Source: https://www.scribd.com/document/110185218/Trips-Related-Patent-Flexibilities-and-Food-Security
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Matched Legal Cases: ['sui generis', 'sui generis', 'sui generis', 'sui generis', 'art/4', 'art/4', 'Sui Generis']

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September 2012 | QUNO - ICTSD
Quaker United Nations Office (QUNO) The Quaker UN Office, located in Geneva and New York, represents Friends World Committee for Consultation (Quakers), an international non-governmental organization with General Consultative Status at the UN. QUNO works to promote the peace and justice concerns of Friends (Quakers) from around the world at the UN and other global institutions. It is supported by the American Friends Service Committee, Britain Yearly Meeting, and the worldwide community of Friends as well as a range of other individual and institutional donors. International Centre for Trade and Sustainable Development (ICTSD) Founded in 1996, the International Centre for Trade and Sustainable Development (ICTSD) is an independent non-profit and non-governmental organization based in Geneva. It has been active in the field of intellectual property since 1997, among other things, through its programme on Innovation, Technology and Intellectual Property (IP). One central objective of the programme has been to facilitate the emergence of a critical mass of well-informed stakeholders in developing countries that includes policy-makers and negotiators as well as representatives from the private sector and civil society, who will be able to define their own sustainable human development objectives in the field of IP and advance these effectively at the national and international level. About the Author Carlos M. Correa is Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics, University of Buenos Aires. Acknowledgements The author is grateful for comments on earlier drafts of this study from Ahmed Abdel Latif, Kiyoshi Adachi, Claudio Chiarolla, Caroline Dommen, Graham Dutfield, Jose Esquinas, Jonathan Hepburn, Pedro Roffe, Geoff Tansey, Robert Tripp, David Vivas and Jonathan Woolley, as well as for feedback from participants in a dialogue held in Geneva on 14 June 2012. The views expressed in this publication are those of the author and do not necessarily reflect the views of QUNO, ICTSD or their funding institutions. This Policy Guide may be downloaded from www.quno.org/economicissues/food-sustainability/ foodLinks.htm#QUNOPUB or http://ictsd.org/programmes/ip/ Hard copies of this Policy Guide are available in English, French or Spanish, on request. QUNO and ICTSD welcome feedback and comments to this document. These can be sent to Caroline Dommen (cdommen@quno.ch) or Ahmed Abdel Latif (aabdellatif@ictsd.ch). Correa, Carlos; (2012); TRIPS-Related Patent Flexibilities and Food Security: Options for Developing Countries, Policy Guide, QUNO-ICTSD, Geneva, Switzerland. Copyright © QUNO and ICTSD, 2012. This work is licensed under the Creative Commons Attribution-Non-commercial-No-Derivative Works 3.0 License. To view a copy of this license, visit http://creativecommons. org/licenses/ bync-nd/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA. Readers are encouraged to distribute, translate or quote from this study, provided the source is acknowledged and that it is for educational or non-profit purposes. QUNO and ICTSD would appreciate being informed of such use. ISBN 978-2-8399-1111-5
ABBREVIATIONS AND ACRONYMS PREFACE IV 1
1. INTRODUCTION 2. INTELLECTUAL PROPERTY PROTECTION OF PLANTS: BRIEF HISTORY AND OPTIONS 3. EXCLUSIONS FROM PATENTABILITY
3.1. Plants 3.2. Essentially Biological Processes 3.3. Plant Varieties 3.4. Ordre Public and Morality
4. PROLIFERATION OF PATENTS ON PLANT MATERIALS
4.1. Multiplicity of Patent Claims 4.2. Distinction Between Invention and Discovery 4.3. Novelty 4.4. Inventive Step
5. SCOPE OF EXCLUSIVE RIGHTS UNDER PATENTS
5.1. Scope Of Claims In Gene Patents 5.2. Unintentional Infringement 5.3. The Farmers’ Privilege 5.4. Research and Breeding 5.5. Compulsory Licenses
6. CONCLUSIONS ENDNOTES REFERENCES
CBD CGN ECJ EPC EPO EU FAO FTA IP IPR ITPGRFA MAS PVP R&D TRIPS UPOV WTO Convention on Biological Diversity Centre for Genetic Resources European Court of Justice European Patent Convention European Patent Office European Union UN Food and Agriculture Organization Free-trade agreement Intellectual property Intellectual property rights Treaty on Plant Genetic Resources for Food and Agriculture Marker-assisted selection Plant variety protection Research and development Trade-Related Aspects of Intellectual Property Rights International Union for the Protection of New Varieties of Plants (UPOV) World Trade Organization
The Quaker UN Office and ICTSD started working on the ways that international intellectual property policy can affect food and sustainability in the late 1990s. Since then, each organization has undertaken a range of activities, including commissioning publications in which examine a subject of importance in the international intellectual property regime, highlight key issues they see arising and make recommendations for policymakers. The aim is to contribute to greater understanding of the impact of intellectual property policy upon people’s lives and thus to better inform debate and policy. This Policy Guide is designed for negotiators and policymakers in the areas of intellectual property, agriculture and food policy as well as breeders, farmers and other members of civil society. We also intend for it to be a useful tool for providers and recipients of technical assistance in the areas of intellectual property and agriculture. This Policy Guide proceeds from the observation that there is insufficient awareness of the flexibilities available for each country to implement the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in a way that is consistent with its food, agriculture and development priorities. These priorities may differ significantly from one country to another, depending on the nature of each country’s agriculture sector and environmental and developmental priorities. The Policy Guide recalls how important the free flow of genetic material and knowledge has been throughout history for progress in plant breeding. The Guide also emphasizes that the flexibilities incorporated in the TRIPS Agreement are an integral part of the agreement. This Guide focuses on patents (as opposed to plant variety protection or plant breeders’ rights). It draws on the wide experience in this area in countries that implement the patent flexibilities discussed, most notably the European Union (EU). Promoting agricultural innovation is key to address food security. At the same time, ensuring that the benefits of such innovation are widely diffused, especially in developing countries, is equally important. It is for each country to strike the necessary balance to achieve this taking into account its specific needs and priorities. We sincerely hope you will find this publication useful particularly at a time when food security has become such a pressing global challenge which requires urgent responses.
Representative, Global Economic Issues, QUNO
Achieving food security1 is a major objective of the international community. The effort to reduce the number of people suffering from food insecurity faces many obstacles, including underinvestment in agriculture and rural development, substantial increases in food prices and poverty. A number of factors related to the production of seeds and control over plant materials and technologies can also impair attainment of food security. The field related to the development and production of commercial seeds is highly concentrated. There is a growing orientation of research and development (R&D) toward commercially attractive crops and varieties, while traditional seed supply systems are eroded. The spread of commercial plant varieties has significantly reduced the genetic variability and increased the vulnerability of agricultural production. In addition – and this is the focus of this Guide – some forms of intellectual property rights (IPRs) can create barriers to the free flow of information and materials (e.g. through farmers’ exchange of seeds), which is essential to sustained levels of food production as well as development of new varieties. IPRs were originally conceived for innovations in manufacturing (such as new machinery, industrial products and processes) and artistic creations (such as literary works or music). More recently, IPRs have been applied to biological processes and products, including living organisms. The expansion of IPRs to plant materials and food has given rise to concerns about the possible implications for food security.2 IPRs generally grant exclusive rights. This means that the right holder can exclude, for a period of time, anyone from using the protected subject matter, unless the national law provides for specific exceptions or limitations. Thus, IPRs remove competition and enable the right holder to charge the price that the market will bear. Hence, the granting of IPRs affects access to protected products and their affordability. Higher prices for seeds and other agricultural inputs may be detrimental to small farmers and increase the concentration of agricultural production for food. In addition, IPRs may have an impact on what agricultural research is done and on the sustainability of agriculture. In this respect, concerns include the: • • • growing orientation of R&D toward commercially attractive crops and varieties; erosion of traditional seed supply systems that are a source of economic independence and resilience in the face of threats such as pests, diseases or climate change;3 loss of crop diversity due to the uniformisation resulting from the spread of commercial varieties.4
Although various factors5 may contribute to these effects, IPRs – particularly patents - may amplify them. Indeed, changes in intellectual property (IP) legislation and jurisprudence have made it possible in some countries to patent plant genetic materials, whether natural or modified. The growing use of patents to protect innovations in plants, as a result of the obligations arising from the TRIPS Agreement and from bilateral and regional free-trade agreements (FTAs) entered into by a number of developed and developing countries6, may drastically transform the paradigm related to the free flow of knowledge and materials (e.g. through farmers’ exchanges of seeds) under which agriculture developed over the past centuries.
