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30 January 2024MedtechLiz Hockley

Delaware jury awards $96.3m damages to Natera over kidney transplant tests

Biotech firm CareDx found to have infringed one of two patents-in-suit through sale of AlloSure and AlloSeq | Damages award consists of $83.6m in lost profits and $12.6m in royalties.

US biotech firm  CareDx has been ordered to pay out more than $96.3 million in damages after it was found to have infringed a patent belonging to rival Natera, through the sale of kidney transplant tests.

The damages award was made public yesterday (January 29) following a jury trial in the US District Court for the District of Delaware, and comprised $83.6 million in lost profits and $12.6 million in royalties.

Natera had sought more than $149 million in lost-profit damages, CareDx was reported to have said in a court filing.

One patent infringed

On Friday (January 26), the Delaware jury determined that CareDx had infringed Natera’s “cell-free” DNA (cfDNA) testing technology covered in US patent 11,111,544, which cites “methods for simultaneous amplification of target loci”.

The infringement relates to sales of CareDx’s molecular diagnostic test AlloSure.

Last week’s damages award also included $92,350 as a royalty payment for the sale of CareDx’s AlloSeq product, which is aimed at identifying genetic matches for transplants.

CareDx was found not to have infringed another Natera patent asserted in the suit, US patent 10,655,180, which covers a “system and method for cleaning noisy genetic data and determining chromosome copy number”.

Both patents are linked to Natera’s Prospera product, a blood test for evaluating the risk of rejection of a transplanted kidney.

In a statement on Monday, Natera said that all asserted claims of the patents had been found to be valid on various grounds, with the jury providing an advisory verdict to the judge that the patents were valid under 35 U.S.C. Sec. 101.

The Austin-based firm said a schedule was to be set for further proceedings to determine whether CareDx’s future sales of new versions of AlloSure and AlloSeq also infringe the asserted patents.

Natera commented: “We are pleased with the jury’s verdict and will continue to deliver innovations backed by rigorous science to improve care for transplant patients.”

CareDx said in a statement on Friday that it intended to appeal.

“Today’s decision does not affect access and availability to CareDx’s current offerings, including AlloSure or AlloMap,” the company said.

“There is no motion pending for injunctive relief.”

The firm also noted that the court had dismissed an additional patent asserted by Natera against CareDx during pre-trial motions.

Disputes over diagnostic methods

In separate litigation involving the two firms’ competing diagnostics tests, CareDx sued Natera for false advertising claims regarding its kidney transplant assessment test,  Prospera, in 2019.

CareDx was initially awarded $45 million in damages but this was rejected by a Delaware federal judge in July last year, who said there was insufficient evidence that consumers had been deceived by Natera’s adverts.

In October last year, the US Supreme Court rejected CareDx’s bid to overturn a verdict invalidating patents it had accused Natera and Eurofins Viracor of infringing.

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Biotechnology
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