Art Scrit, 2001

(Originally published in New College of California Journal of Public Interest Law.)  Citations appear in Footnotes section below.[1]

I.  INTRODUCTION

        The recent history of patenting genetic information is rife with ethical and economic crosscurrents that run swift and deep.  Compared to three and a half billion years of evolutionary history,[2] the potential rate of genetic change driven by biotechnological advances has exponentially accelerated in eight short years from patenting microbes and bacteria in 1980, to animals by 1988.[3]  Since then, human cell lines and genes[4] have also been added to the catalog of patentable material.[5]  Most development around these patents has occurred within the fields of food production and medicine, such as improving livestock and agricultural reserves, as well as disease prevention and genetic amelioration.[6]

        The legal context for these developments involve wide-ranging changes in international trade and the harmonization[7] of patent law under the North American Free Trade Agreement (NAFTA),[8] the General Agreement on Tariffs and Trade (GATT), and the World Trade Organization (WTO).[9]  With regard to the impact of this economic globalization, many commentators have noted the hemispherical divide between the capital and technologically rich North and the genetically resource-diverse South.[10]  Proposals to re-contextualize,[11] redistribute,[12] and redress[13] some of the disparities in economic,[14] legal,[15] and cultural power within these scenarios have proven fleeting when measured against the current pace of science[16] and wealth generation.[17]  As a result, analogies circulating throughout these cultural polarities, such as biopiracy versus genetic harvest,[18] shift just as constantly as the transnational corporations’ ability to nimbly reorganize or relocate,[19] or, as new patent issues[20] arise to reconfigure these resources.

        This article explores some of the problems associated with patenting human genetic materials taken from indigenous people whose cultural beliefs of backgrounds prohibit them from understanding the implications of the patenting process, and who’s position of political power disadvantage them.  This discussion also analyzes some of the models describing current global rifts between intellectual property rights (IPR) and sustainable indigenous knowledge,[21] in order to formulate question about two recent episodes in patent law.  Namely, how does patenting genetic material in human tissue taken from a Guaymi Indian woman in Central America[22] usefully compare to Iceland’s Parliamentary decision[23] to put the code from its own gene pool on the NASDAQ?[24]  Since the North has rarely occupied the position of genetic resource or donor of genetic material until now,[25] this inquiry explores what new casts our notions of resource distribution, human genetic material, cultural identity and belonging may fill.

II.  DISTRIBUTING CONSUMPTION AND R&D

        In fewer than five years, the 135 member-country World Trade Organization, which is a reformulated manifestation of GATT, has become the centralized rule-making regime for a vast reordering of global economic relationships now known as “the new economy.”  Its basic tenets include free trade, deregulation, privatization, and completely new forms of commodification.  Its extensive powers include closed judicial dispute settlement, legislative overrides to national policies and local laws, and far-reaching executive authority.  Its enforcement powers generally take the form of trade sanctions against members who abridge or impede free trade.[26]

        One of the many areas of law incorporated within the WTO is the Trade Related Intellectual Property Rights agreement (TRIPS), which uses the patent laws that the United States has developed for the biotech industry as its model, and guidelines for enforcement:

Before the WTO existed, individual countries made their own decisions about whether to grant IPR protections and at what level . . . Unlike the U.S., most countries in the world do not grant patents on life forms such as plants, animals, and microbes, or on pharmaceuticals because of ethical, cultural, religious, and socioeconomic concerns.  Many southern countries oppose patenting crucial elements of “the commons” – seeds, plants, and other living resources necessary for food and health – believing that they should be freely available. . . . The belief is that such things should not be turned into commodities to be sold only to those who can pay for them.  In contrast, there are no commons under the system promoted in the WTO.  Virtually all life forms and resources are available for corporate ownership.[27]

One of the objectives of the WTO is to harmonize laws, insuring that both intellectual property and access to resources are handled uniformly.  Cultural resistance has proven problematic, however.

        For example, footholds similar to the U.S. policy of patenting transgenic livestock and genetically engineered foods do not exist in Europe for a number of reasons.  Some of this consumer resistance is due to an onslaught of food scares in the last few years, which have included carcinogenic pork from poisoned feed, fall-out from the nuclear power plant failure in Chernobyl which became lodged in the food chain downwind, “mad cow” disease, and the recall of tainted soft drinks, to name a few.  “The comparative patenting disadvantage for Europe [in excluding patent protections for plant or animal varieties, is seen] through the shift of nearly all industrial research and development (R&D) in the field of biotechnology from Europe to the U.S. and Japan . . . leaving Europe as predominantly a market for most biotech products.”[28]

        Consumption comes into play in many other ways.  The technology-rich North’s R&D capabilities are often deployed in ways that are perceived to feed off the South’s biodiversity, develop products, then pass them on to willing or unwilling consumers, depending on which level of dependency they may occupy within the market chain.  Lesser-developed countries (LDCs) are often marginalized as third party participants by the technology-heavy infrastructure that frames genetic harvests as material resource.  These third parties can sometimes negotiate a benefit within the process, but as shown below, under the WTO this has become an anomaly.

A. External Costs and the Power to Contract

David Korten describes the process of externalizing costs under the new global economy:

A basic condition of efficient market allocation is that the full costs of production must be borne by the producer and be included in the producer’s selling price.  Economists call it cost internalization . . . If some portion of the cost of producing a product is borne by third parties who in no way participate in or benefit from the transaction, then economists say that the costs have been externalized, and the price of the product is distorted accordingly.  Another way of putting it is that every externalized cost involves privatizing a gain and socializing its associated costs onto the community.[29]

        Ned Hettinger has similarly identified some of the direct costs of “genetic prospecting,” which involve extraction without proper compensation, and sale of resources back to a typically dependent host from whom they were raided, after copyrighting them:

Biotechnology companies freely collect genetic material from organisms in the South, isolate useful genes, patent the genes, and then sell the products based on these genes back to the countries from which the genes were extracted.  This practice is an embodiment of the mistaken view that only human labor creates value.  On this view, before labor is added, genetic material is worthless and hence free for the taking.[30]

        Patents, under this system of reward, cordon off the underlying ecological and evolutionary continuum for plants and animals.  This system also neglects millennia of cultural practices, such as husbandry and farming which have “improved” the resource up to the point in time before the biotechnician claimed it.  Such external elements are not factored into true cost analyses.  Hence, the proper distribution of benefits across divergent human practices, such as biotech patents on the one hand, and sustainable indigenous knowledge on the other, is obviously askew, since two very different kinds and levels of harvest are called into play.

        Korten’s analysis, nonetheless, succinctly critiques the TRIPS agreement concerning these kinds of extracted benefits:  “When the seller retains the benefit of  . . . unearned profit . . . cost externalizing behaviors [are rewarded].  Passing the benefit to the buyer in the form of a lower price creates still another source of [market] inefficiency by encouraging forms of consumption that use finite resources inefficiently.”[31]  However, in the biopiracy scenarios discussed below, the consumer does not receive any cost benefit when they are the host of the original resource, say, as farmers in LDCs,[32] or where they themselves may be the resource being harvested.

        The lack of informed consent on the part of people in LDCs illustrates some of the most serious problems posed by these cross-cultural negotiations.  This occurs, for example, when the implications and consequences of taking tissue samples from them are not fully explained, and where no written agreements between the parties exist.  In addition to problems associated with translating contractual understandings across cultures, underlying vulnerabilities exist such as unequal bargaining power between the parties at the inception of these exchanges.  People in these scenarios are particularly compromised when they are viewed as a biotech resource by pharmaceutical firms.

        With regard to germ lines of seed varieties, Mark Hanning notes, “contemporary IPR regimes will always fall short of addressing the needs of Indigenous Peoples because those regimes remain grounded in property concepts of [arguably, North-]Western paradigms, and patterns of technological development” concerning innovations, individuality, and temporary exclusivity, conferred by the sovereign power of the nation and jurisdiction in which applicants file their patent claims.[33]

For Hanning, “Indigenous Peoples” includes a wide spectrum of cultural formulations:

Self-determination and the right to subjectively consider oneself to be indigenous, with acceptance by ones’ group as such; descendants of the original inhabitants of a territory who have been overcome by conquest; groups that are not based on centralized political institutions, but rather organized at the level of community and make decisions on a consensus basis; [and] groups with a world-view consisting of custodial and non-materialistic attitudes to land and natural resources, who wish to pursue a separate development to that preferred by the dominant society.[34]

These kinds of groups are the most marginalized by recent trends in economic globalization, and are directly impacted by the TRIPS agreement.  This is due to economic encroachment upon every biosocial eco-niche, which invariably seems to fall within the WTO’s purview.  Developments like TRIPS also provide the backdrop for the recent events unfolding in Iceland.

        The profile of the Icelandic People, although formally analogous to many indigenous groups because of the historical isolation of their gene pool, is just as obviously easily distinguished from several of Hanning’s criteria, primarily because of their centralized political institutions, such as the Icelandic Althing or Parliament.  Nonetheless, some resemblances may prove useful in evaluating the legitimate weight between parties bargaining within the contract model.

