By Monica Heger
Sequenom has sued both Aria Diagnostics and Natera, accusing the companies of infringing a Sequenom patent with their respective noninvasive trisomy 21 and paternity tests.
In its complaint against Aria, filed with the US District Court for the Southern District of California, Sequenom alleges that Aria's prenatal trisomy test infringes its patent, US Patent No. 6,258,540, and that Aria's infringement has been "intentional, deliberate, and willful."
A second complaint against Natera alleges that Natera's noninvasive paternity test, which analyzes fragments of fetal DNA in maternal plasma from a blood draw, infringes the same patent. The suit also claims that Natera "knowingly encouraged others" to infringe when it licensed its test to paternity testing lab DNA Diagnostics Center.
In both suits, Sequenom has requested a judgment that the companies have infringed, a permanent injunction that would restrain the companies from infringing, a monetary award sufficient to compensate Sequenom for the infringement and cover costs incurred because of the suit, as well as "increased damages" that are "not less than three times the amount of actual damages awarded to Sequenom" due to the companies' "willful infringement."
These suits follow pre-emptive suits filed by Aria and Natera in recent weeks against Sequenom requesting judgment that their respective tests do not infringe Sequenom's patent, and alleging that Sequenom has "misrepresented" the scope of its patent (CSN 12/21/2011 and 1/11/2012).
Sequenom licenses the '540 patent at the heart of the suits, entitled "Non-invasive prenatal diagnosis," exclusively from Isis Innovation, the technology transfer arm of Oxford University. The patent is assigned to Dennis Lo, who is currently with the Chinese University of Hong Kong.
Sequenom's sequencing-based MaterniT21 test for the diagnosis of Down syndrome, which it launched in October, is based on this patent.
Aria is also developing a sequencing-based Down syndrome test, which it has described in a paper published in Prenatal Diagnosis. Company officials recently told Clinical Sequencing News that they do not believe the test infringes Sequenom's patent because it uses a targeted sequencing approach rather than a shotgun sequencing approach, and because it uses an internally developed automated process to target the regions of interest (CSN 1/18/2012).
Aria is planning a clinical trial of its test in 25,000 women and has said that it plans to launch its test commercially from a CLIA-certified lab in San Jose, Calif., in the first half of this year.
Natera, which recently changed its name from Gene Security Network, currently offers a noninvasive prenatal paternity test on a microarray platform, but the company has said that it plans to switch to next-generation sequencing and is also planning to develop a sequencing-based test for Down syndrome (CSN 1/18/2012).
Other companies in the space include Verinata Health, which is developing a sequencing-based test for trisomies that it plans to launch sometime this year. Sequenom believes that Verinata's test would also infringe on its '540 patent.
Verinata recently published an abstract describing its test in the American Journal of Obstetrics and Gynecology for February's annual meeting of the Society for Maternal-Fetal Medicine.
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