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Verinata Sues Sequenom over Patent Rights

NEW YORK (GenomeWeb News) – Prenatal diagnostics testing technology firm Verinata Health today filed a lawsuit against Sequenom asking a federal court to find that its cell-free DNA sequencing methods used in its tests do not infringe on a Sequenom patent.

The company also claims Sequenom and its subsidiary, the Sequenom Center for Molecular Medicine infringes on its patent rights.

The lawsuit, filed in US District Court, Northern District of California asks for a declaratory judgment that Verinata's methods "are free from Sequenom's threats that the practice of non-invasive prenatal testing violates" US Patent No. 6,258,540 held by Sequenom.

"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," Caren L. Mason, Chief Executive Officer of Verinata, said in a statement.

The company claims that the '540 patent is invalid as prior art "establishes that 'the claims are old and obvious,'" Verinata said in its complaint. Additionally, "the overbroad scope of the claims, especially as Sequenom apparently construes the patent, renders them neither enabled nor described adequately."

Verinata says its own work in prenatal diagnostics do not infringe on the '540 patent.

The company along with Stanford University also alleges that Sequenom and SCMM willfully infringe on Verinata's exclusive patent rights by offering and performing the MaterniT21 test and other activities.

Specifically, they claim infringement of US Patent Nos. 7,888,017, titled "Non-invasive fetal genetic screening by digital analysis, and 8,008,018, titled "Determination of fetal aneuploidies by massively parallel DNA sequencing," both of which are held by Stanford.

The patents pertain to cell-free DNA analysis techniques, including the use of massively parallel shotgun DNA sequencing. Verinata holds an exclusive license to both patents in the field of genetic analysis by nucleic acid sequencing.

Verinata and Stanford are seeking an injunction to stop Sequenom and SCMM from continued infringement of the patents, damages, and other relief.

A Sequenom spokesperson said the company had no plans to comment on the lawsuit.

The lawsuit is just the latest in a flurry of litigation by companies operating in the prenatal diagnostics space. Yesterday, Sequenom filed a motion for an injunction against Aria Diagnostics, one month after it sued Aria claiming the San Jose, Calif.-based firm infringes on the '540 patent.

Sequenom is also suing Natera claiming infringement of the patent. Meanwhile Natera and Aria have sued Sequenom saying it is overly aggressive in enforcing a broad patent related to the use of circulating cell-free DNA in maternal plasma to diagnosed fetal aneuploidies.

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