        The first country in the world to do so, the Icelandic Parliament narrowly[35] passed a law authorizing sale of the rights to its entire population’s genetic code to a local company, DeCode Genetics, enabling the biotech firm to hold an unusual 12-year monopoly on data marketing rights.  Pharmaceutical firm Roche Holding Ltd., a minority partner, soon signed a $200 million, five-year deal to develop new drugs and tests from the data,[36] and to identify the genes causing twelve diseases.[37]

        Although 25 percent[38] of the nation’s 275,000 people opposed the idea of the database after a prolonged and bitter national debate on ethical grounds, their collective voice may possibly satisfy Hanning’s criteria for indigenous consensus.  However, this population would likely fail to meet the parameters of a community model, no matter how cohesive the group, because of its size.  Ideas about Icelanders’ world-view have also been mediated in news bites.  With regard to custodial and non-materialistic attitudes to land and natural resources, Iceland has been portrayed as “treating its unique genetic heritage as a natural resource, not unlike the fishing grounds that surround it.”[39]

        The main flaws in the Icelanders’ social contract appear in the ways informed consent has been handled.  Kari Stephansson, founder of DeCode, contends, “the plan simply wouldn’t work if [every single] Icelander had to give consent for each experiment DeCode hopes to carry out.  [And] that reverses the usual rule of informed consent; it assumes that people are research subjects unless they specifically request exemption.”[40]

        Ultimately, however, this group is neither a marginalized subpopulation within a larger colonial administration, nor is it non-materialistic by Hanning’s criteria.  On the one hand, the original blend of ninth-century Norse people and Celtic seamen in this population has remained largely unchanged since the country was settled.  On the other hand – with regard to materialism, “in exchange for computerizing Iceland’s entire medical history, DeCode has agreed to provide Icelanders free access to any drugs produced through the database.”[41]

At first glance, it seems these advantages have been negotiated between two equal Northern partners, where one benefits from harvesting itself as its own resource.  Thus, the power to contract, which seems so ephemeral in LDCs and for indigenous groups, finds its locus in Iceland’s transaction.  Accordingly, externalizations of costs upon third parties appear curtailed.  But are they really?  How holistic is this “four corners” (of the contract page) approach, which attempts to isolate any give deal from the larger conditions and factors of human interdependency?  How hegemonic?

        Here, the non-altruistic pharmaceutical interests derive value through the containment mechanisms of the contract itself.  In this model, outlay of resources by both sides is balanced against what each may gain.  The cost of providing research benefits to the Icelanders, only 275,000 strong, is grossly uneven when compared to what the drug company stands to gain: a monopoly on licensing arrangements and products, as well as any other interests that the company targets or discovers related to potential health needs of the entire species.

        These calculations also belie the difference between open and closed systems[42] in that the deal made between these two parties is an example of the legal fiction of a closed system; and much like Korten’s model of external costs, unequal benefits accrue by refusing or ignoring an open accounting of any real depth.

        In this vein, Einar Arnason, one of Iceland’s most respected geneticists, has observed that this agreement is “the greatest hand out in the history of this supposedly competitive business of scientific research.  If you forget the bad science it will encourage, you can think about this:  Iceland gets a few hundred mostly technical jobs; DeCode stands to earn billions of dollars, maybe more.  Sound fair to you?”[43]

B.  Harmonizing Privitizations and Stewardship of The Commons

        While acknowledging the conceptual hurdles inherent in the formal principles of contract law, various practical models dealing with obvious inequalities have been proposed as a distributive justice schematic for IPRs.  Two main approaches have been suggested to deal with the issue of patenting human genetic material as a harvestable resource.  One is to bring every member country of the WTO up to speed about what might constitute a legitimate subject for ownership and actively encourage the parties to develop the same laws to stake all claims.[44]  The other approach is to remove certain things, like humans and their genes, permanently from potential monopolization by placing them in the public domain within a Common Heritage of Humankind model, akin to treatment reserved for celestial bodies, Antarctica, and deep seabeds.[45]

        Many people feel uncomfortable about companies owning property rights to such a largely unregulated[46] and powerful tool.  Recent events mirror both approaches of pushing to universalize the patent procedure, while also considering what should be placed in the public domain.  On March 14, 2000, President Clinton and British Prime Minister Blair issued a joint statement, most probably initiated by Wellcome Trust, a medical research charity in London, providing that the general ownership of the genome, “is mankind’s and should not be owned by any one company, individual or country.”[47]  The biggest champion of the WTO, the Clinton Administration, “tried to walk a fine line between reiterating that public labs should continue to make their gene maps freely available, while endorsing the concept that companies could indeed patent genes that lead to development of specific drugs.”[48]

        As CEO of one of the affected pharmaceutical firms noted, however, “investors failed to distinguish between genome sequences and gene sequences.  The genome, referring to the total human DNA, has no commercial value and cannot be patented.  The genes, which occupy only 3 percent of the genome, can be.”[49]  These distinctions were lost on investors, however, and the NASDAQ biotech index fell almost 13 percent in one day,[50] and 37 percent by the next month,[51] thus compelling the President to further clarify his position on April 5th:

Tony Blair and I crashed the markets for a day or two and I didn’t mean to.  Where public money contributed to basic research, we ought to get it (gene information) out there.  If someone did it with private money, they ought to get a patent on it.[52]

These distinctions between public and  private good often become blurred and problematic.  They are further exacerbated in instances where private efforts are avowedly undertaken on behalf of the public good, as shown in the following cases.

III.  THE HUMAN GENOME DIVERSITY PROJECT & GENETIC IDENTITY

        Begun in 1988, under the auspices of the National Institute of Health (NIH) and the Department of Energy, with its tremendous physical computing power, informatics research capability, and interest in increased mutation rates resulting from the atom bomb,[53] the Human Genome Diversity Project (HGDP) became embroiled in controversy around 1993.  Charges against the agency included the idea that late twentieth-century social scientists should have developed the tact and sensitivity to gather knowledge without perpetuating objectifications of the people they attempted to study.  Science critic Donna Haraway notes that the HGDP attempted to “represent exhaustively – in genetic, physical, and DNA sequence maps – the totality of information in the species genome.”[54]  Haraway further points out that, “however it was precisely the doctrines of difference, representation and agency of ‘universal’ humanism that got the project and its well-meaning organizers into well-deserved trouble.”[55] 

        These problems stemmed from the fact that, during the planning and execution of the project of taking “hair-root, white blood-cell, and cheek-tissue samples,”[56] there was little meaningful engagement or partnership with the indigenous people from whom genetic information was taken.  In several of the more severe cases,[57] permission and consent came under fire as being imbalanced in terms of negotiation power between the parties, and thus, procedurally suspect.  Indigenous groups also consistently encountered problems with researchers who ignored or devalued their formulations of identity[58] and self-representation that might not fit databank or commercial profit formats.[59]  It is within this context that mytho-science fiction narratives began to erupt describing these imbalances.

A.  Isolates of History and the Amplification of Difference

  1. Vampires

        Speaking at a 1997 dialogue session between indigenous peoples and governments, Victoria Tauli-Corpuz noted how indigenous people refer to the HGDP as the “vampire project,” stating:  “We are told that because many of us are on the verge of extinction, our genetic material has to be collected [in] the fastest time possible, because [it] will explain the diversity of human life on earth.”[60]  These notions of people as historic isolates informed the scientists’ concerns, that “what it means to be human would have irredeemable informational gaps . . . Like the vanishing of a rainforest fungus or fern before pharmaceutical companies could survey the species for promising drugs, the vanishing of human gene pools [would be] a blow to technoscience.”[61]  It is within this context that these takings without just compensation[62] – of genetic material from one culture by another – have become legend.

        As of November 1992, HGDP’s repository at the American Type Culture Collection in Maryland held 1,094 human cell-line entries, with more than one-third identified as targets of patent applications.[63]  Seen as the most blatant example of biopiracy so far, patent claim WO 9208784 A1 was filed by the U.S. Secretary of Commerce for the “immortalized” cell line derived from the blood of a Guaymi woman with a unique virus and antibodies holding potential for AIDS and leukemia research.[64]  The sample was collected somewhere near a banana plantation in western Panama under questionable consent circumstances.[65]  Incensed upon discovering the claim, President of the Guaymi General Congress, Isidro Acosta stated: “It’s fundamentally contrary to the Guaymi view of nature and our place in it . . . To take human DNA and patent its products violates the integrity of life itself, and our deepest sense of morality.”[66]

        As an interim measure, however, the Guaymi tried reformulating their ideas to negotiate the return of their genetic material, and decided to seek protection from the U.S. claim under terms originally intended to protect flora and fauna.  It was then that they “learned the disturbing news that nothing in the current GATT draft agreement on IPRs explicitly excluded human patenting.”[67]  Thus, they found themselves subject to the U.S. Secretary of Commerce and previous U.S. negotiations on GATT.  Following their protests at the European Parliament, however, the patent claim on these people was eventually withdrawn in 1993.[68]

