Source: http://biotech-monitor.nl/3403.htm
Timestamp: 2019-05-25 16:11:17
Document Index: 583090543

Matched Legal Cases: ['Art. 27', 'sui generis', 'Art. 27', 'sui generis', 'sui generis', 'Art. 27', 'sui generis', 'sui generis', 'Art. 27', 'sui generis', 'Art. 27', 'Art. 27', 'Art. 27', 'Art. 27', 'Art. 27', 'sui generis', 'sui generis']

Biotechnology and Development Monitor, No. 34, p. 6-9.
Plant Patenting Provision Reviewed in WTO By Jeroen van Wijk
Keywords: Farmers' rights; Patent law; Plant breeders' rights; World Trade Organization (WTO); Non-Governmental Organizations; Private industry; International organization.
Correct citation: Wijk, J. van (1998), "Plant Patenting Provision Reviewed in WTO." Biotechnology and Development Monitor, No. 34, p. 6-9.
The World Trade Organization (WTO) is set to re-evaluate the obligation of member states to protect plant materials legally. Patenting life forms has proven to be an internationally contentious issue in the recent decades, for cultural and ethical reason and due to diverging economic interests. The standpoints of interest groups will basically set the lines for the new WTO negotiations: the biotechnology and seed industry and pressure groups that oppose the patenting of life forms.
The provision at stake is Art. 27.3.(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It states that WTO member states shall provide (utility) patent protection for any inventions in all fields of technology. Inventions related to biological materials, such as genes and gene sequences are not explicitly excluded, so they are considered to be included in the patent coverage. However, member states are allowed to exclude, among other things, plants and animals from protection. Plant varieties may be excluded also, but will then be protected by an effective sui generis system, which means an independent legal system specifically designed for protecting plant varieties. The text provides for a review of subsection 27.3.(b) after four years, which is the year 1999.
Granting intellectual property rights on biological materials has proven to be a highly contentious issue. Differences in interest have become most visible in the disputes between countries at the various international forums at which negotiations on intellectual property protection took place. These disputes tend to distract the attention from the basic stakeholders in plant patenting: the biotechnology and seed industry and a wide range of agricultural, environmental and religious organizations. These interest groups largely influence the positions of the member states in designing a plant patenting policy.
The political perspectives on plant patenting can be placed on a continuum that varies from support for all life-related inventions on the one hand to opposition to any life covering intellectual property right on the other. Below, it will be discussed what the industry and some major pressure groups think of Art. 27.3.(b) of the TRIPS Agreement.
The perspective of the industry
Ever since the 1970s there has been a strong tendency of chemical, seed and biotechnology corporations to merge. As a consequence of their converging interests, their lobby organizations integrated as well. Nevertheless, some important differences in perspective as it comes to intellectual property protection of plant material can be detected.
The biotechnological industry throughout the region of the Organization for Economic Co-operation and Development (OECD) is represented in the International Bioindustry Forum (IBF). IBF’ s members are the Biotechnology Industry Organization (BIO) in the USA, the Industrial Biotechnology Association of Canada and the Japan Bioindustry Association (JBA) and EuropaBio, the umbrella organization of the European biotechnology industry. Some of these organizations host lobby organizations of plant breeding firms as well.
IBF holds that both plants and plant varieties should be protectable under patent law. However, according to Dave Schmickel, legal advisor of BIO, it is not realistic to expect that this can be negotiated in the TRIPS Council, considering the present reluctance which exists even in some other OECD countries, such as Canada. Schmickel states further that the alternative option for protecting plant varieties in the TRIPS Agreement, through a sui generis system, should be understood as plant variety protection (PVP), modelled after the 1991 Act of the International Union for the Protection of New Varieties of Plants (UPOV).
This position is confirmed by Walter Smolders, patent attorney of Novartis (Switzerland) and chairman of the Intellectual Property Working Groups of the International Association for the Protection of New Varieties of Plants (ASSINSEL) and the Green Industry Biotechnology Platform (GIBIP). In this function Smolders is a member of EuropaBio’ s Policy Group on Legal Protection of Biotechnological Inventions. Smolders points out, however, that the protection provided by PVP has some limitations. The fundamental principle of UPOV, i.e. that breeders have free access to protected varieties for further breeding purposes, resulted in the development of "me-too" varieties. Smolders says that the effectiveness of PVP in this respect was improved by the 1991 Act of UPOV. The new Act introduced the principle of "essential derivation", which strengthens the breeders’ right in the case that someone else has used his variety to create a new but similar one. Smolders points out, however, that the implementation of this principle may turn out to be too complex, particularly for minor crops.
