The Human Genome Diversity Project: The Politics of Patents at the Intersection of Race, Religion,...

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The Human Genome Diversity Project:The Politics of Patents at the Intersectionof Race, Religion, and Research Ethics*

BITA AMANI and ROSEMARY J. COOMBE

The patenting of human genetic materials provokes wide-ranging misgivingsabout the appropriate place and scope of intellectual property protections. Theissues implicated range from anti-competitive practices in the market, the iinpo-sition of limits on biomedical research, increasing costs for health care, researchethics, potentials for racial discrimination, and various violations of humanrights. Exploring controversies around the Human Genome Diversity Project,patents on genetic sequences, and patents on higher life forms such as the so-called "Harvard mouse," the authors find that North American patent policy hasdeveloped in the absence of necessary political debate. They link this de-politicizationto the hegemony of neo-liberal principles most fully demonstrated by theincorporation of intellectual property under international trade negotiations.They point, however, to the recent emergence and increasing audibility ol newsocial movements that seek to reposition issues of intellectual property in largerdebates about human rights, distributional equalities, and social justice.

A few years ago, Donna Rawlinson MacLean sought an unusual grantfrom the British Patent Office by filing an application for an invention shecalled "Myself." As MacLean, a poet and casino waitress from Bristol,explained: "It has taken thirty years of hard labor for me to discover andinvent myself, and now I wish to protect my invention from unauthorizedexploitation, genetic or otherwise" (Meek 2000; see also Abate 2000). AfterMacLean provided four self-photos, a copy of her passport, and £130 herapplication was given an official number, GB0000180.0 and filed withoutfurther comment amongst the pending claims. A few weeks later, San Franciscoartist Marilyn Donahue claimed to have "copyrighted" her DNA, documentingher "authorship" by licking a stamp and sticking it on a self-addressed envelope.She commenced a "genome certification program," prompting members ofthe public to "become a certified original human. Copyright your DNA."'

* Address correspondence to Bita Amani, Faculty of Law, Macdonald Hall, Union Street,

Queen's University, Kingston, ON K7L 3N6, Canada. E-mail: [email protected]; or toRosemary J. Coombe, Canada Research Chair, Communication and Culture Program, TELBuilding, Room 3007, 80 Pond Road, York University, 4700 Keele Street, Toronto, ON M3JI P3, Canada. Telephone: (416)736-2100 x30157.

LAW & POLICY, Vol. 27, No. 1, January 2005 ISSN 0265-8240© 2005 UB Foundation Activities Inc., for and on behalf of the Baldy Center for Law andSocial Policy and Blackwell Publishing Ltd.

Amani & Coombe HUMAN GENOME DIVERSITY PROJECT 153

These acts of artistic protest are meaningful not for their legal viability asmuch as for their symbolic value - they call attention to public awarenessof and misgivings about two important trends in the law. First, they com-ment upon the growing commodification of human life forms through theextension of intellectual property protection to human genes, sometimesdescribed as the fundamental building blocks of human identity. Second,and more obliquely, they remark, albeit humorously, upon the law's pro-pensity to recognize smaller and smaller acts of human agency and inter-vention as acts of "authorship" or "invention" that legitimate the conferralof private property rights in the "works" thereby created. In today's intel-lectual property regime "anything under the sun made by man" (Diamondv Chakrabarty 1980: 5) possessing even a minimal modicum of humanintervention may be characterized as an invention or an original work andpotentially the subject for grant of exclusive rights by way of patent or copy-right.2 It is noteworthy, moreover, that neither of these women mention therole of their parents, their families, their ancestors, their communities, theireducation, or their environments in the creation of their "selves" as works.They assert proprietary rights as individuals entitled to the fruits of theirsingular labors and the unique personas that they as individuals claim towholly possess. Their symbolic protests hyperbolically rearticulate the pos-sessive individualism that is characteristic of the system they commentupon, adopting as normative the structure of the proprietary institutionsthey implicitly criticize.

Not all forms of self-possession are legally recognized however. In the1970s, a man named John Moore underwent cancer treatment for leukemiaat the University of California, Los Angeles Medical Center. His doctordiscovered that his spleen tissue produced a rare protein that appeared tobe useful in fighting cancer. Without informing him or obtaining his con-sent, a cell line was created from Moore's tissue and patented by theRegents of the University of California, who profited handsomely from thesale of their "invention." Moore's cell line is now estimated to be worth$3 billion dollars. Moore did not learn about UCLA's "invention" until 1984,when he instituted litigation. Although the California Supreme Court even-tually held in 1990 that the doctors had breached their fiduciary duties byfailing to reveal their research and their financial interest in his cells, italso ruled that there were no grounds for Moore's property claim (Moorev Regents of the University of Calijbrnia 1990). Once the cells were removedfrom his body, his ownership over them ceased because "research onhuman cells plays a critical role in medical research" - to grant the patientproprietary rights would threaten to "hinder research by restricting accessto the necessary raw materials" (ibid.: 18). Moore's cells, then, were con-sidered public domain - raw materials or data - available for the author-ship and inventive activities of others. Not having made the necessaryauthorial investments in creating his spleen, he could make no claim to theworks and the profits that others created, even if these were derivative of cells

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154 LAW& POLICY January 2005

first produced in his body (see generally Ching 1997: 706). Law professorGeorge Annas (who was Moore's attorney) recalls the university's responsewhen he filed the suit:

A university official called and threatened to disbar me. He said, "You can'tinterfere with our mandate to conduct research, to promote science...". Theykept saying "this is going to interfere with the free flow of research materials,to the progress of science," as if science had some overarching value. I kepttrying to point out to him that the patenting process itself stops that free flowof materials. Their own researcher had said, over and over again, "We're notsharing this cell line any more. Don't ask me for any more samples... I've gota patent application pending." So much for the progress of science ... (Annas1993)

Asked later how he had felt about the fact that a part of his body was nowthe subject of a patent held by others, Moore retorted that he felt violated,"like a rape for dollars." He felt the judiciary had abrogated their respons-ibility to the public and to the people by favoring and protecting an indus-try's profits. A few years later he learned that the government of the UnitedStates had attempted to patent the cell line of a Guaymi Indian woman(Bereano 1995; Ching 1997; Khan 1999).' Moore claims that he quicklyrealized the legal precedent established in his own lawsuit had enabled this:

I am known as Patent #4,438,032 ... I am concerned because the dehumani-zation of having one's cells conveyed to places and for purposes that one doesnot know of can be very, very painfil. Why should I or any individual or groupof individuals have their unique genetic materials borrowed, stolen, or boughtfor some fraction of their value for some project of others? How can anyoneelse set and get a price on what may be priceless or sacred to someone else?...Do you think a system that could not protect me will protect the rights ofpeoples and individuals that live in other countries? ... I don't ... I wasviolated by a legal system and a set of values in my own country. (Cited inBurrows 2001: 246)'

Moore's testimony highlights emerging tensions between the norms of theWestern patent system and the moral values held by others with respect tohuman genetic resources that involve issues of racial and religious discrimina-tion as well as research ethics. Although the American government withdrewits patent claim over the cell line of the Guaymi woman as a result of publicprotest, it nonetheless filed two further indigenous human cell line patentapplications that remain controversial.5

The use of human genetic materials may also involve human rights ofcultural identity and integrity. This will be shown by way of an explorationof the controversies generated by the Human Genome Diversity Project andthe patenting of human genetic materials more generally. We will suggestthat the social, moral, and ethical concerns about patents on human geneticmaterials have been largely ignored in an international legal context wheredomestic patent regimes often evolve without public scrutiny or democraticdebate, and where international trade obligations are imposed on stateswithout regard for their international human rights obligations.

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I. THE HUMAN GENOME DIVERSITY PROJECT

To ignore the social meanings conveyed onto the body is to forsake the culturalbeliefs that integrate a society. Imposing Euro-American beliefs such ascommodification is yet another form of cultural imperialism, supplanting andeliminating the beliefs of indigenous peoples in favor of a colonial ideal ofindividualism and profit- namesakes of colonial capitalism. (Khan 1999: 110)

The Human Genome Diversity Project (the Project) was initially proposedas a mechanism for enlarging the Human Genome Project (HGP), itself atwenty-year research effort funded at an estimated cost of twenty billiondollars by the U.S. National Institute of Health (NIH) and Department ofEnergy. The Project aimed to make the HGP reflect a larger number of theworld's peoples and to determine genomic population variations.6 An effortby anthropologists, geneticists, doctors and linguists, it was designed todocument the global genetic variation of the human species. The Projectwould also provide a database for research on human biological and migratoryhistory as well as causes of, potential treatments for, and ways to preventparticular human diseases.

Most of the groups targeted for this research, however, were indigenouspeoples - peoples whose historical isolation and social marginalizationoften account for their genetically distinctive traits. Many of these peopleshave been and continue to be subject to serious economic, legal, and social dis-advantages in the states where they reside. They are losing their languages,their livelihood resources, and, in many instances, the historical territoriesthat define them and their sense of their identities as distinct peoples.Indeed, many of the early proponents of the Project identified indigenousgenetic resources as "valuable" precisely because those who carried theseresources were considered to be on the verge of extinction - "vanishinghuman isolates" as one researcher famously phrased it. Some scientistsbelieved that their genetic make-up held the clues to the evolution of thespecies, as if these people, by virtue of their relative isolation, were therebyembodiments of a primitive human past. In any event, whether it was fortheir propensity to develop a particular genetically based disease, or converselytheir historical immunity from it, indigenous populations became subjectto what they considered to be a form of "genetic mining." Their cell lineswere "immortalized" for the purposes of science, but as living people theywere treated as "specimens." The political and economic conditions that weremaking their continued existence as peoples precarious, or endangeringtheir subsistence and livelihood resources were not considered relevant tothe Project.