        In 1995, the NIH was awarded U.S. Patent No. 5,397,696 on a cell line containing unmodified DNA from the genes of a person from the Hagahai tribe of Papua New Guinea.[69]  The Hagahai, who were only about 260 people, and presumably unable to muster the clout displayed in the previous example, found that their DNA had become property of the U.S. in the first patent application for indigenous peoples’ genes finally approved.[70]  It was these kinds of culture clashes, and problems with informed consent, that nearly derailed the HGDP.[71]  

        After all, these encounters really were not between “traditional” and “modern” peoples, but instead between contemporaneous peoples with diverging discourses, world-views, and histories.  Like the current situation for Icelanders, some indigenous groups have, nonetheless, been able to negotiate some benefit from previous HGDP research.  For example, “the Euchees and Apaches of Oklahoma decided to participate in the HGDP, in part because of their interest in the research on genetics of diabetes, a major health problem of Native Americans.”[72]

        The possibility that genetic collection, sampling, and taking could potentially be culturally compensated highlights the power dynamics in the above scenarios.  Notable are cases where different sovereign groups occupy the same geopolitical parameter, such as the contract-heavy milieu of North America, where there may be more advantages than those available in the Southern hemisphere.  However, as suspect as the political practices of boundary drawing may be, the impact is real wherever culture groups cannot negotiate an acceptable contract – or their beliefs or conditions do not allow such bargains to be struck.[73]

        Paul Billings writes about some of these identity issues working both for and against First Nations Peoples in North America:

Consider the example of 500 indigenous tribes that live in the United States and Canada in semiautonomous relationships with the federal governments.  Tribal membership . . . confers on individuals certain special rights and benefits . . . In addition to those extended with standard national citizenship . . . [such as] the right to own land in special areas.

Inclusion in tribal membership is determined by two competing systems, one official and federal, and the other traditional . . . One involves [family history, another] “blood quanta,” a quasi-quantitative calculation of biological relatedness based on family information . . . Such “quanta” systems have a long and sad history, having been associated with societies where racism was institutionalized and intermarriage often illegal . . . [Whereas,] the traditional [for the tribe, that is] system of membership determination used by the tribes themselves . . . has no legal standing . . . It utilizes traditions which vary from tribe to tribe, and . . . grants membership to adoptees, immigrants from non-indigenous communities and to members of other tribes.

Science now offers DNA-based methods that theoretically could be applied to determinations of tribal membership . . . Such a system would be “rational.” But would it be appropriate?[74]

This reveals how any potential contractual advantages gained from genomic identification, when negotiated between differently situated sovereign groups, often yield a disparate impact upon application, when cultural difference gets amplified.[75]

2.  Frankensteins

        For every “takings” metaphor that arises, still undead from the previous turn-of-the-century vampire stories, there is a companion trope.  This one is about grafting, splicing, cloning, poisonous infusions, and other transubstantiations – the realm of Frankenstein.[76]  Appropriately, current European alarm and aversion to ingesting patented transgenic life forms produced by U.S. agribusiness is signaled through the use of the term “Frankenfood.”[77]  It bespeaks some of the inherent health hazards of these substances, which consumer groups declare include toxicity, allergic reactions, antibiotic resistance, immune-suppression, cancer, and loss of nutrition.[78]  From these cobbled-together articulations of monsters, money, and machinery, a consciousness emerges of people who have either come to recognize themselves as resource objects, or as captive consumer subjects.[79]

B.  Richly Mono, or Richly Diverse?

        The South holds the powerhouse and the genetic diversity of tropical rain forests and the cultural diversity that has evolved within that agro-environtment.[80]  Strewn throughout are alleles responsible for many human genetic disorders, prevalent or even confined to particular ethnic groups, or to small numbers of afflicted individuals.[81]  For example, the patent filed on the Hagahai, discussed above, concerned the way the tribe expresses human t-lymphotropic virus (HTLV-1).[82]  These dispersed evolutionary refinements are woven by man’s interdependent relationships with his environment. As much holds true for Iceland:

Iceland’s population presents a tantalizing opportunity for those who study genetics because all of that blond hair and blue eyes reflects one of the most remarkably homogenous populations in the world . . . restricted by bouts of plague, famine, and volcanic eruption.[83]  Not only did these disasters kill many people, but there was an equally dramatic Darwinian effect: they cut back sharply on the genetic diversity of the island – as if a giant tree had been pruned again and again until only its trunk and a few of the sturdiest branches remained.[84]

        This made it easy to trace a mutation to a sixteenth-century cleric, who carried a few less basic units of DNA on the gene known as BRCA2.  This defect is responsible for virtually every case of hereditary breast cancer in Iceland today.[85]  Other breakthroughs have included the identification of a locus on chromosome 2p13 that contains a gene linked to pre-eclampsia in women – a condition that is indicated in an estimated 2 to 7 percent of the pregnancies worldwide – a disease which occurs at the interface between genes and the environment and results in maternal and infant mortality.[86]

        This kind of isolation has proven to be a potent research tool.  As a methodological framing device, however, it has also reconfirmed indigenous peoples’ fears.  For example, the HGDP practices relayed the North’s beliefs that these groups would succumb as their subsistence environments continued to be degraded.  As units of analysis, they would die out.  At least Iceland shows that isolation is not coequal with extinction.  Unfortunately, it also shows that within a colonialist trajectory, threshold issues of political clout inevitably define how isolation and cultural mobility become valued.

C.  Moveable Feasts and Terminator Technology

  1.  Capturing Value

        Many now suggest copyrighting all resource before it gets away, since capture and extraction practices currently range from informal memento, trophy or souvenir collection, to formal sampling programs.  The Monsanto Magazine, published by the transnational biotech and chemical company, had actually encouraged Monsanto Corporation employees who were “travelling in exotic places to collect plant and soil samples.”[87]  Such practices have led commentators to observe, that “once biological material has left the country, it is practically out of control of the original owner of the tangible good . . . due to the specific trait of self-reproduction of those resources.”[88]  For those who advocate patenting everything before any further steps are taken, the TRIPS would act as a set of default rules about contractual and spatial boundaries, and provide “the host countries of genetic resources the only effective form of protection [against] international exploitation.”[89]

        The underlying business presumption is that of exclusive rights.  Certainly, under the corporate application of the TRIPS mode, “it is not possible to invoke the principles of territoriality and national treatment while simultaneously claiming to justify the appropriation of foreign inventions within its national borders and claiming free access and non-discriminatory treatment of goods and services in the markets of the originators of the appropriated technology.”[90]

        What this means is that LDCs’ dependency grows profits for transnational corporations.  This outlook is seen in the way WTO member countries and transnational pharmaceutical corporations have invoked TRIPS defaults to stop developing countries from providing generic cheaper AIDS drugs[91] to the infirm, and to prevent patent agreements on their copyrighted products[92] from being circumvented.  It is also the mechanism by which agribusiness attempts to prevent small farmers from saving seeds, often in the guise of protecting the environment.[93]

2.  Profit Generation

        There are many problems with monopolies that use-rights and leasing agreements attempt to resolve. One of the more difficult of these has been the seventeen-year limit[94] on patents on mammals, particularly where the time it takes to generate progeny may surpass the time limit on the patent.  For example, the Harvard-DuPont Oncomouse,™ a mouse engineered with a predisposition for cancer, had a reproductive cycle short enough to merit licensing.  Although it was sold on a professional honor system rather than being licensed, the expectation was that if it was used to reproduce more mice from that line, license fees applied.[95]  Within this framework, “patent infringement would occur if a person sold ‘the germ cells, semen, or embryos’ of a patented transgenic farm animal.”[96]  Human embryos straddle these rules, however, since they are considered neither person nor property by law.[97]

        Another related but more complex example is seen in the company SyStemix’s human bone marrow ‘stem cells’ monopoly – on the procedure to isolate a pure strain of the stem cells, as well as stem cells themselves.[98]

On October 29, 1991, the PTO [U.S. Patent and Trademark Office] granted patent rights to a naturally occurring part of the human body . . . What makes the patent remarkable (and legally suspect) is that the patented cells had not been manipulated, engineered, or altered in any way . . . SyStemix now has a monopoly on human stem cells [the progenitors of all types of cells in the blood].[99]

These new kinds of patents far surpass what was previously available in general practice, where researchers could work on the sequences of patented genes in academic work and would have to pay license fees only if they wished to sell an invention based on the sequence.[100]

        They also exponentially outpaced what was legally available in the landmark case, Moore v. Regents of the University of California,[101] decided only one year earlier.  There the California Supreme Court, invoking Diamond v. Chakrabarty,[102] decided ten years previously, found that “federal law permits the patenting of organisms that represent the product of ‘human ingenuity,’ but not naturally occurring organisms,” and thus held, “it is the inventive effort that patent law rewards, not the discovery of naturally occurring raw materials.”[103]  But after 1991, essentially unmodified material could be monopolized, so the boundary and time-line issues expanded considerably.

