Is it Patentable?
Two months ago, in In re Bilski, the Federal Circuit rejected the notion that anything that produces a "useful, concrete, and tangible result" is potentially patentable. Instead, to be patent-eligible, an idea must be "tied to a particular machine or apparatus," or it must "transform a particular article into a different state or thing." (To qualify for a patent, it also has to meet various other requirements, such as being novel.)
As to transformation, the court noted that not just any transformation will do. The transformation "must be central to the purpose of the claimed process," and the "articles" transformed must either be "physical objects or substances" or "representative of physical objects or substances."
Today, in a one-paragraph decision in Classen Immunotherapies, Inc. v. Biogen IDEC, the Federal Circuit put those words into practice:
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.
Here is a claim from one of the patents that was at issue:
- 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 claimed method is not tied to a particular machine or apparatus, but surely "immunizing mammals" transforms particular articles. Why, then, isn't this patent eligible?
The key is that the immunizing of the mammals is not "central to the purpose of the claimed process." While of course the mammals must be immunized in order for someone to ascertain whether the immunization schedule used is effective, that immunizing isn't the point of the claimed invention. Rather, the invention is directed to analyzing the results of the immunizing. The immunizing itself is (to borrow more language from Bilski) "insignificant extra-solution activity" or merely a "data-gathering step" that cannot convert the claim into patentable subject matter.
(As an aside, this decision was issued as a "non-precedential" ruling, which means the judges did not think it added significantly to the body of law. The Classen patents reminded many patent practitioners of the patent in Lab. Corp. of Am. v. Metabolite Labs., Inc. [pdf], the 2006 case where the U.S. Supreme Court agreed to consider the scope of patent eligibility, but then dismissed for technical reasons. Perhaps the Classen judges concluded that even if the legal issue was significant in 2006, post-Bilski it was an easy call.)
It's good to see that the Federal Circuit is taking steps to ensure that the Bilski machine-or-transformation test has teeth, and cannot be avoided by mere artful drafting.