Genevant Sciences and Arbutus Biopharma Initiate International Patent Infringement Enforcement Actions Against Moderna
Genevant Sciences and Arbutus Biopharma (ABUS) have initiated five international patent infringement lawsuits against Moderna across 30 countries. The legal actions target Moderna's alleged unauthorized use of their lipid nanoparticle (LNP) technology in Spikevax® and mRESVIA® products.
The lawsuits have been filed in multiple jurisdictions including Canada, Japan, Switzerland, and the Unified Patent Court (UPC). The companies are seeking monetary damages and injunctions against Moderna's products. Evidence from testing commercial Moderna samples from the U.S. and Europe indicates the presence of LNPs that fall under their patent claims.
This international enforcement expands on their ongoing U.S. proceeding in Delaware, where a jury trial is scheduled for September 2025. The LNP technology, important for mRNA medicine delivery, was developed by Arbutus and Genevant scientists and has been licensed to various third parties.
Genevant Sciences e Arbutus Biopharma (ABUS) hanno avviato cinque cause legali internazionali per violazione di brevetto contro Moderna in 30 paesi. Le azioni legali mirano all'uso presunto non autorizzato della loro tecnologia dei nanoparticelle lipidiche (LNP) nei prodotti Spikevax® e mRESVIA®.
Le cause sono state depositate in diverse giurisdizioni, tra cui Canada, Giappone, Svizzera e il Tribunale Unificato dei Brevetti (UPC). Le aziende stanno cercando risarcimenti monetari e ingiunzioni contro i prodotti di Moderna. Le prove ottenute testando campioni commerciali di Moderna provenienti da Stati Uniti ed Europa indicano la presenza di LNP che rientrano nelle loro rivendicazioni di brevetto.
Questa enforcement internazionale si aggiunge al procedimento in corso negli Stati Uniti in Delaware, dove è previsto un processo con giuria per settembre 2025. La tecnologia LNP, importante per la somministrazione di medicinali mRNA, è stata sviluppata da scienziati di Arbutus e Genevant ed è stata concessa in licenza a vari terzi.
Genevant Sciences y Arbutus Biopharma (ABUS) han iniciado cinco demandas internacionales por infracción de patentes contra Moderna en 30 países. Las acciones legales se dirigen al supuesto uso no autorizado de su tecnología de nanopartículas lipídicas (LNP) en los productos Spikevax® y mRESVIA®.
Las demandas se han presentado en múltiples jurisdicciones, incluyendo Canadá, Japón, Suiza y el Tribunal de Patentes Unificado (UPC). Las empresas buscan daños monetarios e interdictos contra los productos de Moderna. La evidencia de pruebas de muestras comerciales de Moderna de EE. UU. y Europa indica la presencia de LNP que se encuentran bajo sus reclamaciones de patente.
Esta aplicación internacional se suma al procedimiento en curso en EE. UU. en Delaware, donde se programó un juicio con jurado para septiembre de 2025. La tecnología LNP, importante para la entrega de medicamentos de ARNm, fue desarrollada por científicos de Arbutus y Genevant y ha sido licenciada a varios terceros.
Genevant Sciences와 Arbutus Biopharma (ABUS)는 Moderna에 대해 30개국에서 다섯 건의 국제 특허 침해 소송을 시작했습니다. 이 법적 조치는 Spikevax® 및 mRESVIA® 제품에서 그들의 지질 나노입자(LNP) 기술의 무단 사용을 겨냥하고 있습니다.
소송은 캐나다, 일본, 스위스 및 통합 특허 법원(UPC) 등 여러 관할권에서 제기되었습니다. 이들 회사는 Moderna의 제품에 대한 금전적 손해배상과 금지 명령을 요청하고 있습니다. 미국과 유럽에서 상업적으로 수집한 Moderna 샘플의 테스트 결과, 그들의 특허 청구에 해당하는 LNP가 존재하는 것으로 나타났습니다.
이 국제 집행은 델라웨어에서 진행 중인 미국 절차를 확장하는 것으로, 배심원 재판은 2025년 9월로 예정되어 있습니다. mRNA 의약품 전달에 중요한 LNP 기술은 Arbutus와 Genevant 과학자들에 의해 개발되었으며 여러 제3자에게 라이선스가 부여되었습니다.
Genevant Sciences et Arbutus Biopharma (ABUS) ont engagé cinq poursuites internationales pour violation de brevet contre Moderna dans 30 pays. Les actions en justice visent l'utilisation présumée non autorisée de leur technologie des nanoparticules lipidiques (LNP) dans les produits Spikevax® et mRESVIA®.
Les poursuites ont été déposées dans plusieurs juridictions, y compris le Canada, le Japon, la Suisse et le Tribunal Unifié des Brevets (UPC). Les entreprises demandent des dommages-intérêts et des injonctions contre les produits de Moderna. Des preuves provenant de tests d'échantillons commerciaux de Moderna des États-Unis et d'Europe indiquent la présence de LNP qui relèvent de leurs revendications de brevet.
Cette application internationale s'ajoute à la procédure en cours aux États-Unis dans le Delaware, où un procès avec jury est prévu pour septembre 2025. La technologie LNP, importante pour la délivrance de médicaments à ARNm, a été développée par des scientifiques d'Arbutus et de Genevant et a été concédée sous licence à divers tiers.
