How Will a Substantive Patent Law Treaty Affect the Public Domain for Genetic Resources and Biological Material?

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1 _Jwip83_Tvedt 17/5/05 8:28 am Page 311 How Will a Substantive Patent Law Treaty Affect the Public Domain for Genetic Resources and Biological Material? Morten Walløe TVEDT * I. INTRODUCTION The Standing Committee on the Law of Patents (SCP), a specialized committee on patent law under the World Intellectual Property Organization (WIPO), is presently negotiating a Substantive Patent Law Treaty (SPLT). Although its objectives are not expressed in clear language, these negotiations can be assumed to aim at achieving international harmonization on outstanding topics in patent law, such as a common understanding of standards governing the patent criteria, patent applications and patent claims, and their equivalent interpretation. 1 The SPLT negotiations cover three separate legal documents: the draft Treaty (i.e. the SPLT), the draft Regulations under the SPLT and the draft Practical Guidelines. Probably only the draft Treaty will be legally binding in the classic sense of international law, while the Regulations and Practical Guidelines will likely not have treaty status and will therefore probably not be subject to ratification by the legislatures of the contracting parties. However, they will have a normative effect when the SPLT enters into force. In the effort to harmonize outstanding topics of patent law, the negotiations and future interpretations will necessarily touch on some controversial areas. One such area is that of patenting living organisms and genes. 2 There is an international debate addressing how to keep a publicly available, vital room for manoeuvre in research on genetic resources and living organisms. The term genetic resources is defined as a legal term in the Convention on Biological Diversity (CBD), whereas biological material is * Research Fellow, the Fridtjof Nansen Institute, Lysaker, Norway; and Cand. Jur., University of Oslo. The author wishes to thank researcher Martin Bryde at the Fridtjof Nansen Institute for comments and technical assistance. The author may be contacted at: mwt@fni.no. 1 These are the main topics regulated in the draft treaty. The main objectives of the WIPO are, according to the Convention Establishing the World Intellectual Property Organization, Article 3: (i) to promote the protection of intellectual property throughout the world through cooperation among States and, where appropriate, in collaboration with any other international organization, (ii) to ensure administrative cooperation among the Unions. (Unions means: the Paris Union, the Special Unions and Agreements established in relation with that Union, the Berne Union, and any other international agreement designed to promote the protection of intellectual property whose administration is assumed by the Organization.) 2 Property rights to genetic resources and biological material is a heavily debated topic. See, for example, Dhar and Anuradha, 2004; Fowler et al., 2004; Shiva, 2004; Sampath, 2004; Isaac and Kerr, 2004; O Connor, 2003; Tonye, 2003; Gervais, 2003; Boyd et al., 2003; Chambers, 2003; and Gopalakrishnan, 2002.

2 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY a broader concept. This article addresses both, as the patent system is not limited by the definitions in the CBD. A patent will typically not be linked to either of these terms, as the inventor himself describes the invention. In the context of another intellectual property rights (IPR) system, under copyright there has been a debate on the relationship between the public domain for different types of creative works and the extent of protection of creative work. The need to protect new works is held up against the need for a vital public domain within which creative artists can work freely without undue regulatory hindrance. Several particular problems arise when patent law is applied to biotechnology, in particular to genetic resources and biological material. 3 The negotiations of the SPLT in the WIPO take a holistic view, covering inventions in all fields of technology without suggesting any adaptations to specific areas of technology. Thus, there is a particular need for addressing the challenges that the draft SPLT will imply for biotechnology as a specific field of innovation. International harmonization of the term invention with the other patent criteria becomes crucial to the public domain. Indeed, reaching a common understanding of, inter alia, the term invention is a main topic to be dealt with by the SPLT. The present suggestions for harmonization in the draft SPLT are similar to the current interpretation and practice in developed countries. Thus, developing countries will have to change their patent laws the most if the draft Treaty is agreed. A preliminary understanding of the concept public domain can be that it includes those subject-matters (publications, products, and processes) that belong to the public and cannot be covered by individual exclusive rights. This means that genetic resources and biological material in the public domain are those that can be used by the public without restriction. Because a patent grants an exclusive right to the use of an invention by one individual, there is a latent conflict between genetic resources and biological material being in the public domain and the grant of patents to these subject-matters. When core topics in patent law are harmonized, as the draft SPLT will do, the property-rights situation will be affected. Thus, the aim of this article is to explore how a new international treaty on substantive patent law might affect the public domain for genetic resources and biological material. From a public-domain point of view, there are a large number of challenges if not to say problems that are probable consequences of the draft SPLT. This article discusses a moving target albeit a slow-moving one as the draft Treaty has not yet been fully agreed to nor is it at all legally binding. 4 Despite the slow progress, there is a need for analysis of the probable consequences of the ongoing 3 For example, Westerlund (2001) discusses profoundly the concepts of invention or discovery, enabling disclosure and the doctrines of equivalence for biotech patents; and Bostyn (2002) discusses the requirement for enabling disclosure in depth. See also the report from the Nuffield Council (2001), which expresses several concerns. 4 The analysis is based on the latest available edition of the draft Treaty, after the Tenth Session of the negotiations, held in May 2004; available at: (accessed on 2 May 2005).

