Myriad Decision Offers Mixed Bag for Biotech: Biopharmaceutical Claims Likely to Survive, but Outcome for Diagnostic Methods and Methods-of-Screening Claims Is Less Certain

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On March 29, the United States District Court for the Southern District of New York issued its longawaited decision in Association for Molecular Pathology v. United States Patent and Trademark Office (Myriad). The decision on summary judgment, if affirmed on appeal by the Federal Circuit, could significantly impact the patentability of certain types of patent claims in biotechnology.

The Myriad case pitted various not-for-profit clinical medicine and breast cancer organizations, academics, and patients diagnosed with breast cancer against the United States Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation. At issue were 15 claims in 7 Utah patents that are exclusively licensed to Myriad and under which Myriad provides breast and ovarian cancer screening tests.

There were three classes of claims. The first were composition claims: isolated DNAs (breast cancer susceptibility genes (BRCA)). The others were method claims: methods of analyzing a BRCA gene from a human sample, often by comparing that gene with Myriad’s wild-type BRCA gene, and cell-based methods of screening compounds to identify those potentially useful in treating cancers related to mutations in the BRCA genes. Judge Sweet held all three classes of claims invalid for the same reason. They were, in his view, directed to non-patentable subject matter.

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