By: Jeffrey G. Sheldon, Esq.

ed55cf55-3f6c-4bbd-8b87-5e32fcb38cadIn a case closely followed by those in the diagnostic biotechnology field, the United States Supreme Court recently denied Sequenom’s petition to review the Federal Circuit’s ruling in Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015).

Sequenom’s patent had been invalidated by the lower courts as not patent-eligible because, among other things, the claims do nothing more than “detect” a naturally occurring phenomenon.

The denial of Sequenom’s petition leaves the uncertainty which began in 2012 with the Supreme Court’s decision in Mayo Collaborative v. Prometheus Labs, 566 U.S. __, 132 S.Ct. 1289 (2012), which applied the law of patent eligibility under 35 U.S.C. §101 to the diagnostic technology field in order to prevent patents being granted to a particular law of nature, natural phenomena or abstract idea – none of which are patent eligible. The effect of the Mayo ruling has been to deny patent eligibility to inventions, particularly in the diagnostic and computer software fields.

Since the Mayo decision, there has been uncertainty as to whether or not novel diagnostic methods could be protected and enforced. The claim term “diagnosis” triggers the Mayo analysis and ultimately rendereds the claim unpatentable. However, neither the courts nor the U.S. Patent Office has identified what can constitute eligible subject matter for a diagnostic patent claim.  Given the importance of diagnostic inventions, this uncertainty has been a source of frustration and debate within the biotechnology industry.

Although Sequenom’s petition was denied, it is inevitable that the Federal Circuit must return to the question. However, if the Federal Circuit is as constrained by Mayo as is believed by most many patent practitioners, perhaps only Congress can come to the rescue.

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