meeting.  There was, however, some information that China 
was unable to provide or would not provide due to legitimate reasons.  He said that he would be 
happy to seek ideas from some of the Members after the meeting to learn how they compiled in their 
own countries some of the data, that they had asked from China. 
16. Secondly, he reminded Members that questions should merely focus on the review of China's 
implementation of its WTO obligations during the p ast year, rather than seek a preview of China's 
performance in the years to come.  He said that  his delegation was unable to respond to questions 
purely speculating on future events under this mechanism.   
17. Thirdly, he said that during the past four year s of this review, his delegation had found an 
increasing number of questions not relevant to TRI PS from some Members.  This had made the list of 
questions longer, but less relevant to the TRIPS Agreement or China's accession commitments.  He 
requested these Members to re-assess the nature of those questions and to find a more appropriate 
forum for their discussion, e.g. bilateral c onsultations or the ongoing DDA negotiations. 
18. Turning to answering relevant questions in de tail, he said that the blame laid on China by 
some Members for being one of the top produ cers and exporters of counterfeit and infringing 
automotive parts was groundless.  Notwithstanding, China's national IP protection working group had received some complaints about automotive part s counterfeiting and other infringements in some 
local areas, and had held a meeting in Septem ber 2005 to tackle the issue by requiring local 
governments to crack down on those illegal activities. 
19. He encouraged Members to log onto official we bsites of the local governments to obtain local 
IPR "White Papers" and action plans on intellectual property or obtain them fr om the foreign affairs 
office or department of the local government.   
20. Regarding administrative procedures that imposed requirements such as 
consularization/notarization of evidence from a foreign country, which was not necessarily on foreigners but on foreign evidence, China believed th at those requirements were fair and reasonable, 
and consistent with WTO principles and the TRIPS Agreement. 
21. In response to the request put to China by one Member to share the IP protection and 
enforcement provisions under discussion in its ongoing FTA or bilateral negotiations, he said that his 
delegation saw no legitimate reason or right behind th is request.  His delegation would like to request 
that Member to share the provisions under discussi on in the Member’s own ongoing bilateral or FTA 
negotiations after the meeting if possible. 
22. In response to the question on the steps Chin a was considering in order to accelerate the 
involvement of foreign associations in China' s IPR environment, to encourage Chinese-foreign 
associations and to expand the scope of operations of  foreign associations in Ch ina, he said that this 
was a question irrelevant to TRIPS and the transitional review. 
23. Pursuant to the terms of its WTO accession, China had made great efforts to revise its 
legislative regime for all substantive IPRs, whic h had been and should be fully recognized by 
Members.  However, he reminded Members that not  all laws and regulations in China had to be 
revised and urged them to be more patient.  When deemed necessary, further amendment of laws and 
regulations would take place in China, but that may not be done as abruptly as some Members had expected.  Regarding the protection of copyright in  certain fields, such as information networks, 
which was not covered by TRIPS ye t, he asked Members to refer to  the relevant provisions in the 
Copyright Law promulgated in 2001. IP/C/M/49 
Page 6  
 
24. He said that the information regarding the Ch inese National IPR Strategy could be found at 
www.nipso.cn
. 
25. Regarding the questions on private investiga tive firms, he referred Members to China's 
response at the last TRM, as China's position had not changed since then.  
26. As to whether freight forwarders, distributors a nd landlords could also be subject to criminal 
liability in IPR cases, he said that that this depe nded on whether their activities constituted elements 
of a crime committed under the relevant  laws and regulations.  This r esponse also pertained to similar 
questions on the percentage of IPR infringemen t cases transferred to criminal enforcement. 
27. He said that the percentage of IPR infringemen t cases transferred to criminal enforcement had 
nothing to do with cost-recovery limitations e ither.  However, some copyright infringements 
transferred to criminal procedures were defi ned as illegal operation crimes instead of IPR 
infringements, which certainly affected the statistical results, as some Members had mentioned in their written questions. 
28. Regarding the request form one Member for Ch ina's administrative agencies to publish all 
administrative decisions, China had already expressed the view during the last TRM that this was not 
a legitimate request under the TRIPS Agreement or  under China's other commitments, and China had 
no obligation to do so.  He also confirmed that China's administrative agencies were providing written 
decisions with explanations for their enforcement decision and that  their practice had improved during 
past years. 
29. He confirmed that the General Administrati on of Customs was jointly working with the 
Ministry of Public Security to draft guidelines on criminal cases, arising from Customs seizure of 
infringing products in international trade.  Setting standards for arrest was not the mandate of the 
Ministry of Public Security as one Member had put it, but the responsibility of the National People's Congress as well as the responsibility of the Supreme Court and the Supreme Procuratorate. 
30. Regarding the question No. 21 from the USA, he said that China had no new information to 
provide since the last review. 
31. Regarding the relationship between "identical " and "similar" trademarks, as defined in 
Chinese laws, he said that this relationship was the same as interpreted in the TRIPS Agreement.  
Regarding administrative penalties imposed in cases where registered trademarks were used on 
"similar goods", he confirmed that the understanding of the Member c oncerned was correct.  He also 
confirmed that not only administrative penalti es were applicable in cases of service marks 
infringement. 
32. He said that, in view of the difference in natu re between administrative and criminal liability, 
the judicial interpretation promulgated in December  2004 did not stipulate a relationship between the 
number of administrative violations and criminal liability.  The offender would only be prosecuted 
under criminal liability when the degree of violation reached the statutory standard for criminality.  
Since a well-known mark was a type of register ed mark with a higher commercial value, its 
infringement would cross the line of criminality more  easily.  In this connection, setting no specific 
provision for well-known marks would not hamper its protection by the criminal code.  According to 
the judicial interpretation promulgated in Dece mber 2004, the three-times standard was an elevated 
one compared to the relevant provisions  for illegal publications, rather than a more relaxed one as 
some Members had alleged in their questions.  The mention of "illegal income" in the judicial interpretation was a follow-up provision of the crimin al code, which China had no plans to amend.   
33. For all the technical questions regarding the cal culation of the value of counterfeit or pirated 
goods, he referred Members to the judicial interpreta tion issued jointly by the People's Supreme Court  IP/C/M/49 
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and the People's Supreme Procuratorate in De cember 2004.  He said that the Chinese National 
People's Congress had no plans to amend the Criminal Code or other IP laws at this moment, although in-depth research and study in this field would continue.   
34. Regarding elementary, high school and "State Plan" textbooks, he said that Article 23 of 
China's Copyright Law also applied to foreign right holders and that China had so far not received any 
complaints from any right holders.  
35. Regarding China's implementation of Article 10.2 of the TRIPS Agreement, he referred 
Members to Article 14 of China's Copyright Law.  Regarding censorship standards and procedures, 
content review processes and the import and distribut ion regulations of audiovisual products, he asked 
Members to convey these TRIPS non-relevant concerns  to the competent committees or councils in 
the WTO, for example the Committee on Market Access. 
36. Regarding the legal requirements on upper threshol ds of statutory damages or the duration of 
prescription of administrative punishment stipulated by the Chinese law, he said that China believed 
that these were not inconsistent with the TRIPS Ag reement.  The laws concerned had been made and 
promulgated in the context of the situation in Chin a and China had no plan to change them at this 
moment.   
37. He said that fines for penalties for the infringement  of copyright were decided by the judicial 
authorities, based upon the facts of the case, whic h was consistent with principles of the TRIPS 
Agreement. 
38. Regarding protecting the legitimate owners of trademarks against unauthorized third-party 
applications, he referred Members to Articles 13,  14, 30, 31 and 41 of the Trademark Law.  
39. He said that as of the end of 2004, it had take n, on average, 20 months from the date of a 
trademark application to the date of a decision made by the examiner.   
40. He said that in 2004, 153 well-known trademarks  had been recognized by (a) administrative 
proceedings at the CTO;  (b) the Trademark Review and Adjudication Board (TRAB);  or (c) any other administrative agency, 28 of which were fore ign trademarks.  In 2005, 79 such marks had been 
recognized, among which 5 were foreign well-known trademarks under the CTO. 
41. Regarding brands that were the subject of anti-piracy efforts in each city, he asked Members 
to log on to the official websites of the cities concerned, such as www.baic.gov.cn in Beijing and 
www.sgs.gov.cn in Shanghai.  In order to place their brands on the anti-piracy lists, companies could 
submit their applications to the relevant local au thorities, such as those in Shanghai or Beijing. 
42. Regarding the potential legal responsibility of the landlord in certain cases, he referred 
Members to Article 50.2 of the implementing regula tions of the Trademark Law.  China's Trademark 
Law provisions on the infringement of trademarks were  also applicable to operators of wholesale and 
retail markets nationwide.  As regarded notices on an ti-piracy efforts issued in Beijing and Shanghai, 
he said that no other cities in China had pl ans to issue similar notices at this moment. 
43. He said that, in conformity with China’s accessi on commitments, the relevant rules of the 
State Administration of Industry and Commerce of China and the Administration for Quality 
Supervision, Inspection and Quarantine (AQSIQ) prov ided protection for GIs.  The amendment of the 
Trademark Law in 2001, as agreed to in the accessi on report, contained a specific provision on the 
protection of GIs. IP/C/M/49 
Page 8  
 
44. Regarding the detailed procedures of applicati on for the recognition of a well-known mark, he 
referred Members to the www.ctmo.gov.cn, as we ll as to the provisions on the recognition and 
protection of the well-know trade marks. 
45. He confirmed that China was not drafting and had no plan to draft a "highly well-known 
marks" pamphlet. 
46. Regarding allegedly design-infringing goods displa yed at an exhibition, he said that, although 
such an act of display would not immediately be de emed as a violation of Article 11 of the Chinese 
Patent Law, the act of making, prior to the act of di splay, could be considered a violation of the design 
right, i.e. a violation of Article 11. 
47. He confirmed that Article 12 of the Chinese Patent Law conferred on the patentee the right to 
grant licences, regardless of whether the pate ntee was a foreign or a Chinese company.  
48. He confirmed that the Standing Committee of the National People's Congress had no plans to 
amend legislation to provide add itional protection for products, the marketing of which required an 
authorization.  
49. Regarding novelty, he said that the current Chinese laws and regulations regarding the 
novelty requirement were consistent with the TR IPS Agreement and China had no plans to amend 
them. 
50. Regarding the powers of administrations, he sai d that the copyright, trademark and patent 
laws all had specific provisions in this regard.  In  an effort to provide adequate remedies for IPR 
holders and to provide significant deterrents to viol ators, the different administrations executed their 
powers in compliance with the laws governing th em.  According to the Chinese Patent Law, the 
patent administrative authorities did not have the power to impose sanctions such as confiscation or 
fining the patent infringer.  Pursuant to Article 53 of the Trademark Law, once the Administration for 
Industry and Commerce had determined that the f act of infringement had been established, it was 
obliged to order the infringer to immediately cease the infringing activity and to confiscate and 
destroy the goods involved, the tools used to ma nufacture these goods and counterfeit representations 
of registered trademarks and could also impose a fine.  These provisions were in complete compliance 
with the TRIPS Agreement.  In actual enforcement, administrations at all levels penalized the acts of 
trademark infringement by strictly following the law.  This was a significant deterrent to the 
infringers.  There was no provision on confiscati ng illegal income and revoking commercial licences 
in the trademark law or its implementing regulations. 
51. Regarding undisclosed information, he said th at Article 51 of the Administrative Rules on 
Drug Registration provided that, while the new drug  was being examined, the technical requirements 
for it would not be lowered because it had alread y been on sale in overseas markets.  SFDA, the 
Chinese Food and Drug Agency, had established a stringent confidentiality preserving system to prevent information submitted by the applicant from being disclosed.  Reviewers had to register when 
consulting any document and access for each reviewer w as restricted to documents within his/her job 
duty.  So far no leakage of submitted informati on by the staff of SFDA had been found and no 
complaint in this regard had been received from any a pplicant.  He invited drug patent owners to log 
on to SFDA's website ( www.sfda.gov.cn
) to check whether the drug had been applied for by other 
parties.  The regular SFDA procedure on patent disputes was that a patent owner would submit a 
request to the SFDA.  SFDA would then notify other applicants asking them to explain within 40 days 
whether they had infringed that patent, ot herwise their application would be refused. 
52. Regarding the cancellation of trade names simila r to well-known trademarks, he said that at 
present, the Implementation Rules of Trademark Law, the Regulations on Registration of Enterprise  IP/C/M/49 
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Names and the Regulations on Affirmation and Protection of Well-known Trademarks could be 
applied to this matter. 
53. He said that such laws as Counter Unfair Competition Law and Product Quality Law could 
be applied to the protection of i ndications of source.  As to the amendment of the Counter Unfair 
Competition Law, he said this process had started in 1997 and had been added to the legislation plan 
by the Standing Committee of the People's Congress in 2003.  The National Administration of 
Industry and Commerce was responsible for drafti ng the amendment which was currently in the 
public consultation process. 
54. The representative of Japan  thanked the Chinese delegation for its comprehensive responses 
and said that he was encouraged by China's commi tment to improve the protection of intellectual 
property rights as a national policy priority.  During the transitional reviews from 2002 to 2004, Japan 
had raised questions regarding,  among others,  the improvement of enforcement in judicial 
procedures, the protection of well-known marks and the improvement of patent examination 
procedures.  Regarding the improvement of enfo rcement procedures, his delegation appreciated 
China's considerable efforts to improve enforcem ent by issuing new judicial interpretations and 
conducting a nationwide campaign to strengthen the pr otection of intellectual property rights.  In 
terms of the protection of well-known marks, Japan appreciated the implementation of the "Provisions 
on the Determination and Protection of Well-known Marks" in 2003, as well as the publication of lists 
of well-known marks and the recognition of some Japanese company names as well-known marks in 
China.  With regard to patent examination proce dures, it was appreciated that the State Intellectual 
Property Office (SIPO) had been making efforts to improve the procedures.  However, despite these 
efforts by the Chinese authorities, the level of  protection remained unsatisfactory.   
55. A recent survey conducted by the Japanese G overnment had shown that significant problems 
continued to exist in intellectual property protecti on and enforcement in China.  The survey, entitled 
"Field Survey for Infringement of Intellectual Property Rights in China", published on June 23 and available from the METI's website , www.meti.go.jp, indicated that Japanese industry regarded the 
application of administrative sanctions agains t IPR infringement and the way in which Chinese 
governmental authorities addressed the cases as insuffici ently effective and that, as a result, repeated 
infringement was rampant.  At least a half of th e Japanese companies which had made use of remedial 
procedures in China had experienced  repeated infringement.  Theref ore, IPR enforcement in China 
was insufficient to deter further infringements, and IPR infringement in China continually caused 
serious damage to the industry of Japan and that of other countries, including that of China itself. 
56. He underlined the importance of enhancing the criminal prosecution of IPR infringements, 
especially of repeat offenders, as his delegation had emphasized in document IP/C/W/451, and said 
that his delegation was looking forward to a signifi cant improvement of IPR enforcement by China, 
including effective additional measures to address any act of infringement. 
57. The representative of the European Communities
, while thanking China for its update on its 
efforts to improve IP protection in China, said that the statement had not been as detailed and 
comprehensive as he had hoped and that some of th e questions his delegation had asked in document 
IP/C/W/450 had not been answered.   
58. While his delegation took note with satisfa ction of the progress made in Chinese IP 
enforcement, it remained concerned by the high leve l of counterfeiting in China.  He urged China to 
actively pursue its efforts towards a fully effective IP enforcement system and said that his delegation 
was committed to continue to work bilaterally with  the Chinese authorities to improve the situation.  
In this respect, he informed the TRIPS Council th at the first meeting of the EU-China joint IP 
working group, that had been held the previous we ek in Beijing, had proved useful and encouraging 
and that it was important that continued progress was made in that framework. IP/C/M/49 
Page 10  
 
59. The representative of the United States
 thanked China for the answ ers to Members' questions 
and said that her delegation found the TRM mechanis m to be a useful addition to other multilateral 
and bilateral forums for discussing IPRs, including the concerns of China, the United States and other 
countries 
60. Her delegation appreciated China's efforts to improve its IPR enforcement and protection 
environment, including the growth of China's Trad emark Office and Patent Office and the increasing 
docket of the Chinese courts and enforcement agenci es, the credit for which belonged to a large part 
to Vice Premier Wu Yi and her staff.  However,  although China had committed itself to address a 
number of problems in its IPR regime and to si gnificantly reduce IPR infringement levels, IPR 
infringement in China remained rampant and deterre nt processes were necessary to bring this problem 
under control.  The magnitude of IPR infringement in  China was harming the interests of right holders 
in China and around the world.  In this respect, her delegation had welcomed China's President Hu 
Jintao's statement on 13 September 2005 that "China will continue to step up its efforts to protect 
intellectual properties.  And we will certainly enhance our effort in fighting all kinds of violations in 
this regard." 
61. She said that IPR protection had also become critical to the community of China's own right 
holders, as could be seen in the areas of tradem arks, plant varieties a nd design and utility model 
patents where Chinese applications dominated.  In  other areas, such as invention patents, domestic 
applications were increasingly likely to dominate in the near future. 
62. Her delegation welcomed China's commitment to  accede to the WIPO Internet treaties, 
which, in view of over 100,000,000 Internet u sers and rapid broadband deployment in China, was 
important to all copyright owners, including Ch inese writers, composers, publishers, recording 
studios, movie makers and software developers .  The United States welcomed the increased 
transparency of the National Copyright Administration in this drafting process and hoped that accession would proceed smoothly.  
63. The United States also welcomed the State Intellectual Property Protection Office's and other 
agencies' efforts to improve provisions for the tran sfer of cases from the non-deterrent administrative 
process to criminal prosecution, as currently such  transfers constituted onl y a tiny percentage of 
overall administrative cases, and the efforts to clarif y the possibility that exporters could face criminal 
liability. 
64. Unfortunately, however, the situation was dete riorating in certain areas such as squatting on 
foreign trademarks and designs, where whole indus trial designs were now being been imitated under 
the cover of design patents which were not examined , and for which there were no deterrent remedies 
against squatting.  In addition, the Internet and trade shows increasingly provided vehicles for widespread imitation and infringement, including ex port of counterfeit and pirated goods in physical 
form or through uploading movies, software, books, and music.  As China had become a factory to the 
world, Chinese counterfeit products were found throughout the world and across every conceivable 
sector, whether or not the holder of the rights in these products had a factory or presence in China. 
65. At last year's TRIPS Council, her delegation ha d noted several continuing problems in China's 
enforcement environment, including: local protec tionism, institutional deficiencies, over-reliance on 
weak administrative remedies, and concerns about the compatibility of China's criminal enforcement 
system with TRIPS requirements.  Although some steps had been taken, such as the Ministry of 
Public Security's Mountain Eagle campaign regard ing criminal enforcement of trademarks, more 
remained to be done.   
66. Although the Chinese Government's on-going e fforts had had some positive results, there 
were indications that the system remained non-dete rrent.  For example, while China was the second 
largest market for computers in the worl d, its software market was only the 25
th largest.  Sales of  IP/C/M/49 
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legitimate movies and music were also artificially low due to a high piracy level.  Seizures of Chinese 
origin goods by foreign customs authorities remain ed high – over 60% of all seizures in the United 
States alone – and widespread retail sales of count erfeit and pirated goods could be witnessed in any 
major Chinese city.  These retail sales had been  effectively decriminalized by the December 2004 
Judicial Interpretation, and rele gated to this ineffective administrative system.  Her delegation 
continued to be concerned about the apparent lack of criminal remedies available for certain offences, 
especially in the critical area of copyright protection,  where basic structures of a deterrent criminal 
remedy were not in place.  Her delegation also belie ved that there should be a criminal remedy against 
exports of counterfeit goods. 
67. The criminal IPR system was especially importa nt to right holders with limited resources, 
such as SMEs, because they may not otherwise have an understanding of China's IPR system;  lacked 
the capacity to post people in China to handle the local administrative and civil systems; and were 
confronted with large scale commercial counterfeiting and piracy affecting their traditional markets. 
68. She noted that the basic underpinning of TRIPS was rule of law and that criminal procedures 
required decisions in writing, based on evidence, with a right to counsel, applied by independent 
judges trained in law, with a right of appeal, according to a clear process, based on proportionate 
sentencing standards, and other supporting legal structures.  A non-deterrent administrative system 
could not achieve these purposes and could easily beco me self-serving and prejudicial against foreign 
rights, particularly when local laws required di scriminatory treatment in favour of domestic right 
holders. 
69. In this year's TRM, her delegation had pointed  to specific local statutes that provided 
enhanced enforcement or allocation of resources for local companies and had also inquired about 
other mechanisms that could be described as promot ing interests of Chinese right holders or potential 
right holders over those of other Members.  In th is regard, she noted her delegation's concern that 
much of China's enforcement efforts appeared to be directed in favour of China's own companies.  For 
example, according to the data for 2004, over 98%  of China's administrativ e copyright cases had been 
on behalf of Chinese right holders, while approximately only 10% of all administrative trademark 
cases had been undertaken on behalf of foreigners. 
70. While China's responses to these questions were appreciated, her delegati on noted that not all 
questions had been fully answered and no responses had been received to the questions regarding GIs 
and famous brands, as well as to most of the questi ons posed with regard to copyright.  Her delegation 
was looking forward to hearing further answers from the Chinese delegation in this multilateral forum 
as well as in their bilateral discussions. 
71. The representative of Canada  thanked China for the information provided and said that his 
delegation acknowledged China's ongoing efforts in d esigning and passing legislation and regulations 
to deal with IP rights and enforcement.  He info rmed the Council that last week Canada had hosted a 
Chinese delegation from the National Copyright Admi nistration and other departments for a study 
visit to review copyright legislation and enforcemen t issues, which had allowed a useful exchange of 
information between officials engaged in policy, legal, administrative and enforcement activities. 
72. In addition to the well-known economic conse quences, his delegation had increasing concerns 
over the public health and safety aspects of count erfeits and fakes and therefore urged China to 
continue to place a priority on improving IP enfo rcement.  His delegation was looking forward to 
continuing to work with China on this and other IP issues. 
73. The representative of China  thanked Members that had ma de reasonable and sound comments 
on China's IPR protection.  With regard to tho se Members that had made critical comments, he 
expressed his hope that a careful study of his speech  could bring about a be tter and more realistic 
understanding of the challenges and difficulties th e Chinese Government was facing in dealing with IP/C/M/49 
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IP protection. He said that it was unfortunate that  there were few reasonable and rational in-depth 
explorations of the reasons for IP infringement problems, which were a prevailing phenomenon across 
the world and the reasons for which, in his view, would ultimately be found to be economic. 
74. He noted that IPR infringement activities in China were increasingly being organized by 
foreign investors or criminals who sought to prof it from these illegal activitie s.  One of these cases, 
that had been concluded earlier this year in Shan ghai, concerned an American citizen who had set up 
a 3-Dollar DVD website (registered in Russia) and had conducted his illegal piracy activity in China. 
This American citizen had now been punished in accordance with the well-designed Chinese IPR 
laws and regulations.   
75. He urged those Members who had submitted questi ons to study the responses in detail and to 
read the "White Paper" his delegation had submitte d.  His Government had been breaking its back 
fighting against domestic IP infringement and, instead of pointing the finger at the Chinese 
Government, Members should offer their help and sup port in this fight.  He expressed his hope that, if 
Members would take a more developmental persp ective on the Chinese IPR situation, they would 
stand shoulder to shoulder with the Chinese Govern ment to fight against this phenomenon of IPR 
infringement, not only in China but across the world. 
76. Turning to the Council's reporting obligation to the General Council, the Chairman
 suggested 
that the Council follow the same procedure as the pr evious year, namely that the Chairman, acting on 
his own responsibility, would prepare a brief, factua l report.  The content of the cover page to the 
report would be similar to that of the report s ubmitted by the Council in 2004 and the part of the 
minutes reflecting the discussions held under this agenda item would be attached. 
77. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair. 
D. REVIEW 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  
78. The Chairman  suggested that Members continue to di scuss the three agenda items together as 
had been the practice in the Council's past meetings .  He recalled that thr ee new documents had been 
presented at the Council's meeting in June 2005:   one from Switzerland containing questions on 
proposals submitted by other Members relating to the three agenda items (IP/C/W/446);  another from 
Peru on its position in relation to the disclosure of  origin and legal provenance (IP/C/W/447);  and a 
third from the United States relating to the three age nda items (IP/C/W/449).  Since its last meeting, 
the Council had received two new communications : one from Peru containing a case-study on the 
camu-camu fruit ( Myrciaria dubia)  (IP/C/W/458);  and another from India, on behalf of Bolivia, 
Brazil, Cuba, India and Pakistan containing tec hnical observations on an earlier US submission 
circulated as document IP/C/W/449 (IP/C/W/459).1   
79. He recalled that in August 2002, the Secretariat ha d, at the request of the Council, circulated 
three summary notes of issues raised and points made on the three agenda items.  These notes had been circulated in documents IP/C/W/369, 368 and 370, respectively.  At its meeting in September 
2002, the TRIPS Council had requested the Secr etariat to update these three summary notes 
periodically, not after every meeting, but when significant new material was presented.  He had 
                                                     
