The concept of “patentable subject matter” (also known as section ‘101’ patentability) was addressed again by the Court of Appeals for the Federal Circuit (CAFC) last week. As you may recall from my earlier discussion of a Microsoft-related patent case, this legal requirement is really focused on whether the patent claims something that is too abstract to be patentable. In other words, while most of the examination focuses on whether a patent describes something novel, novelty is the second question, and the first question/early threshold of patentable subject matter (or “coarse filter” in the words of the CAFC) is really about whether an inventor is even entitled to an answer to the second question. While the impact of the Supreme Court’s vague opinion on the matter was being debated, the CAFC tried to help us by explaining that an invention is only too abstract to be patentable when it is “manifestly abstract” by issuing an opinion that essentially boils down to ‘unless the invention is so obviously abstract, don’t waste your time with 101 arguments.’
Now, in a case direct from the Supreme Court itself, the CAFC again rejects the high Court’s invitation to provide some teeth to the 101 analysis, instead flatly rejecting the suggestion that the act of “determining” levels of specific metabolites, with no recitation of how to determine anything, was an abstract idea or natural phenomenon. At issue also were claims involving “administering” a drug prior to the “determining” step, but the broader claims dealing only with the determination were also deemed to be patentable — which, again, is to say that validity of the patent should be measured based on its novelty (and various other statutory formalities).
In this case, the CAFC offered a little more support for its conclusion, and the phrases “manifestly abstract” or “coarse filter,” nor the RCT case itself are mentioned. Specifically, the CAFC pointed out that several methods for determining metabolite levels involve “transformations” (alluding to its prior opinion that the invention was patentable because it passed to Machine-or-Transformation test), despite the fact that the claim doesn’t require any particular method of making the determination. As with RCT, this case signals the CAFC’s strong preference to avoid a 101 analysis, and focus in on the other patentability requirements.
Hal Wegner assumes, rightly so, that this case is destined to go back to the Supreme Court. In fact, this case immediately debuted at #2 on his top ten cases to watch. However, if the CAFC reaches a similar conclusion in Classen v Biogen, the focus will again squarely be on the quality of the CAFC’s reasoning in these cases.
According to Mayo v. Prometheus Labs: Bilski and Medical Methods – Patent Law Blog (Patently-O), the CAFC’s opinion in Classen rejected the following claim:
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.
Breaking this method down, it really boils down to:
- injecting a “treatment group” with immunogens
- comparing the incidence, prevalence, frequency or severity of a disorder (related to the immunnogen) in the “treatment group” with a “control group.”
Where Prometheus dealt with determining levels of a specific metabolite, the Classen method is entirely open ended, but for the fact taht it deals with vaccines. In fact, its difficult to think of a way to test a vaccine that would not include these two steps. Originally, the CAFC struck down this patent for failing its MoT test, but a contrast of this patent with the one in Prometheus could help frame the debate at the Supreme Court.