Earth Community Organization (ECO)
the Global Community
Ms. Manjula V. Guru and Dr. James E. Horne
for Discussion Roundtables 4, 16, and 35
Table of Contents|
Despite its many benefits, genetic engineering has caused concern among some people. Some oppose genetic engineering because they fear that harmful, uncontrollable bacteria might be produced accidentally. Others worry about possible environmental damage by the deliberate introduction of organisms whose heredity has been altered. In addition, some people question the morality of manipulating the genetic material of living creatures. In this paper developments in the national and international intellectual property rights policies on biotechnology are perused. Special focus is placed on the cause for worry and the different viewpoints held on the interrelationship of intellectual property rights, genetic engineering, and loss of biodiversity.
Biotechnology has been an issue of concern to policy makers for several years, especially from the perspectives of technological, industrial, environmental, agricultural and development policies. Spurred by technological advances, appreciation of the monetary and non - monetary value of genetic resources has grown, leading to increasing conflict over rights and responsibilities for these resources. Recent years have seen a rapid expansion in the number of programs around the world concerned with the conservation and use of genetic resources. As a result, policies on issues such as access, ownership, intellectual property rights and the equitable sharing of benefits arising from the use of genetic resources, have become of increasing concern. This has, in turn, led to the creation and adoption of several formal international agreements.
Developments in the national and international policies over the last decade have significantly changed the environment relating to the management and control of genetic resources. Some of the significant developments include the entry into force of the Convention on Biological Diversity, the Agreement on Trade Related Aspects of Intellectual Property Rights and the 1991 version of the International Union for the Protection of New Varieties of Plants.
Other significant developments are the re-negotiation of the International Undertaking on Plant Genetic Resources, the conclusion of the 1994 FAO/ CGIAR Agreements and the 1998 External Review of the CGIAR. The increasing presence and pressure by indigenous and local communities in the national and international arena, the re – invigoration of the Global International Properties Issues Division of the World, and the continuing expansion of the scope and strength of intellectual property rights by national legislatures and judiciary systems around the world have also contributed to the stand adopted by national and international policy makers .
This paper analyzes these developments and the different viewpoints held on the interrelationship of intellectual property rights, genetic engineering, and loss of biodiversity.
The extension of Intellectual Property Rights (IP’s) to new plant varieties and biological inventions, including the development of biotechnology’s, has stimulated private companies to invest in plant breeding. The Plant Patent Act of 1930 and the Plant Variety Act of 1970 established plant breeders’ rights for new plants and plant varieties. Over the years, private – sector research expenditures for plant breeding have increased from six million dollars in 1960 to four hundred million dollars in 1992. Nearly 70% of private – sector plant breeding research expenditures in 1989 was for corn, vegetables and soybeans. Private firms have also reacted to changes in IP’s by investing heavily in biotechnology techniques research, which rose from almost nothing in the mid – 1980’s to $595 million in 1992 .
The number of plant patents, Plant Variety Protection Certificates (PVPC’s) and utility patents issued over the last 25 years has risen. The Plant Variety Protection Act (PVPA) stimulated the development of new field crop varieties. By the end of 1994, 3306 PVPC’s had been issued for new crop varieties. The number of PVPC’s issued for new varieties of field crops, grasses, and vegetables climbed from 153 in 1971 – 74 to 992 in 1991 – 94. New soybean, corn, and vegetable varieties accounted for 56% of total PVPC’s awarded. The private sector owns approximately 87% of the total PVPC’s issued. Oats are the only crops for which the public sector holds a higher share of PVPC’s.
Utility patents are the most difficult to obtain and have been awarded primarily for new biotechnology innovations, such as genetically engineered varieties. By December 1994, 324 utility patents had been issued for new plants or plant parts and 38 were issued for animals. Most PVPC’s were however awarded to the private sector.
Besides scientific advancements, intellectual property rights (IP’s) have also strengthened over the years. It is these IP’s which have encouraged private research by allowing innovative firms like Monsanto, Novartis, Pioneer Hybrid, etc., to capture a greater share of the benefits from research. Patenting enables the company to monopolize the market for new plant varieties deriving from the original plant for the term of the patent. Agrecetus, for example, a subsidiary of W.R. Grace, has sought exclusive rights to all genetically engineered varieties of cotton and soybeans in what is known as a "sweeping patent."
