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Biotechnological Inventions and IPRs:Appraisal on TRIPS Agreement Art.27.3 (b)

作者:李辉
All novel technologies require the law to adjust and develop, modern biotechnology is no exception. The rapid development in the field of biotechnology in the past three decades has been regarded as one of the most striking features of our times. It creates a potential of enhanced welfare and growth in the field of life sciences and related economic activities, a potential to meet human needs in medicine, nutrition and fuels. At the same time, however, it poses considerable risks to biodiversity, health and safety on which research is still scarce and not fully conclusive. Besides, biotechnology has, as different from technologies in other fields, touched upon the very foundation of life. Consequently, fundamental ethical concerns have been aroused.[1]
    
    All of the problems invoked by the advancement of modern biotechnology can not be illustrated better in other fields than in IPRs regimes, especially in patent system. Modern biotechnology not only challenged the very foundation of patent theory—distinction between “discovery” and “ invention”(“novelty assessment”), but also played an important role in the “north/south” and “proprietary rights/public domain” debate on the legal status of biological genetic resources from international law perspective. With the harmonizing of patent law and the adoption of TRIPS Agreement, however, the controversy is not eliminated but enlarged, which can be evidenced by the contentious ongoing review process of TRIPS Agreement Art. 27.3(b).
    
    The article proceeds as follows: PartⅠexplains the interrelations between IPRs and the advent of modern biotechnology; PartⅡ gives an outline of the TRIPS Agreement, focusing on the origin, scope, as well as the patent related clauses; Part Ⅲ analyzes the criterion and implications of TRIPS discipline on patentability; PartⅣ elaborates on the background, negotiating history, and term interpretation of Article 27.3(b) of the TRIPS Agreement; PartⅤintroduces the ongoing “review” process of the provision in the multilateral trading forum; PartⅥ is the conclusion, including reflections on the issues in discussion .
    
    Ⅰ Introduction: Biotechnology, Modern Biotechnology, and IPR regimes
    
    When we explore the legal implications of the development of biotechnology, it is important to be aware that biotechnologies are both new and very old, which can be, according to some scholars, divided into three generations. The first generation includes traditional technologies like beer brewing and bread making, which go back thousands of years, and the second begins with the microbiological application of the antibiotics. Tissue culture and modern plant and animal breeding also fall within this ‘generation’. The third generation biotechnologies, or ‘the new biotechnologies’, include the various genetic engineering techniques for transferring DNA from one life-form to another to make transgenic organisms expressing new and useful traits. The first such technique, known as recombinant DNA(r DNA), was invented in 1973 by Stanley Cohen at Stanford University and Herbert Boyer at the University of California at San Francisco, and patented by the former university. The techniques enabled foreign genes to be inserted into micro-organisms and passed on to others through cell division. Since then other genetic engineering techniques have been invented. This latest generation of biotechnologies also includes hybridoma technology, polymerase chain reaction and cloning.[2]
    
    In the literature of some relevant international documents (especially CBD and CPB), “biotechnology” is defied as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”,[3] whereas “modern biotechnology” means “the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid(DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or combination barriers and that are not techniques used in traditional breeding and selection”.[4]It is oblivious that the term “modern biotechnology” here represents the third generation biotechnologies developed since 1970’s.
    
    Compared with other components of the legal system, IPRs regime is naturally to be selected as the first respondent to the development of new technologies. The term “intellectual property” refers to a set of intangible products of human activity that are legally defined. Major forms of intellectual property protection include:
    
    ·Patent and related industrial design.
    
    ·Copyright and related neighboring rights.
    
    ·Integrated circuit layout.
    
    ·Geographical indications of origin.
    
    ·Trademarks.
    
    ·Plant variety.
    
    ·Trade secrets (confidential information)
    
    Among these forms of IPRs, patent and plant variety right are more relevant to the biotechnical innovations. The patent system is designed to grant inventors and innovators exclusivity over their inventions for a limited period in exchange for public disclosure of their inventions. Patent is thus often taken as "a way of maximizing social welfare by providing incentives for inventors to increase the stock of applied technical knowledge in society (through protection) and discouraging inefficient redundancy of inventive effort (through disclosure)."[5] During the second half of the 19th century, the first modern patent laws were adopted in several European countries —in Britain in 1874,Gemany in 1877, and Switzerland in 1887, as well as in the USA( the initial Act of 1793 was revised in 1836, 1870 and 1874) and in Japan (1885).[6] At that time patent legislation was essential designed to protect mechanical and conventional chemical inventions within industrialized countries. In other words, traditional patent law which tailored for the mechanical and conventional chemical innovations is ill-equipped, in my opinion, to deal with the new issues raised by modern biotechnology, including:
    
    1.How to distinguish an “invention” from a mere “discovery” in the context of biotechnical innovations?
    
    2.How to maintain the “public order” principal, especially ethical aspects, when we considering on the patenting of life forms?
    
    3.How to deal with the interfaced problems between patent protection on plant varieties and the UPOV regime?
    
    4.In the process of standardization of patent law, which featured by the negotiation of TRIPS Agreement during the Uruguay round, how to reconcile the different approaches towards biotech-related innovations taken by developed and developing countries?
    
    For answering these questions, significant efforts have been made both at national and regional levels. The landmark US Supreme Court Case Diamond vs Chakrabarty[7] in 1980 paved the way towards the patenting of life forms by stating that the relevant criterion is human involvement in nature and not the distinction between inanimate and living material. In the European continent, the Directive 98/44/EC [8]can be seen as a integrate policy statement by EU members regarding the biotechnological inventions, although dissident opinion still exist.
    