3 _Jwip83_Tvedt 17/5/05 8:28 am Page 313 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 313 negotiations. This is particularly relevant because the Treaty itself, and its accompanying draft Regulations and draft Practical Guidelines, will interact with a number of other treaties and touch on several different areas of controversy. In the larger picture of patent law, there are several treaties that will interact with the SPLT: the signed but not ratified Patent Law Treaty, which harmonizes a variety of procedural topics for the grant of patents; the Patent Co-operation Treaty, with its system for searching the prior art ; and the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) under the World Trade Organization. The SPLT will further harmonize a selection of terms and concepts used in these treaties but which are now left to the interpretation of the States. Besides these treaties, there is another discussion forum in the WIPO addressing, inter alia, genetic resources: the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. 5 There are also a number of other agreements that are not specifically patent-related but are crucial in this context because of their regulation of rights to genetic resources and biological material. The CBD specifies that genetic resources are within the sovereign rights of each country 6 but that all countries should grant access to genetic resources for environmentally sound uses under certain conditions. Also, CBD Article 16 touches upon the relationship to patents. Its paragraph 5 reads: The Contracting Parties, recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to its objectives. Even if this paragraph is geared towards co-operation, it adds to the reasons for assessing the probable effects of a new draft patent law treaty on the public domain for genetic resources and biological material. 7 The Bonn Guidelines, adopted at the Sixth Conference of the Parties (COP-6) of the CBD, include a number of suggestions as to how countries might establish a system for granting such access. The Johannesburg Declaration of the World Summit on Sustainable Development 2002, in its Paragraph 42(o), prescribes the negotiation of a legally binding international regime on fair and equitable sharing of the benefits resulting from the use of genetic resources. 8 The COP-7 mandated the Ad Hoc Working Group on Access and Benefit Sharing of the CBD to negotiate such a regime. 9 5 For more specific information, see the WIPO Website, at: (accessed on 2 May 2005). 6 CBD Articles 3 and A potential research question could be to analyse whether it is probable that the effects of the draft SPLT would be supportive of and do not run counter to its objectives (the objectives of the CBD). The terms of reference for the present article have another scope, however, as it is geared towards the public domain and not only the CBD. However, this analysis also indicates the possibilities and obstacles under the CBD that may result from the draft SPLT. 8 The World Summit on Sustainable Development 2002 Plan of Implementation, Paragraph 42(o) reads: Negotiate within the framework of the Convention on Biological Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources 9 Final Document UNEP/CBD/COP/7/21, Decision VII/19 D.

4 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY In the terms of reference for the Working Group, the COP-7 specifies disclosure of origin/source/legal provenance of genetic resources and associated traditional knowledge in application for intellectual property rights as one element that can be included in an international regime for fair and equitable sharing of benefits. 10 A new treaty regulating substantive patent law would interact with the possibilities for the negotiations of fair and equitable benefit sharing under the CBD. This article investigates the possibilities or obstacles that the draft SPLT might imply from the perspective of these negotiations under the CBD. Another example of treaties that might be affected by the SPLT is the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), which came into force on 30 June It provides for a multilateral system for exchange of plant genetic resources for food and agriculture for a selection of important species. Before such a multilateral system enters into force, however, there shall be negotiated an agreed standard Material Transfer Agreement (MTA). One provision in the ITPGRFA, Article 12.3 (d), deserves attention in this context: Recipients shall not claim any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components, in the form received from the Multilateral System. Thus, also the forthcoming work to establish such a vital multilateral system relates to patent law, emphasizing the importance of analysing the draft SPLT. 11 The Patent Law Treaty and the ongoing negotiations are sailing under the flag of technical negotiations of patent law. The negotiations are undeniably technical but, in addition to harmonizing technical issues, the outcome of these negotiations will seriously affect innovation, social welfare and their global distribution in the coming years. Since biotechnology or life-science has been declared to be the technology of the future, the necessity of assessing the draft Treaty particularly from this specific perspective is implied. However, little has been written about the negotiations, and they are barely within the scope of public attention. 12 The remainder of this article discusses selected issues in the draft SPLT that are particularly significant for the public domain for genetic resources and biological material. Section II looks more closely at the notion of the public domain and explores the ramifications of how it is defined. Section III considers the overall regulation of patent criteria. Section IV looks at how the definition of the term invention affects the public domain. Sections V XI consider the public domain in the light of written 10 Ibid., Annex Terms of Reference for the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing (d), Elements (xiv). 11 Fowler et al. (2004) discuss profoundly the interpretation of this wording. Their perspective is, however, not the relationship between this wording and the patent system. 12 Correa (2004) has, on behalf of the South Centre, prepared a position paper analysing the text from a developing country perspective. This article does not take a pure developing country perspective but a wider look at the relationship between the new WIPO Treaty and the public interest.