Although the TRIPS Agreement provides WTO Members with flexibilities for implementing its provisions in ways that are consistent with their agriculture and food policy objectives, such flexibilities have received little attention so far. In fact, many WTO Members have not used them or have done so only to a limited extent. This contrasts with the situation in the area of public health, where a large range of measures has been debated and adopted nationally and internationally to ensure access to medicines.7 Countries could do much more to develop systems of IP protection that, while being consistent with the TRIPS Agreement, would be adapted to local conditions and reward innovation as well as promote food security. When designing and implementing IP regimes, therefore, crucial choices need to be made about the type and scope of IPRs conferred on plant materials and food. This Policy Guide describes the flexibilities contained in the TRIPS Agreement and how they can be used at the national level to promote and support food security policy objectives. It provides recommendations and options for policymakers and officials in developing countries, taking into account relevant precedents from developing and developed countries. This Guide focuses on flexibilities related to patents as applied in the area of plant materials. Issues related to possible options for implementing plant variety protection, such as in the context of the International Union for the Protection of New Varieties of Plants (UPOV), are not considered here.8 Progress in plant breeding for food has historically been based on open flows of materials and knowledge. The exchange of seeds and knowledge about them has traditionally taken place among farmers. Food crops also moved from their places of origin to distant places around the world where they were adapted and improved. Recognizing the importance of keeping such flows unrestricted for research and breeding is one of the main objectives of the UN Food and Agriculture Organization (FAO) Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA).9 Granting patents on plant varieties and plant components (such as genes) may impede access to genetic resources needed to ensure the continued development of diverse10, adapted and improved plant varieties. The analysis and recommendations of this Guide are based on the assumption that achieving food security requires a legal system that preserves a free flow of knowledge and plant materials, so as to permit a continuous process of improvement and adaptation of plant varieties through research and breeding, the availability of a diversity of materials to respond to local needs and changing conditions (including those generated by climate change), and the diversification (as opposed to concentration) of the supply of technologies and seeds. It is also based on the assumption that patents may encourage innovation in some sectors only when certain contextual conditions exist (such as a solid scientific and technological infrastructure, risk capital and adequate industrial policy), and that it will be up to national governments to decide how to strike a balance between promoting access to, and diffusion of, innovations, on the one hand, and the granting of exclusive rights through IP, on the other.11 After briefly considering the history and different modalities of IPRs applicable to plants, the Policy Guide examines the flexibilities available in relation to the • • • exclusions from patentability; scope of protection when patents are granted; and extent of exclusive rights granted.
2. INTELLECTUAL PROPERTY PROTECTION OF PLANTS: BRIEF HISTORY AND OPTIONS
Plant-related IPRs are not new. The Plant Patents Act was enacted in 1930 in the United States to respond to the demands of the nascent seed industry. It allowed for the protection of asexually reproduced cultivars12 (except tubers) under a system of special “plant patents.” The Netherlands was the first country to introduce, in 1942, a new sui generis form of IPR for plant varieties – known as plant variety protection (PVP) – and Germany followed suit in 195313. PVP evolved, after intense debates, as an alternative to patents in an effort to capture the specific characteristics of innovation in the plant breeding industry,14 namely the fact that a plant variety can only be the outcome of incremental innovation. The PVP model was eventually enshrined in the UPOV Convention signed in 1961 and subsequently revised in 1978 and 1991. The UPOV Convention initially banned double protection by PVP and patents,15 but the 1991 revision permits both. This change reflects the growing trend toward granting patents on plants and their components.16 Currently, PVP and patent protection covering plant DNA and cells and, in some cases, complete plants and plant varieties, coexist in most countries. Only a small number of countries17 have implemented sui generis regimes different from UPOV. There is a significant body of literature and a large number of proposals for the design of such regimes, largely triggered by the wording of Article 27.3(b) of the TRIPS Agreement. The notion of Farmers’ Rights – first mentioned in 1983 in the FAO International Undertaking on Plant Genetic Resources for Food and Agriculture18 and incorporated later into the ITPGRFA19 – and the principles of benefit sharing, as contained in the Convention on Biological Diversity (CBD),20 decisively contributed to shaping those regimes. It is worth noting that “trade secrets” (a form of protection recognized by Article 39 of the TRIPS Agreement) may also apply to innovations in plant breeding, particularly in the case of the production of hybrid seeds. Commercial breeders do not make the parental lines used to generate hybrids available in order to avoid reproduction by third parties. There are significant differences between patents and PVP protection. In the case of the latter, there are also differences depending on whether UPOV 1978, UPOV 1991 or another system applies.21 The main elements of farmers’ rights as understood in the ITPGRFA are: - the right to participate in the sharing of the benefits of the use of genetic resources - the protection of traditional knowledge
- the right to participate in It is important to note that PVP protects materials that decision-making actually exist: in some countries samples thereof must be submitted to the competent authorities; in others, they must be available for as long as the protection is in force. In the case of patents, however, there is no need to provide evidence of the actual existence of the subject matter, but only the possibility of obtaining it. In some countries, such as Australia, Japan or the US, the subject matter of protection covered by patents and plant breeders’ rights may be a plant variety as such.22 However, most countries exclude the patentability of plant varieties, as allowed by the TRIPS Agreement. The rights provided under PVP and patents are similar, but PVP legislation contains two important exceptions: the “breeder’s exception” and the “farmers’ privilege” that most countries do not recognize under patent law. This question is further elaborated below, in section IV.
3. EXCLUSIONS FROM PATENTABILITY
Food security may be negatively affected by the appropriation of plant genetic resources, as it may prevent further research and breeding or limit the possible sources of supply of seeds. Article 27.3(b) allows WTO Members considerable policy space to define national laws in this area. Some of the available options relate to the exclusion from patentability of a) plants b) essentially biological processes, and c) plant varieties.
Article 27.3(b) allows (but does not oblige) WTO Members to exclude plants from patent protection. However, it is important to note that, in the absence of any definition in TRIPS itself, the exclusion for plants can be interpreted in broad terms, inclusive of plants as such as well as plant varieties and species. In addition, countries that opt to implement this exception may exclude plants, whether obtained through conventional breeding processes or through the use of genetic engineering. A large number of national laws provide for the exclusion of plants in general, or plant varieties, with a variety of legal formulations.23 Some countries’ (such as Brazil, Cameroon, Colombia, Cuba and Guatemala) laws also exclude DNA sequences and amino acid sequences corresponding to the peptides or proteins produced by a naturally occurring organism.24 The TRIPS Agreement requires that microorganisms be granted patent protection. Under a literal interpretation of the Agreement,25 the obligation to protect microorganisms is limited to organisms that are not visible to the naked eye, such as bacteria, viruses or fungi, provided that they constitute an “invention” that meets the patentability requirements. The obligation does not extend to microorganisms found in nature, even if isolated. Also, it does not extend to cells or genes, which “are naturally occurring entities that are there to be discovered, like new species or new planets.”26 In some jurisdictions, such as Europe and the US, isolated genes for which a function has been identified have been deemed patentable. This approach has influenced patent legislation and practices in many countries. However, it has been increasingly questioned in recent years. In 2010, a US district court27 rejected claims on isolated DNA or complementary DNA (cDNA) on the grounds that genes are a product of nature and therefore not inventions, even if isolated from their natural environment.28 If finally confirmed, this decision may have a broad impact in different fields of biotechnology.29 An important question is whether the possibility of prohibiting patents on plants may be understood, under the TRIPS Agreement, as applicable also to plant cells, genes and other sub-cellular components.30 It could be argued that none of those components are “plants” and, therefore, that they are not covered by the exclusion provided for in Article 27.3(b). But patenting of such components (even if modified) may be equivalent to patenting the plant as such, since the patent owner may prevent commercial acts31 relating to any plant that contains the patented subject matter and thereby nullify, in practice, the exclusion relating to patents for plants. This might be the case even where one single modified gene or an artificial gene construct is incorporated into a plant (whose genotype may contain several thousands of coding genes).32
The possibility of broadly excluding plants and parts thereof from patentability is limited or completely ruled out in countries that have signed FTAs with the US,33 where there is an obligation to grant patents for plants or to make efforts to do so.34 Recommendation: It may be important for food security to exclude plants from patentability. Excluding plants or plant varieties from patentability is effectively circumvented if national laws allow parts or components of a plant to be patented, since control over the latter leads to control over the former. Countries should therefore consider excluding plants from patentability, whether or not they are genetically modified and excluding from patentability parts and components of plants, including genes, even if isolated.
