“No Work for This Court to Do Here”: Mayo Argues for Following Precedent and Leaving Policy to Congress

In the latest turn of events in the Athena v. Mayo Supreme Court petition¹, Mayo Collaborative Services filed its opposition brief arguing, in essence, that the Court has already spoken on patent eligibility, the Court should leave policy considerations to Congress, and lower courts are not confused about the law.

In this closely watched case, Athena Diagnostics requested that the Supreme Court overturn a lower court’s finding that its patent directed to a diagnostic method is ineligible for patenting under 35 U.S.C. § 101. Athena’s prior request for en banc hearing was denied by the Federal Circuit in an eight-opinion decision. Eleven amicus briefs were filed in support of petitioner Athena, requesting the Supreme Court to clarify its position on subject matter eligibility of medical diagnostic claims, citing concerns for innovation and public health.²

Mayo’s opposition brief begins with a summary of the two-part framework for determining patent subject matter eligibility as set forth in Mayo v. Prometheus,³ noting that “despite ample opportunity, Congress has not acted to change the Mayo/Alice framework, which, despite Athena’s protestations, only allows patent challengers to assert what the law always had been – that natural laws are for all to use, and may not be patented, whether broadly or narrowly, by appending the natural law to an otherwise conventional process.”⁴

The patent at the center of the dispute is U.S. Patent No. 7,267,820 (“the ‘820 patent”), of which claim 1 recites:

1. A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).⁵

Mayo asserts that the ‘820 patent discloses discovery of a natural law, i.e., that certain patients suffering from disease generate autoantibodies to MuSK. Mayo thus argues that the claims do no more than enable diagnosis by swapping out one natural law for another in a well-defined, routine activity for detecting autoantibodies. Regarding Athena and the amici’s claims that scientific research and public health will suffer, Mayo noted that not only are these claims unsupported but are also policy concerns that should be addressed by Congress, and not the courts.

There is thus no work for this Court to do here. This Court has already interpreted § 101 of the Patent Act and laid down a clear boundary around what is and is not patent eligible. Athena’s patent claims fall squarely on the ineligible side of that boundary. 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.⁶

Moreover, Mayo noted that the lower courts have not been “confused,” as alleged by Athena, because all of the lower courts have come to the same conclusion regarding the eligibility of the ‘820 patent claims following the Alice/Mayo framework. Finally, Mayo noted that Athena’s arguments regarding the negative impacts of Mayo on innovation in the field of medical diagnostics are unfounded, citing evidence that investment in diagnostics have increased since 2009, and arguing that Athena’s own stock price has nearly doubled since 2013.

Mayo’s arguments focus on following precedent and leaving the policy to Congress. For now, patent practitioners and those in the medical diagnostics community will continue to closely follow developments in this petition.