        Repercussions of these new laws – the implications of how patents extend through time and across generations of offspring – have yet to be fully appreciated.  As humans encounter patent issues through genomic methods of disease prevention, or genetic amelioration of their makeup, this statutory limitation becomes a legal point of contention.  With irony, if not unexamined bias, some commentators have even suggested that cultural prohibitions strategically deployed to constrain human reproduction until after age seventeen, may in some instances bypass the line drawing of who may own what, carried by whom.[104]  In the meantime, patent applications have already been “carefully crafted to include all female mammals – including humans – that would allow the patenting of women who have been genetically engineered to produce valuable human proteins in their mammary glands . . . [according to the expectation that] ‘someone, somewhere may decide that humans are patentable . . . ’”[105]

        Generational issues also drive current perception and policy.  Under the current system of bio-patents, farmers must pay royalties on offspring of animals they own and breed.  As mentioned above, they are also prevented from saving and using seeds from patented crops.[106]  Monsanto’s infamous “Suicide Seeds” and “Terminator Technology,”[107] lines that can only produce one generation of crop, render the practice of saving seeds for future planting cycles useless, and as a byproduct, develop dependency.  These practices have become so widely criticized that the company has had to retract some of its market strategies.[108]

        Ned Hettinger writes on the environmental ethics of intellectual property.  Of related concern for him is how new life forms can now be made from “scratch”[109] by splicing genetic information across plant and animal species to create new combinations that could never have existed according to basic evolutionary principles.  The direction in which genetic material is transferred informally constitutes what research is socially acceptable.  For example, in the creation of sub-human germ lines,[110] if the direction of transfer goes from implanting human information into sub- or other species, it is more likely to be socially tolerable than the more frontal alternative of dealing with the implications of direct inter-species upgrades to human progeny.

        Other generational problems concerning these patentable life forms lie in the fact that many biotech practices narrow genetic diversity within a very short time.  For example, transgenic salmon with growth hormones always switched on in their pituitary gland as well as their liver, result in market-size fish by 18 months instead of 36.  Besides the many health risks these new life forms carry without reproducing, if they are not effectively sterilized, they aggressively supplant all other varieties extending beyond the eco-niche from which they were developed within a generation or two.[111]  Most indications show that when industrial uniformity is applied to locking market share through the use of patents, by securing control within the time constraints of progeny, the practice temporarily broadens, but potentially constricts over a short time, even the most basic principles of profit generation.

IV.  THE SNOWBALL EFFECT

        The patent policies and practices of the U.S. are swiftly becoming codified as the global standard of monopolizing property under the WTO.  This has triggered a chain reaction between nations as each attempts to regain or protect ownership and use interests in the natural resources they need to sustain their biological and cultural wellbeing.  The race is on to “stake it or lose it” – to patent everything before invaders asserting patent claims are able to monopolize another’s resource as one’s own.  Melissa Sturges surveyed the situation in 1997:

Nation-states are not only responding to the U.S. actions, but also promulgating a defensive effort to protect their investments.  Thus, because the patenting of the genome has had a snowball effect, with countries only patenting their discoveries because other countries have done so, it has become necessary for the United Nations or another international body to implement international regulation on patenting gene sequences.  At present, however, private companies are racing at breakneck speed to patent their discoveries due to lack of regulations.[112]

        More recently, Pamela Sherrid has noted that not only have these speculative practices continued unabated, but a shakeout about who may hold which claim as valid will need to be sorted out by the courts far into the future:

In the U.S., where patent applications remain secret until the patent is granted, the odds are almost overwhelming that competing companies have filed overlapping applications.  Controversy also is brewing between companies that file a patent on a gene without a clear idea of what it does and researchers who later find out more about the gene’s medical usefulness.  Biotech and pharmaceutical firms, which often handle development and marketing of gene-based drugs, will have to sort out who deserves to get what . . . Expect huge patent litigation down the pike.[113]

A.  Genetic Patents

  1.  Hoarding versus Public Domain: The U.S. and France

        In Sturges’s analysis of property rights regarding the Human Genome Project, she notes that the U.S. has consistently acted on behalf of private companies in filing patent applications.[114]  She expresses concern about the U.S. government’s divided allegiance arising from its own applications for gene patents, which conflicts with its duty to regulate patents.[115]  This divided allegiance raises constitutional problems because it enables the government to “first acquire the exclusive rights to a vital technology and then to dispense those rights to persons or entities which are in its favor.”[116]  Sturges concludes, “the patenting actions of the U.S. outraged the international community because [everyone] commenced the HGP with the intent that all countries would openly share the discoveries derived therefrom.”[117]

        At the other end of the spectrum, from the project’s inception and in the spirit of international cooperation, France has donated the discoveries from its human genomic DNA libraries to the United Nations for international distribution.[118]  The European Community has decried the hoarding practices of the U.S. governmental and business alliances, calling for all HGP information to be placed immediately and freely in the public domain.[119]

        Not until the end of his term in office did President Clinton iterate this statement, though many have done so all along.  James Watson, who could have profited by patenting his co-discovery of DNA, has been so opposed to the concept of patenting the genome that he resigned as Director of the HGP in protest of the NIH’s original patent applications.[120]  Public policy, by comparison, seems strictly parsed among the key players[121] in this still unregulated field.  After all, “public dissemination poses a direct threat to the proprietary interests of biotechnology companies because the more results that [have been] made available to the public, the more threatened the proprietary interests of biotechnology companies hoping to claim rights to gene sequences become.”[122]  More elaborate factors at play involve speculation that the administration’s current agenda of affording American seniors Medicare drug coverage directly relates to the strategies it has taken to minimize research expenditure claims now used to justify drug firms’ pricing schemes.[123]

2.. Making Sustainable Indigenous Knowledge Unique

        Hanning outlined the culture gaps between contemporary IPR regimes and the needs of indigenous peoples in 1996:

Whereas current IPR regimes acknowledge only new innovations, [and] confer only temporary protections and exclusivity upon individuals, by the sovereign power of the nation where the applicant lives, indigenous people seek to protect intellectual property developed over time, often through the work of generations by communal efforts, [and] seek to determine [and] legitimize [for] themselves what intellectual property is.[124]

        Ever since the successful award in 1991 of the stem cell patent discussed above, more inroads have been cut into indigenous peoples’ use of their own genetic resources, because the material no longer effectively requires any relevant degree of modification to qualify as a patentable invention.  Mere taking constitutes discover under these guidelines.  Thus, those with the technological infrastructure required only to identify naturally occurring resources in this way, win.  The Southern hemisphere’s lack of sponsorship or infrastructure for local R&D makes them easy targets to raid.  Only those who can afford outsourcing the task of tagging their resources retain some semblance of control.

        Although many indigenous groups in the short history of genetic harvesting have had to either adopt or in some other way deal with agency and incorporation principles of industrially devised contract law, for example, by assigning someone within the group to become the representative holder of its patents, several of Hanning’s contentions remain unresolved.  Since most patent monopolies now last seventeen to twenty years, might this then suggest that resources could revert back into some sort of public domain, where conceivably, they would reoccupy their original nexus, site, and function?  Unfortunately, it is more likely that the infrastructure at the pharmaceutical companies’ disposal will circumvent that from happening.  By changing a molecule or two of original formulations, whenever product patents reach their expiration, companies secure continuity of exclusive rights over materials by these serial amendments.  Thereby, originally unmodified source materials could be perpetually privatized by “the corporate enclosure of our genetic commons.[125]

B.  The TRIPS Model So Far

The central operating principle of the WTO is that global commercial interests . . . should always supercede all others . . . Obstacles to the smooth operation and rapid expansion of global corporate activity . . . [include] national, provincial, state and community laws and standards that are made on behalf of labor rights, environmental protection, human rights, consumer rights, local culture, social justice, national sovereignty, and democracy.[126]

        According to these principles, local self-reliance is subversive to free trade and economic globalization.  Local control over resources may thereby be deemed isolationist or protectionist, in the way the U.S. Supreme Court prohibits individual states gaining advantage over any others, if to do so could be judged as driven by economic motives.  This becomes a matter of degree in assessing the relative power between different countries, however, and is often only revealed through an analysis and accounting of externalized costs.  Promoters of the WTO argue that accelerated growth free from all constraints will generate wealth in a “rising tide [that] will lift all boats.”[127]  For most, however, not only is the terrain that marks the original watermark uneven, but only yachts are lifted[128] by a tide that has become a cataclysmic and destructive flood for everyone else.

  1.  Taking, Consent, Conversion and Reward

        In Moore v. Regents of the University of California,[129] where a cell line named after the leukemia patient from whom it was taken was developed into a lucrative research product, dissenting Justice Stanley Mosk believed that Mr. Moore’s tort theory of conversion[130] made sense, and that this patient had property interests of this material.

He could have contracted with the researchers and pharmaceutical companies to develop and exploit the vast commercial potential of his tissue and its products.  Defendants certainly believe that their right to do the forgoing is not barred . . . and is a significant property right . . . The Court of Appeals summed up the point by observing that the “Defendants position that plaintiff cannot own his tissue, but that they can is fraught with irony.”  It is also legally untenable.[131]

        The irony apparent to Mosk and others was that policy prohibitions against qualifying human body parts as property (directly due to this country’s history of slavery), ultimately favors enterprising researchers, who are allowed to raid and commodify patients’ bodies.  “To freely mine or harvest valuable physical properties of a patient’s body [shows] unjust enrichment . . . particularly when, as here, the parties are not in equal bargaining positions.”[132]

        Cases like these are riddled with the same recurring problem.  It seems no matter what milieu, every scenario examined so far displays a lack of informed consent.  The parties from whom substances are taken are neither properly informed about what transpires, nor do they consciously consent to these transactions.  As a result, no true exchange occurs.