 
1 Colombia was added as a co-sponsor in the document at its request.   IP/C/M/49 
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informed the Council, at an informal meeting in June 2005, that the Secretariat had been in the 
process of preparing such updates.   
80. The representative of the Secretariat  said that since the work on these updates had been 
completed only recently, the Secretariat would take into account the further inputs and discussions at 
the present meeting and circulate the more complete updates thereafter.  He informed the Council that 
the updates would be first circulated in draft form so that delegations would have an opportunity to 
examine them and provide their comments before th ey were circulated as working documents of the 
Council. 
81.   The representative of Peru  introduced document IP/C/W/458, in which a specific case of 
camu-camu was presented to reflect his delegati on's concern about the tendency to use genetic 
resources and associated traditional knowledge to develop patentable i nventions without the 
authorization of, and compensation to, their owne rs.  He recalled that document IP/C/W/441 had 
introduced the work of Peru's National Commis sion for the Protection of Access to Peruvian 
Biological Diversity and to the Collective Knowle dge of the Indigenous Peoples, which sought to 
identify, prevent and avoid biopiracy involving biological resources and traditional knowledge of 
Peruvian origin.  The Commission had begun to an alyse the cases identified in its initial phase of 
searching for potential cases of biopiracy.  For this purpose, it required the support of an expert in each resource in order to compile information on b ackground material, characteristics and associated 
traditional knowledge, and of a patent examiner, in order to analyse compliance with the requirements 
of novelty and inventiveness in each of the cases.   
82. He said that camu-camu was a forest fruit r esembling the cherry and a native plant of 
Amazonia.  It possessed a higher level of ascorbic acid (vitamin C) than any other natural source.  
Amazonian peoples had been aware of the properti es of this species since time immemorial and 
currently used it in the preparation of juices, jams, flavourings, etc.  In recent years, there had been 
growth in the market for natural products derive d from biodiversity, especially in the United States, 
Europe and Asia.  There had also been an incr easing trend to patent inventions developed through 
using genetic resources and traditional knowledge of Pe ruvian origin.  A considerable number of such 
inventions covered by pending pate nt applications or patents granted either did not comply with the 
requirements of novelty and inventiveness or, while  fulfilling these criteria, had been developed 
through genetic resources and trad itional knowledge gained in an ille gal, irregular or questionable 
manner.  The consequent unease generated in countri es traditionally regarded as providers of genetic 
resources and traditional knowledge had been reflecte d in the establishment of regimes restricting 
access to genetic resources and tr aditional knowledge.  This was s upported by the paradigm shift, 
introduced by the CBD, away from the idea of a common heritage of humankind and free access and toward that of recognition of sovereignty over regulating access to resources and protecting traditional 
knowledge.   
83. He said that document IP/C/W/458 set out the process of identification and analysis of patent 
applications and patents involving inventi ons obtained or developed from camu-camu .  At the first 
stage, information on the resources had been compile d with the assistance of an expert on the resource 
who had identified, inter alia , the background material, place of origin, characteristics, traditional 
uses and other known uses of the resource, using in formation derived from research and reviews on 
agricultural, trade, scientific and other topics.  Given that it was common practice among the indigenous peoples to transmit their traditional knowle dge orally from generati on to generation, it was 
not easy to track down much documented background ma terial.  It was therefore necessary to consult 
various studies that included a brief compilation of ethnobotanical knowledge of the resource for 
inclusion in the analysis.  At the second stage, th e novelty and inventiveness of patent applications 
and patents were studied in the light of the info rmation compiled.  Although no definitive study had 
yet been conducted to determine its centre of orig in, various studies led to the conclusion that this 
might be the Peruvian Amazon region, where the worl d's largest natural populations of this species 
were found.  The fruit was an important antioxidant, assisting, inter alia , in the prevention of cancer, IP/C/M/49 
Page 14  
 
heart disease and the effects of stress.  It was al so an important energiser and was crucial for the 
formation of collagen, a protein that helped to fo rm cartilage, skin and the vascular system and keep 
them healthy.  It also contributed to mainta ining a healthy immune system and facilitated the 
absorption of nutrients, including iron, by the digestive system.  Recognizing the various properties attributed to it, including its high ascorbic acid (vitamin C) content, a number of projects had been 
developed in recent years to produce camu-cam u industrially and market it nationally and 
internationally for both dietary and cosmetic us es in line with the boom in natural medicine, 
nutraceuticals and natural products.  In order to ch eck compliance with the n ovelty and inventiveness 
in the patent applications and patents, document IP/C/W/458 analysed the most noteworthy features 
of the product intended to be protected, the most re levant background material, a comparative analysis 
of the claims and the background material, and arrive d at preliminary conclusions.  He said that it was 
not inconceivable that new references might be found to lend fuller support to the analysis. 
84. Furthermore, he said that document IP/C/W/ 458 also presented the constraints and difficulties 
that Peru faced, or might face, in its analysis of potential cases of biopiracy.  First, although in most 
cases the database of the Japanese Patent Office provi ded a literal English tr anslation of patent 
applications and/or patents, the translation was frequently inaccurate or incomprehensible, which led 
to confusion and, in some cases, rendered an analys is impossible.  Second, in some cases the database 
only allowed access to the original documents published in Japanese with no possibility of accessing 
the English translation of the claims, thereby hindering  the analysis.  Third, assistance of translators in 
analysing the Japanese patent applications or pa tents entailed additional costs and considerably 
lengthened the time needed for the analysis.  Fourth, very often th e description of what was intended 
to be protected was unclear.  Fifth, the rela tionship between biological resources and genetic 
resources led to problems of monitoring and identification of cases of illegal access to genetic resources, especially where many resources of Peruvi an origin had been exported as raw material for 
direct consumption or industrial processing in a sear ch for immediate economic benefit.  He said that 
it was not easy for Peru, as a centre of origin of  resources and traditional knowledge, to establish a 
permanent system to identify all the applications and/or patents involving its resources or associated 
traditional knowledge.  For this reason, the Commiss ion was endeavouring to demonstrate technically 
that patents were currently being granted where they  should not be granted.  This provided concrete 
examples in support of the proposed revision of th e TRIPS Agreement and the need to improve the 
systems for searching for background material cu rrently used by intellectual property offices around 
the world, particularly when they concerned inventions derived from biodiversity.  The tables in 
document IP/C/W/458 set out the various patents that had been analysed, and itemized the elements 
that might enable Members to examine those patents. 
85. In conclusion, he said that the current patent system made it impossible to overcome the 
difficulties mentioned in document IP/C/W/458 a nd thus prevented effective compliance with 
Members' obligations set forth in the CBD.  Peru had consistently sought a solution at the 
international level that could strike a balance between legal systems that protected intellectual 
property rights and those that governed access to genetic res ources and traditional knowledge.  
Therefore, in document IP/C/W/447, his delegation had proposed to amend Articles 27 and 29 of the 
TRIPS Agreement with a view to ensuring that a mandatory requirement to disclose the origin of 
genetic resources and/or associated traditional knowle dge in the patent system was included therein.  
This amendment would make the system more tran sparent and secure and would obviate the need for 
countries to identify erroneously granted patent or  patent applications involving their genetic 
resources and traditional knowledge.  
86. The representative of India
, introducing document IP/C/W/459, said that it aimed at 
facilitating understanding of the proposal made by the proponents of the disclosure requirements.2  He 
said that, more specifically, document IP/C/W/459  was in response to document IP/C/W/449 
                                                      
2 IP/C/W/459 is a corrected version of the advance co py submitted to the Secretariat by the delegation 
of India.   IP/C/M/49 
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submitted by the United States.  In its submission, the United States had reiterated that it saw no 
conflict between the TRIPS Agreement and the CBD  and offered the option of a contract-based 
approach to achieve the "widely shared objective of Members".  Document IP/C/W/459 explained the 
fallacies in the US argument and the excessively na rrow interpretation of both the treaties that had led 
the United States to reach such a conclusion.  He said that the US submission ignored instructions 
given in paragraph 19 of the Doha Ministerial Decl aration that, in undertaking the work provided for 
therein, the Council be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and fully take into account th e development dimension, a point recalled in 
paragraph 3 of the agenda for the Council's presen t meeting.  Document IP/C/W/459, on the other 
hand, explained how Article 7 of the TRIPS Agreem ent pointed to a need for a balance between the 
intellectual property regime and the public interest  and how the disclosure requirement would achieve 
this primary objective of the TRIPS Agreement.  It also pointed out that developing countries constituted most of the mega-diverse countries in the world.    
87. Responding to the US argument that there was no express disclosure obligation under the 
CBD, he said that the CBD was not an intellectua l property instrument and therefore did not create 
patent disclosure requirements.  However, the CBD did oblige countries to cooperate to ensure that 
patents and other intellectual property rights did not  run counter to the objectives of the CBD.  The 
disclosure requirement would enable WTO Members to ensure that the CBD obligation was respected, while implementing the TRIPS Agreement.   In paragraph 6 of document IP/C/W/449, the 
United States proposed the adoption of measures at th e national level that were  consistent with the 
CBD principles of prior informed c onsent and benefit sharing.  He sai d that, as explained in paragraph 
4 of document IP/C/W/459, Members needed to ma ke the obligations contained in the national 
regimes of the home countries of the genetic material and associated traditional knowledge enforceable in the countries granting patent rights or the host countries.  The difficulty of such 
transboundary enforcement had been exemplified by  the Yahoo!-Nazi case in document IP/C/W/459.  
Thus, the disclosure requirement under the TRIPS Ag reement would aid international enforcement.  
88. He said that the United States had made some misleading general comments on the disclosure 
proposal in paragraphs 8 and 9 of document IP/C /W/449.  The submissions made by a group of 
developing countries showed that only an internati onally binding solution would solve the real-world 
problems of misappropriation and biopiracy.  He refu ted the claim that erroneously granted patents 
were rare exceptions and added that the burden of having a patent  revoked was more than the burden 
of a full examination of the patent app lication for novelty and inventiveness.   
89. Responding to the US argument that patents b ased on genetic resources might be indigenous 
to one country but freely available in different countries and that patent applicants might face 
difficulty in such situations, he said that, in such  cases, the source would be the country from which 
the patent applicant received the genetic material a nd the country of origin would be the one in which 
the genetic resources were indigenous .  This would not require the pate nt office to interpret laws of 
other countries.  
90. In response to the US argument about the disclosure requirements creating uncertainties and 
an additional burden for the patent office, he said that the obligation on patent applicants was only to 
produce evidence issued by the legally recognized author ity of the country where the relevant material 
or information was accessed and where the benefit- sharing agreement was reached.  There could be 
no dispute if prior informed consent and equitabl e benefit-sharing requirements of the country of 
source and origin were adhered to, unless the patent  applicant had committed fraud.  Furthermore, the 
burden on patent offices was minimal, as the offices we re not expected to interpret the contents of the 
evidence produced by patent applicants but only  to ascertain whether such evidence had been 
provided where a national regime required. 
91. Regarding the contract-based national regime, he said that the United States appeared to 
appreciate the weakness of this alternative appr oach when it called for national regimes with an IP/C/M/49 
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international outlook and supplemented by guidelines  based on international instruments, which was 
the very objective achieved by the internationall y binding disclosure requirements proposed by the 
group of developing countries.   
92. Responding to the US observations on the so-ca lled "widely shared objectives", he said that, 
as indicated in paragraph 11 onwar ds of document IP/C/W/459, there was no option but to introduce a 
disclosure requirement in the TRIPS Agreement in order to achieve a mutually supportive 
implementation of the TRIPS Agreement and the CBD.  
93. In conclusion, he welcomed Members' comment s and questions on document IP/C/W/459, as 
well as their specific suggestions on how to inscrib e such a requirement to fulfil Members' shared 
objectives in the TRIPS Agreement and CBD, while making the requirement least burdensome for 
patent applicants and patent offices.  He indicated that the inclusion of the disclosure requirement was 
an outcome expected by the proponents to paragr aphs 19 and 12 of Doha Development Agenda.   
94. The representative of the United States
 said that Members' new submissions demonstrated 
that the issues were being clarified, converg ences and differences among Members were becoming 
more apparent, more facts on many issues were being addressed, and progress was being made.  For 
example, notwithstanding other significant differences,  it was clear that Members shared the view that 
national contract-based access and benefit-sharing sy stems were essential elements of any solution.  
She said that it was important to build upon the progress that had clearly been made.  She said that the United States was a mega-diverse country and wa s one of several Members that saw no conflict 
between the TRIPS Agreement and the CBD.  Her de legation considered that these agreements could 
be implemented in a mutually supportive manner,  and that no amendment to the TRIPS Agreement 
was needed or warranted.  As noted in document IP/C/W/449, her country  had taken positive steps to 
promote and encourage prior informed consent and e quitable sharing of benefits on mutually agreed 
terms and to ensure that researchers and biopros pectors were aware of new procedures that might 
have been implemented by many countries, even though it was not a member of the CBD.  To this end, important information about these rules was pr ovided on the US State  Department's website, 
which incorporated   links to other websites. 
95. With respect to proposals for new patent discl osure requirements, she said that the proposals 
were not an appropriate solution to the concerns  raised by Members or their objectives.  The 
uncertainties generated by the proposals only further convinced her delegation that the most effective 
way to meet the objectives of ensuring authorized  access and equitable benefit sharing was tailored 
national laws outside the patent system that direct ly and effectively regulated the relevant conduct.  
For reasons expressed in great detail by her delegatio n at the two previous meetings of the Council 
and in documents IP/C/W/434 and IP/C/W/449 , it was clear that the proposed disclosure 
requirements would not fulfil their purported obje ctives.  Such disclosure requirements would not 
be able to ensure prior informed consent or the equitable sharing of benefits from the use of genetic resources or traditional knowledge.   Furthermore, such requirem ents would not even apply to 
situations where the relevant traditional knowle dge or genetic resource was commercialized but not 
patented.  Moreover, the disclosure requirements relating to source and/or origin would generally have little relevance to considerations applicable in preventing mistakenly granted patents.  Perhaps more important than the ineffectiveness of such pr oposals in achieving their goals was the fact that 
such proposals would have significant negative effects on the technological and economic incentives of the patent system and, further, on the sharing of benefits, thereby undermining one of 
the stated justifications for such a proposal.  She said that recent studi es, such as the Pacific 
Research Institute study, indicated  that patent-based access and benefi t-sharing systems would have 
significant negative effects on the development of pa rticular industry sectors that could be engines 
of economic growth, such as biotechnology.  Such negative effects would be spread among developed and developing economies.  This confirmed apprehensions that had been raised by 
various industry representativ es regarding these new patent disclosure proposals and the 
unacceptable risks of uncertainty that they entaile d.  While these industries were those most clearly  IP/C/M/49 
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affected, the uncertainties of the proposals made woul d be likely to have ramifications for a broader 
range of industries. 
96. Furthermore, she said that these proposals did not in any way enhance benefit sharing.  On 
the contrary, the purported remedy proposed by certa in Members - invalidation of the patent due to 
non-compliant disclosure - would destroy or have significant negative consequences on the benefit 
being sought.  As a result, the shared objective of  ensuring the equitable sharing of benefits arising 
from the use of genetic resources or traditional know ledge would clearly not be met.  For example, 
if a challenge to a patent based on improper disclos ure resulted in the revocation of a patent due to 
litigation, this could upset a pre-existing bene fit-sharing agreement, particularly where the 
challenge was initiated by a third party not affiliated with a traditional knowledge or genetic 
resources holder.  This would thereby enable the further commercialization of  the invention in the 
affected market by those having no obligation to share benefits. 
97. Given the inability of these proposals to address the concerns that had been raised, as well 
as negative impacts on the patent system, she said that her delegation could not support them.  On the other hand, her delegation had provided, in documents IP/C/W/434 and IP/C/W/449, an 
alternative solution with concrete  proposals to effectively address the concerns raised by Members 
in a way that would not lead to the negative conseq uences on the patent system that was inherent in 
the current proposals for ne w disclosure requirements. 
98. In addition, she said that the WIPO Interg overnmental Committee on Intellectual Property 
and Genetic Resources, Traditional Knowledge and Folklore (IGC) had recently had its mandate 
renewed by the General Assemblies of WIPO.  Her delegation looked forward to continuing 
deliberation in that forum, particularly with respect to the issue relating to intellectual property and 
genetic resources, which would continue to in form the discussion in  the TRIPS Council. 
99. Responding to the question raised by Switzerland and other delegations about how a 
purely national approach would address problems of transboundary access and benefit sharing, that 
is, where genetic resources and traditional knowledge were used outside the scope of application of 
the national solutions advanced by  the United States, or what w as the "international outlook" 
referred to in the US paper, she said that  national access and benefit-sharing systems could 
effectively monitor access and benefit sharing even where the commercialization that might lead to 
benefit sharing took place in a different countr y.  A contract-based syst em could provide great 
flexibility in this regard and provide an effective solution by including appropriate provisions when disputes arose, such as choice of forum, choice of  law, and/or binding international arbitration 
clauses.  These provisions would be helpful whethe r the dispute was in a particular country or was 
transboundary.  The contract coul d also specify the terms regarding the nature of the benefit-sharing 
arrangement, regardless of the country in which th e commercialization had taken place.  Similarly, 
under a contract-based system, a monitoring plan fo r commercial applications could be established, 
adapted to the facts of each case.  Further, this was not merely a th eoretical exercise, but rather use 
of practical mechanisms currently in wide use in the international arena that would be easily 
adapted to national legislation. 
100. In response to another question raised by Switzerland about how a purely contractual 
approach would address the situation where no co ntract on access and benefit sharing had been 
concluded between the provider and the user of  genetic resources and traditional knowledge, she 
said that cases in which no contract had been co ncluded in violation of the domestic access and 
benefit-sharing regime, as in any other situation where a company failed to comply with domestic 
regulation, would be governed by the requirements and penalties of the domestic access and 
benefit-sharing regime in place.  It is assumed th at a requirement to conclude such an agreement 
existed as part of the access and benefit-sharing regime , then such an absence would be enforced by 
criminal and/or civil penalties specifically designed for the access and benefit-sharing regime. IP/C/M/49 
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101. In reply to the third question raised by Switzerland about how the national contract-based 
approach would take into account the generally long-term nature of research and development 
(R&D) activities involving genetic resources, she said that a cont ract-based system would be 
flexible enough to address issues related to th e long-term nature of R&D activities involving 
genetic resources.  An access and bene fit-sharing system could include, inter alia , regular reporting 
requirements for researchers on the nature of th eir research, including wh ether any new commercial 
applications were envisioned.  In fact, a c ontract-based system was a better mechanism for 
addressing long-term R&D activities, since a patent  might, and sometimes did, expire on a newly 
identified product before a commercially valuable us e of that product was di scovered.  Furthermore, 
a contract-based system could bett er control the distribution of th e genetic resource.  If a patent 
could be applied for, control co uld, for example, be exercised through assignment rights.  She 
further said that, while the US proposals answ ered the important questions addressed to her 
delegation, she did not see that the proposals of other delegations would address these same questions to the same extent. 
102. With respect to the issue raised  by India regarding a patent granted in the United States for 
turmeric as used in healing wounds, she said that this  example appeared to be relevant, in particular, 
to concerns on the prevention of erroneously granted patents.  The Indian delegation had suggested at the previous meeting of the Council that the info rmation hidden by the app licant had been material 
to patentability and would have been provided by hi m had there been a disclosure requirement.  It had 
cited this as evidence of the certainty the disclos ure requirement would introduce into the patent 
system.  She challenged this assertion and said that  the patent had been granted to two Indian 
nationals working at the University of Mississippi Medical Center in Jackson, Mississippi.  The patent 
disclosure did disclose India as the country of traditi onal origin of turmeric, but this information had 
been irrelevant to the patentabilit y issues such as inventorship and the state of the prior art.  
Furthermore, the applicant had been under a discl osure requirement, that is, disclosing information 
material to patentability.  In this instance, it app eared that information regarding healing properties of 
turmeric would have been material to patentability.   This example was instructive in showing that, 
while disclosure of source or origin would not have addressed the issue, a requirement on information material to patentability would.  In this case, if the applicant had hidden the information, he would 
have done so notwithstanding a requirement to disclo se material information that had a severe penalty 
in the United States, namely, the unenforceability of pa tent claims.  This directly contradicted the 
assertion made by India that the applicant would have provided such information if there had been a 
disclosure of origin requirement.  This example dem onstrated that the conclusion drawn by India that 
the introduction of disclosure requirements would strengthen patent examin ation and would alone 
provide an effective solution to bad patents was entirely unfounded.   
103. Regarding concerns raised by India, along with a number of other Members, on the 
burdensome nature of the re-exami nation procedures in the turmeric case, she said that, although it 
had been unfortunate that the original patent examiner had been unable to discover the most 
relevant prior art in this case at the time of th e initial examination, th e re-examination process had 
fulfilled its purpose, because prior art had been brought to the attention of the United States Patent and Trademark Office (USPTO), a re-examination had been filed, and prior art had been applied 
against the claims in an appropri ate and effective manner, leading to  cancellation of all claims in 
this instance within a period of 19 months.  It w as also instructive that the Indian government had 
chosen to pursue the re-examinati on route based on  the objective prior art documents it had found, 
rather than on asserting inequitable conduct based on the inform ation that might have been hidden 
by the applicants.  This pointed to the difficulties that would exist in enforcing any type of disclosure requirement, and refuted the assertion that  new patent disclosure requirements would be 
a simple solution to the concerns raised. 
104. She said that her delegation fully supported efforts to strengthen options to prevent 
mistakenly granted patents.  It believed that  much could be accomplis hed by further studying 
options such as the requirement to disclose info rmation material to pa tentability, the use of  IP/C/M/49 
 Page 19 
 
 
organized databases, and post-gran t opposition proceedings.  Since the turmeric case, the USPTO 
had introduced a procedure to allow prior art to be  brought more easily to the attention of patent 
examiners during patent examinat ion, which could help obviate the need for the re-examination 
process.  She said that her delegation was open to discussing current op position procedures more 
fully in order to strengthen confidence in granted patents. 
105. Finally, she said that the experience of the tu rmeric case must lead to  the conclusion that 
the proposed disclosure re quirements regarding, inter alia , source and/or origin of genetic resources 
or traditional knowledge, would not be effectiv e in addressing concerns over mistakenly granted 
patents and that other more direct options should be pursued that directly addressed this goal and did not have the negative consequences on the pate nt system.  Her delegation looked forward to 
considering other fact-based ex amples in the future in orde r to fully address concerns. 
106. The representative of Canada
 said that her delegation welcomed  the continued debate on this 
issue in order to have a better understanding of all of  the proposals currently on the table.  Regarding 
the US proposal, she asked the United States to provi de further information as to which authorities 
would be involved in monitoring an internationa l contract-based access and benefit-sharing regime, 
and in particular to clarify whether these authorities would be national or intern ational in nature and, 
if the latter, under whose jurisdiction they would operate.  She further asked the United States to 
provide details on the impact it foresaw a disclosure requirement having on the international patent 
system in the scenario where possible sanctions for wrongful or non-disclosure were put into place outside the patent system.  
107. With respect to the EC's stat ement at the Council's June meet ing that there were various 
options, including the Swiss proposal, for amending th e text in the WIPO Patent Co-operation Treaty 
(PCT) and Patent Law Treaty (PLT) to implemen t the mandatory disclosure proposal, she sought 
clarification from the European Communities about these various options and the precise treaty text that it considered could be amended.  The EC had said that its focus on "country of origin", as opposed to "country providing the genetic resour ces", mentioned in Article 15 of the CBD, was 
logical because benefit sharing, wherever possible,  should accrue first to the country which possessed 
the genetic resources in situ  under its sovereign rights, i.e. the count ry of origin.  She asked for further 
details as to how this logic would apply in the case of benefit sharing involving access and use of ex 
situ resources.  
108. Regarding the developing country Members' proposal, she sought clarification on the 
practical means by which these Members envisione d the prior informed consent of local and 
indigenous communities being sought and received by patent applicants and whether these Members 
saw a need to have these declarations verified, and if so, by whom.  In the case of the determination of wrongful or non-disclosure post-patent grant, she as ked for details on which rights to the invention 
these Members foresaw could be partially transferre d to the appropriate party.   She also sought 
clarification as to who would be the appropriate part y to receive such rights:  the source or the country 
of origin named in the application or someone else.   She asked these Members whether they had 
undertaken any analysis of how a proposed patent  disclosure amendment to the TRIPS Agreement 
that allowed for revocation of a patent upon wrongf ul or non-disclosure would impact upon Members' 
other existing obligations in the TRIPS Agreement.   
109. As regards Switzerland's statement that government agencies, who were part of a 
pre-qualified list, could play a practical role in help ing enforce parties' contractual obligations on prior 
informed consent and access and benefit shari ng, she asked for further details on who would 
determine this pre-qualified list and what pr actical role these agencies would play.   
110. The representative of Japan
 said that there were various ways to implement the CBD.  The 
Japanese Government had prepared and circulated a document entitled Guidelines for Access to 
Genetic Resources  to assist Japanese compan ies and research institutes to deepen their understanding IP/C/M/49 
Page 20  
 
of the CBD and to promote win-win relationships between genetic resources-providing countries and Japan.  The implementation of these Guidelines enable d Japan to fulfil its obligations under the CBD.  
Regarding the suggestion for amending the TRIPS Agreement in document IP/C/W/447, he said that 
the CBD and the TRIPS Agreement were mutually  supportive.  The rationale of the proposed 
disclosure requirements could not be explained from the viewpoint of the patent system.  The 
TRIPS Agreement was based on a balance between inte llectual property applicants and third parties.  
If a new obligation, which could not be regarded as a reasonable requirement under the patent system, 
was introduced, it would adversely affect such a ba lance and lead to disincentives in the patent 
system.  Consequently, patent applicants would hesitate to use genetic resources, thus having a 
negative effect on countries pr oviding genetic resources.   
111. With respect to document IP/C/W/459, he said that intellectual property and genetic resources 
were complicated issues and that it was necessary for Members to deepen their understanding of the 
technical questions rather than to politicize the is sue.  His delegation believed that there was no 
conflict between the TRIPS Agreement and the CBD and that the two Agreements were mutually 
supportive.  He could not agree with the statements th at the disclosure of source and country of origin 
was primarily aimed at preventing the granting of patents that did not fulfil the criteria of novelty and 
inventive step and that disclosure of origin was cr ucial in determining these criteria.  His delegation 
believed that information on the source and country of  origin of genetic resources did not affect the 
judgment of novelty and inventive step, nor did it co ntribute to the prevention of erroneously granted 
patents.  He said that there might be some mis understanding concerning the patent system:  if the 
Council were discussing a "discovery", then it might be  true that such information might be important 
for a patent examiner;  however, what it was cons idering was an "invention" which might be made 
based on a "discovery".  The most effective way to  prevent bad patents was to have comprehensive 
databases on genetic resources.  He said that the title  of document IP/C/W/458 "Analysis of Potential 
Cases of Biopiracy" was misleading, since it might not have been Peru's intention to indicate that all 
patents referred to in that docume nt were subject to biopiracy.   
112. The representative of Thailand
 said that his delegation supported the views expressed in 
documents IP/C/W/458 and IP/C/W/459.   
113. The representative of Switzerland  said that Peru's presentation on the camu-camu case 
illustrated the complexity of the issue.  It also  showed that it was expensive and complicated for 
researchers to find patentable subject matter in i nventions relating to genetic resources or traditional 
knowledge.  Language translation was anot her important problem to be addressed. 
114. He recalled that Switzerland had presented document IP/C/W/446 at the Council's June 
meeting, which contained a list of questions on the proposals submitted by other Members with a 
view of helping the Council better understand Memb ers' concerns and evaluate their solutions.  
Switzerland hoped to contribute to the learning pro cess of the Council regarding the legal, technical 
and practical implications of the relevant issu es and proposals.  He said that although several 
Members, such as United States, the European Comm unities, Brazil and India, had replied orally to 
some of the questions, a number of questions re main unanswered.  Therefore, he encouraged 
Members to provide the Council with their written answ ers.  He repeated the remaining questions on 
the developing countries' proposal, including in regard to clarification of the terms "biopiracy,"' "misappropriation" and "country of origin";  the co nsistency of "country of origin" with "Contracting 
Party" providing genetic resources provided for in  Article 15 of the CBD;  the difference between 
"biological resources" and "biological material", and "genetic resources" used in the CBD and the 
FAO's International Treaty on Plant Genetic R esources for Food and Agriculture (ITPGRFA);  and 
how the requirement to provide evidence of prio r informed consent and access and benefit sharing 
would work in practice and what its additional value would be.  He asked whether the concept 
"source" under the EC proposal was broad enough to include the country of origin, as was the case in 
the Swiss proposal.    IP/C/M/49 
 Page 21 
 