Seven hundred and twenty-two populations were identified as "rapidlydisappearing" and "in danger of dying out or being assimilated" (Lock1999: 92). Rather than recognize this as a tragedy for these people, theProject painted it as an opportunity for science: "a vanishing opportunityto preserve the record of our genetic heritage" (Dodson & Williamson 1999:

© 2005 Baldy Center for Law and Social Policy and Blackwell Publishing Ltd.


204-8). But who is this "we," what is "ours," and what people areaddressed as included in the community that will possess shares in thisopportunity? To whose benefit will this valuable record redound? Thosewho are "endangered" are implicitly excluded from the human communityappealed to by Project proponents by virtue of presumptions about theirimmanent and inevitable disappearance. They are thus alienated from thebenefits to which their genetic information contributes. This, in any case, ishow many indigenous peoples saw their role in this "human harvest." Bydubbing it "The Vampire Project" they commented upon its commitment tosucking the last lifeblood of the dying to enrich the living (H. Cunningham1998; Setee 1998). Their DNA was extolled as harboring "a wealth of informa-tion" for the use of others, but as indigenous critics saw it, their continuingexistence as living peoples was not considered to have any particular value.

The criticism was underpinned by a broader skepticism. DNA samplescollected for the Project:

... supposedly help preserve indigenous gene cultures for generations to come[but the] real agenda is the future development of pharmaceuticals that willgenerate huge corporate profits, long after indigenous peoples have been left todisappear... The assumption that indigenous people are doomed adds insultto the indignity of being used as human guinea pigs. The millions of dollars tobe spent on the Human Genome Diversity Project could fund healing andcommunity development for those indigenous peoples that are considered atrisk... (Burrows 2001: 244-45, see also more generally, World Council ofIndigenous Peoples 1993)

There was little indication that the diseases to be studied or the treatmentslikely to be developed from Project research would benefit the indigenouspeoples from whom samples would be taken. Indigenous peoples sufferfrom some of the world's worst health conditions and have access to thepoorest health services (J. Cunningham 2002). They live greatly foreshortenedlives and their rates of mortality from diseases and conditions such as diarrhea,malaria, hookworm, and simple malnutrition are appallingly high, even inthe more developed countries. Society is already equipped with the techno-logies to treat many of these conditions, and they are often as simple andinexpensive as providing adequate food, clean water, sewage, shelter, netting,and simple antibiotics.

Those concerned with issues of social justice quite properly ask why weshould expect indigenous peoples to grant us access to their geneticresources in order to advance medical knowledge about the maladies of theprivileged when we will not provide even the most basic of existing medicinesor infrastructural resources to alleviate their suffering. To the extent thatmany of the forces that account for their declining numbers are a result oftheir forced dislocation from their ancestral territories by Northern industries,this withholding of resources is experienced as especially pernicious.Researchers for the Project devised plans to ". . . collect and analyze 10-15,000samples at a cost of $23-35 million" (Tauli-Corpuz 2001: 261). Each blood

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Anani & Coombe HUMAN GENOME DIVERSITY PROJECT 157

sample to be acquired was estimated to cost US $2,300 to acquire - morethan the per capita gross domestic product in most parts of the world,according to the Journal of Medical Ethics (Dodson & Williamson 1999:205). If only a fraction of that amount were spent on supporting indigenouspeoples' survival rather than capitalizing upon their genetic "disappearance"some of the hostility to this project might potentially have been allayed.

In any case, most future applications for genomic science appear to lie indiagnostics (DNA screening) rather than therapeutics (treatment), which isstill in a rudimentary stage of development. In this gap between diagnosisand treatment lies the unfortunate possibility of using genetic informationfor discriminatory purposes.

... discourses of race and ethnicity undergird discriminatory practices. Theylegitimate barriers to education and jobs. They justify hate crimes. Many fearthat human genetic diversity research will both extend these discriminatorypractices into ncw realms - such as health and life insurance - and providethem with new, more powerful and impenetrable (that is, scientific) sources oflegitimacy. Others fear that genetic diversity research will lead to a new eugenics.(Reardon 2001: 367)

History suggests that this is not unlikely; as medical anthropologistMargaret Lock observes:

[m]any of the newly discovered genetic diseases and disorders came early on tobe associated with categories of race and ethnicity, which replaced an olderdiscourse about lineage and geology. Despite the fact that we know fromresearch on population genetics that "race is only skin deep," the use of raceas a scientific category persists, and racism remains pervasive. (Lock 1999: 92)

This discrimination is another form of injury feared by those who experi-ence the insult of having their cells taken without knowledge or consent,and used for commercial purposes. This is compounded in the U.S. by thefact that Native Americans often have to prove their "distinction" in orderto assert their sovereignty rights; they fear that genetic research might bemanipulated to show that they are insufficiently "different" and thus under-mine their political claims (Reardon 2001: 367).

Scientists hope that differences in susceptibility between populations canbe used to find genes or genetically determined biochemical pathways,which will provide resources with which to create products for treatingcommon diseases like asthma (Cunningham & Scharper 1996). This has, infact, proven true for obesity, but for whom is obesity a primary medicalproblem? Funding for the Project came from developed states and pharma-ceutical companies. Their primary interests were in developing productsthat could be mass-marketed to the world's more wealthy consumers. Asone American indigenous representative remarked: "We have the pooresthealth care in the nation ... Do we really expect that these very expensivegenetic treatments are going to make it to our community?" (Foubister2000).


158 LAW & POLICY January 2005

Indigenous peoples were initially treated by the Project as mere resourcesfor the profit-making activities of others - a means to an end - an affrontto their dignity as peoples and arguably a denial of their rights to self-determination. The ethics of carrying out the Project quickly became amatter of public concern. As philosopher Laurie Ann Whitt notes, however,concern focussed on how this research should be carried out rather than onthe prior normative question of whether it should be carried out in the faceof forceful indigenous opposition (Whitt 1998: 211). Most of the debateconsidered the importance and meaning of "informed consent" in the tak-ing of samples. Early researchers claimed that they could not obtain"informed consent" because the tribal peoples they were dealing with insome instances could not understand the complexities of DNA research(Ching 1997: 698). As ethicists point out, this argument would not be toler-ated in other circumstances. Medical professionals, for example, are notfree simply to perform procedures without finding some means of com-municating to the patient their import and the associated risks assumed.Our laws regulate taking blood samples from criminal suspects and preventthe procurement of such samples from the mentally ill and children withoutsome guardianship and consent. Even basic contract law takes situations ofduress, misrepresentation, and contexts that constitute unconscionabilityinto account.

Obtaining the consent of individuals is, in any case, neither fully appro-priate nor sufficient in the circumstances anticipated. Few indigenousgroups treat all goods as private properties that can be alienated by indi-vidual discretion, and many also recognize a range of collective goods. For theMaori - and their beliefs are echoed by many of the indigenous activists,advocates, elders, and traditional healers whose voices are expressed atinternational conferences and in NGO declarations - a gene embodies thelife spirit. It is the spirit of a people that is passed down from the ancestorsand is the gift to future generations for which the current generation isvested with responsibility. Genes cannot be personally or individually alienatedbecause they are part of the heritage of families, clans, tribes, and embodythe spiritual identity, not of individuals, but of groups and nations. Theissue of using human genetic resources thus touches upon sacred domaininvolving the cosmos of a people, their understanding of their culturalidentity, and their responsibility to reproduce and nurture the continuity ofthat identity in the world (which may also constitute part of their sovereignright to self-determination). Two vocal activists from the internationalindigenous movement that protests practices of "biopiracy" point out thatthis research may further antagonize indigenous peoples through a lack ofrespect for the dead:

... biological materials are taken not just from the living, but also from thedeceased. For most Native peoples this rcpresents a serious violation of thesanctity of our deceased ancestors. Many indigenous peoples regard their bodies,hair, and blood as sacred elements, and consider scientific research on these



materials a violation of their cultural and ethical mandates... [they] alsomaintain a deep commitment to protect and maintain their ancestral identity.While there are no specific words for genes or DNA in our languages, aninterpretation could mean genealogy, heredity, ancestry, or future generations.(Harry & Dukepoo 1998: 8)

"In many indigenous cultures, an individual will not have the right togive or sell a blood sample for gene testing to a researcher without the con-sent of the group (and perhaps not at all)" according to Michael Dodson,director of the Indigenous Law Centre in Australia. Socially, such conductwould be regarded as akin to an unconscionable contract - "comparable inWestern law to the prohibition on a father from selling a child into prosti-tution or slavery which is outrageous in an individualist society where tolimit and bind another's autonomy is taboo" (Dodson & Williamson 1999:207). Cultural respect for the inheritance of the group and its obligations tofuture generations would be violated by such behavior. When groups dogive consent to such research, and this has occurred, it has been accomplishedby group consensus building in accordance with traditional decision-makingpractices, because the proposed transaction brings benefits to the group andits continuing cultural survival. If such consent cannot be obtained, it ismorally arguable that the research should not be permitted to proceed. Thishappens in analogous circumstances when a human ethics committeeblocks a clinical trial on patients, for instance. Research on human subjectsinvolves ethical considerations. It also involves considerations of reciprocity;if scientists want the support of indigenous peoples in their research,they should expect to support efforts to improve the economic and politicalsituation of the people with whom they are working. This, at least, hashistorically been recognized as part of the obligation assumed by the socialscientist. There appears to be no reason why the hard sciences should beexempt when their research involves human subjects in marginalizedcommunities.

Model ethical protocols were eventually developed for the Project, butuntil these are enshrined in legislation, they have little legal weight, exceptperhaps as "customary norms" that might be appealed to in domesticcourts as relevant international law. Principles of informed consent, maxi-mizing benefit, minimizing harm, confidentiality, and the avoidance ofconflict of interest became accepted as guiding principles amongst theregional committees of the Project (Dodson & Williamson 1999). Moreimportant, perhaps, was the recognition that regard for the cultural valuesof the communities in which such resources are sought, and respect for theethical principles that govern in the host community, were both minimaland fundamental conditions for conducting such research.

