Federal Circuit Invalidates Immunization Patent for lack of Patentable Subject Matter

Classen Immunotherapies v. Biogen IDEC (Fed. Cir. 2008)(Nonprecedential)

Judge Moore penned the one-paragraph Classen decision:

“In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they “transform[] a particular article into a different state or thing.” Bilski, 545 F.3d at 954. Therefore we affirm.”

Classen’s claims focus on several methods for evaluating vaccine immunization schedules. Claim 1 of patent 5,723,283 is reproduced below:

  1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises:

    immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and

    comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

The claims here are quite similar to those addressed in the ill-fated Metabolite Supreme Court case. That case was dismissed by the court prior to reaching a final decision based on procedural failures.

The question left in my mind is how the step of “immunizing mammals” is properly disqualified.


  • The panel consisted of Federal Circuit Judges Newman and Moore and District Court Judge Farnan sitting by designation from Delaware. Judge Farnan is a highly experienced patent law judge. The short opinion may well be the only consensus reached amongst the panel. I suspect that Judge Newman would write a much different “full” opinion on the case than would Judge Moore.
  • The accused infringers here include Biogen IDEC, GlaxoSmithKline, Merck & Co, Chiron, and others. I am surprised that these companies – which rely heavily on treatment method patents – would have argued strongly that the “immunizing” step was not sufficient to overcome