Your Genes Are Not Patent Eligible, But Your 'Isolated' Genes Are

In the trial court, Judge Robert Sweet of the Southern District of New York made headline news when he ruled (on summary judgment) that DNA sequences, isolated from the human genes associated with a predisposition for breast and ovarian cancer and used to diagnose mutations in those genes, were products of nature and, as such, not patentable subject matter under 35 U.S.C. ' 101. Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181 (S.D.N.Y. 2009). Judge Sweet's ruling ran counter to the almost three-decade-long policy of the USPTO. backing gene patents. Myriad appealed and a Federal Circuit panel, composed of Circuit Judges Alan D. Lourie, Kimberly A. Moore and William C. Bryson, affirmed in part and reversed in part the lower court. Ass'n for Molecular Pathology, 653 F.3d 1329 (Fed. Cir. 2011). Notably, the circuit court in a reversal of the trial court held that isolated DNA could be patentable. Both parties appealed and the Supreme Court granted certiorari, vacated and remanded the case back to the Federal Circuit for further consideration in light of its recent decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. __, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012).