Tuesday, March 24, 2020

ND Cal reversed by CAFC in Illumina case

The outcome:

Illumina, Inc. and Sequenom, Inc. (collectively, “Illumina”) appeal from a decision of the United States District
Court for the Northern District of California that claims 1–
2, 4–5, and 9–10 of U.S. Patent 9,580,751 (the “’751 patent”) and claims 1–2 and 10–14 of U.S. Patent 9,738,931
(the “’931 patent”) are invalid under 35 U.S.C. § 101 as directed to an ineligible natural phenomenon. Illumina, Inc.
v. Ariosa Diagnostics, Inc., 356 F. Supp. 3d 925 (N.D. Cal.
2018) (“Decision”). Because we conclude that the claims
are directed to patent-eligible subject matter, we reverse.

This was a summary judgment case:

We review a grant of summary judgment according to
the law of the regional circuit. Kaneka Corp. v. Xiamen
Kingdomway Grp. Co., 790 F.3d 1298, 1303 (Fed. Cir. 2015)
(citing Halo Elecs., Inc. v. Pulse Elecs., Inc., 769 F.3d 1371,
1377 (Fed. Cir. 2014)). In the Ninth Circuit, a grant of
summary judgment is reviewed de novo. Leever v. Carson
City, 360 F.3d 1014, 1017 (9th Cir. 2004) (citing Hargis v.
Foster, 312 F.3d 404, 409 (9th Cir. 2002)). Summary judgment is appropriate when “there is no genuine dispute as
to any material fact and the movant is entitled to judgment
as a matter of law.” Fed. R. Civ. P. 56.

The CAFC said this was NOT a diagnostic case:

This is not a diagnostic case. And it is not a method of
treatment case. It is a method of preparation case.

Under Mayo, we have consistently held diagnostic
claims unpatentable as directed to ineligible subject matter. See Athena Diagnostics, Inc. v. Mayo Collaborative
Servs., LLC, 927 F.3d 1333, 1352 (Fed. Cir. 2019) (Moore,
J., dissenting from denial of rehearing en banc) (“Since
Mayo, we have held every single diagnostic claim in every
case before us ineligible.”); see also, e.g., Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743
(Fed. Cir. 2019); Cleveland Clinic Found. v. True Health
Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); Cleveland
Clinic Found. v. True Health Diagnostics LLC, 760 F. App’x
1013 (Fed. Cir. 2019). In contrast, we have held that
method of treatment claims are patent-eligible. See Endo
Pharm. Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347 (Fed.
Cir. 2019); Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019); Vanda
Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d. 1117
(Fed. Cir. 2018). The claims in this case do not fall into
either bucket, and we consider the claims under the Alice/Mayo test.


As an initial matter, there are differences between the
district court and the parties about how to articulate the
natural phenomenon that the inventors discovered. The
district court appeared to find that the relevant natural
phenomenon is either the “testable quantity” of fetal DNA
or “test results” obtained from that fetal DNA. Decision,
356 F. Supp. 3d at 933. Roche’s articulation of the natural
phenomenon was a moving target throughout its briefing
and at oral argument, but appears to be the “size distribution” of fetal to maternal cell-free DNA in a mother’s blood
reflected in Table 1 of the specification, with a particular
focus on the number “500 base pairs” as the critical dividing line between the two. See Appellee’s Br. 14, 18, 21; Oral
Arg. 27:58, 28:35, 29:16. And Illumina asserts more simply
that the inventors’ discovery was that “fetal cell-free DNA
tends to be shorter than maternal cell-free DNA.” Appellant’s Br. 24; see also id. at 8 (“[I]n a sample of cell-free
DNA from a pregnant woman, the DNA that arises from
the fetus is smaller on average than the DNA that arises
from the mother.”).


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