The Federal Circuit appeals court affirmed that Sequenom’s Patent No. 6,258,540 (referred to as the ‘540 Patent) relating to cell-free fetal DNA (cffDNA) didn’t assert claims that were patent eligible and was thus invalid. The decision confirms a trial court ruling that addresses a dispute between Sequenom and Ariosa Diagnostics, Inc., Natera Inc., and DNA Diagnostics Center, Inc. regarding alleged infringement of that patent. Sequenom’s patent relates to its MaterniT21 test. Sequenom claimed Ariosa’s Harmony Prenatal Test and Natera’s Non-Invasive Paternity Test (licensed to DNA Diagnostics Center, Inc.) violated the ‘540 Patent. The trial and circuit appeals courts agreed that the patent claims addressed a natural phenomenon that wasn’t patentable subject matter. The dispute arises out of a discovery of cffDNA in maternal plasma and serum. Two doctors took pre-existing, known technologies and applied them to this new discovery for diagnostic purposes. Doing so could avoid more risky and invasive tests previously used prenatally. The ‘540 patent didn’t claim patent eligibility for the cffDNA discovery but rather the methods for using that cffDNA. Relying on U.S. Supreme Court decisions regarding patentable subject matter in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Association for Molecular Pathology v. Myriad Genetics, the…
