Administering the post-Bilski standard for analyzing whether subject matter is eligible for patenting under 35 U.S.C. §101, the U.S. Court of Appeals for the Federal Circuit reversed-in-part its prior holding that three patents were not eligible.  Classen Immunotherapies, Inc. v. Biogen Idec, et al., Case Nos. 2006-1634, -1649 (Fed. Cir., Aug. 31, 2011) (Newman, J.) (Rader, J., providing additional views) (Moore, J., dissenting).

The three patents at-issue, U.S. Patent Nos. 6,638,739 (the ’739 patent”), 6,420,139 (the’139 patent”) and 5,723,283 (the ’283 patent), have claims of similar scope, all of which were directed to a method of immunizing mammals.  The ’739 and ’139 patent claims required two steps, the first being screening a plurality of immunization schedules and comparing between different immunization schedules and the second being immunizing according to an immunization schedule.  The claims of the ’283 patent only required the first step.  In other words, the immunizing in the ’283 patent refers to the gathering of published data, while the immunizing of the ’139 and ’739 patents is the physical implementation of the mental step claimed in the ’283 patent.

On appeal, the Federal Circuit reinforced the notion that the role of §101 is merely a coarse eligibility filter and that the commercial application of the technology is relevant to deciding whether an invention is so abstract as to negate §101 subject matter.  Distinguishing between §101 “categories” of eligibility and §102 “conditions” of patentability, the Court endorsed the propriety of using the patentability conditions of the rest of the Patent Act to provide a more fine-grained assessment of a patent claim with subject matter that is not manifestly abstract.

The Court stated that the presence of a mental step is not in and of itself fatal to §101 eligibility and that the infinite variety of mental and physical activity negates application of a rigid rule of ineligibility.  The Court held that the immunization step in the ’139 and ’739 patents passes them through the coarse filter of §101, while the abstraction of the ’283 patent does not move principle to application.  The Court also held that the claims ’139 and ’739 patents were “transformative,” but not those of the ’283 patent.  The Court remanded the case in view of the eligibility of the subject matter claimed in the ’139 and ’739 patents.

Chief Judge Rader provided additional views, discouraging rigorous enforcement of §101.  Describing the ease of recasting claims to avoid ineligibility, Chief Judge Rader, joined by Judge Newman, stated that “when careful claim drafting or new claim formats avoid eligibility restrictions, the doctrine becomes very hollow.”  Chief Judge Rader advised that “judges should tread carefully when imposing new limits on the protection for categories of human innovation.”

Practice Note:  The test for whether a patent claim meets the test for subject-matter eligibility appears to be getting less restrictive following the Supreme Court’s Bilski decision.  Chief Judge Rader’s editorial regarding the significance of §101 in the broader scheme of a validity analysis may mean that the Federal Circuit will become more receptive to appeals for cases disposed of as a result of successful §101 challenges.