 
115. He said that his delegation proposed to explicitly enable national legislators to require patent 
applicants to declare the source of genetic resour ces and associated traditi onal knowledge in patent 
applications, if the invention was directly based  on the resources or knowledge in question.  The 
proposal would grant applicants the possibility of satis fying this requirement at the time of filing an 
international patent application or  later during the international phase.  This declaration of source 
would be included in the publication of the interna tional patent application in order to render it 
accessible to the public at the earliest  stage.  The proposed declaration of source aimed at increasing 
transparency in access and benefit sharing and allo wing providers of  genetic resources and traditional 
knowledge to trace their resources or knowledge in pa tentable inventions.  The declaration of the 
source could be further strengthened by establis hing a list of government agencies competent to 
obtain information of patent app lications containing a declaration of the source.  Patent offices 
receiving such patent applications could inform th e competent government agency that the respective 
State was declared as the source.  This informati on could be provided in a standardized letter sent to 
the competent government agency.  The competent gove rnment agency could be either national focal 
points as foreseen under paragraph 13 of the B onn Guidelines on Access to Genetic Resources and 
Fair and Equitable Sharing of the Benefits Arisi ng out of their Utilization (Bonn Guidelines) and/or 
national competent authorities for access and benefi t sharing to be established under paragraphs 14 
and 15 of the Bonn Guidelines.  For easy reference, th is list could be made accessible on the Internet.  
The proposed list and the provided information would enable a State to avoid having to monitor all 
patent applications submitted worl dwide in order to find out whether it had been declared as a source.  
This would facilitate access and benefit sharing.  For example, if the Swiss Patent Office received a 
patent application declaring Canada as the source of  a genetic resource, it would consult the list of 
government agencies competent to receive information about declarations of source in order to verify 
whether Canada designated such a government agency .  If it did, the Swiss Patent Office would send a 
standardized letter to this government agency indi cating that it had received a patent application 
declaring Canada as the source.  This information would enable the Canadian authorities to verify 
whether the inventor or the patent applicant had co mplied with the applicable Canadian provisions on 
access and benefit sharing.   
116. Finally, he said that in document IP/C/W /400/Rev.1, Switzerland had proposed inviting  
WIPO, in close collaboration with the CBD, to furt her consider the establishment of such a list of 
competent government agencies.  His delegati on would appreciate Members' support for this 
proposal.    
117. The representative of the Dominican Republic  said that the investigation carried out by the 
Peruvian competent authorities was a commendable and laudable effort aimed at avoiding and preventing biopiracy.  The investigation had once again shown the urgent need for an effective international solution to the problem of biopiracy.  She said that the most practical and viable solution 
should be found in the framework of the TRIPS Ag reement, which should be rendered compatible 
with the provisions of the CBD.  Accordingly, he r delegation supported the proposal to amend the 
TRIPS Agreement in order to include the disclosure requirements as a prerequisite of patentability.  
She said that the national contractual system would not be a complete solution to biopiracy, and Members needed an effective intern ational solution, which should be legally binding, permanent, and 
predictable.  
118. The representative of New Zealand
 said that his delegation continued to be interested in 
obtaining a clearer sense of the nature and scope of the problem at hand in order to better address it.  
He said that the debate in the TRIPS Council reflect ed a growing consensus that any role played by 
the international intellectual property framewo rk would be one that was supportive of CBD 
objectives.  National systems rather than the intern ational intellectual property system should be the 
primary mechanism of delivering on CBD objectives.  In the absence of a binding international access 
and benefit-sharing regime supported by widespr ead implementation at the national level, he 
wondered how the proposed patent disclosure requi rements would work in pr actice, especially where 
patent applicants might have made use of gene tic resources or traditional knowledge sourced in IP/C/M/49 
Page 22  
 
countries that did not have in place formal access a nd benefit-sharing regimes, or where applicants 
might have complied with existing national laws but  might not have obtained prior informed consent 
from the owners of the resources, or even if con sent had been obtained, might not have concluded a 
benefit-sharing arrangement.  Well-meaning applican ts might have made efforts to obtain consent 
from, and conclude benefit-shar ing agreements with, owners of  genetic resources or traditional 
knowledge before the commercialization of these resour ces.  However, the lack of a formal access and 
benefit-sharing regime in the country of origin mi ght make it difficult to ev en determine with whom 
an access and benefit-sharing agreement should be negotiated.   
119. He said that his delegation took note of possible alternative approaches proposed by the 
United States, including a requirement to disclose information material to patentability, and the 
contract-based system.  It was open to discussion on a range of options, although it had concerns 
about how wide-ranging disclosure requirements coul d work in practice in the absence of a binding 
international access and benefit-sharing regime.  He t hought that the priority should be to identify the 
nature and scope of the problem so that Members co uld identify the best way to address this problem.  
Regarding the camu-camu case, he asked whether na tional access and benefit-sharing laws had been 
complied with in relation to patent applications  for the use of genetic resources or associated 
traditional knowledge.   
120. The representative of Norway
 informed the Council that, in 2004, Norway had introduced a 
disclosure requirement in its patent law in order to support the objectives of benefit sharing and prior 
informed consent provided for in the CBD.  The new provision stated that patent applications concerning biological materials should include inform ation on the country of origin of the material 
and on whether the prior informed consent required in that country had been given.  Although that 
provision did not apply to international patent applications, Norway believed that a multilateral 
system for disclosing and sharing information about the geographical origin of biological material used in patent applications should be established.   It also believed that a mandatory disclosure 
requirement in the TRIPS Agreement would benef it both the basis for granting patents as well as the 
objectives of the CBD.   
121. The representative of Korea
 said that there was little possibility of conflict between the 
TRIPS Agreement and the CBD and the two instru ments could be implemented in a mutually 
supportive manner.  It was the view of his delega tion that introducing the disclosure requirement, 
prior informed consent, and access and benefit sharing as conditions for granting patents would 
impose an undue burden on both patent applicants  and patent authorities.  His delegation was 
particularly concerned about the implications of denying or revoking patents on the ground of non-
compliance with the disclosure requirements.  Re garding the protection of traditional knowledge and 
folklore, he said that it would be better to follow the discussion of this issue in the IGC.  It was 
desirable to establish databases on traditional knowle dge which would prevent erroneously granted 
patents and would allow the utilization of prior ar t with documentation of traditional knowledge.  
122. The representative of the European Communities  said that his delegation was committed to 
discussion on these issues in a constructive spirit with in the mandate given by Ministers at Doha with 
a view to finding ways of interpreting and impl ementing the TRIPS Agreement to support the CBD 
objectives.  He recalled that developing count ries had proposed to introduce the disclosure 
requirements through amending the TRIPS Agreement.   Under their proposal, applicants for patents 
relating to genetic resources or associated trad itional knowledge should provide three types of 
evidence in order to acquire patent rights, that is , the source and country of origin of the genetic 
resource;  evidence of prior informed consent through approval of author ities under the relevant 
national regime;  and evidence of fair and equitable benefit shari ng.  He also recalled that the 
European Communities had agreed to examine and discuss the possible introduction of a system, such 
as a disclosure requirement, that would allow Members to  keep track, at the global level, of all patent 
applications relating to genetic r esources.  Such a system would ensure transparency and allow the 
authorities of countries granting access to their resources to keep track of patent applications based on  IP/C/M/49 
 Page 23 
 
 
the use of these resources.  The new patent disclosure requirement would not in itself achieve the objectives of the CBD, but it could contribute to a solution, in particular in order to help check whether contractual arrangements had been resp ected.  However, he said that the disclosure 
requirement should not affect the balance of rights and obligations set out in the TRIPS Agreement, 
nor the rights of WTO Members to create a favour able environment for research and development 
activities in the field of biotechnology.  The patent  system should continue to be a highly effective 
tool for stimulating innovation, technolog ical progress and economic development.   
123. His delegation considered that the introducti on of a disclosure requirement, provided it was 
appropriately calibrated, should not necessarily be  burdensome either to patent offices or to 
applicants.  In particular, the patent office should not  be required to verify the conditions in which the 
genetic resource and/or associated traditional knowledge had been obtained.  Its role would be limited 
to examining whether the formal requirements had been fulfilled and whether the applicant who had 
declared that the invention was using genetic r esources or traditional know ledge had subsequently 
disclosed the appropriate information.  In the sa me vein, the European Communities believed that the 
patent applicant should not be confronted with insurmountable formalities but should provide the 
information that the applicant knew.  No additi onal research would be required on the part of the 
applicant. 
124. He further recalled that the EC position had been  reflected in its proposal presented at the 8
th 
session of WIPO IGC in June 2005 in order to formul ate a way forward and to ensure an effective, 
balanced and realistic disclosure system at the inte rnational level.  This proposal was a tangible result 
of the commitment made by the European Commun ities in 2002.  As the mandate of the IGC had 
recently been renewed by the WIPO General Asse mbly, he hoped that the EC proposal would be 
further discussed in the IGC.  He said that a bindi ng disclosure requirement should be introduced to 
disclose the country of origin or source of genetic  resources.  This mandatory requirement should be 
applied to all patent applications , which implied that it should be implemented in a legally binding 
and universal manner.  The disclosure requirement w ould then apply to all international, regional and 
national patent applications at the earliest possible stag e.  In order to provide patent applicants with a 
clear idea of what needed to be disclosed, the terms used in the pr oposal, such as "country of origin" 
and "genetic resources", should be the same as in the CBD.  In a standard patent application form, and 
if the invention was directly based on specific ge netic resources, the applicant should declare the 
country of origin.  If the country of origin was unknown, the specific source of the genetic resource 
should be disclosed.  If the applicant failed or re fused to declare the requi red information despite 
being given the opportunity to remedy that omissi on, the logical consequence would be that the 
application should not be further processed in acc ordance with the formal requirements and the 
applicant should be duly informed of this consequence.  If the information provided was incorrect or 
incomplete, the effective, proportionate and dissu asive sanctions should be envisaged outside the 
patent law.  It should be left to the individual country to determine the character and the level of 
sanctions in accordance with its domestic legal pract ices and general principles of law.  His delegation 
was willing to discuss further the mean s to develop such sanctions.   
125. Regarding traditional knowledge, he said that  there could be a requirement on patent 
applicants to declare the specific source of trad itional knowledge associated with genetic resources if 
the applicant was aware that the invention was dir ectly based on such traditional knowledge.  In order 
to achieve the necessary legal certainty, a further in-depth discussion of the concept of "traditional 
knowledge" was necessary.   
126. He further said that an indisp ensable measure that could make the disclosure requirement an 
effective incentive to comply with access and be nefit-sharing rules was to introduce a simple 
notification procedure to be followed by patent  offices.  The patent office, which received a 
declaration of the country of origin or source of  the genetic resources and/or associated traditional 
knowledge, should notify this information to a centrali zed body.  It would be adequate to identify the 
Clearing House Mechanism of the CBD as the central body to which the patent office should send the IP/C/M/49 
Page 24  
 
information.  He said that his delegation was full y committed to the ongoing work in WIPO and was 
also ready to move forward and have a focused  discussion on this issue within the WTO.   
127. He clarified that Directive 98/44/EC of the Eu ropean Parliament and the Council on the legal 
protection of biotechnological inventions, referred to by Peru in document IP/C/W/447, had been 
adopted on 6 July 1998 and subsequently transposed into the national law of the EC member States.  
The preamble of the Directive, in particular Recita l 27, laid down that, if an invention was based on 
biological material of plant or animal origin or if it used such material, the patent application should, 
where appropriate, include information on the geographical origin of such material, if known;  this was without prejudice to the processing of the patent application or the validity of rights arising from the granted patent.  Recital 27 of Directive 98/44/ EC had to be regarded as an encouragement to 
mention the geographical origin of biological material in the patent application.  This was in line with  
Article 16(5) of the CBD since information about the geographical origin of a biological material that 
was the subject of an invention could be helpfu l for the process of equitable benefit-sharing.  
However, to provide such information was not an obligation under EC law, nor did the failure to 
provide such information have any legal consequenc e for the processing of patent applications or on 
the validity of rights arising from granted patents. 
128. Replying to the question raised by Canada about the options for amending the text of the 
WIPO PCT and PLT, he said that his delegation had no definitive view.  The various options included 
amendment of the regulations under the PCT, amendm ent of the PCT, and/or amendment of the PLT 
and its regulations.  His delegation was ready to  discuss these options in the appropriate WIPO 
bodies.   
129. Regarding the concept "country of origin" as opposed to "country providing the genetic 
resources", he said that in some cases, the patent applicant might not be aware of the country of 
origin.  In such a situation, the applicant should d eclare the source of the specific genetic resource to 
which the inventor had had physical access and wh ich was still known to him.  That could, for 
example, be the gene bank or botanical garden or any other ex situ  resource.  Such an obligation had 
two objectives: first, applicants would not have an easy way out by stating that they did not know the 
country of origin since they should at least know  where they had obtained the genetic resource;  
second, the obligation to specify the ex situ  resource, read in conjunction with the obligation to 
disseminate that information through, in partic ular, the Clearing House Mechanism of the CBD, as 
referred to in paragraph 7 of the EC proposal, fac ilitated the monitoring of the correctness of the 
submitted information by any stakeholder.  It could al so provide the country of origin with a tool to 
control whether the research centre or the gene bank had legally obtained the genetic resource in 
question.  He said that the European Communities w as ready to continue this discussion in the context 
of WIPO. 
130. The representative of Ecuador
 said that his delegation shared the concerns expressed by Peru 
in document IP/C/W/458 and also supported docume nt IP/C/W/459.  He said that Members should 
continue their work until the Hong Kong Minister ial Conference and aim to  produce a specific 
mandate regarding the relationship between the TR IPS Agreement and the CBD, which should finally 
lead to an amendment of the TRIPS Agreement.  At present, the Council's work should be guided by 
the possibility of reaching a consensus on th e amendment to the TRIPS Agreement.   
131. The representative of Colombia  said that document IP/C/W/458 was an excellent illustration 
of international developments rega rding pending patent applications involving genetic resources.  The 
situation revealed by Peru was a further instance of  misappropriation of biodiversity, showing that the 
current intellectual property system did not offer a solution to the problem.  She said that her delegation would like to be a co -sponsor of document IP/C/W/459, which reproduced the essential 
points it had raised in the WTO and other internatio nal forums concerning the need to incorporate in 
the TRIPS Agreement provisions requiring applicants  for patents involving biological materials or 
traditional knowledge to disclose, as a prerequisite for the granting of a patent, the source and country  IP/C/M/49 
 Page 25 
 
 
of origin of the biological resources and traditional k nowledge used or incorporat ed in the invention;  
evidence of prior informed consent,  and evidence of fair and equitable sharing of benefits.  With 
regard to the US statement on the adverse effects of the disclosure requirements on patents applicants and the biotechnology industry, and the risks and uncertainty it created, she requested the United States to provide Members with  specific cases illustrating how acce ss had been gained to those 
resources when patents had been granted involving  genetic resources of a third country and, in 
particular developing countries, and to explain why the proposal would result in risks and uncertainty 
for the biotechnology industry.   
132. She said that the CBD stated th at States exercised sovereignty over their genetic resources 
and had the power to determine the conditions fo r access thereto and to establish mechanisms to 
facilitate the fair and equitable sharing of the bene fits derived from the utilization of those resources.  
It also stipulated that access shall be granted "on mu tually agreed terms" and shall be subject to "prior 
informed consent" of the party providing the res ources.  For its part, the TRIPS Agreement obliged 
Members to afford minimum standards of protection, inter alia , for inventions meeting the 
patentability criteria.  Genetic resources and trad itional knowledge associated therewith could serve as 
a basis for inventions eligible for intellectual property protection, particularly in the form of patents.  
The TRIPS Agreement contained no provisions requiring applicants for patents to guarantee 
compliance with the provisions of the CBD.  In th is regard, she reiterated the importance of ensuring 
that the TRIPS Agreement assisted in achieving th e objectives of the CBD, maintaining the mutual 
support, synergies and integrity of both instruments.   Members must seek legal solutions, such as an 
amendment of the TRIPS Agreement, to enable thos e objectives to be attained.  In conclusion, she 
said that Members should continue to work in order to obtain a mandate to amend the TRIPS 
Agreement in Hong Kong. 
133. The representative of Bolivia
 said that the protection of genetic resources and associated 
traditional knowledge should not only be covered by the CBD, but also be contemplated in the context 
of the TRIPS Agreement.  The c ontract-based solution did not fully take into account the reality of 
misappropriation of genetic resources.  It was ex tremely important to include the objectives of the 
CBD, that is, disclosure of source and provenan ce of genetic resources and traditional knowledge, 
prior informed consent and fair and equitable benefit-sharing, in the TRIPS Agreement.   
134. The representative of India  said that his delegation agreed with the conclusion drawn in 
document IP/C/W/458, which strengthened the need fo r a legally binding disclosure requirement in 
the TRIPS Agreement.   
135. Regarding the US response to the turmeric ca se, he said that the United States called the 
erroneously granted turmeric pate nt "unfortunate" and yet recomme nded that Members continue to 
follow this unfortunate route of ha ving to invest resources each time su ch bad patents were granted by 
the USPTO.   The disclosure requirement was meant to alleviate the situation and to ensure that 
traditional knowledge was not commercially monop olized.  Responding to the US and Japan's 
comments that disclosure of source of origin was ir relevant and not material to determining novelty 
and non-obviousness, he said that in the turmeric  case the USPTO had cancelled the patent because 
the traditional knowledge provided by Indi a was material to patentability.  
136. Responding to the question raised by Switzerland on the definitions of biopiracy and 
misappropriation, he said that there was no accep ted definition.  The Action Group on Erosion, 
Technology and Concentration (ETC Group) defi ned biopiracy as "the appropriation of the 
knowledge and genetic resources of farming a nd indigenous communities by individuals or 
institutions seeking exclusive monopoly control (usua lly patents or plant breeders' rights) over these 
resources and knowledge."  The fundamental conf lict between the TRIPS Agreement and the CBD 
was the failure of the former to recognize priv ate intellectual property involved in traditional 
knowledge. Considering traditiona l knowledge and genetic/biol ogical resources as a form of 
intellectual property, biopiracy assumed the same m eaning as piracy of other kinds of intellectual IP/C/M/49 
Page 26  
 
property and was apt.  He further said that WI PO defined misappropriation as "any acquisition, 
appropriation or utilization of traditional knowledge by unfair or illicit means.  Misappropriation may 
also include deriving commercial benefit from th e acquisition, appropriation or utilization of 
traditional knowledge when the person using that kn owledge knows or is negligent in failing to know, 
that it was acquired or appropriated by unfair me ans; and other commercial activities contrary to 
honest practices that gain inequitable benefit fro m traditional knowledge".  Therefore, the terms 
"biopiracy" and "misappropriation" could be used interchangeably. 
137. He said that the CBD defined "country of origin" as the country which possesses genetic 
resources in in-situ  conditions.  In-situ conditions meant conditions wher e genetic resources existed 
within ecosystems and natural habitats, and, in th e case of domesticated or cultivated species, in the 
surroundings where they had developed their distinctive properties.  In other words, country of origin 
meant the country where genetic resources origin ated.  Though not expressly, the CBD afforded 
flexibility to incorporate traditional knowledge into the access framework conditioned by prior 
informed consent and benefit sharing.  In the context of the proposed disclosure requirements, 
"country of origin" meant the country which possesses genetic resources in in-situ  conditions and/or 
the knowledge associated with them.  There shoul d be no additional burden in recognizing the 
protection of traditional knowledge as the spirit of the CBD reflected the need for it. 
138. With respect to the relationship between "source" and "country of origin", he said that Black’s 
Law Dictionary defined "source" as "a place where something is found or whence it is taken or 
derived;  or a person or a thing that originates or sets in motion or is a primary agency in producing 
any course of action or result."  The source of biological resources indicated the actual place from 
where the resources were obtained.  It also connot ed the individual, community or organization from 
which the resources had been obtained.  "Country  of origin" meant the country where genetic 
resources originated.  He said that patent applican ts should disclose both source and country of origin 
in order to enable patent examiners to identify the changes that had taken place, if any, on the genetic 
material when the source and country of origin were different and to determine the novelty and 
inventive step of the claimed invention.  He furt her clarified the relationship between "country of 
origin" and "Contracting Party prov iding genetic resources" referred to in Article 15 of the CBD, and 
said that the CBD foresaw that a genetic resource  could be obtained from a source other than the 
"country of origin".  A country providing genetic resources would be the source of the resources while 
the "country of origin" would be the actual place where the resources were located in in-situ  
conditions.  The law governing access would be the law of  the country of origin.  Article 15.5 of the 
CBD provided that access to genetic resources shall be subject to prior informed consent of the 
Contracting Party providing such r esources unless otherwise determined by that Party.  As genetic 
resources were the private property of the country of  origin, the law governing access must be that of 
the country of origin.  In addition, plant genetic resources under FAO ITPGRFA should not be 
excluded from the proposed disclosure requirements,  because they fall within the framework of 
biological diversity.   
139. Replying to the question as to why the developing countries' proposals referred to the terms 
"biological resources" and "biological material" inst ead of "genetic resources" used in the CBD, Bonn 
Guidelines and FAO ITPGRFA, he said that in lig ht of the CBD, "genetic resources" meant genetic 
material of actual or potential value;  "genetic material" meant any material of plant, animal, 
microbial or other origin containing functional units of heredity; , and "biological resources" included 
genetic resources, organisms or parts thereof, popu lations, or any other biotic component of an 
ecosystem with actual or potential use or value for humanity.  Under these definitions, "biological 
resources" might refer to something that existed in a natural or crude form and to the whole organism, 
including human beings, while "genetic resources" meant something that had been isolated from a 
particular biological resource with the help of ne w technology and screening equipment.  Most of the 
third world nations were rich in  biological resources and associated  knowledge, but did not have the 
capacity to isolate valuable components.  Tr aditional communities possessed knowledge only over 
biological resources but not over the genetic resources  contained in them.  Therefore, most of the  IP/C/M/49 
 Page 27 
 
