The district court held that medical organizations, researchers, genetic counselors, and patients had standing under the Declaratory Judgment Act to challenge patent claims to "isolated" DNA molecules and granted summary judgment that all of the challenged claims were drawn to non-patentable subject matter under 35 U.S.C. 101. On remand for consideration under Mayo Collaborative Services v. Prometheus, Inc., 132 S. Ct. 1289 (2012), the Federal Circuit affirmed with respect to standing and reversed, in part, on the merits. The court reversed a holding that composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under section 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter. The court also reversed a holding that a method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle. The court affirmed that method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.