3.2. Essentially Biological Processes
TRIPS Article 27.3(b) allows the exclusion from patentability of “essentially biological processes” for the production of plants. The meaning of “essentially biological processes” – a concept drawn from the European Patent Convention (EPC) – has been examined in many European Patent Office (EPO) decisions and given a rather narrow interpretation. For instance, in Decision T320/87, Lubrizol (1990), the EPO held that “a novel combination of traditional plant breeding techniques that results in plants and seeds” is patentable. A growing number of applications claim IP protection over conventional breeding methods. According to one study, “in 2008 nearly 25 percent of all patent applications at the EPO related to plants developed by conventional breeding. Some years before, patent applications centred on conventional breeding processes had been the rare exception.”35 In 2010, about 200 patents on seeds with and without the use of genetic engineering were granted by the EPO, and 100 applications were received on plants bred without using genetic engineering.36 The use of marker-assisted selection (MAS) explains the rise in patent applications involving conventional breeding methods. MAS permits breeders to identify genes of particular interest in the plant genome. Then, by means of genetic markers, they can select the plant lines containing the desired trait. This method allows the expression of desired traits without the insertion of genes that are not naturally present in the plant’s genome, thereby avoiding the costly testing that is required for the approval and release of transgenic varieties. An important issue is whether the use of MAS can be considered an “essentially biological process” excludable from patent protection. In considering patents EP 1069819 relating to broccoli and EP 1211926 relating to tomatoes, the Enlarged Board of Appeal of the EPO ruled on 9 December 2010 that the mere use of molecular markers did not render the selection and breeding methods patentable.37 While this decision – still on appeal – seems to confirm the non-patentability of conventional breeding methods (even when based on modern techniques) under European law, it leaves open the possibility of patenting the obtained plants as such.38
Recommendation: Plant breeding methods must be available for unrestricted use to produce new varieties and ensure diversity in the field. National laws should not allow for the patentability of conventional methods for plant breeding, even where selection is assisted by genetic markers. The use of such markers should not be deemed a sufficient ground to grant patents on the products obtained as such.
3.3. Plant Varieties
The TRIPS Agreement mandates the protection of plant varieties, allowing several options: “patents, an effective sui generis regime or a combination of both.” This was one of the most controversial provisions in the TRIPS negotiating process. The initial proposals by the US, Japan, the Nordic countries and Switzerland aimed at broad patent coverage for plants and living organisms. In contrast, most developing countries rejected such an approach.39 Meanwhile, EU countries wanted to preserve the freedom to exclude plant varieties (and animal races) from patentability, as provided for in the EPC. According to TRIPS, therefore, national laws may provide for patents, a combination of PVP with patents and/or sui generis forms of protection, whether or not modelled on the UPOV Convention. In choosing the modality of protection, patents can be excluded for plant varieties as currently is the case for a large number of countries that follow the EPC approach.40 The patentability requirements (particularly the inventive step) seem not only unsuited to plant varieties, but also, given the scope of rights generally granted under patents, they may deter further research and breeding on protected materials and erode the rights of farmers to save and reuse seeds. Recommendation: Countries should assess the different options they have to provide protection for plant varieties in a manner that suits their national agriculture policy and food security objectives. Whether agricultural production in a particular country is essentially based on commercial or on farmers’ varieties, protection of plant varieties under patents is not advisable, as they may restrict further breeding and farmers’ saving and sharing of seeds.
3.4. Ordre Public And Morality
Article 27.2 of the TRIPS Agreement provides for the possibility of refusing patents for inventions 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.” Ordre public or moral grounds to prevent the grant of patents relating to plants have been invoked in some circumstances in national courts, but not admitted so far. In Plant Genetic
Systems, the Board of Appeal of the EPO found that the invention (a genetically modified plant) was not improperly used, and it had not had destructive effects.41 In 1999, a legal challenge was brought in the US against a patent granted to a US citizen on the “ayahuasca” vine, which is native to the Amazonian rainforest. The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and other indigenous and environmental groups objected to the patent because it purported to appropriate for a US citizen a plant that is not only well-known, but also sacred, to many indigenous peoples of the Amazon.42 The patent was objected to, not on ordre public or moral grounds, but because it allowed a US citizen to appropriate a plant that was considered sacred to many indigenous peoples of the Amazon. Although Article 27.2 is likely to be relevant in only a limited number of circumstances, it may be applied, for instance, when the diffusion of a certain plant technology, such as the sterilization of seeds, may have negative effects on agricultural production or the environment. Recommendation: Patents should be denied based on ordre public or moral grounds in cases where food security or the environment are put at risk, for instance, when the dissemination of certain genes may negatively affect particular crops or ecosystems.
Although the patenting of plant materials raises a number of concerns from the perspective of food security, many countries do allow such patenting. Patents are routinely granted in many developed and developing countries (such as China, Chile, India and South Africa) on genetically modified plants, plant cells, genes and other sub-cellular components as well as on enabling plant biotechnologies.43 In these cases, countries can use a number of flexibilities to limit the possible negative impact of patents on agriculture and food security. These flexibilities are examined in this section.
4.1. Multiplicity Of Patent Claims
The wide range of possible claims in connection with a single plant component or trait often leads to situations where a multiplicity of patents applies to one and the same plant. There may be a patent on promoters, another on terminator sequences and others on sequences used for “transportation” and “reporter genes” needed for the genetic transformation of a plant, and in the case of transgenic plants and agrobiotechnology products, each of their numerous components and processes, each may be protected by an IPR.44 This leads to “[t]he development of large patent portfolios of more or less overlapping claim files (‘patent thickets’).”45 The presence even of one single patented component in a plant or plant variety may create a barrier against the utilization of the latter, including for research and breeding. For instance, a patent on a peptide transit used in GA 21 (a genetic construct that makes maize resistant to an herbicide) may prevent the incorporation of this construct in plants, even if the genetic construct as such is in the public domain. The proliferation of patents explains the difficulties that researchers face:46 “a web of proprietary claims now envelops the transfer and use of patented agricultural biotechnologies, thereby limiting the freedom to operate of public and private agencies alike.”47 A telling example is provided by the obstacles found for the use of agrobacterium – the most widely used tool to genetically transform plants – by researchers both in the private and public sectors, due to the complex set of patents relating to this technology.48 Even in cases where a patent (e.g. on a promoter gene) is not in force in the country where a research entity operates, if a product were developed containing patented components, exports to countries where the patent does exist could be prevented by the patent owner. The proliferation of patents is the result of a number of convergent factors, namely the erosion of the traditional distinction under patent law between “inventions” and “discoveries,” and the relaxation of the patentability requirements.
4.2. Distinction Between Invention And Discovery
Although patent law has traditionally relied on a basic distinction between what is merely discovered as opposed to what has been invented, this distinction has become extremely thin or has disappeared. Under many laws (e.g., Australia, EC, Japan and the US), a biological material isolated from its natural environment may be considered an invention even if it previously occurred in nature.
Recommendation: Allowing appropriation of plant materials found in nature through an IP right (even if the patent claimer has done work to isolate them or identify their properties) creates barriers that may negatively affect agricultural research. The TRIPS Agreement does not oblige WTO Members to confer patents on natural biological materials. National laws should establish a clear-cut distinction between “invention” and “discovery” and consider that an “invention” does not exist where a natural substance, such as a gene, has been isolated or the properties or a function thereof identified.
Patents were originally intended to reward new technical contributions to the existing pool of knowledge, and not just the mere disclosure of what already existed. Despite this, some countries’ patent legislation allows patenting of pre-existing subject matter provided it has not been previously disclosed or made available to the public. For instance, under the European approach, a biological material may be considered an invention even if it previously occurred in nature. Thus, in Interferones Alfa-Biogen the EPO held that the availability of DNA sequences in a DNA library did not destroy novelty.49 While in most jurisdictions “novel” is understood as not being disclosed before the date of filing of the application anywhere in the world, the US has applied until recently50 a relative standard of novelty that allowed a number of patent grants on genetic resources or traditional knowledge used in foreign countries but not disclosed in written form. A typical example was the case of US Plant Patent No. 5.751 (1986) relating to a variety of Ayahuasca found in a private garden in the Amazon, whose validity was confirmed despite a formal legal challenge.51 Although new patents may not be obtained in the future in similar cases, patents already granted will remain in force until their expiry, as discussed below. Recommendation: Maintaining access to genetic resources for use and improvement is crucial for agricultural development and food security. National laws should apply an absolute concept of novelty and consider that a substance found in nature is not “novel” even if its composition, properties or characteristics have not been previously described.