5 _Jwip83_Tvedt 17/5/05 8:28 am Page 315 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 315 description, prior art, novelty, inventiveness, industrial application, patent claims, and revocation and invalidation, respectively. Finally, Section XII draws some conclusions. This article does not provide for an analysis of how the draft SPLT will affect the various domestic patent systems. As the negotiations aim at standardization, some of the rules of the drafts will typically already be the current legal situation in one or more countries. The draft SPLT will have the severest effect for those countries with the lowest level of patent protection, mainly the developing countries. 13 II. WHAT IS PUBLIC DOMAIN? This article does not intend to provide an authoritative definition but rather to contribute to understanding the concept of public domain with respect to genetic resources or biotechnology. It approaches the public domain for genetic resources and biological material both from a positive and a negative conceptualization. A positive definition of public domain would be a clear specification of those resources that may never be under exclusive rights, while a negative approach means defining public domain as those resources that are simply outside the scope of eligibility for exclusive rights. A. A POSITIVE DEFINITION OF PUBLIC DOMAIN In all types of innovative activity, there is a need for an intellectual freedom where the inventor can experiment and search for applicable solutions to the problems he sets out to solve. For genetic resources and biological material, the need for flexibility in science is evident and exists on several levels. For example, breeders need access to new genetic varieties to improve those previously bred, and biomedical researchers must scan a large number of compounds in their search for one interesting trait to follow. The question is how this open space can be safeguarded in the case of genetic resources and biological material. Perhaps a positively defined public domain is a solution. Marienhoff, an Argentine public law professor, explains the legal concept of dominio público in Argentine law as a legal regime entailing that certain goods are inalienable e impresciptible. 14 This concept of public property rights implies that the public s right to access and use these goods is inalienable and cannot be delimited or expropriated into a private exclusive right. Marienhoff distinguishes this from publicprivate ownership, whereby the government has the right to sell off public property to private persons. Although this conception is not legally binding in international law, it offers an interesting legal concept to better understand property rights to genetic resources and biological material. Applied to genetic resources and biological material, perhaps certain aspects of nature should be open to the use of everyone and not included under the private rights of private persons. 13 See Correa, 2004, p Marienhoff, 2004, p. 24.

6 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY The idea of plant genetic resources constituting some kind of public domain was adopted by the 1983 Conference of the Food and Agriculture Organization of the United Nations (FAO) in the International Undertaking on Plant Genetic Resources for Food and Agriculture, which declared these resources to be the common heritage of mankind. 15 At least this can be interpreted as an attempt to re-establish an international common resource base. This conception was, however, abandoned in a later statement. 16 However, one interesting observation is that the International Undertaking did not entail any mechanisms for safeguarding what was in the public domain from being included under the private exclusive rights of plant breeders and patents. By the time the CBD was adopted in 1992, the concept of an international, positively defined public domain can be said to have been abandoned; genetic resources were now declared to be within the sovereign rights of countries. Perhaps this abandonment of the international concept of public domain can be seen as a response to a lack of measures to safeguard the open areas and, consequently, of leaving this task of creating safeguarding mechanisms to the nation-state level. For example, Costa Rica has used its sovereign right to declare genetic resources to be dominio público for the benefit of the Costa Rican people. 17 This implies that there is a specific category of property that belongs to the State and the people, and ownership cannot be transferred to individuals. The rule cannot be owned builds upon an assumption that the same government possesses a coherent enforcement mechanism that will challenge any attempt to delimit the common rights of the people and that will bring the resources back into the positively defined public domain. The main challenge of a positive conception of public domain for genetic resources and biological material at the international level is enforcement that is, of institutions and legal mechanisms to safeguard its limits from appropriation. This is illustrated by two international examples of attempts to establish positively defined public domains for genetic resources and biological material. The Centres supported by the Consultative Group on International Agricultural Research (CGIAR) hold large collections of plant genetic resources in trust for the FAO and international society. 18 These collections are to be made available to the public, free of charge. In the standard MTA that accompanies the material, there is a clause stating 15 The International Undertaking on Plant Genetic Resources for Food and Agriculture, available at: Article 1: The objective of this Undertaking is to ensure that plant genetic resources of economic and/or social interest, particularly for agriculture, will be explored, preserved, evaluated and made available for plant breeding and scientific purposes. This Undertaking is based on the universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction. 16 Resolution 3/91 of the Twenty-Sixth Session of the FAO Conference, Rome, 1991, available at: states that the concept of mankind s heritage, as applied in the International Undertaking on Plant Genetic Resources, is subject to the sovereignty of the states over their plant genetic resources 17 Under the Ley de Biodiversidad, No of 30 April 1998, Article The mission of the CGIAR centres is [t]o contribute to food security and poverty eradication in developing countries through research, partnership, capacity building, and policy support, promoting sustainable agricultural development based on the environmentally sound management of natural resources. See CGIAR, 1998, p. 20.

