Intellectual Property Rights and Their Impact on Crop Improvement Research Programs in Developing Countries*

Transcription

1 Intellectual Property Rights and Their Impact on Crop Improvement Research Programs in Developing Countries* Sutat Sriwatanapongse Thailand Biodiversity Center Bangkok, Thailand Abstract Intellectual property rights (IPRs) as legal instruments are increasingly important in encouraging industrial development and economic growth. The conclusion of the new General Agreement on Tariffs and Trade (GATT) in 1994 has obliged member states to stop unauthorized diffusion of innovations in a wide range of technological sectors including those of biotechnology. There has been efforts in the movement toward unified, global IPRs among developed countries. At the same time developing countries are resisting, both formally in international fora and informally through less-thanaggressive administration of their own IPR legislation. As a result, considerable international tension and animosity exist between most developing countries and many developed countries. Most developing countries believe that living organisms and their parts should not be protected through patenting system, the strongest system of protection. Recent multilateral and bilateral negotiations and agreements have brought to the forefront several issues related to intellectual property protection in agriculture. Member countries of the World Trade Organization are obliged to establish a legal system that effectively protects IP in plant breeding, for an example. The Plant Variety Protection system or the Plant Breeders Rights system under the UPOV Convention has been proposed as the sui generis system, an option of plant variety protection system. The system has basically been developed in industrialized countries and few questions still remain to be answered. Such a system is believed not to be readily applicable in most developing countries. An appropriate system may be needed among these countries. At present, biotechnology has been rapidly developed with potential use as a tool in plant breeding. Molecular marker-aided selection will result in new varieties, the same as those developed through traditional breeding. However, using DNA technology genetic engineering could lead to the development of new plant varieties with novel genes that could not be accomplished through traditional breeding. The resulting transgenic varieties are those so-called Essentially Derived Varieties ). This development has caused worldwide debate on possible adverse effects on human health and environment. The European Parliament has therefore come up with the Council Directive on the Legal Protection of Biotechnological Inventions. It is anticipated that the intellectual property regimes would facilitate the maximum innovation in developing useful new crop varieties. Previous studies, especially the one made in Latin America, gave a negative result. It is quite crucial that capacity building on biotechnology and intellectual property system be established in order to stimulate more research and development. Keywords: Intellectual property, patents, plant variety protection, plant breeders rights, sui generis, essentially derived varieties, trademark, genetically modified plan. 81

2 * Paper presented at the IRRI Steering and Technical Committees of the Hybrid Rice Network Meeting, Bali, Indonesia, 31 July to 3 August Introduction countries and few questions still remain to be answered. Will such a system also be useful in less developed countries? What is needed to establish such a system? How will it affect the agricultural sector? How will it affect the conservation of plant genetic resources? The system seems to give protection only to the new varieties, whereas old, traditional varieties should also be under protection and benefit sharing made with the original owners. At present IP issues are attracting the interest of people at all levels. The issue of the patenting of rice varieties, such as the aromatic rice varieties, KDML 105 or Jasmine from Thailand and Basmati from India, by an American company has been under debate. At the same time the issue of the patenting of life forms in the European Union is also of interest. All these have impacts on the trade among the countries involved. The issues and conflicts are still to be resolved, and the question is how. Developing countries are trying to come up with appropriate IP systems. Most of these countries believe that living organisms and their parts should not be patented, since patenting is the strongest IP protection systems. These life forms should be protected using other systems such as the Plant Variety Protection (PVP) System and the so-called sui generis system. Discussion will be made in this paper on these appropriate systems for developing countries. Civilization has created complex societies. Human being used to depend on wild forests for food, feed, and materials for several thousand years. With an increasing world population, man has to compete for biological resources. Agriculture is believed to begin when the first plant was domesticated the beginning of biological ownership or tangible bio-properties. The application of science and technology in improving plant and animal species as well as agricultural inputs and practices has resulted in modern agriculture. Biological property with technological components needs some kind of intangible property protection or intellectual property. Intellectual Property Rights (IPRs) as legal instruments are increasingly important in encouraging industrial development and economic growth. The conclusion of the new General Agreement on Tariffs and Trade (GATT) in 1994 has obliged member states to stop unauthorized diffusion of innovations in a wide range of technological sectors including those of biotechnology. There have been efforts in the movement toward unified, global IPRs among developed countries. At the same time developing countries are resisting, both formally in international fora and informally through less-than-aggressive administration of their own IPR legislation. As a result, considerable international tension and animosity exist between most developing countries and many developed countries. Recent multilateral and bilateral negotiations and agreements have brought to the forefront several issues related to Intellectual Property (IP) protection in agriculture. Member countries of the World Trade Organization (WTO) are obliged to establish a legal system that effectively protects IP in plant breeding, for example. The Plant Variety Protection (PVP) System has been proposed as an option. The System, however, has basically been developed in industrialized Development of IP in Agriculture IP is a broad term for the various rights which the law gives for the protection of economic investment in creative effort. The principal categories of IP which are relevant to agricultural research institutes are patents, plant variety rights, and trademarks (Blakeney 1997). Patent 82

