The Federal Circuit issued a non-precedential opinion today in Classen Immunotherapies, Inc. v. Biogen IDEC. The Federal Circuit affirmed the invalidity of U.S. Patent No. 5,723,283 as containing unpatentable subject matter. The entire opinion is recited here:
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.
Claim 1 of the ‘283 patent states:
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.
This claim is eerily similar to the claim at issue in LabCorp v. Metabolite Labs, dismissed by the Supreme Court on procedural grounds without decision. Three justices filed a dissent in that case, arguing that the claims were directed to non-patentable subject matter and should be invalid. Claim 13 of U.S. Patent No. 4,940,658 states:
A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
The Federal Circuit had affirmed a ruling in the LabCorp case that claim 13 was valid and infringed. Apparently, Bilski has changed all of that.
Dennis Crouch of Patently-O noted: “The question left in my mind is how the step of ‘immunizing mammals’ is properly disqualified.” The Federal Circuit did not tell us much in its 70 word Classen opinion, so maybe we have to look at the voluminous Bilski opinion, where it provided some possible guidance to this question when it addressed what it characterized as “post-solution” activity.
The Diehr Court also reaffirmed a second corollary to the machine-or-transformation test by stating that “insignificant postsolution activity will not transform an unpatentable principle into a patentable process.”
In footnote 14 of Bilski , the Federal Circuit cites In re Grams, 888 F.2d 835, 839-40 (Fed. Cir. 1989) as holding a pre-solution step of gathering data incapable of imparting patent-eligibility under § 101. Thus, the corollary regarding post-solution activity would also apply pre-solution.
It may be that the Federal Circuit characterizes the “immunization” step in claim 1 of the ‘283 patent as “insignificant pre-solution activity” and thus would not affect the patentability of the claim. If this is true, it would be nice if they would provide a bit more explanation, perhaps in the form of a precedential opinion.