Client Alert

Federal Circuit Reaffirms Patentability of Isolated DNA Molecules in View of Supreme Courts Mayo v. Prometheus Decision

August 17, 2012


On August 16, 2012, the U.S. Court of Appeals for the Federal Circuit decided Assn for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406, on remand from the Supreme Court to consider the impact of Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012). As explained below, the Federal Circuits ruling largely aligns with the same panels previously vacated July 29, 2011 decision.

On the threshold issue of jurisdiction, the Court reaffirmed the district courts decision to exercise declaratory judgment jurisdiction because at least one Plaintiff had an intention to actually and immediately engage in allegedly infringing activities.

On the merits, the Court once again held albeit in a fractured analysis that Myriads composition claims directed to isolated DNA molecules, whether limited to cDNAs or not, are patent-eligible subject matter under 35 U.S.C. § 101. Thus, the Court reversed the district courts grant of summary judgment of invalidity under § 101. The Court also reversed the district courts conclusion that Myriads claimed method of screening potential cancer therapeutics is not patent-eligible subject matter because that method involves the creation of transformed host cells. The Court, however, affirmed the district courts decision that Myriads method claims directed to comparing and analyzing DNA sequences are patent ineligible because similar claims were held to be unpatentable in Mayo.

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