3 A patent is a right granted by the government to inventors to exclude others from imitating, manufacturing, using or selling a specific invention for commercial use during a certain period (van Wijk et al. 1993). In most countries the protection is usually years. In order to be eligible for patent protection, the subject matter has to be: novel and inventive, not obvious to a person skilled in the art, industrially applicable and useful. Final receipt of a patent in turn requires that the inventor discloses his invention to the public. Once awarded, patents are territorial, which means that they can only be honored in countries where the patent is awarded. It is the patent claim itself that defines the actual scope of the patent. Under US patent law and in applying the utility patent, inventors are granted exclusive use of their invention for 17 years, during which time the patent holder has the right to exclude others from using the invention, and may profit from the invention by monopolistically selling the product, licensing others to use it, or by selling the patent rights (Butler 1996 ). This opened up new opportunities and possibilities for plant breeders and seed companies. For example, F 1 hybrids were patentable for the first time. Special phenotypic characteristics, and broader phenotypic and genotypic characteristics of plants including plant parts could be patented. The agreement on Trade Related Intellectual Property Rights (TRIPs) states that patents shall be available for any inventions, whether products or processes, in all fields of technology... However, exclusion from patentability of plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological or microbiological processes was made. In addition, it requires that members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. Plant Variety Protection Systems Plant Variety Protection (PVP) or Plant Breeder s Rights (PBR) system, as an alternative to the protection of plant varieties under patent laws, is conferred an exclusive right to do or to license the following acts in relation to propagating material of the variety (Blakeney 1997): produce or reproduce the material, condition the material for the purpose of propagation, offer the material for sale, sell the material, import the material, export the material, stock the material for the purposes described above. As with patents, PBR is established after the registration process. A plant variety is considered to be registrable, if it has a breeder, is distinct, uniform, stable, and has not been, or has only recently been, exploited. The general duration of PBR under the UPOV Convention is 25 years in the case of trees and vines, and 20 years for any other variety. Trademarks A trademark is a sign used to indicate the origin of goods or services (Blakeney 1997). Legal protection is provided for trademarks through a system of registration. The use of a trademark is a warranty of the quality of the goods or services supplied under that mark. The name or acronym of an agricultural research institute is often a warranty of the quality of products and services, and it is worthy of protection. IRRI (International Rice Research Institute) prefix of its rice varieties, for examples, has been under consideration to be under protection. PVP Systems in Developed Countries Member countries of WTO are obliged to establish a legal system that effectively protects intellectual property in plant breeding. One of the options open to the WTO members is the 83

