CareDx Announces District Court Reverses Jury Decision in Patent Infringement Case Overturning Prior $96 Million Verdict
CareDx announced that a District Court has overturned a jury verdict in a patent infringement case, invalidating all patent claims asserted against the company by competitor Natera. This reversal eliminates the previous $96 million verdict against CareDx.
The Court ruled the patents invalid because they failed to describe the claimed invention in sufficient detail. CareDx believes this decision represents the correct legal outcome and benefits transplant patients.
CareDx developed AlloSure®, the industry's first donor-derived cell-free DNA assay for identifying organ rejection in transplant patients, which was commercially introduced in 2017 for kidney transplant patients and later validated for heart and lung transplants.
If Natera appeals, CareDx plans to continue defending its technology. Additionally, the patent underlying the $96 million verdict is subject to a pending ex parte reexamination by the USPTO, which issued a non-final Office action on February 14, 2025, rejecting the claims CareDx was found to have infringed.
CareDx ha annunciato che un tribunale distrettuale ha annullato un verdetto di giuria in un caso di violazione di brevetto, annullando tutte le rivendicazioni di brevetto avanzate contro l'azienda dal concorrente Natera. Questa revoca elimina il precedente verdicto di 96 milioni di dollari contro CareDx.
Il tribunale ha dichiarato i brevetti non validi perché non descrivevano l'invenzione rivendicata con sufficiente dettaglio. CareDx ritiene che questa decisione rappresenti l'esito legale corretto e avvantaggi i pazienti trapiantati.
CareDx ha sviluppato AlloSure®, il primo saggio di DNA libero da cellule derivato da donatori dell'industria per identificare il rigetto d'organo nei pazienti trapiantati, che è stato commercialmente introdotto nel 2017 per i pazienti trapiantati di rene e successivamente validato per i trapianti di cuore e polmoni.
Se Natera presenterà appello, CareDx prevede di continuare a difendere la propria tecnologia. Inoltre, il brevetto alla base del verdetto di 96 milioni di dollari è soggetto a una riesaminazione ex parte pendente da parte dell'USPTO, che ha emesso un'azione d'ufficio non definitiva il 14 febbraio 2025, respingendo le rivendicazioni di cui CareDx è stata ritenuta responsabile di violazione.
CareDx anunció que un tribunal de distrito ha anulado un veredicto del jurado en un caso de infracción de patente, invalidando todas las reclamaciones de patente presentadas contra la empresa por el competidor Natera. Esta reversión elimina el anterior veredicto de 96 millones de dólares contra CareDx.
El tribunal dictaminó que las patentes eran inválidas porque no describían la invención reclamada con suficiente detalle. CareDx cree que esta decisión representa el resultado legal correcto y beneficia a los pacientes de trasplante.
CareDx desarrolló AlloSure®, el primer ensayo de ADN libre de células derivado de donantes de la industria para identificar el rechazo de órganos en pacientes de trasplante, que se introdujo comercialmente en 2017 para pacientes de trasplante renal y más tarde se validó para trasplantes de corazón y pulmón.
Si Natera apela, CareDx planea continuar defendiendo su tecnología. Además, la patente subyacente al veredicto de 96 millones de dólares está sujeta a una reexaminación ex parte pendiente por parte de la USPTO, que emitió una acción de oficina no final el 14 de febrero de 2025, rechazando las reclamaciones que CareDx fue considerada haber infringido.
CareDx는 지방법원이 특허 침해 소송에서 배심원 판결을 뒤집어 경쟁사 Natera가 제기한 모든 특허 청구를 무효화했다고 발표했습니다. 이로 인해 CareDx에 대한 이전의 9천6백만 달러 판결이 무효화되었습니다.
법원은 청구된 발명을 충분한 세부사항으로 설명하지 못했기 때문에 특허가 무효라고 판결했습니다. CareDx는 이 결정이 올바른 법적 결과를 나타내며 이식 환자에게 혜택을 준다고 믿고 있습니다.
CareDx는 AlloSure®를 개발했으며, 이는 이식 환자에서 장기 거부 반응을 식별하기 위한 업계 최초의 기증자 유래 세포 없는 DNA 분석입니다. 이 제품은 2017년에 신장 이식 환자를 위해 상업적으로 도입되었으며, 이후 심장 및 폐 이식에 대해 검증되었습니다.
Natera가 항소할 경우 CareDx는 자신의 기술을 계속 방어할 계획입니다. 또한, 9천6백만 달러 판결의 기초가 되는 특허는 USPTO에 의해 진행 중인 ex parte 재검토의 대상이며, 2025년 2월 14일에 CareDx가 침해한 것으로 간주된 청구를 거부하는 비최종 사무국 조치를 발행했습니다.
CareDx a annoncé qu'un tribunal de district a annulé un verdict de jury dans une affaire de contrefaçon de brevet, invalidant toutes les revendications de brevet formulées contre l'entreprise par le concurrent Natera. Cette annulation supprime le précédent verdict de 96 millions de dollars contre CareDx.
Le tribunal a jugé les brevets invalides car ils n'ont pas décrit l'invention revendiquée avec suffisamment de détails. CareDx estime que cette décision représente le résultat légal correct et bénéficie aux patients transplantés.
CareDx a développé AlloSure®, le premier test d'ADN libre de cellules dérivé de donneurs de l'industrie pour identifier le rejet d'organe chez les patients transplantés, qui a été commercialement introduit en 2017 pour les patients ayant subi une transplantation rénale et validé par la suite pour les transplantations cardiaques et pulmonaires.
