Gene Patenting

Patents give the patent-holder the right to exclude others from making, using, or selling an invention for a limited period of time (generally fifteen to twenty years). They do not confer on patent holders the right to do anything they wish with the invention. Countries regulate patents differently: Many grant patents to the first to file, while the United States grants patents to the first to invent. Patent rights are extended internationally through trade negotiations and political treaties. In the biotechnology arena, patents protect large financial interests.

Patent law in the United States

U.S. patent law requires that the invention (process or product) be: (1) novel—not already in the public domain; (2) non-obvious—not an obvious extension of prior art; (3) useful; and (4) fully disclosed. Interpretations of each criterion are contested.

Prior to 1930, products of nature could not be patented in the United States. The Plant Patent Act of 1930 permitted plant breeders to patent new plants. Until 1980, however, nonplant living matter was not patentable. Two legal cases changed the picture. By determining that a strain of bacteria constituted a patentable invention (Diamond v. Chakrabarty), the U.S. Supreme Court set the stage for patenting organisms as human inventions. (However, at least one critic, Mark Sagoff, argues that Chakrabarty's work did not involve a unique process and should not have been considered a human invention.) Within a few years, the Patent and Trademark Office was granting patents on bioengineered mice and other living organisms.

The second crucial case was Moore v. Regents in 1990. Tissue excised from John Moore during medical treatment was used to develop a commercially valuable line of cells on which a patent was granted to the researcher. Moore sued. The California Supreme Court determined that Moore did not have a proprietary right to his excised tissue or to the cell line developed from it. This decision opened the door for additional efforts to derive patentable tissues from "excess" body parts.

Once patents were granted for living organisms and tissues derived from body parts, it was not long before the Patent and Trademark Office began to permit patents on genes and DNA fragments. Efforts to map and sequence the human genome then sparked a "gold rush" on patents for human genes. By the end of 2000, Human Genome Sciences, Inc., a pharmaceutical company, was reported to hold over one hundred patents on human genes, with applications pending for more than 7,500 additional patents.

Objections to gene patenting

The patenting of genes, organisms, and tissues derived from the human body has not gone undisputed. In 1995, representatives of some eighty religious organizations signed a Joint Appeal Against Human and Animal Patenting. For many religious representatives, permitting patents on life forms is arrogating to humans what rightly belongs only to God: "We believe that humans and animals are creations of God, not [of] humans, and as such should not be patented as human inventions." Indeed, for some, the very framing of the issue as a question of patenting is problematic, since the language of patent rights already determines what questions can be raised. Those who believe that God alone is the author and inventor of living beings would prefer to speak in terms of God's dominion and human duties of stewardship rather than in the language of human rights and patents to human "inventions." Thus, public discourse may already privilege some perspectives and disadvantage others; the very framing of the issues eliminates some ways of seeing the question.

Another argument against gene patenting rests on the notion that the human genome is part of our common human heritage. As such, the genome should be seen as public property and no single person, organization, or group should have the right to exclude others from access to public property. Native Americans, in spite of their diversity of religious and ethical views, generally oppose gene patenting, seeing it as a new form of biopiracy in which colonizers steal from natives anything of value. Serious issues of international justice are raised by such concerns.

In the popular mind, gene patenting is linked with practices such as buying and selling of human body parts. Hence, gene patenting evokes prohibitions against ownership of human beings. If parts of a body can be owned, then there is no reason that all the parts could not be owned, resulting in the ownership of persons. Prohibitions against buying and selling body parts or owning persons exist worldwide. In the West in particular, early Christian belief in a literal resurrection of the body continues today, as Paul Rabinow states, in an "enduring cultural understanding that the 'person' is inextricably tied to the sheer materiality of the body or its parts . . . ." (p. 185). To patent human genes is thus perceived as patenting persons, which is repugnant to many. One critic argues that current patent law in the United States would permit patenting processes for germline genetic intervention, thus leading to rights over a genetically altered human being. The shared presumption that people cannot be owned thus generates some resistance to patenting of human genes.

Even those who do not utilize explicitly religious arguments often wish to set bodies and body parts aside as something that cannot be owned or patented. The European Union Directive of 1998 states that the human body "and the simple discovery of one of its elements, including the sequence of a gene, cannot constitute patentable inventions." Similarly, lawyer and bioethicist George Annas has argued strongly against any "ownership" of human body parts.

Arguments for gene patenting

Proponents of gene patenting counter that patents are not granted on humans or their bodies, but only on genes or gene fragments. More importantly, what is patented is in the laboratory, not in the living person; holding a patent on a gene does not grant ownership of the gene inside someone's body. For example, Article 5(2) of the European Union Directive does permit patenting of gene sequences that are "isolated from" the body or produced by a technical process, provided their industrial application is disclosed. Here, the Directive balances the conviction that life forms per se should not be patentable with the reality that in the contemporary international market access to patents may be crucial for scientists and investors.

