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Federal Circuits Prometheus Decision Reaffirms Patentability of Methods of Treatment

December 21, 2010

By Bruce M. Wexler & Christine Willgoos

On December 17, 2010, The U.S. Court of Appeals for the Federal Circuit decided Prometheus Laboratories, Inc. v. Mayo Collaborative Services, et al., on remand from the Supreme Court. See No. 2008-1403 (Fed. Cir. Dec. 17, 2010). Read the decision here.

The Federal Circuit held that Prometheus's patents claiming methods for determining the optimal dosages of thiopurine drugs to treat certain diseases were directed to statutory subject matter pursuant to 35 U.S.C. § 101. The Court reversed and remanded the district court's grant of summary judgment of invalidity under § 101.

The Court's decision followed Supreme Court precedent in interpreting § 101 as broadly encompassing "any new and useful process, machine, manufacture or composition of matter." See 35 U.S.C. § 101. The Court reaffirmed the propriety of the "machine-or-transformation" test as one means by which to determine statutory subject matter under § 101 in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010). Notably, the Court held that Prometheus's asserted claims "are in effect claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition." See Prometheus, slip op. at 17.