TWN Info Service on WTO and Trade Issues (Nov07/07)
2 November 2007
Published in SUNS #6352 dated 26 October 2007
The WTO’s TRIPS Council held a meeting on 23-24 Oct 2007. Below is a report of that meeting.
The following article is reproduced here with the permission of the South North Development Monitor (SUNS). Any reproduction or re-circulation requires permission of the SUNS (firstname.lastname@example.org).
The least developed countries have joined a proposal co-sponsored by many developing countries that calls for the TRIPS Agreement to be amended so that patent applicants have to disclose the origin of genetic resources and/or associated traditional knowledge used in their inventions.
Lesotho, speaking on behalf of the least developed countries, made this announcement Wednesday at a formal meeting (23-24 October) of the TRIPS Council.
Earlier Tuesday, the first day of the two-day meeting, the TRIPS Council agreed to extend the deadline by two years for countries to accept an amendment to provisions on pharmaceutical patents that would make it easier for poorer countries to obtain cheaper generic versions of patented medicines (see below).
The two-day meeting also discussed issues relating to China's transitional review mechanism, enforcement, and technology transfer and technical cooperation.
According to trade officials, on the issue of enforcement, several developing countries voiced concerns about discussing this issue and insisted that this not be a regular agenda item.
On the TRIPS/Convention on Biological Diversity issue, the least developed countries have now joined the African Group (represented by Uganda) as well as individual countries that include Brazil, China, Colombia, Cuba, India, Pakistan, Peru, Thailand, Tanzania, South Africa, Ecuador, Venezuela and Paraguay as co-sponsors of the proposal outlined in document IP/C/W/474.
The issue of disclosure of origin of genetic resources is being discussed outside the TRIPS Council by some of the major players that include India, Brazil and the European Union as part of the Doha negotiations. According to diplomatic sources, the developing countries are insisting that a satisfactory solution to this issue has to be part of a Doha deal.
The proposal co-sponsored by the developing countries said that the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) is an outstanding implementation issue.
In addition to the intensive technical work in the TRIPS Council, the Director-General has undertaken dedicated consultations through his Friends, including more recently through Mr. Rufus Yerxa, Deputy Director-General, it added.
The proposal noted that there have been extensive discussions in these processes on the introduction into the TRIPS Agreement of a mandatory requirement for the disclosure of origin of biological resources and/or associated traditional knowledge used in inventions for which intellectual property rights are applied for.
The proposal has outlined text in the form of Article 29bis on disclosure of origin of biological resources and/or associated traditional knowledge.
The proposed text said that where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge, Members shall require applicants to disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin.
Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge.
It added that Members shall publish the information disclosed jointly with the application or grant, whichever is made first. It also said that Members shall put in place effective enforcement procedures so as to ensure compliance with the obligations set out in this Article.
In particular, Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of the TRIPS Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations of this Article or provided false or fraudulent information.
According to trade officials, positions remained unchanged on this subject.
Brazil however indicated that it and other members are exploring some flexibility in their positions on the key "implementation" issues and related subjects - biodiversity/traditional knowledge, the extension of the higher level of protection for geographical indications beyond wines and spirits, and the multilateral register for wines and spirits.
However, said Brazil, this would depend on the priority issues of agriculture and non-agricultural market access.
Peru presented its latest paper on its experience in trying to track down bio-piracy (IP/C/W/493). According to trade officials, the paper offers some background data on Peru's genetic and demographic diversity, describes how it tries to track down instances of bio-piracy and gives examples of challenges to "bad" patents in various countries where Peruvian materials (or materials available in Peru) were involved.
Japan presented a proposal for setting up databases of traditional knowledge to help patent examiners decide whether an invention uses existing traditional knowledge and therefore avoiding "bad" patenting. Access to the databases would be restricted only to computers with specific Internet protocol (IP) addresses.
On Tuesday, the TRIPS Council agreed to extend the deadline by two years for countries to accept an amendment to provisions on pharmaceutical patents that would make it easier for poorer countries to obtain cheaper generic versions of patented medicines.
The original deadline of 31 December 2007 has now been extended to 31 December 2009.
According to trade officials, the decision still has to be confirmed when the General Council meets in December, but this is likely to be a mere formality.
Trade officials said that the deadline for ratifying the amendment was extended because so far only 11 countries have accepted the amendment (two-thirds of the membership have to accept before the amendment takes effect).
(The members that have accepted are the United States, Switzerland, El Salvador, Korea, Norway, India, Philippines, Israel, Japan, Australia, and Singapore.)
According to trade officials, the EU said that the European Council of Ministers should approve the acceptance soon.
The African Group (Uganda speaking) urged members to agree to the two-year extension and said that its members will be able to accept the amendment "sooner rather than later."
Canada and Rwanda reported on the first compulsory license issued under the waiver.
Canada said that it received a request from a generic manufacturer, Apotex, on 4 September and the compulsory license - which allows Apotex to produce the generic version without the permission of the patent owner and to export it to Rwanda - was issued on 19 September.
