ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC.

ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC., Appeal No. 2019-1419 (Fed. Cir. March 17, 2020).  Before Lourie, Moore, and Reyna.  Appealed from N.D. Cal. (Judge Illston).  (Patent Eligibility)

Background:

In a 2015 decision, the Federal Circuit held that the claims of a patent owned by Sequenom were invalid under 35 U.S.C. §101 because they were directed to the natural phenomenon that cell-free fetal DNA exists in maternal blood.  Illumina is the licensee of two related Sequenom patents that are directed to distinguishing and separating the tiny amount of fetal DNA from the vast amount of maternal DNA present in a maternal blood sample for further analysis.  Specifically, the patents claim methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA by size discrimination and selective removal of DNA fragments that are above a specified size threshold, followed by analyzing the DNA in the obtained fraction.  Illumina sued Ariosa for infringement of the two patents.  Ariosa moved for summary judgment, arguing that the claims are directed to the patent-ineligible natural phenomenon that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in maternal blood.  The district court granted Ariosa’s motion for summary judgment, holding the claims of the two patents invalid under 35 U.S.C. §101.

Issue/Holding:

Did the district court err in holding the claims invalid under 35 U.S.C. §101?  (continue reading)

Summary by:  Megan Doughty

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