    The debate on the patentability of biotechnical inventions proceeds as the conclusion of Uruguay round negotiation and the came into birth of WTO—the multilateral trading system both as the impetus and outcome of economic globalization. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995 marked a significant step toward the establishment of a global system for the protection of intellectual property rights.
    
    Ⅱ TRIPS Agreement: Origin, Scope, and Patent-Related Clauses
    
    The link between IPRs and trade did not start, as contrary to the opinion of many scholars, at the time of Uruguay Round. In fact, as a compilation of previous multilateral conventions on the matter, The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has not appeared out of a vacuum, it is the culmination of a long maturation of which the root goes a long way back, notably to the General Agreement on Tariffs and Trade (GATT) of 1947, the Berne Convention for the Protection of Literary and Artistic Works of 1886 and the Paris Convention for the Protection of Industrial Property of 1883.
    
    Before the creation of the WTO, multilateral rule-making in the IPRs area was dominated by the WIPO, which administers or co- administers practically all the important conventions in the field. Two factors help to explain why U.S. and European officials chose the multilateral trade negotiations as the forum rather than WIPO.[9] First, WIPO, being a United Nations agency, gives developing countries a strong voice. This is problematic since many of these countries were opposing stronger patent disciplines. By contrast, the General Agreement on Tariffs and Trade (GATT) was a much smaller organization largely dominated at the time by United States and the European Economic Community. Another reason that trade institutions were used to strengthen IPRs is that the powerful dispute settlement mechanism equipped by the WTO will guarantee the effective implementation of TRIPs through, if necessary, cross-sectoral trade sanctions, which is regarded as the biggest advantage enjoyed by TRIPS Agreement over WIPO-administered Conventions.
    
    At the outset of the Uruguay Round, fundamental divergences existed between industrialized counties, which wished to achieve a comprehensive coverage of all IPRs, and DCs and LDCs, which wanted to limit the scope to a code against trade in counterfeit goods.[10] The consequence was that practically all existing IPRs were included in TRIPS.
    
    The TRIPS Agreement consist of the Preamble and PartsⅠtoⅦcontaining seventy-three Articles. In the Preamble, Members recognize that intellectual property rights are private right. PartⅠof the TRIPS Agreement(Article 1 to 8) contains general provisions and basic principles. Article 1(1) states that the provisions of the TRIPS Agreement set minimum standards for the protection of intellectual property rights, and Article 3 and 4 extend the principles of national treatment and most favored- nation treatment, respectively, to the protection of intellectual property rights.
    
    Part Ⅱ of the TRIPS Agreement (Article 9 to 40) sets standards regarding the availability, scope, and use, of intellectual property rights. It requires Members to implement in their national laws provisions regarding copyrights and related rights(Article 9 to 14), trademarks(Article 15 to 21), geographical indications( Articles 22 to 24), industrial designs (Articles 25 to 26), patent(Article 27 to 34), layout designs(topographies) of Integrated Circuits(Articles 35 to 38), undisclosed information(Article 39), and the control of anti-competitive practices in contractual licenses( Article 40). Part Ⅲ of the TRIPS Agreement(Articles 41 to 61) specifies the enforcement of intellectual property rights. Part Ⅵ (Articles 65 to 67) contains transitional arrangements, and Part Ⅶ (Article 68 to 73) institutional arrangements and final provisions.
    
    The patent section of the TRIPS Agreement was one of the most difficult to negotiate. It involved a number of key North-North as well as North-South issues.[11] The result is impressive, in that the scope and coverage of the Section are comprehensive. The Agreement has nine major provisions regarding patents. First, it requires parties to comply with the Paris Convention. Second, it requires parties to provide national treatment with respect to patent protection. Third, it requires that parties make patents available “in all fields of technology”. Fourth, it requires that patent rights be “enjoyable without discrimination as to the place invention, the field of technology, and whether products are imported or locally produced”. Fifth, it establishes disciplines for governments that engage in compulsory licensing. Sixth, it requires that the term of patent protection shall not end before a period of twenty years from the filing date. Seventh, it mandates national enforcement of private patent rights. Eighth, it provides a robust dispute settlement process. Ninth, it allows developing countries to delay implementation of certain provisions. With respect to provisions three to seven above, it should be emphasized that these requirements do not exist in the Paris Convention.
    
    Ⅲ Patentability: Art.27 of TRIPS Agreement and its relevance to biotechnological inventions
    
    Article 27 of TRIPS Agreement defines “patentable subject matter” in three paragraphs as follows:
    
    “1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application (For the purposes of this Article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively). Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
    
    2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
    
    3. Members may also exclude from patentability:
    
    (a)diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
    
    (b)plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”
    
    As promulgated by Art.27.1, Subject to the provisions of paragraphs 2 and 3, “any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application” should be conferred patent rights. This article “makes TRIPS the most important multilateral instrument in this field” and “overcame the main weakness of the Paris Convention in this regard, and instead of relying on domestic law, TRIPS defined the scope of a patent”[12].
    
    A.“product patent’ and “process patent”
    
    According to Art.28.1(b), if the subject matter of a patent is a process, the rights conferred not only include the process per se, but also “the product obtained directly by that process”. This kind of “Product by Process Claims” give rise to special problems in relation to biotechnology, which enabling the right holder to a patent relating to plant or animal biotechnical inventions, through the application of the “process”, obtain the patent rights toward the “plant or animal’ itself.
    