 
nations used the term "biological resources" instea d of "genetic resources".  He noted that the CBD 
did not take away the freedom of a nation to shap e its access regime based on its domestic policy.  As 
the definition of biological resources included gene tic resources, these different terminologies did not 
create any confusion in the context of the disclosure requirements.   
140. Responding to the question of whether the deve loping countries' proposals had implications 
for the WIPO PCT and PLT, he said that such imp lications could be considered once the disclosure 
was made mandatory under the TRIPS Agreement.   
141. Regarding how patent applicants could fulfil th e requirement of the disclosure of evidence of 
fair and equitable benefit sharing, he said that th e patent applicant would be required to annex the 
contract of benefit sharing or a certificate to this effect issued by a competent authority, legal or 
customary, established as per the law of the country,  along with the patent application.  The evidence 
provided by the applicant in relation to benefit sharing acted as a prima facie  proof to discharge the 
applicant's burden.  The assumption was that once th e agreement had been entered into at the national 
level, it manifested a fair and equitable sharing of benefits.  As the benefit-sharing arrangement was a 
prerequisite under the CBD system for the grantin g of access, it would not impose additional burdens 
on the patent applicant.  It was for the national authorities in the country of origin to determine 
whether the sharing of benefits was fair and equita ble prior to the granting of access.  The two factors 
mentioned in document IP/C/W/442, that is, mutually  agreed terms and the reporting obligation, could 
form a concrete basis for the evid ence of fair and equitable benefit sharing at the domestic level.  
Mutually agreed terms would show the various benef its to be shared, the period for benefit sharing, 
and the mechanism of benefit sharing.  The re porting obligation would bind the person seeking access 
to inform the communities and/or the national au thorities of all instances of commercialization and 
patenting.  If the commercialization or patenting of the bioprospecting activities was not made known 
to the appropriate agencies and the benefit arising out of such utilization not shared with them, it 
would be clear that there was no fair and equitable benefit sharing.  Civil and criminal liability, as 
well as the proposed sanctions, could remedy the anom alies in benefit sharing to a great extent.   
142. Replying to the question of whether it was necessary for patent granting authorities to 
determine the veracity of information provided by pa tent applicants and, if so, how they could carry 
out this task, he said that the patent office was not required to test the veracity of the evidence 
produced by the applicant.  When a patent  was challenged during opposition or revocation 
proceedings on the grounds that the evidence wa s false, the opponent should produce necessary 
evidence before the patent office, and the patent office should make a final decision according to the 
patent law.  If a patent was challenged on the groun ds that the benefit-sharing agreement was not fair 
and equitable, the validity of the agreement sh ould be addressed by the appropriate national 
authorities under the access laws and not by the patent  office.  The finding of the authorities would be 
binding on patent offices.   
143. Responding to the question of whether the prior informed consent of the local and indigenous 
communities was necessary and how this procedure woul d be carried out in practice, he said that it 
depended upon the national policy of the country of origin or the country providing genetic resources, 
whether there existed traditional knowledge over the concerned resource, and whether the concerned 
communities were the source of the resources.  If the knowledge and/or the resource rested with the 
communities and the domestic law mandated a prio r informed consent from them, the person seeking 
access to the elements must ensu re that prior informed consen t was obtained from the concerned 
communities.  The procedure for ach ieving this task was based on the law laid down by the country of 
origin.  It would not create any additional burden on the applicant as he would know where to obtain 
the resources and in most of the countries evidence of prior informed consent would be a prerequisite 
for the granting of access to biological resources and traditional knowledge.  
144. Responding to the questions on whether national legi slation in the country of origin would be 
applicable to traditional knowledge or whether th e indigenous or local community could determine IP/C/M/49 
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that the sharing of benefits was equitable and fair , and whether a determination made by entities other 
than the contracting parties on access and benefit sharing would be in line with the contractual 
autonomy foreseen in the CBD, he said that in clusion of traditional knowledge within the access 
regime was a policy question of the country providing access.  It was up to that country to decide fair 
and equitable benefit-sharing.  Either the nati onal authorities or the concerned community or both 
together might carry it out as per the domestic law.   The contractual autonomy envisaged under the 
CBD was subject to prior informed consent and fair and equitable benefit-sharing and was not 
affected by the freedom of implementation of the parties to the CBD.  Since the traditional communities were often weak in the negotiating process,  it would be ideal for them to enter a benefit-
sharing agreement, which would then be supplemented and confirmed by the national regulatory 
authorities. 
145. With regard to circumstances justifying the pr oposed sanctions, he said that the first  
justification was that the disclosure requirement s would not impose additional burdens on patent 
applicants in the procurement of patents.  The pa tent applicant only had to furnish some material 
information and documents that he/she had obtained prior to th e granting of access to genetic 
resources or traditional knowledge.  If the applicant w as not ready to provide the information that was 
crucial in the determination of the issuance of a patent, the application should not be processed.  The 
disclosure of source and country of origin was a cr itical tool in the determination of novelty and 
inventiveness.  If the applicant had made a reasonabl e effort, despite which there were some genuine 
mistakes, the applicant ought to be given a nother opportunity before imposing the sanctions.   
Revocation was proposed as an effective sanc tion to deal with fraudulent or deliberate  non-disclosure.  
Criminal and/or administrative sanctions were also  suggested as alternative or additional measures in 
cases where the applicant wanted to misappropria te genetic resources and associated traditional 
knowledge.  Full or final transfer of the rights we re proposed as an effective tool to deal with 
situations where the claimed invention was fully or  partially the result of the contributions made by 
the resource providers to whom the knowledge rela ting to the resources was known and with whom 
the benefits were not properly shared.  He said that  the aim of the evidence of  prior informed consent 
and benefit sharing was to ensure that providers were  given back a share of the profits gained from the 
contribution they had made in producing a high market  value of the claimed invention.  If that goal 
was not met, the remedy could be nothing other th an revocation or civil/administrative/criminal 
liability. 
146. Replying to the question on th e enforcement of benefit-sharing agreements, he said that the 
enforcement should be based on the access law of the country of origin and the terms of the 
agreement per se .  The agreement could contain the mode of  enforcement coupled with the deterrents 
imposed through the proposed sanctions, such as revoca tion.  The enforcement was not the concern of 
patent offices and not linked to the granting of patents.   
147. The representative of Singapore
 said that the TRIPS Agreement and the CBD did not 
contradict each other and that both agreements  could be implemented in a mutually supportive 
manner.  Robust, effective and well-enforced access and benefit-sharing regime s at the national level 
played a central role in realizing the objectives of  the CBD.  Singapore's experience indicated that the 
contract-based system had been effective in addressing biopiracy and misappropriation issues.  Such a system was flexible and adapta ble to Members' particular le gal systems without undermining 
economic and developmental incentives derived fro m strong intellectual property protection.  
However, his delegation was not a priori  opposed to other solutions, including under the patent 
system.  While proponents had articulated many legal and technical merits for the patent disclosure 
requirements, his delegation was still studying their im plications, particularly on the legal certainties, 
administrative burden and financial ramifications on pate nt applicants and patent offices.  He said that 
proposals should not undermine the primary role of the patent system in encouraging innovation, 
fostering technological progress and promoting econom ic development.  He supported a structured 
and fact-based approach to discussions and said th at it was important for Members to identify and 
agree on the size and the nature of the problem before they made a decision on an appropriate  IP/C/M/49 
 Page 29 
 
 
solution.  The eventual solution might lie in or outside the patent system and Singapore remained open to various proposals.   
148. The representative of Peru
 said that Members' questions and replies on these three issues 
should be distributed to delegations in writing.  Responding to Canada's question on the evidence of 
prior informed consent, he shared India's views.  He said that patent officers were not in a position to 
review all the evidence and there should be a mechan ism at the national level.  In Peru, the patent 
office disseminated relevant information through a register of traditional knowledge and genetic 
resources of the indigenous communities which helped interested parties to pr ovide evidence of prior 
informed consent and benefit sharing.  If there was a legal document regarding the prior informed 
consent, it would be assumed valid and be part of patent formalities.  Replying to Canada's other 
question on the legal effect of wrongful disclosure or non-disclosure, he said that patent offices could 
cancel the granted patent if it was due to bad faith or if evidence of access, prior informed consent and 
benefit sharing was missing and a reasonable am ount of time had been given to allow patent 
applicants to correct the mistakes.  He said th at his delegation did not see any conflict between the 
disclosure requirements and other obligations under the TRIPS Agreement.   
149. Responding to Japan's comment on the title of document IP/C/W/458, he said that the 
document was based on various patent applications a nd granted patents, and it was difficult to identify 
which were erroneous.  It might be easier for pate nt officers to review these cases when translation 
was available.   
150. He recalled that his delegation had replied to Switzerland's question on the definition of 
biopiracy at the Council's last meeting.  He said that although there was no universally accepted 
definition, Peru's Law on Protection of Access to Peruvian Biological Diversity and to the Collective 
Knowledge of the Indigenous Peopl es defined biopiracy as "unauthorized access to and use of 
biological resources or traditional knowledge of the indigenous peoples by third parties without 
compensation and without necessary authorization, an d in contravention of the principles established 
in the Convention on Biological Diversity and the existing rules on the subject.  Such appropriation 
may occur in the course of physical inspection, through ownership rights in products incorporating 
such illegally obtained elements or, in some cases, through the invocation of such rights".  
"Misappropriation" had a more genera l meaning in Spanish, including the exercise of others' rights.  
He once again referred to the definition provi ded on a website, www.biopirateria.org.   
151. Finally, he thanked Norway, the Europ ean Communities and New Zealand for their 
contributions and open-mindedness on  disclosure requirements.  He said that it was important to 
speed up the work in the Council, and hoped that the Hong Kong Ministerial Conference could agree 
to introduce the disclosure requirements as a mandato ry and universal condition for patentability.   
152. The representative of Venezuela  said that his delegation supported the joint submission of 
IP/C/W/459.  He thought documents IP/C/W/459 and IP/C/W458 provided a good summary of the 
status of biodiversity in Member countries.    
153. The representative of the United States  said that India's comments on the turmeric case 
seemed to imply that the disclosure of origin woul d have prevented the err oneously granted patent.  
However, the origin of turmeric, India, had been in cluded in the patent application.  The disclosure of 
origin had not prevented the erroneously granted pa tent from being issued.  The relevant information 
on the ability of turmeric to heal wounds, which was known by the patent applicant, should have been 
disclosed.  This information was about the capability of  the material but not the source of origin.  She 
further said that there was no way of completely e liminating the possibility of the erroneously granted 
patents under any proposal, since those who wished to conceal or give false information or commit 
fraud would do so.  It was critical to have a mechanis m, such as the patent system, that worked to 
prevent this and imposed sanctions when necessary.  She believed that the system in the United States 
worked effectively but her delegation was still open to having further discussion on this issue.    IP/C/M/49 
Page 30  
 
154. The representative of Brazil
 said that the TRIPS Council had undertaken significant technical 
work on the issue of the relationship between th e TRIPS Agreement and the CBD over the past two 
years.  The work had gained considerable momentum when a group of developing countries had proposed a Checklist of Issues (IP/C/W/420) in the TRIPS Council in March 2004.  The Checklist of Issues, which had widely been accepted as an appr opriate basis for discussions on the issue, had 
helped Members focus on a set of important tec hnical points regarding different aspects of an 
international legally binding requirement, which should be included in the TRIPS Agreement to 
require patent applicants to disclose the orig in of genetic resources and associated traditional 
knowledge utilized in the claimed invention, as well  as evidence of prior info rmed consent and fair 
and equitable benefit-sharing.  
155. He noted that there was wi despread recognition both among the WTO Members and the 
international community that an international mandato ry disclosure of origin re quirement in the patent 
system would constitute an effective and adequa te solution to the problem of biopiracy and 
misappropriation of genetic resources and associated  traditional knowledge.  In this regard, in 
complying with the mandates established by Mini sters under paragraphs 12 and 19 of the Doha 
Ministerial Declaration, the TRIPS Council had made significant progress in addressing technical 
aspects of the disclosure of origin proposal.  In the course of the Council's substantive work, Switzerland, the European Communities, Australia, Canada, Malaysia, New Zealand, the Philippines, 
Chinese Taipei and other Members had raised severa l questions and points regarding the scope of the 
disclosure requirement, the extent of the obligation fo r patent applicants, the role of patent offices in 
processing and examining information presented by applicants, the relationship of the disclosure 
requirement with other instruments, such as the FAO ITPGRFA, and definitions of certain terms.  All 
these questions had enriched the debate and had, in effect, further elaborated on the Checklist of 
Issues.  The developing countries who supported th e disclosure requirements had responded to those 
questions both orally and through a number of  written submissions, in particular documents 
IP/C/W/429/Rev.1, IP/C/W/438 and IP/C/W/442.  M eanwhile, responding to an interest expressed by 
Canada, Peru and India had made contributions on  their national experiences, which had underscored 
the usefulness of disclosure of origin in the prevention of the granting of bad patents and 
misappropriation.  
156. He said that the United States had tabled two submissions, IP/C/W/434 and IP/C/W/449, 
disagreeing with the disclosure proposal and defe nding what it considered to be an alternative 
framework for addressing concerns raised by the developing countries.  In two documents, 
IP/C/W/443 and IP/C/W/459, Bolivia, Brazil, Cuba , India, and Pakistan had offered technical 
observations on the US submissions, demonstrati ng that the contract-based approach offered no 
solution to the grave problem of misappropriatio n which continued to victimize mega-diverse 
developing countries and to trouble the internationa l community.  Document IP/C/W/449 appeared to 
accept the need for an internationally recognized an d legally effective disclosure system by proposing 
that the national contract-based system could be in ternational in its outlook and might contain some 
international dispute settlement provisions.  Though  claiming to advance some purportedly "widely 
shared objectives" of WTO Members, the US submissions attempted to discredit the disclosure proposals tabled by developing countries by misrep resenting them and by denying the relevance and 
the nature of the problems raised in their submissions.  
157. He said that biopiracy and misappropriation were real and painful problems.  The 
overwhelming majority of the international commun ity agreed that measures should be taken to 
address the concerns raised by developing countries.   Moreover, it was clear that, to date, the only 
concrete solution on the table to address these problems, by filling in existing legal gaps and 
promoting a relationship of mutual supportiven ess between the TRIPS Agreement and the CBD, 
remained the disclosure of origin proposal.  The technical work in the TRIPS Council had shown that 
the disclosure requirement could be an effective, workable and balanced solution to the problem of 
biopiracy as it not only constituted a necessary measu re for the mega-diverse developing countries, 
but would also embody significant advantages for patent  applicants and the patent system as whole.   IP/C/M/49 
 Page 31 
 
 
As a simple non-burdensome requirement, the disclos ure of origin requirement would build greater 
confidence in the patent system by improving its qua lity and increasing its certainty and predictability.  
The end result could only be a more credible and robust patent system as enshrined in the TRIPS 
Agreement, which would equitably reward all contributions to the innovation process, reduce 
transaction costs and facilitate the flow of inform ation to the benefit of all parties, including 
researchers and the biotechnological industry.  Th e disclosure of origin proposal, furthermore, 
fulfilled the development dimension criterion that Ministers had determined should constitute an 
integral element of Members' work.  Biodive rsity was found in abundance in the developing 
countries, while the technological capability for its exploitation was largely concentrated in the 
developed countries.  The disclosure requirement would help to establish a level playing field, 
whereby all would benefit from the exploitation and sustainable use of the riches of biodiversity and 
associated traditional knowledge.  Fully cognizant of  the fundamental objectives of the intellectual 
property system, his delegation submitted that, as a basic matter of principle and fairness, the 
intellectual property system should neither enc ourage nor condone misappropriation and theft of 
genetic resources and associated traditional knowledge, which cons tituted genuine intellectual and 
economic contributions to innovation.  
158. He said that the TRIPS Council had completed an important technical exercise.  By maturing 
its understanding of the issue, the Council had no w moved on to a stage where the advantages of 
disclosure of origin were widely recognized.  Thou gh some work remained to be done in clarifying 
issues relating to how a disclosure of origin mechan ism could be introduced in the TRIPS Agreement, 
this was essentially a matter for the negotiating pro cess.  It was clear, therefore, that in complying 
with Members' mandates under para graphs 12 and 19 of the Doha Mi nisterial Declaration, whilst 
taking into account the development dimension as in structed by Ministers, Members must now move 
on to a new stage in their work by negotiating how a provision could be introduced in the TRIPS Agreement to ensure that applicants for patents on  inventions developed on the basis of the use of 
genetic resources and associated traditional knowledge  should be required, as a condition to acquiring 
patent rights, to disclose the source and country of  origin of those genetic resources and associated 
traditional knowledge, and to disclose evidence of  compliance with prior informed consent and 
benefit sharing.  This new stage should begin as soon as possible and a deadline should be set for its 
conclusion within the Doha Development Agenda.  Not doing so now would leave an important gap 
in the fulfilment of the promise of development, wh ich was supposed to be at the heart of the Doha 
Development Agenda.  Therefore, he called upon th e Chairman to report to the TNC and the General 
Council that this new level of maturity had been attained in discussions on this issue, and that 
negotiations should proceed in an accelerated manner, given the emerging consensus that disclosure 
of origin not only could but should be included in  the TRIPS Agreement as a workable and effective 
measure to curb biopiracy. 
159. The representative of Indonesia
 said that Members should address how to prevent any conflict 
that might arise between the TRIPS Agreement and the CBD.  He said that his delegation had similar 
experiences to India and Peru regarding biopiracy .  Although the Government had been asked to 
address biopiracy, there was still no proper solution because the TRIPS Agreement was silent on this 
issue.  His delegation was more interested in discu ssion on substantive matters rather than on general 
guiding principles.  With regard to the disclosure of origin requirement, hi s delegation fully supported 
its inclusion in patent applications.  He said that  technical difficulties faced by patent applicants 
should not prevent Members from pursuing a technical solution.  The requirement could be stipulated 
in a flexible way so as to enable patent applicants to satisfy the requirement in due time before the 
granting of patents.  He appealed for continued discussions on the mode of protection and recognition 
of genetic resources, traditional kn owledge, folklore and other trad itional cultural expressions.  The 
issues of misuse or misappropriation of local and cultural property could not be adequately and 
properly addressed without amending the TRIPS Agreem ent.  There should be a new norm stipulated 
in the TRIPS Agreement.  Members should respect  traditional communities' properties and share the 
benefits arising from commercial exploration of th ese properties.  Under national legislation, the 
authorities should request prior informed consent fro m domestic and foreign patent applicants.  In IP/C/M/49 
Page 32  
 
conclusion, he said that his delegation shared the vi ew that the solution to these three issues should be 
included in the Hong Kong Ministerial Conference according to the mandate given at Doha.   
160. The representative of the United States
 said that his delegation disagreed with Brazil's 
statement that the only concrete solution on the table was that of new patent disclosure requirements.  
He said that a wide variety of viewpoints had b een expressed in the Council and his delegation had 
proposed a number of concrete solutions in its r ecent submissions.  The US proposals would address 
the concerns raised by Members in a direct f ashion and without negative consequences which were 
inherent in the proposal of disclosure requirement s.  Responding to Brazil's statement about the US 
submission seeking to discredit the disclosure requirements, he said that the statement was a mischaracterization of the US submission.  The US submission had clearly articulated a detailed 
rationale that was based on analysis of the pr oposals and concluded that the new disclosure 
requirements would have significant negative conse quences without advancing the objectives.  Brazil 
did not underscore the wide divergence of views in  the Council on this issue.  He had emphasized the 
need for further work and discussion in the Council in order to pursue the mandate that would help 
Members clarify the issues and reduce the differenc es among them.  In that light, his delegation did 
not support the proposal made by Brazil.  In view  of the current robust discussion in the Council and 
the different viewpoints that had been expressed, he said that a recommendation by the Chairman on 
this matter would not be appropriate.  
161. The representative of Colombia
 said that her delegation supported the statements made by 
Brazil and also wished to be a co-sponsor of document IP/C/W/459. 
162. The representative of India  said that his delegation fully supported the statement made by 
Brazil.  He said that it was clear that the issue had reached a new level of maturity, calling for serious 
progress in the negotiations on this crucial compone nt of the development dimension in the Doha 
Round.  With the culmination of this stage of discussions on the Checklist of Issues, a number of 
submissions had explained the technical aspects of  the disclosure requirement and responded to 
questions on what the disclosure requirement woul d entail and how it would benefit the developing 
countries.  He said that the Chairman's report to  the TNC and the General Council should reflect this 
reality.   The Chairman should report that most delegations believed that disclosure could be an 
effective, workable and balanced solution to the problem of biopiracy, and that it was now necessary 
to discuss and negotiate elements of this require ment in earnest.  Such a discussion would resolve 
some of the practical aspects of the requirement of  interest to these Members evincing interest in 
identifying such aspects, including the propositi on by the US that national contract-based 
arrangements could be part of the solution.   
163. He said that paragraph 3 of the airgram issued  for this meeting had reflected two obligations 
of the Members:  to fully take into account the principles and objectives of the TRIPS Agreement and 
the development dimension of the issue.  Taking note of these obligations, he urged the Chairman to 
report to the General Council and the TNC that  the disclosure requirement was an essential 
component of this development dimension, coul d be achieved within the objectives of the TRIPS 
Agreement, and was an integral part of the conclu sion of the Doha Agenda for developing countries.  
Finally, he said that the Ministerial Conference was only a few weeks away and developing country delegates would inform their political masters of the progress the Council had made on this issue. 
164. The representative of Peru
 supported the statements made by India and Brazil.  He said that 
the characterization made by Brazil regarding the current status of negotiations was based on the 
facts.  He said that his delegation had presente d a number of concrete cases of biopiracy and 
misappropriation, but it had not seen any concrete case or analysis of the negative effect of the 
disclosure requirements.  He said that it had been ten years since the TRIPS Agreement had entered into force, and a number of countries, especially the least-developed countries, had difficulty implementing the TRIPS Agreement, and therefore it was time to find a way to re-balance and 
improve the current situation.  IP/C/M/49 
 Page 33 
 
 
165. The representative of Japan  said that there was still wide divergence among Members.  It was 
premature for Members to go to the next stage and, therefore, his delegation did not support the suggestion made by Brazil. 
166. The representative of India
 suggested suspending the meeting and keeping these three items 
open for further consideration.     
167. The representative of United States  said that these three items had been discussed in the 
contexts of the TRIPS Council and the outstanding implementation issues and, therefore, there could 
be significant overlap between the discussions in two separate tracks. 
168. The Chairman  clarified that these three agenda items had been discussed in two contexts:  one 
was in the regular session of the Council for TRIPS and the other was in the context of the 
consultations on outstanding implementation issues.   The regular session of the Council was required 
to report to the General Council, but not required to report to the TNC.  The Council's annual report 
would cover its work on these three items.  He pr oposed that the Council keep these agenda items 
open in order to allow further consulta tion on how it should report on these matters. 
169. The Council took note  of the statements made and agreed  to proceed as suggested by the 
Chair.    
170. At the Council's reconvened meeting on 29 N ovember 2005, the representative of India  said 
that paragraph 19 of the Doha Ministerial Decl aration instructed the TRIPS Council to examine , inter 
alia, the relationship between the TRIPS Agreement a nd the CBD.  It also required the Council, in 
undertaking this examination, to take into account  the development dimension and the principles and 
objectives of the TRIPS Agreement contained in Ar ticles 7 and 8.  Given the importance Members 
attached to the development dimension of the Doha Work Programme, th e TRIPS Council's agenda, 
thereafter, had always contained a specific para graph reminding Members of this requirement.  
Accordingly, intensive work had taken place at the technical level in the TRIPS Council since then.  
This work needed to be captured in a report by the TRIPS Council.  He further said that paragraph 52 
of the Doha Ministerial Declaration mandated the General Council to report on the progress of the 
work programme not involving negoti ations to the next Ministerial Session.  Even though the TRIPS 
Council had not yet arrived at a consensus recommenda tion pursuant to its examination of this issue 
and would continue this work beyond the Hong Kong  Ministerial, it would need to report progress to 
the General Council, and the General Council, in tu rn, to the Ministerial meeting as was the process 
for all areas of the Doha Work Programme.  The CBD issue had been raised in the informal Heads of 
Delegation meeting on 28 November 2005 by  many Members, including India. 
171. Given the importance Members attached to the paragraph 19 issues, he said that a separate 
paragraph, namely paragraph 23, had been inserted in the Cancún Draft Ministerial Text, instructing 
the TRIPS Council to continue the work and that the General Council should report to the Ministers 
on this work in the next Ministerial session.  Such  a paragraph would also need to be inserted in the 
Hong Kong Draft Ministerial text.  Therefore, he suggested a text for the Council's report, which 
would be inserted in the draft Hong Kong text.   
172. The Chairman  suggested, in the light of consultations on how the Council should report on 
the three agenda items, that the following additio n be made to the Council's Annual Report 2005:  
"The Council for TRIPS, pursuant to paragra ph 19 of the Doha Ministerial Declaration, 
continued its examination of the proposals by  Members, in particular on the relationship 
between the TRIPS Agreement and the Convention on  Biological Diversity.  The work on this 
issue was intensified in the recent months, l eading to clarifications and technical inputs 
necessary to arrive at a better understanding of  the concerns expressed and the solutions 
offered.  However, further work is required.  The Council agrees that this work shall continue IP/C/M/49 
Page 34  
 
on the basis of paragraph 19 of the Doha Decl aration and the progress made in the Council for 
TRIPS." 
173. The Council took note
 of the statements made and agreed  to proceed as suggested by the 
Chair. 
G. DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE 
TRIPS  AGREEMENT AND PUBLIC HEALTH  
174. The Chairman  recalled that the TRIPS Council had agreed at its last meeting that he continue 
consultations on the preparation of an amendmen t to replace the provisions of the General Council 
decision on the "Implementation of Paragraph 6 of  the Doha Declaration on the TRIPS Agreement 
and Public Health" (hereinafter referred to as "the  Decision"), with a view to reaching agreement as 
soon as possible.  Since that time, he had kept the General Council informed, at its meetings of 
27 July and 19 October, of the progress in these c onsultations.  He had reported to Members in the 
TRIPS Council's informal session on the current st ate of the ongoing consul tations and had taken 
careful note of the views exchanged at that time.  He believed that more time was necessary for the Council to be in a position to agree to a recomme ndation to the General Council on this matter, and 
emphasized that he was very much aware that this matter was of great interest to all delegations and 
that the further process of consultations needed to be as transparent and inclusive as possible. 
175. In the light of the current situation, the Chairman proposed that the Council suspend its 
meeting so as to keep open this agenda item.  He said that it was his intention to reconvene the 
Council once the further work was sufficiently mature, with a view to the Council agreeing on a recommendation to the General Council in good time  in advance of the Hong Kong Ministerial 
Conference. 
176. The representative of Brazil
 said that the issue of TRIPS and public health was taken very 
seriously by his delegation.  A national AIDS Pr ogramme provided free medicine for AIDS victims, 
publicly funded in its entirety.  Another national prog ramme provided universal access to medicines 
for his country's citizens who could not afford to pay for them privately, covering all sorts of illnesses, 
including the ones that were endemic to tropical cl imates.  The cost of medicines weighed heavily on 
his country's tax payers at large, whether wealth y or poor, and was one of the major components of 
expenditures in the national budget. 
177. He recalled that his delegation had played an active role during the whole process leading to 
the Decision.  An amendment to the TRIPS Ag reement incorporating the Decision was a very 
sensitive and important issue.  A de licate balance had been struck th at had made the adoption of the 
Decision possible.  The Decision included a paragr aph which gave the TRIPS Council a mandate to 
prepare an amendment to the TRIPS Agreement based, where appropriate, on the Decision.  No 
reference had been made in the Decision to the Chai rman's Statement read at the time of its adoption 
by the General Council.  He was concerned about references made by  certain Members to an agreed 
solution, an agreed package or other references of this type.  The only agreement recognized by his 
delegation was the Decision itself.  While the value of the Chairman's Statement was not questioned, 
its legal status should not be changed.  For this reason, his delegation had been among those 
delegations that had asked the Secretariat to remove  an asterisked note that it had included on its own 
behalf in the Decision.  The corrigendum issued  by the Secretariat contained additional language 
clarifying that the asterisked note was a Secretariat note for information purposes only and without prejudice to Members' legal rights and obligations.  This corrigendum did not solve the problem, 
because the reference made by the Secretariat was subsequently nullif ied by the affirmation that the 
Decision was adopted in the light of the statement r ead out by the Chairman.  It did not reflect the 
situation during the adoption of the Decision which had been based on a document that had contained 
no asterisked note and no reference to the Chairman's Statement.  His delegation maintained its position that the asterisked note should be removed from the Decision.  IP/C/M/49 
 Page 35 
 
