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Streck Files Patent Suit Against NIPT Firm Cenata in Germany

NEW YORK (GenomeWeb) – Laboratory supplier Streck of La Vista, Nebraska said last week that it has filed a patent infringement lawsuit against German noninvasive prenatal testing company Cenata.

The suit, filed in the district court of Mannheim in Germany, claims that Cenata, which offers Roche's Ariosa Harmony NIPT, infringes Streck's European Patent No. 2228453B1, "Preservation of fetal nucleic acids in maternal plasma."

Streck said it offers a cell-free DNA blood collection tube that has been available in the European Union since 2014 and that many providers of NIPT have incorporated into their assay. According to the company's complaint, Ariosa Diagnostics — which was acquired by Roche in late 2014 — was initially a customer for its blood collection tubes for the Harmony test but stopped using the tubes in the spring of 2015. At that time, Streck said, Ariosa started manufacturing its own Roche-branded tubes. Since then, Streck has been negotiating with Ariosa and Roche about licensing its patent but the parties have not come to an agreement yet.

Streck also said that Roche Diagnostics filed an opposition to Streck's patent with the European Patent Office in September 2017, in which Roche claims that Streck already marketed its cell-free DNA tubes before the priority date of the patent, which Streck denies.

Cenata provides doctors ordering the Harmony test with blood collection kits from Ariosa, which contain the Roche-branded tubes. Streck said that it had the content of two of Roche's blood collection tubes — one obtained from a gynecologist's office in Germany, the other ordered from Roche Diagnostics — analyzed by two different laboratories, one in Germany and one at Streck. Those analyses showed that both tubes contained protective agents and preservatives in concentrations that are protected by Streck's patent, the company claimed.

Streck asked the court to order Cenata to stop offering tests in Germany that isolate fetal nucleic acid by making use of reagents protected by its patent. It also asked the court to award it damages for infringement based on tests that Cenata has conducted since January 2017.

"This lawsuit shows that Streck is committed to protecting its proprietary technologies and its customers," Streck CEO Connie Ryan said in a statement.

Cenata did not respond to a request for comment before press time.