    B.“all fields of technology”
    
    This Article prohibits distinctions relating to the field of technology to which the invention belongs—practices once common in national patent laws. For instance, in India, “chemical processes, methods of agriculture and horticulture, alloys and new uses for known products or process” were excluded from patentability. Argentina was a typical example of another approach which, while excluding pharmaceuticals from patentability, permitted process patents, except in relation to pharmaceutical products producible through a single procedure. Before the amendment in 1992, Art.25 of China's Patent Law excluded the patentability of “pharmaceuticals and substances produced from chemical processes”. Such exclusions are not permissible under Article 27.1.
    
    Ⅳ “Biotechnology Clause”: Art.27.3 (b) of TRIPS Agreement
    
    Article 27.3(b) addresses one of the most controversial issues covered by TRIPS. The often called “biotechnology clause” describes subject matter that Members may exclude from patentability, at the same time, specifically obliges Members to protect microorganisms and certain biotechnological processes.
    
    The drafting of this clause-the single one in the whole TRIPS Agreement subject to an early review-reflected, on the one hand, the strong interests of some developed countries in ensuring protection of biotechnological innovations and, on the other, the important differences existing among such countries with regard to the scope of protection, as well as the concerns of many developing countries about the patentability of life forms. [13]
    
    Article 27.3(b) describes as follows:
    
    “ 3. Members may also exclude from patentability:
    
    …(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”
    
    As described by the clause, Members are allowed to exclude from patentability:
    
    -plants;
    
    -animals; and
    
    -“essentially biological processes for the production of plants or animals.”
    
    Besides, although Members may exclude the patentability of “plant”, the clause contains special provisions concerning “plant varieties”: it requires Members to protect “plant varieties” either by:
    
    -patents
    
    -an effective sui generis system; or
    
    -any combination thereof.
    
    A.Situation Pre-TRIPS
    
    After the decision by U.S. Supreme Court in Diamond v. Chakrabarty(1980), which accepted for the first time a patent on a living organism per se, the patentability of such matters expanded in industrialized countries to include cells and sub-cellular parts, including genes, as well as multicellular organisms. An accepted principle since the 1980s in those countries are that the fact that an invention consisted of, was based on or employed living matter, was not a sufficient reason to exclude patent protection, including for biological material pre-existing in nature (provided that the latter were claimed in an isolated or purified form). Despite this trend, considerable differences remain in those countries with regard to the scope of patentability of biotechnology –related inventions. Divergences were even more profound with respect to developing countries.[14]
    
    In the field of plant varieties, few countries( most of them developed countries) had adopted at the time of the negotiation of TRIPS specific regulation on breeders’ rights and had adhered to the Convention for the Protection of New Varieties of Plant (the UPOV Convention) of December 2, 1961, which was subsequently revised in 1972, 1978 and 1991.[15] In addition, the 1978 Act of the UPOV Convention did not permit the provision of both breeders’ rights and patent protection for the same genera or species (Article 2).
    
    B.Negotiating History
    
    During the negotiation process of TRIPS in Uruguay Round, two drafts had been submitted by the TRIPS Negotiating Group. The first one was called “The Anell Draft”. On 23 July 1990, Lars E.Anell, Chairman of TRIPS Negotiating Group, presented to the General Negotiating Group alternative draft texts: an A and B proposal. The second one, “The Brussels Draft”, corresponded to the Ministerial Text of December 1990 containing the Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negations, Revisions, Trade –Related Aspects of Intellectual Property Rights, Including Trade in Counterfeit Goods.[16] This draft text was prepared by Chairman Anell on his own responsibility and was said to reflect the results of negotiation through 22 November 1990. Both the two drafts above illustrated the negotiating history of ““biotechnology clause”.
    
    1.The Anell Draft
    
    The Anell Draft text showed how substantial the divergences among the parties were. A heavily bracketed text alluded to the possible exclusion from patentability of
    
    “1.4.4 [Any] plant or animal [including micro-organisms] [varieties] or [ essentially biological] processed for the production of plants or animals; [ this does not apply to microbiological processes or the products thereof].[ As regards biotechnological inventions, further limitations should be allowed under national law].”
    
    2.The Brussels Draft
    
    By December 1990, the parties had not agreed on the issue of patent protection for plants and animals, and the differences were still outstanding. The Brussels Draft text provided, in bracketed language, that parties could exclude from patentability:
    
    “[b) A. Animal varieties [ and other animal inventions] and essentially biological processes for the production of animals, other than microbiological processes or the products thereof. PARTIES shall provide for the protection of plant varieties either by patents or by an effective sui generic system or by any combination thereof. This provision shall be reviewed […]years after the entry into force of this Agreement.]
    
    [b) B. Plant and animals, including microorganisms, and thereof and processes for their production. As regards biotechnological inventions, further limitations should be allowed under national law.]”
    
    Paragraph A essentially reflected the views of developed countries, and paragraph B of developing countries. As a simple comparison with the adopted Article 27.3(b) shows, the developed countries’ countries approach finally prevailed to a large extent. As commentated by Correa, “These provisions may be deemed as one of the major concessions of developing countries in TRIPS, at least in terms of the original position of a number of them in the negations”.[17]
    
    C. Possible Interpretations to the Terms
    
    Although the TRIPS Agreement did not define the exact meaning of some professional while very important terms in the “biotechnology clause”, so for there is no WTO jurisdiction on this issue, we can, however, give possible interpretations to these terms with the help from relevant national legislations and international documents.
    