Another problem that may have serious implications for further research and breeding and for the availability of multiple sources of supply of genetic resources – and, hence, for food security – is the low standard often applied to assess the level of inventive step (or nonobviousness) of patent applications relating to plants. This is a more general problem, as it also affects inventions in other fields of technology,52 notably in pharmaceuticals. A telling example of the implications of lax standards of patentability was the US Patent 5894079 (known as the enola patent) granted on 13 April 1999 on a “new field bean variety that produces distinctly coloured yellow seeds.”53 The patent owner had purchased a bag of commercial bean seeds in Mexico and selected the yellow seeds for several generations through conventional methods until he obtained a “uniform and stable population” of yellow seeds. Until the patent was judicially declared invalid, after almost ten years of litigation,
it was used to prevent imports of the yellow bean from Mexico and subjected US production of that kind of bean to the patent owner’s control. A low level of inventive step may also lead to the grant of patents on minor variants of existing products, such as a change of amino acids in a gene construct to modify plants.54 If accepted by patent offices, this kind of applications may generate uncertainty and eventually restrict the availability of generic versions of genetically modified plant varieties after the expiry of the original patent. As noted by a report of the Centre for Genetic Resources (CGN), “[P]atents on genetic properties of plants are too easily granted through careless application of the criteria (the inventiveness test, in particular).”55 “DNA sequences for functional genes can still almost automatically be patented while the technique has meanwhile become state of the art and hardly contains innovative elements.”56 Recommendation: A low standard of inventive step may reduce the sources of supply and limit research and breeding. Patent offices should apply rigorous criteria to establish inventive step in plant-related innovations, so as to grant patents only when the invention is not obvious for a person, or a team of persons, with high technical qualification and experience in the field.
Given the particular nature of plant-related inventions, the extent of the rights conferred under a country’s national law constitutes a key issue for researchers, breeders, farmers and consumers.
5.1 Scope Of Claims In Gene Patents
Few patent laws57 address issues related to inventions consisting of or based on living materials or genetic resources. This remains a largely unregulated area in most countries, including those strongly dependent on agricultural production. In the case of patents covering genes, an important issue is whether the exclusive rights extend to any possible utilization of the gene. If this were the case, nobody could use the patented gene even for functions not discovered or disclosed by the patent owner. An absolute protection of this kind is likely to discourage further research on and prevent other possible uses of a patented gene until the patent expires. Even if research is allowed under a “research exception” – as permitted under many national laws58 – a product that contains the patented gene could not be commercialized without the patent owner’s authorization until the expiration of the patent. This problem may be addressed in different ways. One would involve the grant of a compulsory license due to patent dependency, as permitted by Article 31(l) of the TRIPS Agreement. However, the conditions set out by this provision are quite burdensome, as it may be necessary to demonstrate that the invention claimed in the second patent involves an important technical advance of considerable economic significance in relation to the invention claimed in the first patent. Another way would be to limit the scope of the patent claim to the functions of the gene that were actually discovered by the applicant59 so as not to interfere with third parties’ research and use of the gene for other functions. This second alternative has been suggested by the European Parliament,60 and implemented in Germany but with regard to human DNA only.61 French patent law more broadly stipulates that the scope of a claim is limited to that part of the sequence directly linked to the function specifically disclosed in the specifications, and that such a claim cannot be enforced against a subsequent claim on the same sequence that discloses another specific application thereof.62 In a case related to a plant gene construct that provides resistance to glyphosate, the European Court of Justice (ECJ) interpreted, along the same lines, that the European Directive on the Protection of Biotechnological Inventions (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998) “makes the patentability of a DNA sequence subject to indication of the function it performs” (paragraph 45).63 Recommendation: Broad patent claims related to genetic materials may generate a disproportionate power for patent owners to prevent research or production based on functions/uses they have not discovered, thereby limiting the options for seed producers and farmers. If patents are allowed on genes, they should be limited to the function or use identified by the patent owner.
5.2. Unintentional Infringement
The presence of a trait in a plant protected by a patent may or may not be intentional, as a patented gene trait may disseminate by natural means and appear in plantations unintentionally. A telling example where the legal effects of this situation were considered was the Monsanto Canada Inc. v. Schmeiser case, where Monsanto sued Schmeiser, a Canadian canola breeder and grower, who had harvested and saved from one of his fields canola seed containing Monsanto’s patented transgene that conferred resistance to glyphosate. The Canadian Supreme Court ruled that Schmeiser had infringed Monsanto’s patent despite the fact that the presence of the patented gene in the defendant’s field was deemed to be unintentional.64 However, patent laws may exclude liability in cases of bona fide infringement, as stipulated in Article 44.1 of the TRIPS Agreement. Significantly, Article 9(f) the Swiss patent law, incorporated in 2007, stipulates that a patent does not extend to biological material that was obtained in the agricultural domain by chance (au hasard) or when it is technically inevitable.65 Recommendation: National laws should exempt from liability unintentional infringement caused by the dissemination of patented genetic materials.
5.3. The Farmers’ Privilege
A few patent laws66 clarify the rights conferred with regard to reproductive materials, such as seeds. French law, for instance, makes it clear that plant material can be multiplied or reproduced where it has been legally put on the market by the patent holder or with his or her consent, where this was the purpose for which the material has been marketed; the obtained material, however, cannot be subsequently used for further reproduction or multiplication.67 As noted above, under the UPOV system, a farmer can be allowed to save and reuse seed obtained from cultivation of a protected variety.68 However, under patent law, the protection of a component present in a plant variety (e.g. a gene construct that introduces resistance to an herbicide) may be sufficient to prevent such acts.69 Patent laws may include exceptions to allow farmers to save and reuse seeds, in a manner similar to the farmers’ privilege under PVP regimes. This is illustrated by Article 11 of the European Directive on the Protection of Biotechnological Inventions, under which those acts are admissible although subject to payment of remuneration to the breeders (small farmers do not have to pay such remuneration).70 The exception could be equally provided for without remuneration independently of the farms’ sizes. This would be a key component of a legal regime sensitive to food security policies, since it would reduce costs of production and promote the diversification of the sources of supply of seeds. Recommendation: National patent laws should, where plants and/or their components are patentable, introduce exceptions equivalent to the farmers’ privilege under PVP.
5.4. Research And Breeding
PVP regimes allow the use by breeders of a protected plant variety for research and breeding (the breeders’ exception). This is a mandatory exception under the UPOV Convention and a key feature of PVP regimes.71 This exception “optimizes variety improvement by ensuring that germplasm sources remain accessible to all the community of breeders.”72 Progress in agriculture is indeed based on the use and improvement of existing genetic materials. To encourage such progress, PVP permits a breeder to derive a new variety from a third party’s protected variety. Importantly, the new derived variety can be commercialized without the consent of the owner of the original variety, provided the repeated use of the variety is not necessary for the commercial production of another variety.73 Under UPOV 1991, however, if the variety is deemed to be an “essentially derived variety,”74 its commercialization may be subject to the authorization of the owner of the initial variety (Article 14). In principle, when patent protection exists, the patent owner can prohibit the use, production, sale or offer for sale of any biological material (including a plant variety) that contains the patented subject matter (e.g. a gene). Patent laws may, however, allow exceptions for research and breeding.75 In the US, for instance, the patent law is interpreted as meaning that a variety protected by a plant patent can be used by a third party without authorization as a parent in a commercial breeding program, since infringement will exist only when the accused variety was derived asexually from the protected variety.76 Article 22.V of the Mexican Law on Industrial Property includes a broadly worded exception allowing third parties, in the case of patents related to living material, the use of the patented product as an initial source of variation or propagation to obtain other products, except where such use is made in a repetitive manner. French Law stipulates that the exclusive rights conferred by a product or process patent on a biological material do not extend to the acts accomplished with a view to creating or discovering and developing other plant varieties.77 Similarly, Swiss law stipulates that the rights conferred by a patent do not extend to the use of a biological material for selection or discovery with the purpose of developing a plant variety.78 These exceptions to patent law may not be fully equivalent to the breeders’ exception under PVP. Although, arguably, selection, crossing, etc. of a variety could be legally done without the patent owner’s authorization, the commercialization of a newly obtained variety that contains the patented subject matter may be considered as infringing the patent. Of course, there might be little incentive for third parties to do research and breeding if the outcome thereof cannot be commercialized, unless the time of remaining protection is short. For this reason, the Dutch seeds association, Plantum NL, has suggested an exception, stipulating that the use and exploitation of plant varieties protected by patent rights “should be free, in line with the ‘breeders’ exemption of the UPOV Convention.”79 The compatibility of an exception under patent law – equivalent in its scope and effects to the breeders’ exception – with the TRIPS Agreement (Articles 28 and 30) has not been tested yet. Recommendation: The continuous improvement of plant varieties requires freedom to undertake research and breeding where patented materials are involved. Exceptions to this effect should be adopted even where a country opts not to grant patents on plants (or plant varieties). Even if it opts not to do so, such exceptions should be included if the patentability of plant components is permitted. National laws may permit the commercialization of the newly obtained varieties, on the basis of non-remunerative exceptions. However, the compatibility of an exception of this kind with the TRIPS Agreement has not been tested.