7 _Jwip83_Tvedt 17/5/05 8:28 am Page 317 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 317 that the recipient shall not claim any property rights to the material as such. 19 This can be seen as an attempt to keep certain resources in the agricultural sector available to everyone regardless of their economic position. 20 The CGIAR centres do not possess sufficient legal capacity to enforce the contractual terms stating that the genetic resources received from their collections shall not be covered by IPRs. 21 Thus, the means for an effective enforcement of this fragment of positive public domain is absent. This is compounded by the fact that these clauses are, in general, extremely difficult to enforce. It is, for example, not possible or at least not practical to survey all patent applications and ensure that they are not appropriating accessions or at least parts thereof received from the CGIAR centres. Another attempt to establish a positive conception of international public domain is the ITPGRFA, in which the main idea of the multilateral system is to establish a catalogue of plant genetic resources that shall be kept for free and open use. Like the CGIAR centres, the ITPGRFA also lacks an enforcement capacity with respect to IPRs. Thus, there is far to go before this regime can be an effective positive, international public domain, and it is going to be interesting to follow the forthcoming negotiations under the FAO in this respect. The problem of lack of enforcement mechanisms is widespread. This is also the case for other types of public rights, as for example the sovereign right of countries according to CBD Article 15 and country-specific public domains such as Costa Rica s. Currently, there is no positive conception of public domain for genetic resources and biological material that provides for a sufficient level of enforcement mechanisms. If there are no effective mechanisms for enforcement of a common right or a public domain, a positive definition will not serve its purpose. Thus we are left with a discussion of a negative conception of public domain. The focus in this article is how the draft SPLT and the draft supplementing Regulations under the WIPO will adhere to a negative conception of public domain for genetic resources and biological material Material Transfer Agreement for Plant Genetic Resources Held in Trust by the Centre: The recipient, therefore, hereby agrees not to claim ownership over the material, nor to seek IPRs over that material, or its genetic parts or components, in the form received. The recipient also agrees not to seek IPRs over related information received. Available at: (accessed on 22 April 2005). 20 See Fowler et al., 2004, pp. 641 et seq. 21 See ibid., at p. 649, discussing whether each allele in each accession is included under the term germplasm in the MTAs. 22 Thus, the article will not follow a theoretical discussion of public domain as a legal concept. Also, the lack of enforcement mechanisms has a broader applicability. It also applies to genetic resources and biological material that are already subject to private rights, such as, inter alia, use rights, regardless of whether these rights are exclusive or not. How can these rights be enforced in an international context? This article cannot apply such a broad approach.

8 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY B. A NEGATIVE DEFINITION OF PUBLIC DOMAIN A negatively defined public domain will follow from the interpretation of the scope of private property when applied to this particular subject-matter. If this approach is applied, the point of departure will be that all subject-matters that can in principle be covered by patent law can be included under exclusive private rights. The limit of the public domain is defined negatively by an interpretation of the IPR systems, in this case by the patent system. In copyright law, there has been a profound discussion of the negative definition of the public domain for intangible objects. There, public domain is understood as follows: In the intellectual property context, the term [public domain] describes a true commons comprising elements of intellectual property that are ineligible for private ownership. 23 This definition relies on the positive definitions in another legal system. Another example of an even clearer negative conception of public domain is: what remains after one examines all possible sources of legal protection 24 The definition of public domain will then be what is not be covered by IPRs. A negative definition of public domain as what is not covered by IPRs simply describes what the present legal situation provides for. It is apparently not normative in the strict sense but, looking closer, it is not without normative implications. By applying a negative approach to public domain, normativeness is brought to the arena for IPRs. It is left to the patent law arena to define what shall be in the public domain when it comes to genetic resources and biological material. Then the limit between the exclusive right and the public domain is determined only by an interpretation of the intellectual property legislation. If the public domain for genetic resources or biological material is defined negatively by stating that the resources in the public domain are the resources that cannot be the object of private exclusive rights, how the draft Treaty defines, delimits and interprets patent rights will be of crucial importance. Because the draft SPLT delimits patent rights in terms of what is not covered by them, it will become the authoritative demarcation of the public domain for genetic resources and biological material. Thus, the reformulation of the patent criteria by the draft SPLT will implicitly redefine the limits of the public domain. Unlike the enforcement requirements of a positive definition, a negative definition of public domain for genetic resources or biological material is both determined and enforced through the limits embedded in patent law. Therefore, the following sections of this article investigate how the draft SPLT and its supplementing draft Regulations will determine the scope of the public domain for genetic resources or biological material. 23 Litman, 1990, p See also similar views in Lange, 1981; and Lange, Samuels, 1993, p. 150, who does not support the theory that there is a public domain in copyright law.

