In Classen Immunotherapies, Inc. v. Biogen IDEC, Circuit Judge Moore dissented to just about everything:
I believe that the claims at issue are to a fundamental scientific principle so basic and abstract as to be unpatentable subject matter and therefore I would affirm the district court’s grant of summary judgment of invalidity under § 101…. I also dissent from the majority’s refusal to reach Merck’s appeal of the denial of its motion for summary judgment of anticipation. … Finally, I dissent from the majority’s analysis of infringement and its construction of the safe harbor provision under § 271(e)(1).
Ouch. Not really ambivalent.
Moore expressed dismay that the majority concluded that the ’283 patent claims are not directed to patentable subject matter, but that the claims of the ’139 and ’739 patents are directed to patentable subject matter.
The majority opinion:
“The representative claim of the ‘283 patent is directed to the single step of reviewing the effects of known immunization schedule, as shown in the relevant literature.”
Ummmm…no. Did you read the independent claim in the ’283 patent?
Claim 1 of the ’283 patent was designated as representative:
1. A method …, which comprises immunizing mammals …, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker…
This claim requires two steps: (1) immunizing a group of mammals according to a schedule and then (2) comparing the incidence of chronic immune mediated disorder in the group to a control group.
I am perplexed by the majority’s suggestion that this claim “is directed to the single step of reviewing the effects of known immunization schedules,” Maj. Op. at 20, as the claim clearly requires immunizing mammals and then comparing the results to the known group.
Claim 1 of the ’739 patent requires two steps: (1) compare the incidence of chronic immune mediated disease in two groups of mammals who were immunized according to different schedules and then (2) immunize a mammal according to the lower risk schedule. There is virtually no difference between these two claims for the purposes of our § 101 analysis. One involves immunizing and then comparing (’283 patent); the other comparing then immunizing (’739 patent).
While I confess the precise line to be drawn between patentable subject matter and abstract idea is quite elusive, at least for me, this case is not even close. In the ’283 patent, Classen claims the scientific method as applied to the field of immunization. No limitations exist on the type of drug to immunize with, the schedules that should be used for the immunization, the type of chronic immune disorder to look for, or any limitation on the control group. It is hard to imagine broader claims. It is harder to imagine a more conceptually abstract claim in the immunization area.
The real problem with the Classen decision is that we are left without a good understanding of the test for determining patentability under § 101:
I do not understand the distinction that the majority draws between claim 1 of the ’283 patent and claim 1 of the ’739 patent. Nor do I understand the test the majority proposes for determining patentability under § 101.
Citing Research Corp. Technologies v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010), the majority holds that if the specified method is “functional and palpable,” the claims are drawn to statutory subject matter. Maj. Op. at 17. How do we determine whether any given method or claim is “functional” or “palpable?” Is this a return to the rejected notions of “useful, concrete, and tangible?”
Warren Woessner of Patents4Life viewed the discrepancy thusly:
At best, this is a complete misreading of claim 1 of the ‘283 patent, which should be corrected by issuance of a revised opinion. At worst, it suggests acceptance of the Metabolite dissent, and a bleak future for diagnostic claims that correlate the level of a marker to the presence of a pathology, without reciting a treatment step.
The majority’s construction is contrary to the plain language of the statute and Supreme Court precedent. The statute broadly recites that “[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .” 35 U.S.C. § 271(e)(1). Nowhere does the statute limit the safe harbor to pre-approval uses.