Majority Holds § 101 Does Not Exclude Claims Directed To A Specific, Tangible Application; Judge Moore Finds Majority's Analysis Incomplete

This article previously appeared in Last Month at the Federal Circuit, September 2011

Judges: Rader (additional views, in which Judge Newman joins), Newman (author), Moore (dissenting)

[Appealed from D. Md., Judge Quarles]

In Classen Immunotherapies, Inc. v. Biogen IDEC, Nos. 06-1634, -1649 (Fed. Cir. Aug. 31, 2001), the Federal Circuit, on remand from the Supreme Court, held that two patents contain patentable subject matter under 35 U.S.C. § 101 but that a third patent does not. The Court also affirmed a grant of SJ of noninfringement, but declined to review the denial of a motion for SJ of anticipation under 35 U.S.C. § 102. Finally, the Court concluded that the safe harbor provision of 35 U.S.C. § 271(e)(1) did not protect the accused infringers' activities.

Classen Immunotherapies, Inc. ("Classen") holds three related patents related to its inventor's thesis that the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders, and that immunization should be conducted on the schedule that presents the lowest risk with respect to such disorders. Two of Classen's patents, U.S. Patent Nos. 6,638,739 ("the '739 patent") and 6,420,139 ("the '139 patent"), are directed to a method whereby information on immunization schedules and the occurrence of chronic disease is "screened" and "compared," the lower risk schedule is "identified," and the vaccine is "administered" on that lower risk schedule. Slip op. at 5. The third Classen patent-at-issue, U.S. Patent No. 5,723,283 ("the '283 patent"), is directed to a method involving immunizing mammals in a treatment group according to one schedule and comparing the outcomes to the outcomes associated with a control group. Of the three patents, only the '283 patent does not include performing immunizations in accordance with the information learned by the claimed method.

In an earlier nonprecedential opinion issued before the Supreme Court's decision in Bilski v. Kappos, 561 U.S. __, 130 S. Ct. 3218 (2010), a panel consisting of Judge Newman, Judge Moore (author), and District Judge Farnan (sitting by designation) found all three Classen patents ineligible under § 101 due to their failure to satisfy the machine-or-transformation test. After the Supreme Court issued its Bilski decision, it granted Classen's petition for certiorari, vacated the Federal Circuit's decision, and remanded the case for reconsideration in light of the guidance...