Gene Patents, The Anticommons, and the Biotechnology Industry

Abstract

The legal definition of patentable intellectual property (IP) is rapidly evolving, with passionate proponents of both strong IP protections and increased open access to IP. The discussion in this opinion piece relates to the debate under way in the biotechnology industry, but it mirrors similar debates in other industry sectors. Since the late 1970s and early 1980s, gene patenting--a subset of biologic or deoxyribonucleic acid (DNA) patents--has been deemed strategic to the commercial success of U.S. biotechnology companies, such as Genentech and Amgen (Cook-Deegan 2008). This strategic industry dependency on gene patents, however, is now in legal jeopardy. On March 29, 2010, Judge Robert W. Sweet, of the U.S. District Court for the Southern District of New York, ruled that the patents for test for mutations in the BRCA1 and BRCA2 genes held by Myriad Genetics of Salt Lake City, Utah, were invalid (Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., No. 09-Civ-4515 [SDNY]). The Myriad Genetics patents were invalidated by Judge Sweet on both composition claims and method/ process claims. Drawing on long-recognized principles of molecular biology and genetics, Judge Sweet ruled that the Myriad Genetics patents were improperly granted because they involved law of nature ('composition claims'). Because the claimed comparisons of DNA sequences are abstract mental processes ('method/ process claims'), they also constitute unpatentable subject matter. He also held that the notion that isolating human gene makes it patentable is a 'lawyer's trick' that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result. Judge Sweet's decision is potentially devastating to multibillion-dollar biotechnology industry constructed upon the foundation of solid intellectual property rights; 18.5 percent of the human genes complement that is currently patented (Jensen and Murray 2005) is at risk of being invalidated. Since Myriad Genetics intends to appeal this decision, the Court of Appeals for the Federal Circuit (and likely the U.S. Supreme Court) will eventually decide whether gene tests can be effectively patented separately from the gene itself. The plaintiffs in the Myriad Genetics case, the American Civil Liberties Union and the Public Patent Foundation of New York's Benjamin N. Cardozo School of Law, argued that 15 claims under seven BRCA gene patents (Myriad Genetics 2010) stifled biomedical research by preventing scientists from accessing patented materials or methods they need for further genetic studies (Stiglitz and Sulston 2010). The result, the plaintiffs argued, was that the difficulty of getting approval from holders of exclusive gene patents stifles work on developing multigene diagnostic tests. The Tragedy of the Anticommons In making their argument in this case, the plaintiffs invoked the notion of the tragedy of the anticommons, conceptual mirror image of the tragedy of the commons. The tragedy of the commons occurs when multiple people, acting independently of each other and solely and rationally in their own self-interest, deplete public resource even when it is apparent to all involved in the activity that it is not in anyone's long-term self-interest to do so (Hardin 1968). The solution to this paradox, at least for Garrett Hardin, the concept's originator, is to grant private property rights of exclusion, creating market-based, ownership-centered approach to regulate the use (and help ensure the long-term existence) of the finite resource. Conversely, the tragedy of the anticommons, neologism coined by Michael Heller (1998), refers to public resource that is underused or made unavailable for public benefit because it is too encumbered by private interests. In the field of biomedical research, the anticommons is result, ironically, of policy intended to encourage firms to undertake high-risk pharmacological and biotechnology research (Heller and Eisenberg 1998). …