On July 3, 2019 the Federal Circuit issued its en banc decision in Athena Diagnostics, Inc. et al. v. Mayo Collaborative Services, LLC. The decision came down 7-5 against rehearing on the patent’s eligibility, with a staggering eight separate written opinions (four concurring and four dissenting). The common refrain amongst the opinions, concurrences and dissenting alike, was the need for intervention from the Supreme Court or Congress to address the current binding precedent from Mayo.
The petition arose from a District of Massachusetts case where Athena Diagnostics asserted claims relating the diagnosis of disorders relating to antibodies to a muscle-specific tyrosine kinase (MuSK) in U.S. Patent 7,267,820. Mayo challenged the eligibility of such claims, which was appealed to the Federal Circuit, where they were deemed ineligible by Judges Newman, Lourie, and Stoll. Athena and its co-petitioners petitioned for the case to be re-heard en banc, resulting in the 7-5 denial. Those in favor were Judges Lourie, Reyna, Chen, Prost, Taranto, Hughes, and Chen, while Judges Moore, O’Malley, Wallach, Stoll, and Newman opposed.
In the dissents, the judges emphasized that there was no disagreement in the deliberations as to whether the claims should be eligible. Judge Moore explains that “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.” He goes on to lament the fact that since Mayo, the Federal Circuit has held every single diagnostic claim before it to be ineligible, and cites the many serious research subjects that are negatively impacted by such precedent including breast cancer, tuberculosis, down syndrome, and many more.
On the concurring side, Judge Hughes succinctly represented the court’s current and unfortunate position. Per his opinion, “[T]he bottom line for diagnostics patents is problematic. But this is not a problem that we can solve. As an inferior appellate court, we are bound by the Supreme Court. 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. Such an explication might come from the Supreme Court. Or it might come from Congress, with its distinctive role in making the factual and policy determinations relevant to setting the proper balance of innovation incentives under patent law.”
The Federal Circuit’s emphatic cry for help gives greater importance to the current 101 reform initiatives in congress.
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