In my last post on s. 101, discussing “Cleveland Clinic II” I asked, “Why can’t a diagnostic conclusion be a practical application of a natural law?” and rhetorically answered: “Because the Federal Circuit says it can’t.” In Cleveland Clinic I (Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2007), the panel held patent ineligible claims to a method for assessing a test subjects’ risk of having cardiovascular disease (CVD) by comparing levels of a marker, MPO, in a sample from the subject with levels from control subjects diagnosed as not having the disease. Elevated levels of MPO in the test subject over the control subjects’ MPO levels “is indicative of the extent of the test subject’s risk of having CVD.”
In Athena Diagnostics, Inc. v. Mayo Collab. Services, LLC, Appeal no. 2017-2508 (Fed. Cir., 2019), a divided panel held that a method for diagnosing MG by detecting a marker for MG – autoantibodies against “MuSK”- using immunoassay techniques involving labelled MuSK, such as ELISA – is also a patent-ineligible natural phenomenon. Judge Newman dissented. (Please read my posts of Feb. 7, 2019 for much more about Athena at the Fed. Cir.)
In its petition for rehearing en banc, filed April 8, 2019, Athena poses the questions to be decided:
“1. Whether this Court now recognizes a categorical bias against patent claims to method of diagnosis, an impermissible expansion of the Supreme Courts’ narrowly defined judicial exception to patent eligible subject matter under [s.101]
2. Whether courts may now exclude claim elements that they deem ‘conventional’ in determining whether the claim is ‘directed to’ patent eligible subject matter, or does Supreme Court authority requiring that claims be assessed ‘as a whole’ still apply in Section 101 analysis.”
Athena argued that the claims were wrongly found to be directed to a law of nature, even though the panel described them as reciting multi-step laboratory methods, describing the first-ever assay for MuSK autoantibodies, and requiring novel man-made substances. Athena argued that the panel found that the claims “serve the new and useful purpose of diagnosing [a] serious disease [MG]” and do not preempt natural laws; “[i]n plain terms, the claims recite a ‘process’ indisputably eligible subject matter.”
To support its position that the claims at issue were distinguishable from Mayo and Cleveland Clinic I, Athena had to throw them under a legal bus. At first, I was discouraged by this approach but, upon reflection, I concluded that the claims at issue in Mayo and Cleveland Clinic have a lot in common. In the Mayo claims, the optimal metabolite range was recited in the claim. A broadly recited immunosuppressive drug was given to a “subject” and the level of the metabolite was measured to determine if the subject was receiving an optimal dosage of the drug. Determining the range was not recited in the claims. At the time, I think I called the claims an old use of an old drug. In any case, they were “regimen claims”. In its petition, Athena calls them a “quasi-diagnostic method”.
While the claims at issue in Cleveland Clinic I, directed to the diagnosis of CVD, appear more like diagnostic claims, they lie on the Mayo pathway to doom. MPO was known to be associated with CVD and commercial kits were available to measure it. Cleveland Clinic developed a “healthy subject” control level, then tested for MPO in a patient’s sample to determine if its level was above the normal, or “optimal” level, which indicated the degree of risk for CVD. So, both the Mayo claims and the Cleveland Clinic claims were directed to determining risks, and both claims were directed to determining optimal or abnormal levels of known markers. As summarized by the Athena petition:
“In contrast to Mayo and Cleveland Clinic [I], in which doctors had forever been doing the same steps, no one had ever attempted to detect MuSK [auto]antibodies for any reason. The claims here are simply not, as they would be by analogy to Mayo/Ariosa/Cleveland Clinic, ‘detecting MuSK in unspecified but known manners; [and?] diagnosing with newly discovered information’. The [Athena] method steps are ‘concrete’ in the majorities own view, and essential to the Supreme Court’s whole-claim [reading] requirement.”
To buttress its arguments that the claims are directed to a patent-eligible process, Athena looks to the Myriad [“ANP’] decision, and focuses on claim 20: that “was directed to a method for screening potential cancer therapeutics via change in cell growth rates of transformed cells….The steps included (1) growing man-made cells transformed with an altered BRCA1 gene, with and without a potential therapeutic, (2) determining cells growth rate, and (3) comparing growth rates of the hosts cells. The Court…nonetheless distinguished mayo and held the claims patent eligible because, as in Chakrabarty, the transformed cells are not naturally occurring.”
Athena continues: “Just as in AMP, the labeled MuSK and MuSK epitopes of the asserted claims are novel, man-made molecules that differ markedly from natural MuSK, and the claim method operates on those novel molecules.” [However, the Athena panel] “reaffirmed 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….The majority’s conclusion contradicts the Court’s clear rule in AMP.”
Or, as Judge Newman concluded in her dissent: “The claims are for a multi-step method of diagnosis, not a law of nature….The claimed method determines whether this correlation is present, for diagnostic purposes, but the concept itself is not claimed.” I can only hope that her colleagues on the court will see this distinction-with-a-[huge]-difference.