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Natera Files New Patent Infringement Lawsuit Against CareDx

This story has been updated from a version posted May 16 to include recent changes made by Natera, regarding the patents being asserted.

NEW YORK – Natera has filed a new lawsuit against CareDx, accusing it of infringing the patent covering Natera’s Panorama noninvasive prenatal testing (NIPT) assay technology within the United States.

In documents filed last Friday in the US District Court for the District of Delaware, Natera alleges that CareDx's AlloSure, AlloSeq, KidneyCare, and HeartCare products infringe US Patent No. 11,111,544. The patent, titled "System and method for cleaning noisy genetic data and determining chromosome copy number," covers a system and method for increasing the fidelity of measured genetic data, for making allele calls, and for determining the state of aneuploidy, in one or a small set of cells, or from fragmentary DNA, where a limited quantity of genetic data is available, according to the patent abstract.

In Natera's complaint, the company asks for an order to prohibit CareDx from further engaging in patent-infringing activities and to be awarded damages in compensation for said infringement.

Shortly after filing these documents, Natera filed new documents dropping an assertion of Patent No. 10,526,658 and added an assertion of Patent No. 10,655,180, both of which cover methods for simultaneous amplification of target loci. 

In a statement, CareDx claimed that the two patents being asserted are "variations of the original patent that Natera continues to assert against CareDx." 

Both companies have sued each other for patent infringements in the past. Last year, a judge in the US District Court for the District of Delaware ruled that three patents held by CareDx were invalid in a case that CareDx had filed against Natera and Eurofins Viracor. The patents covered methods of cell-free DNA analysis for noninvasive monitoring of organ transplant rejection.

More recently, a jury awarded CareDx $44.9 million after determining that both companies had engaged in false advertising.