Si Natera fait appel, CareDx prévoit de continuer à défendre sa technologie. De plus, le brevet sous-jacent au verdict de 96 millions de dollars est soumis à une réexamen ex parte en cours par l'USPTO, qui a émis une action de bureau non définitive le 14 février 2025, rejetant les revendications pour lesquelles CareDx a été jugé avoir enfreint.
CareDx gab bekannt, dass ein Amtsgericht ein Geschworenenurteil in einem Patentverletzungsfall aufgehoben hat, wodurch alle Patentansprüche, die von dem Wettbewerber Natera gegen das Unternehmen geltend gemacht wurden, für ungültig erklärt wurden. Diese Rücknahme hebt das vorherige Urteil über 96 Millionen Dollar gegen CareDx auf.
Das Gericht entschied, dass die Patente ungültig sind, da sie die beanspruchte Erfindung nicht ausreichend detailliert beschrieben. CareDx ist der Ansicht, dass diese Entscheidung das rechtlich korrekte Ergebnis darstellt und den Transplantationspatienten zugutekommt.
CareDx entwickelte AlloSure®, den ersten zellfreien, vom Spender abgeleiteten DNA-Test der Branche zur Identifizierung von Organabstoßungen bei Transplantationspatienten, der 2017 kommerziell für Nierentransplantationspatienten eingeführt und später für Herz- und Lungentransplantationen validiert wurde.
Wenn Natera Berufung einlegt, plant CareDx, seine Technologie weiterhin zu verteidigen. Darüber hinaus unterliegt das Patent, das dem Urteil über 96 Millionen Dollar zugrunde liegt, einer anhängigen ex parte Überprüfung durch das USPTO, das am 14. Februar 2025 eine nicht endgültige Amtshandlung erlassen hat, in der die Ansprüche zurückgewiesen wurden, wegen derer CareDx für eine Verletzung gehalten wurde.
- Court invalidated all patent claims against CareDx
- $96 million verdict against CareDx overturned
- USPTO examiner rejected the claims CareDx was found to have infringed
- Potential appeal by Natera could extend legal proceedings
Insights
The District Court's reversal of the
The invalidation of all patent claims asserted by Natera fundamentally strengthens CareDx's competitive positioning in the high-growth transplant diagnostics market. AlloSure, the company's flagship donor-derived cell-free DNA (dd-cfDNA) assay, can now continue its market penetration across kidney, heart, and lung transplant applications without this intellectual property cloud. The court's specific reasoning – that the patents failed to describe the claimed invention in sufficient detail – suggests a fundamental weakness in Natera's intellectual property position rather than a technical legal victory.
What makes this ruling particularly robust is the dual-track validation of CareDx's position. Beyond the District Court's decision, the USPTO examiner's February 14th non-final Office action independently rejected the claims CareDx was found to have infringed. This two-pronged legal victory creates a formidable barrier to Natera's potential appeal, significantly de-risking CareDx's business model.
The transplant diagnostics market represents a specialized but growing segment within precision medicine, with dd-cfDNA technology offering non-invasive monitoring of organ rejection – a critical unmet need for transplant patients. With approximately 40,000 organ transplants performed annually in the US alone, the addressable market for these tests is substantial and recurring, as patients require ongoing monitoring throughout their lives.
This legal victory allows CareDx to refocus resources on market expansion and R&D initiatives rather than litigation defense. The company can now more aggressively pursue broader insurance coverage and potentially accelerate development of next-generation assays without the distraction and financial uncertainty of this patent dispute.
For investors, this represents a significant clearing of execution risk and potentially enables CareDx to strengthen its first-mover advantage in transplant diagnostics – a market where clinical validation, insurance coverage, and physician adoption create substantial barriers to entry once established.
All Patent Claims Asserted Against CareDx are Found to Be Invalid
The District Court ruled that the patents asserted against CareDx are invalid. The Court reached this determination because the patents failed to describe the claimed invention in sufficient detail. CareDx believes that the Court's decision brings this lawsuit to its rightful legal outcome and is a win for transplant patients.
CareDx developed the industry’s first donor-derived cell-free DNA assay, AlloSure®, for identifying organ rejection in transplant patients. AlloSure was first commercially introduced in 2017 for kidney transplant patients and subsequently was validated for heart and lung transplant patients.
If the plaintiff, Natera, appeals, CareDx will continue to vigorously defend its technology.
In addition, the patent that is the basis of the
About CareDx – The Transplant Company
CareDx, Inc., headquartered in
Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the overturning of the jury verdict in the patent infringement case brought by Natera, the non-final Office action issued by the PTO, and the impact of these decisions on CareDx and the ability of CareDx to defend itself in the future. 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, 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, the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 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/20250225064874/en/
CareDx, Inc.
Media Relations
Anna Czene
818-731-2203
aczene@caredx.com
Investor Relations
Caroline Corner
investor@caredx.com
Source: CareDx, Inc.
FAQ
What happened to the $96 million verdict against CareDx (CDNA)?
Why did the District Court invalidate the patents in the CareDx (CDNA) case?
What is AlloSure and when did CareDx (CDNA) introduce it?
What is the status of the USPTO examination of Natera's patent claims against CareDx (CDNA)?
What happens next in the patent dispute between Natera and CareDx (CDNA)?
