TRIPS DEBATE ON BIOLOGICAL MATERIALS: AFRICA REITERATES PROPOSAL TO BAN LIFE PATENTS

• WN Info Service on WTO Issues (June03/3)
  Third World Network: www.twnside.org.sg
  11 June 2003
  
  Dear friends and colleagues
  
  TRIPS DEBATE ON BIOLOGICAL MATERIALS:
  AFRICA REITERATES PROPOSAL TO BAN LIFE PATENTS
  
  At the TRIPS Council meeting on 4-6 June, discussions took place on the
  review of article 27.3(b) of the TRIPS Agreement, on intellectual property
  and traditional knowledge, and on the relation between TRIPS and the
  Convention on Biological Diversity.
  
  The highlights were: (1) a new paper by the Africa Group reiterating their
  demand that patents on all life forms and living processes be prohibited,
  that countries be able to use a sui generis system of their choice, and that
  traditional knowledge be better protected; (2) a paper by a group of
  developing countries elaborating on their earlier proposal that TRIPS
  require patent applications involving genetic materials or traditional
  knowledge to disclose the country of origin accompanied by evidence of prior
  informed consent and benefit sharing arrangements; and (3) a paper by
  Switzerland proposing a mechanism enabling (but not requiring) disclosure of
  source through WIPO.
  
  Below is a report of the papers presented and the discussions. It was first
  published in the SUNS Bulletin of 10 June.
  
  For previous issues of TWN Info or WTO Issues please refer to our website
  www.twnside.org.sg
  
  with best wishes
  Martin Khor
  Third World Network
  
  -------------------------------------
  
  TRIPS COUNCIL DEBATES PATENTS ON LIFE, TRADITIONAL
  KNOWLEDGE and ARTICLE 27.3(b)
  
  By Martin Khor, Third World Network
  Geneva, 6 June 2003
  
  The World Trade Organisation's TRIPS Council on 4-5 June debated proposals
  on the three interconnected issues of the review of article 27.3(b) of the
  TRIPS agreement (dealing with biological materials), traditional knowledge
  and folklore, and the relationship between TRIPS and the Convention on
  Biological Diversity (CBD).
  
  New papers on these subjects were tabled by the Africa Group (presented on
  its behalf by Zimbabwe), by a group of developing countries (presented on
  their behalf by India), and by Switzerland. The Council had also discussed
  the issue of TRIPS and public health, and on non-violation complaints, among
  others.
  
  The Africa Group paper gave a comprehensive treatment of patenting of life
  forms, sui generis systems for protecting plant varieties, and protection of
  traditional knowledge, while the paper by India and other developing
  countries focussed on their proposal on disclosure of country of origin,
  prior informed consent (PIC) and benefit sharing. The Swiss paper dealt with
  disclosure of source countries.
  
  The Africa Group reiterated its position that the TRIPS Agreement should be
  amended to prohibit patents on all life forms, as such patents are contrary
  to the moral and cultural norms of many societies. It also stressed that the
  requirement to protect plant varieties should not in any way undermine but
  support Members' rights to public goals such as food security and poverty
  elimination. There is thus no basis to require Members to adopt
  inappropriate regimes for plant varieties protection.
  
  It proposed that the WTO adopt a Decision on Traditional Knowledge which
  would establish a WTO Committee on traditional knowledge and genetic
  resources to oversee the protection of traditional knowledge and enforcement
  of rights of WTO Members.
  
  The Group expressed concern that the review of TRIPS Article 27.3b has not
  been finalized and that the deadline of December 2002 set at Doha had
  passed. Protection of genetic resources and traditional knowledge will not
  be effective unless international mechanisms are established within the
  TRIPS framework. Other means, such as access contracts and data bases for
  patent examination, can only be supplementary to such international
  mechanisms which must contain an obligation on members collectively and
  individually to prohibit and prevent misappropriation of genetic resources
  and traditional knowledge.
  
  "Patents on life forms are unethical and the TRIPS Agreement should prohibit
  them through modifying the requirement to provide for patents on
  micro-organisms and on non-biological and microbiological processes for the
  production of plants and animals. Such patents are contrary to the moral and
  cultural norms of many societies in Members of the WTO."
  
  These patents make the exception in Article 27.2 for protecting ordre public
  and morality meaningless, said the Africa Group, in relation to Members that
  consider patents on life forms to be contrary to the fabric of their society
  and culture and to be immoral. These members would otherwise invoke the
  Article 27.2 exception.
  