Smolders also points out that the new UPOV Act explicitly states that the "legitimate rights of the breeders" must be recognized when farmers save seed of a protected variety. In the PVP system of the European Union (EU), this provision has resulted in the obligation for the larger farms to remunerate the breeder for saved seed. The United Kingdom is the first EU country that has implemented this principle. The firms that "condition" (i.e. clean, disinfect) the saved seeds for individual farmers are entitled to compute and collect the remuneration for the breeder. According to Smolders, these restrictions on seed saving should apply worldwide. "Otherwise the industry will be encouraged to resort to hybrid varieties or genetically engineered plants that can be patented, or to seek patent protection for plant varieties as such wherever this is possible." He refers to the USA, where patents for plant varieties can be enforced against farmers using such saved seeds and presumably also against breeders developing new varieties from patented varieties. The latter conflicts with the main principle of UPOV, namely that breeders may use PVP protected varieties for further breeding.
Organizations of plant breeding firms tend to diverge from the biotechnology industry when it comes to plant patenting. Patent protection of genetic components is acceptable, but breeders oppose patent coverage for the entire genome of plants. ASSINSEL, for example, argues that the breeders’ exemption, i.e. the right to use a protected variety for breeding purposes, should exist in all rights of protection of plant varieties.
According to Joachim Winter, Secretary General of the Association of Plant Breeders of the European Community (COMASSO), the exclusion of plant varieties from patentability is of "vital importance" to breeders. Plants (i.e. not plant varieties) may be patentable, provided that the patented characteristics may be used under a licence for further breeding. Winter points out that the proposed European Patent Directive (EPD) on the legal protection of biotechnological inventions of the EU includes an "important" compulsory (cross-)licensing provision. In case access to new plant characteristics resulting from genetic engineering through a normal procedure is refused, the breeder may try to get access to the innovation by requesting a compulsory licence with the state. The state, however, can only oblige the genetic engineering firm to licence its invention to the breeder if the new variety constitutes "technical progress of considerable economic interest". Conversely, the draft directive includes the opportunity for compulsory licensing as regards PVP protected plant varieties, which could benefit biotechnology corporations.
The Asia and Pacific Seed Association (APSA), based in Bangkok, also holds that the TRIPS wording of sui generis protection for plant varieties should be PVP. The Association seems to prefer a combination of the 1978 and the 1991 Act of UPOV. According to APSA’ s director, Noel Mamicpic, the association is in favour of the 1991 Act of UPOV as far as the breeders’ exemption is concerned. By including the principle of essential derivation, the new Act restricted this exemption which is considered an advantage to professional plant breeders. On the other hand, Mamicpic says that countries should have the right to choose the species which are eligible for PVP coverage. This opportunity is given by the 1978 Act of UPOV. APSA is also in favour of maintaining the farmers’ privilege, without obligation to remunerate the breeder. Mamicpic adds that the farmers’ privilege may not necessarily be applied to all crops in the same way.
APSA has not yet taken a position on whether or not the opportunity to exclude plants and plant varieties from patent coverage should remain in the TRIPS Agreement. APSA’ s members are of diverse origin, such as private and public seed organizations, government agencies and transnational seed corporations, so that consensus on this issue is not easily achieved. The question of plant patents in Asia will be discussed in an APSA seminar in Manila, in September in 1998.
There is consensus among biotechnology and plant breeding organizations that legal systems for the protection of landraces or wild species would not comply with the obligations under Art. 27.3.(b) of the TRIPS Agreement. According to Bernard Le Buanec, Secretary General of ASSINSEL, the objective of the TRIPS Agreement was to protect modern plant varieties. "PVP does not preclude a country establishing a right for local farming communities, but such a right cannot be considered as PVP", he says. EuropaBio’ s Smolders notes that he has difficulties with proposals for the protection of farmers’ rights or community rights. "Unlike intellectual property rights, these rights seem to be eternal" says Smolders. "Moreover, the plant breeding industry is hardly interested in landraces. For the pharmaceutical industry the situation might be different. We accept that communities or healers are remunerated for their contribution to new medicines, even though that contribution is always very limited."
Perspective of pressure groups opposing life patents
The third position that can be distinguished with respect to the life patenting provision in the TRIPS Agreement is that of those non-governmental organizations (NGOs) which oppose intellectual property protection of biological materials. Examples of such NGOs can be found around the world. Internationally prominent are the Rural Advancement Foundation International (RAFI) in North America and the Europe-based Genetic Resources Action International (GRAIN), Searice in the Philippines and the Research Foundation for Science, Technology and Natural Resource Policy, India. The European Campaign On Biotechnology Patents (ECOBP) is a coalition of nearly 40 organizations in European countries which oppose patents on biological materials because they believe "this fundamentally violates justice and the inherent dignity of life". The coalition strives after the amendment of the proposed biotechnology patent directive of the EU. Other countries where national opposition groups are active include Thailand, Brazil and Colombia.
A recent expression of the anti life-patent perspective is the resolution adopted at the international seminar on sui generis rights, held at the Thammasat campus in Thailand, in December 1997. Representatives of indigenous communities, farmers, governments and NGOs from 19 countries attended the meeting that was co-organized by the Thai NGO Biothai and GRAIN.
