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Majority Holds § 101 Does Not Exclude Claims Directed to a Specific, Tangible Application; Judge Moore Finds Majority’s Analysis Incomplete

August 31, 2011

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Last Month at the Federal Circuit - September 2011

Judges: Rader (additional views, in which Judge Newman joins), Newman (author), Moore (dissenting)

[Appealed from: D. Md., Judge Quarles]

In Classen Immunotherapies, Inc. v. Biogen IDEC, Nos. 06-1634, -1649 (Fed. Cir. Aug. 31, 2001), the Federal Circuit, on remand from the Supreme Court, held that two patents contain patentable subject matter under 35 U.S.C. § 101 but that a third patent does not. The Court also affirmed a grant of SJ of noninfringement, but declined to review the denial of a motion for SJ of anticipation under 35 U.S.C. § 102. Finally, the Court concluded that the safe harbor provision of 35 U.S.C. § 271(e)(1) did not protect the accused infringers’ activities.

Classen Immunotherapies, Inc. (“Classen”) holds three related patents related to its inventor’s thesis that the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders, and that immunization should be conducted on the schedule that presents the lowest risk with respect to such disorders. Two of Classen’s patents, U.S. Patent Nos. 6,638,739 (“the ’739 patent”) and 6,420,139 (“the ’139 patent”), are directed to a method whereby information on immunization schedules and the occurrence of chronic disease is “screened” and “compared,” the lower risk schedule is “identified,” and the vaccine is “administered” on that lower risk schedule. Slip op. at 5. The third Classen patent-at-issue, U.S. Patent No. 5,723,283 (“the ’283 patent”), is directed to a method involving immunizing mammals in a treatment group according to one schedule and comparing the outcomes to the outcomes associated with a control group. Of the three patents, only the ’283 patent does not include performing immunizations in accordance with the information learned by the claimed method.

In an earlier nonprecedential opinion issued before the Supreme Court’s decision in Bilski v. Kappos, 561 U.S. __, 130 S. Ct. 3218 (2010), a panel consisting of Judge Newman, Judge Moore (author), and District Judge Farnan (sitting by designation) found all three Classen patents ineligible under § 101 due to their failure to satisfy the machine-or-transformation test. After the Supreme Court issued its Bilski decision, it granted Classen’s petition for certiorari, vacated the Federal Circuit’s decision, and remanded the case for reconsideration in light of the guidance given in Bilski.

The Federal Circuit on remand characterized the Supreme Court’s Bilski decision as encouraging the “preservation of the legal and practical distinctions between the threshold inquiry of patent-eligibility, and the substantive conditions of patentability.” Slip op. at 14. The Federal Circuit explained that the Supreme Court “recognized the separation of the §101 ‘categories’ of eligible subject matter from the §102 ‘conditions’ of patentability.” Id. at 15.

Applying this distinction to the Classen patents, the Federal Circuit first reviewed the district court’s finding that none of the three patents meets the § 101 threshold because the method claimed in the three patents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule. The Court noted that “the presence of a mental step is not of itself fatal to §101 eligibility, and that the ‘infinite variety’ of mental and physical activity negates application of a rigid rule of ineligibility.” Id. The Court analogized to its recent decision in Research Corp. Technologies, Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010), a case in which the Court concluded that a method was “functional and palpable,” and, therefore, the method claims at issue recited “tangible limitations on performing the specified method of comparing images.” Slip op. at 17. Further citing Research Corp., the Court explained that “the preferable procedure, when the claims are within the general classes of §101 subject matter and not manifestly abstract, is to apply the substantive conditions and requirements of patentability.” Id. at 18.

Observing that “the commercial application of the technology is relevant to deciding whether an invention is so abstract as to negate §101 subject matter,” the Court found that the ’139 and ’739 patents “are directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization on the determined schedule,” and are therefore “directed to a specific, tangible application.” Id.

Because the ’283 patent lacks the step of immunization on an optimal schedule, a step required in both the ’139 and ’739 patents, the Federal Circuit found that the ’283 patent involved only collecting and comparing known information. Without applying the data in a step of the overall method, the ’283 patent failed to qualify for patent eligibility under § 101. The Court found that the ’283 patent claims invite a reader to review existing knowledge; they “do not include putting this knowledge to practical use, but are directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases.” Id. at 21. “In contrast, the claims of the ’139 and ’739 patents require the further act of immunization on accordance with a lower-risk schedule, thus moving from abstract scientific principle to specific application.” Id.