 
178. He recalled that his delegation had stated on previous occasions that it recognized the African 
Group proposal for an amendment to the TRIPS Ag reement as the only proposal on the table.  It 
provided a very good basis for an amendment and his delegation was prepared to work on the basis of 
it towards an amendment to include the Decision.  Some elements in the African Group proposal were 
convincing, such as the suggested removal of th ose parts which became redundant once the Decision 
had been transposed into an am endment to the TRIPS Agreement.  For example, a reference to 
paragraph 6(ii) on regional patent  systems constituted more of a policy advice to certain Members 
then a text that should become an integral part of the TRIPS Agreement and should therefore not be 
included in the amendment.  It should be ensured th at the draft amendment was consistent both legally 
as well as in substance.  He reiterated his delegation' s interest to participate in consultations carried 
out by the Chairman. 
179. The representative of Nigeria, speak ing on behalf of the African Group , supported the 
Chairman's suggestion regarding the organization of future work, which was the most viable option of 
coming to a solution before the Hong Kong Ministeria l Conference.  He reaffirmed that the African 
Group remained engaged in the process. 
180. The representative of India  said that his delegation had a substa ntive interest in this important 
issue, both from the public health perspective, as well as a significant supplier of generic medicines.  
This had been evidenced by the active participation of his delega tion in the process leading to the 
Decision.  The African Group proposal was the only proposal on the table in the TRIPS Council and constituted a good basis for the amendment to the TRIPS Agreement.  The amendment should fully 
preserve the flexibilities provided for in the Decision.  The Chairman's Statement was not part of the 
Decision itself and its status should not be change d.  The subject matter for amendment was the 
Decision, as stipulated in paragraph 11 thereof.  He fully supported the statement made by the 
delegation of Brazil on the issue of the asterisked not e in the Decision.  His delegation was available 
for any discussions, in whatever format, on the am endment, to be organized by the Chairman. 
181. The representative of Argentina
 reiterated her delegation's support for the African Group 
proposal which should be the basis for the negotiatio n of the amendment.  The elements included in 
that proposal deserved careful attention.  She agreed  that certain aspects should not form part of the 
amendment because they were not relevant.  For example, paragraph 6(ii) on regional patent systems had nothing to do with the system established by the Decision.  Her delegation was also concerned about the Chairman's Statement and was not in a positi on to accept a change of its legal status.  At the 
time of adoption of the Decision, the Chairman of  the General Council had formulated the statement 
on his own responsibility, but it was not part of the agreement amongst Members.  The Decision was 
the only existing agreement amongst Members.  Cons idering the importance of this process for all 
WTO Members, informal consultations carried out by  the Chairman needed to be organized with the 
greatest degree of transparency and inclusiveness.  As regards the ast erisked note in the Decision, she 
supported the statement by the delega tion of Brazil according to which this note should be removed so 
that the text of the Decision would be identical to the one adopted in August 2003. 
182. The representative of the Philippines
 said that his delegation remained committed to being 
constructive in these negotiations while preserving the flexibilities developing countries had gained 
from the Decision and bearing in mind fundamental concerns in this process.  The African Group proposal was an important basis for the discussions.  In various formal and informal sessions, his delegation had articulated concerns and reserva tions about the Chairman's Statement and the 
interpretation of certain provisions of the Decision.  Those were accurately reflected in the minutes of 
the relevant meetings.  Any amendment to the TR IPS Agreement pursuant to the Decision should be 
consistent with the humanitarian context in whic h the Decision had been adopted.  His delegation had 
always been a keen participant in the negotia tions, both as regards the drafting of the Doha 
Declaration on the TRIPS Agreement and Public H ealth, and the Decision.  This remained an 
important issue for his Government and his delegati on was ready to participate in any consultations 
leading in due time to a responsible  and mutually acceptable solution. IP/C/M/49 
Page 36  
 
183. The representative of the China
 informed the Council that his delegation was in the process of 
drafting domestic legislation to implement the Decisi on.  Under national patent law, procedures would 
be established for the granting of compulsory licen ces to manufacture generic versions of eligible 
patented pharmaceutical products.  This would cover the supply of the domestic market to address 
public health crises and the export to eligible im porting countries in response to requests received 
from those countries.  He fully supported the Chairman 's efforts in relation to this very important 
issue and expected the Council to push hard for th e completion of the amendment process.  This 
would provide legal certainty for Members in the process of implementing the Decision. 
184. The representative of the United States  noted that the agreement reached on 30 August 2003 
to implement paragraph 6 of the Doha Declaration on the TRIPS Ag reement and Public Health had 
been an important contribution among other efforts to  address the major public health crisis.  For her 
delegation, it was essential that the amendment preserved the entire agreement reached at that time.  Therefore, it had to include an express reference to  both the Decision and the Chairman's Statement.  
Her delegation was not seeking to elevate the status of the Chairman's Statement, but it could neither 
accept it being diminished or eliminated.  This was a technical exercise that could be accomplished 
efficiently and expeditiously without re-opening subs tantive issues.  As regards the asterisked note, 
she remained of the view that the corrigendum i ssued by the Secretariat had been unnecessary and 
that no further action was warranted by the Secretar iat.  Efforts in the TRIPS Council were better 
spent on the important work of reach ing an agreement on the amendment. 
185. The representative of Canada
 considered that the efforts made by many Members to 
implement the Decision underscored that the comm itments were taken seriously.  The amendment 
process should remain a technical and legal drafting exercise to transform the August 2003 deal into a 
permanent part of the TRIPS Agreement.  Although his delegation was not a demandeur  for the 
Chairman's Statement, its implementing legislati on took the Decision and the Chairman's Statement 
into account as both were part of the deal.  His delegation was flexible on how to deal with the 
Chairman's Statement and willing to work with othe rs in a constructive and pragmatic way, but its 
legal status should not be changed.   He hoped that the experience in implementation was helpful.  He 
was looking forward to cooperating with the Chairm an in any useful way.  When working on the 
amendment, one should not lose sight of the reason wh y the Decision had been taken in the first place, 
namely ensuring that the full flexibilities of the TRI PS Agreement could be used to deal with serious 
public health issues. 
186. The representative of Kenya  hoped that a solution could be  reached before the Hong Kong 
Ministerial Conference.  The statements made at the meeting clearly indicated that further efforts were 
needed to get there.  He reminded delegations of the gravity of the health problems that affected 
Africa.  He reported that African Ministers of health had met in Botswa na on 13-14 October 2005 and 
had stressed the need to ensure access to affordab le medicine, noting that access remained limited and 
costly.  They had urged the international community  to address this issue expeditiously and had called 
for a more appropriate permanent solution at th e WTO that would amend the TRIPS Agreement and 
remove all constraints, including procedural requi rements relating to the export and import of generic 
medicines.  He said that his delegation had recently  been accused of blocking consensus on the issue 
but this meeting clearly indicated that this was not  the case.  He hoped that the delegation that had 
given this message to his Minister would bear witn ess to what had been stated.  His delegation stood 
ready to consult further, whether in a small group or  in an open-ended format, so that a solution could 
be reached before the Hong Kong Ministerial Conference. 
187. The representative of Japan  supported the delegation of Ca nada, which had expressed the 
view that the amendment process should remain a technical exercise and not be subject to interpretation of what had been agreed.  It was his delegation's understanding that the Decision had 
been made on the basis of the Chairman's Statem ent without which no Decision would have been 
reached.  IP/C/M/49 
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188. The representative of the European Communities  said that it was in the interest of all 
Members to find a solution that w as agreeable to all.  Settling this matter urgently would allow 
Members to concentrate their efforts on other major outstanding issues.  In its communication 
submitted to the TRIPS Council in November 2003, his delegation had taken the view that the 
amendment process should remain essentially technical, faithfully reflecting what had been agreed in 
August 2003.  Not re-opening discussi ons on substantive issues was important to preserve the general 
balance as the Decision was the result of lengthy  and difficult negotiations.  His delegation had 
informally circulated its ideas on the transposition of the Decision into the TRIPS Agreement.  A 
straightforward, legally secure, effective and perm anent solution within the existing legal framework 
of Article 31 TRIPS was the objective.  He recalle d that the system put into place by the Decision 
could already be effectively used by Members.  As regards the Chairman's Statement, its legal status 
should not be upgraded, but the legal relationshi p between the Decision and the Statement be 
preserved in the context of the future amendment.   Since the Chairman's Statement constituted a 
shared agreement accepted by all Members and cont ext for the interpretation of the Decision, it 
should continue to represent context for the interpretation of the amendment.  He believed that this 
approach would be instrumental in unlocking the situation, but his delegation was also open to 
discussing other options.  He encouraged the Chairm an to intensify his consultations in which his 
delegation was prepared to participate. 
189. The representative of Korea  said that the amendment should be a technical exercise and the 
legal status of the Chairman's Statement should not be changed.  In particular, the voluntary 
commitment undertaken by the so-called partial opt-out Members, including his delegation, should 
not be turned into a legal obligation.  Turning to Korea's domestic implementing legislation, he 
reported that the internal review process would be  completed as soon as possible, hopefully before the 
Hong Kong Ministerial Conference.  The revised pate nt law reflecting the Decision was expected to 
enter into force in December 2005. 
190. The representative of Singapore  said that, notwithstanding the technical nature of this 
exercise, difficulties had arisen owing to differing inte rpretations and perceptions of the legal status of 
the Chairman's Statement and its relationship with  the Decision.  He was of the view that the 
Chairman's Statement formed part of the consensu s reached in August 2003 and could not be ignored 
in the amendment to the TRIPS Agreement.  At th e same time, voluntary undertakings made in good 
faith by some Members should not be turned into binding obligations through their incorporation into 
the TRIPS Agreement.  He was encouraged by the informal proposal drafted by the delegation of the 
European Communities which was balanced and reasonable, and provided a good basis to move 
forward.  In particular, he suppor ted the suggestion that the Chairman 's Statement be reiterated at the 
time of the adoption of the amendment.  This w as one way of preserving the legal status of the 
Chairman's Statement and the voluntary nature of the undertakings made by some Members when the Decision had been adopted.  He recalled that, alth ough the waiver was in place until the amendment 
came into effect, there was a need  to resolve this issue promptly so as to avoid complicating the 
preparations for the Hong Kong Ministerial Conference.  His delegation was interested in participating in any consultations organized by the Chairman. 
191. The representative of Switzerland
 reconfirmed his delegation's commitment to the 
amendment process and to the conclusion of the work  before the Hong Kong Ministerial Conference.  
As regards the transposition of the solution of 30 August 2003 into the TRIPS Agreement,  it was of 
key importance for his delegation that the amendmen t reflected the entirety of the consensus and the 
solution found by the membership at that time.  This could only be done through a purely technical 
amendment which would faithfully reflect the con sensus which had been achieved only after very 
long and difficult negotiations a nd which represented a delicate balance of interests of WTO 
Members.  The Chairman's Statement was part of  the consensus and should therefore also be an 
integral part of the solution.  It needed to be ad equately reflected in the am endment.  He recalled the 
Doha Declaration on the TRIPS Agreement and Public  Health and the flexibilities recognized therein 
in relation to other important concerns referred to by some delegations.  Hi s delegation supported the IP/C/M/49 
Page 38  
 
process of informal consultations held by the Chairm an.  If those consultations were extended to other 
delegations at a later stage, his delegation was inte rested in being included in the process, given that 
Switzerland was a major player in pharmaceutical research and development. 
192. Reverting to the statement made by the Eu ropean Communities, calling for the preservation 
of the balance between the Decision and the Chairman's Statement and stating that the Chairman's 
Statement represented shared understandings of Me mbers and context for the interpretation, the 
representative of India
 referred to a note from the Chairman of 27 August 2003 (JOB(03)/177).  He 
said that he could not find any reference to the context for interpretation in the draft statement 
circulated in that document, and believed that refe rence was merely made at that time to the way in 
which the Decision should be interpreted and implemen ted.  He wanted to clarify how this was going 
to be taken into account when addressing the question of preserving the balance. 
193. The representative of Jamaica  said that the issue of affordable access to pharmaceutical 
products remained a priority for her delegation and hoped that a permanent solution could be found as 
soon as possible, preferably before the Hong Kong Ministerial Conference.  She supported the view 
that the Chairman's Statement was not an integral pa rt of the Decision.  It had been devised during the 
process in 2003 to reach a consensus.  This purpo se had been served and there was no need for the 
Chairman's Statement at this stage.  She sugg ested that the Decision be the only basis for the 
amendment process. 
194. The representative of Australia  supported the process of informal consultations undertaken by 
the Chairman in an attempt to bridge diffe rences and to achieve agreement on a permanent 
amendment to the TRIPS Agreement to incorp orate the Decision in time for the Hong Kong 
Ministerial Conference.  She considered that th e amendment process should be a technical exercise 
reflecting the agreement WTO Members had reach ed in August 2003 w ithout re-opening or 
renegotiating substantive issues.  This implied faith fully preserving the agreement in its entirety.  Her 
delegation was flexible as to how th is could be achieved and encourag ed focused consultations on this 
point.  She noted that the waivers in the Decision remained in place until a permanent amendment was 
agreed and that the Decision was ready for use as it had been implemented by a number of Members. 
195. The representative of Brazil  said that he was fully supportive of the Chairman's efforts to find 
a satisfactory solution to the issue at stake.  He expressed, however, concerns about interventions 
made in the meeting that seemed to imply a certain  disregard for WTO procedures, for example, when 
the Decision was not called by its name but referre d to as an agreement or as a solution or other 
similar terms.  Some countries had apparently an interest in not qualifying it as a Decision of the 
General Council.  His delegation was equally co ncerned about certain delegations' intention to 
consider the Chairman's Statement, which referred to a set of shared understandings of Members, as a 
consensus of the WTO membership.  In his view, this was not how a consensus was reached in the 
WTO.  Certain Members wanted to link the Decision  with the Chairman's Statement to provide for 
something that did not exist in the WTO, such as a sh ared agreed solution or something similar.  This 
was a contortionism of reality, as nothing more th an the Decision and the Chairman's Statement could 
be referred to in relation to the meeting of the General Council of 30 August 2003. 
196. The representative of Brazil also expressed con cern about the disregard for procedures insofar 
as participation in informal consultations had been se lective and partial, and not  all interested parties 
and those who had declared themselves interested in this process were included.  Furthermore, 
reference had been made to documents that were unknown to his delegation, and which had not been 
officially circulated.  They were non-official docum ents and could not be referred to as a basis for the 
negotiation of an amendment to a formal WTO agreem ent.  He asked whether it was the intention to 
proceed with consultations that only involved a few delegations and which were based on documents 
that had not been tabled by any delegation so far.  Another example for the disregard of procedures was the fact that certain delegations self-interprete d certain actions occurring in the WTO in their own 
self-serving manner.  As far as his delegation was concerned, there was nothing in the Chairman's  IP/C/M/49 
 Page 39 
 
 
Statement that could be used to proclaim that it had become context for interpretation of anything in 
the WTO. 
197. The representative of Norway  referred to the fact that, more than two years after the adoption 
of the Decision, there was still no agreement on th e amendment to the TRI PS Agreement.  Although 
there should be no question as to the legal basis fo r the implementation of the Decision, only a few 
Members had implemented the Decision into nationa l law.  This was disappointing considering the 
devastating impact of HIV/AIDS and other pande mics on public health and economic development, 
and the need to ensure that the TRIPS Agreement did not represent an obstacle to access to affordable 
medicines.  She urged interested delegations to bridge the remaining gaps in time to deliver an 
amendment to the TRIPS Agreement at the Hong Ko ng Ministerial Conference.  Her delegation stood 
ready to provide any assistance in this process. 
198. The representative of Malaysia  said that a technical amendment should lead to a permanent 
solution, but the Chairman's Statement should not fo rm part of the amendment.  The Statement was 
not an integral part of the agreement and its lega l status should not be changed.  Her delegation was 
interested in participating in the Chairman's cons ultations to find a permanent solution.  While the 
objective was to find a solution before the Hong Kong Ministerial Conference, she supported the 
statement made by the delegation of Brazil at an informal consultation earlier that day according to 
which no solution was better than a bad solution. 
199. The representative of New Zealand  referred to the risk of unravelling the August 2003 
outcome if Members were not prepared to make concerted efforts over the coming months.  He was 
encouraged by the recent consultations held by th e Chairman and asked for further concerted efforts 
to resolve this important issue.  His delegation w as willing to take a flexible and pragmatic approach 
in working towards a permanent solution.  He join ed those Members that had maintained that the 
amendment should be a technical exercise only and not serve to re-open a debate on substantive 
elements of the Decision.  For his delegation, it w as clear that the Chairman's  Statement had been an 
important element in the achievement of a consensu s in August 2003.  In formulating an amendment 
to the TRIPS Agreement to reflect the Decision, th e issue was not so much a question of whether to 
deal with the Chairman's Statement, but a question of how to deal with it.  He agreed with the 
European Communities that, in order to preserve th e legal relationship between the Decision and the 
Chairman's Statement at the time of the adoption of the amendment, the Statement should be dealt 
with in such a way that it represented an understa nding of Members regarding the way in which the 
amendment itself was interpreted and implemented.  This would provide an aid for, or in technical 
legal terms a context for, interpretation of the amen dment.  His delegation supported dealing with the 
Chairman's Statement in a way that provided cont ext for the interpretation of the amendment without 
elevating or diminishing its status.  The outcome should faithfully reflect the approach taken in 2003. 
200. In response to the delegation of India, th e representative of th e European Communities  
clarified that, when he had earlier referred to the co ntext for interpretation, he had meant to refer to 
the Vienna Convention on the Law of Treaties, more precisely paragraph 2 (a) of Article 31. 
201. The representative of Zambia  said that the problem of access to medicines remained an issue 
of concern to many countries.  The very basis upon which the Ministers had adopted the Doha Declaration on the TRIPS Agreement and Public Hea lth should be born in mind.  He looked forward 
to an effective permanent solution.  He supported th e statements made by the delegations of Brazil, 
India, Jamaica and Nigeria. 
202. Taking up the clarification by the delegation of the European Communities, the representative 
of India
 said that his concerns relating to the ongoing discussion on the status of the Chairman's 
Statement had been reaffirmed.  While he did not see any reference to the Vienna Convention in the 
Chairman's Statement, lawyers could interpret its components to assess whether it constituted a means 
of interpretation, and what kind of means of interpre tation.  In his view, the Chairman's Statement was IP/C/M/49 
Page 40  
 
not the context for interpretation in the sense of  paragraph 2(a) of Article 31 of the Vienna 
Convention, but represented a supplementary means of  interpretation pursuant to Article 32 of the 
Vienna Convention.  The question of whether the St atement constituted a means of interpretation and, 
if so, whether it was part of the context, as suggested by the European Communities and New 
Zealand, or a supplementary means of interpretation could either be left for interpretation after the 
adoption of the amendment or be st ated explicitly in the agreement. 
203. Referring to her statement made at the TRIPS Council in June 2004 and to the Note by the 
Legal Affairs Division of the Secretariat on the legal significance of footnotes in WTO Agreements (12 May 2004), the representative of Argentina
 recalled that in her delegation's view, there was no 
agreement to consider the Chairman's Statement as falling under paragraph 2 of Article 31 of the 
Vienna Convention.  In its note, the Secretariat had quoted jurisprudence which could be referred to 
when analysing the legal status of the Chairman's Statement.  The Secretariat's note had also stated 
that the use of a footnote as a means to incorporat e an amendment into the TRIPS Agreement was not 
determinative of the legal significance of any Chairm an's Statement referred to or reproduced within 
such footnote, but that the precise text of the foot note was decisive.  At the time when the use of a 
footnote was considered to amend the TRIPS Agreem ent, her delegation had already disagreed with 
that conclusion, as WTO Members should unanimous ly agree to accord legal status pursuant to 
Article 31 of the Vienna Convention to the Chairman's  Statement.  She said that it was apparent from 
the discussions over the last two years that ther e was no such unanimity among WTO Members, and 
that the majority of Members considered that the Chairman's Statement lacked sufficient legal value 
to form part of an amendment to the TRIPS Agreement. 
204. The Chairman  said that he had not perceived much ch ange in delegations' positions since the 
last meeting.  He noted that, based on its info rmal paper, the European Communities had been 
consulting with the African Group and the United States.   The issue continued to be of great interest 
to all Members which remained committed to finding  an expeditious solution and were prepared to 
work constructively to this end.  A permanent settl ement of the issue had to be found, preferably 
before the Hong Kong Ministerial Conference.  He noted that there was still a wide gap as regards the 
perception and understanding of the issue.   
205. The representative of Brazil  reiterated his delegation's willingn ess to work with the Chairman 
on an amendment to the TRIPS Agreement.  But his delegation did not agree with consultations that 
only involved three parties.  He did not feel comm itted to any result emerging from bilateral or some 
sort of small plurilateral consultations, as long as t hose consultations did not include all interested 
Members.  He counted on the Chairman to ensure a consultative process that would be inclusive of all 
interested Members.  This could lead to satisfa ctory results to be endorsed by the TRIPS Council.  
Although the issue was very important, he considered that a bad result was worse than no result.  He 
recalled that the issue was not part of the single unde rtaking of the Doha Round.   Therefore, there was 
no reason to push for a result by the Hong Kong Minist erial Conference.  It was more important to 
obtain a good result for developing countries which were struggling to provide medicines and 
assistance to their populations. 
206. The Chairman  clarified that the consultations were not  entirely under his auspices.  It was a 
spontaneous process initiated by the delegation of the European Communities.  Due note had been 
taken of the interest of the delegation of Brazil to participate in the consultations. 
207. The delegation of India  recognized the possibility of Members consulting with other 
Members with a view to generating support for solu tions supported by them.  He thought that the 
delegation of Brazil was referring to the Chairman's i nvolvement in the consultations.  In this case, it 
should be an inclusive process, involving all intere sted Members and no distinction should be made 
between a set of most interested parties, another set of key Members and still another set of ordinary 
Members.  The Chairman could not assume any co mmitment of any Member to a process which was  IP/C/M/49 
 Page 41 
 
 
organized outside the TRIPS Council and in which cer tain Members were not involved, including any 
informal setting called by the Chairman. 
208. The delegation of Brazil  said that it was helpful to obtain the Chairman's clarification that the 
consultations had been spontaneously organized by some Members.  This did not require the 
agreement by other delegations, since any Member c ould consult spontaneously with other Members.  
His earlier remarks were referri ng to consultations held under th e Chairman's auspices, which 
represented a different situation. 
209. The Chairman  said that any agreement emerging from the consultations between some 
Members should be put to the entire membership.  He undertook to ensure full transparency of the 
process.  He reiterated his proposal, made at the beginning of the discussion, on how to proceed with 
this item. 
210. The Council took note  of the statements and agreed  to proceed as suggested by the Chair. 
211. Reconvening the meeting on 29 November, the Chairman  said that he had been keeping in 
touch with delegations.  He had fu rther consulted, jointly with the Chair of the General Council, to 
assess whether there was a sufficient basis for a final effort to seek agreement on this matter prior to 
Hong Kong.  There had been recent developments whic h, in his view, justified further efforts to be 
made in coming days.  He, therefore, proposed that  the TRIPS Council once more agree to suspend its 
meeting so as to permit further consultations on this  agenda item.  He said that he would ensure that 
the consultations would be carried forward in a transparent manner.   
212. The representative of Brazil  said that, as his delegation had not been part of these 
consultations, it reserved its position on their fina l outcome.  In his view, a position could only be 
taken on this issue once a formal report on the status  of the Chair's consultations would have been 
presented to the Council, so that delegations coul d consult with their authorities on that possible 
outcome.  The consultations should not only be carri ed out in a transparent manner, but they should 
also be inclusive of all interested Members. 
213. The Council agreed  to proceed as suggested by the Chairman. 
214. Reconvening the meeting on 6 December, the Chairman  said that he was pleased to inform 
the Council that, in the light of the consultations th at he had held, he was now in a position to seek its 
approval for a proposal that the Council might make to the General Council for a decision on an amendment to the TRIPS Agreement.  Accordingly, he  proposed that the Council decide to approve a 
proposal for a decision on an amendment to the TRIPS Agreement (JOB(05)/318 and Corr.1) for 
forwarding to the General Council.
3  He also proposed that the Council approve the forwarding, along 
with the draft decision, of the text of a statement to be made by the Chairman of the General Council 
prior to the adoption by the General Council of the proposal (JOB(05)/319 and Corr.1), and the text of 
a statement concerning paragraph 4 of Article 31 bis of the proposed amendment to the TRIPS 
Agreement also to be made by Chairman of the General Council prior to the adoption of the proposal 
(JOB(05)/320). 
215. The Council so agreed . 
H. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 
OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
216. The Chairman  recalled that paragraph 8 of the Decisi on on the Implementation of Paragraph 6 
of the Doha Declaration on the TRIPS Agreement a nd Public Health provided that the Council for 
                                                      