5.5. Compulsory Licenses
As an alternative to an uncompensated exception equivalent to the breeders’ exception, patent laws could provide for a remunerative exception based on a compulsory license: a breeder who might be prevented from legally commercializing a new plant variety because it contains one or more third parties’ patented components, may be entitled to obtain a compulsory license on the relevant patent/s. It is important to note in this connection that the TRIPS Agreement does not limit the grounds for the grant of compulsory licenses. Article 12 of the European Directive on the Protection of Biotechnological Inventions provides an example of compulsory licenses for situations of coexistence of patents and PVP, subject to a number of conditions: a) The breeder has applied unsuccessfully to the holder of the patent for the right to obtain a contractual license; b) The breeder can show that his variety “constitutes a significant technical progress of considerable economic interest” (Article 12.3(b)) with regard to the patented invention. c) The owner of the relevant patent/s can obtain a “cross license” on the plant variety. The European Directive, conversely, allows a company owning patents on a gene or other components to obtain a compulsory license on a third party’s plant variety that incorporates such a gene or components (Article 12.2). Swiss patent law (Article 36a), as amended in 2007, also introduced the right of a breeder to request a compulsory license when he cannot obtain or exploit his title without infringing a patent under conditions similar to those established by the referred to European Directive. The burden of proof imposed on the breeder for obtaining a compulsory license under these provisions is problematic, since it relies on the comparison of subject matters of very different nature. A plant variety, as such, cannot represent “significant technical progress” with regard, for instance, to a patented gene; rather, the incorporation of the latter may improve a plant variety, for instance, by enhancing its resistance to pests, drought or herbicides. Compulsory licenses may be provided for in national laws subject to less stringent conditions, consistent with Article 31 of the TRIPS Agreement. Recommendation: National patent laws should provide for compulsory licenses in cases where the exploitation of a protected plant variety would infringe a patent. A cross-license may be granted to the patent owner with regard to the concerned variety.
There is significant room under existing international law for countries to decide whether or not to grant patent protection for plants (including plant varieties) and their parts and components. Available options include: • • Exclude plants (whether genetically modified or not), plants varieties and essentially biological processes for the production thereof from patent protection. If patents are granted, introduce the following features: • • • • • • Clear distinction between discovery and invention; Rigorous examination of novelty and inventive step; Use-bound protection covering only the function of the gene specified in the claim; Research and breeding exemption, including the commercialization of a new variety; Allow farmers to save and reuse seeds.
Address the interface between patent and PVP through compulsory licenses.
The sharing of information and materials has historically allowed for the continuous innovation by breeders and farmers and contributed to a sustainable supply of seeds. While there is no evidence suggesting that patents may provide an important incentive for agricultural innovation, food security can be put at risk by the appropriation of plant genetic resources under patent rights. Governments may opt to use the flexibilities examined above to avoid or mitigate the possible impact of patents in this field. While discussing which options would be most suitable for a particular national situation is beyond the scope of this study, a wide range of alternatives is available and can be applied consistently with existing international rules.
1	Food	security	is	defined	as	“when	all	people,	at	all	times,	have	access	to	sufficient,	safe	and	nutritious	food	to	meet	their	dietary	needs	and	food	preferences	for	an	active	and	healthy	life”.	Article	1	of	the	1996	Rome	Declaration	on	World	Food	Security.	2	See	Special	Rapporteur	on	the	right	to	food,	De	Schutter,	O.	(2009),	Seed Policies and the Right to Food: Enhancing Agro-biodiversity, Encouraging Innovation,	Report	(A/64/170)	presented	at	the	64th	session	of	the	UN	General	Assembly	(21	October	2009),	available	at:	www.srfood.org/images/stories/pdf/officialreports/20091021_report-ga64_seed-polici es-and-the-right-to-food_en.pdf 3	Special	Rapporteur	on	the	Right	to	Food,	op.	cit.	p.	4. 4	See,	e.g.,	Chiarolla,	C.	(2011), Intellectual Property, Agriculture and Global Food Security. The Privatization of Crop Diversity, and	Jackson,	L.A.	(2000)	“Agricultural	Biotechnology	and	the	Privatization	of	Genetic	Information.	Implications	for	Innovation	and	Equity”	3	The Journal of World Intellectual Property;	Blakeney,	M.	(2009)	Intellectual Property Rights and Food Security,	Wallingford,	Oxon,	CABI. 5	Thus,	seed	certification	laws	may	encourage	the	planting	of	a	limited	number	of	commercially	developed	varieties,	while	discouraging	the	diffusion	of	farmers’	varieties	better	adapted	to	local	conditions.	The	possibility	of	obtaining,	in	many	cases,	higher	yields	and	increased	income	than	with	farmers’	varieties	also	favours	the	diffusion	of	the	former. 6	The	TRIPS	Agreement	(Article	27.3(b))	obliges	WTO	members	to	provide	some	form	of	IP	protection	for	plant	varieties	(although	not	necessarily	patents),	whereas	FTAs,	particularly	those	with	the	US,	require	actions	to	grant	patents	over	plants. 7	As	exemplified	by	the	Doha	Declaration	on	the	TRIPS	Agreement	and	Public	Health,	adopted	by	the	4th	WTO	Ministerial	Conference	in	November	2001. 8	For	discussions	of	UPOV,	see	Dutfield,	G.	(2011),	Food, Biological Diversity and Intellectual Property - The Role of the International Union for the Protection of New Varieties of Plants (UPOV),	QUNO,	available	at:	www.quno.org/geneva/pdf/economic/ Issues/UPOV%20study%20by%20QUNO_English.pdf.	See	also	Eaton,	D.	et	al.	(2006),	Intellectual Property Rights for Agriculture in International Trade and Investment Agreements: A Plant Breeding Perspective,	available	at:	siteresources.worldbank.org/ INTARD/Resources/Note11_IPR_Agri.pdf 9	For	a	number	of	crops	important	for	food	security.	Article	12.3(d)	of	ITPGRFA	stipulates	that	Parties	are	not	allowed	to	assert	IPRs	on	plant	genetic	resources	and	their	parts	and	components	obtained	through	the	ITPGRFA	System	“in	the	form	received.”	10	The	reduction	of	genetic	diversity	is	a	major	determinant	of	food	insecurity.	The	lack	of	genetic	diversity	in	potato,	for	instance,	was	responsible	for	the	‘Great	Irish	Famine’	in	1845.	A	plant	disease	(‘late	blight’)	led	to	massive	crop	failure,	widespread	famine,	and	a	million	deaths.	11	Evidence	on	the	impact	of	different	forms	of	IP	on	agricultural	innovation	is	particularly	elusive,	despite	some	efforts	to	identify	and	quantify	their	effects.	See,	e.g.,	Dutfield,	G.	(2003)	Intellectual Property Rights and the Life Science Industries: A Twentieth Century History.	Burlington,	VT:	Ashgate,	and	Boldrin,	M.	and	Levine,	D.	(2007)	Economic and
