Title: Patent Policy, Natural Products, and the Gene Patent Debate: Seeking the Proper Judicial Mode of Analysis
Abstract: Two recent court decisions challenge the patentability of “isolated and purified” human genes. The Federal Circuit’s 2009 decision in In re Kubin held for the first time that a gene’s sequence can be obvious, in violation of Section 103 of the Patent Act, if the prior art discloses the encoded protein and a method of identifying the corresponding gene. More recently, a 2010 decision by a federal district court in Association for Molecular Pathology v. USPTO [hereinafter Myriad] held that the gene patents at issue were not patentable subject matter under Section 101 of the Patent Act because they were not “markedly different” from the versions of the genes found in nature. I argue that neither Kubin nor Myriad represents the appropriate judicial approach to the gene patent debate - a debate animated by policy concerns, only some of which are properly considered by the judiciary. After concluding that the decisions in Kubin and Myriad cannot be supported by the text of the Patent Act, I propose that, to the extent courts feel compelled to invalidate patents on natural products such as human genes, the scope of this prohibition should be limited by the patent policy implicit in the Constitution's Intellectual Property Clause - the advancement of technological progress. Under this approach, some policy concerns (such as encouraging research and maintaining the public domain) may properly be considered by the judiciary in shaping patent doctrine, while others (such as the morality of patenting nature and the implications of such patents for access to medical screening or treatment) must be left to the political branches.
Publication Year: 2011
Publication Date: 2011-04-29
Language: en
Type: article
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