To attempt to disseminate information on the Project amongst targetedpopulations, to facilitate potentially beneficial research, and to encouragegreater consistency in legal approaches adopted by indigenous commun-ities to protect themselves from the proprietary interests of external


160 LA W & POLICY January 2005

researchers, the Indigenous Peoples' Council on Biocolonialism producedthe "Indigenous Research Protection Act (IRPA)" in 2000. IRPA provideslegal resources to empower constituent populations with means to elevatetheir status from passive "subjects" of research and "objects" of datamining, to partners in the research process itself. Indigenous groups now insistthat scientists recognize them as active participants and consultants in theprocess of planning research projects that involve their genetic resources.

One area of obvious ethical concern under the Project involves therecruitment of interested populations. For samples to be collected, it is nowgenerally accepted that the ability to communicate scientific informationand the purposes of genetic research must be developed on both sides. Therisks of host communities who fear stigmatization must be addressed, asmust issues of genetic susceptibility and vulnerability to instances of geneticreductionism based on racist assumptions. This involves respecting theprivacy of groups, maintaining confidentiality about group identities, andpublic education efforts so that peoples do not find themselves sociallyidentified with particular diseases. It also requires that members of the com-munities whose genetic heritage is being studied be involved in planning theimplementation of genetic research. IRPA is designed to provide a pre-cedent for negotiating this kind of involvement and to form the basis forcommunity contracts that may enable legal remedies in cases of breach ofagreement. Such initiatives are necessary because bioethical protocols havefailed to respond to the unique circumstances posed by population-basedresearch, particularly with respect to the diversity of processes for groupdecision-making in the context of cross-cultural encounter. Ultimately,compensating for this failure must involve local capacity-building, andcultural sensitivity training for scientists, as well as the development ofcross-cultural translation skills on the part of both foreign and indigenousresearchers. This, at least, has been the emphasis of indigenous NGOs,many of whom would prefer to see a moratorium on such research if theseconditions cannot be secured. While the U.S. earmarked 5 percent of itsannual Project funds to address associated ethical, legal, and social implica-tions, very little of this work came to fruition, it is suggested, because ofthe failure of Project researchers to accept indigenous peoples as researchcollaborators (Harry 2001). The model protocol developed (described as"arguably the most detailed ethics document in human population genetics,"Brodwin 2002: 57) nonetheless had as its primary goal "holding together aspecific research project as the political landscape shifts beneath it" (ibid.)rather than any redress of the historical inequities that have characterizedindigenous involvement in scientific research.

Ultimately, the Project's North American Committee embraced the prin-ciple that informed consent must involve communities rather than indi-viduals in its model ethical protocol (Foubister 2000).' Genetic informationis similar to a medical family history in that it may reveal information aboutpersons other than the individual from whom it is taken, and has the added


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risk of lending itself to practices of genetic determinism. Moreover, in theU.S. context, some indigenous groups are recognized as sovereign nationsand as such should be able to regulate what research, if any, is permissiblein their jurisdictions. For other groups and in other jurisdictions, indi-genous peoples' standing under international human rights law arguablyprovides them with similar legal capacities. They may want to assert somedegree of control over both the direction of the research and the dissemina-tion of results to help safeguard against any genetically determinist or racistinterpretations that may influence the uses to which the research is put.Traditional elders and local religious or spiritual authorities should also beinvolved in establishing the parameters of meaningful informed consent inparticular communities given the meanings that genetic heritage appears tohave amongst so many of the world's indigenous peoples. The politicaldifficulties in identifying relevant "groups" and in securing group consent,should not, however, be underestimated and it is clear that the process ofidentifying a group and obtaining consent is a complex and dialectical one(Reardon 2001: 373-78).

Internationally, some of these principles were affirmed by UNESCO'sadoption in October 2003 of the International Declaration on HumanGenetic Data (the Declaration) a standard-setting instrument designed toguide states in developing legislation.8 Recognizing our "common geneticheritage," it affirms the immediate need for safeguards in genetic research,testing, screening, counseling, and data-banking. Such data "may have a signi-ficant impact on the family, including offspring, extending over generations,and in some instances on the whole group to which the person concernedbelongs" and "may have cultural significance for persons or groups"(Article 4(a) (ii) and (iv)). While not a legally binding instrument, theDeclaration encourages and elaborates standards to regulate the collection,storage, and use of human genetic data to respect human dignity and pro-tect human rights and fundamental freedoms, including freedom of research(Article 1). It provides for benefit sharing (Article 19), genetic counseling(Article 11), and confidentiality stipulating that:

[i]t is ethically imperative that clear, balanced and comprehensive informationshall be provided to the person whose prior, free, informed and express consentis sought without inducement, and that such information shall specify thepurpose for which human genetic data being derived from biological samplesare used and stored ... The information should also indicate that the personconcerned can withdraw his or her consent, without coercion, and whichshould entail neither a disadvantage nor a penalty for the person concerned.(Article 14)

No community rights are granted, although cultural pluralism on ethicalreview boards is urged. Few jurisdictions have been willing to insist upona standard of meaningful informed consent in genetic research that wouldrequire that consent be acquired in terms of prevailing community culturalnorms. Most North American, European, and international bodies now



require that separate and additional consents be obtained for each andevery new use of genetic material congruent with an emerging consensusthat the dignity of the person demands that exploitation of human geneticmaterial cannot be viewed simply as another use of natural resources. Eventhe most carefully articulated code of ethics enshrined in legislation govern-ing genetic research, however, is unlikely to stem the growing commercialimperatives to patent these research findings and the legal and social contro-versies such patents increasingly engender.

II. THE PATENTING OF GENETIC MATERIALS

When Columbus stumbled upon a land new to him, he was carrying "letterspatent" from the king and queen of Spain. Those documents made thediscovery and the exploitation of a whole "New World" possible, legal andrewarding ". . . [W]hat was necessary for the invasion and exploitation of otherpeople's land, what was essential to the colonization, was to have a means ofdeclaring inhabited land "empty" -void of true human beings. (Burrows 2001:238)

The current trend of expanding patents to all fields of innovation and tech-nology indicates a paradigm shift in intellectual property as well as thehegemony of neo-liberal principles in international trade regimes. In theUnited States, like many other jurisdictions, the expansion of patentablesubject matter to include human genetic materials has arguably beenaccomplished through bureaucratic inertia, agency capture of key govern-ment offices, and judicial deference to patents granted in support of indus-try interests rather than any obvious legislative intent. While courtsgenerally balance proprietary rights against civil liberties with a view toconsidering issues of social justice, key decisions with respect to the scopeof patentable subject matter have been made by setting questions of thepublic interest conspicuously aside. The inclusion of biotechnologicallymodified life forms and genetic materials as patentable subject matteremerged arbitrarily as national patent offices simply complied with thedemands of industry actors for greater protection of their commercial inter-ests with the advance of molecular genetics.

During the 1980s, most patent and trademark offices became dependentfor their operations and maintenance, not upon government funds, butopen revenues generated from applicants' fees. During the same period,arguably, patent offices became more subject to the pressures of applicants,now perceived as "clients" to assist applicants to obtain patents, rather thanto consider the larger constitutional objectives and public policy goalsinvolved in making these determinations. The United States Patent andTrademark Office (USPTO) typifies these developments. As the world'slargest and most important patent-granting body, its operations are verysignificant. Notoriously understaffed by peoples whose job security is tenuous,


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in the 1990s it appears to have rewarded patent examiners based uponnumbers of patents granted (Gleick 2000; Merges 1999; Streitfield 2003),creating a work climate that discouraged research to seriously ascertainwhether the claimed inventions were actually innovations in new fields oftechnology (like genomic research) where there was little easily accessible"prior art" - publications that indicate what would be "obvious" to a personskilled in the field (Kesan 2002).

On average, it appears that only eighteen to thirty-six hours are expendedin the USPTO in reviewing a patent application and conducting the entireexamination including searching prior art, interviewing applicants, andengaging in correspondence (Lemley 2001: 1508). It is no surprise, then,that the USPTO grants approximately 75 percent of patent applications,whereas courts invalidate some 46 percent of litigated patent claims (Allison& Lemley 1998: 208). Only about 2 percent of patents are ever litigated and"less than two-tenths of one percent of all issued patents actually go tocourt" - no doubt because of the costs (a full trial through to appeal mightcost $1.5 million dollars for each party according to Lemley 2001: 1501-2).

Rather than providing an incentive for genuine innovations, patentsincreasingly appear to function more as means of extortion in the marketsfor new technologies. As American lawyer and Silicon Valley entrepreneurGary Reback (known for representing clients including Sun Microsystems,Netscape, Oracle, and Apple, and for initiating the assault to break upMicrosoft's operating system monopoly) remarked:

There are those who view the patent system as the seedbed of capitalism-theplace where ideas and new technologies are nurtured. This is a romantic myth.In reality, patents are enormously powerful competitive weapons that are pro-liferating dangerously, and the U.S. Patent and Trademark Office (USPTO)has all the trappings of a revenue-driven, institutionalized arms merchant.(Reback 2002)

The USPTO appears to be a regulatory apparatus staffed by those whohave little desire or incentive to consider the social costs of granting broadmonopoly rights on new technological innovations in emergent fieldsdespite the anti-competitive practices encouraged by the issuance of patentson "innovations" that are neither novel nor non-obvious. It has clearlyabdicated any role in forming patent policy unless it has decided that morepatents are better, in which case this is still a change in patent policy un-authorized by Congress and without demonstrable public benefit (Reback2002). Because patent application proceedings are not publicized, it isdifficult to obtain standing to challenge patents until after they have issued,and there is little opportunity for public debate about the issues involved oreven for educated expert scrutiny of the merits of claims (Kesan 2002) untilafter these grants have been made (by which point commercial enterprisesare already making investment decisions in expectation of these privileges).When patents in fields involving genetic research do receive judicial scrutinyin the U.S., judges appear loathe to intervene to overturn them, but they



seem more willing to interfere where the patent application has been initiallyrejected. As a consequence, a "patent gold rush" has taken place in the U.S.as hundreds of thousands of patent applications have been filed on geneticsequences (Rai 2000). Nonetheless, many scholars and scientists worldwidefeel that not only has the threshold for patenting gene and amino acidsequences been set too low, but that these "innovations" fail to meet eventhe most basic domestic requirements for issuance of a patent (Keays 1999).

