Owning the Genome: A Moral Analysis of DNA Patenting

Chapter 1

THE CONTROVERSY OVER PATENTING DNA Since 1976, the United States’ Patent and Trademark Office (PTO) has issued over 16,000 patents on isolated and purified deoxyribonucleic acid (DNA) sequences or on processes used to identify, isolate, copy, sequence, or analyze DNA sequences (PTO 2002). In 1999 alone, the office received over 3,000 patent applications pertaining to DNA sequences or DNA-related technologies (Enserink 2000). Although the practice of DNA patenting is scarcely more than a couple of decades old, it has created an enormous controversy. The storm began brewing in 1994, when the National Institutes of Health (NIH) applied for patents on thousands of gene fragments in an attempt to undercut private efforts to patent these DNA sequences. The PTO rejected these applications, however (Zurer 1994). During that same year, over thirty organizations representing indigenous peoples announced formal declarations objecting to gene patenting, the ownership of life, and the commercial exploitation of indigenous peoples. These organizations were responding, in large part, to the NIH’s patent applications on viral genes taken from the Hagahai people in Papua, New Guinea and natives of the Solomon Islands as well as the Human Genome Diversity Project , aka “the vampire project” (Taubes 1995; Crigger 1995). While the NIH’s applications did not seek patents on human genes, these organizations nevertheless argued that the patents would harm and exploit indigenous peoples and violate their cultural values. Researchers claimed that these patents could deter scientific progress and that the NIH, a government agency, should not be involved in any attempt to exert proprietary control over DNA: the NIH 1 1 Introduction and Overview should encourage public dissemination of DNA and not private control. In defense of its patent applications, the agency claimed that it hoped to encourage private investment in the development of vaccines based on these viral genes and that it intended to grant nonexclusive licenses to companies. In 1995, the PTO awarded the NIH a patent on a viral gene taken from residents of Papua, New Guinea. Responding to objections from researchers as well as the public, the NIH withdrew its request to patent viral DNA sequences taken from residents of the Solomon Islands, although it retained the Papua, New Guinea patent at the request of clinicians working with that population, who felt that the population could benefit from research and royalties generated by the patent (Resnik 1999b). In 1995, the PTO awarded the NIH and Genetic Therapy Incorporated patents on techniques for modifying cells ex vivo. Opponents of this patent argued that it was too broad and that it would stifle research (Beardsley 1994). The patent even drew Congress’ ire, which considered but rejected a measure that would have prevented many types of gene patents (Kevles and Berkotwitz 2001). On May 18, of the same year, about 180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference in Washington, DC, objecting to biomedical patenting. In their “Joint Appeal against Human and Animal Patenting” (1995) these leaders denounced all attempts to patent nature. Some of the members of the Joint Appeal compared gene patenting to slavery, while others claimed that gene patents treat human beings as marketable commodities (Joint Appeal 1995; Andrews 1995; Peters 1997; Hanson 1997; Rifkin 1998). Religious leaders and organizations also took their mission to stop gene patenting beyond the Joint Appeal and published articles and editorials on the subject (Christian Century 1995; Land and Mitchell 1996). For Rifkin, the Joint Appeal vindicated ideas he had voiced for years. Since the 1970s, Rifkin has been the biotechnology industry’s gadlfy. He has written books denouncing attempts to modify, engineer, patent, or own living things. His Foundation on Economic Trends, a Washington-based nonprofit organization, champions Rifkin’s admonitions and concerns about the biotechnology revolution (Rifkin 1983, 1985, 1998, 2000). From 1995–1999, the controversy continued as researchers, scholars, and government officials objected to private efforts to patents DNA technologies and DNA sequences. During this period, a handful of genomics companies, such as Celera Genomics, Human Genome Sciences, Genset, and Myriad Genetics were created with the explicit mission of marketing genetic information for use in diagnosis, therapy, and drug discovery. Their business plans called for DNA patenting, protein patenting, and the commercialization of genomics information services (Fisher 1999; Wade 2000a,b,c; Marshall 1999a,b,c; Wicklegren 1999). Many pharmaceutical and biotechnology companies , such as Incyte Pharmaceuticals, Glaxo Welcome, Millenium Pharmaceuticals , Genentech, Perkin Elmer, and Monsanto, also took an interest in 2 Owning the Genome [18.117.182...