  TRIPS has not provided adequate means to prevent patents mainly in developed
  Members that misappropriate genetic resources and traditional knowledge
  mainly from developing Members. A solution needs to be found through
  improving the TRIPS agreement.
  
  The Africa Group paper elaborates on possible areas of agreement and
  disagreement among Members. For issues where there is common understanding,
  the TRIPS Council can agree on a Decision to be immediately operational, and
  to be forwarded to the Trade Negotiations Committee. On areas without common
  understanding, the TRIPS Council can continue working within a specific time
  frame.
  
  On possible areas of agreement, the Group wishes that delegations confirm a
  common understanding on the following:
  
  * Members have the right and freedom to determine and adopt appropriate
  regimes in satisfying the requirement to protect plant varieties by
  effective sui generis systems. Such regimes may draw upon the ITPGR, the
  CBD, UPOV 1978 and the Africa Model Legislation on protecting local
  communities, farmers and breeders and the Regulation of Access to biological
  resources. Systems of protection should address local realities and needs.
  The Africa Model Legislation and Regulation of Access is one example of a
  sui generis system which was developed to protect the rights and knowledge
  of farmers, indigenous peoples and local communities, in a manner suiting
  the circumstances of Africa.
  
  * The non-commercial use of plant varieties and the system of seed saving
  and exchange as well as selling among farmers, are rights and exceptions
  that should be ensured as matters of important public policy to ensure food
  security and preserve the integrity of rural or local communities.
  
  While the legitimate rights of commercial plant breeders should be
  protected, these should be balanced against the needs of farmers and local
  communities. Any sui generis system should enable Members to retain their
  right to adopt and develop measures that encourage and promote the
  traditions of their farming communities and indigenous peoples in innovating
  and developing new plant varieties and enhancing biodiversity.
  
  * TRIPS, CBD and ITPGR should be implemented in a mutually supportive and
  consistent manner. Members retain the right to require within their domestic
  laws the disclosure of sources of any biological material that constitutes
  some input in the inventions claimed, and proof of benefit sharing.
  
  * Traditional knowledge and inventions of local communities should be
  protected. It is important to develop international mechanisms ensuring
  equity in the use of genetic resources and traditional knowledge through
  appropriate international arrangements to supplement domestic laws and
  measures.
  
  * Genetic resources and traditional knowledge should be documented to assist
  searches and examining novelty and inventive step.
  
  In finding solutions to concerns raised under Article 27.3(b), cooperation
  with civil society organizations is vital whilst indigenous people and local
  communities should fully engage.
  
  On areas of disagreement, the Africa Group proposes the following:
  
  * Patenting life forms: The Group maintains its reservations about patenting
  any life forms. It proposes that "Article 27.3(b) be revised to prohibit
  patents on plants, animals, micro-organisms, essentially biological
  processes for the production of plants or animals, and non-biological and
  microbiological processes for the production of plants or animals."
  
  For plant varieties to be protected under TRIPS, the protection must clearly
  (and not just implicitly or by way of exception) strike a good balance with
  the interests of the community as a whole and protect farmers' rights and
  traditional knowledge, and ensure the preservation of biodiversity.
  
  In any case the TRIPS Council must ensure that the exceptions for ordre
  public or morality in Article 27 para 2 are not rendered meaningless by any
  provisions in para 3(b) through requiring Members to do what is contrary to
  ordre public and morality in their societies. "The barest minimum in this
  regard would be to clarify that para 3(b) does not in any manner restrict
  the rights of Members to resort to the exceptions in para 2."
  
  * Patenting of micro-organisms, and non-biological and microbiological
  processes: The Africa Group has consistently raised serious concerns about
  patents on life forms and research tools, and has maintained that there
  should not be a possibility, within TRIPS, of patents on micro- organisms as
  well as on non-biological and microbiological processes for the production
  of plants and animals.
  
  The Group views that the distinction drawn in Article 27.3(b) for
  microorganisms and for non-biological and microbiological processes is
  artificial and unwarranted, and should be removed from TRIPS, so that the
  exception from patentability in para 3(b) covers plants, animals and
  microorganisms as well as essentially biological, non-biological and
  microbiological processes for the production of plants and animals.
  
  * Misappropriation of genetic resources and traditional knowledge: Such
  misappropriation has taken the form of obtaining patents in developed
  countries inconsistent with the will of the communities and countries that
  have sovereignty over the resources.
  
