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Illumina, Inc. v. Ariosa Diagnostics, Inc.

“Method of Preparation” for Purifying/Amplifying Fetal DNA Held Patent Eligible

Illumina, Inc. v. Ariosa Diagnostics, Inc., __ F.3d __, 2020 WL 1264002 (Fed. Cir. Mar. 17, 2020) (LOURIE, Moore, Reyna (dissenting)) (N.D. Cal.: Illston) (4 of 5 stars)

Fed Cir reverses summary judgment finding Illumina’s claims unpatentable as addressing subject-matter ineligible natural phenomena under § 101. Illumina’s claims related to methods of preparing/amplifying cell-free fetal DNA in a sample taken from a mother’s bloodstream. The opinion reasons, “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” Op. at 8. Assuming without deciding that Illumina’s claims relate to the natural phenomenon that “cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream,” the opinion reasons that the claims are not “directed to that natural phenomenon but rather to a patent-eligible method that utilizes it.” Id. at 9. It reasons that because the claims employ “specific process steps” that change the mixture’s composition so as to result in a “DNA fraction that is different from the naturally-occurring fraction in the mother’s blood,” the claims are patent-eligible. Ariosa, 788 F.3d 1371 (Fed. Cir. 2015), is not contrary because those claims merely addressed detection of a natural phenomenon, whereas these are to development of a preparation. Myriad, 569 U.S. 576 (2013), is also not contrary because those claims were to a naturally occurring DNA segment, and that opinion expressly declined to extend its holding to method claims addressing a preparation. The opinion also cites CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016), approvingly, noting that in that case a method of preserving hepatocytes was patent eligible notwithstanding that the method related to an observation that hepatocytes can survive multiple free-thaw cycles.

Dissent: Judge Reyna reasons that the patents’ “only claimed advance is the discovery of [a] natural phenomenon.” Dissent at 1. His opinion emphasizes that, other than the discovery that cell-free fetal DNA is generally shorter than maternal DNA, the patents have nothing new or useful about the invention. In his view the majority’s treatment of “methods of preparation” differently from other methods under Ariosa is impermissible. Because Illumina’s claims merely “apply[ ] a known laboratory technique to a newly discovered natural phenomenon,” id. at 11, and because of additional concerns about Illumina’s claims preempting a broad array of work, Judge Reyna would have affirmed.

KEYWORDS: PATENTABLE SUBJECT MATTER; NATURAL PHENOMENA; METHOD CLAIMS; LIFE SCIENCES