III. DOMESTIC PATENTABILITY STANDARDS

The patenting of human gene sequences raises a number of controversiesinvolving the proper interpretation and application of patent law policy andbasic requirements. The traditional rationale for granting patents on com-mercial innovations was to serve the utilitarian function of welfare maxi-mization by providing a necessary incentive for innovative activity and itsdisclosure to the public. There are grave doubts about whether these objec-tives are being met in the case of patents that encompass genetic sequences.These doubts are shared both by scholars and by those involved in science,biotechnology, and the health industries, who argue that too many patents,some of dubious quality and validity, are posing unnecessary constraints oncompetition, follow-on research, and downstream innovation (Eisenberg 2000).

Patents in most jurisdictions are granted only for inventions that arenovel, non-obvious, and have a utility that must be disclosed along with thepreferred embodiment of the patent so as to enable those skilled in the artto reproduce, use, and to benefit from the invention. Novelty means theinvention is new and not in the public domain; non-obviousness means thatone skilled in the art or science to which it pertains would not have consid-ered the invention obvious; and utility has generally been interpreted asindustrial utility or some form of commercial application. Throughout the1980s the USPTO issued patents only for genes that closely correspondedto foreseeable commercial products such as therapeutic proteins or diagnostictests for recognized diseases. By 1991, however, the National Institutes ofHealth (NIH) started mass patent applications for anonymous gene frag-ments or raw genomic DNA sequences, despite the fact that the function ofthese genes remained unknown. Often, the only utility asserted was theiruse as genetic probes or expressed sequence tags (ESTs). The USPTOrejected a few of these early applications on the basis that the sequenceswere merely research tools, but granted many others. Later, the NIHabandoned their own early patenting practice in the interests of promotingmedical research, and thus opposed the grant of patents on parts of thehuman genome without known or disclosed utility. Private firms nonethe-less adopted this practice of referring to vague functions in patent applica-tions and were often granted exclusive rights to many unknown futureapplications.



In 1995, the USPTO issued new guidelines on utility stating that ESTswere patentable and corporations quickly adopted the practice of patentingDNA sequences and gene fragments without identifying a correspondinggene, protein, biological function, or potential commercial product (Gilbert& Wilson 2001). For example, Human Genome Sciences (HGS) is a pri-vate American firm that holds over 200 genomic patents and has expresseda desire to own the whole genetic sequence of bacteria necessary to create anumber of vaccines. Under the relaxed guidelines, HGS patented a proteinthat had no known function at the time of application; another companylater discovered that this protein served as the entryway for the AIDS virusto infect cells. HGS is entitled to royalties on any drug that targets this pro-tein despite the fact that they neither invented nor discovered the industrialapplication of the sequence (Pollak 2000). As of June 2000, more than6,000 gene patents had been granted in the United States, 1,000 of whichwere for sequences from the human genome (ibid.).

Patents appear to be given freely and arbitrarily for very slight and obvi-ous efforts that yield nothing in terms of real human benefit. It would seemthat merely isolating a gene in a petri dish and, in the loosest of terms,explaining what function the gene might perform in the human body andwhat applications it might have is sufficient to claim it as your own prop-erty and to claim a stake in every future use of it. Consequently, the WorldMedical Association and many other scientific bodies (including theProject) have insisted that patents should not be granted for naturallyoccurring DNA sequences alone without discovery of a new function andthe development of a new invention (Smith & Kettleberger 1994: 38). Thismakes sense in terms of the basic rationales for patent protection. To en-able researchers to patent partial and uncharacterized DNA sequences is toenable monopolies to enclose the raw materials necessary to make scientificadvances. These are routine discoveries, made in ways that are now obviousto those in the field. As a group of British scientists pointed out, if the prin-ciples now governing patents in genetic advances had been applied in chem-istry, the very elements themselves would have been patented (ibid.: 44).The President of the US National Academy of Sciences puts it this way:

Patent laws are based on the principle that public disclosure of a valuable newinvention through the patenting process should be encouraged and rewarded,allowing others to use and build on the invention to create additional benefitsto society. In return, the inventor is rewarded with monopoly rights over theuse of the invention for a limited period of time. (Alberts & Klug 2000)

He emphasizes that it is critical that the benefits to the public be at leastreasonably commensurate to this reward. Given the enormous potential ofthe human genome sequence and the long duration and extensive scope ofpatent rights, the granting of broad monopoly rights to any portion of itshould be regarded as extraordinary - and occur only when new inventionsare likely to confer benefits of considerable significance to humankind. It isa trivial matter today - using a computer search of public databases - to


166 LAW& POLICY January2005

use DNA sequences to identify new genes with particular types of biochem-ical functions. Such a discovery, scientists and health policy advocatesargue, should not be rewarded with a broad patent for future therapies ordiagnostics using these genes when the actual applications are merelybeing guessed at or completely unknown, as they were for example, withrespect to the protein involved in the operation of the AIDS virus discussedearlier.

Others believe that the legal requirement of utility should serve to pre-vent the patenting of simple sequences in most jurisdictions. Patents shouldissue only for the combination of the gene or sequence and an obvious bio-physical utility or use for that sequence which is novel and not obvious topeople skilled in the art and science. Yet, some critics argue, that even thisgoes too far in granting protection for too little innovation. The problem,they suggest, is that the function of a sequence is not an invention. Even ifa scientist discovers a new utility in the body, that discovery itself is not aninvention of anything. It was not created by human agency and inter-vention. Mere "discoveries" were not traditionally patentable because theycreated unjustified monopolies for too little effort and investment, and servedto slow down and discourage, rather than encourage scientific researchprogress (Austin & Amani 2001). Such patents effectively stake claims toeverything that might in the future be discovered about these genes, theirfunctioning, and their medical uses. This puts financial impediments andadministrative barriers in the way of those researchers who would genuinelygo further, actually meeting the patent policy objectives by promotingprogress in science through a determination of biological functions and thedesignation and design of beneficial human applications. They also impedethe development of diagnostics and therapeutics by raising barriers to entry,limiting competition and raising prices in health-care markets.

In an influential 1998 article, "Can Patents Deter Innovation? The Anti-commons in Biomedical Research," Michael Heller and Rebecca Eisenbcrgargued that rather than serving to promote scientific innovation, patentswere hindering biomedical research.

Under the commons model, the federal government sponsored pre-market or"upstream" research and encouraged broad dissemination of results in thepublic domain. Unpatented biomedical discoveries were freely incorporated in"downstream" products for diagnosing and treating disease. In 1980, in aneffort to promote commercial development of new technologies, Congressbegan encouraging universities and other institutions to patent discoveries aris-ing from federally supported research and development and transfer their tech-nology to the private sector ... A resource is prone to underuse in a "tragedyof the anti-commons" when multiple owners each have the right to excludeothers from a scarce resource and no one has an effective privilege of use ...Privatization can go astray when too many owners hold rights in perviousdiscoveries that constitute obstacles for future research ... The result has beena spiral of overlapping patent claims in the hands of different owners, reachingever further upstream in the course of biomedical research. (Heller & Eisenberg1998; see also Shand 2001)



Similarly, Carl Shapiro suggests that the American patent system may beslowing down the commercialization of new technologies by creating "pat-ent thickets," which are increasing in existence and complexity in severalkey industries such as biotechnology, semiconductors, and computer soft-ware. A "patent thicket" can be described as an overlapping set of patentrights requiring anyone interested in commercializing new technology toseek and bundle licenses from multiple patentees (Shapiro 2001: 28). Com-panies that hold gene patents tie up the ability of others to do more ex-ploratory research and product development. They do this with refusals tolicense, or with huge royalty demands, and with exorbitant demands tocontrol the course of future drug development using the gene sequences,and attempts to control the costs of new drugs derived from the sequenceby insisting upon a share of the drug royalties even though the drug devel-opment likely involves far more investment and innovation than the initialsequencing efforts. This is creating a situation that is considered extortion-ate in the industry and to limit the number of viable drugs being developed.Within the medical community, it is seen to compromise the quality ofpatient care by preventing the use of necessary diagnostic testing (Smith &Kettelberger 1994: 38, see also American College of Medical Genetics1999). 9

One solution might be to introduce a system of compulsory licensing atreduced royalties for clinical testing, although most medical geneticistsbelieve that patients should have rights to have such tests done free ofcharge. A better solution might be to change the structure of the system bywhich patents are granted and to insist upon the proper application of theexisting principles. For instance, "the hundreds of thousands of patentapplications that have been filed on gene sequences of unknown functionshould be denied on obviousness grounds" (Rai 2000: 216).

The USPTO arguably attempted to restrict the flood of genomic patentapplications (or reduce some of the controversy surrounding them) in 2001by issuing Utility Guidelines that imposed a stricter utility threshold requir-ing that applicants disclose a "specific, substantial, and credible utility."While the new guidelines allegedly raise the bar, they also implicitly confirmthat applications for patents on gene sequences that do meet these require-ments will be granted a patent and that the issue of whether these should beconsidered inventions or mere discoveries will not be addressed. For thoseconcerned with the allocation of scarce resources and the just distributionof the benefits of technology, this is an abdication of office's responsibilityto the public. The policy effectively allows intellectual property protectionsto impede the future evolution and direction of research while threateningthe development of health policy with the risks and exigencies of litigation.