The license is valid for two years, with the possibility of extending for another two years if the approved quantity of 260,000 has not all been exported by then, Canada said.
The medicine is TriAvir, a fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine.
According to trade officials, Canada said that it has completed a review of its revised law and the experience of issuing a compulsory license.
The report should be finished soon and Canada said that it hopes to present it at the next TRIPS Council meeting. It added that the waiver (agreed in 2003) and amendment are not the only tool for helping poorer countries acquire cheaper medicines. Canada said that it is working on tax incentives as another way of achieving this.
China said that it would appreciate countries presenting information on the lessons they have learned, as Canada had promised, because this would help other countries change their own laws.
Switzerland said that its Parliament passed revised laws in June, and these will take effect in "early 2008".
Trade officials said that previously, Norway, Canada, India and the EU formally informed the TRIPS Council that they had changed their laws.
With regards to China's transitional review mechanism, trade officials said that China described in detail the "impressive" actions it has taken to strengthen intellectual property protection - some of this highlighted in its document IP/C/W/505.
It also replied at length to most of the questions asked by Japan, the US and EU (documents IP/C/W/498, 502 and 503). According to trade officials, it however declined to answer some of the questions on the grounds that these were related to a current dispute.
Trade officials said that Japan, the US and EU recognized China's efforts but voiced concerns about an increase in piracy and counterfeiting. The US and EU said that over 80% of counterfeits they seized were from China, although Chinese piracy has declined in some areas - the US mentioned software piracy.
On the issue of enforcement, trade officials said that this was on the agenda because Japan wanted to introduce its new paper. However, Brazil, China, Argentina and India reiterated their concerns over discussing this issue and continued to insist that it is not a regular agenda item.
According to trade officials, Japan's paper (IP/C/W/501) focuses on its customs seizures. Increasingly, counterfeited products arrive in smaller packages - particularly by post, which Japan partly attributed to the development of electronic commerce - and described as for "personal use".
Japan said that it has responded by focussing more on personal-use items, and by strengthening information on databases, the customs' internal Intranet, and training.
According to trade officials, the US, Chinese Taipei, Canada, the EU and Switzerland appreciated Japan's information - some of them expressing an interest in the reference to e-commerce and the use of the Intranet. They defended discussing this issue in the TRIPS Council.
Brazil said that the Council's mandate on discussing enforcement should be on whether and how countries are complying with enforcement provisions written into the TRIPS Agreement, and not on what it called "trade measures at the border".
According to trade officials, Brazil then went through the TRIPS section on enforcement, provision by provision, and asked how Japan was complying with the many requirements (such as to ensure that the procedure is fair and equitable, that there are no undue delays, that accused parties have a fair hearing and are allowed judicial review).
Japan said that it would reply to Brazil later.
With respect to Art. 66.2 of the TRIPS Agreement (developed countries reporting on how they meet the requirement to provide incentives to their companies and institutions to transfer technology to least-developed countries) and Art. 67 (on technical cooperation), reports on both had been supplied by Switzerland, Japan, the EU and some of its members, New Zealand, Norway, the US and Australia.
Sierra Leone and Uganda also presented papers on their needs for technical cooperation. According to trade officials, this made them the first two least-developed countries to do so under the TRIPS Council's 2005 decision to allow least-developed countries until 1 July 2013 to implement the TRIPS Agreement.
The decision includes provisions for "enhanced technical cooperation" for these countries and says: "With a view to facilitating targeted technical and financial cooperation programmes, all the least-developed country Members will provide to the Council for TRIPS, preferably by 1 January 2008, as much information as possible on their individual priority needs for technical and financial cooperation in order to assist them taking steps necessary to implement the TRIPS Agreement."
Trade officials said that the US, EU and Egypt welcomed the two countries' papers and urged others to do the same. The EU hoped that by the next meeting, more papers would be available so that the Council could discuss the issues in depth.
According to trade officials, Brazil went through a large number of items in several reports from developed countries and argued that they were too long and complicated, and inappropriate for the two articles.
For example, Brazil questioned whether some assistance is truly for technology transfer under Art. 66.2 and whether "harmonizing" intellectual property laws is appropriate for Art. 67 when the TRIPS Agreement says that countries are free to choose how to protect intellectual property in their own ways.
Trade officials said that Brazil, China and India raised concerns particularly over sections supplied by the European Patent Office for the EU's report on technical cooperation, which they described as un-factual, erroneous, subjective and patronizing.
On the other hand, developed countries defended their reports.
Chairperson Ambassador Yonov Agah of Nigeria reported that members remain deadlocked over whether to make the secretariat of the Convention on Biological Diversity (CBD) an observer in the TRIPS Council.
According to trade officials, Brazil and Egypt said that this was illogical since the CBD is more directly concerned in some of the Council's work than some existing observers. Brazil urged the Chair to provide more information on who objects and why at the next meeting.
The next meeting of the TRIPS Council is scheduled for 26-27 February 2008.