9 _Jwip83_Tvedt 17/5/05 8:28 am Page 319 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 319 III. EXPLICIT AND EXHAUSTIVE HARMONIZATION OF PATENT CRITERIA A first observation concerns the relationship between the main rule and the exemption established by the draft SPLT regarding grounds for refusal of a patent on a claimed invention: [Prohibition of Other Requirements] No Contracting Party may require compliance with any requirement relating to the examination of an application or the grant of a patent on a claimed invention different from or additional to the requirements provided for in paragraph (1). 25 This point of departure entails that the Treaty will prohibit all other reasons for rejecting a patent than those explicitly listed therein. Even if the TRIPS Agreement has been interpreted as imposing obligations specifying the legal grounds for rejecting a patent application, 26 the new obligation in the SPLT will state a clearer and more explicit main rule. Only those reasons listed in the SPLT will be legal as reasons for rejecting a claimed patent. The clear language is likely to make it impossible to broaden the scope of an exemption by interpretation. Only the alternatives listed in paragraph (1) of this Article will be legal patent criteria. From the perspective of the public domain, the question then is whether these legal grounds for refusing a patent safeguard the needs of a vital public domain. These grounds are stated in the draft SPLT as follows: [Grounds for Refusal of a Claimed Invention] An application shall be refused where the Office finds that such application or a claimed invention in the application does not meet any of the following requirements: (i) the applicant does not have the right to the patent referred to in Article 4; (ii) the claimed invention does not meet the requirements of Articles 6, 11(2) and (3) and 12; (iii) the application does not meet the requirements of the Patent Law Treaty, as implemented in the applicable law, and of Articles 5 and 10; or (iv) an amendment or correction results in a disclosure as prohibited by Article 7(3). 27 This list refers to both formal and material patent requirements. A preliminary observation shows that none of these alternatives specifies any particular exemptions for genetic resources and biological material. Apart from significantly reducing the degree to which Member States can exercise discretion, this will narrow the possible legal alternatives provided by both the negotiations of an access and benefit-sharing (ABS) system under the CBD and of a standard MTA under the ITPGRFA. Before looking into how each of these reasons to reject a patent relate to the public domain, there is a need to have a quick look at the legitimate exceptions in paragraph (3) for the purpose of determining whether the needs of the public domain, the CBD and 25 Article 13(3) Draft SPLT, SCP/10/4, p. 25. Unless otherwise indicated, quoted items from the draft SPLT or from the draft Regulations that are in square brackets indicate that the expression is not yet agreed to in the negotiations. Thus, these square brackets indicate the lack of international consensus in the Standing Committee on the Law of Patents, not that something has been added to the quotations. 26 Trebilcock and Howse, 1999, p Article 13(1) Draft SPLT, SCP/10/4, p. 24.

10 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY the ITPGRFA are covered: [Compliance With Applicable Law on Other Matters] A Contracting Party may also require compliance with the applicable law on public health, nutrition, ethics in scientific research, environment, access to genetic resources, protection of traditional knowledge and other areas of public interest in sectors of vital importance for their social, economic and technological development. 28 This draft paragraph entails that access to genetic resources and protection of traditional knowledge are specified as legitimate laws to be complied with. At first sight, this provision can appear to be weighted towards the obligation according to paragraph 1, but the wording reads: A Contracting Party may also require compliance with the applicable law There are several issues that are interesting from our perspective. First, the word may indicates that the Members signatory to the SPLT are not obliged to ensure that patents are not in breach of such regulations. Thus, the wording does not oblige the Member countries to take legal measures to ensure compliance with CBD or ITPGRFA legislation. Second, the wording suggests permissiveness: i.e. that a contracting party may require such compliance as a basic condition for granting a patent. Even if this can seem to be a plausible interpretation at first sight, a closer look at the interplay with the provision in paragraph (3) clearly indicates that compliance with such other applicable law cannot be imposed as a patent criterion. The patent criteria are exhaustively listed in paragraph (1), whereas paragraph (3) regulates issues outside the patent system. Compliance with such legislation must be dealt with outside patent law and cannot have any effects on the granting of a patent. This is similar to what has been put forward as an interpretation of the TRIPS Agreement: i.e. that compliance with, for example, access legislation or legislation regarding traditional knowledge cannot be included in the patent act as a patent criterion. 29 This excludes the possibility of the CBD and the ITPGRFA using the international patent system to ensure compliance by private parties. The obligation locks out the future possibility of enforcing and safeguarding a positively defined public domain by using norms of the patent system. Thus, even if this provision gives a linguistic impression at first sight of being open to such legislation, it precludes the possibility of establishing a provision for safeguarding a positively defined public domain for genetic resources and biological material by means of patent law. This will remove the future possibility of reaching consensus on using the existing institutional structure in patent law to safeguard the public domain for these resources. If the link to other legal regimes is to be ensured, there is probably a need for a more specific reference to them and a clear legal alternative in the wording establishing compliance with other legal regulations as an additional patent criterion. 28 Article 13(4) Draft SPLT, SCP/10/4, p See, for example, the EU Patent Directive 98/44/EC, Article 1, number 2; compare Article 27 TRIPS. See also Dhar and Anuradha, 2004, p. 608.

