CareDx Reiterates Position that it Does Not Infringe the ‘544 Patent, Injunction Motion is Irrelevant

Rhea-AI Summary

CareDx has reiterated its position that it does not infringe Natera's '544 patent, emphasizing that Natera's injunction motion is irrelevant to its current business operations. The company clarified that it stopped using the previously alleged infringing AlloSure process since August 2023, switching to a new process believed to be non-infringing. The validity of the '544 patent is still under judicial review. CareDx further noted that previous claims by Natera on other patents were dismissed or found non-infringing. The ongoing litigation is not expected to affect CareDx's ability to provide its AlloSure and AlloMap services to transplant patients and clinicians.

Positive

• CareDx has ceased using the alleged infringing AlloSure process since August 2023.
• The injunction motion by Natera is claimed to be irrelevant to CareDx's current business operations.
• Previous claims by Natera on other patents were dismissed or found non-infringing.
• CareDx continues to provide AlloSure and AlloMap services without disruption.

Negative

• The underlying validity of the '544 patent remains under judicial review.
• Ongoing litigation and motions could pose potential uncertainties for CareDx.

CareDx Reiterates Position that it Does Not Infringe Natera’s ‘544 Patent

Injunction Motion has No Impact on CareDx’s Business or Patient and Clinician Access to AlloSure or AlloMap

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 responded to Natera, Inc.’s filing of a motion for an injunction related to patent 11,111,544 (the ‘544 patent).

The motion seeks to stop CareDx from using a prior AlloSure® process that Natera alleged infringed the ‘544 patent. That process is no longer in effect. As CareDx informed Natera and the Court, since August 2023, CareDx has utilized a new AlloSure process that it believes does not infringe on the ‘544 patent.

The underlying validity of the ‘544 patent also remains subject to judicial review.

“We believe the motion against a process that is no longer in effect is irrelevant, and the District Court is still considering the fundamental question of the validity of the ‘544 patent,” said John W. Hanna, CareDx President and CEO. “We greatly appreciate the continued support of the transplant community as we seek to resolve these matters, allowing us to return our full attention to serving patients and developing clinical innovations that improve transplant care.”

Natera has previously claimed infringement on three patents:

1. Prior to trial, the District Court dismissed patent 10,597,724 (the ‘724 patent) as invalid as patent ineligible.
2. At trial, CareDx was found not to have infringed on patent 10,655,180 (the ‘180 patent).
3. The ‘544 patent is the subject of post-trial motion practice in which, among other things, CareDx is seeking to invalidate that patent on the same grounds as the ‘724 patent.

Natera’s motion does not impact CareDx’s business or ability to continue providing transplant patients with AlloSure or AlloMap®.

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 injunction motion brought by Natera, the impact of the verdict on CareDx, and CareDx’s motion seeking judicial review of the January 2024 jury verdict including the validity of the ‘544 patent. 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 Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the quarterly report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240529194946/en/

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

aczene@caredx.com

Investor Relations

Greg Chodaczek

investor@caredx.com

Source: CareDx, Inc.

FAQ

Does CareDx infringe Natera's '544 patent?

CareDx asserts that it does not infringe Natera's '544 patent and has ceased using the alleged infringing process since August 2023.

What impact does Natera's injunction motion have on CareDx?

CareDx claims that Natera's injunction motion has no impact on its business operations or ability to provide AlloSure and AlloMap services.

What is the current status of the '544 patent?

The '544 patent's validity is still under judicial review, with CareDx seeking to invalidate it.

What were the outcomes of previous patent claims by Natera against CareDx?

Previous claims by Natera were either dismissed as invalid or found non-infringing by the court.

What is the stock symbol for CareDx?

The stock symbol for CareDx is CDNA.