Case Studies in Biopiracy Pharms and Farmers

Advocates for the global South have been clamouring for proprietary treatment of TK, and that demand shows no sign of abating (Heald, 2003, p. 536). For the time being, potential property interests abound whenever biodiversity is exploited for commercial gain. In order to resolve the conflicting claims of the North and the South, let us return to the annals of the biodiversity battles. One set of conflicts may be considered 'pharmaceutical' in flavour; the other, 'agricultural'.

Let us first consider the 'pharm'. Imagine a wonder plant teeming with extraordinary chemical properties. The local population and professional botanists agree that it deserves the title of 'village pharmacy' (Wilson, 1992, p. 285). The developing country in which this wonder plant is native supplies both the genetic material and the ethnobiological knowledge that a US life sciences company uses to develop pesticides, antiseptics and even contraceptives. One product in particular, a pesticide and insect repellant, is markedly more stable and effective than traditional formulations known to, and used by, farmers in the source country. Not only does the US company fail to compensate the source country, but it also asserts patent rights on this pesticide and on other products developed from that wonder plant, and TK of its uses. It stands in position to collect a patent-driven premium from the very villagers who informed the company of the wonder plant's properties and who helped harvest the company's first samples of the plant.

The real story of W.R. Grace's encounter with India's neem tree reflects some elements of the biopiracy paradigm (see National Research Council, 1992). Almost as notorious is the story of Eli Lilly & Co.'s derivation of vinblastine and vincristine, two cancer-fighting alkaloids, from the rosy periwinkle (see, e.g. Hunter, 1999, p. 130). Vinblastine is used in treating Hodgkin's disease (see Little, 1998); vincristine has become the drug of choice for treating childhood leukemia (see Veerman, 1996). The commercialization of products derived from neem and the rosy periwinkle has sparked controversies over alleged acts of biopiracy.

Nevertheless, many stories are so thoroughly riddled with inconsistencies and outright lies that all biopiracy narratives, pending further clarification, must be consigned to the realm of 'rural' legend. Grace has no patent on neem-derived products in India (see Foster, 1998, p. 308), and it is 'not clear that the Grace patent', granted under US law (see Walter, 1994), 'will have any [negative] economic or social effect in India' (Marden, 1999, p. 285). The European Patent Office's decision to revoke the Grace patent further weakens its impact on India (see Decision Revoking European Patent 043625 7, 2001). The fear that the Grace patent would deprive Indian villagers of the right to continue traditional uses of neem (including the use of the tree's branches as toothbrushes) is purely scurrilous. Neem in its natural form is unpatentable (see Funk Bros. Seed Co. v Kalo Inoculant Co., 1948, p. 130); so are improvements made by Grace unless the inventive step taken by the company was not obvious from pre-existing uses of neem.

As for the rosy periwinkle, Madagascar has an even weaker claim of unjust treatment (see Marie, 2003). The rosy periwinkle is native to Madagascar but grows throughout the tropics. In 1952, Robert Laing Noble, a member of the medical faculty at the University of Western Ontario, received 25 rosy periwinkle leaves from his brother, Clark Noble, who in turn reported that the leaves were used in Jamaica for diabetes treatment when insulin was unavailable. The leaves had little effect on blood sugar but strongly inhibited white blood cells. By 1958, Robert Noble's research team at Western Ontario successfully isolated and purified the potent alkaloid extract now known as vinblastine. Working independently, Eli Lilly & Co. found that a crude extract of the whole periwinkle plant prolonged the lives of mice with leukemia. Eli Lilly eventually synthesized vincristine. In so far as Jamaica has a much stronger claim as the source of TK that facilitated the development of vinblastine and vincristine, even advocates of benefit-sharing find it difficult, if not altogether impossible, to fashion a convincing case that Eli Lilly should compensate Madagascar (see, e.g. Cunningham, 1993).