    1.“essentially biological processes” and “non- biological processes”
    
    The notion of “essentially biological processes” is inspired by Article 53(b) of the 1973 Convention on the Grant of European Patents (referred to as “European Patent Convention” or “EPC”).[18] According to the explanations from Implementing Regulations to the Convention on the Grant of European Patents[19] and Directive 98/44/EC[20], “essentially biological processes” means “A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection”.
    
    Different approaches have been taken by national patent legislation towards this issue. Some European countries, such as Switzerland, Hungary, Bulgaria, Iceland, Norway, and Canada, Korea, Thailand and South Africa excluded the patentability of “essentially biological processes”; Nevertheless Australia, Japan, New Zealand and Romania regard “essentially biological processes” as patentable subject matters.[21] In U.S., “naturally occurring essentially biological processes” can not obtain patent protection[22].
    
    The different attitude towards “essentially biological processes” and “non- biological processes” in the national patent legislation is, in my opinion, a reflection of the development of modern biotechnology. The notion of “essentially biological processes” has been defined on the basis of the degree of “technical intervention”; if the latter plays an important role in the determination of or control over the results, the process may be patentable. Under this notion, conventional breeding methods (e.g., crossing, selecting) are categorized into “essentially biological processes” thus are generally not patentable. In contrast, methods based on modern biotechnology (e.g., tissue culture, insertion of genes in a plant) where the intervention is significant, would be patentable.
    
    It is noteworthy that, in China’s current patent legislation, transgenetic plants and animals are regarded as “plants and animals produced from biological processes such as genetic engineering and DNA recombination technique” [23] (emphasis added). In other words, “genetic engineering and DNA recombination technique” are categorized into “biological processes” by China’s patent legislation, which is in contrast to the EU members’ understandings and practices.
    
    2.“micro-organism” and “microbiological process”
    
    A “micro-organism” is an organism that is not normally perceptible by the eye. The scientific concept of “micro-organism” refers to “a member of one of the following classes: bacteria, fungi, algae, protozoa, or viruses”.[24]
    
    It should be pointed out that there is, both in national laws and international conventions, no universally accepted legal definition of “micro-organism” in the field of patent legislation,
    
    In China’s patent law, “animals and plant” are not patentable subject matters.[25] Whereas “micro-organism” is regarded as “neither belongs to animal, nor to plants”, thus under certain circumstances, “micro-organism” can be the subject matter of a patent. Guideline to the Patent Examination of China prescribes that “micro-organism which existed in the nature and had not been processed by human techniques is mere a discovery, being without industrial applicability, can not be conferred patent rights; If the micro-organism in question had been isolated from nature and processed into purified substance which capable of industrial application, then the micro-organism per se is the subject of patent protection.[26]
    
    Directive 98/44/EC on the protection of biotechnological inventions introduces the notion of “biological material” to deal with the “micro-organism” problem. Article 3.2 of the Directive regulates that “biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature”.
    
    It can be concluded, by a simple comparison, that China and EU take similar approaches to the patentability of “micro-organism”.
    
    “Microbiological process” is defined, in the Implementing Regulations to the Convention on the Grant of European Patents and Directive 98/44/EC, as “any process involving or performed upon or resulting in microbiological material”.
    
    3.Plant Varieties
    
    TRIPS obliges Members to protect “plant varieties” by means of patents, an effective sui generis regime or a combination of both. While granting of patents is regulated under considerably detailed standards, the only requirement with respect to a sui generis system is that it must confer an “effective” protection. Countries can, thus, determine the scope and contents of the rights to be granted.
    
    The flexibility permitted by Article 27.3(b) in relation to the forms of protection for plant varieties has been the reflection, to a large extent, of the lack of consensus on the matter among the industrialized countries during the TRIPS negations. While in the USA, Australia and Japan a plant varieties may be patented as such, this is not the case in Europe. The reference to a “sui generis system” may be deemed to suggest the breeder’s rights regime, as established in the UPOV Convention,
    
    The 1961 Act and 1991Act of UPOV Convention give different definitions on “Plant Varieties”. In UPOV 1961, “Plant Varieties” refers to “any cultivar, clone, line, stock, or hybrid which is capable of cultivation”, whereas a more detailed definition can be found in Article 1 of UPOV 1991 as follows:
    
    “Varity” means a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be:
    
    - defined by the expression of the characteristics that results from a given genotype or combination of genotypes,
    
    - distinguished from any other plant grouping by the expression of at least one of the said characteristics, and
    
    - considered as a unit with regard to its suitability for being propagated unchanged”.
    
    By comparing the above definitions on “Plant Varieties”, we can see the influential impact from the advent of biotechnology on the UPOV regime.
    
    Both the Directive 2100/94/EC [27]and Article 23(b) of Implementing Regulations to the Convention on the Grant of European Patents copied the definition of “Plant Varieties” from UPOV 1991.
    
    In China’s regulation on the Protection of New Plant Varieties of Plants which enacted in 1997, “Plant Varieties” is described as “a cultivated plant variety, or a developed one based on a discovered wild plant, which is new, distinct, uniform and stable, and whose denomination is adequately designated”.[28]
    
    It can be inferred from above analysis that there is no easy work to give a exact definition on “Plant Varieties”. In fact, the progress of modern biotechnology has challenged the notion of “Plant Varieties”—how to distinguish between “plant” and “plant varieties” in the time of genetic engineering; Should transgenetic plants be regarded as “plant” or “plant varieties”? These questions have been the subject of hot debate in the ongoing “review” process on Article 27.3(b).
    
