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Court invalidates Sequenom's prenatal test patent

The US Court of Appeals for the Federal Circuit has dealt Sequenom a setback, ruling that the San Diego–based company's patent for its noninvasive prenatal test is invalid. The case has implications for innovation incentives and access to an important new technology. The decision upholds a ruling by a California district court in favor of Basel-based Roche's Ariosa Diagnostics unit, San Jose, California, against Sequenom in 2013. Sequenom's test, which uses DNA found in maternal blood samples to determine certain fetal characteristics, avoids the risk of more invasive tests, such as taking samples from the fetus or placenta. The court ruled that detecting DNA in blood falls under the US Supreme Court's rule against patenting natural phenomena (Nat. Biotechnol. 32, 403–404, 2014). While calling the test “a positive and valuable contribution to science...[e]ven such valuable contributions can fall short of statutory patentable subject matter, as it does here.” Another judge wrote in a concurring opinion that though he was obligated to invalidate the patent claims, “[b]ut for the sweeping language in the Supreme Court's Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”

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Court invalidates Sequenom's prenatal test patent. Nat Biotechnol 33, 791 (2015).

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