Athena Diagnostics, Inc. et al. v. Mayo Collaborative Services, LLC
Docket No. 2017-2508
NEWMAN (D), LOURIE, STOLL
February 6, 2019 (Petition for rehearing denied July 3, 2019)
Update (July 3, 2019): Athena’s petition for rehearing regarding the invalidation under § 101 of its antibody-disorder “correlation” claims denied. Selected excerpts from concurrences and dissents:
“The only unconventional aspect is the inventors’ discovery of what the Supreme Court would call the natural law—the correlation between MuSK autoantibodies and the neurological disorder myasthenia gravis—but we cannot premise eligibility solely on the natural law’s novelty.”
“The multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is.”
“Despite assertions to the contrary, the doctrines of novelty under § 102, obviousness under § 103, and enablement and written description under § 112 cannot adequately guard against the dangers of overclaiming” and “§ 101 serves an important purpose not served by these other provisions in the Patent Act” (e.g., In re BRCA1).
“Diagnostic claims grounded in novel, non-obvious techniques that render a given diagnosis possess an inventive concept continue to be granted.”
“We have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible… § 101 and Mayo, when read together and in their entireties, compel the holding that the claims in Athena are eligible.”
“These antibodies and their reaction with the MuSK protein were not known, nor the use of this procedure to diagnose Myasthenia Gravis”, this decision is “a misperception of the Court’s decision in Mayo” (“Athena’s diagnostic method is not a law of nature; it is a novel man-made method of diagnosis of a neurological disorder.”)
“Our inflexible following of Mayo has created flawed decisions that are inconsistent with the precepts of Mayo and our patent system as a whole.”