    4.“effective sui generic system”
    
    As mentioned above, UPOV regime is generally accepted as a “sui generic system” for the protection of plant varieties. Industrial property protection for plant varieties is not new. Historically, patent protection was considered inappropriate for the protection of new plants and hence systems of plant variety protection were created.In the 1920s and 1930s several countries introduced legislation that gradually evolved into a sui generis system of protection (“breeders’ rights”) distinct from patent system. Based on requirements of distinctness, novelty, uniformity and stability, breeders’ rights have typically been permitted to control the commercialization of propagating materials (like seeds), without interfering, however, either with the use of saved seeds by farmers on their own land(“farmers’ privilege) or with the development of new varieties by a third party taking as a starting point a protected variety(“breeders’ exemption”). Such sui generis regime obtained recognition at the international level in the 1960s with the adoption of the UPOV Convention. The Convention introduced minimum standards for the recognition of breeders’ rights and, as mentioned, it initially prohibited the provision of patent and sui generis protection for plant varieties.[29]
    
    The most controversial issue raised in the interpretation of Article 27.3 (b) of TRIPS Agreement is that whether the “sui generic system” for the protection of plant varieties refers only to UPOV regime. Some developed countries take a view that for the fully implementation of TRIPS Agreement, Members should introduce “sui generic system” into their national legislations.[30] However, most developing countries rejected such interpretation to “sui generic system” by arguing that Members are entitled to select other forms of regimes, which conform to the aims and principles of CBD[31] and ITPGFA[32], to protect plant varieties.[33] In fact, UPOV Convention is initially developed within industrialized countries for the mutual protection and has no relevance to the developing countries. It is the drafting of TRIPS Agreement that makes the UPOV regime into the global discussion. So far developing counties have made considerable efforts with the aim to breaking the “monopoly” of UPOV regime in the filed of plant varieties protection. For example, The African Unity Organization (AUO) drafted African Model Legislation for the Recognition and Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Genetic Resources in 2000, which, in the light of the aims and principles of CBD, emphasizing on the protection of the rights of indigenous communities and the regulation of the multinational corporation’s activities in relation to the obtaining of biogenetic resources in Africa. India also passed Protection of Plant Varieties and Farmers’ Rights Act in 2001 linking the protection of plant varieties with farmers’ rights.
    
    Ⅴ “Review” of Article 27.3(b)
    
    As mentioned above, Article 27.3(b) is the only clause in the whole TRIP Agreement subject to an early review. The discussions concerning the review of Article 27.3(b) were amongst the most controversial discussions in the work of the Council for TRIPS. This review has now been underway in the Council for TRIPS since December 1998[34]. The discussions have dealt not only with the review of Article 27.3(b) but also with the relation with the Convention on Biological Diversity (CBD) and traditional knowledge.
    
    A. Reasons for the “review” and forthcoming controversies
    
    At the time of the Uruguay Round, as said above, most Contracting Parties to the GATT had not yet acquired any experience on the protection of biotechnological inventions. Article 27.3(b) was accepted, as an agreement in principle, but subject to be reviewed after further experience was acquired on its practical implications.
    
    When the debate on the review of Article 27.3(b) was opened in the TRIPS Council in April of 1999, developed countries hesitated to engage in discussions concerning changes in its language. Instead, they would rather engage in analyzing the information gathered concerning the implementation of Article 27.3(b) by Members.[35]In other words, developed country WTO Members tried to keep the review within the scope of the provision’s language, that is, within the issue of patentability of biotechnological inventions, thus avoiding to expand the scope of the review into areas not comprised by the provision. On the other hand, developing countries were adamant that Article 27.3(b) called for a substantive review of its provisions, and not a mere examination of its implementation. Actually, developing countries were interested in adding language to Article 27.3(b) so as to reflect commitment made by WTO Members under the Convention on Biological Diversity. These two proposals were repeatedly made by developing countries in the course of the review: new provisions should be added to the TRIPS Agreement specifying the intellectual property rights and of indigenous and local communities[36]; Patent applicants should be required to identify clearly the source and the country of origin of biological material and patents inconsistent with Article 15 of the CBD must not be granted.[37] At the TRIPS Council meeting held on March 21,2000, the Chair set out a list of issues which could be used to structure the discussions around the review of Article 27.3(b), as follows:
    
    - the link between the provisions of Article 27.3(b) and development;
    
    - technical issues relating to patent protection under Article 27.3(b);
    
    - technical issues relating to sui generis protection of plant varieties;
    
    - ethical issues relating to patentability of life forms;
    
    - the relationship to the conservation and sustainable use of genetic maerial;
    
    - the relationship with the concepts of traditional knowledge and farmers’ rights.[38]
    
    B. Doha Declaration and the Review of Article 27.3(b)
    
    The review of Article 27.3(b) was also one of the TRIPS issues dealt with at the Ministerial Meeting at Doha in 2001. In this respect, the Doha Declaration included the following mandate for the Council for TRIPS:[39]
    
    “19. We instruct the Council for TRIPS, in pursuing its work programme including under the review of Article 27.3(b), the review of the implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this Declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by Members pursuant to Article 71.1. In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Article 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.”
    
    Implementing this mandate, the Council for TRIPS has been discussing, inter alia, the following agenda items:
    
    (a)the review of the provisions of Article 27.3(b);
    
    (b) the relationship between TRIPS and the Convention on Biological Diversity(CBD);
    
    (c)the protection of traditional knowledge and folklore.[40]
    
    The discussions thus far revealed differences between developed and developing countries and touched in particular on major issues on which these two large groups of WTO Members may disagree, namely the patenting of life forms and plant varieties and relationship between TRIPS, the CBD and generally the protection of the traditional knowledge.[41]
    
    C.Main Issues in Discussion
    
    During the process of the review of Art.27.3 (b), TRIPS Agreement, many issues have been raised, including:
    
    1.Review of Article 27.3(b)
    
    1) Protection for plant varieties and animal inventions
    
    Arguments in favor of protection by patent protection were that the adequate protection was necessary to promote investment and facilitate transfer of technology and that this protection should be granted on an international level. Arguments against were that the broad patent protection would facilitate “bio-piracy”, impede the use of exchange of the seeds by the farmers, and would not enable appropriate prior informed consent of the communities involved.
    
