Federal Circuit Reverses Course On Classen, Finds That Many Method Claims Satisfy 35 USC § 101, Safe Harbor Of 35 USC § 271(E)(1) Does Not Shelter Many Defendants

Author:Ms Courtenay Brinckerhoff, Stephen B. Maebius and Jacqueline D Wright Bonilla
Profession:Foley & Lardner

On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), on remand from the Supreme Court after Bilski v. Kappos (U.S. 2010). The Federal Circuit first decided Classen's appeal in 2008, when a panel comprised of Circuit Judges Newman and Moore and District Judge Farnan (sitting by designation) held in a one-paragraph, non-precedential decision authored by Judge Moore that Classen's claims do not satisfy 35 USC § 101. The second time around, the Federal Circuit (by a panel that included Chief Judge Rader in place of Judge Farnan) took a closer look at Classen's claims, and determined that two of the three Classen patents at issue indeed are directed to subject matter that is patent-eligible under 35 USC § 101. In this decision, the Federal Circuit has provided useful guidance for method claims that involve some type of information gathering. It appears that if the claims recite a step of "putting this knowledge to practical use," such as an active treatment step based on the information, they are likely to be patent-eligible under 35 USC § 101. On the other hand, if the claimed methods culminate in obtaining information, and nothing more, they may be vulnerable to challenge under 35 USC § 101.

Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader. Chief Judge Rader wrote a separate opinion to express "additional views," which was joined by Judge Newman. Judge Moore wrote a dissenting opinion.

Procedural Background

Classen asserted three patents against Merck and other defendants who participated in studies evaluating the risks associated with different vaccination schedules. The district court granted motions for summary judgment that the claims were invalid under 35 USC § 101 and not infringed because the alleged infringing activities were sheltered by the "safe harbor" of 35 USC § 271(e). The Federal Circuit originally upheld the district court on the § 101 issue. Classen sought and was granted certiorari by the Supreme Court, but the Court vacated and remanded to the Federal Circuit shortly after it issued its decision in Bilski v. Kappos. (See Foley's PharmaPatents Blog for a discussion of the Supreme Court's post-Bilski treatment of Classen at http://tinyurl.com/3zocr3s.) The Claims at Issue

The three Classen patents at issue (U.S. Patent 6,638,739; U.S. Patent 6,420,139; and U.S. Patent 5,723,283) are based on Dr. Classen's discovery that the particular schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders such as diabetes, asthma, hay fever, cancer, multiple sclerosis, and schizophrenia. The patents collectively include 230 claims, but Classen designated two representative claims for the district court's analysis.

Claim 1 of the '739 patent was designated as representative of the claims of both the '739 patent and the '139 patent, and recites:

  1. A method of immunizing a mammalian subject which comprises: (I) screening a plurality of immunization schedules . . . , by (a) identifying [first and second patient populations that were immunized with] . . . "infectious disease-causing organism-associated immunogens according to" ... [first and second immunization schedules] and (b) comparing the effectiveness of said first and second screened immunization...

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