4 system of PVP or PBR protection. The meaning of PVP and PBR protection is essentially similar and could be used interchangeably (van Wijk and Jaffe 1996). The system has basically developed in industrialized countries and its impact to agriculture in developing countries remains to be seen. According to Barton (1994), the Plant Variety Protection (PVP) or Plant Breeders Rights (PBR) is a special form of intellectual property protection tailored to the needs of plant breeding. In its traditional form, it differs in three important ways from the regular patent system: 1. The application process is much simpler and cheaper than for the regular patent system. 2. The farmer can reuse seed harvested from a previous planting, assuming that the seed breeds true-to-type. In contrast, a farmer probably cannot in the same way reuse seed that is protected by a regular patent. 3. The breeder is able to use a protected variety in developing new varieties. The analogous question with respect to regular patents is governed by the rather unclear and limited research exemption. In 1961, the International Union for the Protection of New Varieties of Plants (UPOV) was established for coordinating the intercountry implementation of PBR among 22 member countries. After its entering into force, the Convention was revised in 1972, 1978, and With the growing privatization of plant breeding research and the increasing size of farm holdings in industrialized countries, the demand for eliminating the breeders exemption and the farmers privilege grew (Dhar and Roa 1999). This resulted in the modification of the UPOV 1991 in the following two significant respects: 1. The 1991 UPOV Convention (UPOV 1991) strengthens the position of the PBR holders by eliminating the breeders exemption for essentially derived varieties. The breeder who inserts a single new gene into a PBRprotected variety will have to obtain permission from the holder of the original rights before marketing the new variety. 2. Under the 1991 UPOV Convention (UPOV 1991), farmers are not allowed to use their own harvested material of the protected varieties for the next production cycle on their own farms. However, due to lack of consensus among UPOV members, the 1991 version contains an optional exception which provides the information that it is up to a national government to decide whether or not to have this farmers privilege. The purpose of the UPOV Convention is to give protection to new varieties. To be eligible for protection, varieties have to contain the following characteristics: 1. distinct from existing, commonly known varieties, 2. sufficiently homogeneous or uniform, 3. stable, and 4. they must not have been commercialized prior to certain dates established by reference to the date of the application for protection. New Varieties: Essentially Derived Varieties Essentially Derived Variety (EDV), as outlined by Hunter (1993), means that, a new variety derived from a protected variety if, in view of its characteristics and method of development, it would be considered by a plant breeder of ordinary skill in the species to have incorporated in the new variety essentially the entire genotype of the protected variety. Factors to be considered in evaluating the method of development should include the source of the germplasm used and the breeding methods employed, including the reasonably expected results of those methods. Under this concept the dependency exists in favor of the protected variety, the Initial Variety (IV). The aim is to foster the breeding of new and increasingly productive varieties using the IV as base and new biotechnologies as tools. The protection system as well as the sharing of benefit is not yet clear and it needs further development of the concept. The concept of EDV is quite complex and difficult to implement. Private companies in developed countries such as the US prefer to use patent system in protecting the varieties 84

5 because it gives the strongest protection. The PVP, on other hand, is more flexible with few exceptions. EU Directives on plant variety protection follow more or less that of the US in allowing the patenting of life forms. How much impact these developments will be on the agricultural development of developing countries remains to be seen. EU Directive on the Protection of Biotechnological Inventions In early 1998 the European Parliament and the Council Directive on the Legal Protection of Biotechnological Inventions has been adopted (Anon. 1998). The inventions concerning plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety. Therefore, plant and animal varieties, including essential biological processes for the production of plants or animals, are not patentable. Under this Directive, compulsory crosslicensing has been provided. A breeder may apply for a compulsory license for nonexclusive use of the invention protected by the patent inasmuch as the license is necessary for the exploitation of the plant variety to be protected, subject to payment of an appropriate royalty. The holder of a patent concerning a biotechnological invention may also apply for a compulsory license for non-exclusive use of the plant variety under protection. Development of PVP Systems in Developing Countries According to Evenson (1993), IPRs are not designed merely to facilitate the transfer of technology from one country to another. They are designed to stimulate R&D and inventive activity in all countries including developing countries. They also are designed to stimulate the removal of secrecy from ideas so that those ideas can facilitate and stimulate other inventions. It is quite interesting to assess the IPR development in developing countries. Van Wijk and Jaffe (1996), for example, provide results of a study in five Latin American countries on the impact of PBRs in developing countries. Though the period in which the PVP system enforcement in the Latin American countries was too short to draw conclusions about its impact, there were enough indications. The experience in Argentina, and to a lesser extent in Uruguay and Chile, indicated that PVP had supported the domestic plant breeding industry as anticipated. The main losers seemed to be the seed dealers involved in unauthorized seed trade. In Asia few international fora have been organized in recent years in order to discuss the IPRs issues relating to the protection of living organisms plants, animals and microorganisms. The Southeast Asia Regional Institute for Community Education (SEARICE) organized the Southeast Asian Seminar / Workshop of the Crucible Group on Intellectual Property Systems in Southeast Asia: Distilling Diversity Towards Meeting Global Challenges in the Philippines in PVP system as well as the protection of biological resources in each country was discussed. This year the International Seminar on Sui Generis Rights was held in Bangkok during 1 6 December The Seminar came with a clear message to the WTO and to the international community at large about the need to allow for exclusion of life forms from patentability and other IPR systems, and the need to recognize true sui generis rights in helping indigenous peoples and local communities to conserve and protect their biological diversity. At the ISNAR Regional Seminar on Planning, Priorities and Policies for Agricultural Biotechnology held in Singapore in 1994, IPR was one of important national policy issues in the discussion. All eight countries in Asia, Thailand included, expressed their concerns on the international development of IPR. The following issues and concerns were raised: 1. The scope of IPR protection in agriculture is not clear: Under the PVP system, only new varieties are protected. The question is how the traditional varieties or land races could be covered? An alternative may be to use other systems such as the UNESCO 85

