Ass’n for Molecular Pathology v. United States Patent and Trademark Office, 2011 U.S. App. LEXIS 15649 (Fed. Cir. July 29, 2011) (LOURIE, MOORE, concurring in part; BRYSON, concurring in part and dissenting in part) MyriadGenetics07292011.fc
Major issues: claims to isolated genes; claims to comparing gene sequences to detect cancer; Bilski; patent eligible subject matter
In a much-watched case, known generally by the name of the patent owner, Myriad Genetics, a Federal Circuit panel addressed Section 101 issues concerning claims to isolated DNA and to methods of screening for cancer by DNA testing. The panel also addressed the issue whether the plaintiffs, “an assortment of medical organizations, researchers, genetic counselors, and patients” had “standing under the Declaratory Judgment Act to challenge Myriad’s patents.”
On standing, the Federal Circuit held that “at least one plaintiff,” a doctor, had standing. On the merits, the majority distinguished between claims to isolated genes and screening by cell growth rates and claims to methods of comparing DNA sequences. The former but not the latter were for patent eligible subject matter.
Pertinent to this decision is the Supreme Courts June 20, 2011 grant of certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, CPLRG 0071 (Fed. Cir. 2010), which involves Section 101 issues on patent claims concerning medical diagnostics.
UPDATE: The Supreme Court reversed in the Prometheus case. See CPLR 0079. On March 26, 2012, the Supreme Court remanded the Myriad Genetics case. Thereafter, on August 16, 2012, the Federal Circuit, in a divided panel decision, affirmed its prior approach. Myriad2012.fc Thus, applying Mayo, the majority held that the “composition claims to `isolated” DNA molecules” did not “cover patent-ineligible products of nature under § 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter.” It also held that the “method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells” as not “directed to a patent-ineligible scientific principle.” However, it held that the “method claims directed to `comparing’ or `analyzing’ DNA sequences are patent ineligible” because the “claims include no transformative steps and cover only patent-ineligible abstract, mental steps.”