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ARTICLE · 16 JUNE 2015

Fed Circuit: Sequenom's Diagnostic Method Claims Invalid Under §101

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
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The Mayo framework provides that first whether the claims at issue are directed to a patent-ineligible concept is determined.

United StatesIntellectual Property

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed the Northern District of California's finding that the method claims in U.S. Patent 6,258,540 ('540 patent) for detecting paternally-inherited cell-free fetal DNA ("cffDNA") in maternal plasma or serum were invalid because these claims were not directed to patent eligible subject matter (Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 2014-1139, 2014-1144 (Fed. Cir., June 12, 2015)). The inventors of the '540 patent established methods for detecting paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The Court applied a 2 part test as set forth in Mayo (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (U.S. 2012)) and held that "[w]here claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible

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