U.S. District Court Upholds Validity of CINVANTI® Patents
Heron Therapeutics (HRTX) announced a favorable ruling from the U.S. District Court for the District of Delaware in its patent litigation against Fresenius Kabi USA. The court upheld the validity of Heron's patents (U.S. Patent Nos. 9,561,229 and 9,974,794) for CINVANTI® injectable emulsion, which expire in 2035, and found they would be infringed by Fresenius' proposed generic product.
The litigation began in July 2022 after Fresenius submitted an Abbreviated New Drug Application seeking approval for a generic version of CINVANTI®. Heron will now seek a court order to prevent Fresenius from launching its generic version until the patents expire in 2035.
Heron Therapeutics (HRTX) ha annunciato una decisione favorevole da parte del Tribunale Distrettuale degli Stati Uniti per il Distretto del Delaware nella sua causa per brevetto contro Fresenius Kabi USA. Il tribunale ha confermato la validità dei brevetti di Heron (Brevetti degli Stati Uniti n. 9.561.229 e 9.974.794) per l'emulsione iniettabile CINVANTI®, che scadranno nel 2035, e ha constatato che sarebbero stati violati dal prodotto generico proposto da Fresenius.
Il contenzioso è iniziato a luglio 2022 dopo che Fresenius ha presentato una Domanda di Nuovo Farmaco Abbreviata per ottenere l'approvazione di una versione generica di CINVANTI®. Heron ora cercherà un'ordinanza del tribunale per impedire a Fresenius di lanciare la sua versione generica fino alla scadenza dei brevetti nel 2035.
Heron Therapeutics (HRTX) anunció una decisión favorable del Tribunal de Distrito de EE.UU. para el Distrito de Delaware en su litigio por patentes contra Fresenius Kabi USA. El tribunal sostuvo la validez de las patentes de Heron (Números de Patente de EE.UU. 9,561,229 y 9,974,794) para la emulsión inyectable CINVANTI®, que caducan en 2035, y determinó que serían infringidas por el producto genérico propuesto por Fresenius.
El litigio comenzó en julio de 2022 después de que Fresenius presentó una Solicitud de Nuevo Medicamento Abreviada solicitando la aprobación de una versión genérica de CINVANTI®. Heron ahora buscará una orden judicial para evitar que Fresenius lancen su versión genérica hasta que las patentes caduquen en 2035.
Heron Therapeutics (HRTX)는 델라웨어 지방법원에서 Fresenius Kabi USA를 상대로 한 특허 소송에서 긍정적인 판결을 받았다고 발표했습니다. 법원은 Heron의 특허(U.S. Patent Nos. 9,561,229 및 9,974,794)의 유효성을 유지했으며, 이는 2035년에 만료되고, Fresenius의 제안된 일반 의약품이 이를 침해할 것이라고 판단했습니다.
소송은 2022년 7월에 Fresenius가 CINVANTI®의 일반 버전에 대한 승인을 요청하는 축약 신약 신청서를 제출한 후 시작되었습니다. 이제 Heron은 특허가 2035년에 만료될 때까지 Fresenius가 일반 버전을 출시하지 못하도록 법원에 명령을 요청할 것입니다.
Heron Therapeutics (HRTX) a annoncé une décision favorable du tribunal de district des États-Unis pour le district du Delaware dans son litige sur les brevets contre Fresenius Kabi USA. Le tribunal a confirmé la validité des brevets de Heron (Brevets des États-Unis n° 9,561,229 et 9,974,794) pour l'émulsion injectable CINVANTI®, qui expirent en 2035, et a établi qu'ils seraient enfreints par le produit générique proposé par Fresenius.
Le litige a commencé en juillet 2022 après que Fresenius a soumis une demande abrégée de nouveau médicament demandant l'approbation d'une version générique de CINVANTI®. Heron cherchera maintenant une ordonnance du tribunal pour empêcher Fresenius de lancer sa version générique jusqu'à l'expiration des brevets en 2035.
Heron Therapeutics (HRTX) gab bekannt, dass das US-Bezirksgericht für den Bezirk Delaware in ihrem Patentstreit gegen Fresenius Kabi USA eine günstige Entscheidung getroffen hat. Das Gericht bestätigte die Gültigkeit der Patente von Heron (US-Patente Nr. 9.561.229 und 9.974.794) für die injizierbare Emulsion CINVANTI®, die 2035 abläuft, und stellte fest, dass Fresenius' vorgeschlagenes Generikum diese verletzen würde.
Der Rechtsstreit begann im Juli 2022, nachdem Fresenius einen Antrag auf Zulassung eines Generikums von CINVANTI® gestellt hatte. Heron wird nun beim Gericht eine Anordnung beantragen, um Fresenius daran zu hindern, sein Generikum bis zum Ablauf der Patente im Jahr 2035 auf den Markt zu bringen.
- Court ruling protects CINVANTI® patent exclusivity until 2035
- Prevention of generic competition for CINVANTI® for next 11 years
- Strengthens company's intellectual property position
- Decision is subject to appeal, creating potential future legal uncertainty
Insights
The Delaware District Court's ruling represents a significant legal victory for Heron Therapeutics, effectively protecting their CINVANTI® franchise until 2035. The court's decision validates two key patents ('229 and '794) and blocks Fresenius Kabi's attempt to launch a generic version. This outcome maintains Heron's market exclusivity for CINVANTI®, a vital antiemetic drug used in chemotherapy patients.
The ruling's implications are substantial: it prevents generic competition for over a decade, securing Heron's revenue stream from CINVANTI®. While Fresenius can appeal, such patent decisions are often upheld at the appellate level. The strength of Heron's patent portfolio suggests robust protection against future generic challenges. This type of patent litigation outcome typically provides significant shareholder value by ensuring long-term market exclusivity for branded pharmaceuticals.
This court victory has substantial financial implications for Heron Therapeutics. CINVANTI® generates significant revenue for the company and maintaining market exclusivity until 2035 protects a important income stream. With a relatively small market cap of
The ruling eliminates a major near-term threat to the company's business model and cash flow. Patent protection for another decade allows Heron to continue investing in R&D and commercial operations without immediate generic pressure. This decision particularly benefits Heron given its current market position and the importance of CINVANTI® to its product portfolio. The extended exclusivity period provides a clear runway for maximizing the drug's commercial potential.
— Court Rules in Favor of Heron in Patent Lawsuit Against Fresenius Kabi
The district court decision concludes the litigation initiated in July 2022 in response to Fresenius' submission of an Abbreviated New Drug Application with the
"We are pleased with this anticipated result of the proceeding and will continue to vigorously defend the CINVANTI® patent estate in the future," said Craig Collard, Chief Executive Officer of Heron. "The team at Heron takes great pride in the result of our successful history of developing injectable products, which is demonstrated by the strength of our intellectual property and the performance of our innovative drugs like CINVANTI® in serving patients with serious unmet needs."
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.
Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
View original content to download multimedia:https://www.prnewswire.com/news-releases/us-district-court-upholds-validity-of-cinvanti-patents-302321651.html
SOURCE Heron Therapeutics, Inc.
FAQ
When will Heron Therapeutics' (HRTX) CINVANTI patents expire?
What was the outcome of Heron Therapeutics' (HRTX) patent lawsuit against Fresenius Kabi?
When did the patent litigation between Heron Therapeutics (HRTX) and Fresenius Kabi begin?