Game Theory Against Intellectual Monopoly,	available	at:	http://levine.sscnet.ucla.edu/ general/intellectual/against.htm	(particularly	chapter	4). 12	A	cultivar	is	a	race	or	variety	of	a	plant	that	has	been	created	or	selected	intentionally	and	maintained	through	cultivation.	Asexual	reproduction	is	the	reproductive	process	that	involves	only	one	organism	and	results	in	two	or	more	organisms,	which	can	preserve	unaltered	certain	desired	traits	(e.g.	disease	resistance,	flavour,	etc). 13	See	Van	Overwalle,	G.	(1999),	“Patent	Protection	for	Plants:	A	Comparison	of	American	and	European	Approaches,”	IDEA – Journal of Law and Technology	39(2),	p.	161. 14	See	Dutfield,	G.	(2003),	Intellectual Property Rights and the Life Science Industries, Ashgate,	London,	p.	186. 15	UPOV	1978,	Article	2(1). 16	See	Dutfield,	G.	(2011),	op. cit. 17	Notably	India,	Thailand	and	Malaysia.	See	also	African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources	approved	by	the	Organization	of	African	States	in	2000,	available	at:	www.opbw.org/nat_imp/model_laws/oau-model-law.pdf 18	Available	at:	www.fao.org/ag//CGRFA/iu.htm 19	Available	at:	ftp://ftp.fao.org/docrep/fao/011/i0510e/i0510e.pdf. 20	Available	at:	www.cbd.int/convention/convention.shtml 21	For	a	comparison	of	the	scope	of	rights	conferred	under	patents	and	UPOV	1978	and	1991,	see	Jördens,	R.	(2002),	Legal and Technological Developments Leading to this Symposium: UPOV’s Perspective,	WIPO-UPOV	Symposium	on	the	Co-Existence	of	Patents	and	Plant	Breeders’	Rights	in	the	Promotion	of	Biotechnological	Developments,	WIPOUPOV/SYM/02/2,	p.	3. 22	For	a	legal	definition	of	‘plant	variety’	see,	e.g.,	Article	1(vi)	of	UPOV. 23	For	a	more	detailed	analysis	of	national	legislations,	see	WIPO	(2009),	Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights.	Document	prepared	by	the	Secretariat,	SCP/13/3;	WIPO,	and	Barbosa,	D.	and	Grau-Kuntz,	K.	(2010)	Exclusions	from	Patentable	Subject	Matter	and	Exceptions	and	Limitations	to	the	Rights	-	Biotechnology,	SCP/15/3,	2010,	available	at:	www.wipo.int/edocs/mdocs/scp/en/scp_15/ scp_15_3-annex3.pdf 24	Boettiger,	Graff,	Pardey,	Van	Dusen	and	Wright,	op.	cit.p.	1093. 25	As	mandated	by	Article	31	of	the	Vienna	Convention	on	the	Law	of	the	Treaties. 26	Nuffield	Council	on	Bioethics	(2002), The Ethics of Patenting DNA. A discussion paper, London,	p.	23. 27 American Molecular Pathology, et. al., v. U.S. Patent and Trademark Office,	et.	al.,	available	at:	http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_ opinion.pdf. 28	In	support	of	this	interpretation,	an	amicus curiae brief	of	the	US	Department	of	Justice	argued	that	‘[T]he	chemical	structure	of	native	human	genes	is	a	product	of	nature,	19
and	it	is	no	less	a	product	of	nature	when	that	structure	is	‘isolated’	from	its	natural	environment	than	are	cotton	fibers	that	have	been	separated	from	cotton	seeds	or	coal	that	has	been	extracted	from	the	earth’	(available	at:	http://graphics8.nytimes.com/ packages/pdf/business/genepatents-USamicusbrief.pdf). 29	On	March	26,	2012,	the	U.S.	Supreme	Court	remanded	the	case	to	the	Court	of	Appeals	for	the	Federal	Circuit	for	further	consideration	in	light	of	its	decision	in	Mayo Collaborative Services v. Prometheus Laboratories, Inc. 30	Some	national	laws	refer	to	living	organisms,	‘in	whole	or	in	part’,	thereby	preventing	the	patenting	of	any	components	of	plants.	See	WIPO	(2009),	op.	cit. 31	As	defined	in	Article	28.1	of	the	TRIPS	Agreement. 32	The	rice	plant,	for	instance,	has	about	50.000	genes. 33	Twenty	countries	(most	of	them	developing	countries)	have	signed	FTAs	with	the	US.	See	http://www.ustr.gov/trade-agreements/free-trade-agreements. 34	For	instance,	the	US	FTAs	with	Chile,	Peru,	Colombia	and	CAFTA-DR	include	‘best	endeavor	clauses’	to	make	available	patents	for	plants,	while	other	FTAs	(e.g.	with	Morocco)	contain	a	straightforward	obligation	to	make	patents	available	for	plants.	35	Then,	C.	and	Tippe,	R.	(2009),	The Future of Seeds and Food Under the Growing Threat of Patents and Market Concentration,	available	at:	www.no-patents-on-seeds.org/images/ documents/report_future_of_seed_en.pdf,	p.	14. 36	Then,	C.	and	Tippe,	R.	(2010),	Seed Monopolists Increasingly Gaining Market Control Applications and Granting of Patents in the Sphere of Animal and Plant Breeding in 2010,	available	at:	www.no-patents-on-seeds.org/sites/default/files/news/patente_ report_2011_final_en.pdf,	p.	2. 37	Cases	G	2/07	and	G	1/08.	38	See	Then,	C.and	T.,	Ruth	(2010),	op.	cit,	p.	3. 39	See	for	instance	UNCTAD-ICTSD,	(2005)	Resource Book on TRIPS and Development. An Authoritative and Practical Guide to the TRIPS Agreement.	New	York:	Cambridge	University	Press.	p.	391. 40	See	WIPO,	Barbosa,	D.	and	Grau-Kuntz,	K.	op.	cit. 41	PLANT	GENETIC	SYSTEMS/Glutamine	synthetase	inhibitors:	T	356/93,	5	EUR.	PAT.	OFF.	REP.	357,	360	(1995). 42	See	CIEL, The Ayahuasca Patent Case,	available	at:	www.ciel.org/Bio/ayahuascapa tentcase.html. 43	See	Boettiger,	Graff,	Pardey,	Van	Dusen	and	Wright	(2004),	‘Intellectual	Property	Rights	for	Plant	Biotechnology:	International	Aspects,’	in	Paul	Christou	and	Harry	Klee	(eds.),	Intellectual Property Rights for Plant Biotechnology: International Aspects. Handbook of Plant Biotechnology,	John	Wiley	and	Sons,	Chichester.	p.	1093. 44	See	Kowalski,	S.P.,	Ebora,	R.V.,	Kryder,	R.D.,	and	Potter,	R.H.	(2002),	“Transgenic	Crops,	Biotechnology	and	Ownership	Rights:	What	Scientists	Need	to	Know,”	Plant Journal,	Aug;	31	(4):407-21.