    The proposed solutions range from maintaining the status quo, to retaining the existing exceptions with further clarifications, to deleting the exceptions from patentability in Article 27.3(b) to prohibiting completely the patenting of any life form.
    
    2) Scope of the exceptions to patentability
    
    Different views regarding the scope of the exceptions to patentability, namely for defining what plants, animals, and micro-organisms are; [42]whether a part of the plant or animals is patentable; whether microorganisms should be excluded from patentability, or should this be left to national legislation; finally a view that classification in Article 27.3(b) corresponds to the other international classifications, in particular that contained in the CBD.
    
    3) Ethical exceptions to patentability
    
    Many ethical consideration were invoked with respect to the exceptions from patentability in Article 27.2, including that the patenting of life forms itself is unethical, and contrary to ordre public and morality; that commercial exploitation of such inventions should be prevented; that the inventions contrary to ordre public and marality should be excluded from the patentability on various grounds, including the protection of life and health of humans, animals, and plants; specific concerns relating to public health, human rights, agricultural security, bio-piracy, traditional knowledge and farmers’ rights.
    
    4) Applicability of patent protection to plant varieties
    
    Here the discussion have centered on how the requirements for patentability should be applied in the case of plant and animal inventions, as well as microorganisms. Defining these criteria has been left to national legislation up until now, meaning that different criteria may be applied in different countries. There were also some concerns about having too low a threshold for these criteria of patentability. In this connexion, a difference was made between discoveries and inventions. Traditionally, inventions are patentable and discoveries are not. Many other issues regarding what constitutes a discovery and what constitutes an inventive step( or “non –obviousness”)were raised. Patenting of genes, more specifically DNA sequences was also discussed. On the side of the spectrum views are that genes, if isolated, are patentable. Another view is that they are not patentable under TRIPS, since they are a part of the living organisms.
    
    5) Sui generis protection of plant varieties
    
    There were views that protection of plant varieties is beneficial for agricultural development, since it promotes development of new plant varieties. Others believed that such protection is unfavorable for developing countries, their agriculture, development and traditional communities and their knowledge.
    
    6) Relation to UPOV
    
    The TRIPS Agreement does not specifically refer to the sui generis system of protection provided in the UPOV Convention. One view was that UPOV system is an effective system and that there should be a clear reference in the TRIPS Agreement to the UPOV system of protection [43]in particular to the 1991 version of the Convention, which is more patent –like than previous versions, which were considered to impose a lower lever(or “copyright-like”) of protection. The opposing view is that the UPOV system is not suitable for developing countries and, thereof, that it should not be directly referred to in the TRIPS Agreement. In other words, countries should be left to choose which system they prefer (UPOV, ITPGRFA of FAO or the CBD).
    
    7) Relationship with traditional knowledge and farmers’ rights
    
    A number of developing countries expressed the view that the protection of plant varieties, especially plants with medical characteristics, has a direct effect on the protection of traditional knowledge. These countries believe that the current system provided in Article 27.3(b) is flexible enough to protect the traditional knowledge and indigenous communities, and thereof should not be changed. However, the opposing view has been that the sui generis system in TRIPS primarily targets the protection of the commercial varieties of plants, and that the Agreement does not prevent Members from protecting farmers’ rights within their national sui generis system of protection. The protection of farmers’ rights has also been seen as broader issues, going beyond the scope of the TRIPS Agreement.
    
    2.Relationship between the TRIPS Agreement and the CBD
    
    Various views have been expressed concerning this relationship. They can be summarized as follows:
    
    1) There is inherent conflict and the TRIPS Agreement should be amended to remove such conflict.
    
    The proponents of this view argue that the TRIPS Agreement allows for the patentability of genetic material, which leads to the appropriation of such material by private parties and is inconsistent with the sovereign rights of countries over their genetic resources as provided in the CBD. The second argument is that the TRIPS Agreement does not require prior informed consent and benefit-sharing, as provided for in the CBD. The proponents of this view suggest amendments to the TRIPS Agreement to exclude the patentability of life forms and parts thereof, or, in the alternative, to exclude from patentability inventions based on traditional or indigenous knowledge and any derived products. There was also suggestion that the Agreement should amended to exclude from patentability inventions inconsistent with Art.15 of CBD.
    
    2) There is no conflict between the two instrument and they can be implemented in mutually supportive manner.
    
    The proponents of this view argue that the objectives and purposes of the Agreement and CBD deal with different subject-matter and that granting of patent right over genetic material does not conflict with the provisions of the CBD regarding the sovereign rights of countries over their genetic material. Thereof, in their view there is no need to amend the Agreement.
    
    3) There is a possible conflict which requires clarification so that the instruments could be implemented in mutually supportive manner
    
    The proponents of this view argue that there is a considerable overlap in subject matter of the two instruments, and interaction between them. According to advocates of this point of view, the exception contained in Article 27.3(b) should be maintained, but TRIPS should be amended to include certain provisions of the CBD, namely requirement to disclose the origin of genetic material or traditional knowledge used, as well as obtaining prior informed consent, and including appropriate benefits- sharing obligations. This balancing could be done on several levels, including WIPO, the CBD, the FAO and the TRIPS Agreement.
    