Germany's Hoechst corporation (now AgrEvo) achieved genetic tolerance of glufosinate (the company's best-selling herbicide) in crops through the introduction of two resistant genes - one of which is derived from a Cameroonian soil sample. AgrEvo is one of the industry’s leading developers of transgenic herbicide tolerant plants, and glufosinate is the company’s flagship, with sales of over 2500 tonnes per year .
2.1. Intellectual Property Rights and Genetic Engineering within the U.S.:
Over the past quarter of a century, the U.S. Congress and the courts have greatly strengthened the protection of intellectual property rights for biological inventions, including plants. The original Patent Act of 1790 provided no protection for plants or animals, no matter how much intellectual effort had gone into producing a particular variety or breed. Plants and animals were considered to be "products of nature" and thus cannot be patented.
In 1930 Congress passed the Plant Patent Act, which allowed the granting of "plant patents" for asexually reproduced plants—those that are reproduced by means other than seeds, such as by tissue culture or propagation of cuttings. Asexually reproduced plants, which are genetically identical to their donor plants, include many types of fruit and nut trees and also ornamental plants. The act did not include protection for sexually reproduced plants because at the time it was thought that plants grown from seed could not be guaranteed to be identical to their parents. The act also excluded tuber crops.
Forty years later Congress provided a different sort of protection to sexually reproduced plants other than hybrids with the Plant Variety Protection Act of 1970. By this time it was clear that plants grown from seed could remain true to type from generation to generation, so the act allowed the U.S. Department of Agriculture to safeguard new varieties that were stable, distinct, and uniform by issuing Plant Variety Protection Certificates. The protection offered by these certificates, however, was relatively weak. Only exact copies were covered, so a breeder could introduce minor cosmetic changes in a variety and get a separate certificate.
Furthermore, the owner of a protected variety could not prevent other breeders from using the plant in their own breeding programs. Nor could the owner of a variety keep farmers from saving seeds for their own use or to sell to others.
This protection was upgraded in the 1994 Plant Variety Protection Act Amendments. Now the protection certificates guard against "essentially derived varieties," which are varieties that differ from the protected plant by only minor changes, although Congress was rather vague on what differentiates "minor" from "not minor" changes. Farmers must now get a license to sell seeds of protected varieties, although they may still keep the seeds for their own replanting. The 1994 amendments also extended protection to tuber crops and first-generation hybrids.
Despite this string of laws expanding protection, the most significant change in intellectual property rights for biological inventions did not come from Congress. It came instead from the U.S. Supreme Court and the U.S. Patent and Trademark Office. In the landmark 1980 case Diamond v. Chakrabarty, the court ruled that a genetically engineered microorganism could be patented under the 1790 Patent Act. Such an organism meets the criterion of a "manufacture" or "composition of matter," the court held. Following this ruling the U.S. Patent and Trademark Office extended the reasoning to plants and animals in a series of rulings during the 1980s. Now utility patents—the type of patent created in the 1790 act—can be awarded for new types of plants, including seeds, plant parts, tissue cultures, and plant genes and also for new breeds of non-human animals.
Although it is more difficult and expensive to receive a utility patent than a plant patent or a Plant Variety Protection Certificate, the utility patent provides much stronger and broader protection. The standard is obviousness, and the test for obviousness is whether the claimed subject matter would have been obvious to a person of ordinary skill in the art at the time the invention was made. This is a legal determination. A biotech patent, as any other patent, must demonstrate utility as well as novelty. Being useful in scientific research does not count. The utility test may be passed by a new therapeutic based on animal trial; for example, assuming it would have the same effect on humans. The test of obviousness is more subjective. A patent examiner must decide whether the subject matter of the invention would have been obvious at the time the invention was made to a hypothetical person having ordinary skill in the art. The judgement of obviousness rests on evidence from the prior art that a particular avenue of investigation would have been "obvious to try" and would hold a reasonable expectation of success. Using a genetically engineered cell to produce a protein has been ruled obvious, for example. Reasonable expectation of success goes to motivation or rationale as to why one of ordinary skill in the art would have found the claimed invention obvious. If the invention as claimed is not obvious, an innovation can be patented.