45	Louwaars,	N.,	Dons,	H.,	van	Overwalle,	G.,	Raven,H.,	Arundel,	A.,	Eaton,D.,	and	Nelis,	A.	(2009),	Breeding Business. The future of Plant Breeding in the Light of Developments in Patent Rights and Plant Breeder’s Rights,	Centre	for	Genetic	Resources,	(CGN)	Wageningen,	p.	52. 46	See,	e.g.,	Atkinson,	R.C.,	Beachy,	R.N.,	Conway,	G.,	Cordova,	F.A.,	Fox,	M.A.,	Holbrook,	K.A.,	Klessig,	D.F.,	McCormick,	R.L.,	McPherson,	P.M.,	Rawlings,	H.R.	Rapson,	R.,	Vanderhoef,	L.N.,	Wiley,	J.D.,	Young,	C.E.	(2003),	“Intellectual	Property	Rights:	Public	Sector	Collaboration	for	Agricultural	IP	Management,”	Science,	July,	11;301(5630),	p.	174-5. 47	Nottenburg,	C.,	Pardey,	P.G.,	and	Wright,B.	D.	(2002)	“Accessing	Other	People’s	Technology	for	Non-profit	Research’	46	Australian Journal of Agricultural and Resource Economics	389	at	391-92. 48	See	Roa-Rodriguez,	C.	and	Nottenburg,	C.	(2003)	Agrobacteriummediated	transformation	of	plants.	CAMBIA,	www.bios.net/Agrobacterium;	Chung,	S.M.,	Vaidya,	M.	and	Tzfira,	T.	(2005)	“Agrobacterium	is	Not	Alone:	Gene	Transfer	to	Plants	by	Viruses	and	Other	Bacteria,”	Trends in Plants Science,	available	at	www.cambia.org/daisy/bios/1381/ version/live/part/4/data. 49	Decision	T	46	A	of	February14,	1989. 50	This	aspect	of	the	legislation	has	been	changed	by	the	‘America	Invents	Act’	(Bill	HR	1249)	signed	by	the	US	President	on	September	16,	2011. 51	CIEL,	op.	cit.	52	See,	e.g.,	Jaffe,	A.	and	Lerner,	J.	(2004),	Innovation and Its Discontents: How Our Broken Patent System is Endangering Innovation and Progress, and What to Do About It, Princeton University Press; and Federal Trade Commission (2003), To Promote Innovation: the Proper Balance of Competition and Patent Law Policy,	available	at:	www.ftc.gov/ os/2003/10/innovationrpt.pdf. 53	See,	e.g.,	Shashikant,	S.	and	Asghedom,	A.	(2009),	‘The	‘Enola	Bean’	dispute:	patent	failure	&	lessons	for	developing	countries’,	TWN Info Service on WTO and Trade Issues (Aug09/11),	Third	World	Network,	www.twnside.org.sg. 54	For	instance,	AR	P040100492,	which	claims	EPSPS	tolerant	to	glyphosate	by	mutations	of	aminoacids	in	positions	102	and	106. 55	Louwaars,N.,	Dons,	H.,	van	Overwalle,	G.,	Raven,	H.,	Arundel,	A.	Eaton,	D.,	and	Nelis,	A.	op.	cit.	p.	53.	56	Id. 57	The	European	legislation	is	noticeable	in	this	regard. 58	See	Correa,	C.	(2005),	International Dimension of the Research Exception,	SIPPI	Project,	AAAS,	Washington	D.	C.,	available	at:	http://sippi.aaas.org/intlexemptionpaper.shtml. 59	These	claims	are	generally	known	as	‘use-bound’	claims. 60	Available	at:	www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-20050407&language=EN. 61	Patent Act	of	December	16,	1980,	as	last	amended	by	the	Law	of	February	28,	2005
62	Article	L613-2-1	of	the	French	Industrial	Property	Code. 63	Case	C-428/08,	Monsanto	Technology	LLC	v	Cefetra	BV	et	al.	More	specifically,	the	ECJ	General	Advocate	held	that	‘Directive	98/44	permits	and,	in	fact,	requires	an	interpretation	to	the	effect	that,	in	EU	territory,	the	protection	conferred	on	DNA	sequences	is	a	‘purpose-bound’	protection	(paragraph	29).	See	http://curia.europa.eu/ jurisp/cgi-bin/gettext.pl?where=&lang=es&num=79899690C19080428&doc=T&ouvert=T& seance=CONCL#Footnote7. 64	[2004]	1	S.C.R.	902,	2004	SCC	34,	available	at:	http://csc.lexum.umontreal.ca/ en/2004/2004scc34/2004scc34.html. 65	A	bill	was	also	introduced	in	California	(US)	to	exempt	from	infringement	a	farmer	who	did	not	know	he	was	planting	seeds	containing	an	infringing	material,	when	he	acted	bona fide,	or	when	a	patented	genetically	modified	organism	(GMO)	was	found	at	insignificant	levels.	See	www.infogm.org/spip.php?article3705. 66	See,	e.g.	article	22.VI	of	the	Mexican	patent	law;	article	L613-2-4	(as	incorporated	in	2004)	of	the	French	patent	law;	article	8.1	of	the	European	Directive	on	Biotechnological	Inventions	98/44. 67	French	patent	law,	article	L613-2-4	(as	incorporated	in	2004). 68	While	the	farmer’s	privilege	is	automatic	under	the	1978	version	of	UPOV,	it	is	an	optional	exception	to	breeders’	rights,	and	subject	to	conditions,	under	UPOV	1991.	The	application	of	this	exception	may	be	subjected	to	payment	of	compensation	to	the	breeder.	See,	e.g.	the	Council	Regulation	(EC)	No	2100/94	of	27	July	1994	on	Community	plant	variety	rights,	available	at:	www.cpvo.europa.eu/documents/lex/394R2100/ EN394R2100.pdf. 69	For	instance,	in	a	decision	by	the	US	Court	of	Appeals	of	the	Federal	Circuit	in	Monsanto v. McFarling	(302	F.3d	1291,	Fed.	Cir.,	May	2007),	a	farmer	was	condemned	to	pay	a	fixed	compensation	per	bag	of	saved	seed.	See	www.cafc.uscourts.gov/opinions/05-1570.pdf,	and	Correa,	C.	(2009),	Trends in Intellectual Property Rights Relating to Genetic Resources,	Commission	on	Genetic	Resources	for	Food	and	Agriculture,	Rome:	Background	Study	Paper	No.	49,	Rome,	available	at:	ftp://ftp.fao.org/docrep/fao/meeting/017/k533e.pdf. 70	See	also	http://eurlex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnu mdoc&lg=EN&numdoc=31994R2100&model=guichett.	71	See	UPOV,	Access to Genetic Resources and Benefit-Sharing. Reply of UPOV to the Notification of June 26, 2003, from the Executive Secretary of the Convention on Biological Diversity (CBD)	(adopted	by	the	UPOV	Council	at	its	session	number	37,	on	23rd	October	2003),	available	at:	www.upov.int/export/sites/upov/en/news/2003/pdf/ cbd_response_oct232003.pdf). 72	Jördens	(2002),	op.	cit.,	para.	12. 73	See,	e.g,	article	5(3)	of	the	UPOV	Convention	(1978). 74	An	‘essentially	derived	variety’	would	exist,	for	instance,	when	a	gene	construct	is	inserted	in	an	existing	variety.	The	concept	is	defined	in	article	14(5)(b)	of	UPOV	1991.	75	See	Henson-Apollonio,	V.	(2002),	Patent Protection for Plant Material,	WIPO-UPOV	Symposium	on	the	Co-existence	of	Patents	and	Plant	Breeders’	Rights	in	the	Promotion	TRIPS-Related Patent Flexibilities And Food Security: Options For Developing Countries
of	Biotechnological	Developments,	Geneva,	October	25,	available	at:	www.upov.int/en/ documents/Symposium2002/pdf/wipo-upov_sym_02_4.pdf. 76	Based	on	Imazio Nursery v. Dania Greenhouses,	69	F.3d	1560,	36	USPQ2d	1673,	CAFC	1995. 77	Article	L613-5-3	(as	amended	in	2004). 78	Any	agreement	that	limits	or	nullifies	the	exception	would	be	deemed	null	and	void. 79	Plantum NL position on patents-and plant breeders’ rights,	adopted	6	May	2009.	See	also	a	similar	proposal	in	Louwaars,	N.,	Dons,	H.,	van	Overwalle,	G.,	Raven,	H.,	Arundel,	A.,	Eaton,	D.,	and	Nelis,	A.	op.	cit.,	p.	57.