The Canadian patent office tends to follow U.S. practice on issues of pat-entability and similar patents on gene sequences have issued. Faced with aproblem of allocating scarce financial resources in the publicly fundedhealth-care system, the Ontario provincial government decided to fund the



least-expensive domestically available diagnostic screening test for thebreast cancer genes, BRCA1 and BRCA2. Myriad Genetic LaboratoriesTechnologies Inc. (along with the University of Utah and the United Statesgovernment, who are also patent holders) considers this test to be aninfringement of their patent - claimed for cancer-testing processes thatincorporate the breast cancer-linked gene sequences that are necessary tocarry out all such tests (Amani 2002: 76; see also Williams Jones 2002).Myriad's authorized Ontario patent licensee charges a price for providingthe test that is approximately five times that charged by the provincial govern-ment's current provider. Should this provider be visited with a patent injunc-tion obtained because of Myriad's rights in a gene sequence it isolated,breast-cancer testing in the province would be effectively terminated.

European health-research institutes have taken a more forthrightapproach to resolving the same dilemma. In 2001, the Institut Curie, theBelgian national center of human genetics, and other public health groupschallenged the Myriad-patented innovation as lacking in novelty, assertingthat its genetic sequence was not adequately described, the claims were toowide, and that the use of the patent to preclude testing constitutes an abuseof a monopoly that imposed restrictions on innovation (Dorozynski 2001:589). As the European Patent Institute summarized:

Further arguments against the patent include concerns that it will jeopardisethe development of research and the identification of new tests and diagnosticmethods in breast cancer research. The opposition division's sole responsibility,however, is to consider oppositions under the law laid down in the EuropeanPatent Convention, the legal basis for European patents since 1977. (EuropeanPatent Institute 2004a)

Once again, we see social arguments being given short shrift by a patentoffice, even in a jurisdiction where public order and morality are legally recog-nized. Nonetheless, the patent was revoked on 18 May 2004 after the firstday of a public hearing (European Patent Office 2004b). No official groundsfor the decision had been released when this article went to press, but newssources suggest that the Board found that the claim did not reveal sufficientinvention (Pollack 2004). Myriad asserted its determination to appeal thedecision (ibid.).

The fact that DNA sequences have been subject to patents for more thantwenty years has not clarified acceptable legal practice in the area andindustry claimants are continually "pushing the envelope" (Eisenberg 2002).As new discoveries are made in genomics research, the patent system hasstruggled to keep up with industry advances. This trend will undoubtedlycontinue with progress made in proteomics and the rise of nanotechnology(ETC Group 2003). DNA sequences subject to patent claims in the 1980sand 1990s were patents on cloned genes that enabled the production ofproteins, similar to the kind of claim a pharmaceutical firm makes when itseeks exclusivity in a chemical compound that can be used as a drug. However,more recent discoveries pertain to DNA sequences obtained via the


Amani & Coonbe HUMAN GENOME DIVERSITY PROJECT 169

"large-scale, high-throughput sequencing of entire genomes" which "lookless like new chemical entities than they do like new scientific information"(ibid.: 417). The tendency to expand claims to include DNA sequence infor-mation as stored in any computer readable medium promises to furtherexacerbate these effects. As Eisenberg warns, this "would extend patentablesubject matter beyond what the PTO and the courts have recognized thusfar, departing from a long tradition of freedom of access to the informationdisclosed in issued patents" (ibid.: 429).

IV. PATENTING HIGHER LIFE-FORMS

If the extension of patents to the "building blocks of life" has becomeincreasingly controversial, patents on organisms themselves are even moreso. In the 1980 U.S. Supreme Court decision in Diamond (1980), the Courtrejected the argument that living things could not be considered patent-able, and upheld a patent on genetically engineered bacterium useful incleaning-up oil spills on the grounds that "anything under the sun made byman" was a proper subject for a patent. This invention, however laudablein environmental terms, has operated as the precedent authority for evermore grants of patents on genetically modified organisms that are now thesubject of environmental controversy. In 1987, the USPTO issued a posi-tion statement that opened the way for the patentability of non-humanhigher life stating that "nonnaturally occurring nonhuman multi-cellularliving organisms, including animals ... [would be considered] patentablesubject matter" under patent law (Chisum 1997). In 1988, the scope of patent-able subject matter was formally extended to include higher life with the firstanimal patent issued for Harvard College's claims to exclusive rights over agenetically engineered "mammal" granted under U.S. Patent 4,736,866.Harvard had designed an "oncomouse," genetically modified to carry anoncogene that gave it a greater propensity to develop cancer at a certainstage in its development without further exposure to carcinogens; the onco-mouse was useful for expediting and facilitating cancer research. Patents havesince been issued on an array of other animals including sheep and cattle.

In Europe, Harvard's attempt to patent this mouse was somewhat morecontentious. Initially the application was refused in 1989 by the EuropeanPatent Office (EPO) on the basis that the patent was prohibited by theEuropean Patent Convention which expressly excludes "plant or animalvarieties or essentially biological processes for the production of plants oranimals" (Article 53, see European Patent Office 1989; Kevles 2002). Thisdecision was rejected by the Technical Board of Appeal; they refused tointerpret this language to include humanly invented animals. The Boardinstead stressed the need to consider whether the invention should beexcluded as contrary to public order and morality under Article 53(b)because of the potential suffering of the animal and the potential risks

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posed to the environment which, it suggested needed to be weighed againstthe benefits to human beings arising from the research thereby facilitated.

On 4 October 1991, the Examining Division issued a communicationindicating that it would grant Harvard the patent, which it did in April of1992 (European Patent Office 1992). It took the added rare measure of pub-lishing in the Bulletin comments on the fundamental patentability issuesinvolved in the application." This decision provoked ten more years of con-troversy, because it determined that mice, being in a higher taxonomicclassification than a species, could be the subject matter of a patent ifsufficient invention was demonstrated. The potential adverse effects of atechnology were held sufficient reason to regulate its use, but not to preventa patent from issuing in the first instance. Concerns over the need to pro-tect the environment from the unwanted spread of genes and animals fromcruelty were considered to be outweighed by the overwhelming consensusin the scientific community that the oncomouse would be instrumental infurthering cancer research. Once again, the scientific research process wasreified and valorised over and above all other social considerations whilethe costs of monopoly rights to the actual practice of research remainedunaddressed.

Nonetheless, an ever more vocal movement that opposes the commodit-ization of life forms appears to be making itself heard.'' We will considerthe competing principles at work in the international legal context wheretrade, intellectual property, environmental, and human rights norms comeinto potential conflict. The growth of an international civil society move-ment that opposes patents on life forms has organized in multiple fora, andtheir arguments are beginning to resonate in some centers of power. 2 Therecent decision by the Canadian Supreme Court on the patentability ofHarvard's oncomouse is significant. Given that the state was heavilyinvested in biotechnology as a source of economic growth, it was assumedby legal and business commentators (and confirmed by the Federal Courtof Appeal) that Canada's industrial needs would take precedence andensure the patentability of genetically modified life forms. The refusal of theSupreme Court of Canada to follow the United States and Europe and recog-nize the validity of these patents suggests that critical scrutiny of these patentswithin relevant industrial sectors as well as growing public opposition tothem may at last be having some impact.

One problem clearly manifest in the Harvard mouse case - as in manygenomic innovations - is the breadth of the rights claimed. Harvard notonly claimed rights to the invention of a cancer-developing mouse, butabstracted to the broader classification of a transgenic non-human mammal(President & Fellows Harvard College v Canada 2002 para. 123). The patentclaim is thus effectively much broader than the actual invention, and unlessit is "read down" only to cover transgenic rodents, it could severely restrictinnovation and the progress of science in this field. It extends beyond exclusiverights to the means (process claims) to make such a rodent to include the



genetically modified mouse itself (product claims). The Canadian Courtrecognized that a patent covering both product and process claims wouldhave permitted Harvard to exclude others who might independently inventthe same or similar products, even if they used a different process (Amani2003). Harvard and its licensee, Dupont, were granted a monopoly over theplasmids, the transgenic material (genetic sequences), the oncoeggs, as wellas on the process of creating the transgenic mammal. The Court appearedto recognize that to grant a patent to the product itself would bestow Harvardwith a legal windfall because any offspring of the mouse would necessarily bea combination of nature's invention (the mouse) and Harvard's interven-tion (the transgenic material), but would nevertheless violate Harvard'spatent.

In the absence of a patent right over the actual animal, Harvard andDupont claimed that a rogue Canadian lab might attempt to make "genericmice" (akin to the concern over "generic drugs") by using traditional breed-ing methods between the oncomouse and a naturally occurring mouse toproduce, in accordance with Mendelian genetics, 50 percent of offspring withthe oncogene (Unger 2002). If the university were to receive a patent overthe actual animal, as it did in the United States, the resulting ownershipof the progeny would extend the patent well beyond any act of human inven-tion to claim monopoly rights over the mouse's own capacity for reproduc-tion (which clearly exists independent of Harvard's ingenuity). Accordingly,the Supreme Court of Canada denied rights to the mouse itself on the narrowground that the disclosed invention did not constitute a "manufacture" or"composition of matter," and thus did not fall within the available forms ofinvention recognized by the Canadian patent statute.

