Stanford sues Natera over transplant testing patents
Stanford University has accused genetic testing company Natera of infringing two patents that cover a non-invasive method of testing if transplanted organs are being rejected.
In a claim filed at the US District Court for the District of Delaware yesterday, March 26, Stanford and exclusive licensee CareDx claimed that Natera was infringing US patent numbers 9,845,497 and 8,703,652.
The patents were invented in recent years by Stanford academics, which then licensed the patents to CareDx, a California-based molecular diagnostics company.
CareDx uses the patents as a basis for AlloSure, a non-invasive blood test that measures donor-derived cell-free DNA (dd-cfDNA), an indicator of kidney injury.
cfDNA is fragmented DNA in the bloodstream that originates from cells undergoing cell injury and death, and when an injury occurs, dd-cfDNA increases in the blood.
CareDx’s technology is being used without permission by Natera, in violation of patent laws, and Natera must be held accountable, claimed Stanford.
In mid-2018, Natera announced that it had developed a kidney transplant rejection biomarker.
“The assay works by measuring the fraction of dd-cfDNA in the recipient's blood, which can spike relative to normal cfDNA when the transplanted organ is injured due to immune rejection,” said a later press release from the company, which also announced a partnership to begin distributing the test.
Stanford and CareDx are seeking an order to stop Natera from infringing and damages.
In a press release, Peter Maag, CEO of CareDx, said: “If IP is disrespected, it is the transplant community that is impacted.”
He added: “We will continue to monitor activities in the transplant field and vigorously defend our IP where appropriate to protect our substantial investments and leadership position.”
Responding to the suit, Natera said it was confident it would prevail in the dispute.
“We are not surprised that CareDx would attempt to disrupt the imminent commercialisation of Natera’s innovative organ transplant rejection test, which does not require donor genotyping, and will compete with CareDx’s older test,” added Natera.
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