In April 1987 the Patent Office announced that it "now considers nonnaturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter." It’s not completely clear as to how this statement can be given any one interpretation.
2.2. GATT, Biotechnology and Intellectual Property Rights:
The Uruguay Round of negotiations, which concluded on 15 April 1994 in Morocco, under the rules of GATT have been a focus in IP discussions since talks began in 1986. For the first time in GATT, IP is seen as a trade topic. With the adoption of the latest agreement, signatory states are obliged to adopt a patent system for microorganisms and to establish either patents or some sui generis form of IP for plants. It is left open to governments whether they would also patent animals. One possible mechanism to implement a sui generis system of protection for plant varieties, is the Plant Breeders' Rights system. Article 27:2 in the new trade agreement allows countries to exclude from patentability any inventions whose applications are seen to cause "serious prejudice to the environment." To the extent that IP could adversely affect plant genetic diversity by accelerating genetic erosion, this environmental clause may enable countries to restrict or avoid patent protection on plants. The applicability of this clause is disputed however, as it might be difficult (or impossible) to prove the intricate relationships between patents and genetic erosion in court.
The Biodiversity Convention was negotiated under the auspices of the United Nations Environment Program ("UNEP") and was opened for signature at the United Nations Conference on Environment and Development in 1992. The Convention came into force on 29 December 1993. The Convention defines the term "technology" to include biotechnology, and covers technologies that assist further conservation and sustainable use of genetic resources as well as technologies that do not cause significant damage to the environment and result from the use of genetic resources to which access is provided by Contracting Parties [Article 2].
The Biodiversity Convention operates at three levels, i.e. genes, species, and ecosystems, and extends to all genetic resources, namely, plant, animal and microbial. It affirms that the conservation of biodiversity is "a common concern of humankind", and that States have sovereign rights over the biological resources in their territories. Under the Biodiversity Convention, States are responsible for conserving their biological diversity and for using it in a sustainable manner. Access to a Party's genetic resources must be on mutually agreed terms and on the basis of prior informed consent of the Party providing the resources [Article 1].
The objectives of the Biodiversity Convention are "the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising from the use of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding". The Biodiversity Convention provides for sharing research and development activities, benefits from the results of research and development, and commercial use of these results on mutually agreed terms [Article 5].
Access to or transfer of technology has to be provided in line with the provisions mentioned below, and as far as possible and as appropriate, incentives have to be provided to preserve genetic diversity. Similarly, in order to preserve and make sustainable use of biodiversity, the Convention provides for increased encouragement and interaction with regard to information, research, training, public education and awareness, and technical and scientific cooperation. With regard to several aspects including, inter - alia, sharing in research and development, in the benefits of the results of research and development and of the commercial application of these results, such sharing has to be on mutually agreed terms [Article 6]. In the negotiation of the Biodiversity Convention, issues related to IP’s were important in the context of provisions dealing with access to and transfer of technology (Article 16 of the Convention).
3.1. The Cause for Worry:
Genetic engineering techniques have made possible the extension of the private ownership and patenting of life - forms down to the level of the gene. The new patenting and intellectual property regulations will permit corporations to continue to freely appropriate unpatented seeds from around the world, to modify a single gene of these seeds, and then patent and acquire exclusive rights over them. These new patenting laws are clearly designed to transfer the ownership and control of the world's seed diversity - most of which has been developed and maintained by traditional farmers in the Third World – into the hands of First World corporations. Meanwhile, seed/biotech corporations have been buying out or taking control of seed banks and smaller seed companies in order to reduce the availability of unpatented and non-hybrid seed varieties. It is in the interests of these corporations that farmers repurchase these patented seeds year after year.
