Federal Circuit Issues Eight Opinions Explaining the Decision Denying En Banc Review of Diagnostic Method Patent

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, No. 2017-2508 (Fed. Cir. July 3, 2019), the Federal Circuit denied a petition for rehearing en banc where the previous panel had held the asserted medical-diagnostic claims in this case unpatentable under the Supreme Court’s Mayo decision. The Court held that the claims in this case were directed to a law of nature, namely the correlation between the presence of particular MuSK autoantibodies in bodily fluid and certain neurological diseases.

The per curium order, however, was accompanied by 8 separate opinions: 4 concurrences (to which 7 judges subscribed) and 4 dissents (offered by the remaining 5 judges). The majority judges’ reading of the Supreme Court’s Mayo decision was that the medical-diagnostic claims in this case must be held unpatentable, although all of them questioned the wisdom of this outcome. The remaining 5 judges wanted to “rethink” their previous interpretation of Mayo, believing that its holding had been extended too far. What all the judges agreed on was that clarification or reevaluation is needed from Congress or the Supreme Court on the correct scope of § 101 as applied to the medical-diagnostic methods in this case.