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Federal Circuit Finds Claims Directed to DNA Primers and Methods of Use Unpatentable

By Veronica Mullally Munoz

The Federal Circuit's decision in Univ. of Utah Research Found. v. Ambry Genetics Corp., 2014-1361, -1366 (Fed. Cir. Dec. 17, 2014) is the latest in the series of Myriad cases dealing with the patentability of genetic material. The U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013), held that claims drawn to isolated DNA were patent-ineligible subject matter. Ambry Genetics (Ambry) began offering BRCA1 and BRCA2 diagnostic testing kits following that decision. In July 2013, Myriad Genetics, the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development LP, and Endorecherche, Inc. (collectively “Myriad” hereinafter) sought to, inter alia , enjoin Ambry and asserted infringement of six claims (from three patents) that had not previously been considered by the Federal Circuit or the Supreme Court. The Utah District Court denied Myriad's motion for a preliminary injunction and the Federal Circuit panel, Prost, Clevenger and Dyk affirmed. Circuit Judge Dyk delivered the opinion of the court.

The four composition of matter claims on appeal are directed to primers which are short, synthetic, single-stranded DNA molecules that bind complimentary target DNA and enable synthesis of DNA having all or part of the sequence of a BRCA gene in a DNA polymerase chain reaction (PCR). The two method claims on appeal involve comparison of wild-type BRCA gene sequences with the patient's BRCA gene sequence. The lower court held all six claims patent ineligible as claiming naturally occurring DNA sequences and/or abstract ideas.

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