High Court Won't Review Sequenom Patent Eligibility Case

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By Tony Dutra

June 27 — The life sciences industry took a big hit June 27 when the U.S. Supreme Court denied Sequenom Inc.'s petition for review of natural phenomenon-based patent eligibility ( Sequenom, Inc. v. Ariosa Diagnostics, Inc., U.S., No. 15-1182, review denied, 6/27/16 ).

The U.S. Court of Appeals for the Federal Circuit said it was bound by the “sweeping language” of the Supreme Court's 2012 Mayo Collaborative Servs. v. Prometheus Labs. Inc. decision as it ruled against patenting the discovery here: detecting paternity-identifying DNA in a serum or plasma sample from a pregnant female. Sequenom asked the high court to clarify the test to allow a patent when the first discoverer of a natural phenomenon applies known techniques to produce a new medical diagnostic procedure.

The rejection comes despite statements by the appeals court, in panel opinions and en banc rehearing dissents, that Mayo went too far. The high court also was not swayed by the 22 amicus briefs urging a broader view of patentable subject matter under 35 U.S.C. §101.

Source Material:

Case below: 788 F.3d 1371 (Fed. Cir. 2015)

Documents (No. 15-1182): Petition 3/21/16 Ariosa response 5/20/16 Natera response 5/20/16 Reply 6/6/16

Sequenom's U.S. Patent No. 6,258,540 underlies its MaterniT21 test. The case arose when Ariosa Diagnostics Inc. of San Jose, Calif., and Natera Inc. of San Carlos, Calif., filed separate complaints seeking a declaration that their Harmony Test and Non-Invasive Paternity Test, respectively, do not infringe any claims of Sequenom's patent.

The Federal Circuit ruled that Sequenom's discovery was directed to the natural phenomenon of paternally inherited cell-free fetal DNA (cffDNA)—failing step one of the Mayo test—and that its method of detection was merely routine and conventional activity—failing step two. Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371, 115 U.S.P.Q.2d 1152 (Fed. Cir. 2015)(114 PTD, 6/15/15).

Though the full court denied Sequenom's request for en banc rehearing, Judge Pauline Newman said that Mayo could be distinguished, Judge Timothy B. Dyk said he would draw a different line than the Supreme Court and Judge Alan D. Lourie, joined by Judge Kimberly A. Moore, flatly disagreed with the high court. Ariosa Diagnostics Inc. v. Sequenom Inc., 809 F.3d 1282, 117 U.S.P.Q.2d 1153 (Fed. Cir. 2015).

Goldstein & Russell P.C., Bethesda, Md., represented Sequenom. Irell & Manella LLP, Los Angeles, represented Ariosa, and Gibson Dunn & Crutcher LLP, Washington, represented Natera and its licensee, Diagnostics Center Inc.

To contact the reporter on this story: Tony Dutra in Washington at adutra@bna.com

To contact the editor responsible for this story: Mike Wilczek in Washington at mwilczek@bna.com

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