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Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC

Denial of § 101 En Banc Petition Results in Eight Opinions Discussing the State of Law

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, __ F.3d __, 2019 WL ____ (Fed. Cir. July 3, 2019) (Per curiam; Concurrence by Lourie (joined by Reyna, Chen); Concurrence by Hughes (joined by Prost, Taranto); Concurrence by Dyk (joined by Hughes, partially joined by Chen); Concurrence by Chen; Dissent by Moore (joined by O’Malley, Wallach, Stoll); Dissent by Newman (joined by Wallach); Dissent by Stoll (joined by Wallach); Dissent by O’Malley) (D. Mass.: Talwani) (5 of 5 stars)

Fed Cir denies Athena’s petitions for panel rehearing and rehearing en banc. The mandate affirming the district court’s dismissal on § 101 patent ineligibility grounds will issue July 10, as described in the panel opinion (915 F.3d 743 (Fed. Cir. 2019)

Lourie concurrence: In Judge Lourie’s view the court could “accomplish little” by rehearing the appeal, “as we are bound by the Supreme Court’s decision in Mayo (566 U.S. 66 (2012)).” Op. at 1 (citation added). “If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle’s law, Maxwell’s Equations, etc. I would not exclude uses or detection of natural laws. The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.” Id. at 2. He defends the Federal Circuit’s post-Mayo cases as “consistent,” and in the present appeal sees no “way clear to distinguish Mayo in a useful, principled fashion.” Id. at 4.

Hughes concurrence: Judge Hughes describes the issue of § 101 eligibility as “fraught . . . especially as applied to medical diagnostics patents.” Op. at 1. He invites the Supreme Court, or Congress, to provide “further explication of eligibility standards” in that area, noting that such standards “could permit patenting of essential life saving inventions based on natural laws while providing a reasonable and measured way to differentiate between overly broad patents claiming natural laws and truly worthy specific applications.” Id. at 2.

Dyk concurrence: Judge Dyk disagrees that §§ 102, 103, or 112 could “adequately guard against the dangers of overclaiming,” and describes how § 101 serves that purpose. Op. at 3 et seq. He is concerned that Mayo fails to leave “room for sufficiently specific diagnostic patents,” and invites the Supreme Court to reconsider that case’s breadth. Id. at 5. He also describes “tension” between Mayo and Myriad, 569 U.S. 576 (2013), in which Myriad seems to suggest that “an inventive concept can sometimes come from the discovery of an unknown natural phenomenon and its application for a diagnostic purpose,” while Mayo seems to reason otherwise. He provides thoughts on how to limit Mayo so as to establish patent eligibility for some “specific application” of a natural law, but not for broad law-based claims. Id. at 9. In his view the claims in this appeal might be eligible under such an approach.

Judge Chen joins this opinion from the discussion of the MayoMyriad tension forward.

Chen concurrence: Judge Chen views Mayo’s reasoning as clear, but raises questions about whether the Supreme Court intended to “override central tenets” of Diehr, 450 U.S. 175 (1981). Read alone, Diehr suggests that the claims in this appeal would be patent eligible. His opinion describes the history of Flook, 437 U.S. 584 (1978), and Diehr, and compares the reasoning of those cases to Mayo and Alice, concluding, “there is a serious question today in patent law as to what extent Diehr remains good law in light of Mayo. We are not in a position to resolve that question but the Supreme Court can. Resolution of the present confusion is important because if Mayo in fact overruled the principles in Diehr . . . , then that would be a significant incursion on the settled expectations that had existed for 30 years since Diehr.” Op. at 12.

The opinion then analyzes Athena’s claims, reasoning that they are patent-ineligible under Mayo because, under that case, “the association of an antibody and a medical disorder is deemed to be a law of nature rather than an application of a law of nature[.]” Id. at 13.

Moore dissent: Judge Moore would have granted rehearing en banc because she believes Mayo is distinguishable. She criticizes the court for “turn[ing] Mayo into a per se rule that diagnostic kits and techniques are ineligible,” and disagrees with that approach. Her opinion describes how diagnostic kits deserve patent incentives, then distinguishes Athena’s claims from those in Mayo. “The concreteness and specificity of the claims in Athena moves them from reciting a law of nature to a particular application of a law of nature.” Op. at 20. She also notes that, unlike in Mayo, part of the inventiveness here was the discovery of the “before unknown relationship” between certain antibodies and a certain disorder. “[T]o wholly ignore the inventiveness of the discovery when assessing patent eligibility closes our eyes to the statute enacted by Congress.” Id. at 21.

Newman dissent: Judge Newman would have granted rehearing en banc. She criticizes the court for “mistakenly enlarg[ing]” the reasoning of Mayo, “in substance and in application.” Op. at 2. She disagrees that under Mayo, diagnostic methods are treated as laws of nature, discusses the statutory and judicial history of § 101, and then offers a history of the court’s “inconsistent rulings between diagnos[tic method claims] and treatment of disease [claims].” Id. at 8. The opinion covers some of the criticisms from amici from that approach, and urges action en banc.

Stoll dissent: Judge Stoll criticizes the court for applying a “bright-line rule of ineligibility for all diagnostic claims,” and would have acted en banc to correct that rule. Op. at 1–2.

O’Malley dissent: Judge O’Malley agrees with Judge Moore. She writes to criticize recent Supreme Court decisions that “have instructed federal courts to read into Section 101 an ‘inventive concept’ requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.” Op. at 1–2. She urges Congressional patent reform to “clarify that it meant what it said in 1952.” Id.