Ariosa Diagnostics, Inc.v. Sequenom, Inc., No. 14-1139 (Fed. Cir. 2015)Annotate this Case
In 1996, Drs. Lo and Wainscoat discovered cell-free fetal DNA (cffDNA) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery,they implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, they obtained the 540 patent, which does not claim cffDNA or paternally inherited cffDNA, but claims methods of using cffDNA to diagnose certain fetal characteristics based on the detection of paternally inherited cffDNA. The district court found that the asserted claims of the 540 patent are not directed to patent eligible subject matter and were invalid under 35 U.S.C. 101. The Federal Circuit affirmed. While the discovery regarding cffDNA was a significant contribution to the medical field, that alone does not make it patentable.