CareDx organ-transplant patents ineligible, affirms Fed. Circuit

The United States Court of Appeals for the Federal Circuit is seen in Washington, D.C., U.S. REUTERS/Andrew Kelly

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  • “Most restrictive patent-eligibility decision yet,” says CareDx attorney
  • Court says patents use conventional techniques to test patients’ blood for potential organ rejection

(Reuters) – Natera Inc and Eurofins Viracor Inc defeated rival CareDx Inc’s claims on Monday that their tests for determining a transplant patient’s risk of organ rejection infringe its patents.

CareDx’s patents cover conventional, patent-ineligible methods for detecting DNA levels in the blood, the U.S. Court of Appeals for the Federal Circuit said, affirming a Delaware court decision.

CareDx attorney Edward Reines of Weil, Gotshal & Manges said the Federal Circuit’s Monday decision is “the most restrictive patent-eligibility decision yet, which will further suffocate innovation in the life-saving arts.”

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Patent eligibility is a polarizing issue for attorneys and judges, and critics have said conflicting court precedent has produced unpredictable decisions and undermined the U.S. patent process. The U.S. Supreme Court turned away a request to hear a closely watched case on the issue last month.

“At this point Supreme Court intervention is crucial to stem the anti-patent tide,” Reines said.

A CareDx spokesperson said in a statement that the company “strongly disagrees” with the decision, and is considering appealing to either the full Federal Circuit or the U.S. Supreme Court.

Natera’s chief legal officer Daniel Rabinowitz said in a press release that the company was “pleased that multiple courts have rejected CareDx’s baseless claims against Natera’s proprietary technology.”

Eurofins Viracor also said in a statement that it was “very pleased” with the decision.

CareDx sued Natera in 2019 for infringing the patents, which CareDx licenses from Stanford University. The patents cover methods of measuring the levels of an organ donor’s DNA in a transplant recipient’s blood to predict whether their body will reject the organ.

A Delaware judge found last year that CareDx’s inventions were ineligible for patent protection. CareDx argued on appeal that its innovations were patentable advances over earlier measurement techniques.

But Circuit Judge Alan Lourie wrote for a three-judge panel that the patent was “replete with characterizations of the claimed techniques in terms that confirm their conventionality.”

CareDx had also conceded that it did not discover the relationship between the DNA measurements and the risk of organ rejection, the court said.

A jury awarded CareDx nearly $45 million in March on its claims that Natera falsely advertised the effectiveness of its kidney-rejection tests.

The cases are CareDx Inc v. Natera Inc and CareDx Inc v. Eurofins Viracor Inc, U.S. Court of Appeals for the Federal Circuit, Nos. 2022-1027 and 2022-1028.

For CareDx: Edward Reines of Weil, Gotshal & Manges

For Natera: Gabriel Bell of Latham & Watkins

For Eurofins Viracor: William Jay of Goodwin Procter

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Blake Brittain

Thomson Reuters

Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at

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