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N C J Law Technol. 2014 Jun;15(4):597-637.


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William Rand Kenan, Jr. Professor at the University of North Carolina School of Law and an investigator in the Center for Genomics and Society at the University of North Carolina School of Medicine. A.B., Harvard; J.D., Ph.D., Duke.
Research professor of public policy studies, medicine, and biology at Duke University. AB, Harvard; MD, University of Colorado. He is funded in part by grant P50 HG 003391 from the National Human Genome Research Institute (NHGRI), FasterCures, and the Ewing Marion Kauffman Foundation.
Postdoctoral Research Fellow at the Center for Genomics and Society at the University of North Carolina School of Medicine. He received his Ph.D. in Neuroscience from New York University, his J.D. and Master of Bioethics from the University of Pennsylvania School of Law and Perelman School of Medicine, and his B.A. from the University of Puerto Rico.


Myriad Genetics' long-time monopoly on BRCA gene testing was significantly narrowed by the Supreme Court's decision in AMP v. Myriad Genetics, Inc., and will be further narrowed in the next few years as many of its still-valid patents expire. But these developments have not caused the company to acquiesce in competition. Instead, it has launched a litigation offensive against a number of actual and potential competitors, suing them for infringement of numerous unexpired patents that survived the Supreme Court case. A parallel strategy may have even greater long-term significance, however. In announcing expanded operations in Europe, Myriad has emphasized that it will rely less on patents and more on its huge proprietary database of genetic mutations and associated health outcomes-a strategy that could be used in the United States as well. Myriad has built that database over its many years as a patent-based monopolist in the BRCA testing field, and has not shared it with the medical community for more than a decade. Consequently, Myriad has a unique ability to interpret the health significance of patients' genetic mutations, particularly in the case of rare "variants of unknown significance." This article reviews the current state of Myriad's patent portfolio, describes its ongoing litigation offensive, and then analyzes its proprietary database strategy. The article argues that Myriad's strategy, while legally feasible, undercuts important values and objectives in medical research and health policy. The article identifies several ways in which the research and health care communities might fight back, but acknowledges that it will be a difficult uphill fight.


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