        Public policy is also often outpaced by the kinds of technological developments described in these interactions.  In an attempt to slow things down for a moment of reflection, and “to block the patenting of genetically engineered human genotypes, . . . on April 7, 1987, the U.S. Patent and Trade Office (PTO) proclaimed that a ‘claim directed to or including within its scope a human being will not be considered to be patentable’ because the grant of an exclusive property right in a human being ‘is prohibited by the Constitution.’”[133]  It is argued that this administrative agency has overstepped the bounds of both its authority and competency, with regard to Constitutional law and its reading of the applicability of the Thirteenth Amendment.[134]

        Under the WTO, public policy is also outpaced by market expansion.  With improvements in transplant technologies, for example, “the new and urgent demand for new organs, combined with the prohibitions of organ sales in many Western countries such as the U.S., Great Britain, and Germany, has resulted in a growing international market for human organs . . . In 1991, the World Health Organization reported that organ selling in the Third World had reached ‘alarming proportions.’”[135]  Today, these issues remain far from resolved.  Since the human embryo contains the most potent stem cells, “the prospect of turning human embryos into spare parts factories touched a nerve in Congress, which several years ago banned federal funding for such research.  [But] that ban did nothing to stop private firms . . . from paying for their own experiments.[136]

2.  Self-selection, Survival, and Sustainability

        “The rush to decipher human genes has triggered a money-making free-for-all akin to the claim-jumping disputes in the Gold Rush era.”[137]  But should possession of this new golden resource, located in human bodies and people who occupy real places on earth, be rewarded, or should protections of the labor of inventiveness involved in finding, identifying, mining and refining these resources prevail?  Given that our property models need to be overhauled, questions about the Icelandic gene pool seem to confound these kinds of boundaries and distinctions.

        For all the potential benefits the Icelanders have self-selected, in partnering with DeCode and Roche for promises of disease prevention, the next logical question about germ-line amelioration now crests upon everyone’s ethical horizon.  Over the last few years, artificial reproductive technologies have offered Northern couples similar kinds of choices about progeny, through the weeding-out process that often occurs in selecting only the most hearty of their now often multiple offspring to be born.[138]  The stages of genetic engineering made available through these therapies have swiftly shifted from correcting somatic defects in non-reproductive cells to germ-line therapy, which can affect progeny, to gene therapy enhancement, which generates borderline definitional problems between normative characteristics and disease, and, ultimately, the most charged stage of gene therapy, the reintroduction of eugenics and the possibility of changing whole populations.[139]

        Iceland’s closed system relationship with the research and pharmaceutical firms presents exactly these issues to the world in rather sharp profile.  The outlines of their particularized situation are not drawn by the many isolated individual choices that people who can afford reproductive technologies often face.  Rather, the Icelanders are presently cast by their collective decision, perhaps rendered nation-wide, as those of an entire people of a particular culture, race, and gene pool.

        Rethinking the distribution of biosocial and ecological good on such a specific and localized but globally impacted scale now becomes our present challenge.  An open systems analysis is required in weighing the challenges and choices that the Icelanders have now encountered, because these issues now ripple across the entire genome, and these problems can no longer be imagined as curtailed to any specific isolatable human group.  To ignore these responsibilities may conceivably lead one class or cultural group to breed itself into a separate species within a very short time.[140]  However Iceland reckons this Darwinian challenge, they have changed their capability to upgrade their entire genetic makeup, due fundamentally to the closed system contract model offered by transnational corporeal enterprise.  As a Northern, technologically savvy population and culture, these people now offer the species the most intriguing question.  What might a holistic sustainable system entail?

V.  CONCLUSION

        Many have already renounced the practice of patenting human genetic information, yet categories of patentable material continue to expand.  Within the framework of the WTO this is understandable, since the international market is based upon unbridled competition in securing monopolies over the use of information and materials.  The rush to patent everything “discoverable” has been spurred by disparities in member nations’ trading and negotiation powers.  The result has been to stake a claim or lose the resource race.  The harmonization of patent laws proposed, predictably enough, are those devised by the U.S. and the biotech interests able to perform R&D in forms no one else can.  If research projects appear unethical, components can be farmed out, distantly offshore, out of sight.  It seems too late to resound alarm over what has become standard practice.  But the practice is far from standardized.  Because of this, the very gaps found in differences of value that provide the mechanisms by which profits can be captured, can also be used as portals to intervention. 

        Rather than the piecemeal bans and retractions that have been made by the executive branch, a governmental regulatory agency should be formed to consistently deal with some of the glaring problems facing the subjects and objects of genetic research.  Much money has already been set aside for the ethics branches of every major research project involving the human genome, yet public policy seems frozen if not stale.  In retrospect, much of the debate appears to be nothing more than public relations sponsored by or for transnational corporate interests.

        Since the Human Genome Project has often been analogized to the arms race,[141] the government has a vested security interest in how the map may eventually be used.  However, the regulation that is formulated often appears duplicitous.  The U.S. government works both ends against the middle, often pitting the Patent Office, sometimes for, sometimes against, business interests.  For example, so far the government holds the highest number of patents, surpassing those of any other research or corporate interest.  The U.S., arguably, also holds the most sway over the WTO, often strategically determining many of its policy forays.

        International regulation with some teeth is also needed.  The fora employed so far around biodiversity have had as much enforcement power as the United Nations, a mere advisory body compared to the vast muscle of WTO sanctions.  There are many examples, including “the U.S.’s refusal to sign the biodiversity treaty at the June 1992 Earth Summit because the treaty encouraged the South to preserve its genetic diversity by giving it rights to profit from uses that might be found for the genetic materials extracted from its lands.”[142]

        As a political body that could conceivably challenge some of the WTO’s power, the European Parliament appears a good candidate for establishing guidelines.  This occurred where the Guaymi effectively used that body as a forum to reclaim their pirated genetic property, contesting GATT provisions.  However, that was long before GATT was folded into the more powerful WTO.  The related forum of the Icelandic Parliament, although problematically situated by the recent events of gambling for genetic rewards for its people, also occupies an important power point along this continuum.  Even if the European Union has trouble comprehending the LDCs’ situation under the WTO, at the very least Europe has found itself a critical consumer subject to U.S.-engineered biotech products; and it has proven to be as wary of U. S. patent practices and as outspoken as any other group.  As a watchdog against some of the WTO’s more severe incursions, the EU also brings with it an historical appreciation, as recently-colonized colonizers, as well as the critical mass of political clout that LDCs could use.

        Commentators have also proposed presumptive indigenous copyrights and a system of sovereign public use for intellectual property.  Internationally, an open systems model of public good or usefulness would need to be devised and agreed upon, which appears problematic and somewhat conditional due to the sheer level of translation problems between substantive and economic value described above.  At one level, however, a model of presumptive sovereign “eminent domain”[143] of private property for “public use,” if proper compensation is made, exists under the Fifth Amendment of the U.S. Constitution. 

        This model might help one to understand some of the skirmishes that the U.S. government has had around genetic patents – seen by its shifting definitions of what constitutes a true patent on this material.[144]  Since the government is allowed to take property from one private owner and give it to another in the name of public use,[145] the current administration’s strategies often betray these balances of social utility, commerce, health care, and competitiveness, and may actual offer circuitous, albeit ethical, resolutions.

        Another proposal might be donor incentive programs with returns in knowledge, much like the example unfolding in Iceland, but where instead the benefits of discoveries about entire classes of diseases get distributed back to the entire species, and not a single population or to individual humans.  Silver bullet approaches to medicine that target profit streams, so far, have constrained the possibility of this happening.  But the very recognition of this problem also provided the motivation and early policy determination to map the entire code of the human genome so humanity could be more roundly understood.

        In its glib $50 million ad campaign, “Let the Harvest Begin,”[146] Monsanto recently proclaimed itself the global vehicle for solving the problem of world hunger.  Hopefully, this examination helps to uncrate some of the assumptions embedded in all the public relations maneuvering by transnationals who hype the wonders of biotech’s promise.  It is time to retool our policies away from a hoarded, fenced-off, short-term system of generating profits.  Let us recapture the significance of harvest, as an extended future continuum of shared plenty that more fully accounts for human identity and sustenance.

FOOTNOTES

1 This article was originally published in New College of California Journal of Public Interest Law, Volume 2, 2001.

2 Ned Hettinger, Patenting Life: Biotechnology, Intellectual Property, and Environmental Ethics, 22 B.C. Envt’l Aff. L. Rev. 267, 268 (1995).

