Court Upholds Patent Eligibility of “Method of Preparation” Claims in Modified Opinion

In Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. Aug. 3, 2020), the Federal Circuit denied Appellees’ petition for a rehearing en banc, but granted their petition for panel rehearing in order to withdraw and replace the original March 17, 2020 opinion. The divided panel maintained their holding that the claims of Illumina’s patents are directed to patent-eligible subject matter but modified the opinion to expand upon and further clarify their reasoning.

The majority again concluded that the claims of U.S. Patent Nos. 8,580,751 and 9,738,931 are patent eligible because they are directed to methods of preparing a fraction of cff-DNA that balanced the need to exclude maternal DNA while retaining enough fetal DNA for testing. The Court found that these particular patents “exploited” the natural phenomenon that cff-DNA tends to be shorter than maternal DNA, but explained that the claims were nevertheless directed to patent-eligible subject matter because “human-engineered [size] thresholds” were utilized to carry out the separation. The majority emphasized “human-engineered” multiple times in the modified opinion.

Judge Reyna renewed his dissent, arguing that the claims were directed to a natural phenomenon because they “involved” a natural law, and that conventional separation techniques were, in his view, insufficient to save the patents.