The Supreme Court's Myriad Effects on Scientific Research: Definitional Fluidity and the Legal Construction of Nature
5 U.C. Irvine Law Review, 2015, Forthcoming
39 Pages Posted: 31 May 2015 Last revised: 11 Mar 2016
Date Written: May 29, 2015
This article examines the implications for biomedical research of the Supreme Court’s ruling in Association for Molecular Pathology v. Myriad Genetics that isolated DNA does not comprise patentable subject matter but that complementary DNA (cDNA) does. Although most of the commentary surrounding this case has focused on the availability of genetic diagnostic tests, this Article considers the related and important implications of this opinion for scientific research. At the outset, it argues that this issue is beset with definitional complexity, as it is often difficult to disentangle “commercial” from “research” uses of patented genes. This Article further argues that context matters significantly in assessing the impact of the Court’s ruling on research. Accordingly, this Article examines the implications of Myriad Genetics from three perspectives. First, considering the conduct of Myriad Genetics itself, it argues that the Supreme Court’s decision creates greater real and perceived freedom to operate for uses of BRCA genes that may yield important scientific insights. Second, reviewing the literature on gene patents and anticommons, this Article argues that the Court’s ruling will help enhance access to diagnostic testing more generally, thus advancing biomedical research. Third, at a doctrinal level, this Article suggests that Myriad Genetics may have significant long-term implications. The Court’s opinion reflects a strong policy interest in excluding “nature” from patentable subject matter as well as a high degree of discretion in determining the contours of nature for that purpose. Such a policy-oriented, pragmatic approach to patent eligibility may create significant flexibility to challenge patents in research contexts going forward.
Keywords: Patents, patent law, intellectual property, scientific research, gene patents, biomedical research, Supreme Court, Myriad Genetics, patentable subject matter, physical phenomena, DNA, isolated DNA, cDNA
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