This story has been updated with a statement from Natera.
NEW YORK – CareDx and Stanford University have added a third patent to their patent infringement lawsuit against Natera, filing an amended complaint in the United States District Court for Delaware.
The plaintiffs now also claim that Natera has infringed on US Patent 10,329,607, which is exclusively licensed to CareDx from Stanford.
The suit, which was originally filed last March, claimed that Natera was infringing on patent numbers 9,845,497 and 8,703,652, which are also exclusively licensed to CareDx from Stanford. The patents cover methods of cell-free DNA analysis for noninvasive monitoring of organ transplant rejection, which CareDx uses as the basis for its AlloSure organ transplant diagnostics. CareDx asserted that Natera had infringed on that intellectual property through its marketing and performance of a kidney transplant rejection test, which it performs at its CLIA-certified laboratory in San Carlos, California, to analyze cell-free DNA from transplant patients to inform rejection.
On March 12, CareDx filed an amended complaint adding the '607 patent, which covers noninvasive monitoring of organ transplant rejection through cell-free DNA analysis. It said Natera has infringed on that patent by performing its Kidney Transplant Rejection test in the US.
CareDx and Stanford asked for a jury trial, and also asked the court to render judgement that Natera had infringed the three patents. The plaintiffs are also asking for damages or other monetary relief, including costs and an order enjoining Natera from further infringement of the patents.
The filing of the amended complaint also caused the court to set aside a previously filed recommendation from a magistrate judge that the court deny a motion from Natera to dismiss the lawsuit. Natera had asserted that the subject matter in the '497 and '652 patents was ineligible for patenting, and asked the court to dismiss CareDx's case. But a report from a magistrate judge recommended that this motion be denied.
However, given the filing of the amended complaint, the motion to dismiss was rendered moot, according to the court. In a ruling on March 13, the judge said that the magistrate's recommendations had been vacated, and that Natera's original motion to dismiss had been denied without prejudice. The company is free to refile a motion to dismiss based on the amended complaint.
CareDx also has a second lawsuit pending against Natera. The false advertising suit, which was filed in April 2019, accuses Natera of trying to "mislead" patients and clinicians into thinking that Natera's Prospera kidney transplant test is superior to CareDx's AlloSure organ transplant diagnostics.
In an email, a spokesman from Natera told GenomeWeb that the company is "gratified that the judge vacated the magistrate's recommendations and invited Natera to file a new motion to dismiss, one that the judge himself will decide."