African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources, Organization of African States, 2000. Available at: www.opbw.org/nat_imp/model_laws/oau-model-law.pdf. Atkinson, R.C., Beachy, R.N., Conway, G., Cordova, F.A., Fox, M.A., Holbrook, K.A., Klessig, D.F., McCormick, R.L., McPherson, P.M., Rawlings, H.R. Rapson, R., Vanderhoef, L.N., Wiley, J.D. and Young, C.E. “Intellectual Property Rights: Public Sector Collaboration for Agricultural IP Management,” in Science, July, 11;301 (5630), 2003. Barbosa, D. and Grau-Kuntz K. Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights–Biotechnology, WIPO/SCP/15/3, 2010, Available at: www. wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3-annex3.pdf Blakeney, M. Intellectual Property Rights and Food Security, Wallingford, Oxon, CABI, 2009. Boettiger, S., Graff, G.D., Pardey, P.G., Van Dusen, E. and Wright B.D “Intellectual Property Rights for Plant Biotechnology: International Aspects,” in Paul Christou, P. and Klee H. (eds.), Intellectual Property Rights for Plant Biotechnology: International Aspects. Handbook of Plant Biotechnology, John Wiley and Sons, Chichester, 2004: 1089-1113. Boldrin, M. and Levine, D.K. “Economic and Game Theory against Intellectual Monopoly,” 2007. Available at: http://levine.sscnet.ucla.edu/general/intellectual/against.htm. Centre for International Environmental Law (CIEL), The Ayahuasca Patent Case, Available at: www.ciel.org/Bio/ayahuascapatentcase.html. Chiarolla, C. Intellectual Property, Agriculture and Global Food Security. The Privatization of Crop Diversity, Edward Elgar, 2011. Chung, S.M., Vaidya, M. and Tzfira, T. “Agrobacterium is Not Alone: Gene Transfer to Plants by Viruses and Other Bacteria,” in Trends in Plants Science, 2005. Available at: www.cambia. org/daisy/bios/1381/version/live/part/4/data. Correa, C. “International Dimension of the Research Exception,” SIPPI Project, AAAS, Washington D.C., 2005. Available at: http://sippi.aaas.org/intlexemptionpaper.shtml. Correa, C. Trends in Intellectual Property Rights Relating to Genetic Resources, Commission on Genetic Resources for Food and Agriculture, Rome: Background Study Paper No. 49, Rome, 2009. Available at: ftp://ftp.fao.org/docrep/fao/meeting/017/k533e.pdf. De Schutter, O. Seed Policies and the Right to Food: Enhancing Agrobiodiversity, Encouraging Innovation, Background Document to the Report (A/64/170), 64th session of the UN General Assembly, 2009. Available at: www.srfood.org/images/stories/pdf/ officialreports/20091021_report-ga64_seed-policies-and-the-right-to-food_en.pdf. Dutfield, G. Food, Biological Diversity and Intellectual Property - The Role of the International Union for the Protection of New Varieties of Plants (UPOV), QUNO, 2011. Available at: www.quno.org/geneva/pdf/economic/Issues/UPOV%20study%20by%20QUNO_English.pdf. Dutfield, G. Intellectual Property Rights and the Life Science Industries: A Twentieth Century History, Burlington, VT: Ashgate, 2003. Eaton, D.; Louwaars, N. and Tripp, R. Intellectual Property Rights for Agriculture in International Trade and Investment Agreements: A Plant Breeding Perspective, World Bank Agricultural
and Rural Development Notes Series, 2006. Available at: siteresources.worldbank.org/ INTARD/Resources/Note11_IPR_Agri.pdf. European Parliament Resolution on Patents for Biotechnological Inventions, 2005. Available at: www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2005-0407&langu age=EN. Federal Trade Commission To Promote Innovation: the Proper Balance of Competition and Patent Law Policy, 2003. Available at: www.ftc.gov/os/2003/10/innovationrpt.pdf. Henson-Apollonio, V. “Patent Protection for Plant Material,” WIPO-UPOV Symposium on the co-existence of patents and plant breeders’ rights in the promotion of biotechnological developments, Geneva, October 25 2002. Available at www.upov.int/en/documents/ Symposium2002/pdf/wipo-upov_sym_02_4.pdf. Jackson, L.A. “Agricultural Biotechnology and the Privatization of Genetic Information. Implications for Innovation and Equity,” in The Journal of World Intellectual Property, 3(6), 2000: 825-848. Jaffe, A.B. and Lerner, J. Innovation and Its Discontents: How Our Broken Patent System is Endangering Innovation and Progress, and What to Do about It, Princeton University Press, 2004. Jördens, R. Legal and Technological Developments Leading to this Symposium: UPOV’s Perspective, WIPO-UPOV Symposium on the Co-Existence of Patents and Plant Breeders’ Rights in the Promotion of Biotechnological Developments, WIPO-UPOV/SYM/02/2, 2002. Kowalski, S.P., Ebora, R.V., Kryder, R.D. and Potter, R.H. (2002), “Transgenic Crops, Biotechnology and Ownership Rights: What Scientists Need to Know,” Plant Journal, Aug; 31 (4):407-21. Louwaars, N., Dons, H., van Overwalle, G., Raven,H., Arundel, A., Eaton,D., and Nelis, A. “Breeding Business. The Future of Plant Breeding in the Light of Developments in Patent Rights and Plant Breeder’s Rights,” Centre for Genetic Resources, (CGN) Wageningen, 2009. Nottenburg, C., Pardey, P.G., and Wright, B.D.) “Accessing Other People’s Technology for Nonprofit Research” 46 Australian Journal of Agricultural and Resource Economics 389, 2002: 391-92. Nuffield Council on Bioethics The Ethics of Patenting DNA, A discussion paper, London, 2002. Roa-Rodriguez, C. and Nottenburg, C. “Agrobacterium Mediated Transformation of Plants,” CAMBIA, 2003. Available at: www.bios.net/Agrobacterium. Shashikant, S. and Asghedom, A. “The ‘Enola Bean’ dispute: Patent Failure & Lessons for Developing Countries,” TWN Info Service on WTO and Trade Issues (Aug09/11), Third World Network, 2009. Available at: www.twnside.org.sg. Then, C. and Tippe, R. Seed Monopolists Increasingly Gaining Market Control Applications and Granting of Patents in the Sphere of Animal and Plant Breeding in 2010, 2010. Available at: www.no-patents-on-seeds.org/sites/default/files/news/patente_report_2011_final_en.pdf Then, C. and Tippe, R. The Future of Seeds and Food under the Growing Threat of Patents and Market Concentration, 2009. Available at: www.no-patents-on-seeds.org/images/ documents/report_future_of_seed_en.pdf.
UNCTAD-ICTSD, Resource Book on TRIPS and Development. An Authoritative and Practical Guide to the TRIPS Agreement, New York: Cambridge University Press, 2005. UPOV, Access to Genetic Resources and Benefit-Sharing. Reply of UPOV to the Notification of June 26, 2003, from the Executive Secretary of the Convention on Biological Diversity (CBD), 2003. Available at: www.upov.int/export/sites/upov/en/news/2003/pdf/cbd_respon se_oct232003.pdf Van Overwalle, G. “Patent Protection for Plants: A Comparison of American and European Approaches,” in IDEA – Journal of Law and Technology 39(2), 1999: 143-194. WIPO, Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights, SCP/13/3, 2009. Available at: http://www.wipo.int/edocs/mdocs/scp/en/scp_13/ scp_13_3.pdf
Related Quaker UN Office publications Food, Biological Diversity and Intellectual Property: The Role of the International Union for the Protection of New Varieties of Plants (UPOV), Graham Dutfield, 2011 Disclosure of origin and Access and Benefit Sharing: The special case of seeds for food and agriculture, Walter Smolders, 2005 Patents, Trade & Food, 2004 Sui Generis Systems for Plant Variety Protection: Some Options under TRIPS, Biswajit Dhar, 2002 Micro-organisms, Definitions and Options under TRIPS, Margaret Llwewlyn& Mike Adcock, 2000
Related ICTSD publications The Influence of Preferential Trade Agreements on the Implementation of Intellectual Property Rights in Developing Countries, Ermias Tekeste Biadgleng and Jean-Christophe Maur, UNCTAD-ICTSD, 2011 Trading in Genes: Development Perspectives on Biotechnology, Trade, and Sustainability, Ricardo Meléndez-Ortiz and Vicente Sánchez, eds, Earthscan, 2005 Resource Book on TRIPS and Development, UNCTAD-ICTSD, Cambridge University Press, 2005. Nutrition and Technology Transfer, John Barton, UNCTAD-ICTSD, 2004
Quaker UN Office (QUNO) 13 avenue du Mervelet 1209 Geneva, Switzerland Tel : +41 22 748 4810 Fax : +41 22 748 4819 quno@quno.ch www.quno.org International Centre for Trade and Sustainable Development (ICTSD) International Environment House 2 7 Chemin de Balexert, 1219 Geneva, Switzerland Tel: +41 22 917 8492 Fax: +41 22 917 8093 ictsd@ictsd.ch www.ictsd.org The TRIPS Agreement provides WTO Members with flexibilities for implementing its provisions in a way consistent with their agriculture and food policy objectives. However such flexibilities have received little attention so far. Many WTO Members have not used them or have done so only to a limited extent. This policy guide describes the TRIPS-related patent flexibilities that may be desirable and necessary for supporting agriculture and food policy objectives and how they may be applied. It seeks to encourage developing countries to implement intellectual property policy in a way that is consistent with such objectives.
Trips Related Patent Flexibilities and Food Security by International Centre for Trade and Sustainable Development16 viewsEmbedDownloadDescriptionFood security is a pressing global challenge. Agricultural innovation is critical to addressing it. Equally important is ensuring that the benefits of such innovation are widely diffused, especiall...Food security is a pressing global challenge. Agricultural innovation is critical to addressing it. Equally important is ensuring that the benefits of such innovation are widely diffused, especially in developing countries.The TRIPS Agreement provides WTO members with flexibilities for implementing its provisions in a way consistent with their agriculture and food security objectives. Yet such flexibilities have received little attention so far. This Policy Guide by Carlos Correa seeks to fill this gap. The Guide provides an overview of TRIPS-related patent flexibilities that support agriculture and food security objectives.This Guide is designed for negotiators and policymakers in the areas of intellectual property, agriculture and food policy as well as breeders, farmers and other members of civil society. It also intended to be a useful tool for providers and recipients of technical assistance in the areas of intellectual property and agriculture.Interests: Books, Society & Culture, Social Issues, Agriculture & FoodRead on Scribd mobile: iPhone, iPad and Android.Copyright: Attribution Non-Commercial (BY-NC)Download as PDF, TXT or read online from ScribdFlag for inappropriate contentShow moreShow less
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