June 11, 2015
Authored and Edited by Paula E. Miller; William B. Raich, Ph.D.
In Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), the CAFC affirmed the district court’s determination that the asserted method claims are invalid because they are not directed to patent eligible subject matter under 35 USC § 101. The patent at issue involves methods of amplifying and detecting cell-free fetal DNA in the plasma of pregnant women. The CAFC applied the two-step framework of Mayo Collaborative Services. v. Prometheus Laboratories, Inc., 132 (2012), holding that (1) the claimed methods were directed to an application that started and ended with a naturally occurring phenomenon and (2) the additional elements of the method did not amount to significantly more as they were conventional, routine, and well understood. Further discussions of the decision can be found on Finnegan’s Federal Circuit IP Blog and Finnegan’s IP Updates.
The CAFC denied Sequenom’s petition for a rehearing en banc in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282 (Fed. Cir. 2015). The order was accompanied by two concurring opinions and one dissenting opinion. Further discussions of the decision can be found on Finnegan’s Federal Circuit IP Blog.
United States Court of Appeals for the Federal Circuit (CAFC), Ariosa Diagnostics Inc. v. Sequenom Inc., patent-eligible, Food and Drug Administration (FDA)
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