Sequenom and the Future of Patentable Subject MatterJune 30, 2016

On June 27, the Supreme Court denied Sequenom’s petition from the Federal Circuit’s 2015 decision in Ariosa v. Sequenom. The relevant patent claimed methods of measuring cell-free fetal DNA (cffDNA) in maternal plasma and serum in order to identify fetal characteristics. The Federal Circuit assessed whether the claimed methods were directed to a naturally-occurring phenomenon, and thus unpatentable. Consistent with Supreme Court precedent, the Federal Circuit found the claims unpatentable, noting that where  “claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent-eligible subject matter if the methods [of collection] themselves are conventional, routine and well-understood applications in the art.‚¬

The Supreme Court’s refusal to hear the Sequenom case further cements the existing framework of assessing method claims created jointly through Alice and Mayo. In 2012, the Supreme Court held in Mayo Collaborative Services v. Prometheus Laboratories that processes of natural laws are not patentable unless the processes have additional features that provide practical assurance the process does more than monopolize a law of nature. The patent at issue in Mayo pertained to a method of testing and assessing levels of thiopurine in the blood stream, and providing an effective dosage of thiopurine accordingly. The court found that the steps of the method for assessing thiopurine blood levels and formulating a dosage merely informs about certain laws of nature; essentially this information amounts to a series of steps that add nothing significant beyond the sum of their parts taken separately. Again addressing method claims, albeit in a different discipline, the Supreme Court in Alice held that computer-implemented inventions drawn to an abstract idea are not patent-eligible simply by implementation using a generic computer. The patents inAlice covered a computerized trading platform that dealt with financial transactions where a third party settles obligations between two others so as to eliminate risk—essentially an electronic escrow service. The use of a generic computer for implementation failed to transform the abstract ideas of risk management into patent-eligible subject matter.

Based on the precedent of Alice and Mayo, the framework for assessing whether an abstract idea or natural phenomenon is patent eligible consists in asking (1) whether the claims at issue are directed to a patent-ineligible concept, and (2) if so, whether there is an inventive concept that transforms the abstract idea.Alice further noted that courts may consider whether there are any additional elements of each claim both individually and as an ordered combination to determine whether additional elements transform the claim into a patent-eligible application. This existing framework has posed significant challenges for the patentability of software as well as medical diagnostic and treatment methods. Those watching Sequenom’s petition had hoped the Supreme Court would accept, and relax the existing structure somewhat. However, the Court’s denial of Sequenom’s petition further solidifies the Alice-Mayo analysis, indicating the framework is here to stay for a while.

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