On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature. The claims on review recited a method of diagnosing disorders related to muscle specific tyrosine kinase (MuSK) by detecting autoantibodies to an epitope of MuSK. The majority of the panel generally felt confined by the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories setting forth a two-step framework for determining whether claims are patent eligible. [Summarized here [5/30 Blog Post]] Although the Federal Circuit will not re-hear the matter, the en banc decision uniquely lays out eight separate opinions acknowledging the problems of the current patent eligibility jurisprudence, and requests that the Supreme Court or Congress take action. The separate opinions include the following notable dicta:
Judge Lourie (concurring, joined by Judge Reyna and Judge Chen)
“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.”
Judge Hughes (concurring, joined by Judge Prost and Judge Taranto)
“I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents. 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.”
Judge Dyk (concurring, joined by Judge Hughes and Judge Chen)
“Thus, it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility. In the life sciences, development of new diagnostic methods is often based on researching complex biological systems. The inventive concepts in this area may lie primarily in the application of a natural law.”
Judge Chen (concurring)
“New methods for diagnosing medical conditions, as a general matter, intuitively seem to be the kind of subject matter the patent system is designed for: to encourage the risky, expensive, unpredictable technical research and development that people would not otherwise pursue in the hope that if they discover something of great medical value, then they will be protected and rewarded for that successful effort with a patent.”
Judge Moore (dissenting, joined by Judge O’Malley, Judge Wallach, and Judge Stoll)
“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. None of my colleagues defend the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible.”
Judge Newman (dissenting, joined by Wallach)
“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. The Court in Mayo did not exclude such methods from eligibility for patenting.”
Judge Stoll (dissenting, joined by Wallach)
“Interpreting Mayo, our prior opinions seem to take for granted that the Supreme Court has foreclosed all avenues of patent protection for diagnostic claims…Our inflexible following of Mayo has created flawed decisions that are inconsistent with the precepts of Mayo and our patent system as a whole.”
Judge O’Malley (dissenting)
“I believe that 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. Specifically, 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.”
This dicta is promising and may signify the real possibility of change (and certainty) to patent eligibility standards in the diagnostics field. Although it remains to be seen if Athena will file a petition for certiorari review with the Supreme Court, either the Supreme Court or Congress has been given a call to action.
The en banc decision can be viewed here.
[1] Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).