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The Intellectual Property StrategistColumns & DepartmentsIntellectual PropertyPatent Litigation

IP News

By Jeff Ginsberg and Matthew Weiss
May 01, 2020

Federal Circuit: Method of Preparation Claim is Patentable

On March 17, 2020, a Federal Circuit panel of Judges Lourie, Moore, and Reyna, issued an opinion, authored by Judge Lourie, with Judge Reyna dissenting, in Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 2019-1419. The panel reversed the Northern District of California's decision that claims directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA are directed to a natural phenomenon, concluding that the claimed subject matter is patent-eligible. Slip Op. at 2.

The asserted patents arose from a discovery that, in maternal plasma, most fetal DNA is smaller than most maternal DNA. Id. at 3-4. Following this discovery, the inventors developed "methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA." Id. at 4. The majority distinguished the present case from prior patent-eligibility cases by explaining that it was "not a diagnostic case" or "a method of treatment case" but was "a method of preparation case." Id. at 8. Since Mayo, the Federal Circuit has "consistently held diagnostic claims unpatentable as directed to ineligible subject matter" and found that "method of treatment claims are patent-eligible." Id. But a method of preparation does not fit neatly into either category.

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