The district court’s holding of ineligibility for patenting under §101 is reversed as to the claims of the ’139 and ’739 patents, and affirmed as to the ’283 patent. The judgment of non-infringement is affirmed as to Merck, and is vacated as to Biogen and GlaxoSmithKline insofar as based on §271(e)(1).
Of history in the case:
On the initial appeal of that ruling, this court applied its en banc decision of In re Bilski, 545 F.3d 943 (Fed. Cir. 2008), held that the Classen methods are not associated with a machine and do not transform matter, and affirmed the district court’s holding of ineligibility under §101 on that ground. Now upon the Supreme Court’s ruling in Bilski v. Kappos that the machine-or-transformation test is not the sole standard of eligibility for patenting, we again review the district court’s decision, with the benefit of this court’s analyses of eligibility in Research Corporation Technolo- gies, Inc. v. Microsoft Corporation, 627 F.3d 859 (Fed. Cir. 2010); Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, _ S. Ct. _ , 2011 WL 973139 (June 20, 2011); and Associa- tion for Molecular Pathology v. U.S. Patent & Trademark Office, _ F.3d _, 2011 WL 3211513 (Fed. Cir. July 29, 2011).
Of mental steps:
The district court held that none of the Classen claims meets the threshold under §101 of eligibility for patent- ing, reasoning that the method claimed in all three pat- ents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule. The district court did not discuss whether the claims were anticipated or obvious in view of the prior art, and it appears that this aspect was not raised, in the district court, in the context of §101. However, precedent has recognized that the presence of a mental step is not of itself fatal to §101 eligibility, and that the “infinite vari- ety” of mental and physical activity negates application of a rigid rule of ineligibility. See Application of Prater, 415 F.2d 1393, 1402 n.22 (CCPA 1969).
Of permissive approach:
The distinction between a concrete, physical step of a process claim, as compared with data gathering or insig- nificant extra-solution activity, warrants specific consid- eration in the context of evolving technologies, for “Congress took [a] permissive approach to patent eligibil- ity to ensure that ‘ingenuity should receive a liberal encouragement.’” Bilski, 130 S. Ct. at 3225 (quoting Chakrabarty, 447 U.S. at 308, in turn quoting Thomas Jefferson). The Bilski Court emphasized the “expansive terms” of §101 as evidence of the intent “that the patent laws would be given wide scope,” id. (quoting Chakra- barty, 447 U.S. at 308). Thus the Court rejected the Federal Circuit’s proposal in Bilski that the “machine-or- transformation” test should be the exclusive test for patent-eligible processes, and emphasized the classical “three specific exceptions to §101’s broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas.’” Id. (quoting Chakrabarty, 447 U.S. at 309). The Court reaffirmed the proposition that “the prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of [a] formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’” Id. at 3230 (quoting Diehr, 450 U.S. at 191-92).
The dissent argues that there is “no distinction” between the claims of the ’283 patent and the claims of the ’139 and ’739 patents. The patents, which were separately filed after the patent examiner required restriction because “the inventions are distinct,” distinguish the ’283 method where, according to Classen, a person simply reviews known knowledge on immunization effects, from the ’139/’739 methods that require physical immunization based on that review. Even if the question as to the ’139 and ’739 patents were deemed to be close, the ’139/’739 method of immunizing on the low-risk schedule determined by the ’283 method of reading the literature, may be generously viewed as traversing the boundary into eligibility for substantive review.
All three Classen patents contain claims whose breadth is not of “staggering” character. Our holding is not that any claim is “patentable,” whatever its breadth, but that the claims are eligible at the threshold for review for substantive patentability.
And, we have the maxim: that which infringes if later anticipates if earlier-->
Merck states that Classen’s claims are anticipated by the prior use of that schedule, for “that which infringes if later anticipates if earlier,” Polaroid Corp. v. Eastman Kodak Co., 789 F.2d 1556, 1573 (Fed. Cir. 1986) (quoting Peters v. Active Mfg. Co., 129 U.S. 530, 537 (1889)).
the general rule that the denial of a summary judgment motion is not appealable. Kendall v. City of Chesapeake, Va., 174 F.3d 437, 443-44 (4th Cir. 1999).
Chief Judge Rader added some "additional views" which began:
In the last several years, this court has confronted a rising number of challenges under 35 U.S.C. § 101. The language of § 101 is very broad. Nevertheless, litigants continue to urge this court to impose limitations not present in the statute. Subject matter eligibility under section 101 has become the “substantive due process” of patent law – except that reading non-procedural require- ments into the constitutional word “process” has more historical and contextual support than reading abstract- ness into the statutory word “process” because Title 35 already contains ample protections against vague claims. See 35 U.S.C. § 112. Indeed it is difficult to “invent” any category of subject matter that does not fit within the four classes acknowledged by Title 35: process, machine, [article of] manufacture, or composition of matter. This court should decline to accept invitations to restrict subject matter eligibility. In order to highlight some public policy reasons that the statute places few, if any, limits on subject matter eligibility, these additional views are offered.
Judge Moore dissented:
Respectfully, I must dissent from the majority opinion on several grounds. 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. Classen claimed a monopoly over the scientific method itself. I also dissent from the majority’s refusal to reach Merck’s appeal of the denial of its motion for summary judgment of anticipation. Instead, I would affirm because the district court properly concluded that summary judgment was improper where Merck failed to offer any proof that its prior use included one of the claim elements. Finally, I dissent from the majority’s analysis of infringe- ment and its construction of the safe harbor provision under § 271(e)(1) which is contrary to the plain language of the statute and clear Supreme Court guidance.