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Patent Claims Against LabCorp Allowed to Proceed

by | Feb 23, 2015 | Essential, Lab Compliance Advisor

A patent infringement case filed by Verinata Health against Ariosa Diagnostics and LabCorp will be allowed to proceed. A federal district court Feb. 20 denied a motion by  LabCorp to dismiss contributory and induced infringement claims concerning patents related to prenatal genetic abnormality detection (Verinata Health Inc. v. Ariosa Diagnostics Inc., N.D. Cal., No. 3:12-cv-05501-SI. The U.S. District Court for the Northern District of California did grant LabCorp’s motion to dismiss direct infringement claims by Verinata Health Inc. and Stanford University. The court also granted the plaintiffs leave to amend the complaint and indicated that with the amendment, the direct infringement claim would be “plausible, non-speculative, and sufficient.” According to the complaint, Verinata owns U.S. Patent No. 8,318,430 (“Methods of fetal abnormality detection,” issued Nov. 17, 2012) and has an exclusive license from Stanford for U.S. Patent No. 8,296,076 (“Noninvasive diagnosis of fetal aneuploidy by sequencing,” issued Oct. 22, 2012). Verinata and Stanford stated in the complaint that in early 2012, Verinata began offering the verifi prenatal test that analyzes cell-free DNA from a pregnant woman to determine whether the fetus is at risk of having an abnormal number of chromosomes. They also alleged that in or around May 2012, […]

A patent infringement case filed by Verinata Health against Ariosa Diagnostics and LabCorp will be allowed to proceed. A federal district court Feb. 20 denied a motion by  LabCorp to dismiss contributory and induced infringement claims concerning patents related to prenatal genetic abnormality detection (Verinata Health Inc. v. Ariosa Diagnostics Inc., N.D. Cal., No. 3:12-cv-05501-SI. The U.S. District Court for the Northern District of California did grant LabCorp’s motion to dismiss direct infringement claims by Verinata Health Inc. and Stanford University. The court also granted the plaintiffs leave to amend the complaint and indicated that with the amendment, the direct infringement claim would be “plausible, non-speculative, and sufficient.” According to the complaint, Verinata owns U.S. Patent No. 8,318,430 (“Methods of fetal abnormality detection,” issued Nov. 17, 2012) and has an exclusive license from Stanford for U.S. Patent No. 8,296,076 (“Noninvasive diagnosis of fetal aneuploidy by sequencing,” issued Oct. 22, 2012). Verinata and Stanford stated in the complaint that in early 2012, Verinata began offering the verifi prenatal test that analyzes cell-free DNA from a pregnant woman to determine whether the fetus is at risk of having an abnormal number of chromosomes. They also alleged that in or around May 2012, Ariosa Diagnostics and LabCorp began offering the Harmony Prenatal Test, a noninvasive test for Down syndrome, that Verinata and Stanford alleged infringed the ’076 and ’430 patents. Verinata and Stanford jointly asserted the following claims against the defendants regarding the ’076 patent, and Verinata alone asserted those claims against the defendants regarding the ’430 patent: direct infringement, induced infringement, and contributory infringement. Ariosa and LabCorp moved to dismiss the claims asserted against LabCorp. In an opinion authored by Judge Susan Illston, the court noted that allegations regarding LabCorp’s involvement rested on three things: a May 7, 2012, press release that stated the Harmony Test “will be offered through LabCorp and will be available at its 1,000+ patient service centers,” literature on Ariosa’s Web site that described the test, and statements that “Defendants have [performed] and continued to perform the [Harmony Test] on samples of maternal blood.” Direct Infringement Dismissed—for Now The defendants moved to dismiss the complaint, arguing that the plaintiffs had failed to adequately allege LabCorp’s infringement. They also moved to dismiss the plaintiffs’ request for enhanced damages. Because the plaintiffs agreed to withdraw that request, the court granted the defendants’ motion to dismiss that element of the complaint. According to the argument that the plaintiffs failed to adequately plead direct infringement under 35 U.S.C. §271(a), the first amended complaint alleged that the defendants were “practicing” the patent but did not allege directly that LabCorp “makes, uses or sells” the patented invention, as required by Fed. R. Civ. P. 84, Form 18. The court agreed with the plaintiffs that the defendants’ unsubstantiated claims regarding the actual role LabCorp played in preparing and running the Harmony Test should not be considered in a motion to dismiss. “However,” Illston wrote, “the Amended Complaint does not expressly allege that LabCorp ‘makes’ or ‘uses’ the Harmony Test. Therefore, the Court grants defendants’ motion to dismiss, but allows plaintiffs leave to amend to clearly allege that LabCorp is directly liable under the ‘make’ and ‘use’ prongs of §271(a). If amended, the revised allegations, when combined with inferences from language contained in Ariosa’s press release, would be plausible, non-speculative and sufficient.” The court also found that the plaintiffs should be allowed to amend their complaint to expressly allege that LabCorp sold and/or offered to sell the Harmony Test in violation of Section 271(a).

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