11 _Jwip83_Tvedt 17/5/05 8:28 am Page 321 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 321 Because the draft Treaty states the grounds for refusal of a patent in Article 13(1), with subsequent references, patent applicants are eligible for a patent if they are not subject to any of these grounds. This implies that the burden of proof is reversed; the Patent Office must find a ground for refusing a patent. After the patent applicant has indicated that his invention meets the patent criteria, the patent application may be rejected if and only if the Patent Office finds that it does not meet all of them. The draft SPLT embeds a principle without any discretionary grounds for refusal of a patent application. This is not a new approach for the West European and U.S. patent offices but entails that the draft SPLT establishes a system where it can be difficult to prove that a patent includes elements previously in the public domain (or under another type of public right to use). The patent offices will become the only institutional structures to safeguard the limits of the public domain for all types of technologies, including that of genetic resources and biological material. This can imply challenges for the ABS system of the CBD and for the multilateral system envisaged under the ITPGRFA. Indirectly, the draft SPLT establishes a subordination of the other UN organizations, such as the FAO and the CBD, to the WIPO when it comes to the question of safeguarding a vital public domain for genetic resources and biological material. The present draft SPLT rejects the possibility that these other UN organizations become defenders of a positively defined public domain in the future, which is going to lock the definition of the public domain to the negative one. IV. THE DEFINITION OF INVENTION AND THE PUBLIC DOMAIN The draft SPLT does not suggest any positive definition of invention as a legal term. Also, under the draft SPLT the legal concept of invention will be open for a dynamic interpretation. The definition of invention is also a core element for maintaining the public domain. If, for example, naturally occurring genes or other biological substances that previously were open for the use of everyone in the public domain are deemed eligible for patent protection and then can be included under private exclusive rights, the public domain might be reduced. Thus, the definition of invention will affect the public domain for genetic resources or biological material. The draft Treaty approaches the definition negatively by stating that mere discoveries shall not be considered eligible for patent protection. 30 From a general understanding of language, naturally occurring substances such as genes and biological material are pre-existing and therefore subject to discovery rather than invention. Biological material has been developed through selection and evolution over a long period of time. The last decades have shown that patent offices in developed countries have changed this natural linguistic interpretation by granting exclusive rights to naturally occurring biological materials, first to microorganisms and later to genes, cells and other biological material. 31 This development is partly rejected by developing 30 Article 12(1)(b)(i) Draft SPLT, SCP/10/4, p For a thorough analysis of the changes in the legal notion of invention and discoveries in Europe and the United States, see Westerlund, 2001, pp

12 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY countries. The TRIPS Agreement does not imply an obligation with respect to interpreting invention in this manner. Presently, there is no internationally agreed conception of the dichotomy invention discovery. Therefore, on this point, the draft SPLT will alter the legal situation internationally. One explanation for the draft SPLT not defining the term invention might be to reduce the lack of political consensus as a potential obstacle for the whole body of negotiations. Leaving the term invention undefined and vague opens up the possibility of a dynamic legal interpretation. This might lead to a similar interpretation worldwide, as has been the case in developed countries. The choice of wording in this paragraph entails a potential to limit the public domain to the said resources. The draft wording will leave it to the practice of the patent authorities to determine when a patent claim is a mere discovery rather than an invention or patentable discovery. Since unanimity is required to approve a later alteration of the obligations under the Treaty as interpreted by the authorities, changes in the legal situation will require new political negotiations. Thus, it can prove to be difficult to review the legal interpretation and subsequent practice of the term mere discovery for the purpose, inter alia, of keeping a vital public domain. This is particularly so for terminology that is as open for interpretation as is the subtle understanding of invention with respect to living organisms as subject-matter for patents. Such a legal situation has an inherent potential to reduce a negatively defined public domain further than the wording indicates through future interpretations and practice. A. THE RELATIONSHIP TO THE INTERNATIONAL TREATY ON PLANT GENETIC RESOURCES FOR FOOD AND AGRICULTURE For the multilateral system envisaged under the ITPGRFA, the material shall not be eligible for IPRs in the form received. This wording is clearly chosen for the purpose of maintaining the plant genetic resources under the multilateral system in the public domain. The ITPGRFA does not specify further how this term shall be understood. From the perspective of the ITPGRFA, it is then interesting to discuss how the term in the form received relates to that of mere discovery. The term in the form received gives a clear impression that it covers the state in which the material was when it was handed over to the new recipient. It does not indicate that a substantial change must occur before it is eligible for protection under IPRs. A possible understanding by the patent authorities can then be that material in the form received will also be a mere discovery and that only a small amount of processing will entail that it is no longer in the form received and also not a mere discovery, and consequently patentable. These issues regarding the term invention leave the public domain for genetic resources and biological material open to be determined negatively by the practice of the patent offices.

