Source: http://www.twn.my/title/twninfo21.htm
Timestamp: 2017-10-20 23:21:46
Document Index: 639729149

Matched Legal Cases: ['sui generis', 'sui generis', 'sui generis', 'sui generis', 'sui generis', 'sui generis']

TRIPS DEBATE ON BIOLOGICAL MATERIALS: AFRICA REITERATES PROPOSAL TO BAN LIFE PATENTS
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.
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).
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.
“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.
· 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.
· 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.
· 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.
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.
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 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.
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.