Ariosa Diagnostics, Inc. v. Sequenom, Inc.

19 F. Supp. 3d 938, 2013 WL 5863022, 2013 U.S. Dist. LEXIS 156554
CourtDistrict Court, N.D. California
DecidedOctober 30, 2013
DocketNo. C 11-06391 SI
StatusPublished
Cited by4 cases

This text of 19 F. Supp. 3d 938 (Ariosa Diagnostics, Inc. v. Sequenom, 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
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 19 F. Supp. 3d 938, 2013 WL 5863022, 2013 U.S. Dist. LEXIS 156554 (N.D. Cal. 2013).

Opinion

ORDER GRANTING PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT AND DENYING DEFENDANT’S MOTION FOR SUMMARY JUDGMENT

SUSAN ILLSTON, United States District Judge

Cross-motions for summary judgment by plaintiff/counterdefendant Ariosa Diagnostics, Inc. and defendant/counterclaim-ant Sequenom, Inc. came on for oral argument on October 11, 2013. Having considered the parties’ motion papers, pleadings and arguments, and for good cause shown, the Court GRANTS Ariosa’s motion for summary judgment and DENIES Sequenom’s motion for summary judgment.

BACKGROUND

In this declaratory judgment action, plaintiff Ariosa, formerly known as Aria Diagnostics, Inc., seeks a declaration that its non-invasive prenatal test, the Harmony test, using cell-free fetal DNA circulating in the blood of a pregnant woman does [941]*941not directly infringe or contribute to the infringement of U.S. Patent No. 6,258,540 (“the ’540 patent”), licensed by defendant Sequenom.

1. The ’540 Patent

Sequenom is the exclusive licensee of the ’540 patent, which Sequenom licensed from Isis Innovation Limited (“Isis”). See Docket No. 37, Tatman Decl. ¶¶ 3^1 The ’540 patent is entitled “Non-invasive Prenatal Diagnosis,” and was issued to inventors Yuk-Ming Dennis Lo and James Stephen Wainscoat on July 10, 2001 and assigned to Isis. U.S. Patent No. 6,258,540 The ’540 patent relates to prenatal detection methods performed on a maternal serum or plasma sample from a pregnant female, which methods comprise detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. Id. at 2:1-4. “This invention enables non-invasive prenatal diagnosis, including for example sex determination, blood typing and other genotyping, and detection of pre-eclampsia in the mother.” Id. (Abstract).

According to the patent, conventional pre-natal diagnostic DNA tests such as amniocentesis and chorionic villus sampling involved invasive procedures with risks to the mother and the pregnancy. ’540 Patent at 1:12-17; see also Docket No. 35, Evans Decl. ¶¶ 34-37. Therefore, non-invasive techniques began to be developed that used maternal blood or serum. ’540 Patent at 1:18-20. Prior noninvasive DNA research had focused on detecting fetal cells in a mother’s bloodstream, because the presence of cell-free fetal DNA was not known. Id. at 1:28-36; see also Docket No. 35, Evans Decl. ¶ 21. However, these techniques were time-consuming or required expensive equipment. ’540 Patent at 1:36-37; see also Docket No. 35, Evans Decl. ¶¶ 39-41 (“Ultimately, neither approach, using fetal cells or the other noninvasive screening measurements described above, has proved sufficiently successful or reliable to replace invasive testing.”).

The ’540 patent is based on the discovery in 1996-1997 by Drs. Lo and Wains-coat that cell-free fetal DNA (sometimes referred to as “cffDNA”) is detectable in maternal serum or plasma samples.1 ’540 Patent at 1:50-51; see also Docket No. 35, Evans Decl. ¶ 45. This discovery was important because according to the patent, “[t]he detection rate is much higher using serum or plasma than using nucleated blood cell DNA extracted from a comparable volume of whole blood, suggesting there is enrichment of foetal DNA in maternal plasma and serum.” ’540 Patent at 1:55-58.

The three independent claims of the ’540 patent are as follows:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
[942]*94224. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises: removing all or substantially all nucleated and anueleated cell populations from the blood sample, amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally [sic] inherited fetal nucleic acid.
25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises obtaining a non-cellular fraction of the blood sample amplifying a paternally inherited nucleic acid from the non-cellular fraction and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

’540 Patent at 23:60-67; 26:20-36.

2. Procedural Background

Ariosa filed this declaratory relief action against Sequenom on December 19, 2011, seeking a declaration that its Harmony Test does not infringe any claims of the ’540 patent.2 Docket No. 1, Compl. On March 8, 2012, Sequenom filed an answer against Ariosa and a counterclaim for infringement of the ’540 patent. Docket No. 33. On March 8, 2012, Sequenom also filed a motion for a preliminary injunction, seeking to enjoin Ariosa from making, using, selling, offering for sale, or importing into the United States the Harmony Prenatal Test. Docket No. 34.

On July 5, 2012, the Court denied Se-quenom’s motion for a preliminary injunction. Docket No. 121. In the order, the Court found that Ariosa had raised a substantial question with regard to the validity of the ’540 patent based on Ariosa’s argument that the ’540 patent does not cover patent eligible subject matter. Id. at 16-19. Sequenom appealed the Court’s denial of its motion for a preliminary injunction. Docket No. 123.

On August 9, 2013, the Federal Circuit vacated the Court’s order denying the preliminary injunction and remanded the case for further proceedings. Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 2013 U.S.App. LEXIS 16506 (Fed.Cir.2013). In vacating the order, the Federal Circuit rejected this Court’s initial claim construction, but offered no opinion as to whether there is or is not a substantial question regarding the subject matter eligibility of the asserted claims of the ’540 patent. Id. at *16-17. Rather, the Federal Circuit remanded with directions that this Court examine subject matter eligibility of the asserted claims in the first instance in light of the Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., — U.S.-, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013) and the Federal Circuit’s claim construction holdings. Id. at *16.

By the present cross-motions for summary judgment, the parties move for summary adjudication of whether claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of ’540 patent are drawn to patent-eligible subject matter.

LEGAL STANDARD

1. Summary Judgment

Summary judgment is proper “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter [943]*943of law.” Fed.R.Civ.P. 56(a). The moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S.

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19 F. Supp. 3d 938, 2013 WL 5863022, 2013 U.S. Dist. LEXIS 156554, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ariosa-diagnostics-inc-v-sequenom-inc-cand-2013.