Significantly, the Court recognized that the patentability of life forms"was a highly contentious matter that raises a number of extremely com-plex issues" more appropriately addressed through parliamentary debate,public dialogue, and the civil society participation integral to the resolutionof political issues in a liberal democracy (President & Fellows of HarvardCollege 2002). In this, the Court was undoubtedly influenced by the CanadianCouncil of Churches who, in partnership with the Evangelical Fellowship ofCanada, acted as interveners in the case. These interveners were also sup-ported by a network of environmental activists who saw the case as pivotalin stemming the tide of genetic commodification. It was well known thatthe Court received a flood of letters from those with religious and environ-mental concerns while considering the case. As noted in a discussion guidepublished by interveners after the release of the decision:

The race to patent genes is at fever pitch. Some think of it as a kind of 21stcentury gold rush. Others have called it the new enclosure movement (remem-ber the movement to "enclose" and privatize common land that was the fore-runner of the industrial revolution in Britain'? What is now being privatized isnot common land, but bits of the internal structure of life itself) ... the numberof patents on human genetic material may already be as high as four million

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... Whole movements are afoot to protect "the genetic commons" but so farthose movements are dwarfed by the army of interests championing thenew array of intellectual property rights. (Canadian Council of Churches2003: 8)13

This Canadian decision is an important recognition that the issues posed bythe commodification of genomic research and innovation are political onesthat need to be subject to the full viscidities of democratic dialogue anddebate and, we would suggest, weighed with other norms of social justiceand sources of international obligation. This recognition emerges in thecontext of a fundamental transformation of the international legal environ-ment governing intellectual property protections.

V. THE CHANGING INTERNATIONAL LEGAL CLIMATE

Many scholars have pointed with alarm to the expansion of intellectualproperty rights at the hands of administrative bodies and judges who areloathe to intervene in markets for expensive, complex, and controversialtechnologies, and who are content to presume that more rights providemore incentives for more research and more innovation. Fewer have con-sidered the failure of legislatures to assume responsibility when these pre-sumptions have proven unfounded. The failure of the U.S. legislativebranch to take any initiative to counter USPTO practices during this periodis no doubt over-determined. The dominance of neo-liberal rhetoric and thehegemony of trade concerns over domestic public policy considerations, thegrowing lobby power of the pharmaceutical, agrichemical, and biotechnologyindustries (Drahos & Mayne 2002: 205; Sell 2002), the political quietude ofa populace largely uneducated in intellectual property matters (Litman 2001),unenlightened about the importance of maintaining a public domain generally,and (understandably) ignorant of the implications of commercializing bio-technological advances more specifically, are all forces and variables thathave combined to produce legislative inertia in the U.S.

If members of the public in a highly industrialised state like the U.S. wereless than fully involved or cognizant of the repercussions of intellectualproperty decisions made during this period, marginalized peoples in devel-oping countries - such as the peoples whose cell lines were of such interestto genetic researchers under the Project - have come to an awareness oftheir implications later still. When developing countries became members ofthe World Trade Organization and adhered to a new global regime for pro-tecting intellectual property rights (the TRIPS Agreement) they did so froma position of pronounced disadvantage (Drahos 1995). Many of them cameto the bargaining table with no expertise in intellectual property; indeed,many states had no teachers or courses in intellectual property in any oftheir universities. As Susan Sell shows, an awareness of the inequitiesinvolved in upholding the intellectual property rights claimed by the



multinational corporate actors at whose behest the Agreement waspromulgated emerged only after the ink was dry (Sell 2002). New socialmovements that challenge the assumptions which enable corporations toclaim their own activities as the source of all innovation, and question thedominant market fundamentalism that assumes private properties to besuperior to collectively held public goods or goods held in commons, areslowly changing the international political field in which patent issuesare determined. Indigenous peoples and the NGOs that represent themare central to these movements (Coombe 2001). To understand this, somedelineation of the international legal instruments within which theynegotiate is necessary.

During the same period that U.S. and European courts were upholdingthe practices of patent examiners inclined to uphold ever more expansiveindustry claims (in genomics and elsewhere), representatives of industrywere actively lobbying for the inclusion of intellectual property rights underthe provisions of the global trade regime. Their success in doing so wasremarkable; today, more patents are granted for less innovative contribu-tions that are more enforceable than ever before because of their governanceby the World Trade Organization (WTO) and its adoption of the Agreementon Trade Related Aspects of Intellectual Property (the TRIPS Agreement)as a binding obligation on all Member states. TRIPS imposes a minimumpatent term of twenty years and makes violations of state obligations toenact and enforce patent laws punishable through the threat of economictrade sanctions.

Although a cursory overview of the minimum obligations to be met bymember states in the WTO under the TRIPS Agreement would suggest thatdeveloping countries have some room for manoeuvre, the dominance ofU.S. interests in promulgating authoritative interpretations of these provi-sions has been considerable. Member states are obliged to make patentsavailable "for any invention, whether products or processes, in all fields oftechnology, provided that they are new, involve an inventive step and arecapable of industrial application ... without discrimination as to the placeof invention, the field of technology and whether products are imported orlocally produced" (TRIPS Article 27(1)).

In deference to European traditions and sensibilities, permissable ex-ceptions include inventions "necessary to protect ordre public or morality,including to protect human, animal or plant life or health or to avoid seri-ous prejudice to the environment" (Article 27(2)), as well as diagnostic,therapeutic and surgical methods and plants, and animals other than micro-organisms (Article 27(3)). Not unreasonably, these provisions were anti-cipated to provide opportunities for taking into account public concernsabout the scope of commodifiction. As early as 1989, the World Council ofChurches produced a statement demanding a "ban on experiments involvingthe genetic engineering of the human germline" (Tauli-Corpuz 2001: 266; seealso World Council of Churches 1989). Moral objections to gene patenting



have become more and more organized and vocal in the past decade. Religiousorganizations have been in the vanguard of asserting moral objections togene patenting, with more than eighty global religious groups denouncing genepatents in 1995.

Despite over a decade of controversy involving an active religious, en-vironmental, and human rights movement opposed to the "patenting of life,"the European Union declined to interpret public order or morality in afashion that would pose limits on the patenting of human genes. The 1998Biotechnology Directive, now part of European Community law, does pro-hibit the patenting of human clones, and patenting of innovations thatinvolve industrial use of embryos, as well as "parts of the human body...at various stages of its formation and development, and the simple dis-covery of one of its elements." Nonetheless, Article 5 provides that "elementsisolated from the body, including genes, will be patentable if their [indus-trial] utility can be established." The delay in implementing these provisionsinto national legislation in many of the member states, however, suggests thatthe issue is still a controversial one (although patents continue to issue).

The prospects of using the public order and morality provisions in thisDirective (which mirror those of the TRIPS Agreement) to limit patents onhuman genetic materials appear increasingly remote as these have beeninterpreted in the European Patent Office to be restricted to inventions thatthreaten national security or an individual's physical integrity in society. Apivotal case in 1995 involving the patentability of DNA fragments deter-mined that the "morality" exception applied only "to ensure that patentswould not be granted for inventions which would universally be regarded asoutrageous" (In Re Howard Florey Institute-Relaxin 1995, discussed inJenkins 2001: 9), thereby imposing a standard that is arguably impossible toachieve. Moreover, it was held that the invention - human DNA fragmentswith a particular encoding - did not involve the patenting of human life.The capacity of a patent-granting body to so determine the meaning andboundaries of human life was questionable to many; for others it revealeda shocking and even sacrilegious arrogance. On appeal the Technical Boardof Appeal affirmed that ". . . DNA is not 'life' but a chemical substancewhich carries genetic information and can be used as an intermediate in theproduction of proteins..." (In Re Howard 1995: 541-42).

Although it is possible for member states of the WTO to interpret theseprovisions differentially, it now appears highly unlikely that those who areopposed to the patenting of human genetic material generally or geneticsequences derived as a consequence of the Human Genome DiversityProject (the Project) more specifically, will find any relief from the relentlessexpansion of patenting in the more industrialized states within the restrictedconfines of intellectual property law and practice. Instead, indigenouspeoples and supportive NGOs have been insisting that TRIPS Agreementobligations must be interpreted in the context of international environmentallegal conventions, international customary law, and international human



rights obligations. In making these arguments, they are increasingly sup-ported by a number of different United Nations bodies.

The patenting of genetic material is a topic that has attracted increasingconcern and controversy in the field of biodiversity preservation, the focusof the 1992 United Nations Convention on Biological Diversity (CBD) thatconcluded in Rio de Janeiro as part of the Earth Summit. Now ratified byover 180 nation states, the CBD has become an important locus for organ-izing and negotiations by developing countries, international NGOs, andindigenous peoples seeking to counter neo-liberal interpretations of theTRIPS Agreement. The politics surrounding access and benefit-sharing withrespect to non-human (plant, animal, soil, etc) genetic resources under theConvention on Biological Diversity are too complex to engage here (see Coombe2001, 2003b, forthcoming). Suffice it to say that indigenous opposition tothe Project is closely tied to grievances and arguments made, and oppor-tunities that have been capitalized upon in this related arena of controversy.In both arenas of "bio-colonialism," activists "observe links between Westernexploitative practices, and the production of diversity as a site of infor-mational and commercial value" (Reardon 2001: 367). Indeed, one of theNGOs which most vociferously opposed and publicized the Project (theRural Advancement Foundation International, now renamed the ETCGroup) had been committed for two decades to showing that the identityand survival of indigenous populations and rural farming communitiesdepended upon preventing the commodification of plant germplasm cul-tivated in farmers' fields. The potential for the patenting of human geneticdiversity quickly elicited their concern. The role of this NGO in opposingpractices of "bioprospecting" and publicizing these practices as instances of"biopiracy" is not without its critics (Brown 2003; Greene 2003; Hayden2003). However we evaluate them, it is clear that such NGO activities havealerted indigenous peoples to the inequities of global regimes that permitunauthorized and uncompensated flows of genetic resources which are sub-sequently privatized as corporate intellectual property without recognitionof the efforts and contributions of peoples from whose territories andbodies these resources are taken or their meaning in local lifeworlds (Coombe2003b, forthcoming; MeManis 2003).

