Federal Circuit's Ariosa Decision, Good Chance For Rehearing En Banc

In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of many since the Supreme Court's Mayo decision involving patent invalidation under Section 101 of the Patent Act, Ariosa is unusual in that the asserted patent covered what most experts in the medical field consider to be a groundbreaking discovery; the very type of discovery that the patent system is intended to protect. In response to the panel's decision, and perhaps encouraged by Judge Linn's provocative concurrence, the Appellant, Sequenom, filed a petition for rehearing en banc and twelve amici curiae filed briefs in support of Sequenom's petition. On October 19, Appellees Ariosa and Natera filed responses to Sequenom's petition following an invitation from the Federal Circuit. While it is always difficult to predict whether the Federal Circuit will rehear a case en banc, the court's invitation for a response from the Appellees, Linn's concurrence, and the strong support of Sequenom's amici curiae suggest that the prospect for Ariosa is promising.

A Primer on Patentable Subject Matter

It is an undisputed doctrine of patent law that laws of nature, natural phenomena, and abstract ideas are not eligible for patent protection. And since 2010, the Supreme Court has expanded on this doctrine, issuing four landmark rulings invalidating patents under Section 101. Bilski v. Kappos, 561 U.S. 593 (2010); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012); Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013); Alice Corp. v. CLS Bank International, __ U.S. __, 134 S. Ct. 2347 (2014). In each of the four cases, the Supreme Court reinforced the doctrine of patent-ineligibility as a means of invalidating patents.

The current framework for analyzing patent eligibility is a two-part test that was established by the Supreme Court in Mayo. Mayo, 566 U.S. at 1297. First, courts must determine whether the claims are generally directed to a patent-ineligible concept (i.e., a law of nature, natural phenomenon, or abstract idea). Id. If the question is answered in the affirmative, courts must then determine whether the claims contain an "inventive concept," or "elements or a combination of elements... sufficient to ensure that the patent in practice...