Once the Supreme Court issued its opinion in Mayo Collaborative Services v. Prometheus Laboratories, Inc., __ U.S. __ (March 20, 2012) (“Prometheus”), many commentators believed the fate of the petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, et al. (“Myriad”) was sealed. Today, the Supreme Court confirmed that assumption by granting certiorari in Myriad, vacating the Federal Circuit’s decision and remanding the case for further consideration in light of its decision in Prometheus.

BACKGROUND

At issue in Myriad are both composition claims directed to isolated DNA sequences, specifically the BRCA-1 and BRCA-2 genes, and method claims directed to screening for the presence of mutations in those genes. In a 2-1 decision, the Federal Circuit concluded that the isolated genes were patentable subject matter under 35 USC § 101. [See our previous client alert here.] The court held that because the isolated DNA molecules are chemically cleaved from native DNA, they have “markedly different” characteristics and therefore do not fall within the “products of nature” exception to § 101. The Federal Circuit also held that all but one of Myriad’s method claims were unpatentable, rejecting the method claims that cover simply “analyzing” or “comparing” a patient’s BRCA sequence with a normal one to determine whether cancer-predisposing mutations exist. The court also examined whether the coalition of groups and individuals bringing suit against Myriad had standing to bring a declaratory judgment action and found that only Dr. Ostrer, a researcher at New York University, had standing, because he was ready, willing, and able to perform BRCA1/2 screening in the event Myriad’s claims were invalidated.