On October 1st, Athena filed a petition for a writ of certiorari to the Supreme Court following the Fed. Cir.’s fractured denial for its petition for rehearing en banc in Amgen v. Mayo. The original request for rehearing en banc posed two questions. In brief, whether the Fed. Cir. now has effectively created a per se rule that claims to diagnostic methods are not patent-eligible (PE) and whether courts may now exclude claim elements that they deem conventional in determining whether a claim is directed to PE subject matter.
In its petition for cert., Athena collapsed these questions into a single question aimed at the facts of the case:
“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.”
To begin with, I only used the term “Questionable” above, to introduce my thoughts about the “Questions Presented” in the petition. The petition is very well-written and explains the science embodied in the assay very clearly. I would have liked the question to be presented very broadly, such as “Whether, in the case of a claim to a diagnostic assay for a medical condition based on a naturally-occurring correlation, patent-eligibility is satisfied when the inventors both discovered the naturally-occurring correlation and discovered its utility to detect the medical condition.” Well, that’s an attempt to ask the S. Ct. to resolve the broad question: Are “If A, then B” diagnostic claims PE.
However, the Fed. Cir. did not address claim 1 of the patent-in-suit, that was framed that broadly:
“1. A method for diagnosing neurotransmission or developmental disorders related to [MuSK][ed. note: “B”] in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSk](ed. note: “A”).”
The S. Ct. rules say, to effect, that you cannot pose a question that was not ruled on below, directly or implicitly. So the question was based on the Fed. Cir.’s opinions about claims 7-9. These claims recited the use of labeled MuSK to detect the presence of autoantibodies, basically by using the steps normally used in an ELISA assay: contacting labelled MuSK with the sample, immunoprecipitating any MuSK – autoantibody complexes from the sample and monitoring for any label on the complexes. So the compounds never previously linked to the condition are the autoantibodies to MuSK and the man-made molecules are labelled MuSK and its complexes with the autoantibodies.
Framed this narrowly, claims 7-9 distinguish Mayo v. Prometheus and Cleveland Clinic. In Mayo, the “A” marker was the known metabolite of a class of immunosuppressive drugs, and the metabolite concentration in the sample from a patient to whom the drug was administered was correlated to a known “medical condition” – bad side effects or lack of efficacy. In Cleveland Clinic, the marker, the known enzyme MO was known to be associated with CVD and kits were available to assay for MO.
In the question, the “specific chemical steps never previously performed” to detect the autoantibodies were only novel because they employed the novel compound, labelled MuSK to bind to any autoantibodies in the sample. Per se, the steps were well-known in ELISA assays, but the steps certainly were “specific chemical steps.”
I went back and re-read the original Athena Fed. Cir. decision, and all of these points were argued by Athena and dismissed. In its petition. So the question is properly proposed. But, in search of a “win”, a lot of questions may remain unanswered. Particularly notable is that diagnostic claims based on genotyping will remain patent-ineligible. Also, depending on the target molecule, there may well be ways to detect it that do not involve the ELISA techniques, and so may not involve man-made molecules.
Athena discusses “multiple points of confusion” in the Fed. Cir.’s application of S. Ct. precedent:
- Tension between the holdings of Athena and Myriad. Myriad held that cDNA was patent-eligible, even though it was easy to make, as “an artificial molecule created by a lab technician.” Athena argues that its diagnostic claim begins with a novel man-made composition and that it is “counterintuitive…that a claim would become less patentable when it is made more specific through the addition of multiple steps.” This is a strong argument – post–Durden, any use of a patentable composition of matter is also patentable. Judge Lourie tries to side-step this black letter law and just plain fails:
“We just reaffirm that use of a man-made molecule in a method claim employing standard techniques to detect or observe a natural law may still leave the claim directed to a natural law.”
2. “Courts have struggled to apply the principles articulated in the context of the unusual facts of Mayo to more typical patent claims.” This needs no further comment.
3. “Courts have struggled with the level of abstraction at which to determine whether the steps of a claim ‘transform an unpatentable law of nature into a patent eligible application of such a law [and Athena’s claims are plenty specific].
4. Evidence of “no preemption” has been ignored, while preemption by itself is sufficient to render a claim patent ineligible.
5. “Courts have struggled with what it means to review a claim ‘as a whole.’” Pre-Mayo, the courts followed Diehr and did not divide claims into new and old elements and search for an inventive concept after disregarding any natural law recited in the claims.
Will the Supreme Court take up a question that requests re-analysis of a diagnostic claim that comprises so much detail? Stay tuned.