    3.Patentability of genetic material and the CBD
    
    The main concern here has been that patenting the genetic material according to the TRIPS Agreement is inconsistent with the CBD because it limits access to such material and conflicts with the sovereign right of countries over their genetic resources. Also, there is concern that the criteria for patentability of the TRIPS Agreement are broad and enable the patenting of genetic material in its natural state or of material that has been isolated from its natural state. The opposing view is that patenting of the genetic material does not conflict with the sovereign rights of WTO Members. Patenting of genetic material only permits the right holder to prevent others from using, producing or marketing the protectable subject mater, but it does not bestow an ownership on the source of the genetic material. The criteria of patentability are not too broad per se; the broad scope derives from the incorrect application of the principles of the TRIPS Agreement.
    
    4.The TRIPS Agreement and Prior Informed Consent
    
    The proponents of the inconsistency theory (between the TRIPS Agreement and the CBD) argue that TRIPS is incompatible with the CBD because allows for grant of a patent on genetic material without requiring prior informed consent and benefit sharing, as provided in the CBD. Therefore, they proposed that Article 27.3(b) of TRIPS be amended to include the following condition for patentability: disclosure of any source of genetic material used, disclosure of any traditional knowledge, evidence of prior informed consent and the evidence of equitable benefit-sharing. The opposing view is that these conditions are not suitable for inclusion in the TEIPS Agreement, but rather should be implemented in national legislation, and should be contractually regulated, or through governmental funding- granting activities.[44]
    
    Ⅵ Conclusion
    
    Although biotechnology was known since fermentation was used to produce beer and make bread, the economic interest in biotechnology has increased extraordinarily since “modern” biotechnology emerged in the late of 1970s as a result of the development of monoclonal antibody technology and the techniques of molecular biology and recombinant DNA. Since the 1980s considerable progress has been made in the field of biotechnology- based pharmaceuticals as well as in the application of genetic engineering to animals and plants.
    
    However, the development of “modern” Biotechnology” was occurred only in few industrialized or technique- advanced countries. Most developing countries, while enjoy most of the biodiversity available in the world, had little experience regarding the IPRs protection of biotechnological inventions. Unfortunately, when the negotiation of TRIPS Agreement began to appear in the agenda of multilateral trading forum, minority’s point of view prevail at last. That is the origin of Article 27.3(b) of TRIPS Agreement and the forthcoming controversial “review”.
    
    When we look at the evolution and controversial review process of Article 27.3(b) of TRIPS Agreement, two trends can be observed: Firstly, the substantial impact from the advent of modern biotechnology on the IPRs regime, especially patent system and UPOV regime; Secondly, the huge gap between developing and developed countries regarding the IPRs protection on biotechnology-related innovations.
    
    In my opinion, the multilateral trading system-WTO, which aimed to the promotion of globe trade liberalization, is not the suitable forum for the discussions of biotechnological inventions. The provisions of Article 27.3(b) of TRIPS Agreement should be substantially amended for the building up the equitable regime of benefit sharing and access to the biological genetic resources.
    
    Reference
    
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    Cartagena Protocol on Biosafety to the Convention on Biodiversity, June 5, 1992, 39 International Legal Material 1027(2000).
    
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    European Union’s Council Regulation 2100/94, 27 July 1994, on Community Plant Variety Protection, Official Journal L 227, 01/09/1994,p.1-30
    
    Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, 6 July 1998,1998 OJ L213.
    
    S. Biber-Klemm and T. Cottier(ed.): Rights to Plant Genetic Resources and Traditional Knowledge, Basic Issues and Perspectives, CAB Publishing, 2006.
    
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    --------------------------------------------------------------------------------
    
    *This article is funded by the project between Institute of Federalism, University of Fribourg, Switzerland and Center for International Law Studies, Chinese Academy of Social Sciences. The author wishes to expresses his sincere appreciation to Prof. Dr. Lidija R. Basta Fleiner for her valuable help and instructions.
    
    [1] See International Law on Biotechnology, Draft Report, Biotechnology Committee of International Law Association, Toronto, 2006.
    
    [2] See Graham Dutfield: Intellectual Property, Biogenetic Resources and Traditional Knowledge, Earthscan Publishing, London, 2004, p15.
    
    [3] Article 2 of Convention on Biodiversity.
    
    [4] Article 3(i) of the Cartagena Protocol on Biosafety to the Convention on Biodiversity, 5 June 1992, 39 International Legal Material 1027(2000).
    
    [5] John S. Leibovitz, Inventing a Nonexclusive Patent, 111 Yale L.J. 2251, 2256 (2002)
    
    [6] See S. Biber-Klemm and T. Cottier(ed.): Rights to Plant Genetic Resources and Traditional Knowledge, Basic Issues and Perspectives, CAB Publishing, 2006, at p115.
    
    [7] 447 US 303(1980).
    
    [8] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, 6 July 1998,1998 OJ L213.
    
    [9] Steve Charnovitz: Patent Harmonization under World Trade Rules, in The Journal of World Intellectual Property, Vol.1, issue 1, at p. 129.
    
    [10] See Ituku Elangi Botoy: From the Paris Convention to the TRIPS Agreement, A One-Hunderd- and Twelve-Year Transitional Period for the Industrialized Countries, in The Journal of World Intellectual Property, Vol.7, issue 1, at p123.
    
    [11] UNCTAD-ICTSD: Resource Book on TRIPS and Development, Cambridge University Press,2005, p 388.
    