3 Subsequently circulated as document IP/C/41. IP/C/M/49 
Page 42  
 
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.  
Furthermore, the paragraph provided that this review should be deemed to fulfil the review 
requirements of Article IX:4 of the WTO Agreement. 
217. The representative of Canada
 recalled that, at the last TRIPS Council meeting, a Canadian 
expert had outlined Canada's legisl ation and regulations that implem ented the Decision.  Canada was 
distributing a paper that provided a written explan ation of some aspects of the legislation and 
regulations (IP/C/W/464).  This paper outlined sever al issues, such as eligible importers, eligible 
pharmaceutical products, the application process, th e "good faith clause" which implemented aspects 
of the Chairman's statement, anti-diversion measur es, royalties and aspects of termination.  He said 
that the Canadian system was flexible, as the list of eligible products had rece ntly been updated to add 
a fixed-dose combination antiretroviral medication u sed in the treatment of HIV/AIDS.  A special 
review stream had been put in place by the Minister  of Health to expedite  the approval of products 
that came under this system and that had not prev iously been approved for use in Canada.  He drew 
attention, in particular, to the part of the paper th at outlined how a country c ould take advantage of the 
Canadian system.  His delegation was committed to making the system work and would be prepared 
to provide any further information, clarification or  explanation of the Canadian system, including to 
those who wished to take advantage of it. 
218. The representative of the European Communities  informed the TRIPS Council that his 
delegation expected the Council of the European Unio n and the European Parliament to reach soon an 
agreement on the draft regulation proposed by th e European Commission.  This would allow the 
adoption of legislation implementing the Decision prior to the Hong Kong Ministerial Conference. 
219. The representative of Argentina  said that legislation adopted by Members to implement the 
Decision should not prejudice the interpretation and application of the Decision at the national level 
by other Members.  She said that no precedents shou ld be set in the way in which the Decision would 
be required to be implemented.  She recalled that the freedom of WTO Members in Article 1.1 of the 
TRIPS Agreement to determine the appropriate met hod of implementing the provisions of the TRIPS 
Agreement, which included the Doha Declarati on on TRIPS and Public Health and the Decision, 
remained in effect. 
220. 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 modelled on that of last year's  report, which had been circulated as JOB(05)/255.  
The draft cover page contained factual informa tion on the implementation and use of the system 
established under the Decision and on the work on th e preparation of an amendment to the TRIPS 
Agreement pursuant to paragraph 11 of the Decision.  He said that his intention was to attach to the 
cover note the part of the minutes of the meeting reflecting the discussions held under this agenda 
item.  This format would follow the way that the Council prepared its report last year. 
221. The Council so agreed . 
I. NON-VIOLATION AND SITUATION COMPLAINTS  
222. The Chairman  recalled that paragraph 1(h) of the General Council Decision of 1 August 2004 
on "Other elements of the Work Programme" provided, inter alia , that the General Council and other 
relevant bodies should report on their work on such ot her elements in line with their Doha mandates 
to the Sixth Ministerial Conference.  It also provided that the moratorium on non-violation and 
situation complaints covered by paragraph 11.1 of the Doha Mini sterial Decision on Implementation-
Related Issues and Concerns was extended up to the Sixth Ministerial Conference.  This matter had 
been on the agenda of the Council's last two mee tings.  At those meetings, the Council had discussed 
the matter on the basis of, inter alia , an updated Secretariat summary note on the points raised in the  IP/C/M/49 
 Page 43 
 
 
Council's substantive discussion of this matter so far (IP/C/W/349/Rev.1).  Given that the present 
meeting was the Council's last meeting before th e Hong Kong Ministerial Conference, it was now 
necessary to consider what kind of recommendations they could provide to the Ministerial Conference. 
223. He further recalled that he had taken that ma tter up at the Council's informal meetings on 
20 and 25 October.  In order to facilitate the cons ideration of the matter, he had noted that there 
appeared to be three main options for such recomme ndations.  At one end of the spectrum, one option 
would be to follow the proposal by a number of Members contained in document IP/C/W/385, and to recommend to Ministers that violations of the t ype identified in Article XXIII.1(b) and (c) of 
GATT 1994 be determined inapplicable to the TRIPS Agreement.  At the other end of the spectrum 
was the option of non-violation and situation comp laints being available under the TRIPS Agreement 
without subjecting them to any specific guidance as to their scope and modalities over and above 
those already envisaged by the DSU, i.e. the gene ral safeguards provided in Article 26 of the DSU.  
The third option would be to recommend that the mora torium be further extended so as to allow the 
TRIPS Council more time to consider the sc ope and modalities of non-vi olation and situation 
complaints in the area of TRIPS.  If the Council we re to follow this option, it should consider the 
length of any such further extension, i.e. whethe r it should be extended until the conclusion of the 
Round, or whether the timing should be determined in some other way.  In principle, there would be a 
fourth option, namely that the Council would reco mmend that non-violation and situation complaints 
be made available to disputes arising under the TRI PS Agreement, but made subject to some specific 
additional guidance on their scope and modalities.  However, no proposals for such provisions had 
been submitted. 
224. The representative of Canada
 said that she could not see how the non-violation concept, 
designed for market access agreements where concessions were made on a product-by-product or 
service-by-service basis, would apply to TRIPS, a sui generis  agreement that dealt with the creation of 
minimum standards.  Canada had been raising t hose concerns since before the end of the Uruguay 
Round.  While hoping that a consensus could be achie ved that non-violation complaints did not apply 
to TRIPS, her delegation was willing to  continue discussion on this item.  
225. The representative of Colombia4 said that his delegation's position remained as reflected in 
document IP/C/W/385, which it had co-sponsored.   In its view, the Council should recommend to the 
Ministerial Conference that the violations of the ty pe identified in Article XXIII:1(b) and (c) of the 
GATT 1994 be determined inapplicable to the TRIPS Agreement. 
226. The representative of Argentina  believed that, as had been pointed out by Canada, the 
possibility of challenging legitimate government measures through non-violation complaints would 
lead to uncertainty.  Due to these considerati ons her delegation was in favour of making such 
complaints inapplicable to TRIPS.  A large majo rity of Members supported this solution, and she 
believed that the Council should make a recommendation to the Sixth Ministerial Conference 
accordingly. 
227. The representative of Peru  concurred with the points made by Canada, Argentina and 
Colombia.  He believed that, at Hong Kong, Me mbers could achieve consensus to make such 
complaints inapplicable to TRIPS. 
228. The representative of Malaysia , associating herself with the statements made by Canada, 
Argentina, Colombia and Peru, said that her delegati on hoped that a resolution to this issue could be 
achieved at the forthcoming Ministerial Conference. 
                                                      
4 As requested by the delegation of Colombia, th e following reflects the statement it made at the 
Council's informal meet ing of 25 November. IP/C/M/49 
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229. The representative of Japan
 said that the examination of the scope and modalities for non-
violation complaints pursuant to Article 64.3 of th e TRIPS Agreement had not yet been completed.  
Therefore, the Council should continue its exam ination of the scope and modalities for such 
complaints in order to ensure the predictability of their application. 
230. The representative of the United States  said that his delegation continued to consider that non-
violation and situation complaints were fully appr opriate in the TRIPS context.  It expected the 
moratorium to expire at the Sixth Ministerial Conference.  It was unambiguously clear to his 
delegation that, in Article 64, non- violation and situation complaints  had been contemplated in the 
context of the TRIPS Agreement and had been an in tegral part of the final package negotiated during 
the Uruguay Round.  The objective of non-violation and situation complaints was to discourage 
actions that evaded obligations without directly vi olating them.  A clear reason had not been provided 
as to why the TRIPS Agreement should not benefi t from the same objective.   The United States 
remained willing to discuss how such complaints app lied to the TRIPS Agreement.  In the view of his 
delegation, Article 26 of the DSU was very help ful and important guidance for Members concerning 
non-violation disputes under TRIPS and it would be interested in focusing the discussions on that 
issue. 
231. The representative of Brazil  said that it had been clear for some time that there was an 
emerging consensus in the Council that non-violation and situation complaints should not apply to the 
TRIPS Agreement.  His delegation hoped that the fo rthcoming Ministerial Conference would be in a 
position to confirm that understanding. 
232. The representative of Chile  supported the statements by Cana da, Argentina, Colombia, Peru, 
Malaysia and Brazil. 
233. The representative of Thailand  said that non-violation and situ ation complaints should not be 
applicable to the TRIPS Agreement. 
234. The representative of Switzerland  said that his reading of Article 64.2 and 64.3 favoured the 
applicability of non-violation and situation complaints  in the TRIPS context, just as in the context of 
other WTO Agreements.  The purpose of the moratori um, as contained in para graph 2 and referred to 
in paragraph 3, and of its extensi on in the Doha Declaration, had been  to allow the examination of the 
scope and modalities of such complaints in the TR IPS context.  His delegation was aware of the 
concerns raised by other dele gations and was ready to continue discussing the matter if other 
Members felt that there was a need for clarification.  Proposals which would help guide and structure and inform such a discussion substantively were we lcome.  Therefore, his delegation was flexible 
with regard to options two, three a nd four referred to by the Chair.   
235. The representative of the European Communities
 said that non-violation and situation 
complaints should not apply to the TRIPS Ag reement.  The TRIPS Council should make a 
recommendation to this effect to the Hong Kong Mini sterial Conference.  As Argentina had indicated, 
it was difficult to imagine how to transpose the non-violation complaints concept from GATT to 
TRIPS, since this would introduce elements into th e TRIPS Agreement that might lead to uncertainty 
and a lack of clarity.  As Canada had indicated, the Agreement was not a market access agreement or an agreement on tariff concessions.  The Agreemen t obliged Members to put in place clearly 
prescribed legislation and to enforce it.  Any failure to comply with these obligations could be directly 
addressed as a violation of the Agreement.  On the other hand, any behaviour that restricted market 
access or reduced benefits under tariff concessions could be addressed under GATT or GATS.  As a 
consequence, there seemed to be little practical scope for non-violati on and situation complaints under 
the Agreement.  However, his delegation was open to further discussions on this matter and could, 
therefore, go along with an extension of the existing moratorium.  IP/C/M/49 
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236. The representative of Ecuador  said that he was in favour of a recommendation to make such 
complaints inapplicable to the TRIPS Agreement.  He also supported the document by Peru which 
gave a technical explanation of the matter. 
237. The representative of India  associated his delegation fully with what he described as the 
emerging consensus within the TRIPS Council to recommend that non-violation and situation 
complaints did not apply to the TRIPS area.  Fo r brevity, he referred to his delegation's earlier 
submissions and statements which, in his view, fully justified why the Council should make such a 
recommendation.  He added that his delegation did no t read Article 64.2 and 64. 3 to be in favour of 
application of such complaints in the TRIPS ar ea.  They were necessary in order to provide a 
possibility to discuss whether such complaints should apply and, if so, what the scope and modalities 
of their application would be.  The discussion over the last few years had demonstrated that it was 
simply not possible to determine the scope and m odalities in a way that would be relevant for a 
minimum standards agreement such as the TRIPS Ag reement, as distinguished from other areas such 
as market access concessions to which non-violati on and situation complain ts had traditionally 
applied. 
238. The representative of Indonesia  said that non-violation and s ituation complaints should not 
apply to the TRIPS Agreement. 
239. The representative of Cuba , noting that Cuba's position had been presented in a document 
introduced at earlier meetings and co-sponsored with  others, said that such complaints were not 
applicable to the TRIPS Agreement. 
240. The representative of Venezuela  agreed with those who did not wish to include this standard 
in the deliberations. 
241. The Chairman  said that, although a majority of the delegations that had spoken had expressed 
a preference for option one, there had also been s upport for option two, and many had also expressed 
flexibility with regard to option three.  There was no consensus on any of the options.  Therefore, the 
Council was not in a position to make any recommendati ons at that stage.  This meant that further 
work might need to take place in the time leading up to the Ministerial Conference.  He indicated that 
he would report accordingly to the Chairman of  the General Council and that the TRIPS Council's 
overall report to the General Council would describe the work done on this matter. 
242. The Council took note  of the statements made. 
J. TRANSITION PERIOD FOR LEAST -DEVELOPED COUNTRIES ;  REQUEST FOR EXTENSION  
243. The Chairman  said that, by means of a letter dated 13 October 2005, the Ambassador of 
Zambia, on behalf of the LDC Members of the WT O, had informed him that the LDC Group intended 
to make a formal submission to the TRIPS Council requesting an extension of the transitional period 
under Article 66.1 of the TRIPS Agreement, and asked that this request be put on the agenda of the 
present Council meeting.  A communication from the delegation of Zambia on behalf of the least-
developed country Members of the WTO had subseque ntly been circulated as document IP/C/W/457. 
This communication contained a request for an exte nsion of the transitional period under Article 66.1 
for a further 15 years.  He recalled that there had already been some discussion on this matter at the 
Council's informal meetings on 20 and 25 October. 
244. Introducing document IP/C/W/457, the represen tative of Zambia, speaking on behalf of the 
least-developed country Members of the WTO , said that, after careful consideration, these Members 
regarded 15 years to be the minimum period to be re quested.  After this period, they should hopefully 
be in a position to implement TRIPS, although they would continue to need help, by way of technical 
assistance and capacity building, from their cooperati on partners.  It was clear that any transitional IP/C/M/49 
Page 46  
 
period less than that would a mean a death sentence to many of their people.  The exemption under 
Article 66.1 had been granted in recognition of the economic, financial, and administrative constraints 
faced by LDCs that had prevented them from observing immediately all the obligations set out in the TRIPS Agreement.  The exemption further reflected  the fact that LDC Members had special needs 
and requirements, including the need for flex ibility to create a viable technological base. 
245. The socio-economic situation of the countries in  question had changed very little over the past 
ten years to enable them to comply with their obl igations under the TRIPS Agreement, and that the 
difficult situation of LDCs was widely recognized by the international community.  In particular, he 
referred to the 2004 Least-Developed Country Report by UNCTAD according to which "if past trends 
persist, the least-developed countries are likely to become the major locus of extreme poverty in the 
world economy by 2015".  LDC Members had compe ting needs against grave financial inadequacies 
which had made it difficult for them to meet sev eral obligations, includi ng compliance with the 
provisions of the TRIPS Agreement.  Their economies were at a stage of development that required focused and immediate attention in fundamental ar eas such as health, education and food security.  
Even in these areas, LDC Members were already confronted with critical human resource problems, 
and financial and administrative constraints. 
246. He said that it was widely recognized that a viable technological base was a fundamental 
requisite for the implementation of an effectiv e intellectual property system that would support 
national development efforts.  LDCs had an inad equate technological base to support an effective 
system of IPR protection and had barely deve loped institutional linkages that would support 
implementation of obligations under the TRIPS Agreement.  They, therefore, required additional time 
to formulate and implement IP laws and policies in appropriate ways to achieve their national 
priorities and needs, including creating a viable te chnological base to be able to benefit from IP 
protection. 
247. The compliance with TRIPS provisions required alignment of national laws with various 
fields, such as civil and criminal procedures in courts, administrative procedures, intervention of 
police and customs authorities.  Most of their economies were faced with human resource constraints 
to administer, implement and enforce IP legisla tion.  Upgrading existing institutional framework 
would require extensive financial resources, an issue beyond their current national budgets.  Several 
studies, including a study by the World Bank, ha d shown that the process of becoming TRIPS 
compliant, i.e. drafting legislation, setting up/up grading appropriate ins titutions and providing 
sufficient human resources and enfo rcement mechanisms all involved s ubstantial costs.  He referred 
to the 2002 World Economic Prospects report of the World Bank, which stated that if training costs 
were included, a comprehensive upgrade of the IPRs  regime in the poorest countries would require an 
expenditure of $1.5 to $2 million plus recurrent costs.   He added that other studies had estimated even 
higher costs. 
248. He said that these weaknesses and vulnerabiliti es constituted special circumstances requiring 
LDCs to have "maximum flexibility in the domestic implementation of laws and regulations in order 
to enable them to create a sound and viable technol ogical base".  This was clearly articulated in the 
TRIPS Preamble, as well as in Article 66.1 of the TRIPS Agreement. 
249. In concluding, he expressed his hope that, dur ing this transitional period of 15 years, 
developed countries would make greater effort s and undertake more commitments to provide 
incentives to enterprises and ins titutions in their territories for the purpose of promoting and 
encouraging technology transfer to LDC Members in accordance with Article 66.2 of the TRIPS 
Agreement.  These efforts would go a long way to a ssist LDCs to create a viable technological base.  
This commitment by developed countries had been  reaffirmed in paragraph 11.2 of the Doha 
Ministerial Decision on Implementation-Related Issu es and Concerns that emphasized its importance 
and mandatory nature.  IP/C/M/49 
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250. The representative of Tanzania , associating her delegation w ith the statement made by 
Zambia, said that the special needs and requirement s of LDC Members referred to in Article 66.1 had 
changed very little.  This remained a ground for mo tivating their request for an extension of the 
transitional period.  In Tanzania , capacity building among implemen ting agencies remained a problem 
and some key legislation was not yet TRIPS compliant. 
251. The representative of Uganda  said that the reasons given by Zambia as to why the LDC 
Group should be exempted from applying certain ob ligations under the TRIPS Agreement reflected 
the present conditions in Uganda.  Uganda, therefore,  fully supported Zambia's  statement.  The ten-
year exemption for LDCs had been granted in recognition of the economic, financial and 
administrative constraints faced by LDCs that prevented them from observing immediately all the 
obligations set out in the TRIPS Agreement.  The LDC exemption also reflected the fact that LDC 
Members had special needs and requirements, includ ing the need for flexibil ity to create a viable 
technological base. 
252. During the last ten years, Uganda had al ready taken steps towards implementing the 
obligations set out in the Agreement.  However, Uganda's economy had conti nued to be vulnerable, 
and its economy's performance had been greatly unde rmined by the continued declining prices of its 
commodities in the international markets.  It contin ued to face negative terms of trade, and continued 
to struggle to diversify its economy to be able to fight and alleviate the prevailing poverty.  Uganda 
had, therefore, been unable to develop an adequate technological base to fully derive benefits from the 
TRIPS Agreement. 
253. He added that the cost of developing an appr opriate institutional infrastructure to implement 
the Agreement was substantial.  There was neither  sensitivity towards IPRs and their benefits nor 
developed institutions, and the gene rally weak human resource base would require both extensive and 
intensive training, including of judges, police, and other IPRs stakeholders.  This would require huge 
resources and additional time for mobilizing the re quired human and financial resources to bring the 
domestic legal systems and other infrastructure into conformity with the provisions of the 
TRIPS Agreement.  In Uganda, incomes remain ed low, human resources weak and the economy 
vulnerable.  LDCs had fallen deeply into poverty and despair, and lacked  the necessary human and 
technical capacity to implement their obligations.  Therefore, they would need to be assisted to 
achieve some level of development that would help them implement their obligations under the 
Agreement. 
254. In view of the continuing and deteriorating ec onomic, financial and administrative constraints 
faced by Uganda and other LDCs, as well as the need for flexibility to create a viable technological 
base in accordance with Article 66.1 of the Agre ement, the representative of Uganda urged all 
Members to accord the joint request  for extension a favourable response.  He hoped that during this 
additional transitional period there would be commi tment by the developed country Members, as 
envisaged under Article 67 of the Agreement, to pr ovide technical and financial assistance to LDCs to 
assist them in setting up all the necessary infrastructur es to fully implement the Agreement.  Uganda 
also regarded the requested period instrumental  in allowing it to build the necessary domestic 
institutions and legal framework to implement the Agreement. 
255. The representative of Cambodia , associating himself with statements made by Zambia and 
Uganda, said that Cambodia's situation concerning financial, economic and institutional issues, as 
well as legislation to bring its IPR regime into co mpliance with the TRIPS Agreement, was similar to 
that outlined by Zambia and Uganda.  Therefore, ex tension was required for it to fulfil its obligations 
under the Agreement. 
256. The representative of Argentina  said that, under the TRIPS Agreement, IPRs had become a 
component of international trade arrangements.  Minimum standards of protection set in the 
Agreement involved significant legal and institutiona l transformations in many developing and least-IP/C/M/49 
Page 48  
 
developed countries.  The Agreement gave rise to a significant increase in the flow of fees from those countries to the industrialized countries.  She sai d that the World Bank considered that, for six 
developed countries, the net increase in fees deriving  from patents as from the entry into force of the 
TRIPS Agreement represented US$40 b illion.  According to her, the total earned by those countries, if 
all types of intellectual property rights were take n into account, was estimated by the World Bank at 
US$60 billion. 
257. She said that the complex economic implicati ons deriving from agreements on intellectual 
property, particularly the TRIPS Agreement, had raised numerous questions  and concerns at the 
international level.  Whilst this complexity made it difficult to arrive easily at a single answer, she 
said that there was concurrence in pointing out the difficulty in identifying the positive effects of the 
TRIPS Agreement for developing and least-developed countries.  Furthermore, recent studies had 
shown that intellectual property di d not seem to have played an important role when enterprises in 
developed countries had decided upon their transacti ons and investments in developing and least-
developed countries.  There was no systematic proof  as to how stronger IP protection had influenced 
the flow of transfer of technology.  Recent World Bank studies had concluded that enhanced 
protection had led neither to a greater number of lic ensing contracts nor generated greater transfer of 
technology ("Intellectual Property and Developmen t.  Lessons from Recent Economic Research", 
World Bank, 2005). 
258. She added that, with the Doha Declaration on  the TRIPS Agreement and Public Health, WTO 
Members had started to consider the concerns of developing and least-developed countries in 
connection with the TRIPS Agreement.  She said that  still more would have to  be done in order to 
strike a proper balance between the creation of pr ivate incentives and the achievement of the required 
transfer of technology and meeting of developmen t objectives.  The growing concern of developing 
countries had recently been voiced in WIPO, where Argentina, Bolivia, Brazil, Cuba, the Dominican 
Republic, Ecuador, Egypt, Iran, Kenya, Peru, Sie rra Leone, South Africa, Tanzania and Venezuela 
had tabled a proposal for the establishment of a WIPO development agenda.  Explaining the basic 
concepts of this proposal, she said that, in order to  ensure proper protection for intellectual property, 
guarantees would also have to be given concerning tr ansfer of technology and investment flows so as 
to reduce the growing technological divide between developed and developing countries.  National IP 
policies would have to be coherent with the t echnological, industrial, cultural, social and public 
interests of developing countries as well as of LDCs, which would have to have the required 
flexibility to meet these objectives. 
259. Argentina, therefore, regarded it necessary to approach IP protection as a function of the 
balance which must be struck between the interests of the private sector and public sector investments 
relating to development as laid down by in Articl es 7 and 8 of the Agreement.  In Argentina's view, 
IPRs, not being an end in themselves, could only contribute to economic and social development if 
they were integrated in national objectives when de fining public policy.  It was obvious that they 
could not contribute to development if they were considered in isolation, outside the domain of 
national interest and outside th e development objectives of developing and least-developed countries. 
260. Being aware of the difficulties that LDCs and developing countries faced in implementing the 
TRIPS Agreement notwithstanding their efforts, she supported the request made by Zambia on behalf 
of the LDCs to the effect that an extension of the transitional period for these countries be granted. 
261. The representative of Senegal
, supporting Zambia's statement, invited Members of the 
Council to look favourably at the request by LDCs. 
262. The representative of Lesotho  said that what the representative of Zambia had stated was true 
not only for Lesotho but for all LDCs.  It was not  easy to amend laws to conform with TRIPS 
obligations, due to the reasons already mentioned by  other LDCs and Argentina.  She confirmed that  IP/C/M/49 
 Page 49 
 