13 _Jwip83_Tvedt 17/5/05 8:28 am Page 323 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 323 B. NO EXEMPTION FOR ANY FIELDS OF TECHNOLOGY TRIPS Article 27.3 makes an exemption from the obligation to grant patents for the case of plants and animals. This exemption has importance for the public domain in plant and animal breeding. The TRIPS Agreement opens the possibility for countries to choose a sui generis property protection for plant varieties. In the draft SPLT, there are no similar exemptions or alternatives. Thus, if the negotiations reach consensus, countries will no longer have the right to exercise discretion in exempting these fields of technology from patent protection and to provide for a specific form of protection instead of patents, but only in addition to patent protection. This will restrict the freedom of the Member countries and extend the subject-matters eligible for patent protection beyond the existing legal situation. This will open the way for double intellectual property protection for the inventions which are also considered to be plant varieties and leave countries with less room for manoeuvre. V. THE WRITTEN DESCRIPTION AND THE PUBLIC DOMAIN As patents are exclusive rights to commercial use of abstract objects, the extent of this exclusive right depends upon a written description. 32 What is interesting here is how the requirements for the written description can affect the public domain for genetic resources and biological material. A. EXCLUSIVE REGULATION The draft Treaty, Article 5(1), prescribes the following main rule for requirements for patent applications: [(1) [Requirements Concerning Parts of Application] (a) Except where otherwise provided for by this Treaty and the Regulations or the Patent Law Treaty, no Contracting Party shall require compliance with any requirement relating to the request, description, claims, drawings or abstract of an application different from or additional to the requirements relating to the request, description, claims, drawings or abstract which are provided for under the Patent Cooperation Treaty in respect of international applications. 33 This provision specifies that three treaties are relevant for regulating an application for a patent: the SPLT, the Patent Law Treaty and the Patent Co-operation Treaty. Furthermore, it includes the draft Regulation to the draft SPLT as relevant for requirements in the written description. Under the CBD and the ITPGRFA, there has been a long debate about including a disclosure requirement as a patent criterion. The purpose of such a requirement is to safeguard the public domain and other rights to genetic resources and biological material by using the patent system. These suggestions are not included in the current draft SPLT. Article 5 uses strong wording: no 32 As follows from Article 13(1)(iii) Draft SPLT, SCP/10/4, p. 24, Articles 5 and 10 are legal grounds for refusing the grant of a patent. 33 Article 5(1)(a) Draft SPLT, SCP/10/4, p. 10.

14 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY Contracting Party shall require compliance with any requirement different from or additional to Thus, the draft SPLT does not leave room for the patent system to be an institutional structure for enforcing any certificates of origin or a standard MTA. Moreover, the current draft SPLT will narrow down the possible outcomes from the other United Nations negotiations. This affects the public domain by removing the possibility of using the patent system as a legal mechanism for enforcement in the future. Thus, a possibility of defining the public domain in a positive manner and the possibility of using the patent system as a means to safeguard the public domain will be restricted by the adoption of the draft SPLT. A way of solving this problem for the other negotiations under the United Nations, such as those under the CBD and the ITPGRFA, is to include in draft SPLT Article 5(1) that requirements agreed on in other UN fora can be included as criteria in the written description of a patent. Inclusion of this clause is a political question for the negotiations but, from the perspective of the public domain, the CBD and the ITPGRFA, such a clause would leave open an important possibility. B. DISCRETION IN FAVOUR OF THE PATENTEE Draft SPLT Article 5(1)(b) specifies an exemption to this strict wording by stating that: [(b) A Contracting Party shall be free to provide for requirements which, from the viewpoint of applicants and patentees, are more favorable than the requirements referred to in subparagraph (a) in so far as they relate to the form or contents of an application.] 34 This implies a wide discretion for the Members. The terms favorable for the applicants and the patentees clearly indicate that countries are free to determine a less restrictive and, thus, a less informative description of the patented invention than that required by the draft Treaty. This has an effect on the public domain. After the twentyyear period of protection ends, the invention, as it was described in the patent application and the patent claims, falls into the public domain. If these requirements are made less comprehensive, less information will be included in the patent application and the patent claims. Thus, less information or knowledge will be brought to the public domain as a result of patents in all fields of technology. Consequently, the use of the discretion embedded in this Article might have the effect that the public domain does not increase as it is supposed to upon the expiration of patents. C. ENABLING DISCLOSURE Patent law is a trade-off between granting an exclusive right to new inventions and making information available so others can learn and further research and development 34 Article 5(1)(b) Draft SPLT, SCP/10/4, p. 10.

