Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation
Halozyme Therapeutics (NASDAQ: HALO) has filed a patent infringement lawsuit against Merck in U.S. District Court in New Jersey over the subcutaneous formulation of Keytruda. The complaint alleges that Merck's subcutaneous (SC) Keytruda infringes multiple patents related to Halozyme's MDASE technology, which were filed beginning in 2011.
The lawsuit comes as Merck plans to launch SC Keytruda in 2025 following completed phase 3 clinical testing. Halozyme claims Merck developed the SC formulation without permission, despite being aware of Halozyme's patents. The company is seeking damages and injunctive relief to stop the infringement.
Importantly, the disputed MDASE patent rights are separate from Halozyme's ENHANZE® licensing program and will not impact existing licensees or related revenues. The patents stem from Halozyme's research involving nearly 7,000 modifications to human hyaluronidases, which enable rapid subcutaneous administration of therapeutic drugs.
Halozyme Therapeutics (NASDAQ: HALO) ha intentato una causa per violazione di brevetto contro Merck presso il Tribunale Distrettuale degli Stati Uniti nel New Jersey riguardo alla formulazione sottocutanea di Keytruda. La denuncia sostiene che il Keytruda sottocutaneo (SC) di Merck violi diversi brevetti relativi alla tecnologia MDASE di Halozyme, depositati a partire dal 2011.
La causa arriva mentre Merck pianifica di lanciare il Keytruda SC nel 2025, dopo aver completato la fase 3 dei test clinici. Halozyme afferma che Merck ha sviluppato la formulazione SC senza autorizzazione, pur essendo a conoscenza dei brevetti di Halozyme. L’azienda richiede risarcimenti e un provvedimento ingiuntivo per fermare la violazione.
È importante sottolineare che i diritti sui brevetti MDASE contestati sono separati dal programma di licenza ENHANZE® di Halozyme e non influenzeranno i licenziatari esistenti né i ricavi correlati. I brevetti derivano dalla ricerca di Halozyme che ha coinvolto quasi 7.000 modifiche agli ialuronidasi umani, permettendo una rapida somministrazione sottocutanea di farmaci terapeutici.
Halozyme Therapeutics (NASDAQ: HALO) ha presentado una demanda por infracción de patente contra Merck en el Tribunal de Distrito de Estados Unidos en Nueva Jersey por la formulación subcutánea de Keytruda. La denuncia alega que el Keytruda subcutáneo (SC) de Merck infringe múltiples patentes relacionadas con la tecnología MDASE de Halozyme, presentadas desde 2011.
La demanda surge mientras Merck planea lanzar Keytruda SC en 2025 tras completar la fase 3 de ensayos clínicos. Halozyme afirma que Merck desarrolló la formulación SC sin permiso, a pesar de conocer las patentes de Halozyme. La compañía busca daños y perjuicios y una orden judicial para detener la infracción.
Es importante destacar que los derechos de patente MDASE en disputa son independientes del programa de licencias ENHANZE® de Halozyme y no afectarán a los licenciatarios existentes ni a los ingresos relacionados. Las patentes provienen de la investigación de Halozyme que involucró casi 7,000 modificaciones a las hialuronidasas humanas, lo que permite una rápida administración subcutánea de medicamentos terapéuticos.
Halozyme Therapeutics (NASDAQ: HALO)가 뉴저지 미국 지방법원에 Merck를 상대로 Keytruda의 피하 주사 제형 관련 특허 침해 소송을 제기했습니다. 소송장에는 Merck의 피하(Keytruda SC) 제형이 2011년부터 출원된 Halozyme의 MDASE 기술 관련 다수의 특허를 침해했다고 주장하고 있습니다.
이번 소송은 Merck가 3상 임상시험을 완료한 후 2025년에 Keytruda SC를 출시할 계획인 가운데 제기되었습니다. Halozyme는 Merck가 Halozyme의 특허를 인지하고 있음에도 불구하고 허가 없이 SC 제형을 개발했다고 주장하며 손해배상과 침해 중지를 위한 금지 명령을 요청하고 있습니다.
중요한 점은 이번 분쟁의 MDASE 특허권이 Halozyme의 ENHANZE® 라이선스 프로그램과 별개이며 기존 라이선스 사용자나 관련 수익에 영향을 미치지 않는다는 것입니다. 이 특허들은 치료제의 신속한 피하 투여를 가능케 하는 인간 히알루로니다제 약 7,000건의 변형 연구에서 비롯되었습니다.