  The Group paper noted efforts such as developing access contracts and
  databases for patent offices (used to examine patent claims for novelty,
  inventiveness and usefulness) that are being undertaken in WIPO but
  considered them inadequate as these do not amount to effective international
  mechanisms.
  
  Also, the Group felt that work in WIPO should not delay or put off work in
  WTO. Work on this issue in WIPO has been very slow while misappropriation
  continues unabated. The WTO must find measures in spelling out the rights
  and obligations of members and addressing breaches of obligations. A
  solution to concerns relating to patenting that constitutes a
  misappropriation should take the form of obligations that are enforceable in
  the WTO framework.
  
  The Group thus suggested the TRIPS Council adopt a Decision on protecting
  traditional knowledge, which was annexed to their paper. The draft Decision
  states that the existence of traditional knowledge in any form shall defeat
  the novelty and inventiveness requirements of patents under any laws of all
  Members.
  
  Where any invention is derived from traditional knowledge or based on in
  situ genetic resources of any member, then no intellectual property rights
  shall be granted in any member unless CBD requirements have been fully
  complied with. Members shall require in their laws that any IPRs granted in
  breach of this Decision shall be cancelled forthwith. No IPRs shall be
  granted without recognition of the traditional knowledge involved.
  
  * Relation between TRIPS and CBD: The major issue is how to fill the gaps in
  TRIPS. There should be TRIPS obligations requiring every Member to prohibit
  and prevent misappropriation of genetic resources and traditional knowledge,
  through requirements for disclosure of the source of the resources and
  knowledge involved in the claimed inventions, and a demonstration of
  compliance with domestic procedures in the member where the resources and
  knowledge originate.
  
  The Group proposed modifying Article 29 to contain these rights and
  obligations, by including the requirement for equity, disclosure of the
  community of origin, and demonstration of compliance with domestic
  procedures for all such patent applications.
  
  The paper by Brazil, Cuba, Ecuador, India, Peru, Thailand and Venezuela is
  aimed at strengthening the arguments (made previously in a paper at a TRIPS
  meeting in June 2002) for inserting a provision in TRIPS "that mandates
  patent applicants for inventions that use biological resources and
  traditional knowledge, to disclose the source of origin of such resource and
  knowledge, as well as provide evidence that they have obtained the necessary
  prior informed consent (PIC), and complied with national laws on benefit
  sharing." This is critical to ensure that TRIPS and CBD are implemented in a
  mutually supportive manner.
  
  The paper by Brazil and others notes extensive documentation exists on
  biopiracy, misappropriation and the issue of bad patents, including for
  quinoa and ayahusca, tumeric, neem, kava, barbasco, endod and bitter gourd.
  There are formidable obstacles for a country of origin to pursue legal
  remedies as this is expensive, complicated and cumbersome.
  
  Disclosure of origin of the resource and associated traditional knowledge
  and evidence of PIC and benefit sharing can reduce bad patents, enable the
  patent office to ascertain the "inventive step" claimed in a patent
  application, enhance ability of countries to track and challenge bad patents
  and improve compliance with their national laws on PIC and benefit sharing,
  and increase the patent system's credibility.
  
  The paper counters some arguments made by other Members against the earlier
  proposal. To the charge that the proposal would violate the TRIPS principle
  of non-discrimination between fields of technology, the paper argues that
  there would be discrimination only if the three criteria of patentability
  (novelty, inventiveness and usefulness) are applied differently to different
  fields of technology. But the different norms of disclosure for inventions
  based on biological resources and traditional knowledge would not constitute
  such discrimination.
  
  The proposed measure would also not constitute an unnecessary burden as it
  is a reasonable procedure based on knowledge readily available with a patent
  applicant. Requiring disclosure would not be a legal and administrative
  nightmare, as had been suggested (by the US). The requirement would instead
  lead to a comprehensive international solution so that countries that are
  victims of biopiracy do not need to divert resources to revoke bad patents.
  
  The paper also argues that disclosure, evidence of PIC and benefit sharing
  should be placed within the patent law system as leaving it outside would
  render the requirements ineffective. On the US suggestion that the use of
  databases on traditional knowledge and practices by patent examiners would
  be adequate to redress biopiracy, the paper gives reasons and cases to show
  that the use of databases has limitations and cannot substitute for expanded
  disclosure norms.
  