There are two strategies now being used to prevent farmers from being able to save and replant their seeds from the previous year's crop. Firstly, seeds may be engineered to be biologically sterile, like the hybrid seeds of the Green Revolution. Hybrid seeds produce high yields but do not perform well if they are saved and replanted, ensuring that farmers repurchase their seeds every year. Genetic engineering now makes possible the creation of hybrid varieties of some common food crops that had previously proven too difficult or too costly to hybridize using earlier plant breeding techniques. It will also be possible for scientists to deliberately engineer any crop variety to be sterile or non-reproducible. This technique, which critics refer to as 'Terminator Technology', has been patented in the USA, and will be used to target important crops such as wheat and rice. In these ways, the logic of 'planned obsolescence', and therefore the interests of the corporation, will be able to be engineered directly into the seed's DNA.
In developing new products, scientists take plant samples from the field to the laboratory, where the simple act of moving a single gene from one spot to another within a cell - whether or not it causes an actual variation in the next generation, creates a "plant variety" deemed sufficiently "new" to qualify as a patentable invention. In most cases, such genetic engineering experiments produce nothing worthwhile. In a few cases, the variations have desirable traits that can be reproduced and marketed. The emphasis on finding and isolating plants with the most marketable traits leads to the decline of other plant species, as only those required to create the new techno-varieties are cultivated. In the U.S. alone, the focus on commercial varieties has already led to the loss of many varieties of plants in seed bank storage. In developing new products, scientists take plant samples from the field to the laboratory, where the simple act of moving a single gene from one spot to another within a cell - whether or not it causes an actual variation in the next generation, creates a "plant variety" deemed sufficiently "new" to qualify as a patentable invention. In most cases, such genetic engineering experiments produce nothing worthwhile. In a few cases, the variations have desirable traits that can be reproduced and marketed. The emphasis on finding and isolating plants with the most marketable traits leads to the decline of other plant species, as only those required to create the new techno-varieties are cultivated. In the U.S. alone, the focus on commercial varieties has already led to the loss of many varieties of plants in seed bank storage. A survey of U.S. seed banks showed that some varieties of non-commercial crops such as chufas, martynia and rampion have been lost entirely.
In addition, the privatization of genetic resources that have been engineered and patented accelerates the trend toward monocultural cropping. Just as a mere handful of varieties of patented hybrid corn now cover millions of acres of the midwestern U.S. corn belt, where prairies once hosted thousands of varieties of grasses supporting birds and butterflies, bees and other life, so too will the biodiversity of other lands shrink as patented crops take over. In India, for example, peasant producers now cultivate some 50,000 varieties of rice, developed through traditional practices over the millennia. This astonishing variety arose from subtle differences in soil and climatic conditions through mutation, evolution, and the deliberate application of cultural preferences. The GATT-TRIPs rules would prohibit these farmers from harvesting and reusing the seed of any rice variety that has been patented. (Unlike hybrid species cultivated by plant breeders, genetically engineered plants do produce viable seed.) Lack of access to seed stocks will cause the abandonment of much of India's biologically diverse agriculture, which in turn sustains healthy diversity in surrounding ecosystems.
At the heart of the issue is horizontal gene transfer - the transfer of genes by vectors such as viruses and other infectious agents - that is exploited by genetic engineers to make transgenic organisms. Horizontal gene transfer is the transfer of gene by infection, between species that do not interbreed. It has been known to occur among bacteria and viruses for at least 20 years. While natural vectors respect species barriers, the barrage of artificial vectors made by genetic engineers are designed to cross species barriers, thus greatly enhancing the potential for creating new viral and bacterial pathogens, and spreading drug and antibiotic resistance. Totally unrelated pathogens are now showing up with identical virulence and antibiotic resistance genes.
Secondly, all patented seeds will now be legally sterile, as the new patenting and plant breeding regulations give patent holders rights which enable them to prohibit farmers from freely saving and replanting their seeds. Farmers either have to repurchase their seeds, or pay royalties to the company to save and replant patented seeds. To help enforce these regulations, new DNA 'finger-printing' techniques can be used to identify the genetic structure, and therefore the ownership, of crops growing in any farmer's fields. For the first time in history farmers are losing both the ability and the right to save and replant their seeds. Yet it is these very practices of saving, replanting and crossbreeding seeds by farmers that have created the enormous diversity of domesticated crops and crop varieties we have inherited to this day.