3 Diamond v. Chakrabarty, 477 U.S. 303, 309 (1980), where the U.S. Supreme Court allowed the patenting of a genetically altered oil-eating bacterium; see also id. at 270, for analytical bridgework to the Court’s later claim that Congress intended patentable subject matter to “include anything under the sun that is made by man”.  Utility patents for plants came next, prohibiting sexual reproduction of protected plant varieties, and by the end of the decade, Harvard University, sponsored by DuPont, received the first patent of animal life, a research mouse which could reproduce, but was sold on a professional honor system, rather than being licensed.  For example, if a resulting new line of offspring were devised, then licensing fees were due.

4 Moore v. Regents of the University of California, 51 Cal.3d 120 (1990), where the California Supreme Court ruled that Moore, a leukemia patient, had no ownership interests in cells taken from his spleen after they were removed from his body for pharmaceutical cell line development.

5 Hettinger, supra note 2, at 271, discussing a biotech company that has patented human bone marrow “stem cells,” and obtained a monopoly over their commercial use.  The company developed a procedure to isolate a pure strain of the stem cells and received a patent not only in the particular process for isolating them, but in the stem cell themselves.  Now no one can use stem cells commercially without getting a license from SyStemix, even if they come up with a new way to obtain the cells; see also Shannon Bownlee, Staking Claims on the Human Body, U.S. News and World Report, Nov. 18, 1991, at 89.

6 John A. Robertson, Genetic Selection of Offspring Characteristics, 76 Bost. U.L. Rev 421 (1996).

7 As one commentator describes it:

The WTO’s goal is the ‘harmonization’ of international standards.  Regulations requiring that imported products meet local standards on such matters as recycling laws, use of carcinogenic food additives, auto safety requirements, bans on toxic substances, labeling, and meat inspection could all be subject to challenge.  The offending country must prove that a purely scientific justification exists for [more stringent standards].  The fact that its citizens simply do not want to be exposed to the higher level of risk accepted by lower WTO standards isn’t acceptable to the WTO as a valid justification. . .  Once these agreements are ratified by the world’s legislative bodies, any member country can challenge, through the [enforcement and sanction powers of the] WTO, any law of another member country that it believes deprives it of benefits it expected to receive from the new trade rules.

David Korten, When Corporations Rule the World, 174 (Kumarian Press 1995); see generally Debi Barker & Jerry Mander, Invisible Government: The World Trade Organization – Global Government for the New Millennium, International Forum on Globalization Primer (1999)

8 Mark Hanning, An Examination for the Possibility to Secure Intellectual Property Rights for Plant Genetic Resources Developed by Indigenous People of the NAFTA States; Domestic Legislation Under the International Convention for Protection of New Plant Varieties, 13 Ariz. J. Int’l & Comp. L. 175 (1966); North American Free Trade Agreement, Dec. 17, 1992, Can.-Mex.-U.S. 32 I.L.M. 605 (1993) at art. 1701(2) (d). (NAFTA).

9 Steven Shrybman, The World Trade Organization: A Guide for Environmentalists, West Coast Environmental Law Draft (Mar. 1999); see also Barker & Mander, supra note 7.

10 Andrew Kimbrell, Biocolonialism,The Case Against the Global Economy and a Turn Toward the Local, 131 (Jerry Mander & Edward Goldsmith, eds., Sierra Club Books 1996); see also Korten, supra note 7, at 30 & 112; see Hanning, supra note 8, n.7-8.

11 Melissa L. Sturges, Who Should Hold Property Rights to the Human Genome? An Application of the Common Heritage of Humankind, 13 Am. U. Int’l L. Rev. 219 (1997).

12 Joseph Straus, Bargaining Around the TRIPS Agreement: The Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual Property Transactions, 9 Duke J. Comp. & Int’l L. 91, 96-98 (1988).

13 Rural Advancement Foundation International (RAFI), Patenting Indigenous People, Earth Island Journal, Fall 1993, at 13.

14 Rick Weiss, Gene Enhancements’ Thorny Ethical Traits: Rapid-Fire Discoveries Force Examination of Consequences, Washington Post, Oct. 12, 1997, at Section A.

15 Steven M. Pepa, International Trade and Emerging Genetic Regulatory Regimes, 29 Law & Pol’y Int’l Bus. 415 (1988); see also supra notes 3-5.

16 Office of Technology Assessment (OTA), New Developments in Biotechnology: Patenting Life, (1989), U.S. Government Printing Office.  See generally Paul Rabinow, Making PCR: A Story of Biotechnology (Univ. of Chicago Press 1996).

17 David Shenk, Biocapitalism, Harper’s Dec. 1997, at 37-45.

18 Sturges, supra note 11, at 245.

19 Korten, supra note 7, at 217.

20 OTA, supra note 16.

21 Hanning, supra note 8.

22 RAFI, Following Protest, Patent Claim Withdrawn on Guaymi Indian Cell Line, 9 Genewatch: A Bulletin of the Council for Responsible Genetics 6-7 (1994).

23 Michael Specter, Decoding Iceland: The Next Big Medical Breakthroughs May Result from One Scientist’s Battle to Map the Viking Gene Pool, The New Yorker, Jan. 18, 1999, at 40.

24 Icelandic Gene Company Heading for NASDAQ, National Post, Jan. 25, 2000.

25 For example, the Human Genome Diversity Project (discussed below) also surveyed “historical isolates” of Eastern Europe, thus, temporarily reinvigorating an east/west polarization.

26 Barker & Mander, supra note 7, at 9:

For example, the U.S. recently won a challenge against an EU ban on imports of beef that have been fed rBGH [Bovine Growth Hormone], a hormone many people feel is dangerous to human health.  The U.S. retaliatory tariffs against the EU did no target beef products, but luxury specialty items like Dijon mustard, prosciutto, fancy cheeses and other lucrative export item crucial to Europe’s traditional agricultural system.

27 Id. at 31-32.  Recently “transnational pharmaceutical corporations have invoked TRIPS to stop developing countries from providing generic” un-copyrighted equivalents of their products.;  Id. at 9. Barker & Mander further note:

[the] framework for the TRIPS agreement was directly shaped by a lobbying group called the Intellectual Property Committee, a coalition of 12 major U.S. corporations: Bristol Myers, DuPont, General Electric, General Motors, Hewlett Packard, IBM, Johnson & Johnson, Merck, Monsanto, Pfizer, Rockwell and Warner.  . . . Not one person from any NGO [non-government organization] was involved in developing the agreement or even permitted to comment.

Id. at 33.

28 Straus, supra note 12 (emphasis added).

29 Korten, supra note 7, at 76 (emphasis in original).

30 Hettinger, supra note 2, at 301.

31 Korten, supra note 7, at 76-77.

32 Hanning, supra note 8.

33 Id. at 196.

34 Id. at 178.

35 R. C. Lewontin, People Are Not Commodities, N.Y. Times, Jan. 23, 1999, at A3.

36 John Schwartz, Iceland Sells Its Own Genetic Code, San Francisco Chronicle, Jan. 12 2000, at A9.

37 Nightline: A Genetic Bank (ABC television broadcast, May 13, 1999) [hereinafter Nightline].

38 See Id.

39 World News Tonight: A Closer Look – Iceland Gives Genetic Info Up to Research (ABC television broadcast, Feb. 18, 1999) [hereinafter World News Tonight].

40 Specter, supra note 23, at 49; see also Laura Johannes, DeCode Genetics Comes Under Criticism for Not Getting Consent in Iceland Study, Wall Street Journal, June 15, 2000, at B17.

41 World News Tonight, supra note 39.

42 Anthony Wilden, System and Structure: Essays in Communication and Exchange, 309-394 (Tavistock 1980), where the relationship between capital and entropy is discussed.;  Id. at 356-359.  As a methodological tool, the fiction of a closed system, largely analogous to contractual erasures of externalized costs, allows specific forms of analyses to occur:

In studying a closed system once can follow the classical experimental method of the physical sciences.  One can isolate a single variable or change the variable in turn in order to make experiments on the system, without taking its context into account . . . to arrive at generalized predictions.  In an open system, on the other hand, this same method would yield inexplicable results.  Changing the variables of the system would lead to variations in the context (the environment) of the system, which would in turn influence the behavior of the system studied.

See also generally Georg Lukas, History and Class Consciousness, at 125-134 (MIT Press 1971), where in a similar vein, Kant’s notion of reification, the idea of a “thing-in-itself,” is critiqued as a form of false consciousness.;  Id at 83, Lukacs also notes that such rationalist conceptualizations of free-standing actors, as objects, do not take into account the larger totality, or political ecology (say, of open versus closed systems) of human interactions, and thereby seamlessly and ontologically generate cultural objectifications and commodifications.  Arguably, formal written contracts are often deployed in a similar fashion to cordon-off or mask an awareness of specific materialist relationships and preconditions informing any culturally-loaded transaction:

The essence of a commodity-structure . . . is that a relationship between people takes on the character of a thing and thus acquires a “phantom objectivity,” an autonomy that seems so strictly rational and all-embracing as to conceal every trace of its fundamental nature: the relationship between people. 