The CBD explicitly recognizes the importance of the knowledge, prac-tices and innovations that "indigenous and local communities embodyingtraditional lifestyles" to the ongoing preservation of biological diversity,and calls upon states to find means of protecting it and sharing benefitsfrom its use - recognizing indigenous and traditional "communities" as keystakeholders in negotiations over the use of genetic resources. Negotiationsover the best means of implementing these requirements are ongoing, butthis has been an important arena for the emergence of indigenous peoplesand communities (via the NGOs that represent them) as political actors onan international stage dominated by nation states. During these negoti-ations, a new discourse of authorship and innovation has emerged in which



the creative contributions of indigenous peoples are insisted upon (Coombe2003b).

[T]o consider only the inventions of white men in white lab coats to be inventionsworthy of recognition and reward is to hold a fundamentally racist view ofhuman creativity: it amount[s] to once again declaring land "empty" of inhab-itants so that it may be claimed... [B]y enclosing biological materials in patents,trade agreements were about to transform the rich creative interactions ofcultural and biological diversity into a new economics of scarcity. (Burrows2001: 241)

Claims with respect to the human creativity involved in the development ofplant, animal, and other nonhuman genetic resources were gaining widerlegitimacy during the same decade that the Project came into public view.Not surprisingly, a similar "counternarrative" to the dominant narrative of

corporate research innovation and reward emerged here (Coombe 2003b).The commercialization of new genetic technologies, coupled with the

trend towards market fundamentalism, clearly "redefined the limits of what

is considered patentable and what is knowledge in the public domain"(Willison et al. 2001) and consequentially created new forms of distribu-

tional inequalities in the information economy. "Any new technology intro-duced into a society which is not fundamentally just will exacerbate thedisparities between rich and poor" (Bogve Declaration 1987), but for thosewhose very identities and bodily distinctions render them valuable resources

for the purposes of others, these disparities may be especially resented. Forsome peoples, the issue is less about the validity or desirability of patentinginventions derived from materials and information gleaned through theProject, but the simple ethics of compensation under the circumstances.

If scientific research for which samples are obtained produces goods of

some value, the indigenous peoples who contributed to that result through

the provision of genetic resources, might be viewed, and arguably should beviewed, as collaborators in that research just as providers of unique data ina scientific experiment resulting in an outcome would expect to receive

some recognition and compensation. Those who bring their genetic heritageto the enterprise bring something essential to it and it is, arguably, an

unjust enrichment for others to have the exclusive benefit of the knowledgeand product that improves their health but leaves those who provided the

essential raw material no better off. The valuation of the gene discovery is aseparate matter. The bulk of the inventive process may take place after the

genetic materials are obtained; but even if we accept that profits shouldaccrue predominantly to "inventors" in a more scientific sense, this cannotjustify the tiny to nonexistent compensation that is so often provided toindigenous peoples who may ultimately have a legal claim in restitution,and possibly for a breach of contract pursuant to the IPRA.

Compensation may take many forms, not only a percentage of possiblepatent royalties (always a long term and risky proposition), but the pro-vision of education in endangered local languages, local health care, or



capacity building in the form of scientific training, legal education, ortechnology transfer (these are all actual examples of arrangements thathave been made with indigenous peoples who are providing governmentorganizations, non-profit organizations, and corporations with indigenousknowledge, plant and animal genetic resources, as well as human geneticmaterials). Indeed, proposed protocols for the North American DiversityProject eventually acknowledged that researchers should anticipate thatcertain groups have norms of reciprocity that make it incumbent uponresearchers to give something of local value to communities in return fortheir participation in any research (Dodson & Williamson 1999: 203-8).

VI. INTELLECTUAL PROPERTY AND HUMAN RIGHTS

We have seen that courts are notoriously reluctant to make determinationsabout public order and morality, even if the full range of interested partiescould afford access to them or gain standing. Government patent officesare arguably even less competent to do so. The recent Canadian SupremeCourt decision is a welcome but unique departure from the predominantlegal practice of simply upholding patents on genomic innovations withoutfuller consideration of the issues involved. The determination of howand why the patenting of gene sequences is contrary to public order andmorality should ideally be a matter of more thorough public dialogue anddemocratic determination. The "public" and the "morality" recognized inintellectual property debates, are, however, usually conceived of in nationalterms. Indigenous peoples across the globe have enormous political hurdlesto overcome to be recognized as "nations" in the states where they reside;they face even greater hurdles if they are to have their interests recognizedin the major patent-granting jurisdictions as part of the relevant publicinterest.

To the extent that most jurisdictions in the world oblige themselves toadhere to international human rights laws by virtue of their ratification ofthe two covenants that constitute the Universal Bill of Human Rights,however, the body of relevant normative principles is far more expansivethan a mere reading of the TRIPS Agreement would suggest. With respectto traditional knowledge, for instance, state governments not only haveobligations to indigenous peoples subject to their own jurisdictions, butobligations to indigenous peoples (including forest dwellers and marginal-ized tribal groups) globally (Coombe 1998). States party to the CBD mustattend to the protection and conservation of biodiversity outside of theState's jurisdiction to the extent that this may be integrally related to thecultural integrity, environmental protection, and heritage rights of indigen-ous peoples across the globe. Arguably, international human rights lawobliges state governments to ensure that all intellectual property rights aregranted and exercised in a manner that does not entail violations of human


178 LAW& POLICY January2005

rights - an obligation that extends to the monitoring of corporate intellec-tual properties. The unfettered expansion of patents has provoked renewedattention to the positioning of intellectual property within human rightsregimes (Shiva 1997; Great Britain. Commission for Intellectual PropertyRights 2001). NGOs have and will continue to be central to this process. AsPeter Drahos puts it, the objectives for NGO strategy must go beyond theneed for critical reforms of patent office regulatory administration:

Political lobbying also needs to be directed at regulating intellectual propertyoffices with a new jurisprudence of intellectual property. Preeminent here is theneed for indigenous rights groups to lead demands for intellectual propertyrights law and administration to be constrained by fundamental internationalhuman rights obligations. (Drahos and Mayne 2002: 205)

Indigenous NGOs clearly frame their opposition to the Project in theseterms.

For those of us whose human rights have been grossly violated, from colon-ization to the present, it is important that we assert our rights to have controlover our own bodies, our territories and resources, and our knowledge andcultures. This is what our opposition to the Human Genome Diversity Projectis all about. (Tauli-Corpuz 2001: 253)

Amongst the human rights, the right to self-determination arguably holdsthe greatest promise for indigenous populations to assert control over theirgenetic material (Ching 1997: 715-17). The International Covenant on Civiland Political Rights (ICCPR 1966) asserts that "[a]ll peoples may, for theirown ends, freely dispose of their natural wealth and resources without pre-judice to any obligations arising out of international economic co-operation,based upon the principle of mutual benefit, and international law. In nocase may a people be deprived of its own means of subsistence." The terms"natural wealth and resources" may include genetic materials. "Because feder-ally recognized Native American tribes are considered sovereign nationswithin a sovereign nation, they already have a legal right to determine whatresearch can proceed on their community" (Foubister 2000).

Objections cloaked in human rights terminology however, go beyondrights to self determination, which theoretically are assuaged throughproper research disclosure, engagement in devising protocols, full andinformed consent, compensation, and benefit-sharing for the communitiesinvolved. Genomic patenting may implicate the human rights of all of us.The International Covenant on Economic, Social and Cultural Rights(ICESCR) (1966) affirms many rights arguably violated by gene patents.The impediments such patents pose to access and delivery of health servicesmay be construed as a violation of the right of "everyone to the enjoymentof the highest attainable standard of physical and mental health" (ICESR1966) and the obligations of states to ensure "[t]he creation of conditionswhich would assure to all medical service and medical attention in theevent of sickness." Certainly, current patent regimes act as obstacles to the


Ainani & Coonbe HUMAN GENOME DIVERSITY PROJECT 179

realization of the highest attainable standard of health by imposing addi-tional costs (royalty rents) that must be internalized by users.

The ICESCR explicitly includes intellectual property rights (to benefitfrom the protection of the moral and material interests resulting from anyscientific, literary, or artistic production of which one is an author) in anArticle that obliges states to equalize and diffuse rights to take part in cul-tural life and to enjoy the benefits of scientific progress. The commercial-ization of science through patenting does not always meet these otherobjectives as a general matter, but patents based on distinctive geneticmaterials provided by indigenous communities seem particularly offensivewhen these peoples are denied access to basic medicines and technologies(the right to share in scientific progress and its applications) while their owngenetic resources provide benefits for others.

Why do we deny that an individual's cells are "scientific, literary or artisticproductions" when we are prepared to deem the mere isolation of that cellin an obvious manner for an unknown purpose an innovation? In a legalsystem that creates fictions of corporations as persons capable of intellectualproperty ownership, it is not a huge leap to concede that Mr Moore con-tributed to a scientific production through his bodily creation of his cells andhas a right to have his moral interests protected. The independent protestacts asserting individual authorship over individual genetic material withwhich we opened this article are oblique comments upon the failure of thesystem to recognize individual moral and material interests in the field ofgenetics. Multiplied, such acts of protest might force us to re-examine thepriorities of a system that has been so demonstrably unaccountable to thelarger public.

