Federal Circuit Judges Suggest Further Clarification Needed On Patent Eligibility in the Life Sciences

Author: Emily R. Gabranski
Editor: Jeff T. Watson

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Nos. 14-1139, -1144 (Fed. Cir. Dec. 2, 2015), the Federal Circuit denied Sequenom’s petition for a rehearing en banc of the panel’s decision that Sequenom’s asserted claims were patent ineligible under 35 U.S.C. § 101. The order was accompanied by two concurring opinions and one dissenting opinion.

In his concurring opinion, where he was joined by Judge Moore, Judge Lourie agreed with the panel’s application of Mayo Collaborative Services. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), but expressed concerns about the Mayo test itself. Judge Lourie wrote that Sequenom’s claims “should not be patent-ineligible on the ground that they set forth natural laws or are abstractions,” but rather “the finer filter of § 112 might be better suited to treating these as questions of patentability.” Similarly, in his concurring opinion, Judge Dyk voiced concern that “a too restrictive test . . . may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences.”

In contrast, Judge Newman disagreed with the panel’s application of Mayo, writing in her dissenting opinion: “Precedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting.” Judge Newman also stated that the facts of Ariosa “diverge significantly” from the facts and rulings of Mayo.


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