43 Specter, supra note 23, at 48.

44 Straus, supra note 12, at 104, where Straus notes, under Article 3 of the Convention on Biological Diversity (CBD), regarding the sovereign rights of states over their natural resources are explicitly recognized, that the country providing genetic resources is entitled to share benefits from the commercial use of its genetic resources, and such sharing be based upon mutually agreed terms.  However, CBD is a panel that can only make policy recommendations, has no binding legal impact or means of enforcement, and is often ignored by the WTO.

45 Sturges, supra note 11, at 223-224.

46 Id.

47 Alex Berenson & Wade, supra note 47, at C17.

48 Tom Abate, Call for Access to Genome Data, San Francisco Chronicle, Mar. 15, 2000, at A11.

49 Berenson & Wade, supra note 47, at C16.

50 Pamela Sherrid, Patent Woes Will Keep Biotech Stocks Bouncing, U.S. News & World Report, Mar. 27, 2000, at 60.

51 Tom Abate, Big Gene Step for Celera, Source Says, San Francisco Chronicle, Apr. 6, 2000, at B6.

52 Id.

53 Donna Haraway, Modest_Witness@Second_Millennium.FemaleMan(c)Meets_OncoMouse(tm): Feminism and Technoscience, 246-252 (Routledge 1997); see also Robert Mullan Cook-Deegan, Origins of the Human Genome Project, 5 Risk: Health, Safety & Env’t 97, 103 (1994); see Naomi Aoki, Scientists Planning Computerized Drug Design, San Francisco Chronicle, Feb. 26, 2001, at B4.  Bioinfomatics is:

The computer science working quietly behind the scenes of the genomic revolution, helping to generate, manage and analyse the flood of data spewing from the world’s laboratories on life’s innermost workings.  And as biology increasingly becomes an information science, biotechnology and pharmaceutical companies are betting on bioinformaticts to transform the nature of drug discovery and health care.

54 Id. at 246, where Haraway discusses the conceptualization of a “consensus DNA sequence.”

55 Id. at 248, crediting Cori Hayden’s UCSC unpublished 1994 manuscript.

56 Id. at 249.

57 The Guaymi of Panama and the Hagahai of Papua New Guinea, for example.

58 See Paul Billings, Iceland, Blood and Science, 87 American Scientist, May 1, 1999, government reformulations of sovereign land rights based on DNA relatedness challenge indigenous social classification systems regarding use rights, and cultural belonging.

59 Haraway, supra note 53, at 246.

60 Victoria Tauli-Corpuz, Globalization and Trade Liberalization: Impacts and Implications for Indigenous Peoples and the Commission on Sustainable Development, Statement presented during the Dialogue Session of Indigenous Peoples with Governments, Fifth Session of CSD, Apr. 15, 1997, New York.

61 Haraway, supra note 53, at 248.

62 U.S. Cont. Amend V., which states in relevant part: “nor shall private property be taken for public use, without just compensation.”

63 RAFI, supra note 13.

64 RAFI, supra note 22.

65 Id.

66 Id. at 7.

67 Id. at 6.

68 Id.

69 Tauli-Corpuz, supra note 60, Section 4.

70 Id.; see also John C. Avise, The Genetic Gods, 196 (Harvard 1998).

71 Patricia Kahn, Genetic Diversity Project Tries Again, 266 Science 720-722 (1994).

72 Haraway, supra note 53, at 252.

73 Billings, supra note 58.

74 Id.

75 Rabinow, supra note 16, at 3.  The invention of polymerase chain reaction (PCR) has led to the development of technology which amplifies source DNA.  Thus, instead of attempting to perfect magnification technology to examine miniscule material, in PCR, the unit of analysis becomes more detectable simply by multiplying it – through the process of unzipping, matching and re-zipping strands of DNA.  This standardized process has industrialized all further genomic research.

76 B.E. Rollin, The ‘Frankenstein Thing’: The Moral Impact of Genetic Engineering of Agricultural Animals on Society and the Future Science, 306-7, Agricultural Bioethics: Implications of Agricultural Biotechnology (Steven Gendel et al. eds. 1990).

77 Barker& Mander, supra note 7, at 8.  See also: What Do You Get If You Cross . . . ?, The Economist, Aug. 15, 1987, at 67-68; see also Donald G. McNeil, Jr., Let Them East Horse! Epidemic Errors, NY Times, Feb. 4, 2001, Sec. 4, at 1 & 5; see also Jodi K. Biehl, Mad Cows and Panicked People, San Francisco Chronicle, Jan. 29, 2001, at A1 & A6, where the U.S. Department of Agriculture spokesperson noted, “We don’t have a history of importing products that would be a net risk like meat and bone meal.  Rather, we’re a net exporter of them.”; see also: A Pall Over Britain, San Francisco Chronicle, Mar. 2, 2001, at A1 & A13, in tandem with their political resistance, motivated by health fears about the consumption of American transgenic beef, Europeans have also been faced with a steady onslaught of food scares concerning the safety of their own livestock, including “mad cow,” and “foot-and-mouth” diseases.

78 Julie A. Nordlee at al., Identification of a Brazil-Nut Allergen in Transgenic Soybeans, Vol. 334, No. 11 New England Journal of Medicine (1996); see also: The Hidden Health Hazards of Genetically Engineered Foods, The Center for Food Safety Review, Newsletter, Washington, D.C. (Dec. 1999).

79 The European Community’s resistance to being at the receiving end of U.S. R&D is discussed in Part II, supra.  Barker & Mander, supra note 7, at 8, indicate that “ a consumer organization attempting to pass a law requiring all genetically modified food, or ‘Frankenfood,’ to be labeled, is likely to find that such a law could be ruled a barrier to trade and investment by the WTO.  Such a law would then have to either be discarded, re-written or ‘paid’ for via trade tariff penalties or direct sanctioned payments.”

80 Hanning, supra note 8, at 7.

81 Avise, supra note 70, at 195.

82 Id. at 196.

83 Schwartz, supra note 36.

84 Specter, supra note 23.

85 Id.

86 Unnur Jokulsdottir, DeCode Genetics of Iceland Maps a Gene Linked to Pre-eclampsia, PR Newswire, Sep. 20, 1999.

87 Hettinger, supra note 2, at footnote 175; See generally Jonathan King, Breeding Uniformity, 15 Amicus J. 25 (1993).

88 Straus, supra note12, at 105.

89 Id.

90 Id.

91 Barker & Mander, supra note 7, at 9.  African governments have been prevented from providing AIDS drugs in these scenarios.

92 Id. at 34. “India’s current law deliberately excludes plants and animals from patenting in order to maintain local control over these life forms.  This helps to maintain low prices for some products such as pharmaceuticals.  Under the current TRIPS [agreement] . . . developing countries must, by the year 2005, provide some form of patent protection for plant varieties that is GATT-compliant, i.e., that allows foreign companies the right to patent local plant varieties.”

93 Tom Abate, Monsanto CEO Portrayed as More Friendly Than Fiendish This Year: Genetically Engineered Food Now Touted as Hope to Feed Third World, San Francisco Chronicle, Apr. 10, 2000, at C1.

94 Tom Abate, Call it the Gene Rush – Patent Stakes Run High, San Francisco Chronicle, Apr. 25, 2000, at A8, for certain utility patents, 20-year monopolies are granted on any drug or therapy that comes from patented genetic materials.

95 Hettinger, supra note 2.

96 Transgenic Animal Patent Reform Act, H.R. 4970, 100th Cong. (1988); and H.R. 1556, 101st Cong. (1089); Patent Competitiveness and Technological Innovation Act, H.R. 5598, 101st Cong.  Each act ultimately failed due to U.S. agribusiness’s concerns over cost containment.

97 The U.S. does not extend Constitutional protection to human embryos.;  See, e.g., Roe v. Wade, 410 U.S. 113 (1973), a woman has a right to an abortion; Davis v. Davis, 842 S.W.2d 588 (1992), an embryo is not a person or property; Laurie McGinley, Clinton Bans Certain Funding for Embryos, Wall Street Journal, Dec. 5. 1994, at B5.

98 Hettinger, supra note 5.

99 Kimbrell, supra note 10, at 136.

100 Berenson & Wade, supra note 47, at 17.

101 51 Cal.3d 120 (1990).

102 477 U.S. 303, 309 (1980).

103 Moore, 51 Cal.3d, at 159.

104 Kevin D. DeBre, Patents on People and the U.S. Constitution: Creating Slaves or Enslaving Science, 16 Hastings Const. L.Q. 221, at n.98.  In this culturally loaded and biased discussion, DeBre notes, that since patent protection on mammals only lasts seventeen years, persons born with patented DNA material would, sometimes not reproduce until after the patent had expired.

105 Kimbrell, supra note 10, at 136-137, quoting British patent attorney Brian Lucas.

106 Hettinger, supra note 2, at 301.

107 Abate, supra note 93

108 Karen Lehman & Al Drebs, Control of the World’s Food Supply, The Case Against the Global Economy and a Turn Toward the Local, at 129-130 (Sierra Club Books 1996): “On Oct. 2, 1993, five hundred thousand Indian farmers demonstrated against GATT and vowed to protect their right to produce and protect their own seeds.  They created a charter of farmers’ rights, especially the right to conserve, reproduce, and modify seed and plant material.”

