Posts Tagged: "Mayo Collaborative Services v. Prometheus Laboratories"

The 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs changed the landscape for patenting diagnostic inventions in the United States. Patent eligibility/ineligibility in the United States stems from two sources: (1) 35 U.S.C. § 101, and (2) judicially-created exclusions, including laws of nature, natural phenomena, abstract ideas, and mental processes. In Mayo, the Supreme Court struck down method of treatment claims for being directed to a law of nature. While Mayo did not create this exclusion, it significantly expanded its applicability to diagnostic-based inventions. This paper explores Federal Circuit case law on patent eligibility of diagnostic-based inventions since the Mayo decision, as well as provides practical guidance on drafting diagnostic patent claims in light of these decisions.

The most dominant, divisive issue in patent law over the last decade—Section101-eligibility and the Supreme Court’s Mayo-Alice framework—appears to have just become more divisive. Indeed, at least part of the reason for the controversy is that, with Mayo-Alice as the governing test, courts as a preliminary matter can decide Section101-eligibility based on considerations of an “inventive concept” and patentability—issues the Court once declared were “not relevant” to the separate eligibility provision of the Patent Act. Be that as it may, the Federal Circuit has recently issued certain decisions indicating that Section 101 now incorporates another vast area of invalidity; viz., the requirements for “enablement” under 35 U.S.C. §112(a). See, e.g., Customedia Technologies, LLC v. Dish Network Corp., 951 F.3d 1359, 1365-66 (Fed. Cir. March 6, 2020). In this article, we examine how this new requirement for Section 101 has emerged, the recent precedent on the issue, and the Patent Act’s requirements that undermine such Section 112(a) considerations for a Section 101-eligibilty test.

Athena Diagnostics today filed its reply brief to Mayo Collaborative Services at the Supreme Court in the closely-watched petition asking the High Court to clarify U.S. patent eligibility law. The reply reiterates the points made in Athena’s petition for certiorari and dismisses Mayo’s argument in November that “any further action regarding the patentability of medical diagnostic claims such as Athena’s that employ conventional, known techniques should and does rest with Congress.” The reply comes three days after the United States Solicitor General recommended that SCOTUS grant cert in Athena or “another such case”, rather than in Hikma Pharmaceuticals v. Vanda Pharmaceuticals.

Athena Diagnostics filed its petition for certiorari with the U.S. Supreme Court yesterday in Athena Diagnostics v. Mayo Collaborative Services. There is a strong argument for the Court to grant the petition, and patent stakeholders on all sides are sure to weigh in via amicus briefs over the next month. The petition could represent the best chance for clarifying Section 101 law in the near-term, since patent reform efforts on the topic have been seemingly stalled. Below are a few initial reactions from the patent community to Athena’s arguments.

The Federal Circuit recently reversed the District of Minnesota’s denial of summary judgment in Solutran, Inc. v. Elavon, Inc., Nos. 2019 U.S. App. LEXIS 22516 (Fed. Cir. July 30, 2019) (Before Chen, Hughes, and Stoll, Circuit Judges) (Opinion for the Court, Chen, Circuit Judge), holding that the claims at issue, which related to processing paper checks, were invalid under 35 U.S.C. § 101. The physicality of the limitations of the claims did not save the claims. See Physicality of Processing Paper Checks Does Not Save Solutran’s Claims. “[W]e have previously explained that merely reciting an abstract idea by itself in a claim—even if the idea is novel and non-obvious—is not enough to save it from ineligibility,” Judge Raymond Chen of the Federal Circuit explained for the majority. The Federal Circuit can state that proposition until every single judge is blue in the face and there will be one exhausting, inescapable truth—it is wrong! Indeed, this logical impossibility is written into so many Federal Circuit decisions one must wonder how it is possible any of the judges who believe this nonsense were ever able to achieve an acceptable score on the LSAT in order to gain admission to law school in the first place.

With more dissents than any other Federal Circuit Judge in history,  Judge Pauline Newman is driven by a need to safeguard our national system of innovation. Judge Newman has argued throughout the years that the Federal Circuit was created to rebuild and renew the patent system to encourage and incentivize industry, which is precisely the purpose both the Carter and Reagan Administrations had in mind when advocating for the creation of the Federal Circuit, which ultimately took form in 1982. Judge Newman has no qualms about speaking out in dissents when the objective of the Federal Circuit to bring certainty to U.S. patent laws is being hindered, in her view, by the majority, regardless of the complexities or dollar-values at stake in the case. In fact, in one interview she declared, “I have not hesitated to comment when I think that a panel isn’t going in quite [the] appropriate direction. Others have felt that perhaps I haven’t gone in quite the appropriate direction . . . . [A]ll in all it seems to me that it’s quite healthy to present a certain amount of turmoil to practitioners in the short run. But in the long-run I think the law is better for it.” George C. Beighley, Jr., “The Court of Appeals for the Federal Circuit: Has It Fulfilled Congressional Expectations?,” 21 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 671, 675–76 (2011). Clearly, she is interested in getting the law right for the greater good as she sees it, regardless of the impact her dissent may have on relationships or status quo.