Amy E. Sestric


On July 29, 2011, the United States Court of Appeals for the Federal Circuit upheld the validity of several controversial patents in Association for Molecular Pathology v. United States Patent and Trademark Office.' The patents, exclusively assigned to Myriad Genetics, Inc. (Myriad), claim two human genes fundamental to understanding, researching, and diagnosing common strains of familial breast and ovarian cancers. Patients expressed concern that Myriad's exclusivity over the two genes made diagnosis excessively expensive and precluded the availability of independent second opinion testing. Although the Supreme Court of the United States vacated and remanded the Federal Circuit's decision, the Federal Circuit issued an opinion that reaffirmed the validity of Myriad's gene patents on August 16, 2012. Despite the apparent finality of the Federal Circuit's decision, the law surrounding gene patents remains equivocal, and the American Civil Liberties Union (ACLU) recently petitioned the Supreme Court for certiorari. Myriad's patents will someday expire, but cancer patients need diagnosis and treatment immediately. Moreover, the progression of science will keep the legal issues surrounding gene patents alive for many years. In particular, patents on epigenetic information implicate many of the same legal issues as gene patents. Recent legislative solutions to problems in nonscientific realms of patent law illuminate possible methods of restructuring the patentability of human genes to better serve social concerns. Specifically, the legislation used to preempt the patentability of tax strategies provides an attractive alternative to the current law surrounding gene patents. Until Congress creates a new exception to patentability, however, courts will continue to struggle with the validity of human gene patents.

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