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Verinata Health, Inc. v. Sequenom, Inc.

United States District Court, N.D. California

February 2, 2015

VERINATA HEALTH, INC., et al., Plaintiffs,
v.
SEQUENOM, INC., et al., Defendants.

ORDER DENYING CROSS MOTIONS FOR SUMMARY JUDGMENT AND STAYING CASE

SUSAN ILLSTON, District Judge.

On January 23, 2015 the Court heard argument on the parties' cross motions for summary judgment. Having considered the arguments of the parties and the papers submitted, the Court hereby DENIES the parties' motions for summary judgment. Additionally, the Court STAYS this proceeding as set forth below.

BACKGROUND

I. Factual Background

The innovations at issue involve methods to conduct non-invasive prenatal DNA testing. Fetal DNA testing can aid sex determination, blood typing and other genotyping, and detection of pre-eclampsia in the mother. It can also detect fetal aneuploidy, which is a disorder in which the fetus has an abnormal number of chromosomes, instead of the normal 23 pairs. Common aneuploidy disorders include Down syndrome (a third copy, or "trisomy, " of chromosome 21), Edwards syndrome (a third copy of chromosome 18), and Patau syndrome (a third copy of chromosome 13).

On February 15, 2011, the PTO issued the 017 patent, entitled "Non-invasive Fetal Genetic Screening by Digital Analysis, " and on August 30, 2011, it issued the 018 patent, entitled "Determination of Fetal Aneuploidies by Massively Parallel DNA Sequencing." The 018 patent is a continuation of the 017 patent, and has a nearly identical specification. Stanford is the patent owner and Verinata is the exclusive licensee of these patents. They previously alleged that Sequenom was infringing these patents. See Verinata I, infra.

The patents explain that "[s]ince aneuploidies do not present a mutational change in sequence, and are merely a change in the number of chromosomes, it has not been possible to detect them in a fetus without resorting to invasive techniques, " because researchers believed that determining whether a fetus was carrying an extra chromosome required distinguishing fetal DNA from maternal DNA. The 018 Patent, Abstract. However, the patent inventors discovered that "digital amplification allows the detection of aneuploidy using massively parallel amplification and detection methods." Id. By using sophisticated molecular counting techniques, the researchers could determine small under or over-representations of a chromosome that would reveal fetal aneuploidy, without the need to distinguish between the maternal and fetal DNA. See id. 21:10-30.

II. Procedural Background

This dispute began in 2011, when Ariosa[1] filed a declaratory relief action against Sequenom, seeking a declaration that Ariosa's "Harmony Test" does not infringe any claims of U.S. Patent No. 6, 258, 540 ("the 540 patent"). Aria Diagnostics, Inc. v. Sequenom, Inc., C 11-6391-SI (filed Dec. 19, 2011). Sequenom filed a counterclaim against Ariosa, asserting infringement of Sequenom's 540 patent. Subsequently, two other companies, Natera and Verinata, also filed declaratory judgment actions in this Court seeking judgments that their products do not infringe Sequenom's 540 patent and asserting that the 540 patent is invalid. See Natera Inc. v. Sequenom, Inc., C 12-0132-SI (filed Jan. 6, 2012) (regarding Natera's "Non-Invasive Paternity Test"); Verinata Health, Inc. v. Sequenom, Inc. (Verinata I), C 12-0865-SI (filed Feb. 22, 2012) (regarding Verinata's "Verifi Prenatal Test"). Sequenom then filed counterclaims alleging that Natera, DNA Diagnostics Center, Verinata, and Stanford are infringing the 540 patent. See id. On October 30, 2013, this Court held the 540 patent to be invalid. Sequenom has appealed this ruling to the Federal Circuit, and that appeal is pending. C 11-cv-6391 SI, Docket No. 254.

In Verinata I, Verinata[2] and Stanford also alleged that Sequenom was infringing U.S. Patent Nos. 7, 888, 017 ("the 017 patent"), 8, 008, 018 ("the 018 patent"), and 8, 195, 415 ("the 415 patent"). In addition, Verinata and Stanford filed a case alleging that Ariosa and LabCorp are infringing U.S. Patent Nos. 8, 296, 076 ("the 076 patent") and 8, 318, 430 ("the 430 patent"). See Verinata Health, Inc. v. Ariosa Diagnostics, Inc. (Verinata II), C 12-5501-SI (filed Oct. 25, 2012). Finally, Illumina filed a case alleging that Ariosa is infringing U.S. Patent No. 7, 955, 794 ("the 794 patent"). See Illumina, Inc. v. Ariosa Diagnostics, Inc., C 14-1921-SI (filed April 25, 2014). This final action was consolidated with Verinata II.

Verinata and Sequenom ultimately reached a settlement in Verinata I which resolved all of their respective claims, save the issue of written description of the 018 Patent and 833 Application, Docket No. 320, which is the subject of the present motion.

Beginning in March 2013, the Patent Trial and Appeal Board ("PTAB") declared three interferences between (1) patents and patent applications listing as inventors Drs. Yuk-Ming Dennis Lo, Rossa Wai Kwun Chiu, and Kwan Chee Chan of the Chinese University Hong Kong ("CUHK") (collectively, "Lo") and (2) patents and patent applications listing as inventors Drs. Stephen Quake and Hei-Mun Christina Fan of Stanford University, (collectively, "Quake"). On April 7, 2014, the PTAB issued orders finding that the claims of the 018 Patent and 833 Application lack a sufficient written description as required by 35 U.S.C. § 112(a).[3] Docket No. 252, Bosch Decl. Exhs. 3-5.

Stanford appealed the PTAB's decision pursuant to 35 U.S.C. § 146. Now before the Court are Stanford and CUHK's cross-motions for summary judgment on the issue ...


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