The stories of hoodia, neem and rosy periwinkle are contrasted with a more explicitly agricultural hypothetical situation. A commercial plant breeder in the USA develops a pest-resistant variety of soybeans. Although public support for plant-breeding research has declined in the USA (see Frey, 1996), publicly sponsored agricultural research spans a broad spectrum of advanced genomic technologies (compare Service, 1998, with Pollack, 2001, p. A1). Nevertheless, perhaps aware that classical plant breeding continues to hold the key to food security in a world with a burgeoning population (see Knight, 2003; Thro and Zankowski, 2003), the breeder in question eschews transgenic modification in favour of conventional techniques such as cross-breeding and chemical mutagenesis. In developing the new variety, the company draws on older public varieties, available free of charge from the nearest land grant university: 7 U.S.C.§304, 2000 (donating land in each state for 'the endowment, support, and maintenance of at least one college where the leading object shall be . . . to teach such branches of learning as are related to agriculture and the mechanic arts'); 7 U.S.C. §2201, 2000 (directing the Department of Agriculture 'to acquire and to diffuse among the people of the United States useful information on subjects connected with agriculture, in the most general and comprehensive sense of that word, and to procure, propagate, and distribute among the people new and valuable seeds and plants'); Baron, 1987, p. 509 ('The greatest service which can be rendered [to] any country is to add a useful plant to its culture'); and on previously registered proprietary varieties. After combining the collective wisdom of the USAs publicly supported agricultural universities with its own research, the company markets protected seed in the USA and abroad. However, true to traditional agricultural practice, farmers in the developing world save seeds for future planting and even engage in 'brown-bag' sales to other farmers, all without compensation to the commercial breeder (Asgrow Seed Co. v Winterboer, 1995).

This latter story is rarely treated as one creating a conflict between biodiversity and biotechnology. Its legal roots, however, predate the Rio convention by nearly a decade. The conflict between commercial breeders and traditional farmers became known as the 'seed wars' of the early 1980s (Kloppenburg and Kleinman, 1991). In 1983, the UN Food and Agriculture Organization (FAO) adopted a resolution called the International Undertaking on Plant Genetic Resources (Report of the Conference of FAO, 1971). In order 'to ensure that plant genetic resources of economic and/or social interest, particularly for agriculture, will be explored, preserved, evaluated and made available for plant breeding and for scientific purposes', the Undertaking invoked the 'universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction' (Report of the Conference of FAO, 1971, 285, art. 1). Furthermore, it proclaimed that plant genetic resources should be available 'free of cost, on the basis of mutual exchange or on mutually agreed terms' (Report of the Conference of FAO, 1971, 285, art. 5). The Undertaking negated not only plant breeders' IPRs but also farmers' rights - namely, the traditional agricultural practices of saving seed for future planting, for resale to neighbouring farmers and perhaps even for development of other varieties through conventional cross-breeding.

Crippled by the bitter division between North and South on biodiversity and by its own failure to clarify the common heritage principle (Bordwin, 1985), the FAO eventually answered some of the concerns raised by a sceptical North. In a 1989 'interpretation' of the 1983 Undertaking, the FAO declared that '[p]lant breeders' rights as provided for under UPOV [the International Convention for the Protection of New Varieties of Plants] are not incompatible with the International Undertaking' (Interpretation, 1989). It also acknowledged that 'the term "free access" does not mean free of charge' (Interpretation, 1989). At the same time, the 1989 Interpretation endorsed the 'concept of farmers' rights', acknowledging

'that farmers of all regions have made' an 'enormous contribution . . . to the conservation and development of plant genetic resources, which constitute the basis of plant production throughout the world' (Interpretation, 1989).

Before Rio, farmers' rights were regarded as a basis for redirecting some profits from biotechnological inventions towards farmers in 'Vavilov centers', or 'original centers of plant genetic material' (Gooden, 1991, p. 8; Cleveland and Murray, 1997). Russian botanist Nikolai I. Vavilov 'theorized that the world's crops had originated in eight definable centers of origin' (Tilford, 1998, pp. 384-385, describing Vavilov's work as one of three contemporary developments - along with the discovery of Mendelian genetics and advances in plant hybridization - that have severed agricultural success from biological diversity). It was in these centres - all located in less-developed countries - that agriculture had originated, he suggested, and that 'the greatest genetic diversity was to be found' (Fowler and Mooney, 1990, p. 32). Equating Vavilov's eight centres - China, India (including Indo-Malaya), Central Asia, the Middle East, the Mediterranean, Ethiopia, southern Mexico and Central America, as well as the Andes (with two lesser centres in South America: the island of Chiloe off the coast of southern Chile and an eastern centre in Brazil and Paraguay) - with the 'Third World', however, stretches credibility. China, India and certain parts of the Mediterranean, though less wealthy than the top tier of developed nations, are by no means destitute. A quick glance at Vavilov's map also demonstrates that the agronomist, the pharmacologist and the ecologist have distinct maps of biodiversity. Simply put, the geography of biodiversity varies considerably when viewed through any of a diverse range of anthropocentric lenses.

