Posts Tagged: "Ariosa v. Sequenom"

CAFC Affirms Invalidation of Stanford Organ Transplant Rejection Test in Latest Patent-Eligibility Blow to Medical Diagnostics

On July 18, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in CareDx, Inc. v. Natera, Inc. affirming a summary judgment ruling of the District of Delaware, which invalidated claims from three Stanford University patents licensed by CareDx as patent  ineligible. The decision marks yet another blow to medical diagnostic testing, this time in the context of organ transplants, and the prospects of their developers for obtaining enforceable patent rights.

Illumina v. Ariosa: En Banc Rehearing Denied, Illumina Patents Again Upheld on Rehearing

On August 3, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing en banc and issued a modified opinion, following a petition for rehearing filed by Ariosa in Illumina, Inc. v. Ariosa Diagnostics, Inc. Sticking closely to the reasoning of its March opinion, the CAFC reversed a decision by the United States District Court for the Northern District of California that claims of U.S. Patent Nos. 9,580,751 (the ’751 patent) and 9,738,931 (the ’931 patent) belonging to Sequenom and Illumina (Illumina) were invalid under 35 U.S.C. § 101 as being directed to an ineligible natural phenomenon.

Illumina v. Ariosa Diagnostics: A Closer Look

The Federal Circuit recently found that a method for preparing an extracellular DNA fraction from a pregnant human female and using it for analyzing a genetic locus involved in a fetal chromosomal aberration was not directed to a natural phenomenon, and thus eligible for patenting. Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. March 17, 2020) (“Illumina v. Ariosa”). The decision includes a dissent. Appreciation of the reasoning of both the Majority and the Dissent is essential to understanding the current state of the debate on subject matter eligibility of processes involving natural phenomenon. The all-important question in such cases centers on how to determine whether such an invention is directed to a judicial exception. Stated differently, when does an invention that uses a natural phenomenon turn into a patent-eligible process rather than being directed merely to the natural phenomenon?

CAFC Holds Sequenom’s Prenatal DNA Patent Claims Eligible Under 101

The U.S. Court of Appeals for the Federal Circuit (CAFC) has reversed a district court decision finding certain claims of two patents covering prenatal DNA testing patent ineligible. The CAFC held that “the claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps” and thus were patent-eligible. The patents at issue in the case acknowledge but are not related to the patented invention held invalid in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373 (Fed. Cir. 2015). The opinion was authored by Judge Lourie, with Judge Reyna dissenting.

Consider the Courage of Judge Newman at the Federal Circuit

With more dissents than any other Federal Circuit Judge in history,  Judge Pauline Newman is driven by a need to safeguard our national system of innovation. Judge Newman has argued throughout the years that the Federal Circuit was created to rebuild and renew the patent system to encourage and incentivize industry, which is precisely the purpose both the Carter and Reagan Administrations had in mind when advocating for the creation of the Federal Circuit, which ultimately took form in 1982. Judge Newman has no qualms about speaking out in dissents when the objective of the Federal Circuit to bring certainty to U.S. patent laws is being hindered, in her view, by the majority, regardless of the complexities or dollar-values at stake in the case. In fact, in one interview she declared, “I have not hesitated to comment when I think that a panel isn’t going in quite [the] appropriate direction. Others have felt that perhaps I haven’t gone in quite the appropriate direction . . . . [A]ll in all it seems to me that it’s quite healthy to present a certain amount of turmoil to practitioners in the short run. But in the long-run I think the law is better for it.” George C. Beighley, Jr., “The Court of Appeals for the Federal Circuit: Has It Fulfilled Congressional Expectations?,” 21 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 671, 675–76 (2011). Clearly, she is interested in getting the law right for the greater good as she sees it, regardless of the impact her dissent may have on relationships or status quo.