shutterstock_418900891_jejim
jejim / Shutterstock.com
27 March 2019Americas

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.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Big Pharma
29 January 2020   DNA testing developer Natera is suing ArcherDX, a molecular technology company, for allegedly infringing a patent related to multiplex polymerase chain reaction technology.
Americas
3 September 2020   California-based molecular diagnostics company CareDx and Stanford University have dropped their patent infringement suit against Tai Diagnostics, nearly five months after filing the complaint.
Americas
15 March 2021   Stanford University can’t patent a genetic testing method as it is based on “abstract mathematical calculations”, the US Court of Appeals for the Federal Circuit has ruled.

More on this story

Americas
15 March 2021   Stanford University can’t patent a genetic testing method as it is based on “abstract mathematical calculations”, the US Court of Appeals for the Federal Circuit has ruled.
Big Pharma
29 January 2020   DNA testing developer Natera is suing ArcherDX, a molecular technology company, for allegedly infringing a patent related to multiplex polymerase chain reaction technology.
Americas
3 September 2020   California-based molecular diagnostics company CareDx and Stanford University have dropped their patent infringement suit against Tai Diagnostics, nearly five months after filing the complaint.

More on this story

Americas
15 March 2021   Stanford University can’t patent a genetic testing method as it is based on “abstract mathematical calculations”, the US Court of Appeals for the Federal Circuit has ruled.
Big Pharma
29 January 2020   DNA testing developer Natera is suing ArcherDX, a molecular technology company, for allegedly infringing a patent related to multiplex polymerase chain reaction technology.
Americas
3 September 2020   California-based molecular diagnostics company CareDx and Stanford University have dropped their patent infringement suit against Tai Diagnostics, nearly five months after filing the complaint.