INTELLECTUAL PROPERTY

Current industrial biotechnology is primarily oriented to the needs of large-scale commercial agriculture, rather than to those of the subsistence farmer. Most developing countries lack the financial resources and are limited in the scientific infrastructure needed to develop their own biotechnology programs for the crops that are important to feed their people. The long-term decline of public agricultural research, the increasing privatization of GM technologies, and the growing emphasis on the crops and priorities of the industrialized nations do not bode well for feeding the increasing populations of the developing world. As noted previously, without changed incentives for sharing access to GM technologies, the world is unlikely to direct much of its research for improved nutrition and employment-based access to staples for the poor.

The application of modern genomics research techniques to plant species promises an explosion of new knowledge and information that may lead to important new advances in agricultural production and the quality, quantity and variety of food products. Actual realization of these advances will depend to a significant extent on both publicly and privately funded research and on the development efforts of commercial companies supported by private investment. As in other areas of biotechnology, intellectual property rights are likely to play an important role in securing economic returns for the intellectual and financial investments that make the research and developments possible. An important consideration regarding such intellectual property rights in inventions and discoveries resulting from genomic research and from other applications of biotechnology is that overly broad intellectual property



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TRANSGENIC PLANTS AND WORLD AGRICULTURE INTELLECTUAL PROPERTY Current industrial biotechnology is primarily oriented to the needs of large-scale commercial agriculture, rather than to those of the subsistence farmer. Most developing countries lack the financial resources and are limited in the scientific infrastructure needed to develop their own biotechnology programs for the crops that are important to feed their people. The long-term decline of public agricultural research, the increasing privatization of GM technologies, and the growing emphasis on the crops and priorities of the industrialized nations do not bode well for feeding the increasing populations of the developing world. As noted previously, without changed incentives for sharing access to GM technologies, the world is unlikely to direct much of its research for improved nutrition and employment-based access to staples for the poor. The application of modern genomics research techniques to plant species promises an explosion of new knowledge and information that may lead to important new advances in agricultural production and the quality, quantity and variety of food products. Actual realization of these advances will depend to a significant extent on both publicly and privately funded research and on the development efforts of commercial companies supported by private investment. As in other areas of biotechnology, intellectual property rights are likely to play an important role in securing economic returns for the intellectual and financial investments that make the research and developments possible. An important consideration regarding such intellectual property rights in inventions and discoveries resulting from genomic research and from other applications of biotechnology is that overly broad intellectual property

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TRANSGENIC PLANTS AND WORLD AGRICULTURE rights should not be granted. To grant such rights would stifle further research and development. Intellectual property rights should be narrowly tailored to be commensurate with the actual scope of new inventions and discoveries so as not to impede continuing research, innovation and development. For the above reasons, it is important to consider the impact of intellectual property rights on developing countries. To benefit the growing populations of the developing world, new plant varieties will have to be developed through a variety of sources, including: (i) farmers who select plants that succeed best in their particular locality for the retention of seed for future use or sale; (ii) public or pro bono research institutions financed out of taxes or charitable grants that provide improved varieties to appropriate users free or at cost; and (iii) for-profit companies interested in creating new products and markets that develop new varieties financed through profits from seed sales. As instruments of public policy, intellectual property regimes should facilitate the maximum possible innovation in development of beneficial new crop varieties through individual, public and corporate sources, as well as promote research collaboration. Special attention should be paid to international conventions that may affect innovation in agriculture. These conventions include Trade Related Intellectual Property (TRIPs), patent law, plant variety protection and the Convention on Biological Diversity. To be effective, these conventions should be consistent with each other so as to reduce any distortions in the promotion of innovation by farmers, public research institutions, and for-profit corporations. At present, it appears that many less developed countries are reluctant to join in international intellectual property agreements on plants because they believe that such agreements will create a system that strongly favors the corporate sector—while simultaneously hampering the public and private sector efforts that support their own citizens. In fact, many of the intellectual property rights that exist today in industrialized nations apply to the tools used in

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TRANSGENIC PLANTS AND WORLD AGRICULTURE research and development to produce new transgenic plant varieties. If the rights to these tools are strongly and universally enforced —and not extensively licensed or provided pro bono in the developing world—then the potential applications of GM technologies described previously are unlikely to benefit the less developed nations of the world for a long time (i.e., until after the restrictions conveyed by these rights have expired). Private companies today can obtain plant varieties free of charge from farmers and from non-commercial institutions such as the CGIAR, add one or more proprietary traits, and then release seed with a variety of forms of legal or technical protection against copying, farm retention, or farm-to-farm transmission. Thus, a market-based system exists, based in part on non-reimbursed contributions from farmers and institutions such as the CGIAR. This heavily concentrates advances in research within companies whose legitimate search for profit naturally fails to focus their research on poverty and long-term sustainability issues. Transgenic plants have intensified the dilemma because a high level of skill and infrastructure is needed to develop them. Moreover, broad patents have been granted to companies that secure their competitiveness in the market place. To help compensate, public-sector research by farmers, the CGIAR, and by national agricultural research systems needs to be strengthened and provided with increased resources and attention—both from governments and from the world's agricultural scientists. In addition, intellectual property rights should be obtained by these public-sector institutions for their discoveries so that these rights can be used in negotiations with the private sector to produce increased public benefit. Intensive agriculture requires the use of certified seed (i.e., seed free of pathogens, pests, and weeds) and growers purchase new seed every year as an established practice. Most growers plant hybrid varieties of maize (corn) and other crops that are more uniform and vigorous than ordinary varieties because of heterosis (hybrid vigor) and these advantages are lost when second genera-

