Athena Diagnostics, Inc. v. Mayo Collaborative Services LLC (Supreme Court 2019)
I enjoy comparing the Question Presented in a petition for writ of certiorari with the brief in opposition. Perhaps the eligibility answer depends on how you frame the question.
In Athena, the patentee whose claims were invalidated by the Federal Circuit asked the following question:
Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.
In its newly filed response, the accused infringer Mayo reframes the question as follows:
Whether patent claims to a method of diagnosis are ineligible under 35 U.S.C. § 101 where the claims employ admittedly “standard” and “known” laboratory techniques to detect the presence of an autoantibody that, when present, correlates to a particular disease.
The opposition brief provides its explanation of the briefing thus far: Policy arguments best left for Congress.
Athena, amici, and various Federal Circuit judges disapprove of this outcome [that the claims are ineligible]. They plead that all medical diagnostics should be patent eligible. They posit that patent claims making use of man-made materials; or that require multiple laboratory-based steps, however conventional; or that detect something no one had previously looked for should be patent eligible. And they speculate, without any record support, that scientific research and the public health will suffer if all medical diagnostic methods are not patent eligible, even in the face of dramatically increased investment in diagnostics since Mayo.
But these are all policy concerns for Congress to examine and address; this Court’s precedent, including Mayo, has already considered each one.
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.
I like the general idea of getting Congress involved when we need a change in the statute. Eligibility though is somewhat unique since we have had the same statute almost without amendment since 1793 (“useful art, machine, manufacture or composition of matter”). The original U.S. patent Act (1790) was slightly narrower (“useful art, manufacture, engine, machine, or device”). For the past 230 years, the U.S. Courts have been doing their work on the statute — adding atextual gloss and meaning. And, while Congress has repeatedly altered many of the patent law provisions, it has left this language virtually untouched (“useful process, machine, manufacture, or composition of matter”). Point being here, a substantive amendment on eligibility would be unprecedented in American law and thus should be done with deliberative caution.