  It also argues that the use of contracts and national laws whilst useful
  cannot achieve the main aim of disclosure norms, i.e. to stall the reward of
  a patent for knowledge or information misappropriated from another country.
  National systems cannot by themselves protect traditional knowledge. The
  ability of national patent offices to prevent biopiracy does not ipso facto
  lead to a similar action on the patent application in other countries whilst
  benefit sharing mechanisms set up by national law would need to be
  recognized in user countries.
  
  The paper seeks a simple mechanism whereby patent laws in different
  countries make an effective determination of inventorship, prior art and
  further do not reward a patent applicant for violating the source countries'
  laws on access and benefit sharing. Adequate amendments should thus be
  introduced in TRIPS to ensure harmonious and mutually supportive
  implementation of the provisions of TRIPS and CBD.
  
  In contrast to the two other proposals, the Swiss paper does not envisage
  any need to amend TRIPS. It proposes to explicitly enable national patent
  law to require the declaration of the source of genetic resources and
  traditional knowledge in patent applications by amending the regulations
  under the Patent Cooperation Treaty of WIPO to enable parties to require
  patent applicants to declare the source. This would also apply to the Patent
  Law Treaty of WIPO.
  
  Switzerland views WIPO as the primary forum to deal with the issue of IPRs
  and traditional knowledge. Moreover, TRIPS and CBD can be implemented
  without conflict and there is no need to modify the provisions of either.
  
  It should be noted that the Swiss proposal on disclosure is different from
  the other two proposals. While the developing countries' proposals are that
  disclosure of the source, PIC and benefit sharing should be made mandatory
  requirements through amending TRIPS, the Swiss proposal is only for enabling
  countries to require that applicants declare the source, and that through an
  amendment of a WIPO treaty. The measure is thus more limited and moreover
  would not be mandatory but it would be left to each country whether to adopt
  or not.
  
  Many developing countries supported the African paper or the paper of other
  developing countries or both. Those who spoke in support included Peru,
  Brazil, Kenya, Venezuela, Cuba, Colombia, and Dominican Republic. Several
  said that work in this area should be carried out in the WTO and not only
  left to WIPO.
  
  China said the current intellectual property system ignored the contribution
  of traditional knowledge. TRIPS should incorporate the CBD's three
  principles of sovereignty over resources, prior informed consent and
  equitable benefit sharing.
  
  However, several developed countries such as Japan and Canada said that WIPO
  has technical expertise in this area and the TRIPS Council should wait to
  see what emerges in WIPO.
  
  The US said traditional knowledge should be removed from the agenda in the
  TRIPS Council. It did not consider the use of TRIPS as a suitable means to
  ensure disclosure, PIC and benefit sharing. Contracts would be more
  effective. It did not see conflict between TRIPS and the CBD, and said that
  WIPO should be the lead agency on this issue.
  
  The EC welcomed the Swiss proposal. It also welcomed the Africa proposal,
  except it includes provisions that are not acceptable to all, especially the
  proposed ban on the patents on life forms. It agreed with the African
  Group's flexible approach on sui generis protection of plant varieties, on
  flexibility for small farmers' rights to re-use seeds and on the need to
  make TRIPS and CBD compatible. The EC was also willing to accept a mandatory
  disclosure requirement, but it would leave open the question on where this
  could be done, i.e. WTO or WIPO.
  
  There was a procedural debate on how the TRIPS Council should proceed,
  specifically whether it should submit a report to the TNC. Several
  developing countries including Brazil, India, Colombia and China wanted a
  report to be made to the TNC but this was objected to by the US. The Council
  chairman, Ambassador V.G. Menon of Singapore, said that since there was no
  consensus whether to report to the TNC, he would only brief Dr. Supachai of
  the meeting.
  
  Only one statement was made, by the US, on the agenda item on the review of
  TRIPS under Article 7l.1. The US stated that the TRIPS agreement was
  functioning well, but some countries had not yet notified their laws and it
  urged them to do so.
  
  On the issue of non-violation complaints, developing countries in general
  supported the position that there should not be non-violation complaints in
  the TRIPS agreement. They were thus in support either that TRIPS be amended
  to reflect this, or at least that the present moratorium on non-violation
  complaints cases be further extended when it ends at the Fifth Ministerial.
  
  The US was however in favour of ending the moratorium. Canada said it had
  been opposed to non-violation cases and would like to extend the moratorium.
  Australia had sympathy for ending non-violation complaints in TRIPS.
  Switzerland could accept extending the moratorium but only for one more
  time.
  
  The Council chairman said there was no consensus on the issue and he would
  try to work towards a consensus position on this by the Cancun ministerial
  in September.
  
  
  
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