Ariosa Diagnostics Prevails in Patent Battle Against Sequenom

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October 2013

On October 30, Irell & Manella LLP secured a major court victory for its client Ariosa Diagnostics, Inc., a San Jose-based molecular diagnostics company, 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, Ltd. In a 20-page ruling, Judge Susan Illston of the U.S. District Court for the Northern District of California granted summary judgment in favor of Ariosa, thereby invalidating the '540 patent and giving Ariosa a complete victory in the case. The patent was based on naturally-occurring cell-free fetal DNA in blood samples from pregnant women, and Sequenom claimed that it covered tests for non-invasive prenatal testing for fetal chromosomal abnormalities such as the abnormality that causes Down syndrome. The patent was invalidated because the Court found it attempted to cover a natural phenomenon, which is not patent-eligible subject matter.

Sequenom spent almost two years trying to prevent Ariosa from making and selling its popular HarmonyTM Prenatal Test, but Irell successfully beat back Sequenom’s repeated attempts to block its sale with an injunction. The decision allows Ariosa to continue selling the HarmonyTM Prenatal Test, an affordable, highly accurate, non-invasive blood test for maternal and fetal health.

The Court’s decision traces law on patent subject matter eligibility under Section 101 of the Patent Act from 1948 to the present. Among other cases, it relies on the Supreme Court’s 2013 Association for Molecular Pathology v. Myriad decision, which struck down a patent that allegedly covered a test for breast cancer. Judge Illston’s highly significant ruling is believed to be among the first invalidations of a diagnostic patent by a court since Myriad was decided, and thus will likely be studied carefully by lawyers and scientists in the molecular diagnostics field.

Ariosa is represented by David Gindler, Andrei Iancu, Sandra Haberny and Lauren Drake.