Ariosa Win Upheld by Federal Circuit

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June 2015

On June 12, 2015, Irell & Manella LLP secured an appellate victory in favor of Ariosa Diagnostics, Inc., a San Jose-based molecular diagnostics company.  In a major precedential opinion, the Court of Appeal for the Federal Circuit affirmed the district court’s summary judgment ruling invalidating, for failure to recite patent-eligible subject matter, the patent that Sequenom, Inc. had asserted against Ariosa in early 2012. The Federal Circuit’s ruling affirms Ariosa’s complete victory in the case. 

In the district court, Sequenom alleged that Ariosa’s popular Harmony™ Prenatal Test—a highly accurate, non-invasive blood test to evaluate the risk of fetal chromosomal abnormalities, such as Down Syndrome—infringed Sequenom’s patent, U.S. Pat. No. 6,258,540 (the “’540 patent”), which was based on the alleged discovery of naturally-occurring cell-free fetal DNA in the blood of pregnant women.  

In October 2013, Judge Susan Illston of the U.S. District Court for the Northern District of California granted summary judgment in favor of Ariosa, finding that the ’540 patent was invalid because it was not directed to patent-eligible subject matter.  The court found that the patent did nothing more than append routine and conventional scientific methods to the natural phenomenon of cell-free fetal DNA in a pregnant woman’s blood. The Federal Circuit affirmed the district court’s decision in full. Relying in large part on the Supreme Court’s 2012 opinion in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts, the Federal Circuit concluded that practicing the method claims in the ’540 patent “does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”  

The Irell team representing Ariosa included David Gindler, Andrei Iancu, Lisa Glasser, Mike Ermer, David Schwarz, Josh Gordon, Sandra Haberny, Cathy Moses, Lauren Drake and Elizabeth Tuan.