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Article: May 2020: Life Sciences Update

Supreme Court Denies Certiorari in Closely Watched Athena Case

On January 13, 2020, after its conference on January 10, 2020, the United States Supreme Court denied certiorari in Athena Diagnostics Inc. v. Mayo Collaborative Services, LLC, No. 19-430--despite the unusual situation of several Federal Circuit judges requesting the Supreme Court take up the case.

In Athena, the patent holder sued for infringement of a patent directed to a diagnostic test that required detecting the presence of certain antibodies by contacting the sample with a radioactive-labeled protein. The district court dismissed the case, ruling the patent invalid based on 35 U.S.C. § 101 pursuant to Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), as claiming a law of nature as opposed to a patentable invention.

The Court of Appeals for the Federal Circuit affirmed the decision. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 753-54 (Fed. Cir. 2019). And on July 3, 2019, the Federal Circuit denied Plaintiff Athena’s petition for rehearing en banc. 927 F.3d 1333 (Fed. Cir. 2019). The denial of the petition, however, led to eight separate concurring and dissenting opinions from active Federal Circuit judges, an unusually large number, demonstrating significant splits of opinion regarding the patentability of diagnostic test kits, as well as express requests for either Supreme Court or Congressional clarification regarding such patentability.

Accordingly, on October 1, 2019, Athena filed a petition for writ of certiorari at the United States Supreme Court. Over ten parties submitted briefs in support of the Court taking up the case and revisiting or clarifying its precedent regarding subject matter eligibility for diagnostic testing patents. Athena’s petition focused on the multiple opinions below, arguing that the Federal Circuit is divided and has called for the Court’s guidance and that there were many “points of confusion” in applying the Court’s precedent.

As mentioned above, despite the several opinions of Federal Circuit judges, the Court denied the petition. Following the denial, commentators have noted that the issue of patent eligibility for diagnostic test kits can be addressed in Congress by statute instead of asking the Supreme Court to clarify or amend its precedent. Indeed, Judge Hughes of the Federal Circuit (joined by Judges Prost and Taranto), as well as Judge O’Malley, called for Congress to intervene on this issue. 927 F.3d at 1337, 1373. It remains to be seen whether Congress will take up this issue, but that appears to be the next battleground for diagnostic testing patents.