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In Suit, Aria Says Sequenom 'Misrepresents' Scope of Patent for Noninvasive Prenatal Testing

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By Monica Heger

In a lawsuit
filed this week, Aria Diagnostics alleges that Sequenom is overly aggressive in its enforcement of a broad patent related to the use of circulating cell-free DNA in maternal plasma to diagnose fetal aneuploidies.

In its complaint, filed with the US District Court for the Northern District of California, Aria requests a declaratory judgment that a test it is developing to diagnose fetal aneuploidies does not infringe Sequenom's patent.

Aria does not disclose the technology it is using, but said it has begun a clinical trial for the test, which it plans to launch in early 2012 from a CLIA-certified laboratory.

The patent in dispute is US Patent No. 6,258,540, "Non-invasive prenatal diagnosis," assigned to Dennis Lo of the Chinese University of Hong Kong and exclusively licensed by Sequenom. It covers "a method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female."

According to the suit, Aria believes that Sequenom has "misrepresented" the scope of the '540 patent, with the goal of "deterring potential competitors from entering the market and deterring doctors and health care providers from using anyone other than Sequenom."

In the complaint, Aria does not contest Sequenom's exclusive right to the patent, only that Aria's test does not infringe the patent.

Sequenom recently launched MaterniT21, its sequencing-based noninvasive Down syndrome test. Company officials have stated publicly on several occasions that any other group looking to launch a similar test would be infringing it’s the '540 patent (CSN 7/27/2011).

In August, Sequenom licensed the IP to LifeCodexx, giving the GATC Biotech subsidiary the right to develop the test in Europe. Sequenom cited the licensing agreement as a sign of the strength of the patent (CSN 8/17/2011).

According to Aria, Sequenom has made it clear that it will enforce the patent if Aria launches its test. Aria said it received a letter from Sequenom's counsel dated Dec. 6 requesting a "detailed explanation" of why Aria's test would not infringe on the '540 patent. The letter stated that Aria has until Jan. 6, 2012, to provide such an explanation.

The letter "cannot be viewed as a benign invitation to chat about the relationship of Sequenom's patent to Aria's business," the suit said. "It is a shot across Aria's bow."

The suit is the first of what is likely to be a long patent dispute involving the reach of the '540 patent, as other companies are looking to enter the prenatal diagnostics market.

Verinata Health, for instance, is planning to launch a sequencing-based fetal aneuploidy test in 2012.

Verinata holds a patent that it licensed from Stephen Quake at Stanford University, No. 8,008,018, titled "Determination of fetal aneuploidies by massively parallel DNA sequencing." The patent's claims cover a method for determining fetal aneuploidy in maternal tissue using next-gen sequencing (CSN 9/7/2011).

Sequenom, however, has said that it plans to enforce its '540 patent, which it believes Verinata would infringe if it launches a sequencing-based diagnostic for fetal aneuploidy.

In its complaint, Aria seeks a judicial declaration that its test does not infringe the '540 patent, as well as an award for attorneys' fees and other expenses and "an award of such other and further relief as the court may deem just and proper."


Have topics you'd like to see covered by Clinical Sequencing News? Contact the editor at mheger [at] genomeweb [.] com.

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