6 Folklore Provision for the Protection of Traditional Varieties. 2. Economic concerns: The patented products seem to be more expensive than the regular one because of the added cost in the process of patenting. Patented plant varieties may be too expensive for poor farmers. Private company representatives response that the government should be able to find ways to control the price similar to other products. The Sui Generis System The term sui generis system has no uniform meaning (Smith 1996). The term is often used as denomination of alternative rights regimes for the protection of community or indigenous innovations not protected under conventional intellectual property laws, or even as a system embodying farmers and indigenous peoples rights. It is anticipated that this system could be used for the protection of the old varieties or land races. The system has been suggested as one instrument to trigger for benefit sharing mechanisms. However, as the coverage of any sui generis system will inevitably be less broad than the scope of access legislation or product authorization laws could be, it seems that the sui generis system is not the most suitable instrument for addressing the issue of benefit sharing. The reward system for plant varieties may require that complimentary legislation be implemented simultaneously, providing for the fair and equitable benefit sharing and recognizing traditional resource rights including Farmers Rights. Technological Development Developing countries may be rich in biological resources but poor in technologies. Many countries have developed many improved plant varieties using both conventional and modern biotechnology. There may be three ways to improve domesticated varieties: Use traditional breeding results in new, improved varieties. Use molecular marker-aided selection (MAS) and the resulting varieties are regular varieties. Use genetic engineering by inserting a desirable gene into a crop variety. The transformant is called transgenic variety or genetically modified plant (GMP). Developing countries are catching up with developed countries in traditional plant breeding. However, the capacity and capability of applying advanced biotechnology are still lacking. The lack of infrastructure, human and financial resources have created a big gap between the technology generated countries and the technologically-excluded countries. About half of the world s developing countries are able to adopt modern biotechnology in production and consumption (Juma 2000). It is essential, therefore, to assist those developing countries with less technological capacity and capability in all aspects of development. Among countries with some capability to apply technologies in crop improvement, few issues and problems such as biosafety, IPRs, and bioethics need to be resolved. Only IPRs issues will be discussed. Impact of IPRs on Developing Countries The impact of IPRs on agriculture in developing countries was discussed by Juma (2000). To benefit the growing populations of the developing world, new plant varieties will have to be developed. There are three practical ways: (i) farmers could select plants that succeed best in their locality for the retention of seed for future use or sale, (ii) public institutions provide improved varieties to appropriate users free or at cost; and (iii) for profit companies interested in creating new products or varieties, they could obtain plant varieties from farmers and from noncommercial institutions such as the CGIAR centers for further improvement. With the addition of one or more proprietary traits, the variety could be released in a variety of legal forms or by technical 86

7 protection. A decision tree illustrating technology objectives and options for IPR was described by van Wijk et al. (1993). Trade secrets, a form of intellectual property protection, could be used in the commercial sector in developing countries. However, they do not seem a viable option for the protection of public-sector innovations. The following impacts of IPRs on crop improvement in developing countries will be discussed: Impact on research and development: Although the study made in Latin America gave a negative result in supporting this assumption, it is believed that intellectual property regimes would facilitate the maximum possible innovation in development of beneficial new crop varieties. This may be through individual, public, and corporate sources, as well as through promotion of research collaboration. Impact on germplasm exchanges: Developing countries have come up with their own system on intellectual property protection of crop varieties. Some countries extend the protection to cover traditional varieties and wild species. The exchange of germplasm has become more and more complicated and difficult. Socio-economic impact: Technologies available at present are mainly under intellectual property protection and belong to transnational companies. Countries with less capacity may depend more and more on these technologies. Those countries with the capability to adopt technologies may have to go to a complicated negotiation process. This may result in higher cost of seeds resulting in higher cost of production. Recent Genetic Use Restriction Technology (GURT) development further complicates the issue (Juma 2000). Farmers in developing countries normally save seeds for the next planting. With GURT or terminator technology that prevents seeds from germination, it may not be fair for the poor farmers. However, it may be more desirable to use GURT technology to terminate a transgenic trait to be able to express in the following generation. Questions still remain how these developing countries could develop their own technologies. With the lack of infrastructure and resources, it may take some years to reduce dependency on imported technologies. Partnership arrangements with both public and private institutions may be an immediate solution. It is interesting to note the recommendation from the report prepared under the auspices of the Royal Society of London, the US National Academy of Sciences, the Brazilian Academy of Sciences, the Chinese Academy of Sciences, the Indian National Academy of Sciences, the Mexican Academy of Sciences, and the Third World Academy of Sciences (Juma 2000). It concluded that developing countries could get potential benefits of GM technology through the following: 1. Where appropriate, farmers must be allowed to save seed for future use if they wish to do so; publicly funded research should investigate the value and limitations of reusing seed and the results of this research should be made freely available to interested parties. 2. Broad intellectual property claims, or claims on DNA sequences without a true invention being made, should not be granted, because they stifle research and development. 3. Possible inconsistencies among international conventions, such as those that pertain to Patent Rights and the Convention on Biological Diversity (CBD), should be identified and clarified. 4. Research institutions should establish partnerships among industrialized and developing countries so that the benefits GM research, applications and licensing will become much more widely available. 5. An international advisory committee should be created to assess the interests of private companies and developing countries in the generation and use of transgenic plants to benefit the poor not only to help resolve the intellectual property issues involved, but also to identify areas of common interest and opportunity between private sector and 87

