The petitioner in Athena Diagnostics, Inc. v. Mayo Collaborative Services, No. 19-430, has asked the Supreme Court to consider the question whether diagnostic claims are patent eligible.

In 2015, Athena Diagnostics, Inc. (“Athena”) sued Mayo Collaborative Services (“Mayo”) for infringing its patent covering a method for diagnosing myasthenia gravis by detecting autoantibodies to muscle specific tyrosine kinase (MuSK). The inventors had discovered both MuSK autoantibodies (naturally occurring, but previously unknown) and the link between MuSK autoantibodies and myasthenia gravis (naturally occurring, but previously unknown). In 2017, the district court held these claims were patent ineligible.

The Federal Circuit affirmed, citing Mayo, holding that these diagnostic claims were directed to a natural law—namely, the correlation between the presence of naturally occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases—and recited conventional techniques to detect that natural law. Athena petitioned for rehearing en banc, which the Federal Circuit denied. The Federal Circuit issued eight opinions concurring with and dissenting from that denial.

Athena petitioned the Supreme Court for review. In its petition, Athena argued the eight opinions concurring and dissenting from the denial of rehearing en banc evidence “an unprecedented cry for help from [the Supreme Court] to clarify the patent eligibility of medical diagnostic tests.” Athena highlighted issues with Section 101 that it contends require clarification. According to Athena:

  1. Courts find it difficult to reconcile invaliding a diagnostic claim using man-made molecules as patent ineligible, when those molecules are non-natural products that may be patent eligible.
  2. Although Mayo related to a previously known drug and a previously performed measurement, there is uncertainty regarding how to weigh claims like those at issue here that apply a newly discovered natural law in a new process.
  3. Courts have ignored the level of specificity in the claims (reagents, techniques, etc.) and have even treated very specific claims as mere applications of natural law.
  4. The desire to avoid preemption of natural laws has turned into a “one-way ratchet” where preemption is sufficient, but not necessary, to render a claim ineligible.
  5. While claims are considered as a whole, existing Section 101 analysis requires breaking claims into individual elements to find a natural law.

Athena noted that, since the Supreme Court’s decision in Mayo, “the Federal Circuit has invalidated every diagnostic claim to come before it as ineligible subject matter.” And, it noted the USPTO’s rejection rate for diagnostic applications rose from 7% before Mayo to a high of 64% after Mayo.

On November 22, 2019, Mayo filed a brief in opposition, contending Athena’s patent is directed to a natural law, and the Supreme Court has already held in Mayo that claims to a natural law using only routine and conventional detection techniques are not patent eligible. Mayo disputes any negative impact to the diagnostics field and asserts a change to Section 101 eligibility is a matter reserved for Congress.

On December 9, 2019, Athena filed its reply brief, emphasizing that certiorari should be granted to clarify confusion surrounding Section 101. Athena emphasized the amicus briefs filed; the split in the Federal Circuit; and the United States’ suggestion in its brief in Hikma Pharms. USA Inc. v. Vanda Pharms. Inc. that the Court should grant certiorari in this case.

The Supreme Court has not yet decided the disposition of Athena’s petition.