On Monday, March 26, 2012, the U.S. Supreme Court sent the Myriad gene patent case back to the Federal Circuit in light of its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 US ____ (2012). The prior Federal Circuit decision, issued by a divided panel in July of 2011, generally upheld the patentability of genes and genetic methods. Late last year, a petition for certiorari was filed before the Supreme Court. Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011), petition for cert. filed sub nom, Ass’n for Molecular Pathology v. Myriad Genetics, Inc. (Dec. 7, 2011) No. 11-725. Monday’s decision granted certiorari and summarily vacated that prior decision, remanding the case back to the Federal Circuit for further consideration in light of Prometheus.

The patent claims at issue in the Myriad case fall into three general categories: 1) compositions of isolated DNA; 2) methods of screening for potential cancer therapeutics; and 3) diagnostic methods, generally relating to identifying potential genetic alterations in the BRCA1 ‘breast cancer gene;’ the methods directed to analyzing human samples for the presence of certain mutations, or comparing human tumor samples against non-tumor samples for the presence of alterations.