One of the consequences of the non-reproducibility of these 'static' seeds is that plants will no longer be able to dynamically evolve within and maintain their adaptation to local agroecological conditions, such as local climates, soils and pests. Through these processes the seed is transformed from a self-generating and shared resource into a commodified input of an industrialized production system. These biotechnological interventions can also be understood as further extending the colonization and commodification of the seed. Techno-industrial agriculture colonizes the seed in the sense that it penetrates into and takes control of the functioning of the seed, and imposes its own logic upon it - the logic of accelerated productivity, in-built obsolescence, and private-corporate ownership. The seed is commodified in two senses: first, in the sense that farmers must pay for a product that they formerly attained from the plant at no cost; and secondly, in the sense that farmers are no longer involved in the reproduction of the seed, and therefore are not able to shape the character of it, and are instead delivered a ready-made, pre-packaged product. In these ways, farmers will become more dependent on the agribusiness corporations that supply the seeds and other agricultural inputs.
Farmers that are already locked into the techno-industrial system will find it difficult to avoid the adoption of any new seeds or inputs that increase the 'productivity' of their farms, regardless of how narrow, short-term and ecologically degrading these 'productivity increases' are. Farmers otherwise risk being priced out of the market due to the downward pressure on prices that result from increased levels of output. It is small-scale Third World farmers whose livelihoods have been most seriously affected by such dynamics. The new biotechnologies also present a further threat to farmers where new tissue culture techniques are used to manufacture industrial substitutes for agricultural crops. For example, the development of artificial sweeteners replaces the need for sugar-cane crops, thereby reducing their demand and further depressing prices. Other crops that are currently threatened by industrial substitutes include cocoa and vanilla. Third World communities and countries that have been forced into dependency upon these cash crops are the hardest hit by this form of substitutionism.
The countries and peoples from which the original plant material came see few of the benefits - or the cash - derived from its use. These generally go to big corporations in the developed world, which can take out patents on parts and processes of plants, animals - and even humans. Estimates place an annual value of $32 million on medicinal plants from the South used by the North's pharmaceutical industry. California's $160-million barley crops are being protected from the lethal yellow dwarf virus by a gene plundered from Ethiopia - a country which in 1993 had a GNP of just $100 per person. The sugar content of tomatoes in the North has been increased, producing a $5 - 8 million-a year rise in the crop's commercial value - thanks to a wild tomato strain found in Peru, a country which in 1993 could afford to spend a mere $28 on health per person. The sugarcane industry in the southeastern US has been saved from collapse thanks to a disease-resistant gene from a wild Asian strain of sugarcane. Last September, RiceTec, Inc., an Alvin, Texas based company won U.S. patent #5,663,484 claiming the breeding of Asia’s famous aromatic "Basmati" rice. The patent covers Basmati grown anywhere in the Western Hemisphere. RiceTec also slapped its brand on any breeding crosses involving 22 farmer – bred Basmati varieties from Pakistan – and, effectively – on any blending of Pakistani or Indian Basmati strains with the company’s other proprietary seeds. This patent jeopardizes an annual Basmati export market of Rs. 1200 crores (approx. US $277 million), and threatens the livelihood of thousands of Indian farmers.
Since a landmark decision in the US in the 1980s, human material too is patentable. Indigenous peoples are particularly vulnerable as their genes have been relatively isolated and therefore are more likely to have 'useful' properties. The Human Genome Diversity Project is a multi-million dollar scheme that aims to 'harvest' the genes of indigenous peoples. In 1991 cells were taken from a Guaymi woman from Panama who had leukaemia. Without her consent, the US Government filed a patent on her cell-line in 1993, effectively acquiring rights over part of her body to be used for commercial purposes. In 1995 the US Government filed a patent on a human cell-line of a Hagahai person from Papua New Guinea. The cell-line is potentially useful in treating adult leukaemia. It also filed patents on the cell-lines of two people from the Solomon Islands with a potential for producing vaccines. The people from whom this blood was taken knew nothing about it. Although the above patents have now been withdrawn after huge opposition, more are in the pipeline.
