July 11, 2019
On July 3, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit denied the en banc rehearing petition filed by Athena. Significantly, although the Federal Circuit will not hear this decision en banc, it appears that most if not all of the Federal Circuit judges are hoping to see this case advance to the Supreme Court. The state of the law on patent eligibility of diagnostic methods has been in flux over the last several years, and the Federal Circuit has signaled strongly that the Supreme Court should review this decision and clarify the law in this area.
Notably, while the order for denial was a 7–5 decision, it included eight separate opinions by the 12 Federal Circuit judges, four concurring and four dissenting. In particular, the concurring opinions were written by combinations of Judges Lourie, Reyna, Chen, Hughes, Prost, Taranto, and Dyk. The dissenting opinions were written by combinations of Judges Moore, O’Malley, Wallach, Stoll, and Newman.
In his concurrence, Judge Lourie states that he agrees with the court’s decision not to rehear this case en banc, pointing out that “we can accomplish little in doing so, as we are bound by the Supreme Court’s decision in Mayo.”Judge Lourie continues, “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,” again noting that “we do not write here on a clean slate; we are bound by Supreme Court precedent.”
Judge Lourie argues that while “[a]mici and others have complained that our eligibility precedent is confused . . . our cases are consistent,” pointing out that they “have distinguished between new method of treatment claims and unconventional laboratory techniques, on the one hand, and, on the other hand, diagnostic methods that consist of routine steps to observe the operation of a natural law, a clear line. Beyond that, I do not see a way clear to distinguish Mayo in a useful, principled, fashion.”
In his concurrence, Judge Hughes summarizes the overall sentiments of the Federal Circuit judges by stating that the “multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is,” noting that “this is not a problem that we can solve” and that “[a]s an inferior appellate court, we are bound by the Supreme Court.” Along the same theme, he concludes by saying, “I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents,” asserting 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,” and noting that such an explication might come from the Supreme Court or Congress.
In Judge Dyk’s concurrence, he states that the Mayo/Alice framework has “proven to be both valuable and effective at invalidating overly broad, non-inventive claims that would effectively ‘grant a monopoly over an abstract idea.’” However, he asserts, “The problem with § 101 arises not in implementing the abstract idea approach of Alice but rather in implementing the natural law approach of Mayo.”
Judge Dyk shares the concern voiced by the dissenting judges that “the Mayo test for patent eligibility should leave room for sufficiently specific diagnostic patents,” pointing out that “Mayo left no room for us to find typical diagnostic claims patent eligible, absent some inventive concept at Mayo step two.” He notes, “it is the Supreme Court, not this court, that must reconsider the breadth of Mayo.”
Judge Dyk also observes the tension between Mayo and the Supreme Court’s 2013 holding in Association for Molecular Pathology v. Myriad Genetics, stating that “Myriad thus recognized that an inventive concept can sometimes come from the discovery of an unknown natural phenomenon and its application for a diagnostic purpose,” while under Mayo, “a natural phenomenon itself, no matter how narrow and specific, cannot supply the requisite ‘inventive concept.’” He suggests that “it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility.”
Under the refinement proposed by Judge Dyk, the claiming of natural laws should be prevented by tying those laws to a specific and useful application at Mayo step one, which would lead to a determination of the “inventive concept” at Mayo step two. Also under this refined analysis, Athena’s claims would likely be patent-eligible because they don’t claim a natural law itself, but claim specific methods of diagnosing a neurological disorder by detecting specific antibodies.
In his consenting opinion, Judge Chen discusses various major precedent cases, including Mayo and the Supreme Court decisions in Parker v. Flook (1978) and Diamond v. Diehr (1981), pointing out that Mayo in fact reversed Diehr, but also that “[w]hen it comes to applying the judicial exceptions, it bears noting that the Mayo analytical approach is considerably harder to apply consistently than the Diehr framework, and more aggressive in its reach.” He goes on to assert that the “notion that adding claim language can convert an otherwise patent-eligible claim into a patent-ineligible claim is counterintuitive and a very difficult thing to explain to 8,000 patent examiners.”
Judge Chen also observes “there is a serious question today in patent law as to what extent Diehr remains good law in light of Mayo,” and he echoes his fellow judges in saying that “[w]e are not in a position to resolve that question, but the Supreme Court can.”
Judge Moore begins her dissenting opinion by stating, “This is not a case in which the judges of this court disagree over whether diagnostic claims, like those at issue in Athena, should be eligible for patent protection. They should.” She goes on to explain that “[n]one of my colleagues defend the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible.” She frames the difference between the consenting and dissenting judges as being “whether the Supreme Court’s Mayo decision requires this outcome,” stating that while “[t]he majority of my colleagues believe that our hands are tied and that Mayo requires this outcome,” she believes Mayo does not. In other words, Judge Moore believes that Mayo is distinguishable.