 
while, on their part, the will was there, the means were  lacking.  That was why they had requested an 
extension of the exemption for another 15 years. 
263. The representative of Brazil , associating himself with Argentina's statement, said that there 
were enduring concerns that the TRIPS Agreement might not be a development friendly agreement.  
It had imposed a number of burde nsome and complex obligations on  developing countries since it had 
entered into force.  In making strenuous efforts to co mply with its terms, Brazil had had to cope with 
numerous economic, social and administrative costs.  After the advent of the Agreement, Brazilian 
imports of certain IP protected products from deve loped countries had increased by over 1,000 % in a 
period of under ten years.  Given that this was the situation in Brazil, a middle-income developing 
country, he said that it would be hard to imagine what kind of a burden would be placed on LDCs if 
they were now required to begin to implement all pr ovisions of the TRIPS Agreement.  Therefore, he 
encouraged all Members to agree to the request that  the delegation of Zambia  had made on behalf of 
the LDC Group. 
264. He added that, in practice, the Agreement had not been helpful to developing countries. When 
these countries had raised development related con cerns with respect to the Agreement and the 
intellectual property system in general, e.g. in the field of biodiversity, they had been told that these 
concerns were not entirely relevant to the Agreem ent.  When developing countries had called for the 
incorporation of a development di mension and development agenda in to the IP system, they had met 
with what seemed to be a self-serving dogma and unf ounded assertions to the effect that IP protection 
and in particular stronger IP protection were au tomatically conducive to development and to the 
transfer of technology.  Such assertions, however, flew in the face of the historical record and of the 
experience of developed countries who in the past ha d utilized extensively weak IP protection regimes 
in order to develop a proper technological base.  These assertions had also been contradicted by 
numerous empirical studies that had been conducted in  recent years, including those that had been 
referred to by the delegation of Argentina.   
265. In concluding, he said that it was time that th e international community, including the WTO, 
took adequate measures to ensure that the IP systems included a development dimension.  The 
adoption of the Doha Declaration on the TRIPS Agreement and Public Health was important, but 
there were many other things that could still be don e.  In this regard, the request made by Zambia 
provided the WTO with another valuable opportunity to demonstrate that it was not insensitive to the 
needs and concerns of developing countries and in particular, LDCs. 
266. The representative of Japan  said that, according to the text of Article 66.1 of the 
TRIPS Agreement, LDC Members were required to explain their duly motivated requests.  Based on 
such explanations, Members should consider whether or  not to accord the extension.  In that process, 
Members should pay attention to the balance betw een the Members who had already implemented the 
Agreement and the Members who had made the request.  Attention should also be paid to implications 
for countries who wished to join the WTO.  Applyi ng these points to the present constellation, careful 
consideration would be required in order to assess whether the submitted explanation was sufficient.  
In his view, extensions should be accorded on a Member-by-Member basis in accordance with each 
country's situation.  Given that his delegation ha d received the request only a week ago, it needed 
more time to evaluate it before taking a decision. 
267. The representative of the United States  said that, while he understood the concerns that had 
been raised by LDCs in making this request, in particular human resource constraints, levels of 
poverty and similar considerations, he had some concerns about the request.  IP protection was a 
necessary ingredient, although certainly not the so le ingredient in establishing a sound investment 
climate, establishing a viable technology base and in leading to economic development.  In that light, 
he strongly disagreed with a number of comments by  the delegations of Argentina and Brazil.  He 
said that numerous studies supported the view that strong IP rights were complementary and 
necessary for establishing a viable technological basis and promoting economic development.  At a IP/C/M/49 
Page 50  
 
recent WTO symposium on sustainable development, it had been stated that there were strong positive 
correlations between the adoption of TRIPS reforms in low- and middle-income developing countries 
and levels of technology transfer.  One notable fi nding in the presentation in question was that there 
had not been such indicia of technology transf er among LDCs, many of which had not yet assumed 
their TRIPS obligations.  For him, it seemed premature,  or perhaps even irresponsible, to send a signal 
that all LDCs might be incapable of protecting IP.  As to the WIPO development agenda and related 
comments by Argentina, he noted that many proposals by both developed and a significant number of developing countries had been made at WIPO in that context that recognized a positive relationship 
between robust IP protection and tech nological and economic development. 
268. While recognizing the good intentions behind the request for extension, he wondered whether 
a blanket extension might merely serve to delay the development of a viable technology base in 
LDCs.  Furthermore, the proposal might not adequately  take into account the fact that different LDCs 
had achieved different levels of im plementation and that the situation therefore varied from country to 
country.  In that light, the decision would have to be  based on the actual needs of particular countries.  
One could build on what had already been done at the national level in these countries and thereby 
ensure that all WTO Members would reap the benef its of the TRIPS Agreement.  More information 
on the status of implementation efforts by individual countries and, in particular, on the areas where challenges were faced, would be useful in coming to a comprehensive and positive decision on the request.  In this regard, he noted that a num ber of LDC delegations, for example Uganda, had 
specifically mentioned the need for assistance.  This would allow his delegation to identify particular 
areas where these challenges were face d and where assistance was needed. 
269. The representative of the European Communities
 said that his delegation was in principle 
ready to look sympathetically at an extension of the transition period under Article 66.1 of the TRIPS Agreement for a certain period of time but , as it had received the request only one week 
before, it was still in the process of looking into  it.  He invited delegations to make positive 
contributions to future discussions on this matter, including the concerns raised by the United States 
and Japan. 
270. The representative of India
 felt that LDCs had a legitimat e concern with regard to the 
difficulties they would face if the obligations under the TRIPS Agreement were to fully kick in for them in 2006 and referred to the experience of othe r developing countries, including India.  It was 
clear from the statements by Argentina, Brazil and the United States that any conclusion that strong IP protection would lead to development or transfer of  technology would be premature at this juncture.  
In his view, this was supported by the presentation by a professor from a US university, at the WTO 
symposium on trade and environment on 11 Octobe r 2006, as his study had not indicated any 
evidence of IP protection leading to either transf er or absorption of technology or increased foreign 
direct investment.  He fully supported the joint request by the LDCs, which was a good basis for taking a decision. 
271. The representative of Venezuela
, supporting the statements by Argentina, Brazil and India 
and the request by LDCs, said that LDCs' ability to make IP an effective tool for their own development was often not sufficiently taken into account. 
272. The representative of Switzerland
 made only preliminary remarks, given that he had received 
the request only recently.  While being favour able and sympathetic towards requests under 
Article 66.1, he said it was important that the C ouncil ensure structured and coherent procedures 
under that Article.  The language and spirit of Artic le 66.1 suggested that an extension should be 
granted on the basis of information about the state of play in an individual LDC Member and should take into account the specific needs and situation of  that Member.  Such information, forming a duly 
motivated request, would serve as an important sour ce of information and orientation for the other 
Members and the WTO Secretariat in efforts to provide the LDC Member in question during its 
extended transitional period with technical assist ance and support which focused on its specific needs,  IP/C/M/49 
 Page 51 
 
 
so that desired progress by the end of that period could be achieved.  In this context, it should be 
borne in mind that a functioning IPR system was conducive to the development of a national economy 
and an important condition for providing incentives for technology transfer.  There was a need for 
more time and work on the necessary modalities and procedures under Article 66.1.  The Council should be in a position to properly evaluate requests made under it.  The Council should also take into 
account how similar requests were handled by othe r WTO bodies, including in the Council for Trade 
in Goods. 
273. The representative of Cuba
, supporting the LDCs' request, said that TRIPS minimum 
standards were designed for those economies that were presently developed,  and did not provide a 
means to spur development.  The LDCs' stat ement had underscored the various shortcomings. 
274. The representative of Norway  said that the protection of IP was an essential tool to ensure 
investment in research and development and re muneration to drivers of economic and cultural 
development.  However, her delegation recognized the particular difficulties for LDCs in 
implementing the TRIPS Agreement, and expressed he r general support for a request for an extended 
transition period.  She said that she would come back with more detailed comments later, as the 
request that had been received only a few days earlier was still being studied by her authorities. 
275. The Council took note  of the statements made and agreed  to keep this agenda item open so as 
to allow more time for the consultations on the matter. 
276. Reconvening the Council's meeting on 29 November 2005, the Chairman  informed the 
Council that he had held consulta tions with the LDC Group and tho se delegations that had expressed 
concerns about the request.  In the light of these consultations, he had circulated for the Council's 
consideration a draft decision on the extension of the transitional period under Article 66.1 for least-
developed country Members.  This draft had been  discussed at the Council's informal meeting on 
29 November.  In the light of these discussions, he  proposed that the Council adopt the "Draft 
Decision on the Extension of the Transition Period for Least-Developed Countries under the 
TRIPS Agreement" as contained in document JOB(05)/310. 
277. The representative of Zambia, speaking on behalf of the LDC Group5, thanked the Chair for 
his leadership in the course of the informal consu ltations that had led to the preparation of a draft 
decision and expressed her gratitude to the delegations  that had participated in the consultations for 
their positive and useful engagement.  In commenti ng on the draft decision, she said that the LDCs 
had exercised a great deal of flexibility.  While ha ving requested a 15 year transition period, the LDCs 
would have preferred to receive a period of at least ten years, as such a period would have allowed 
them to identify the priority needs mentioned in pa ragraph 2 of the draft decision, and also take full 
advantage of the technical assistance envisaged in its  paragraph 3.  Although it  was unfortunate that 
they had not attained what they had initially soug ht, the group considered seven and a half years 
worthwhile as a basis for the transition.  While  the LDC Group understood the reasoning behind the 
standstill clause in paragraph 5 of the draft decisi on, it was nonetheless concerned about the fact that 
this limited the scope of policy space that LDCs could exercise during the transition period.   
278. The representative of Zambia , reiterating her thanks to the Chair and appreciation of the 
positive engagement of other delegations, said th at her delegation formally supported the draft 
decision. 
279. The representative of Uganda , supporting the statement made by Zambia on behalf of the 
LDC Group, said that all the LDCs had shown a great  level of flexibility in this negotiation.  As 
Zambia had pointed out, although the LDC Group would have preferred to receive at least a ten-year 
                                                      
5 As requested by the delegation of Zambia, this pa ragraph reflects the statement it made on behalf of 
the LDC Group at the Council's informal meeting of 29 November. IP/C/M/49 
Page 52  
 
transition period with considerable policy space at the domestic level, it could accept the draft 
decision and was grateful for the constructive engagement of Members 
280. The representative of Rwanda
 associated herself with the statements made by Zambia on 
behalf of the LDC Group, Uganda, Rwanda and Senegal.  Commenti ng on paragraphs of the draft 
decision that her delegation was particularly concer ned about, she said that she did not see the need to 
link technical assistance under Article 67 to the extens ion of the transition period.  If, however, this 
link was to be made, she would have preferred to also mention Article 66.2 in this context.  Her 
delegation was also concerned about  paragraph 5 of the draft decisi on, which she believed reduced the 
policy space available for LDCs during the transi tion period.  However, her delegation could 
nonetheless accept the draft decision in its current form as a compromise.  
281. The representative of Senegal  associated himself with the statement made by Zambia on 
behalf of the LDC Group.  Although this draft d ecision was a compromise and the LDC Group would 
have preferred to achieve more, his delegation s upported the consensus r eached in the decision. 
282. The representative of Bangladesh associated himself with the statement made by Zambia on 
behalf of the LDC Group, Uganda, Rwanda and Senegal.  Commenting on the paragraphs of the draft 
decision that his delegation was particularly con cerned about, he said that Bangladesh would have 
preferred to have a ten-year transition period and to  avoid the linkage of the extension with technical 
assistance and a notification requirement, and it ha d serious difficulties in accepting the formulation 
of paragraph 5, particularly the inclusion of th e word "practice".  Howe ver, his delegation could 
accept the draft decision in the spirit of solidarity with the LDC Group.  
283. The representatives of Madagascar , Nepal , Lesotho , Haiti  and Cambodia  associated 
themselves with the statement made by the dele gation of Zambia on beha lf of the LDC Group and 
said that they were ready to adopt the dr aft decision.  The representative of Haiti  also supported the 
statements by Rwanda and Senegal,  and the representative of Cambodia  the statements made by other 
LDCs.  
284. The representative of India  noted that the LDC Group had shown a readiness to adopt the 
decision, while being flexible on some of their demands and some of the obligations contained in the 
draft decision.  His delegation deferred to the LDCs ' desire to adopt the decision as proposed.  As 
regarded the provision of technical cooperati on for LDCs by developed country Members and 
relevant international organizations  referred to in paragraphs 3 and 4 of the draft decision, India 
would be happy to offer, on request, its expe rience as a developing country on its process of 
implementing the obligations under the TRIPS Agre ement, which might be useful for LDCs.   
285. The Council took note  of the statements made and adopted  the draft decision as proposed.6 
K. SPECIAL AND DIFFERENTIAL TREATMENT PROPOSALS REFERRED TO THE COUNCIL  
286. The Chairman  recalled that, in its Decision on the D oha Work Programme of 1 August 2004, 
the General Council had recalled Ministers' decision in Doha to review all special and differential 
treatment provisions with a view to strengthening  them and making them more precise, effective and 
operational, and recognized the progress that had been made so far.  With regard to all those WTO 
bodies to which proposals in Category II had been re ferred, the General Council had instructed them 
to complete the consideration of these proposals expe ditiously and report to th e General Council, with 
clear recommendations for a decision, as soon as possi ble and no later than July 2005.  At its meeting 
in June 2005, the TRIPS Council had agreed to aut horize him to report to the General Council that the 
TRIPS Council reiterated its recommendation concerni ng the text that had been forwarded to the 
                                                      
6 The Decision on "Extension of the Transition Period for Least-Developed Countries" was 
subsequently circulated in document IP/C/40.  IP/C/M/49 
 Page 53 
 
 
General Council for appropriate action by the Ch air of the TRIPS Council in August 2003, and to 
provide a brief factual report on what had happened with regard to the other proposals.  The Chair's 
report had been circulated as document IP/C/36. 
287. The Chairman said that, as he had informed Members at the Council's informal meeting on 
20 October, he had recently received a letter, dated 13 October 2005, from Mr. Faizel Ismail, Chair of 
the Special Session of the Committee on Trade and Development.  In this letter, Mr. Ismail had 
indicated that the Category II proposals remained with  the respective bodies.  At the July meeting of 
the General Council, the Chair of that body had agr eed to the course of action that the Chair of the 
Special Session of the CTD had proposed, namely th at the Special Session would continue to monitor 
and coordinate its efforts with that of the Ne gotiating Groups and other WTO bodies to which these 
proposals had been referred by the General Council. 
288. The Chairman further informed the Council that  Mr. Ismail had met on 24 October with the 
Chairs of the various bodies to which Category II pro posals had been referred.  As he had indicated at 
the Council's informal meeting of 20 October, he had informed Mr. Ismail that in regard to the TRIPS 
Category II S&D proposals the situation remained as set  out in the report to the General Council at its 
meeting of 29 July. 
289. He proposed that the Council authorize him to re port to the General Council, if requested to 
do so, that the situation remained as described in the TRIPS Council's report of July 2005. 
290. The Council so agreed . 
L. REVIEW OF IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 
291. No statements were made  under this agenda item. 
292. The Council agreed  to revert to the matter at its next meeting. 
M. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL 
INDICATIONS UNDER ARTICLE 24.2 
293. The Chairman  recalled that Article 24.2 provided th at the Council should keep under review 
the application of the provisions of the GI Section of the Agreement, and that the first such review 
should take place within two years of the entry into force of the WTO Agreement. 
294. The representative of th e European Communities  reiterated that his delegation attached great 
importance to this review.  He believed that a mo re focused and structured way should be found to 
continue to work on it.  In prev ious discussions, several ideas had b een floated on how to carry this 
work forward, including his delegation's suggestion for an option paper.  He was open to examining 
any proposal on how to structure future work.  Firs t, one should concentrate on the relevant mandate, 
which was to examine the application of TRIPS provisions on GIs and not on implementing 
legislation.  A substantial exercise had already been  carried out with regard to national implementing 
legislation, which should not be replicated under this  item.  Secondly, one should take advantage to 
the maximum extent possible of the work done so far,  in particular of the replies to the checklist of 
questions and the Secretariat's summary paper (IP/C/W/253/Rev.1).  The summary paper already 
contained many of the elements mentioned by delegations, such as how Members applied their 
obligations and a list of practical examples of GI pr otection.  It was a valuable instrument in moving 
the work forward. 
295. It was essential to set up an agenda for future  work, which could, for example, be based on 
the different sections of the summary paper:  ov erview of the means of protection available, 
definition, criteria for recognition, etc.  Such an approach would allow Members to comment on the IP/C/M/49 
Page 54  
 
summary paper, and also provide any necessary updates.   It would be helpful to draw general lessons 
from Members' replies to the checklist in a structured  manner, making sure that the approach was of a 
general nature and not focused on the way Members had implemented their obligations on GIs.  He 
requested the Chair to provide an agenda for futu re work or otherwise indicate how he would intend 
to pursue this matter in the future. 
296. The representative of the United States
 said that, during earlier discussions under this item, 
his delegation had indicated that it was willing to wo rk on the item.  It had supported a proposal made 
by Australia some time ago that the Council "walk through" the various provisions on GIs, paragraph by paragraph.  He shared the EC view that the Secretariat's effort in compiling Members' responses to the checklist had been very important.  However, it would be premature to structure the discussions 
around the headings of that document.  However,  his delegation was open to and interested in 
attending any consultations that the Chair might hold on this matter pursuant to the EC's request. 
297. The Council took note
 of the statements made and agreed  to revert to this matter at its next 
meeting. 
N. THIRD ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION 
OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
298. 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 reports a nnually 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.  The Council had taken up its fi rst annual review of deve loped country Members' 
reports on their implementation of Article 66.2 at it s meeting in November 2003.  At its meeting in 
June 2005, the Council had agreed to request deve loped country Members to submit a second set of 
updates to these reports on actions they had taken or planned in pursuance of their commitments for 
the present meeting.  The Secretariat had issu ed, on 18 July airgram WTO/AIR/2329 to remind 
developed country Members of this request.   
299. The Council had received updated informa tion from the following developed country 
Members:  Japan;  Switzerland;  Canada;  Ne w Zealand;  the European Communities and certain 
member States (the Czech Republic, Denmark, Fi nland, France, Germany, the Slovak Republic, 
Spain, Sweden and the United Kingdom);  Norway ;  and the United States (being circulated in 
document IP/C/W/452 and addenda).   
300. As regarded the purpose and conduct of the revi ew of this information, he recalled that 
paragraph 2 of the Decision explained that the a nnual review meetings should provide Members with 
an opportunity to pose questions in relation to the information submitted and request additional 
information;  discuss the effectiveness of the incentives provided in promoting and encouraging 
technology transfer to least-devel oped 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. 
301. The representative of Rwanda  said that his delegation was very pleased to have received this 
information pertaining to the various measures under way to encourage companies to transfer 
technology to LDCs.  His delegation had not yet been able to carry out an in-depth analysis so as to 
assess the way in which results had been generated by these measures.  The level of technological 
development in LDCs was still in a fledgling stage.   He called upon developed countries to implement 
more measures for the purpose of truly enabling their enterprises to engage in an effective 
technological transfer.  It was important to see what  could be done to make su re that those measures  IP/C/M/49 
 Page 55 
 
 
were not only adopted but actually implemented.  One way forward would be to set up a committee of 
experts comprised of members from developed and least-developed countries.  It would also be beneficial to have input from specialists involve d in such undertakings.  Such a committee would be 
better able to formulate recommendations to smooth th e way for such technology transfer and to make 
sure that that transfer would be effective.  He called upon developed count ries to re-examine the 
various measures that they had adopted so as to  further strengthen them and make them truly 
effective, in order that technological deve lopment would become a reality in LDCs.  
302. The representative of Zambia
 expressed her delegation's appreciation to the Members that had 
undertaken to implement the provisions of Article 66. 2.  Her delegation might wish to make specific 
comments once it had had time to study the reports. 
303. The Chairman  urged those developed country Members that had not yet provided reports to 
do so, and said that it was his intention to provide  delegations an opportunity, at the Council's next 
meeting, to make further comments on the inform ation submitted for the present meeting that they 
might not yet have been able to study. 
304. The Council took note  of the statements made. 
O. TECHNICAL COOPERATION AND CAPACITY -BUILDING  
305. The Chairman  recalled that the Council had agreed, at its meeting in June 2005, to hold its 
annual review of technical cooperation at the present meeting.  In preparation for this annual review, 
developed country Members had once more been requ ested to update information on their technical 
and financial cooperation activities relevant to the implementation of the TRIPS Agreement in time 
for this meeting.  Other Members who had al so made technical cooperation available were 
encouraged to share information on these activities if they so wished.  The Secretariat had issued an 
airgram on 18 July (WTO/AIR/2628) reminding Me mbers of this request.  In addition, 
intergovernmental organization observers to the Council as well as the WTO Secretariat, had also 
been invited to provide information.   
306. The Council had received information from th e following developed country Members:  
Switzerland;  Australia;  Japan;  Canada;  New Zealand;  Norway;  and the European Communities 
and certain member States (Austria, the Czech Republic, Denmark, Finland, France, Germany, 
Portugal, Spain, Sweden and the United Kingdom) (being circulated in document IP/C/W/455 and addenda).  Updated informa tion had been obtained from the following intergovernmental 
organizations:  the OECD, WHO, UPOV, and WIPO  (document IP/C/W/456 and addenda).  As 
regards the information received from WIPO, the doc ument that had been circulated to Members 
contained only the three-page cover note to the communication.  Further detailed information was 
contained in the annexes to this cover note, that  amounted to some 550 pages.  He said that these 
annexes were available for consultation at the WT O Secretariat, and could also be accessed through 
the WIPO website at the address indicated in the do cument.  He said that he understood that most 
delegations had already received this information as part of the documentation of the September 
WIPO Assemblies.  Updated information on the WT O Secretariat's technical cooperation activities in 
the TRIPS area could be found in document IP/C/W/454. 
307. The representative of India
 thanked the developed count ries and inter-governmental 
organizations who had made available technical assi stance to developing countries, in particular the 
ones that had assisted India and the Asian and P acific Region through their joint programmes.  He 
also specifically thanked Japan for certain events re ferred to in its report (IP/C/W/455/Add.2).  Noting 
that the submissions were meant to provide de tails of technical assistance and capacity building 
efforts, he drew attention to document IP/C/W/455/ Add.1 submitted by Australia.  In paragraph 9 of 
that document, Australia had listed as technical assi stance an activity that one of its officials had 
conducted through meetings in New Delhi that had concerned the protection of GIs.  In his view, IP/C/M/49 
Page 56  
 
