Verinata Health Files Action Against Sequenom to Vindicate its Rights in the Face of Sequenom's Threats

REDWOOD CITY, Calif., Feb. 23, 2012  /PRNewswire/ -- Verinata Health, Inc., a privately-held company dedicated to maternal and fetal health, announced today that it has commenced an action against Sequenom, Inc. and its wholly-owned subsidiary, Sequenom Center for Molecular Medicine, LLC ("Sequenom CMM"), in federal court. 

The action, filed in the Northern District of California, seeks a declaratory judgment that Verinata's cell-free DNA sequencing analysis techniques used in its proprietary prenatal diagnostics are free from Sequenom's threats that the practice of non-invasive prenatal testing violates Sequenom's rights in U.S. Patent No. 6,258,540 ("the '540 patent").  It also asserts that both Sequenom and Sequenom CMM willfully infringe Verinata's exclusive patent rights by offering and performing the MaterniT21™ prenatal test, among other activities.

"We believe that we have the leading intellectual property in the field of non-invasive prenatal diagnostics using cell-free DNA sequencing analysis techniques and we expect to vindicate those rights through this legal action, which is necessitated by Sequenom's threatening statements," stated Caren L. Mason, Chief Executive Officer of Verinata.

Verinata's Complaint asserts that the '540 patent is invalid because, among other things, the prior art establishes that "the claims are old and obvious" and  "the overbroad scope of the claims, especially as Sequenom apparently construes the patent, renders them neither enabled nor described adequately."  It also states that Verinata's activities in the field of prenatal diagnostics do not infringe the '540 patent.

In addition, claims brought jointly by Verinata and Stanford University allege infringement of U.S. Patent Nos. 7,888,017 ("the '017 patent" titled "Non-invasive Fetal Genetic Screening by Digital Analysis") and 8,008,018 ("the '018 patent" titled "Determination of Fetal Aneuploidies by Massively Parallel DNA Sequencing").  Stanford is the patent owner and licensor for the '017 and '018 patents and is joined in the infringement action for these patents because it is a necessary party.  The patents cover pioneering cell-free DNA analysis techniques, including the use of massively parallel shotgun DNA sequencing.  Verinata holds an exclusive license to the '017 and '018 patents in the field of genetic analysis by nucleic acid sequencing.  Each of the '017 and '018 patents claims priority to a U.S. application filed on February 2, 2006, and the '017 and '018 patents issued on February 15, 2011 and August 30, 2011, respectively.  Verinata and Stanford seek an injunction to halt Sequenom and Sequenom CMM's infringement of the patents, in addition to damages and other relief.

Verinata Health, Inc.

Verinata is driven by a sole, extraordinary purpose – maternal and fetal health. Our initial focus is to develop and offer non-invasive tests for early identification of fetal chromosomal abnormalities using our proprietary technologies. We aim to reduce the anxiety associated with today's multi-step process, the unacceptable false-positive rates, the non-specific and sometimes confusing results of current prenatal screening methods, as well as the risk of current invasive procedures. In support of national guidelines recommending first trimester aneuploidy risk assessment, we believe women who desire such an assessment should be offered a single blood draw test with a definitive result.  Verinata has completed its blinded pivotal study to clinically validate the sensitivity and specificity of its first prenatal test.  The verifi™ prenatal test is a non-invasive assay for the determination of the three primary chromosomal aneuploidies for trisomies 21, 18 and 13.  For more information about Verinata, please go to www.verinata.com.

SOURCE Verinata Health, Inc.