RTM - Gene Patents, the Anticommons, and the Biotechnology Industry

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 a 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 a “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 a 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.”

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Volume 53, Issue 5, September-October 2010

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