The Federal Circuit recently handed down a long-awaited Section 101 decision, one with potentially far-reaching consequences for biotech diagnostic patents. In Ariosa Diagnostics Inc. v. Sequenom Inc., No. 14-1139 (Fed. Cir. June 12, 2015), the Federal Circuit, applying the U.S. Supreme Court's test for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), invalidated Sequenom's breakthrough patent on noninvasive prenatal diagnosis through the amplification and detection of paternally inherited cell-free fetal DNA ("cffDNA") in the blood of pregnant women. According to the court, "even such valuable contributions can fall short of statutory subject matter" under the test set out in Mayo. In addition to its implications for other biotech patents and investment in diagnostics, the Federal Circuit's decision illustrates the potentially unintended consequences of Mayo and the need for a legislative solution so that breakthrough manmade inventions remain patent-eligible.
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