Federal Circuit Finds Patent Eligibility of “Method of Preparation” Claims

In Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. Mar. 17, 2020), the Federal Circuit reversed the district court’s grant of summary judgment, holding that the claims of U.S. Patent Nos. 8,580,751 (“the ’751 patent”) and 9,738,931 (“the ’931 patent”) were directed to patent-eligible subject matter and were not invalid under 35 U.S.C. § 101.

The claims of the ’751 and ’931 patents are directed to methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA. Illumina filed suit against Ariosa alleging infringement of the ’751 and ’931 patents.  Ariosa moved for summary judgment of invalidity under 35 U.S.C. § 101. The district court granted Ariosa’s summary judgment motion, holding that the claims of the ’751 and ’931 patents were directed to ineligible subject matter.

On appeal, the Federal Circuit reversed the district court’s grant of summary judgment and remanded the case for further proceedings. The Court began by noting that “[t]his is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” Applying step one of the Alice/Mayo test, the Court considered whether the claims were “directed to” the natural phenomenon that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream. The majority held that the claims were not directed to a natural phenomenon, but rather, to a patent-eligible method that “exploit[s] that discovery in a method for preparation of a mixture enriched in fetal DNA.”  Thus, the majority held that the claims were not directed to patent-ineligible subject matter.

Judge Reyna dissented, arguing that the claims are directed to a natural phenomenon and that the method steps are routine, conventional steps that are not sufficient to yield patent eligible subject matter.