In addition to the Court’s determinations regarding § 101, the Court declined to review the district court’s denial of SJ of invalidity based on anticipation. Stating that there was no record, no factual findings, and no basis for factual inferences, the Court declined to rule on the anticipation question in view of its general rule that a party may not appeal the denial of an SJ motion.

The Federal Circuit next affirmed the district court’s grant of accused infringer Merck & Co., Inc.’s (“Merck”) motion for SJ of noninfringement. The Court agreed with the district court that Classen’s complaint alleged infringement by Merck based on Merck’s participation or facilitation of a particular study, and Classen could not prove its infringement allegations where Merck presented uncontroverted evidence that it had no involvement in that study. The Court also affirmed the district court’s rejection of untimely motions filed by other accused infringers for SJ on the same grounds as Merck, finding the district court acted within its discretion.

Finally, addressing arguments regarding the safe harbor provision of 35 U.S.C. § 271(e)(1), the Federal Circuit found that the statute provided no protection for the activities of accused infringers Biogen IDEC and GlaxoSmithKline. The Court explained that the statute provides safe harbor for the use of 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 . . . . ” Id. at 26 (quoting 35 U.S.C. § 271(e)(1)). Interpreting the statute in view of the legislative history, the Court found that the safe harbor provision was intended to protect the expedited development of information for regulatory approval of generic counterparts of patented products. Thus, the Court concluded that the safe harbor provision does not apply to information that is routinely reported to the FDA after marketing approval has already been obtained, such as the reporting by the accused infringers of vaccine relationships, recommendations in view of relevant literature, adverse vaccine effects, or other regulation-required information to the FDA.

Judge Moore, the author of the first Classen opinion finding the three patents subject matter ineligible under the machine-or-transformation test, dissented with the majority opinion here, authored by Judge Newman, who also was a member of the earlier Classen panel. In Judge Moore’s view, the claims at issue are to a fundamental scientific principle that is too basic and fundamental to be patentable. Comparing the method claimed in the Classen patents to the claimed method in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 1350 (Fed. Cir. 2010), cert. granted, __ S. Ct. __ (June 20, 2011), Judge Moore would have found all three patents subject matter ineligible under 35 U.S.C. § 101. According to Judge Moore, in Prometheus, the Federal Circuit concluded that administering drugs transforms the human body, but that the Prometheus court did not end its analysis there. Rather, the Prometheus court concluded that the transformative steps in the claims were not merely data-gathering steps or insignificant postsolution activity and that the claims recite specific treatment steps with specific drugs. Judge Moore found no such analysis in the majority opinion with regard to the Classen patents. Moreover, Judge Moore found no consideration of the extent of preemption by “these staggeringly broad and abstract claims.” Moore Dissent at 3.

Judge Moore would also have affirmed the district court’s denial of Merck’s motion for SJ of anticipation, interpreted the safe harbor provision of § 271(e)(1) more broadly to include both preapproval and postapproval uses of patented inventions, and found that accused infringers Biogen IDEC and GlaxoSmithKline were not entirely protected by the safe harbor because some of the activities accused of infringement did not reasonably relate to the development and submission of data to the FDA.

In addition to joining the majority opinion, Chief Judge Rader filed “additional views,” joined by Judge Newman, expressing the view that the Federal Circuit should decline to accept invitations to restrict subject matter eligibility despite a rising number of challenges under 35 U.S.C. § 101. Judge Rader explained two unintended consequences of § 101 restrictions. First, patent claim drafters devise new ways to write claims to avoid judicially imposed restrictions, such as the Beauregard claim. This “game where lawyers learn ingenious ways to recast technology” makes the doctrine hollow, increases the costs of prosecution, and harms naïve inventors who draft claims poorly. Rader Additional Views at 4. Second, Judge Rader explained that restrictions on subject matter patentability could drive innovation outside the United States.

Summary authored by John S. Sieman, Esq.