On July 20, 2012, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in The Association for Molecular Pathology v. USPTO (Myriad). This important case considers whether isolated genes are patent eligible subject matter under 35 U.S.C. § 101 in view of the Supreme Court’s recent decision in Mayo v. Prometheus, which held a method applying an abstract idea through conventional and routine techniques was not patent eligible.
Myriad Genetics holds patents directed to isolated DNA encoding the BRCA1 gene and cancer screening methods based on identifying alterations in BRCA1. The Association for Molecular Pathology (AMP) and other plaintiffs sued the USPTO and Myriad, alleging isolated DNA is not patent eligible because it is a product of nature. The Federal Circuit held in a split decision that claims directed to isolated DNA and screening methods for potential cancer therapeutics are patentable subject matter. 653 F.3d 1329 (Fed. Cir. 2011). Judge Bryson’s dissent argued that an isolated gene is not different from a native gene and, like the extraction of a natural mineral, is not patent eligible.
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