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<i>Ariosa Diagnostics v. Sequenom </i>
On June 12, 2015, the U.S. Court of Appeals for the Federal Circuit, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., slip opinion No. 2014-1139, 2014-1144 (Fed. Cir. June 12, 2015), affirmed a grant of summary judgment of invalidity of another patent in the biotech space. The patent at issue ' U.S. Patent No. 6,258,540, directed to methods of detecting and using cell-free fetal DNA in non-invasive prenatal diagnosis ' was deemed invalid for lack of patent-eligible subject matter. The decision adds to a long and growing list of patents that have fallen in the wake of the Supreme Court's recent 35 U.S.C. '101 jurisprudence. See, Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012); Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, 133 S. Ct. 2107 (2013); Alice Corp. v. CLS Bank Int'l, 573 U.S. ___, 134 S. Ct. 2347 (2014); Bilski v. Kappos, 561 U.S. 593 (2010).
The Patent in Sequenom
The claims of the '540 patent at issue in Sequenom are directed to methods of amplifying and detecting the small fraction of paternally inherited cell-free fetal (cff) DNA from within the total amount of cffDNA circulating in the maternal bloodstream. Cell-free fetal DNA is difficult to differentiate from cell-free maternal DNA, but the inventors of the '540 Patent discovered that by focusing on specific sequences of paternal DNA that the mother is known to not share, cffDNA can be readily distinguished from cell-free maternal DNA. See, Appellants' Petition for Rehearing en Banc at 4, Ariosa, supra note 1. This was a significant discovery. Researchers had long utilized the cellular portion of maternal blood in prenatal diagnoses. However, maternal plasma and serum was never used for that purpose. It was routinely discarded as waste prior to the discovery of cffDNA in it and prior to the filing of the '540 Patent. See, Appellants' Petition at 3, supra note 3.
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