San Jose, Calif., October 31, 2013 – Ariosa Diagnostics, Inc., won summary judgment yesterday in a patent infringement litigation involving U.S. Patent No. 6,258,540 against Sequenom, Inc., an exclusive licensee of the patent from Isis Innovations, Inc. The United States District Court for the Northern District of California invalidated the ‘540 patent at issue, giving Ariosa a complete victory in the case. The patent at issue is related to the detection of fetal cell-free DNA in the bloodstream of pregnant women, and Sequenom claimed that it applied to tests for the determination of certain fetal genetic characteristics. The Court invalidated Sequenom’s patent because it attempts to cover this natural phenomenon, which the Court found is not patent-eligible subject matter.
“Ariosa is an innovator in prenatal testing, and we are extremely pleased with the Court's decision in our favor,” said Dianna DeVore, vice president of intellectual property and legal affairs at Ariosa Diagnostics. The ruling extends established Supreme Court and Federal Circuit precedent, and validates Ariosa’s long-standing view that it has freedom to develop new, innovative and market-leading technologies to provide improved genetic testing for pregnant women.
In light of repeated public threats by Sequenom regarding enforcement of its ‘540 patent, Ariosa filed suit against Sequenom in December 2011, seeking a declaratory judgment that its Harmony™ Prenatal Test did not infringe Sequenom’s patent. Sequenom counterclaimed for patent infringement and moved for a preliminary injunction.
Sequenom unsuccessfully spent almost two years trying to prevent Ariosa from making and selling the Harmony Prenatal Test, a proprietary and innovative test that provides important information about whether a fetus is at risk of having certain chromosomal abnormalities, including Down syndrome, based on a simple blood draw from a pregnant woman.
Ariosa is represented in the litigation by Irell & Manella LLP.