The United States Supreme Court on Monday, June 27, 2016 denied Sequenom Inc.’s petition for review of “natural phenomenon”-based patent eligibility. The Federal Circuit had previously ruled that based upon the “sweeping language” in the Supreme Court’s 2012 Mayo Collaborative Servs. v. Prometheus Labs. Inc. decision, detecting paternally inherited fetal DNA in a serum or plasma sample from a pregnant female is not patentable subject matter. Sequenom, startups, and large life science companies had hoped that the high court would grant Sequenom’s petition to clarify the test to allow a patent when the first discoverer of a natural phenomenon, in this case the presence of paternally inherited fetal DNA, applies known techniques, such as PCR, to produce a new medical diagnostic procedure.
Although this decision has many companies and potential investors spinning, Sequenom has stated that the impact to its business was minimized by having patent rights in multiple foreign jurisdictions.
Take-away: Seeking patent protection for diagnostics in foreign jurisdictions is more important than ever as the landscape in the United States remains uncertain. Petition in Sequenom, Inc. v. Ariosa Diagnostics, Inc., U.S., No. 15-1182, review denied 6/27/16.
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