The principle of directing profits towards farmers in Vavilov centres coexisted comfortably with at least nominal adherence to the common heritage principle. Both notions soon disappeared from international law. At its 25 th session, the same meeting that generated the 1989 'Interpretation' of the International Undertaking on Plant Genetic Resources, the FAO conference adopted Resolution 5/89, which repeatedly stressed the 'particular' importance of farmers' rights 'in the centres of origin/diversity' (also described as 'the areas of origin or diversity of plant genetic resources') (Resolution 5/89, 1989). The same resolution 'recogniz[ed] that . . . plant genetic resources are a common heritage of mankind to be preserved, and to be freely available for use, for the benefit of present and future generations' (Resolution 5/89, 1989).

Within 4 years, the UN support for the common heritage principle in the international law of plant genetic resources evaporated entirely. By its 27th session, in 1993, the FAO conference explicitly aligned the Undertaking 'with the outcome of the negotiations of a Conference on Biological Diversity' and that treaty's explicit 'recognition] that the authority to determine access to genetic resources rests with . . . national governments' (Resolution 7/93, 1993). The CBD expressly repudiated the 'heritage of mankind' approach that animated the original 1983 FAO Undertaking. The adoption of its central principle, that 'States have . . . the sovereign right to exploit their own resources pursuant to their own environmental policies', capped the FAO's abandonment of common heritage in favour of sovereign control (Convention on Biological Diversity, 1992, art. 3). By declining to treat the genetic world as a global commons, the CBD strengthened not only breeders' rights but also farmers' rights.

The renunciation of the common heritage principle is the ultimate legacy of the International Undertaking on Plant Genetic Resources. In endorsing an alternative regime based exclusively on 'sovereign rights', the CBD has abjured the international commitment to plant genetic resources as a common heritage of humanity and endorsed international entitlements for the two most powerful stakeholder groups in the controversy, commercial plant breeders and farmers.

Whatever its fate as positive law, the Undertaking serves an indispensable juris-prudential function. Its emphasis on farmers' rights reminds us that agriculture is also a life science. Prosperity in farming depends on the very practices that Southern critics ascribe to Northern biotechnology companies. 'Copying' - often a deviant and difficult deed for would-be infringers in many other industries - is the definition of agriculture. Whether cultivating plants or raising animals, farmers specialize in plying reproductive techniques and technology. Whoever wields the plow and the scythe thereby controls the power to create and to kill (see, e.g. Leopold, 1949, pp. 214-220; Campbell, 1959, p. 177). Stories of origin, especially those stressing humanity's fall, dominate legal narratives about agriculture and environmental protection. After all, 'there is one story in the world, and only one' (Steinbeck, 2002, p. 411); '[f]or every constitution there is an epic, for every decalogue a scripture' (Cover, 1983, p. 4; Cover, 1985, p. 180, n. 7, describing the origins of law in 'the sacred narratives of our world'; Ball, 1989). Little wonder, then, that biologists derive 'intense spiritual feelings' from the 'unfathomable complexity and . . . sublime beauty' of the biosphere at its fullest and most diverse (Takacs, 1996, p. 255).

Although the stakes are smaller and the relative economic strengths of the players are reversed, the brown-bagging farmer takes a free ride on the intellectual contributions of US land grant universities and plant breeders, just as American and European biopirates have expropriated the ethnobiological traditions of the developing world. After sufficient iterations of this game, it becomes impossible to tell where the creative process begins and ends, to distinguish inventor from infringer. When innovative acts follow each other as if they were so many pancakes in a stack, there is no coherent way to identify one side as the 'inventive' one (Lemley, 1997).

The global South cannot decry 'biopiracy' and proclaim 'farmers' rights' in the same breath. Both practices exploit the reproductive capacity of non-human organisms in order to expropriate ideas developed by other human beings. The only difference is the magnitude of the pecuniary stakes. Indeed, even the contrast between 'pharm' and 'farm' evaporates upon closer inspection. Pharmaceutical products are almost as susceptible as seeds to unauthorized duplication. Drugs tend to be durable, subject to intense demand, relatively inexpensive to produce, easily transported and readily imitated at a minute fraction of the original research and production costs (Stamm, 1991). In their struggle against drug-copying enterprises, pharmaceutical companies do not so much rue the loss of retail sales in less-developed countries as they fear grey-market 'leakage' of those drugs back into the lucrative markets of the developed world (Scherer and Watal, 2002, describing this phenomenon as 'parallel trade'; K Mart Corp. y Cartier, Inc., 1988). Economically speaking, seeds are no different.