In the resolution, the participants reaffirmed their "total and frontal opposition to extension of IPR to life forms, be it on humans, animals, plants, micro-organisms, or their genes, cells and other parts." They called for revision of the TRIPS Agreement in order to allow countries to exclude life forms and biodiversity-related knowledge from IPR monopolies. The participants further agreed that the sui generis option of TRIPS Art. 27.3.(b) should not be taken as an opportunity to establish specific right forms over biodiversity or indigenous/local knowledge. "It is the conference’ s conviction that such rights will be linked to IPR and will result in new and further monopoly rights over plant varieties" says the resolution.
The participants of the Thammasat seminar only recognize sui generis systems that exist independently from the TRIPS Agreement. These systems should protect their "inalienable rights", which include farmers’ rights, and apply to indigenous peoples, farmers, fisherfolks and other local communities which derive their livelihoods from biodiversity.
Will the TRIPS Agreement be amended?
The WTO body in charge of the review is the Council for TRIPS. It is one of the three so-called "Subsidiary Councils" which were formed when the WTO was established in 1994. The other Councils are for trade in goods and for services. They are headed by the General Council that falls directly under WTO’ s main body, the Ministerial Conference.
What the review of Art. 27.3.(b) will look like is difficult to predict. The modalities for the review process have not yet been discussed in the Council. The term "review" has several meanings. Review may refer to verification, such as the review in the TRIPS Council of the "national implementation legislation". During this review process, which ended in November 1997, WTO members mutually verified the implementation of the TRIPS Agreement of fellow-members. These included 30 mostly developed countries which had to ensure that their laws and practices complied with the Agreement on January 1, 1996.
The term "review" with respect to Art. 27.3.(b) carries another meaning and refers to examination with the possibility of amendment. This review may entail a different procedure. If some member states aim at a modification of amendment of Art. 27.3.(b), the WTO amendment rules will apply. This means that, in order to be accepted by the Ministerial Conference, consensus is required in respect of the amendment. Considering the controversial character of life patenting, reaching consensus on changing Art. 27.3.(b) may take some time.
If the review has not ended in 1999, the process may interfere with the review of national implementation of the entire TRIPS Agreement of developing countries, excluding the least developed countries, which is scheduled for the year 2000. Moreover, there have been some proposals to start a new round of trade negotiations in the year 2000. This new round should deal with all WTO built-in agenda items, i.e. all reviews and negotiations that are provided for in the General Agreement on Tariffs and Trade (GATT) in 1994. In the case of a new round, the review of the plant and animal patenting provision of the TRIPS Agreement is likely to be postponed.
At the moment, governments have not yet come up with a policy to embark on the review of Art. 27.3.(b) in the TRIPS Council. When asked for an opinion, negotiators of various WTO members, such as the USA, India, Thailand and Brazil, explain that they do not want to burn their fingers at this point in time and prefer to state that they are "reviewing their position".
The EU seems not to be preparing for war in the TRIPS Council. Sources at the EU Commission confirmed that considering the political sensitivity of the issue of patenting life, the Commission will presumably be neutral vis-à-vis other countries. It was said that pressing for patent coverage for plants and animals in WTO would open a Pandora’ s box. Even though patent protection for plants is considered to be important, it is not a matter of life and death, according to the Commission sources.
The same sources maintained that the effective sui generis system for plant varieties presumably will be understood by the Commission as a PVP modelled on the 1991 Act of UPOV. In 1994, former GATT director general, Peter Sutherland, apparently in an effort to ease opposition to the TRIPS Agreement in India, suggested in an Indian newspaper article that protection comparable to UPOV’ s 1978 Act would be acceptable for complying to the TRIPS Agreement. He argued that it would be unreasonable if the TRIPS Agreement were to foreclose the opportunity that still existed in UPOV to adhere to its 1978 Act. Sutherland also said that the 1978 convention was the one in force among the countries proposing the TRIPS provision on the protection of plant varieties at the time it was negotiated. And under UPOV’ s 1978 Act, he said, Indian farmers would be able to retain seed from their harvest to sow their land.
University of Amsterdam, O.Z. Achterburgwal 237, 1012 DL Amsterdam, the Netherlands. E-mail jvwijk@mail.uva.nl
WTO (1997), Council completes first review of intellectual property laws: almost 2 years work aimed at avoiding disputes. Briefing paper. Geneva: WTO.
Biothai and GRAIN (1997), The Thammasat Resolution. Building & Strengthening our sui generis rights. Bangkok: Biothai/GRAIN.
European Campaign On Biotechnology Patents (1998), Guide for the second reading on the European Life Patent Directive. Brussels: ECOBP.
P. Sutherland (1994), "Seeds Of Doubt. Assurance On ‘ Farmers’ Privilege’ ". The Times of India, 15 March 1994.
Personal communication with B.LeBuanec (ASSINSEL), N.Mamicpic (APSA), D.Schmickel (BIO), W.Smolders (EuropaBio), J.Winter (COMASSO).