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