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TRANSGENIC PLANTS AND WORLD AGRICULTURE tion seed is used. In addition, some growers are under contract with food processors who demand specific quality standards that require new seed to be purchased annually. However, for some crops (e.g., soybeans) many growers save seed to plant in subsequent years (seed re-use) until reduced yields induce them to buy new seed. Saving seed is often not an optimal practice for reasons related to the contamination of seed with pests and pathogens. In developing countries, government programs often attempt to provide clean seed at affordable prices. However, in many instances, small growers cannot afford to purchase new seed every year, and they wish to maintain their long-standing practice of saving some of the seed from one year's crop in order to plant next year's crop. Historically, fertility and reproduction of grain crops in Africa, Asia and parts of the Americas have acquired a deep spiritual significance. Seeds are exchanged freely and are given away to travelers from far away lands. In any case, it is clear that growers in developing counties feel strongly that it is their right to decide whether to use their own seed or purchase fresh certified seed (Nuffield Council on Bioethics 1999). The general public would seem to be very much on the side of the growers on this issue. To ensure financial return for their investments, many biotechnology seed companies have sought to prevent the use of second-generation seed produced from transgenic crops. For example, growers who purchase transgenic plant seeds are often required to sign contracts that specifically prohibit the saving and replanting of second-generation seed. Over the long term, the most significant form of intellectual property protection for seeds may prove to be technological. A specific example of this that has been the source of much controversy is a patent application for an invention whereby traits in transgenic plants would be expressed only if a certain chemical activator was applied to seeds or plant (genetic use restriction technology, GURT) (Oliver et al. 1995). This technology involves the use of a chemical treatment of seeds or plants that either

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TRANSGENIC PLANTS AND WORLD AGRICULTURE inhibits or activates specific genes involved in germination. One technology would involve a complex three-gene system whereby one gene produces a protein that interferes with proper plant embryo development, thus preventing seed germination. The expression of this gene is allowed by applying tetracycline (or other chemicals) which prevents a recombinase gene from being repressed by an induced protein. Once the recombinase is expressed after tetracycline application, a blocking sequence placed between a transiently active promoter and the killer gene is removed, thus allowing the expression of the protein lethal to the plant embryo. The seed sold to farmers would be pre-treated with either tetracycline or other chemicals (copper, steroids, etc.). Most experts agree that there are considerable technical problems yet to be solved and that GURT will not be available for commercialization for several years. The possible commercialization of GURT technology for controlling the use of transgenic plant seeds has generated considerable public debate, being referred to as “terminator technology.” On the one hand, growers, especially in developing countries, maintain their right to retain and plant second-generation seeds. On the other, the seed companies seek to obtain a return on investment so that they can continue to invest in new technologies. Both parties, as well as the general public, have an important stake in these issues. There is a clear need for a resolution that serves the wider public interest. In an alternative GURT, the transgenic traits would be expressed only if a certain chemical activator was applied to seeds or plants. In this case, farmers would retain the ability to save their own seed, yet lack access to the added traits in the absence of payment for chemical activators. GURTs potentially have beneficial applications for consumers, growers, and the environment that should not be overlooked in debates over intellectual property rights. For example, GURTs could be used to prevent transgenes from spreading to closely related wild plants by preventing germination of any

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TRANSGENIC PLANTS AND WORLD AGRICULTURE crossbred seeds. Furthermore, this technology could potentially eliminate the problems of “volunteer” plants that appear from seed left in the field after harvest. Volunteer plants must be eliminated before the next crop is planted because they are hosts for pests and pathogens and can nullify the benefits of crop rotation. As with any growth regulator applied to crops, there are possible environmental or human health issues associated with the use of chemical activators (i.e., tetracycline, copper, steroids) and these would need to be addressed. Other concerns regarding the use of GURT are economic, related to the intellectual property rights and the monopoly of production of transgenic plants by particular companies. It is critical that the potential benefits of GM technology become available to developing countries. To this end, we recommend that: (i) where appropriate, farmers must be allowed to save seed for future use (re-use seed) if they wish to do so; publicly funded research should investigate the value and limitations of re-using seed and the results of this research should be made freely available to interested parties; (ii) broad intellectual property claims, or claims on DNA sequenees without a true invention being made, should not be granted because they stifle research and development; (iii) possible inconsistencies among international conventions, such as those that pertain to patent rights and the Convention on Biological Diversity, should be identified and clarified; (iv) research institutions should establish partnerships among industrialized and developing countries so that the benefits of GM research, applications and licensing will become much more widely available; and (v) 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 public sector institutions.