Illumina, Inc. v. Ariosa Diagnostics, Inc.

356 F. Supp. 3d 925
CourtDistrict Court, N.D. California
DecidedDecember 24, 2018
DocketCase No. 18-cv-02847-SI
StatusPublished
Cited by3 cases

This text of 356 F. Supp. 3d 925 (Illumina, Inc. v. Ariosa Diagnostics, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Illumina, Inc. v. Ariosa Diagnostics, Inc., 356 F. Supp. 3d 925 (N.D. Cal. 2018).

Opinion

SUSAN ILLSTON, United States District Judge

On May 15, 2018, plaintiffs Illumina, Inc. and Sequenom, Inc. (collectively "plaintiffs") filed this action against Ariosa Diagnostics, Inc. ("Ariosa"), Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc., (collectively "Roche"), alleging infringement of U.S. Patent Nos. 9,580,751 ("the '751 patent") and 9,738,931 ("the '931 patent"). Dkt. No. 1. This case was assigned to this Court on June 6, 2018. Dkt. No. 16.

Roche answered the complaint on July 9, 2018 and counterclaimed against plaintiffs, seeking declaratory judgment of noninfringement and invalidity of both asserted patents. Dkt. No. 21. Ariosa responded to the complaint with substantially the same answer and counterclaims on July 9, 2018. Dkt. No. 25. On August 9, 2018, both defendants modified their responses and submitted amended answers and counterclaims *928against plaintiffs. Dkt. Nos. 40, 41. Plaintiffs answered the amended counterclaims on August 23, 2018. Dkt. Nos. 46, 47.

On August 31, 2018 all defendants moved for summary judgment, seeking a finding that claims 1, 2, 4, 5, and 9-10 of U.S. Patent No. 9,580,751 and claims 1-2 and 10-14 of U.S. Patent No. 9,738,931 are invalid and unenforceable because they are not drawn to patent-eligible subject matter under 35 U.S.C. § 101. Dkt No. 48 at 1:10-14. The parties stipulated to an enlargement of time for plaintiffs to respond, which the Court granted. Dkt. Nos. 51-53. Oral argument was held on December 21, 2018.

I. The '751 Patent

Illumina is the exclusive licensee of the '751 patent pursuant to an amended 2014 Pooled Patents Agreement between Illumina and Sequenom. Dkt. No. 1 ¶ 7. The '751 patent is titled "Non-Invasive Detection of Fetal Genetic Traits," and was issued to inventors Sinuhe Hahn, Wolfgang Holzgreve, Bernhard Zimmermann, and Ying Lim on February 28, 2017 and assigned to Sequenom, Inc. U.S. Patent No. 9,580,751. The '751 patent relates to prenatal detection methods performed on a maternal serum or plasma sample from a pregnant female, and the claims specifically focus on procedures to separate fetal and maternal DNA in a maternal blood sample. See id. at 7:55-9:8. The basis for the patent is the "surprising finding" that "fetal DNA has a relatively small size of approximately 500 base pairs or less" and separating the smaller fragments "provides a possibility to enrich for fetal DNA sequences from the vast bulk of circulatory extracellular maternal DNA." Id. at 1:56-2:6.

According to the patent, "the presence of circulatory extracellular DNA in the peripheral blood is a well established phenomenon" and it has been shown that "fetal DNA is present in the maternal circulation." Id. at 1:22-25. However, it can be difficult to examine the fetal DNA because that "major proportion (generally > 90%) of the extracellular DNA in the maternal circulation is derived from the mother." Id. at 1:35-44. Separation by size discrimination from maternal DNA "leads to a fraction which is largely constituted by fetal extracellular DNA" that can then be analyzed for various fetal genetic traits. Id. at 2:7-20.

The only independent claim of the '751 patent is as follows:

1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
(a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 500 base pairs,
wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
(c) analyzing a genetic locus in the fraction of DNA produced in (b).

Id. at 7:53-8:56.

II. The '931 Patent

Illumina is the exclusive licensee of the '931 patent pursuant to an amended 2014 Pooled Patents Agreement between *929Illumina and Sequenom. Dkt. No. 1 ¶ 7. Like the '951 patent, the '931 patent is entitled "Non-Invasive Detection of Fetal Genetic Traits," and was issued to inventors Sinuhe Hahn, Wolfgang Holzgreve, Bernhard Zimmermann, and Ying Lim on February 28, 2017 and assigned to Sequenom, Inc. U.S. Patent No. 9,738,931. The '931 patent relates to prenatal detection methods performed on a maternal serum or plasma sample from a pregnant female and the claims specifically focus on procedures to separate fetal DNA from a maternal sample through size discrimination methods. See id.

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Related

Illumina, Inc. v. Ariosa Diagnostics, Inc.
967 F.3d 1319 (Federal Circuit, 2020)

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