Athena Diagnostics, Inc. et al. v. Mayo Collaborative Services, LLC

Docket No. 2017-2508

February 6, 2019

Brief summary: DC finding that method claims relating to a correlation between antibodies to a protein (“MuSK”) and neurological disorders are invalid under § 101 affirmed.

Summary: Athena (as exclusive liceness) appealed DC granting Mayo’s motion to dismiss under Rule 12(b)(6) and finding claims 6-9 of US 7,267,820 directed to methods for diagnosing neurological disorders such as myasthenia gravis (MG) by detecting antibodies to muscle-specific tyrosine kinase (“MuSK”) invalid under § 101 as being directed to a natural law and lacking an inventive concept. The FC panel opinion explains that about 20% of MG patients were found to produce autoantibodies against MuSK and that “[p]rior to their discovery, no disease had been associated with MuSK.” The FC panel opinion explains that the DC “concentrated its analysis on claims 7-9 (“representative of claim 6”). Claim 7 is dependent on independent claim 1 (not at issue here) and includes contacting labeled “MuSK or an epitope or antigenic determinant thereof” with a “bodily fluid”, immunoprecipitating any antibody/MuSK complexes, and “monitoring for said label”, “wherein the presence of said label is indicative of” an MuSK-related disorder. Claim 9 (dependent on claim 8), which the FC opinion “focus[ed] on”, “further recites” MuSK being labeled with the radioactive label iodine-125 (125I). The FC panel opinion explains that the ‘820 specification states that techniques such as immunoprecipitation, radioimmunoassays, and detection by ELISA are “know per se in the art”. It also explains that “[p]atent eligibility under § 101 is a question of law based on underlying facts” (Aatrix Software, FC 2018; Berkheimer, FC 2018) “that may be resolved on a Rule 12(b)(6) motion when the undisputed facts require a holding of ineligibility” (SAP, FC 2018). The FC reviewed the relevant § 101 precedent, noting that SCOTUS “has advised” that the “Mayo” exceptions to patentability (“laws of nature, natural phenomena, and abstract ideas”) “must be applied cautiously, as ‘too broad an interpretation of this exclusionary principle could eviscerate patent law’” (Mayo, US 2012). Under Mayo, the FC panel explains, “adding conventional steps, specified at a high level of generality,’ to a law of nature does not make a claim to the law of nature patentable.” The FC panel reviewed the claims under the two-step Alice procedure (Alice, US 2014). Athena argued “that the claims are directed a new laboratory technique that makes use of man-made molecules”, and Mayo countered that “the claims are directed to a natural law” relating to the autoantibody-MG correlation and included only “concededly standard immunoassay techniques”. The FC panel agreed with Mayo because the correlation “exists in nature apart from any human action”, contrasting this case with CellzDirect (FC 2016; “claims as a whole recited ‘a new an improved way of preserving hepatocytes’”; see also BASCOM, FC 2016) and likening it to Cleveland Clinic (FC 2017; claims covering correlation between MPO and cardiovascular disease included “no meaningful non-routine steps”; see also Ariosa (FC 2015)). The FC panel concluded that “[t]he claims here are directed to a natural law because they recite only the natural law together with standard techniques for observing it” and the fact that “the routine steps are set forth with some specificity is not enough to change that conclusion” (see the Alice step two analysis as well). The Vanda decision (FC 2018) was also referenced as an example of “claiming a new treatment for an ailment, albeit using a natural law” without “claiming the nature law.” Judge Newman’s dissent argued that the FC panel “again departs from the cautious restraints” of Mayo, “[t]his court’s decision on patent-ineligibility are not consistent”, and “[c]laim limitations cannot be discarded when determining eligibility under” § 101 (Diamond, US 1981).

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