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Verinata Health Sues Sequenom Over Prenatal Diagnostic Patent Rights

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Verinata Health said last week that it is seeking a declaratory judgment from a federal court that its sequencing-based methods for prenatal diagnostics do not infringe on a patent held by Sequenom.

Also included in the action, which was filed in the US District Court for the Northern District of California, are claims alleging that Sequenom infringes on two patents held by Stanford University and licensed to Verinata: US Patent Nos 7,888,017 and 8,008,018.

Verinata and Stanford are seeking an injunction to halt Sequenom's alleged infringement, in addition to damages and other relief.

"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 Mason, Verinata's CEO, said in a statement.

In the complaint, Verinata asserts that Sequenom's patent, US Patent No. 6,258,540, is invalid because of prior art that establishes that the "claims are old and obvious." Furthermore, the complaint charges that "the overbroad scope of the claims, especially as Sequenom apparently construes the patent, renders them neither enabled nor described adequately."

Verinata is planning to launch a noninvasive sequencing-based fetal trisomy test in March, and recently published the results of a validation study in the American Journal of Obstetrics and Gynecology (CSN 2/15/2012).

The company claims that patents it licensed from Stephen Quake's group at Stanford University — the '017 patent titled "Non-invasive Fetal Genetic Screening by Digital Analysis" and the '018 patent titled "Determination of Fetal Aneuploidies by Massively Parallel DNA Sequencing" — not only cover the methods it plans to use in its test, but also have priority over Sequenom's '540 patent.

Additionally, Verinata alleges that by administering its MaterniT21 test, Sequenom "willfully infringe[s]" its '017 and '018 patents.

Sequenom, however, has previously said that it believes the '017 and '018 patents do not apply to next-gen sequencing-based methods of diagnosing fetal aneuploidies, only to digital PCR methods (CSN 9/7/2011).

The field of sequencing-based prenatal diagnostics has become increasingly competitive and litigious in the past year.

Sequenom was the first to launch its noninvasive sequencing-based trisomy test this fall, and is currently embroiled in legal disputes with Aria Diagnostics, Natera, and now Verinata Health, all of which are developing noninvasive sequencing-based trisomy tests.

Aria and Natera have also filed suits claiming that Sequenom misrepresents the scope of its '540 patent. Sequenom is suing both companies for patent infringement (CSN 1/25/2012) and this week said that it is seeking an injunction against Aria to halt the use and development of its Harmony Prenatal Test (see story, this issue).

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