those meetings had been meant as an advocacy of  the Australian position on GIs, and not technical 
assistance.   
308. The representative of Australia
 said that his delegation had put forward a document that set 
out in quite extensive detail the technical coopera tion activities that Australia had conducted in a 
range of areas.  It showed that Australia wa s committed to assisting developing countries across a 
range of areas to better understand forms of IP prot ection, costs and benefits.  In that context it had 
also held some discussions with India and others about Australia's own experiences and explaining the 
approach Australia had taken to GIs and other forms of protection, such as trademark protection.  He 
did not believe that Australia was the only Member that had undertaken this type of activity and said 
that attempts to discuss its positions should not be mischaracterized. 
309. The representative of Rwanda  urged developed countries to provide technical assistance and 
capacity building for LDCs also in the field of re search and development.  While IP had a positive 
effect on research and developmen t in developed and some developi ng countries, this component was 
lacking in LDCs.  Assistance in this area would not only help LDCs to comply with the TRIPS Agreement, but also help them to devel op a viable technological base so that they could 
benefit from IP. 
310. The representative of the European Communities
 asked the delegation of Australia whether 
the activity that had taken place in India was similar to those that had taken place in China (paragraph 
7), Indonesia (paragraph 11), Pakistan (paragraph 18 ), the Philippines (paragraph 19) and Viet Nam 
(paragraph 22).  The representative of Australia  said his earlier statement and the report clearly 
explained the nature of the assistance that Austra lia had been provided in a number of countries.  
Australia tried to speak to as many developing co untries to increase know ledge and understanding of 
IP protection and the costs and benefits.  The EC  document indicated that the EC Commission and 
some member States had undertaken  activities that seemed similar. 
311. The representative of India  said that his understanding was that the activity in question was a 
short bilateral meeting to discuss Australia's position on GIs.  The representative of Australia  
wondered whether there was a misunderstanding con cerning two meetings held in New Delhi, a 
bilateral meeting referred to by the delegation of India, and a wo rkshop on IP matters.  The Chairman  
said that, in the event of different views about activ ities, it might be better to agree on their nature on 
a bilateral front.  
312. The representative of Brazil  said that the document provided by WIPO (IP/C/W/456/Add.3) 
appeared to set the information on technical coopera tion within the context of a development agenda 
of WIPO, which was a proposal by Brazil, Arge ntina, and 12 other developing countries and 
supported by an even greater number of developi ng countries in WIPO.  The development agenda was 
an all-encompassing, very broad type of platform proposal to mainstream development concerns into 
all different WIPO activities, including norm setting,  transfer of technology, technical cooperation and 
issues related to governance of WIPO and its mandate  as a UN agency.  In his view, the WIPO paper 
seemed to give the impression that the issue of a development agenda for WIPO could be narrowed 
down into a few technical cooperation activities.   These technical cooperation activities did not 
translate into the concept of the proposed deve lopment agenda.  In its submission, the WIPO 
Secretariat seemed to have attempted to indicat e that it was sensitive to development issues in 
response to certain criticisms that had been made in  the context of the development agenda regarding 
the way in which WIPO promoted IP treaties and th e enforcement of those treaties in the developing 
world through its technical cooperation programme.  As  an example, he referred to paragraph 4 of the 
document, where WIPO had mentioned that the second priority area was to provide legal and general 
advice on using the flexibilities in the TRIPS Agreem ent and WIPO treaties in developing countries.  
To that date, his delegation had not seen any exampl es of this.  Such a statement should be further 
elaborated with concrete facts.  He said that, in the area of technical coope ration, WIPO had basically 
seen its role as an agency for enfo rcement of obligations contained in  IP treaties in the developing  IP/C/M/49 
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world, instead of giving a more balanced view of  the system and promoting in developing countries 
both the obligations and the rights of these countries under those treaties.  By "the rights" he meant 
the rights to use also the flexibilities contained in al l of those treaties which were part of the balance 
of the IP system.   
313. The representative of WIPO  said that the document had been prepared by WIPO to elaborate 
the development cooperation activities of WIPO.  It had not been prepared only in response to the 
ongoing discussion on the development agenda proposal  by various developing countries.  While the 
document attempted to be detailed and comprehens ive in its description of technical cooperation 
activities, it did not go into detail on specific areas such as flexibilities in IP which were included in 
WIPO's legislative assistance to developing countries.   In her view, Brazil's characterization of WIPO 
as an enforcement agency was unfounded.  Howeve r, expression of such concerns were to be 
welcomed and should be brought to the WIPO  Assemblies and various committees in WIPO. 
314. The representative of Brazil  said that his concern about the mischaracterization of the 
development agenda had to do with the fact that  the WIPO submission began by mentioning the Inter-
sessional Intergovernmental Meeting (IIM) of June 2005, and everything that followed seemed to be 
related to that meeting rather than WIPO's tec hnical cooperation activities which had not been dealt 
with in that meeting.  Technical cooperation activ ities in WIPO were dealt under a different body, 
namely the Permanent Committee on Cooperation for Development Related to Intellectual Property 
(PCIPD) which had been specifically created for that purpose.  The statement about advice on 
flexibilities needed to be backed by supporting info rmation, documentation and evidence, which to his 
knowledge did not exist.  The lengthy document, perhaps more than 500 pages long, had been 
prepared for the IIM June meeting, and contained a list of computer entries on activities throughout 
the world on a country by country basis with mini mal information on the nature of each activity.  
Some of them concerned WIPO experts travelling to different developing countries for the purposes 
of seminars, forums or meetings;  others concerned financial assistance for the purchase of computers for national patent offices and activities of that sort .  This did not amount to assisting countries to use 
flexibilities contained in the IP system. 
315. The representative of Argentina
 supported the statement by Brazil, which had summed up the 
development agenda that had been tabled by 14 countries with ample backing of developing country 
members of WIPO.  She was surprised that the repre sentative of WIPO had felt that the statement was 
unfounded.  The lengthy WIPO document summari zing the activities of 2002 had been submitted 
inappropriately in the wrong forum in respect of t echnical cooperation.  It was still being examined by 
her authorities.  She said that, in the field of t echnical cooperation, extende d in-depth consultations 
with each of the developing countries were necessary in order to ensure that the technical cooperation 
offered would meet the individual requirements for industrial and technological development.  A 
"one-size-fits-all" approach for developed and de veloping countries which did not take into account 
differences in the level of industrial and technological  development would not yield real results.  She 
said that Argentina would scrutinize this matter cl osely, both in the TRIPS Council and in WIPO. 
316. The Council took note  of the statements made. 
P. ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS – COMMUNICATION FROM THE 
EUROPEAN COMMUNITIES  
317. The Chairman  recalled that, at its meeting in June, the Council had discussed a 
communication from the European Communities on "E nforcement of Intellectual Property Rights" 
(IP/C/W/448).  A number of delegations had said th at their comments were only preliminary and that 
they intended to make further comments after an alyzing the paper, and the European Communities 
had indicated that it intended to reply to some of the comments made on subsequent occasions and 
that it might make further suggestions relating to the matter. IP/C/M/49 
Page 58  
 
318. The representative of the European Communities
 said that its communication underlined the 
worrying evolution of counterfeiting and piracy wo rldwide.  Elaborating on the proposals contained 
therein, he said that the increase in value, volum e and scope of IPR infringements indicated that the 
level of execution and the results of the implemen tation of the TRIPS enforcement rules had to be 
questioned and could possibly be improved.  Lack of enforcement of IPRs was being debated in 
forums such as the G8, Interpol, the OECD, the WCO and WIPO.  It would be hard to understand or 
justify why the TRIPS Council would not provide it s contribution to improving the situation.  The 
European Communities reaffirmed its conviction that the Council, which was responsible for 
monitoring the compliance of 148 countries with the most comprehensive multilateral set of rules in 
the field, should be in a position to assess how these rules were being implemented by competent 
national authorities.  For this purpose and without prejudice to Members' rights and obligations under 
the TRIPS Agreement, the Council should foster a dialogue among Members with a view to identifying solutions to such implementation deficiencies. 
319. Members had, in the past, already provided a valu able contribution to that debate in the form 
of their replies to the Checklist of Issues on Enfo rcement (IP/C/5), an exercise launched by a Decision 
of the Council of 21 November 1995.  In his delegation's view, a summary of these contributions 
could constitute a useful element for future di scussions.  Therefore, it requested that the WTO 
Secretariat provide a synopsis of Members' c ontributions pursuant to the Checklist of Issues. 
320. The objective of the EC communication was to understand where the main problems, 
difficulties and shortcomings were by a detailed examination of the implementation of TRIPS 
provisions on enforcement.  To achieve this obj ective, he proposed that the discussion should be 
structured and focused in the following manner:  specific enforcement mechan isms described in the 
different sections of Part III of the Agreement s hould be discussed separately in detail in subsequent 
meetings of the Council, and the discussion should be pursued along the following steps:  first, 
identification of difficulties to implement the rele vant TRIPS provisions from a legal, technical, 
logistical point of view and other aspects;  second,  examination of appropriate mechanisms to address 
the identified difficulties (technical cooperation, c ooperation from right holde rs, human and financial 
resources, administrative obstacles or other);  and third, search of a coordinated response at the TRIPS level through various tools, for example the promotio n of best practices.  He suggested that the first 
theme to be discussed should be "border measures", i. e. the application of Articles 51- 60 and 69 of 
the Agreement, given the relevance and effectiv eness of such measures in the fight against the 
transnational circulation of goods infringing IPRs.  Customs' prime role in stopping the international 
movement of fake goods was shown by the fact that  they were responsible for approximately 70% of 
all seizures of counterfeits made globally.  His dele gation intended to submit a paper shortly with the 
proposals he had just outlined. 
321. The representative of Japan
, welcoming the EC proposal, said that with the development of 
high technology and mass distribution, counterfeiting was now causing damage worldwide.  In Japan, 
the number of counterfeit goods suspended by the customs authorities was on an upsurge.  
Particularly in recent years, illegal profits from th e sale of counterfeit and pirated goods were said to 
be flowing to criminal organizations and terrori st groups.  Products of inferior quality were 
threatening the health and security of consumers.  Considering these facts, all Members should make 
concerted efforts to stop counterfeiting.  In its future discussions, the Council should pay due attention 
to the issues discussed in other forums such as WIPO, APEC and the OECD.  The Council should 
identify the specific items to be discussed;  paragr aph 26 of the document contained suggestions to be 
considered in this regard. 
322. The representative of Brazil  agreed with the European Communities that piracy and 
counterfeiting constituted serious problems that a ll WTO Members and the international community 
should effectively address.  However, he disagreed with the focus and the ove rall conceptual approach 
of the EC document, as well as with the activities that it proposed that the TRIPS Council should 
undertake.  He said that Brazil took its rights and obligations under the TRIPS Agreement very  IP/C/M/49 
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seriously and, like other developing countries, had spent the better part of the last decade enacting 
numerous measures and legislation to comply wi th the terms of this complex and burdensome 
Agreement.  Implementation of TRIPS provisions was still an ongoing process for many, if not most, 
developing countries, as many of the transition pe riods foreseen in the Agreement had only recently 
expired, or, in the case of LDCs, were at that time s till being enjoyed.  In view of this, the statement in 
document IP/C/W/448 that "the level of execution a nd the results of the implementation of the IPR 
enforcement measures prescribed by the TRIPS Agre ement can be questioned and must be improved" 
was unbalanced and unfair.  He agreed with a point ma de by India at the June meeting that it would be 
premature for the Council to engage in discussions on effective enforcement when the implementation 
of the Agreement had yet to be completed in many countries. 
323. In his view, the EC proposal to use the Counc il to examine Members' TRIPS implementation 
and to make recommendations on improving that im plementation through, for example, the laying 
down of benchmarks, including su ggestions of best practices, clearly went beyond the Council's 
practice at that time.  In  fact, the EC proposal would have the Council play a de facto  norm-setting 
role that, contrary to what the EC document s uggested, was neither required by nor foreseen in 
Article 68 of the Agreement.  Furthermore, the in-depth examination and de facto  norm setting role 
proposed by the European Communities would add a new level of intrusiveness to the Council's 
monitoring activities vis-à-vis  Members' implementation efforts.  This did not seem consistent with 
Article 1.1 of the Agreement, which afforded Me mbers the flexibility to determine how best to 
implement their TRIPS obligations within their own legal system and practice.   
324. He said that the WIPO Advisory Committee on Enforcement already provided a forum for 
exchange of information and coordination on en forcement matters.  He saw no reason why the 
Council should duplicate its work.  Moreover, he said that it should be noted that when deciding to 
establish the Advisory Committee on Enforcement in the year 2002, WIPO member states had 
deliberately chosen to exclude norm-setting, including the elaboration of best practices, from the Committee's mandate.  At that time, numerous devel oping countries had rejected the idea that the new 
WIPO enforcement body should play an intrusive a nd TRIPS plus norm-setting role, exactly what the 
European Communities would now like to see the Council do.  He hoped that the 
European Communities would not expect developing c ountries to be inconsistent in their positions by 
agreeing in the Council to something they had already rejected in WIPO. 
325. In concluding, he said that he believed that the EC proposal, including as further elaborated 
by the European Communities at the present meeting, not only went beyond the Council's practices 
and mandate, but was also fundamental ly misguided and premature.  He  therefore asked that this item 
be removed from the agenda of a ll future Council meetings, as he did not believe that it would be 
useful to continue deliberations on the basis of th e EC document.  Noting that the Dispute Settlement 
Body was in charge of addressing perceived or alleged cases of Members' non-compliance with their obligations under all Agreements administered by the WTO, he said that his delegation was concerned 
about the enforcement by Members of their obligations under several WTO bodies, including under 
decisions already adopted by the DSB, in  particular in the area of agriculture. 
326. The representative of Argentina
 said that the inclusion of this item on the Council's agenda 
was unfounded, because Article 68 of the Agreement provided that the Council would monitor the 
operation of the Agreement, in particular Members' compliance with their obligations thereunder.  In 
a general way, this monitoring role saw to it that  the Agreement was complied with.  The Agreement 
contained various provisions such as Articles 24.2, 27.3(b), 66.1 and 63.2, which were monitored by 
the Council.  Agenda item B provided an opportuni ty for Members to deal with questions of 
application and enforcement of the Agreement.  Th e Council's regular agenda already covered various 
elements that had been mentioned.  Furthermore, she referred to Article 7, which provided that the 
protection of IPRs should contribute to the transfer of technology, to the mutual advantage of users 
and producers, and noted that the document only hinged on one element.  As to the EC proposal that 
the Secretariat sum up the replies to the Checklist on Enforcement, she said that this was not the right IP/C/M/49 
Page 60  
 
time to deal with this matter.  This item shoul d not remain on the Council's agenda.  It did not 
represent the interests of the majority of Members.  She also noted that the topic of the document had 
already been dealt with within  the framework of WIPO.   
327. The representative of Canada
, referring to her delegation's stat ement at the June meeting, said 
that she was open to examining the role of the Counc il on this important issue, particularly looking for 
ways that could add value to work done in other bodies.  Her delegation would carefully examine the 
specific EC proposals, once available, and it was willing to discuss the item at future meetings.  
328. The representative of the United States  expressed support as a general matter for the EC 
proposal to discuss enforcement issu es in the Council.  He believed that it was an appropriate and 
legitimate exercise to continue discussions on enfo rcement in the Council.  Furthermore, such a 
discussion could be very helpful.  Given that the European Communities had made its detailed 
proposals on how one might structure the discussion at the present meeting, his delegation needed more time to consider the proposals, also bearing in mind the current tasks relating to the forthcoming 
Hong Kong Ministerial Conference. 
329. The representative of India
 associated himself with the statemen t made by Brazil.  In the light 
of the circumstances of the impending Ministeria l meeting, he also supported the recommendation 
made by Brazil and Argentina to dele te this item from the Council's agenda. 
330. The representative of Egypt  said that, for the time being, taking up a new issue would place 
too great a burden on developing countries and go beyond their capabilities, given that many 
resources were already consumed by those items on the Council's agenda that had not yet been 
finalized.  As a developing country, Egypt was c oncerned that adding new measures could complicate 
enforcement procedures.  Already, almost one thir d of the Agreement (Articles 41 to 61) dealt with 
enforcement. 
331. The representative of China  agreed that IP protection, especially the fight against piracy and 
counterfeiting, was a worldwide issue.  However, it supported the position of Brazil, Argentina and 
India that the EC proposal went beyond the competence of the Council.  Given that the Hong Kong 
Ministerial Conference was approaching, the Council should concentrate on issues such as an 
amendment to the Agreement pursuant to the pub lic health decision, protection of traditional 
knowledge and the discussion on the relationship be tween TRIPS and CBD.  There was no need for 
further activities in the Council relating to implemen tation of the Agreement.  The WIPO Advisory 
Committee on Enforcement, which had a mandate for th e exchange of informat ion, awareness-raising 
and the coordination of technical assistance progr ammes, should be well equipped to discuss and 
address the issue of enforcement.  He said that Ch ina agreed with Brazil that this item should not be 
included in the Council's future agendas.   
332. The representative of Switzerland  joined those delegations that had raised concerns about the 
rising tide of counterfeit and pirated products in inte rnational trade.  This was a very important issue 
to be addressed by the Council.  While he shared the US view that the next few weeks leading up to 
the Hong Kong Ministerial Conference might not be the right time, he wished to revert to the matter at 
the Council's next formal meeting.  At that mee ting, his delegation intended to comment on the EC 
proposal in more detail. 
333. The representative of the Philippines  thanked the European Communities for providing some 
specificity to their ideas as original ly outlined in document IP/C/W/448.  Like Brazil, he believed that 
Members had made good faith efforts to comply w ith TRIPS provisions to ensure that effective 
measures were available to permit effective action ag ainst infringement of IPRs.  He referred to the 
concerns and points that his delegation had raised at the Council's June meeting, some of which had 
not yet been fully clarified by the European Communities.  IP/C/M/49 
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334. The representative of Chile  said he was not convinced that the issue belonged to the Council 
rather than to WIPO's Advisory Committee on Enfo rcement.  He did not share the EC interpretation 
of Article 68.  Given the ongoing work in WIPO, the OECD and other forums, at present there was no 
need to take up the issue in the Council. 
335. The representative of Korea  said that his delegation was supportive of strengthening 
enforcement activities.  It firmly believed that  strong IP protection w ould help in industrial 
development and foreign direct investment.  In that regard, the Korean Government had made 
strenuous efforts to improve its IP protection by revising laws and re gulations, strengthening 
enforcement, and organizing public awareness ca mpaigns.  His delegation intended to comment on 
the EC proposals made at the meeting once they were available as an official document. 
336. The representative of the European Communities  said that this was an appropriate matter for 
discussion in the Council, bearing in mind that Part II I of the Agreement was de voted to enforcement.  
Article 68 was fully applicable to this area.  He noted that there had been many other items on the 
Council's agenda that some delegations did not li ke to discuss.  Discussions would provide an 
opportunity to reconcile the concerns that had been expressed with the need to improve enforcement.  
The fact that discussions also took place in other forums was not unique to enforcement.  The EC 
proposal was not to discuss enforcement in general, but the application of the enforcement provisions 
of the Agreement.  The purpose was neither to provide for a mandate for the Council for new norm-
setting activities, nor to make it a tribunal assessi ng Members' implementation of the enforcement 
provisions.  He did not want the discussion to be about increasing Members' obligations.  Rather, the 
discussion was to help countries improve their enfo rcement activities while reconciling them with the 
concerns that had been expressed. 
337. The Council took note  of the statements made and agreed  to revert to the matter at its next 
meeting. 
Q. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 
338. The Chairman  suggested that, given time constraints a nd the fact that there were no relevant 
new developments to report, the Council not take up this item. 
R. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
339. The Chairman  said that the list of the 17 pending requests for observer status in the 
TRIPS Council by other intergovernmental organizations was contained in document 
IP/C/W/52/Rev.11.  He recalled that the Council had discussed these pending requests at its previous meetings, but had not been able to reach consensus on any of them.  He informed the Council that he 
had received a letter, dated 19 October 2005, from Mr. Yash Tandon, Executive Director of the South 
Centre, formally reiterating the South Centre's request of November 1998 for observer status, and 
asking that the request be officially tabled fo r consideration at the present Council meeting.   
340. The representative of Rwanda
 said that his delegation fully supported the request made by the 
South Centre. 
341. The representative of Brazil  said that his delegation fully supported the request made by the 
South Centre as well as that presented by the CBD. 
342. The representative of the United States  said that his delegation had some concerns on granting 
observer status to some of the organizations in qu estion, for reasons including, but not limited to, the 
fact that guidelines had not yet been established by the General Council. IP/C/M/49 
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343. The representative of Egypt
 said that her delegation wished to reserve its right to come back 
to the item and give a written opinion on it. 
344. The Council agreed  to revert to the matter at its next meeting. 
S. ANNUAL REPORT TO THE GENERAL COUNCIL  
345. The Chairman  said that the draft Annual Report of the Council had been circulated in 
document JOB(05)/256.  It still needed to be update d so as to reflect the discussions at the present 
meeting. 
346. The representative of Argentina  said that, at its June meeting, the Council had agreed to 
discuss an EC communication on "Enforcement of Intellectual Property Rights".  In the light of the discussions which had taken place and the reservatio ns expressed by a number of countries regarding 
the inclusion of this item on the agenda, it was her view that section XV of the draft did not correctly 
reflect the state of play in the debate, especially when it referred to a "new" communication as if there 
had been earlier ones.  Therefore, she asked that this paragraph be reviewed, perhaps also mentioning 
that Members had discussed the EC communication with  a view to considering whether to include an 
item on the agenda pertaining to enforcement of IPRs. 
347. The Chairman
 suggested that section XV be amended by deleting the word "new".  
348. The representative of th e European Communities  said that he would leave it to the Chair to 
state whatever he felt was most accurate. 
349. The representative of India  suggested that title of section XV be  reworded to reflect the actual 
discussion, which was discussion on a proposal by  the European Communities on enforcement of 
IPRs.   
350. The representative of Brazil  supported the proposal by India regarding the title of section XV.  
He also supported Argentina's point that the item in  question was not deemed by many countries to be 
an accepted item of the Council's agenda and that th ere was quite a considerable dissent with regard to 
the fact that this issue was the object of discussion in the Council.  Many dele gations did not consider 
that it fell within the Council's mandate.  
351. The Chairman  proposed that the Secretariat be reque sted to revise and update the draft report 
to reflect the discussions at the present meeting, and that the revised draft report be faxed to Members, 
who would have one week to comment on the revised and updated parts.  As to the three items that 
were left open, he suggested that  the Secretariat be requested to prepare an addendum to the report 
that would contain additional information on the Co uncil's work, were the session to be reconvened.  
This addendum would be approved through a written procedure. 
352. The Council so agreed .7 
353. At the reconvened meeting on 29 November, the Chairman  recalled that the Council had 
requested the Secretariat to prepare an addendum to the Council's Annual Report that would contain 
additional information on the Council's work at the reconvened meeting.  He proposed that the 
addendum be approved through a written procedure, that the Secretariat circulate a draft by the end of 
the morning and that delegations would be asked to  make any comments by 6 p.m. of that day. 
354. The Council so agreed .8 
                                                      
7 The Annual Report (2005) of the Council for TRIPS was subsequently circulated in document 
IP/C/38.  IP/C/M/49 
 Page 63 
 
 
T. OTHER BUSINESS  
Requests for information pursuant to Article 63.3 of the TRIPS Agreement 
355. The Chairman  said that the Council had just received communications from the United States, 
Switzerland and Japan that contained requests addr essed to China to provid e certain information 
pertaining to the subject-matter of the TRIPS Agr eement pursuant to its Ar ticle 63.2 (subsequently 
circulated as documents IP/C/W/461-463, respectively).  
356. The representative of China  said that his delegation had taken note of the letters from the 
United States, Switzerland and Japan regarding the cl arification of IP enforcement cases for the years 
2001-2004 based on Article 63.3 of the TRIPS Agreemen t.  His capital was studying these letters and 
the interpretation of paragraph 3 and the other paragraphs of that Artic le to define the nature and the 
scope of Members' rights and obligations under it.  Since his delegation had just received the 
documents, it was not in a position to give compre hensive responses.  While taking an active and open 
attitude towards enhancing its c ooperation with all Members and in ternational organizations, China 
was not taking on additional obligations that went  beyond the international conventions to which it 
had acceded.  As a Member fulfilling its WTO obligati ons in a responsible way, China believed that 
Members should refrain from making such proposals based on unilateral interpretations of rights 
granted by multilateral legal instruments, even with claimed cooperative or best intentions. 
357. The representative of the United States  said that his delegation had made a request to the 
delegation of China pursuant to Article 63.3 of th e Agreement for six clarifications regarding cases 
that China had previously identified as reflecting its enforcement of IPRs.  He hoped that this request 
would enhance understanding of IP enforcement in China by clarifying and building upon information 
that had been provided in the April 2005 White Pape r, which China had circulated informally to the 
present session of the TRIPS Council and also upon info rmation it had provided in other contexts.  He 
looked forward to working cooperatively with his colleagues from China on the request and to receiving its full response. 
358. The representative of Japan
 said that his delegation had provided to China a letter in 
conformity with Article 63.3 of the Agreemen t requesting detailed info rmation regarding IP 
enforcement in China.  He looked forward to receiving China's reply. 
359. The representative of Switzerland  said that, in accordance with Article 63.3 of the Agreement, 
his delegation had submitted a request to China fo r further information and clarification on certain 
legal and institutional enforcement asp ects with regard to judicial d ecisions and administrative rulings 
reported by China to the Council.  Commending Chin a for its efforts and progress in putting in place 
national legislation consistent w ith the Agreement, he encouraged  China to focus on implementation 
and enforcement of that legislation at all levels, whether criminal, civil or administrative, since infringement of IPRs was still widespread and c ould only be countered through effective and 
sustainable enforcement action.  His delegation ha d submitted the request in order to better understand 
how in the reported cases, the enforcement procedures had been applied in practice for the benefit of 
IP right holders.  Such information would help th e Swiss Government to reassure Swiss companies 
present and active on the Chinese market to invest further in innovative research and development 
oriented industries in China.  His delegation look ed forward to working together with China on the 
matter in a cooperative spirit and would try to be  of assistance wherever China should think it 
desirable. 
360. The Council took note
 of the statements made. 
                                                                                                                                                                     
8 The Addendum was subsequently circulated in document IP/C/38/Add.1. IP/C/M/49 
Page 64  
 
Dates of the Council's meetings in 2005 
361. The Chairman
 suggested that the Council agree on the following dates for the Council's 
meetings in 2006:  14-15 March;  14-15 June;  and 24-25 October. 
362. The representative of Brazil  requested the Chair and the Secretariat to avoid overlap with 
major meetings at WIPO, as many delega tes covered both meetings.  The Chair  informed the Council 
that the dates had already been coordinated with WIPO. 
363. The Council agreed  on the dates for the Council's meetings in 2006 as suggested by the Chair. 
__________