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CareDx Issues Statement in Patent Infringement Case

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CareDx, Inc. (Nasdaq: CDNA) has been found to have not infringed on Natera, Inc.'s patent 10,655,180 but was found to have infringed on patent 11,111,544. The District of Delaware jury awarded Natera damages of $83,679,521 in lost profits and $12,535,500 in past royalties for alleged infringement by AlloSure from September 2021 through August 2023. CareDx intends to seek judicial review of the verdict. The decision does not impact patient or physician access to CareDx's current offerings, including AlloSure or AlloMap.
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  • CareDx was found to have infringed on Natera patent 11,111,544, resulting in significant damages. The company intends to seek judicial review of the verdict, potentially leading to prolonged legal proceedings and additional costs.

The jury's decision in the patent litigation between CareDx and Natera has significant legal and financial implications. The ruling of non-infringement on one patent and infringement on another suggests a complex legal landscape in the biotechnology patent space. The considerable damages awarded to Natera, including both lost profits and past royalties, can be a substantial financial burden for CareDx. However, the intention to seek judicial review indicates that the legal process is ongoing and the final financial impact may not be immediate.

From a legal standpoint, this case underscores the importance of intellectual property rights in the healthcare sector. The outcome of the judicial review could set a precedent for future patent disputes in the industry. It is also noteworthy that there is no current motion for injunctive relief, which means that CareDx can continue to offer its AlloSure and AlloMap tests without interruption for the time being, avoiding a potential disruption in patient care.

The jury verdict has direct financial consequences for CareDx, particularly due to the sizeable damages awarded. Investors and stakeholders should be aware that the $83.7 million in lost profits and $12.5 million in past royalties represent a significant expense that could affect CareDx's financials. This could potentially impact the company's stock price, operating income and future investment in research and development.

It's crucial to monitor how the market reacts to this news, as well as the outcome of the judicial review. The review process could result in a reduction or increase of the damages or even a reversal of the infringement finding. Stakeholders should consider the various scenarios and their implications on the company's fiscal health and strategic positioning within the competitive landscape of transplant diagnostics.

The patent litigation outcome between CareDx and Natera is an important event for competitors and customers within the transplant diagnostics market. The decision highlights the competitive nature of the market and the value placed on proprietary technology. For competitors, this serves as a reminder of the potential risks associated with patent infringement and the need for robust research and development to innovate within legal boundaries.

For customers, particularly physicians and patients, the assurance that there will be no impact on their access to AlloSure or AlloMap testing is crucial. The ability of CareDx to continue its operations without interruption may help maintain customer loyalty and trust. However, the long-term financial impact on CareDx could affect its market share and investment in future products, which in turn could influence the overall dynamics of the transplant diagnostics market.

CareDx Found to Have Not Infringed on Patent ‘180

CareDx Intends to Seek Judicial Review of Decision and Monetary Damages on Patent ‘544

No Impact to Patient or Physician Access to AlloSure or AlloMap Testing

BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the jury verdict in the patent litigation brought by Natera, Inc. (Nasdaq: NTRA).

CareDx was found to have not infringed on Natera patent 10,655,180 (the ‘180 patent) and found to have infringed on Natera patent 11,111,544 (the ‘544 patent). During pre-trial motions, the Court dismissed an additional patent asserted by Natera against CareDx. The District of Delaware jury awarded Natera damages including lost profits of $83,679,521 and past royalty of $12,535,500 for alleged infringement by AlloSure, occurring from September 2021 through August 2023. CareDx intends to seek judicial review of the verdict.

Today’s decision does not affect access and availability to CareDx’s current offerings, including AlloSure® or AlloMap®. There is no motion pending for injunctive relief.

CareDx will continue to improve transplant patient care by providing innovative solutions throughout the entire patient journey.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the jury verdict in the patent infringement case brought by Natera, the impact of the verdict on CareDx and CareDx’s plans to seek judicial review of the decision regarding the ‘544 patent and monetary damages. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that the impact of the verdict differs from CareDx’s estimates; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 filed by CareDx with the SEC on May 10, 2023, the quarterly report on Form 10-Q for the quarter ended June 30, 2023 filed by CareDx with the SEC on August 8, 2023, the quarterly report on Form 10-Q for the quarter ended September 30, 2023 filed by CareDx with the SEC on or about November 8, 2023, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

aczene@caredx.com



Investor Relations

Greg Chodaczek

investor@caredx.com

Source: CareDx, Inc.

FAQ

What is the ticker symbol for CareDx, Inc.?

The ticker symbol for CareDx, Inc. is CDNA.

What patent did CareDx infringe on?

CareDx was found to have infringed on Natera patent 11,111,544.

What damages were awarded to Natera?

Natera was awarded damages of $83,679,521 in lost profits and $12,535,500 in past royalties for alleged infringement by AlloSure from September 2021 through August 2023.

What will CareDx do following the verdict?

CareDx intends to seek judicial review of the verdict.

How will the verdict impact patient and physician access to CareDx's offerings?

The verdict does not affect access and availability to CareDx's current offerings, including AlloSure or AlloMap.

CareDx, Inc.

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About CDNA

caredx: transforming transplant patient care through novel surveillance management solutions caredx, inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. by combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, caredx is at the forefront of organ transplant surveillance and pre-transplant hla typing solutions. nasdaq:cdna about allosure® allosure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. allosure is a clinical-grade, proprietary next-generation sequencing (ngs) based test to detect donor-derived cell-free dna (dd-cfdna) in order to identify organ injury in kidney transplant recipients. allosure is analytically validated as a sensitive, specific, and precise measurement of dd-cfdna. allos