Halozyme Therapeutics (NASDAQ : HALO) a déposé une plainte pour violation de brevet contre Merck devant le tribunal de district des États-Unis dans le New Jersey concernant la formulation sous-cutanée de Keytruda. La plainte allègue que le Keytruda sous-cutané (SC) de Merck enfreint plusieurs brevets liés à la technologie MDASE de Halozyme, déposés à partir de 2011.
Cette action en justice intervient alors que Merck prévoit de lancer le Keytruda SC en 2025, après avoir terminé les essais cliniques de phase 3. Halozyme affirme que Merck a développé la formulation SC sans autorisation, malgré la connaissance des brevets de Halozyme. L’entreprise demande des dommages-intérêts et une injonction pour faire cesser la violation.
Il est important de noter que les droits de brevet MDASE contestés sont distincts du programme de licence ENHANZE® de Halozyme et n’affecteront pas les licenciés existants ni les revenus associés. Les brevets proviennent des recherches de Halozyme impliquant près de 7 000 modifications des hyaluronidases humaines, permettant une administration rapide sous-cutanée des médicaments thérapeutiques.
Halozyme Therapeutics (NASDAQ: HALO) hat eine Klage wegen Patentverletzung gegen Merck beim US-Bezirksgericht in New Jersey eingereicht, betreffend die subkutane Formulierung von Keytruda. Die Klage behauptet, dass Mercks subkutanes (SC) Keytruda mehrere Patente verletzt, die sich auf Halozymes MDASE-Technologie beziehen und seit 2011 angemeldet sind.
Die Klage erfolgt, während Merck plant, SC Keytruda im Jahr 2025 nach Abschluss der Phase-3-Studien auf den Markt zu bringen. Halozyme behauptet, Merck habe die SC-Formulierung ohne Erlaubnis entwickelt, obwohl Merck von Halozymes Patenten wusste. Das Unternehmen fordert Schadensersatz und eine einstweilige Verfügung zur Unterbindung der Verletzung.
Wichtig ist, dass die umstrittenen MDASE-Patentrechte getrennt vom ENHANZE®-Lizenzprogramm von Halozyme stehen und keine Auswirkungen auf bestehende Lizenznehmer oder damit verbundene Einnahmen haben werden. Die Patente stammen aus Halozymes Forschung, die fast 7.000 Modifikationen an humanen Hyaluronidasen umfasst, welche eine schnelle subkutane Verabreichung therapeutischer Medikamente ermöglichen.
- Patent portfolio protection could lead to potential damages or licensing revenue from Merck
- Lawsuit demonstrates strength and value of Halozyme's MDASE technology IP
- Legal action doesn't affect existing ENHANZE licensing program revenue stream
- Legal costs associated with patent litigation
- Uncertainty of lawsuit outcome could impact investor confidence
- Risk of extended legal proceedings affecting resources and management focus
Insights
Halozyme sues Merck for unauthorized use of patented subcutaneous delivery technology in upcoming Keytruda formulation, seeking damages and injunction.
Halozyme's lawsuit against Merck represents a significant intellectual property confrontation in the pharmaceutical space. At the heart of this dispute is Halozyme's MDASE technology, which enables rapid, high-volume subcutaneous drug delivery – a valuable innovation that improves patient experience by reducing treatment burden.
The legal claims appear substantive, based on patents Halozyme has held since 2011 resulting from research into nearly 7,000 modifications to human hyaluronidases. This extensive R&D created what Halozyme describes as a "roadmap" for selecting modifications that impact enzyme activity and stability – representing a major advancement in the field.
What makes this case particularly noteworthy is Halozyme's assertion that Merck proceeded with development despite being "long aware" of Halozyme's patents. This allegation, if proven, could potentially support claims of willful infringement, which typically carries enhanced damages.
Halozyme is pursuing both monetary damages and injunctive relief that could potentially block Merck's planned 2025 launch of subcutaneous Keytruda. Patent litigation in pharmaceutical cases often involves complex scientific evidence and can extend for years through various appeals.
Importantly, Halozyme has explicitly clarified that this litigation doesn't affect its ENHANZE® licensing program or associated revenues, as the MDASE patents at issue are separate from those licensed through ENHANZE®. This strategic distinction helps isolate the dispute to specifically target Merck's alleged unauthorized use without disrupting Halozyme's broader business relationships.
Halozyme's patent lawsuit against Merck demonstrates strong IP protection stance, with potential upside from damages while safeguarding existing revenue streams.
This litigation highlights Halozyme's commitment to aggressively protecting its intellectual property, a crucial asset for biotechnology companies. By challenging a pharmaceutical giant like Merck, Halozyme signals to the market that it won't allow unauthorized use of its proprietary technologies, regardless of the opponent's size.