Another threat is where genetic engineering accelerates the trend of substituting crops with industrial systems based on cell culture. Corporate giants would control biosynthetic food factories. Farmers and consumers would have little choice over what is produced. Supplementing these factories would be contract controlled farming, the altered states way.
Genetic-industrial agriculture will enable seed-chemical corporations to extend their control over farmers in both the developed as well as the developing world, and over the entire industrial food chain. A recent example is a patent filed by W R Grace & Company on a neem product and a process of extracting the storage-stable compounds will prevent farmers using neem as a source of home made pesticide. The argument that improved varieties or neem products will be available to farmers and should therefore be considered, as sufficient reciprocity is not tenable. Those who benefit will be either commercial farmers in the west or green revolution farmers in developing countries who grow crops which consume much of the pesticides. However, those who grow neem trees or collect its seeds and provide knowledge about its use are generally the farmers in rain fed regions who will not benefit so much from this.
For patents to be granted, their application must include a full written description of the invention and how to carry it out. Patents on biological materials have been criticized by some for not fully disclosing necessary details to enable the invention to be successfully repeated. The very nature of life forms makes such a full description impossible. Some argue that "life" patents run counter to the very rules of the patent system in which it is assumed that an inventor gets a patent in return for a full disclosure of the invention. Proponents of the system deny that this is a major problem, but fully agree that invention concealment, where it occurs, is unacceptable.
3.2. Same Issues: Different Viewpoints
The question of whether intellectual property rights contribute to genetic erosion, or whether the diversification of breeding activity increase genetic diversity, has been subject to considerable debate. Those who feel that intellectual property rights contribute to genetic erosion say that although the direct effects might be tenuous, the indirect effects can be very significant. Intellectual property enhances incentives for commercial plant breeding, shifting efforts inexorably toward the development of varieties with the largest market potential, that is, major crops that are widely adapted across large areas and with characteristics that best meet the needs of commercial farmers and the marketing and processing industries. Crops with less commercial potential that are adapted to specific environmental niches, or that are better suited to the needs of smaller scale farmers, risk being neglected and, as their comparative profitability suffers, may be abandoned. The effects are the same whether IP provides a stimulus to private-sector breeding or forces public-sector research, which is increasingly strapped for funds, to focus its attention on commercial agriculture. As private breeding companies become stronger, pressures are created to reduce public spending on plant breeding and to concentrate instead on basic research for corporate use.
Intellectual property means that seed companies obtain a higher return on protected varieties than on unprotectable traditional varieties. There is a strong tendency to make only minor changes in the market leader and rely on marketing to sell the variety as something really new. Intellectual property establishes a commercial bias in favor of the newest varieties, and emphasizes physical distinctiveness and uniformity at the expense of significant genetic variability. To this end, IP results in increased genetic uniformity and, where diversity still exists, more genetic erosion.
An important concern in the area of environment has been that global biodiversity (including genetic resources) is being depleted over time and hence a need to conserve and use it in a sustainable manner has been emphasized. Biodiversity is valued for maintaining the possibility of responding to new situations that may arise, for instance, in the area of agriculture and medicine, and because of its links to the sustainability of certain ecosystems. The initial response of the international community to the threat of genetic erosion was to build a network of "gene banks" where genetic materials, for example, seeds of abandoned varieties, could be stored and conserved ex situ. However, this method of conservation led to some loss of viability and of characteristics and, over time, the focus has changed towards in-situ conservation of biodiversity. Therefore, incentives for conserving and sustaining animal and plant biodiversity in the natural habitats have been increasingly emphasized. For example, farmers and local communities are now being encouraged to conserve traditional plant varieties on-farm or in situ. A second group holds the view that there is no evidence that IP is a major cause of crop genetic erosion. There is concern, however, that, unless properly monitored and controlled, the presence of IP can contribute to a market and regulatory environment unfriendly to unprotected commercial seed and farmers' varieties or both. There is obviously, a greater capacity to manage this concern in rich than in poor countries. And the criteria for distinctiveness, uniformity, and stability, combined with the cost and risk of developing new varieties, could bias commercial breeding toward uniformity. It is also probable that, to the extent that IP encourages breeding investment, genetic diversity would be a by-product of more breeding work. It is important to create incentives for breeders to develop specialized varieties, for example, of subsistence crops and those adapted to marginal areas. This might be achieved, for example, through extending the period of protection for such varieties. Perhaps the best insurance is the continued involvement of a strong public- sector breeding effort.