8 public sector institutions. Concluding Remarks Intellectual property issues, patent, PVP, trademarks, etc., are quite new to people in developing countries. The IP systems have been mostly developed by developed countries and their philosophy, culture, socio-economic and environmental situations are much different from those in developing countries. The IP systems are very complicated and it takes time for us in the developing world to understand them and adjust ourselves to the situation. The principles behind the systems are to protect the inventions developed using advanced technologies or knowledge. With diverse socio-economic status among countries in the developing world, appropriate IP systems in each country should be developed. The only way to have an appropriate IP system is to learn from mistakes. If we do not have one, we never know that it would work! References Anon The European Parliament and Council Directive on the Legal Protection of Biotechnological Inventions. Official Journal of the European Communities, L. 213/13, Barton, J.H Intellectual Property Rights: Plant Variety Protection. ABSP Workshop Series, July Washington, DC. Blakeney, M The Practical Management of Intellectual Property by Research Institutes. Paper presented at the ISNAR Management Course for Selected Asian Countries. Jakarta, Indonesia, 3-14 November Butler, L.J Plant Breeders Rights in the US: Update of a 1983 study. In: J. van Wijk, and W. Jaffe (Eds.), Intellectual Property Rights and Agriculture on Developing Countries, University of Amsterdam. Dhar, B.; and Roa, C.N Plant Breeders and Farmers in the New Intellectual Property Regime: Conflict of Interest? In: S. Shantaram and J.F. Montgomery, Biotechnology and Biodiversity: Science and Ethical Issues for Sustainable Development. Science Publ. Enfield, NH, USA. Evenson, R.E Global Intellectual Property Rights Issues in Perspective: A Concluding Panel Discussion. In: Global Dimensions of Intellectual Property Rights in Science and Technology. National Academy Press, Washington, DC, USA. Hunter, B Science Based Identification of Plant Material. In: P.S. Baenziger; R. Kleese; and R.F. Barnes (Eds.), Intellectual Property Rights: Protection of Plant Materials. CSSA Special Publication No. 21, Madison, WI, USA: CSSA, pp Juma, C Biotechnology in the Global Economy. Int. J. Biotech. 2: 1-6. Smith, S Farmers Privilege, Breeders Exemption and the Essentially Derived Varieties Concept: Status Report on Current Developments. Proc. Seminar on the Impact of Plant Breeders Rights in Developing Countries: Results of a Study in Five Latin American Countries, 7-8 March 1995, Santa Fe de Bogota, Colombia. UPOV International Convention for the Protection of New Varieties of Plants, 2 December 1961, as Revised at Geneva on 10 November 1972, on 23 October 1978, and on 19 March UPOV Publication No. 221E. Geneva: Union International pour la Protection des Obtentions Vegetales. van Wijk, J.; Cohen, I.; and Komen, J Intellectual Property Rights for Agricultural Biotechnology Options and Implications for Developing Countries. A Biotechnology Research Management Study. ISNAR Research Report No. 3. The Hague: International Service for National Agricultural Research. van Wijk, J.; and Jaffe, W The Impact of Plant Breeders Rights in Developing Countries: Results of a Study in Five Latin American Countries. Proc. Seminar on the 88

9 Impact of Plant Breeders Rights in Developing Countries: Results of a Study in Five Latin American Countries, 7-8 March 1995, Santa Fe de Bogota, Colombia. 89