Two major arguments are proffered for gene patenting. First, such patents are part of the intellectual property rights tradition in which people have rights over things they have invented. Article 27 of the Universal Declaration of Human Rights specifically provides that every person has a right to "protection of the moral and material interests resulting from any scientific . . . production of which he is the author." The notion that there is a right of ownership deriving from authorship has deep roots. Seventeenth-century philosopher John Locke held that each person had a "property" in his own person and therefore in the work of his hands; by "mixing his labor" with objects (within certain constraints), a person gained a property right in those objects. This labor theory of property forms the basis for a deeply held conviction that patents are justified because they embody a right to the work of one's hands or one's mind.

However, under contemporary conditions, the one who discovered a gene may not hold the patent. More often, the patent holder is an employing institution or corporation that sponsors the research. Hence, the notion that there is a right to the work of one's hands or mind applies only ambiguously to the modern circumstances of gene patenting.

The second and more prominent argument for patenting genes and DNA fragments is a utilitarian one: patents, as William Haseltine writes, "ensure the rapid and open dissemination of new knowledge, encourage innovation, and promote commerce" (p. 59). Since patents are granted only where there is full disclosure of the invention, patents promote open dissemination of knowledge. Since they exclude others from using the invention, they provide time for commercial developments and thus encourage innovation. These are typical arguments made in the biotechnology industry.

Whether the patenting system has these good effects is difficult to ascertain. Both the Council for Responsible Genetics and the Human Genome Organization (HUGO), representing the coordinated mapping and sequencing efforts of many scientists worldwide, assert that patents work against the tradition of shared knowledge among researchers. The current climate of collaboration between universities and private industry raises particular concerns that patenting may not encourage open sharing of information but rather discourage it in the interests of developing commercial applications. Patent holders often permit free access to information for those doing basic research but restrict access for those doing applied research with commercial potential. In light of these and other considerations, some urge a moratorium on any further gene patenting. Others argue that even if patenting does contribute to the free flow of information, stimulate innovation, and promote commerce, these good effects must be balanced by principles of international justice and the common good, which might require some limitations on gene patenting.

See also Biotechnology; Creation; DNA; Genetics; Human Genome Project

Bibliography

andrews, lori b., and nelkin, dorothy. body bazaar: the market for human tissue in the biotechnology age. new york: crown, 2001.

annas, george j. "outrageous fortune: selling other people's cells." hastings center report 20, no. 6 (1990): 36–39.

chapman, audrey r. "a human rights perspective on intellectual property, scientific progress, and access to the benefits of science." in intellectual property and human rights, world intellectual property organization, publication # 762 (e). geneva, switzerland: wipo, 1999a.

chapman, audrey r., ed. perspectives on genetic patenting: religion, science, and industry in dialogue. washington, d.c.: american association for the advancement of science, 1999b.

chapman, audrey r. unprecedented choices: religious ethics at the frontiers of genetic science. minneapolis, minn.: fortress, 1999c.

gold, e. richard. body parts: property rights and the ownership of human biological materials. washington, d.c.: georgetown university press, 1996.

haseltine, willliam. "the case for gene patents." technology review 5 (2000): 59.

hensley, scott. "celera's human genetic code will be available on web site," wall street journal. 8 february 2001.

howard, ken. "the bioinformatics gold rush." scientific american 283, no. 1 (2000): 58–63.

kondo, leroy l. "major considerations in meeting requirements for patents in biotechnology." biotechnology law report 17, no. 6 (1998): 794.

locke, john. "second treatise on civil government" (1690). in social contract: essays by locke, hume, and rousseau, ed. ernest barker. new york: oxford university press, 1962.

mattei, ugo. basic principles of property law: a comparative legal and economic introduction. westport, conn.: greenwood, 2000.

rabinow, paul. "severing the ties: fragmentation and dignity in late modernity." knowledge and society: the anthropology of science and technology 9 (1992): 169–187.

regalado, antonio. "the great gene grab." technology review 5 (2000): 50.

sherry, stephen f. "the incentive of patents." in genetic ethics: do the ends justify the genes? eds. john f. kilner, rebecca d. pentz, and frank e. young. grand rapids, mich.: eerdmans, 1997.

shulman, seth. "toward sharing the genome." technology review 5 (2000): 60.

wright, karen. "the body bazaar: the market in human organs is growing." in bioethics, justice and health care, eds. wanda teays and laura purdy. belmont, calif.: wadsworth, 2001. first published in discover 19 (1998): 115–120.

court cases

diamond v. chakrabarty (447 u.s. 303, 1980).

moore v. regents (793p.2d 479. cal 1990 cert.den.111 s.ct.1388, 1991).

internet resources

sagoff, mark. "patented genes: an ethical appraisal." issues in science and technology online. national academy of sciences, spring 1998. available from http://stills.nap.edu/issues.

who owns life? the american journal of bioethics on-line. produced by the university of pennsylvania center for bioethics and the mit press. available from http://ajobonline.com.

karen lebacqz