It is commonly stated, although not necessarily proven, that the presence of IP is hampering international germplasm exchange and, hence, accesses to sources of diversity by breeders. Genebank directors and breeders are possibly more reluctant to "give away" germplasm that might have commercial value. Given developments in GATT and increasing legislative activity on IP in the South, further study, including surveys and empirical data collection, are needed. In Europe, the controversial plan to allow patenting for products derived from living things was endorsed only after it had been altered to exclude all cloning and the patenting of human embryos. The battle for EU-wide copyright on genetic advances has raged for nearly a decade.
A third group maintains that crop genetic erosion is a serious problem, but IP issues seem connected to this problem largely for political reasons. The political turmoil stirred up over IP has caused a constraint in international germplasm exchange and that this constraint could have negative implications for genetic diversity. A major cause of genetic erosion has been a negative side effect of the introduction of improved varieties from public-sector national and international research programs — varieties that have helped feed an additional 500 million people and that were developed without any influence from IP. Habitat destruction and changes in farming systems are also significant causes of genetic erosion, unconnected to IP. Far from exacerbating genetic erosion, IP, by increasing investor confidence and offering breeders an opportunity to profit from their work, increases and diversifies the number of breeding institutes and stimulates the development of a wider range of crop varieties. The variety of strong breeding programs also supports genetic diversity by increasing the support for genetic resources conservation as a matter of enlightened self-interest. Broad demographic and agronomic factors have caused genetic erosion. Intellectual property may prove to be one of our best hopes to increase genetic diversity.
The task of discerning all the relevant issues having a bearing on the conservation and management of genetic resources and then integrating them into consistent policy is extremely complex. With continuing globalization and increased understanding of the world’s interdependence on all levels, few important issues can meaningfully be addressed without undertaking the complex process of unweaving and understanding relevant issues and then integrating a policy response.
Better analytical tools are needed to enable policy – makers to evaluate the trade – offs and consequences of particular decisions. Analysis of recent developments in terms of their objectives, interests and relations to one another is a necessary first step in developing better analytical tools for policy – makers. The following set of recommendation made by the Crucible Group should be seriously considered by all national and international agencies involved in the policy making process.
1. National governments must be free to make their own decision regarding patents without external compulsion. A decision on patents must flow from national needs and national innovation strategies and fit within the social and ethical framework of the country.
2. Developing-country governments may wish to delay any patent law over life forms until the current ambiguities and uncertainties are resolved, either through treaty changes or court decisions in industrialized countries.
3. Only governments with strong judicial systems should contemplate patent protection. Registration and litigation will be demanding and resource consuming.
4. Countries adopting a patent system related to living materials must be prepared to divert human and financial resources toward the development of a patent office with specialist skills in biomaterials. In some countries, this could draw funds and talent away from other nationally important priorities.
5. Although it is possible to apply for worldwide patents, it is not possible to defend such patents other than country-by-country. Because most developing and underdeveloped nations will be unable to defend their claims themselves, they will need either powerful financial help or a strong partner to whom they will license their patents so that they can be defended in various countries. All else being equal, licensing arrangements may not yield as profitable a return as direct exploitation; thus, in some situations, licensing may be a realistic if not optimal choice.
6. The research exemption, guaranteed under patent law, protects the right of scientific workers to use patented inventions without charge or prejudice for noncommercial investigations. This exemption must be unambiguously secured so that science can be pursued without fear of litigation. Some researchers now worry that patents courts could order an end to their investigations.
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