Federal Circuit Reaffirms the Patentability of Isolated DNA in Association for Molecular Pathology v. Myriad

On August 16, 2012, the U.S. Court of Appeals for the Federal Circuit issued another split decision in Association for Molecular Pathology v. Myriad Genetics, No. 2010-1406 (Myriad). Each of the three categories of claims under review in Myriad revolved around the discovery that certain mutations in the BRCA1 and BRCA2 genes correlate with an increased risk of breast and ovarian cancers.

Myriad arose from an appeal of a decision of the United States District Court for the Southern District of New York holding that Myriad’s patent claims to isolated BRCA1 and BRCA2 genes and to screening for potential cancer therapeutics via changes to growth rates of transformed cells were not patent eligible under 35 U.S.C. § 101. In addition, Myriad’s claims to methods of “analyzing” or “comparing” a patient’s BRCA sequence for detecting the presence of cancer-predisposing mutations were also held by the District Court to be patent-ineligible. After the Federal Circuit’s decision last year and a further appeal to the U.S. Supreme Court, the Supreme Court remanded the case back to the Federal Circuit for reconsideration in view of the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. 132 S. Ct. 1289 (2012) (Prometheus). In Prometheus, the Court held that claims directed to a method of optimizing 6-thioguanine therapy for treating an immune-mediated gastrointestinal disorder were patent ineligible under 35 U.S.C. § 101.

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