The Southern countries that urge recognition of IP in indigenous knowledge are often proponents of weakening proprietary protection on pharmaceuticals, agricultural chemicals and educational materials in the name of increased access (Emmert, 1990; Kruger, 2001). A study by the World Intellectual Property Organization (WIPO) found that respondents in 28 less-developed countries, despite their misgivings about IP as a legal concept and about aspects of specific IP laws, often 'expressed interest in exploring further the actual and potential role' of IP in protecting TK (World Intellectual Property Organization, 2001, p. 223). Subsequent WIPO publications have committed the organization to the project of developing models for protecting genetic resources, TK and folklore at the international level (see, e.g. World Intellectual Property Organization, 2000, 2003). North and South, the local attitude towards IP depends on what is being protected and what posture towards protection delivers the greatest benefit to local interests.

One further note of caution is in order. The Southern campaign to enhance the proprietary status of its genes and memes - its germplasm and its ethnobiological knowledge - will engage not only the law of property, but also the entire legal apparatus of the industrialized world. This is especially true of Southern memes, the cultural practices that distinguish the countries of the South from a world in which cultural and political baselines are set by the wealthy and powerful North. Every 'living thing', including a meme, is a selfish 'imperialist, seeking to transform as much of its environment as it can into itself and its seed' (Russell, 1974, p. 30). Some ethnobiological memes may affirmatively harm the environment, or at least conflict with competing values expressed through environmental law. Asian folk medicine drives global demand for rhinoceros horns and black bear claws (Muffett, 1996). On opposite sides of the Pacific, Japanese appetites (Japan Whaling Ass'n v American Cetacean Soc'y, 1986; Sumi, 1989) and Makah rituals (North Pacific, 1997, applying the whaling convention's exemption for 'traditional uses of whale product by local aboriginal, indigenous or native communities in meeting their nutritional, subsistence and cultural requirements'; United States v Washington, 1984) clash with the International Convention on Whaling (International Convention, 1948). Consumers in Florida who prize the eggs of endangered sea turtles as aphrodisiacs pay US$36 per dozen (Canedy, 2002). The shocking prevalence of 'analogics' - aphrodisiacs by zoological analogy that have at most placebo value for men seeking enhanced sexual performance - makes it plausible to contemplate whether widespread distribution of Viagra at low or no cost could be justified as a way to promote biodiversity conservation (Why Rhinos, 1998).

With respect to environmental norms, the developing world enjoys no moral superiority. 'Small-scale communities are seldom as humane and ecologically sound' as their advocates 'portray them to be' (Lewis, 1992, p. 91). 'Small firms . . . are responsible for a massively disproportionate share of water and air pollution' (Pierce, 1998, p. 559). Agriculture is especially the suspect. 'One would be hard-pressed to identify another industry with as poor an environmental record and as light a regulatory burden' (Chen, 1995; Ruhl, 2000, p. 269, 2001). Smaller, family-owned farms routinely underperform their larger, corporate counterparts in core tasks such as soil conservation and erosion control (Lee, 1980; Tweeten, 1983). Lest the perceived hegemony of the North lend undue currency to the romantic myth of the 'noble savage' (Coleman, 1994), it should be remembered that the propensity to destroy the environment flourishes in any cultural setting.

Any environmental advantage along the developmental divide favours countries whose legal systems have adopted the most comprehensive and coherent rules for managing their citizens' contact with the living world in an age of grow-

ing scarcity and declining diversity. In industrialized societies, the law has comfortably assimilated the achievements of life scientists and shaped their attitudes. Nations such as the USA routinely confer patents, Plant Variety Patent Certificates (PVPC) and other IPRs for biological innovations. However, with equal vigour Western nations also subject those scientists to rigorous regulatory schemes in order to preserve the environment and prevent ethical abuses (Agricultural Risk Protection Act, 2000; Animal Welfare Act, 2000; Plant Protection Act, 2000). Nature over nurture, leisure over labour: in domestic and international legal conflicts, environmental imperatives should prevail over cultural claims and in all events over full employment (Chen, 2000, 2001).

Ethnobiological knowledge has likewise come of age. In contemplating whether to make cultural knowledge eligible for proprietary protection, cultural practices should be subjected to legal scrutiny (Calabresi and Melamed, 1972). Whether eth-nobiological knowledge becomes a full-fledged form of IP, or whether a sophisticated understanding of ethnobiological knowledge counsels strongly against unduly expanding IP within the laws of the industrialized world, the exercise of determining the status of this knowledge under the law of property should represent merely the first step towards the complete integration of human traditions into positive law.

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