15 _Jwip83_Tvedt 17/5/05 8:28 am Page 325 THE SPLT AND PUBLIC DOMAIN FOR GENETIC RESOURCES 325 may take place in that field of technology. According to SPLT Article 10: [General Principle] The application shall disclose the claimed invention in a manner sufficiently clear and complete for that invention to be carried out by a person skilled in the art. The disclosure of the claimed invention shall be considered sufficiently clear and complete if it provides information which is sufficient to allow that invention to be made and used by a person skilled in the art on the filing date, without undue experimentation [as prescribed in the Regulations] (emphasis added.). 35 The draft Regulation prescribes this: Rule 10: Sufficiency of Disclosure Under Article 10 When assessing absence of undue experimentation under Article 10(1), the factors to be considered shall include: (i) the breadth of the claims; (ii) the nature of the claimed invention; (iii) the general knowledge of a person skilled in the art; (iv) the level of predictability in the art; (v) the amount of direction provided in the application, including references to prior art; (vi) the amount of experimentation required to make or use the claimed invention on the basis of the disclosure. 36 These definitions do not specify in detail what is meant by in a manner sufficiently clear and complete. This is, however, crucial to determine the breadth of the patent claims and, thereby, the scope of the exclusive right. This is a complex issue. Different patent systems have applied different interpretations of this requirement. 37 The description shall be sufficient to allow that invention to be made and used by a person skilled in the art. This person skilled in the art is defined in the following manner: A person skilled in the art means a hypothetical person with general knowledge and ordinary skill in the relevant field of the art at the relevant date. 38 Thus, a certain level of information is required in the patent application, but the exact level of information is not positively regulated in the draft Treaty and is thereby left to patent practice. Such information will be of decisive importance when the scope of the patent protection is determined. If the public domain is determined negatively as what is not covered by patents and if there is a low requirement for the level of information in the patent application, there will be a chance that broad patents will be granted and thus a danger of decreasing the public domain. There are different competing ways to determine what is a sufficient level of information. 39 The draft SPLT does not 35 Article 10(1) Draft SPLT, SCP/10/4, p Rule 10 Draft SPLT Regulations, SCP/10/5, p For a thorough analysis of this particular issue, see Bostyn, 2002, pp Rule 2 Draft SPLT Regulations, SCP/10/5, p See, for example, Bostyn, 2002, pp For example, the two alternatives the one way approach and the whole area approach are likely to have different effects on the public domain.

16 _Jwip83_Tvedt 17/5/05 8:28 am Page THE JOURNAL OF WORLD INTELLECTUAL PROPERTY provide for a solution to this issue and leaves the situation with respect to the public domain uncertain. D. DEPOSIT OF GENETIC RESOURCES AND BIOLOGICAL MATERIAL The main principle in patent law is that the patent applicant must describe his invention by the use of language. When the patenting of living organisms, in particular microorganisms, got off the ground in the 1970s, countries decided to accept the deposit of biological material as a supplement to the written description criteria. The draft Regulation states: [Deposit of Biological Material] Where: (i) (ii) an application refers to biological material which is not available to the public; and that material cannot be described in the application in such a way as to enable a person skilled in the art to carry out the claimed invention without having access to that material, as required by Article 10, or to describe the claimed invention in compliance with Article 11(3) without a person skilled in the art having access to that material; the applicant may, to the extent that the material cannot be described in the application as set forth in item (ii), remedy the non-compliance with these Articles by depositing the material with a depositary institution in accordance with the applicable law. 40 This entails that in a specific situation, the written description can be supplemented or replaced by a physical deposit of biological material. Such deposit then makes it easier for a patent to be granted to inventions covering biological material even if the patent applicant has not reached such a technical level where he is able to describe the invention by words alone. This implies a reference in the draft Treaty to the system in place under the Budapest Treaty. 41 Does deposit of biological material bring it into the public domain? The Budapest Treaty itself does not regulate the availability of the biological material in deposit for competitors or for the public. The Budapest Treaty Regulation Rule 9.2 specifies, in contrast, a principle of secrecy: No international depositary authority shall give information to anyone whether a microorganism has been deposited with it under the Treaty. Furthermore, it shall not give any information to anyone concerning any microorganism deposited with it under the Treaty except to an authority, natural person or legal entity which is entitled to obtain a sample of the said microorganism under Rule 11 and subject to the same conditions as provided in that Rule. 42 The regulations under Rule 11 imply restricted access to the biological material in deposit. Private parties cannot access the samples in deposit. It therefore appears that the 40 Rule 11(1) Draft SPLT Regulations, SCP/10/5, p The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, 28 April 1977, amended on 26 September Regulations Under the Budapest Treaty, ibid., adopted on 28 April 1977 and amended on 20 January 1981 and 1 October 2002, Rule 9.2, Secrecy.