The Federal Circuit has, in a nonprecedential opinion issued today in Classen Immunotherapies v. Biogen Idec, affirmed the invalidity of U.S. Patent No. 5,723,283 on patentable-subject-matter grounds.  (Dennis Crouch quotes the one-paragraph opinion, and Claim 1 of the ‘283 patent, here.)

The Classen ruling puts it all on the Bilski case.  Bilski, recall, states as follows:

The machine-or-transformation test is a two-branched inquiry; an applicant may show that a process claim satisfies § 101 either by showing that his claim is tied to a particular machine, or by showing that his claim transforms an article. See Benson, 409 U.S. at 70. Certain considerations are applicable to analysis under either branch. First, as illustrated by Benson . . . the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility. See Benson, 409 U.S. at 71-72. Second, the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity. See Flook, 437 U.S. at 590.

In re Bilski, 545 F.3d 943, 961-62 (Fed. Cir. 2008).

What’s intriguing about Classen is that it doesn’t appear to rely on the more general considerations stated in Bilski, i.e., the need for “meaningful limits on the claim’s scope” and the derogation of “insignificant extra-solution activity.”  Of course, Classen is highly compressed, clocking in at a total of 68 words (including words in citations), so I may wrong about this.  But here’s the (one and only) sentence providing the court’s rationale:

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.”

(Quoting Bilski.)

At first blush, however, Classen Claim 1 does appear to recite a transformation of a physical article – namely, a mammal (actually, more than one), which the process takes from an unimmunized to an immunized state:

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.

It would appear, then, that the Federal Circuit doesn’t view the mammal recitation in Classen Claim 1 to be a transformed article or a machine.

If I’m right about the Federal Circuit’s view, I think there’s some tension between Bilski & Classen, on the one hand, and the Supreme Court’s decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), on the other hand.  Chakrabarty holds that a genetically modified bacterium is a patentable “manufacture” or “composition of matter” under section 101.  Classen appears to imply that something – namely, a mammal – could be a manufacture under section 101, and at the same time not the sort of article a transformation in which renders a method patentable under section 101.

Of course, one could counter that I’m eliding – improperly – an important difference between the single-cell bacterium in Chakrabarty and the much more complex, higher life form recited in Classen.  Is it possible, for example, to hold that a genetically modified bacterium is a manufacture for section 101 purposes but that a genetically modified mammal is not a manufacture for section 101 purposes?  Of course!  Indeed, the Supreme Court of Canada did just that in the 2002 Harvard College case rejecting the patentability, in Canada, of the Harvard oncomouse.  Interestingly, the patentable subject matter statute in Canada is copied from our own 1793 Patent Act and uses the same terms, “manufacture” and “composition of matter.”

Perhaps patentee Classen Immunotherapies will seek certiorari on the ground that the Federal Circuit’s rejection of the method claim can’t be squared with Chakrabarty’s holding that a genetically modified bacterium is a manufacture . . .