It has taken more international protests however, to focus attention onthe incommensurability between rights to take part in cultural life andrights to privately control intellectual properties, when the latter are con-stituted by the genetic substance of those who are deprived of the former. Ifcommunities hold strong, and in some cases, religious, objections to theownership and private possession of human life, how substantive is theirright to take part in the cultural life of societies where the patenting of genesequences themselves (as distinct from derivative inventions) is enabled bythe state? We do not pretend to have an answer to this question, but wewould like to suggest that our collective social failure to even pose it demon-strates both political irresponsibility and cowardice. In the face of suchcowardice, it is not surprising that indigenous peoples have unequivocallycondemned the Project as a violation of their human rights and called for amoratorium on this research (see Indigenous People's Council on Biocolon-ialism at http://www.ipcb.org/resolutions/modelres.html).

Unfortunately, human rights express fragile and relatively recent normsthat represent the highest standards to which we hold ourselves in inter-national society, rather than our actual practice. Nonetheless, these standardsprovide a mirror in which we see that the practice of granting patents over

© 2005 Baldy Center for Law and Social Policy and Blackwell Publishing Ltd-


human genetic materials produces some ugly reflections on the state of politicsin a neo-liberal economy.

POSTSCRIPT

The enormous efforts undertaken by indigenous peoples to disclose andpublicize the social, racial, and political implications of the Project mayexplain why it was ultimately unable to secure necessary funding and hasnow been abandoned. In its place, the HapMap Project (referring to thehaplotype map) has emerged to carry on research to help us to understandhow the three billion bits of DNA in the human genome are organized intosequence variations described as haplotype blocks. Humans share in com-mon 99 percent of their DNA sequences, and genes closely groupedtogether are often inherited as a linked group called a "haplotype" suchthat any variations that exist in the linked genes might be useful in identifyinggene-based sources of diseases such as asthma, cancer, diabetes, and heartdisease. The gene-related disease would be passed along with the haplotypethat is its genetic source (Tyler 2003).

Dr Richard Gibbs, director of Baylor's Human Genome SequencingCentre, predicts that "[i]n 10 to 20 years when you go to the doctor, he orshe is going to want to know a lot more about your family history thanphysicians do now... [a]nd your physician will get that history from lookingdirectly at your DNA." HapMap will encourage further population-basedresearch examining why a certain portion of the population might get anage-related illness at a different stage of life or how a variation may impactour body's response to environmental factors and susceptibility to infections.The project has $100 million in funding and is expected to take approxim-ately three years, involving nine research groups and both private and publiclabs in five countries using blood samples taken from people in Nigeria,Japan, China, United States, and parts of Europe.

Who will hold the patents on this genetic research and how will they beused? How will these patents affect health-care costs, influence insurancecompanies, or facilitate new forms of discrimination? The HapMap Project,by diversifying the targeted populations, should serve as a warning that therelevance of the politics of patents with respect to human genetic researchextends beyond the imagined boundaries enclosing indigenous communities.We will all feel the impact of this research and the repercussions of patentsgranted on its genetic findings because of our shared, if differentiatedgenetic heritage. Once turned into proprietary information in the new infor-mation economy, however, it will cease to be "ours." This information willbe simply incorporated into new monopolies to which public interests willbe subjected and human beings subjugated unless we demand that decisionsabout the scope of patents be recognized as political choices in which we allhave some stake.

0 2005 Baldy Center ror Law and Social Policy and Blackwell Publishing Ltd.

Ainani & Coomnbe HUMAN GENOME DIVERSITY PROJECT 181

BITA AMANI is Assistant Professor, Queen's University Faculty of Law, Kingston,Ontario; and consultant on gene patents to the Ontario Advisory Committee on Predic-tive Genetic Technology (2001). She is an S.J.D. candidate, University of TorontoFaculty of Law (trade-human rights conflicts in patenting of life funding by SSHRC andCILP); and has an LL. B. from Osgoode Hall Law School, York University.

ROSEMARY J. COOMBE is Canada Research Chair in Law, Communication and CulturalStudies, Faculties of Arts and Law, York University. She holds ajoint doctorate in Lawand Anthropology from Stanford University. Her book, The Cultural Life of IntellectualProperties: Authorship, Appropriation and the Law was published by Duke UniversityPress in 1998.

NOTES

1. For a sample viewing of her performance art, Donahue DNA growing on PetriPlates, go to the artist's website at http://www.mudhaus.com/marilyn/donahueand links to related articles on the proliferation of her DNA protest project.

2. If, as we shall argue, the requirements for obtaining a patent have been substan-tially relaxed in recent years, the requirements for a grant of copyright may beeven more relaxed with respect to originality. The term of protection, moreover,is significantly - by some seventy years - longer, explaining the preference forthe latter form of monopoly protection (Philipkoski 2001; Shactman 2002). Themost recent attempt to use copyright to garner protection has been to encodeDNA sequences as MP3s or other such music files and then copyright these"genetic songs" as creative works of authorship. This method of attracting DNAcopyright protection through the encoding of the genetic information in tech-nological hardware is itself the subject of a patent application, which if granted,would deny anyone other than the original inventor of such a method, fromstoring or retrieving genetic data in this way.

3. See also Uinsionn MacDubghaill, "Now No Life is Safe from the Patent Lawyer,"The Irish Times, October 16, 1993, at Home News 4: "Patrick Mooney of theRural Advancement Foundation International (RAFI, now ETC,) claims thatby the end of 1992, more than 2,851 patent applications had been filed by theUnited States National Institute of Health, including an application of the cellline of a 26 year old Guaymi Indian Woman from Panama" (in Khan 1999: n. 8).

4. In the "Testimony of John Moore to the Committee on Human Genome Diversityof the National Academy of Sciences," 16 September 1996, an occasional paperof The Edmonds Institute, Edmonds, Washington, page 2.

5. See http://nativenet.uthscsa.edu/archive/nl/9510/0310.html for a statement fromRAFI (Rural Advancement Foundation International, an interest group) com-menting on how patents in the United States set the pace and precedent forinternational patenting regimes. The U.S. patent for the cell lines of two SolomonIslanders was rescinded after formal protest from the Island's ambassador to theU.S. Secretary of Commerce. Other patents were and continue to be sought byresearchers for genes and cell lines of the Hagahai people from Papua NewGuinea in attempt to find a cure to Leukemia. See http://www.rz.uni-frankfurt.de/-ecstein/gen/env/98; the former patent claim ".... has the title 'Solomon Islandsvariants of human T-lympotropic virus' which were derived from 'a 40-year oldwoman with history of transfusion-acquired hepatitis from Marovo Lagoon inWestern Province and patient 2 was a 58-year old man with hepatosplenomegalyfrom Guadacanal in Guadacanal Province ... ' In March and August 1990, bloodspecimens were collected, after obtaining prior informed consent, from two



native Salomon Islanders, who were previously identified as being HTLV-I sero-positive by immunofluorescene and Western analysis. .. ' " explains the patentpublication. "The Novelty under patent claim is a human T-cell line useful forthe production of vaccines against infection with HTLV-I and a variety of bio-assays for its detection. The patent was assigned to the U.S. Dept Commerce,Publication Number WO-9215325-A." The second was for ". . . the U.S. govern-ment patent application, 'Papua New Guinea Human T-Lymphotropic virus',International Publication Nr. WO 93/03759, claiming a patent on a cell line ofthe Hagahai. 'In May 1989, 25 ml of heparinized blood was drawn from each of24 Hagahai men and woman, of whom 7 had confirmatory and 17 had in-determinate HTLV-I Western immunoblots. Blood samples were collected in thefield, and were rushed to the Papua New Guinea Institute of Medical Researchin Goroka, where they were processed in a laboratory.'" The patent is assignedto the U.S. Department of Health and Human Services and the National In-stitutes of Health. It is important to note that even where consent is given to doresearch and testing, the populations are generally not informed that their specimensmay be subject to secondary purposes i.e. commodification through patenting.

6. For more information, see http://www.cowan.edu.au/pa/hgsa/consymlO.htm,reporting on a 1997 conference in Western Australia, "Human Genetics: Diversityand Disease."

7. For a discussion on why the conventional model of scientific research is in-appropriate for population genetics and how a democratic model for research ismore desirable in this area, see the memorandum by David King (1999).

8. For full text the draft, see http://unesdoc.unesco.org/images/0013/O01312/131204e.pdf#page=27.

9. For full text of the statement, see http://genetics.faseb.org/genetics/acmg/pol-34.htm. The ACMG specifically articulates their concern over enforcementpractices by gene patent holders through ". . . monopolistic licensing that limitsa given genetic test to a single laboratory, royalty-based licensing agreementswith exorbitant up-front fees and per test fees, and licensing agreements thatseek proportions of reimbursement from testing services. These limit the acces-sibility of competitively priced genetic testing services and hinder test-specificdevelopment of national programs for quality assurance. They also limit the numberof knowledgeable individuals who can assist physicians, laboratory geneticistsand counselors in the diagnosis, management and care of at-risk patients."

10. For a comprehensive timeline, see the Official Journal of the EPO, 10/1992 online athttp://www.european-patent-office.org/news/pressrel/pdf/oj1992-l0_p588-593.pdf.

11. For a discussion of how resistance to patent monopolies have become part ofbiodiversity politics in an indigenous struggle for land, democracy, and self-determination, see Harvey (2001).

12. Growing concern about corporate intellectual property monopolies is reflectedin discussions at the World Social Forum 2002, which may be considered one ofa larger group of social movements (see Balakrishnan 2003; Cavanagh et al.2002; Fisher & Ponniah 2003).

13. For a discussion of threats to the commons from corporate patents on lifef orms,in the context of a larger discussion of principles of sustainability and the critiqueof corporate globalization, see Cavanagh et al. (2002: 79-106).

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Q 2005 Baldy Center for Law and Social Policy and Blackwell Publishing Ltd.


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CASES CITED

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INTERNATIONAL INSTRUMENTS CITED

European Union

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International

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UNESCO (2003) International Declaration on Human Genetic Data, October 2003.Available at http://unesdoc.unesco.org/images/0013/001312/131204e.pdf#page=27.


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