The case centers specifically on Merck's subcutaneous formulation of Keytruda, which has completed Phase 3 testing and appears headed for market launch later this year. As one of Merck's flagship products, Keytruda generates substantial revenue, and a subcutaneous version would represent a significant advancement in administration convenience.
From a financial perspective, this lawsuit creates potential upside through either damages or forced licensing if Halozyme prevails, while the company has simultaneously protected its existing business by clarifying that the dispute does not impact its ENHANZE® program or associated revenue streams. This strategic positioning limits downside risk while pursuing potential gains.
Halozyme's technology clearly delivers substantial value by enabling rapid subcutaneous administration of therapeutics that would otherwise require lengthy intravenous infusions. This patient-centric innovation emerged from extensive research into thousands of enzyme modifications – representing significant R&D investment that warrants protection.
While patent litigation inherently carries uncertainty and legal expenses, Halozyme appears to be taking a calculated approach by pursuing this action only after Merck allegedly proceeded with development despite awareness of the patents. The timing – filing just before Merck's anticipated launch – suggests a carefully considered legal strategy.
Complaint filed in
Halozyme is seeking damages and injunctive relief to stop the infringement
Halozyme believes the subcutaneous formulation of Merck's cancer medicine, Keytruda, infringes multiple patents that Halozyme filed beginning in 2011 to protect its groundbreaking MDASE subcutaneous delivery technology. Subcutaneous (SC) Keytruda has completed phase 3 clinical testing and Merck has publicly commented on its intention to launch the SC product in 2025. Merck has used Halozyme's technology to develop SC Keytruda without Halozyme's permission.
"We are filing this lawsuit to protect the innovative technology that we pioneered through years of painstaking research and development," said Dr. Helen Torley, president and chief executive officer of Halozyme. "Our technology can ease the burden of treatment and improve patient outcomes by making possible rapid, high-volume subcutaneous drug delivery for patients with serious medical conditions."
Halozyme partners with pharmaceutical companies to make subcutaneous versions of important medicines available for the benefit of patients. Halozyme's MDASE hyaluronidase technology is protected by a robust patent portfolio. Halozyme expected Merck to obtain a commercial license for the intellectual property it is using, but Merck has failed to do so and instead plans to launch SC Keytruda while knowingly infringing on Halozyme's MDASE patents.
The patents at issue arise from Halozyme's extensive research into nearly 7,000 modifications to human hyaluronidases. Among their uses, these hyaluronidases pioneered by Halozyme provide a mechanism for the rapid subcutaneous administration of therapeutic drugs. Halozyme's research and development resulted in a roadmap for selecting potential modifications to human hyaluronidases that can impact their activity and stability. Halozyme's comprehensive studies and innovations were a significant advancement to the field of human-derived hyaluronidases.
"Merck has long been aware of Halozyme's patents and still proceeded to appropriate Halozyme's technology in order to develop SC Keytruda," said Halozyme's Chief Legal Officer, Mark Snyder. "Based on their public comments, it appears they intend to launch SC Keytruda later this year despite the clear infringement of our patents. In our lawsuit, we are seeking damages and injunctive relief to stop the infringement."
None of the MDASE patent rights which Halozyme is seeking to enforce in this suit relate to the Company's ENHANZE® licensing program. The MDASE patents are not licensed to any of Halozyme's licensees. Therefore, the outcome of this dispute will not impact ENHANZE®, the ability of any licensee to use ENHANZE®, or revenues Halozyme receives from ENHANZE® licensees.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris, Inc.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of Halozyme's ENHANZE® and MDASE™ drug delivery technologies, the possible method of action of these technologies, their potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of these technologies including facilitating more rapid delivery of high-volume injectable medications through subcutaneous delivery and potentially easing the treatment burden for patients and improving patient outcomes. These forward-looking statements also include statements with respect to Halozyme's patent infringement suit against Merck Sharp & Dohme, Corp., to enforce Halozyme's patent rights, including Halozyme's belief that Merck's SC Keytruda infringes multiple Halozyme patents, Merck's public statements with respect to the timing of the commercial launch of SC Keytruda and Halozyme's belief that the suit will not impact its ENHANZE® licensing program. These forward-looking statements involve risks and uncertainties beyond Halozyme's control that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors and Halozyme can offer no assurance with respect to such forward-looking statements and cautions the reader not to place undue reliance on these forward-looking statements. In particular, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. Actual results could also differ materially from expectations contained in this press release as a result of other risks and uncertainties including those related to the enforceability and validity of our patents, the cost of litigation, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatments and competitive conditions. These and other factors that may result in material differences from the forward-looking statements contained in this press release are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Paul Gallagher
Teneo
917-573-5051
paul.gallagher@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
FAQ
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