Notably, Judge Moore states that the Federal Circuit’s precedent has “ignored the truth that claims to specific, narrow processes, even if those processes involve natural laws, are not directed to the natural laws themselves.” She asserts that “[w]e have misread Mayo and how it fits within the framework of the judicially-created exceptions to § 101 for laws of natures, natural phenomena, and abstract ideas.” In addition, she makes a policy-based point, stating that “[t]he math is simple, you need not be an economist to get it: Without patent protection to recoup the enormous R&D cost, investment in diagnostic medicine will decline.” She continues, “To put it simply, this is bad. It is bad for the health of the American people and the health of the American economy. And it is avoidable depending on our interpretation of the Supreme Court’s holding in Mayo.”
Judge Moore further explains, “I do not understand Mayo to render ineligible a claim which covers a specific concrete application of a natural law simply because such a claim is diagnostic as opposed to therapeutic,” asserting that “[b]oth should be eligible.” In conclusion, she states that “[i]n the wake of Mayo, we have painted with a broad brush, suggesting that improved diagnostic techniques are not patent eligible.” She advises patentees whose diagnostic method claims are invalidated that there is “[n]o need to waste resources with additional en banc requests. Your only hope lies with the Supreme Court or Congress.”
Judge Newman dissented on the original Athena decision and dissented here again, stating that “I write again in dissent because of the importance of medical diagnosis and the critical role of the patent system in achieving new diagnostic methods.” Similarly to Judge Moore, Judge Newman observes that the Supreme Court in Mayo “did not hold that methods of diagnosis are subject to unique patent-eligibility rules,” and she believes “[w]e have mistakenly enlarged the Court’s holding, in substance and in application.” In particular, she argues that “Athena’s diagnostic method is not a law of nature; it is a novel man-made method of diagnosis of a neurological disorder. The Athena diagnostic method, a multi-step method performed by a combination of specific chemical and biological steps, was unknown in the prior art.” She concludes that the “Court in Mayo did not exclude such methods from eligibility for patenting.”
Judge Newman then appears to adopt the premise raised at a recent Senate subcommittee hearing that “courts have clouded the line to exclude critical medical advances like life-saving precision medicine and diagnostics.” She concludes that the case “presents an opportunity for judicial review and judicial remedy,” and that “[a]lthough diagnostic methods are not the only area in which section 101 jurisprudence warrants attention, Federal Circuit precedent is ripe for reconsideration specific to diagnostic methods, to correct our application of the Mayo decision and to restore the necessary economic incentive.”
In Judge Stoll’s dissent, she states that “Federal Rule of Appellate Procedure 35 directs us to order rehearing en banc when ‘the proceeding involves a question of exceptional importance.’” She chose to dissent separately from the decision of the majority to deny en banc review “because the question of the eligibility of diagnostic inventions is exactly the type of exceptionally important issue that warrants full consideration by this court.” Judge Stoll agrees with Judges Newman and Moore that “a wholesale bar on patent eligibility for diagnostic claims has far-reaching and long-ranging implications for the development of life-saving diagnostic methods.” She continues, “The eligibility of life-saving inventions is not only one of the most important issues of patent law, but of human health,” and concludes, “the importance of the issue here mandates that we consider it en banc.”
Judge O’Malley states in her dissent that although she agrees with all her dissenting colleagues, she writes separately because “confusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress’s direction to the courts to apply 35 U.S.C. sections 101, et seq (‘Patent Act’) as written.” In particular, Judge O’Malley asserts that “the Supreme Court has 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.” She then urges Congress “to amend the Patent Act once more to clarify that it meant what it said in 1952.”
Judge O’Malley laments that “although Congress so amended the Act decades ago, we continue to apply the invention requirement today under a new name—the ‘inventive concept’ requirement.’” She closes her opinion by stating that “claims directed to uses of natural laws rather than the natural laws themselves would be eligible under § 101 as written.” She continues, “Because the Supreme Court judicially revived the invention requirement and continues to apply it despite express abrogation, I dissent to encourage Congress to clarify that there should be no such requirement read into § 101; to clarify that concepts of novelty and ‘invention’ are to be assessed via application of other provisions of the Patent Act Congress designed for that purpose.’”
At this point, the only remedy for Athena is to file a petition for a writ of certiorari by the Supreme Court. The Supreme Court has not granted any such petitions on patentable subject matter eligibility in about five years. However, the present Athena decision presents eight well-reasoned Federal Circuit judicial opinions, most of which urge the Supreme Court to revisit and/or refine the Mayo decision. It would not be surprising to see the Supreme Court agree to hear this case. Fitch Even attorneys will report on any decision from the Court in a subsequent alert.
For more information on this case, please contact Fitch Even partner David M. Kogan, author of this alert.
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