109 Hettinger, supra note 2, at 275.

110 Id.

111 Carl Kaesuk Yoon, Altered Salmon Leading Way to Dinner Plates, But Rules Lag, NY Times, May 1, 2000, at A1-A19; See also Sarah Schmidt, Frankenfish or Salmon Savior?, Puget Sound Gillnetters Association, Newsletter, Sept. 19, 1999, Six Prince Edward Island fish farmers formed OvaTech, a company to distribute transgenic modified AquAdvantage™ salmon developed by A/F Protein Canada Inc. of St. John’s, Newfoundland, and Waltham, MA.  In the same issue, Alexandra Morton’s public advisory of Nov. 2, 1999 notes that the Atlantic salmon recently escaped from west-coast fisheries were “profusely infected with bacteria similar to the E. coli family . . . resistant to 11 of 18 antibiotics tested. [Since] antibiotic resistance commonly jumps from one bacteria to another, ‘bacteria in my body could suddenly become resistant to penicillin just because I handled the fish.’”  A public health warning to wear gloves and boots when handling the infected transgenic form was, therefore, issued.  See also: Return to Genesis of Eden? Wild Salmon Threatened by Fish Farm Species, NY Times, Nov. 1, 1996, noting that more than on fourth of salmon spawning in Norwegian rivers and streams are escapes from fish farmers.

112 Sturges, supra note 11, at 237.

113 Sherrid, supra note 50.

114 Sturges, supra note 11, n. 11; see also Christopher J. Harnett, The Human Genome Project and the Downside of Federal Technology Transfer, 5 Risk: Health, Saftety & Env’t, 151-152 (1994).

115 G. Kenneth Smith & Denis M. Kettleberger, Patents and the Human Genome Project, 22 AIPLA Q.J. 27, 32-33 (1994).

116 Thomas Lizzi, Comment, From Benevolent Administration to Government Employee Inventions, Human Genomes, and Exclusive Licensing: Is Governmental Ownership of Patents Constitutional?, 24 Duq. L. Rev. 299, 301 (1996).

117 Barbara Looney, Should Genes Be Patented? The Gene Patenting Controversy: Legal, Ethical, and Policy Foundations of an International Agreement, 26 Law & Pol’y Int’l Bus., 231-233 (1994).

118 Smith & Kettleberger, supra note 115.

119 David R. Bently, Genomic Sequence Information Should be Released Immediately and Freely in the Public Domain, 274 Science 533 (1996).

120 Justice Michael Kirby, The Human Genome Project – Promise and Problems, 11 J. Contem. Health L. & Pol’y 1, 17 (1994).

121 Biotech Shares Plunge Again Amid Attempt to Make Gene Data Public, Dow Jones Business News, Mar. 14, 2000, where President Clinton and British Prime Minister Blair applauded efforts of scientists working on the HGP to make their discoveries public; see also Sturges, supra note11, n.94; see Smith & Kettleberger, supra note 115, at 63.  The U.S. initially demonstrated its acknowledgement of the need for international collaboration in a Congressional report that recognized the need for international unity in the project, but in the years since, two administrations allowed the NIH to pursue a policy that is diametrically opposed to cooperation.

122 Sturges, supra note 11, n.94.

123 Robert Langreth & Ralph T. King, Jr., Biotechnology, Genomics Stocks Plunge on Fear U.S. May Curb Gene-Data Sales, Wall Street Journal, Mar. 15, 2000, at A8.

124 Hanning, supra note 8, at 195.

125 Kimbrell, supra note 10, at 136.

126 Barker & Mander, supra note 7, at 2.

127 Clarence Lusane, Race in the Global Era: African Americans at the Millennium 13 (South End Press 1997), In Clinton’s push of NAFTA through Congress, a policy objective of the previous Bush Administration, this slogan was meant to signal how unfettered economic development may redress economic and racial divisions.

128 Barker & Mander, supra note 7, at 4.

129 51 Cal.3d at 120.

130 See Bryan A. Garner, ed., Black’s Law Dictionary, Pocket Edition 139 (West Group, 1996).  In tort law, conversion is the wrongful possession or disposition of another’s tangible property as if it were one’s own.

131 Moore, 51 Cal.3d at 177.

132 Id. at 183.

133 DeBre, supra note 104, at 250-252.

134 Id., where the role of the US. Patent and Trade Office is discussed:

To the extent that the PTO rejects patent applications on the basis that the inventions will produce a constitutional injury, the PTO fails to fulfill its duties.  Even if the PTO had the authority to enact a rule that inventions must not have unconstitutional uses, the PTW is not competent to assess the constitutionality of a human invention’s uses.  Nor is the PTO competent to resolve the difficult moral and ethical problems that invention of artificially engineered human genotypes will pose.  Therefore, the PTO’s prohibition on patenting of human inventions on the grounds of unconstitutionality not only ignore the meaning of the patent laws it administers, but also disregards limits on its power as an administrative agency . . . If the Supreme Court is not competent to resolve such issues, the PTO is not either.  Chief Justice Berger, writing for the Court in Chakrabarty, referred to the “gruesome parade of horribles” of pollution, disease, the risk of loss of genetic diversity, and the potential for depreciating the value of human life posed by genetic research and technological development, and concluded that the Court is “without competence to entertain these arguments – either to brush them aside . . . or to act on them.” 

Diamond v. Chakrabarty, 477 U.S. 316-317.  Politically sensitive issues such as these are traditionally left to the legislature to resolve.

135 Kimbrell, supra note 10, at 141.

136 Tom Abate, Hearings on Stem Cell Research Just the Start of Long Debate, San Francisco Chronicle, Apr. 24. 2000, at B1; see also Tom Abate, Religious Leaders Question Research, San Francisco Chronicle, Jan. 15, 2001, at B4 “Making the case for stem cell research was Tom Okarma, chief executive of Geron Corp. of Menlo Park, which holds patents on stem cell and cloning technology – and therefore stands to profit or lose depending on which way the controversy shakes out.”; see Judy Holland, Scientists Fear Stem Cell Ban, San Francisco Chronicle, Jan. 15, 2001, at B4.

137 Abate, supra note 94.

138 Lori Andres, Genetics, Reproduction and the Law, 35:7 Trial, July 1, 1999:

Malpractice cases have been brought against doctors by parents of children born with genetic diseases.  The suits usually allege that the doctors either did not tell the parents of the availability of genetic testing for the fetus or performed the genetic tests inaccurately.  Wrongful birth cases are now recognized in 22 states and D.C. . . The early cases, brought in the 1960s, befuddled the courts because the defendants could not have done anything to prevent the harm to the child.  Abortion was illegal, so couples could not choose to abort a seriously ill fetus.

139 Robin Herman, Tinkering with the Essence of Humanity: Scientists and Theologians Debate the Morality of Genetic Engineering, Washington Post, Oct. 8, 1991; Robertson, supra note 6, at 422.

140 Shenk, supra note 17, at 45:

If left up to the marketplace, designer genes could even allow the wealthy to pass on not only vast fortunes but also superior bioengineered lineages, thereby exacerbating class divisions . . . We will compete for better code.  Such a eugenic culture, even one grounded in a democracy, will inevitably lead to the intensified recognition and exaggeration of certain differences.  In a newly human-driven evolution, the differences could become so great that humans will be literally transformed into more than one species.  But even if this doesn’t happen, our thin metaphysical membrane of human solidarity might easily rupture under the strain.

141 Abate, supra note 94, at A7.

142 Hettinger, supra note 2, at n.176.

143 See U.S. Const. Amend. V.; see also Bryan A. Garner, ed., Black’s Law Dictionary, Pocket Edition (West Group, 1996).  Eminent domain: The power of a governmental entity to convert privately owned property, especially land, to public use, subject to reasonable compensation for the taking.; Id. at 220.  Taking: In constitutional law, the government’s actual or effective acquisition of private property, either by ousting the owner and claiming title or by destroying the property or severely impairing its utility.; Id. at 614. Takings Clause: The Fifth Amendment provision that prohibits the government from taking private property for public use without fairly compensating the owner. 

144 Tom Abate, Gene Patent Opponents Not Licked Yet, San Francisco Chronicle, Mar. 20. 2000, at B1 & B4, discussing self-copyrighting as an act of civil resistance:

Have someone take a snapshot of you licking a first-class stamp.  Enclose the snapshot in a self-addressed envelope, using the stamp as postage.  When the letter arrives, drop it in the file drawer.  The cancelled stamp proves you “authored” the saliva sample . . . [But] Assistant General Counselor for the U.S. copyright office doubts licking a stamp meets the legal test for a copyright, which is meant to protect creative works. 

“You don’t have any creative control over your DNA.”

145 Joseph W. Singer, Property Law: Rules, Policies and Practices, 1205 (Aspen 1997).

146 Charles Margulis, Greenpeace Genetic Engineering Campaign, Biotech Ads, in Letters to the Business Editor, San Francisco Chronicle, Apr. 24, 2000, at B9.