    [12] Daniel Gervais: The TRIPS Agreement: Drafting History and Analysis, Second Edition, Sweet&Maxwell, 2003. p220.
    
    [13] See UNCTAD-ICTSD: Resource Book on TRIPS and Development, Cambridge University Press,2005, p 388.
    
    [14] See World Intellectual Property Organization, Memorandum on Exclusion from Patent Protection, Doc. No.HL/CE/IV/INF/1, reprinted in 27 Industrial Property, 192(1988).
    
    [15] UPOV is a French acronym for what is referred to in English as the International Union for the Protection of New Varieties of Plant. WIPO and UPOV are closely associated. The UPOV Convention is a shorthand for the treaty administered by that organization.
    
    [16] MIN.TNC/W/35/Rev.1, 3 Dec.1990.
    
    [17] Correa Carlos M.: Biological Resources and Intellectual Property Rights, 5 Eur. Intell. Pro.Rew.(EIPR)154.
    
    [18] Article 53 of EPC describes: “European patens shall not be granted in respect of: …(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof."(emphasis added)
    
    [19] Rule 23(b).
    
    [20] Art.2 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the protection of biotechnological inventions
    
    [21] WTO Council for Trade –Related Aspects of Intellectual Property Rights: Review of the Provisions of Article 27.3 (b), 18 February 2003, IP/C/W/273/Rev.1,p5-8.
    
    [22] Ibid, at p26.
    
    [23] Article 7.1.2.3, Guideline to the Patent Examination, Order No.12 of Intellectual Property Bureau of People’s Republic of China, 18 October, 2001.
    
    [24] See J. Coombs, Macmillan Dictionary of Biotechnology, Macmillan, London and Basinstoke 1986, P.198.
    
    [25] Article 25.1.4 of Patent Law of PRC.
    
    [26] Article 7.1.2.1, Guideline to the Patent Examination, Order No.12 of Intellectual Property Bureau of People’s Republic of China, 18 Oct, 2001.
    
    [27] European Union’s Council Regulation 2100/94, 27 July 1994, on Community Plant Variety Protection, Official Journal L 227, 01/09/1994,p.1-30.
    
    [28] Article 2, Regulations of the People’s Republic of China on the Protection of New Varieties of Plant.
    
    [29] The limitation contained in Article 2 of the 1978 Act was not applicable to countries that provided double protection before the expiry of the period for signature of the 1978 Act( Article 37). This allows the United States to maintain both patents and breeders’ rights for plant varieties.
    
    [30] European Communities,IP/C/M/25, para.74; Japan, IP/C/W/236, IP/C/M/40, para.40, para.98; Switzerland, IP/C/M/30, para.166; United States, IP/C/W/162; Uruguay, IP/C/M/28, para.132
    
    [31] The Convention on Biological Diversity.
    
    [32] The International Treaty on Plant Genetic Resources for Food and Agriculture.
    
    [33] Brazil, IP/C/M/30, para.183, IP/C/M/25,para. 94; India, IP/C/W/161, page 4; Malaysia, IP/C/M/ 37,para. 202, IP/C/M/29, para.206, IP/C/M/29,para.83; Mexico, IP/C/M/ 26,para. 76;Singapore,IP/C/M/30,para.172 ;Zambia, IP/C/M/28,para.147 ; Zimbabwe, IP/C/M/ 36/Add.1,para.201 ; African Group, IP/C/W/404,p.2.
    
    [34] In Dec.1998, the TRIPS Council issued Illustrative Questions: Review of the Provisions of Article 27.3(b),IP/C/W/122), marking the beginning of the review.
    
    [35] See e.g., WTO documents IP/C/M/23, of June 2, 1999 and IP/C/M/24, of October 29,1999.
    
    [36] See e.g., WTO documents IP/C/W/163, of November 8, 1999, IP/C/W/356, of June 24, 2002, and IP/C/W/356/Add.1, of November 1, 2002.
    
    [37] See e.g., WTO documents IP/C/W/ IP/C/W/356, of June 24, 2002 and IP/C/W/356/Add.1, of November 1, 2002.
    
    [38] See WTO document IP/C/M/226, of May 24, 2000.
    
    [39] See paragraph 19 of the Ministerial Declaration, WT/MIN(01)/DEC/1of 20 November 2001.
    
    [40] See, e.g., WTO/AIR/2322 of 27 May 2004, WTO/AIR/2246 of 5 February 2004, and WTO/AIR 2104 of 20 May 2003.
    
    [41] For the overview of the discussion and views presented during the review of Art.27.3(b) see Notes by Secretariat, Review of the Provisions of Article 27.3(b), document IP/C/W/369; The Protection of Traditional Knowledge and Folklore, document IP/C/W370 and The Relationship between the TRIPS Agreement and the Convention on Biological Diversity, document IP/C/W/368.
    
    [42] See J.Watal, Intellectual Property Rights in the WTO and Developing Countries, (Kluwer, 2001) at p.132.
    
    [43] See Review of the Provisions of Art.27(3)(b), Relationship Between the TRIPS Agreement and the Convention on Biological Diversity and Protection of Traditional Knowledge and Folklore; Information from Intergovernmental Organization: ADEENDUM, WTO Document IP/C/W347/Add.3 of June 11, 2002.
    
    [44] For a more detailed explanation of the opposing views, see The Relationship Between the TRIPS Agreement and the Convention on Biological Diversity: Summary of Issues Raised and Points Made: Note by the Secretariat, WTO Document IP/C/W/368 of August 8,2002, at paras 20.