Genevant Sciences und Arbutus Biopharma (ABUS) haben fünf internationale Klagen wegen Patentverletzung gegen Moderna in 30 Ländern eingereicht. Die rechtlichen Schritte zielen auf die angebliche unbefugte Nutzung ihrer Lipid-Nanopartikel (LNP)-Technologie in den Produkten Spikevax® und mRESVIA® ab.
Die Klagen wurden in mehreren Jurisdiktionen eingereicht, darunter Kanada, Japan, die Schweiz und das Einheitliche Patentgericht (UPC). Die Unternehmen fordern finanzielle Entschädigungen und Unterlassungsverfügungen gegen die Produkte von Moderna. Beweise aus Tests kommerzieller Moderna-Proben aus den USA und Europa zeigen das Vorhandensein von LNPs, die unter ihre Patentansprüche fallen.
Diese internationale Durchsetzung erweitert das laufende Verfahren in den USA in Delaware, wo ein Geschworenenprozess für September 2025 angesetzt ist. Die LNP-Technologie, die für die Lieferung von mRNA-Medikamenten wichtig ist, wurde von Wissenschaftlern von Arbutus und Genevant entwickelt und an verschiedene Dritte lizenziert.
- Expansion of patent enforcement to 30 countries strengthens potential monetary compensation
- Evidence from product testing supports patent infringement claims
- Multiple venues for seeking damages and injunctive relief increase chances of favorable outcome
- Established licensing revenue stream from LNP technology to other third parties
- Legal proceedings could be lengthy and costly
- Uncertain outcome of patent litigation
- No immediate revenue impact from enforcement actions
Insights
This expanded patent litigation represents a significant escalation in Arbutus and Genevant's enforcement strategy. By filing in multiple strategic jurisdictions—Canada, Japan, Switzerland, and the Unified Patent Court covering 27 European countries—they've created a comprehensive legal net targeting 30 countries simultaneously.
The litigation focuses on lipid nanoparticle (LNP) technology, the critical delivery system that enables mRNA therapeutics to function by protecting the mRNA and facilitating cellular uptake. What strengthens their position is the submission of physical evidence from testing commercial Moderna samples, suggesting they've conducted due diligence before filing.
The request for both monetary damages and injunctive relief is particularly aggressive. In pharmaceutical patent litigation, the threat of injunctions creates substantial leverage, as it could potentially force Moderna's products off market in multiple territories. The UPC filings are especially significant as they streamline enforcement across numerous European markets simultaneously.
This multi-jurisdictional approach accomplishes several strategic objectives: it increases settlement pressure, complicates Moderna's defense strategy, and creates the possibility for favorable rulings in some jurisdictions to influence others. With the U.S. trial scheduled for September 2025, these international filings create additional pressure points that could accelerate settlement discussions rather than risk adverse rulings across multiple markets.
This expanded patent enforcement campaign significantly enhances Arbutus's potential for substantial financial recovery and strengthens its position in the LNP technology marketplace. The litigation targets not just Spikevax but potentially other Moderna products using similar LNP technology, broadening the potential financial impact.
From a valuation perspective, this aggressive patent strategy highlights that Arbutus's intellectual property portfolio may be undervalued relative to its fundamental importance in enabling mRNA therapeutics. The company appears confident in the strength of its patents, evidenced by the investment in simultaneous multi-jurisdictional litigation.
The financial implications extend beyond potential damages from Moderna. A successful outcome would validate Arbutus's patent portfolio, potentially increasing licensing revenue from other pharmaceutical companies developing mRNA therapies. This could transform Arbutus from being valued primarily on its clinical pipeline to recognition as a key technology enabler in the mRNA space.
For investors, this litigation introduces both opportunity and risk. The timeline remains uncertain, and litigation outcomes are inherently unpredictable. However, the comprehensive approach suggests a strong conviction in their legal position. The most significant near-term catalyst will be the U.S. trial in September 2025, though developments in any of these international cases could trigger settlement discussions sooner.
BASEL, Switzerland and VANCOUVER, British Columbia and WARMINSTER, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio (a subsidiary of Roivant Sciences, Ltd. (Nasdaq: ROIV)), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, Inc. and certain affiliates. Together, the enforcement actions target alleged infringing activities in 30 countries.
Genevant and Arbutus are seeking monetary relief and injunctions against Spikevax® and, where applicable, additional Moderna products that Moderna has represented use the same LNP technology, including mRESVIA®. Where permitted to do so at this stage, Genevant and Arbutus submitted evidence from testing of commercial Moderna product samples sourced from the U.S. and Europe indicating that the samples contain LNPs falling under the protective scope of the claims of their lipid composition patents.
The cases are:
- Canada: Federal Court of Canada File No. T-704-25, seeking a permanent injunction and damages or, if Genevant so elects, an accounting of Moderna’s profits, attributable to infringement of Canadian Patent No. 2,721,333.
- Japan: Tokyo District Court Case No. 2025 (Wa) 70079, seeking a permanent injunction and reasonable royalty for infringement of Japanese Patent No. 5,475,753.
- Switzerland: filing a case seeking a permanent injunction and monetary relief, which upon later choice of Genevant and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254.
- Unified Patent Court (UPC): Case 10280/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna’s unfair profits, from infringement of EP 2 279 254.
- UPC: Case 10284/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna’s unfair profits, from infringement of EP 4 241 767.
The UPC actions together seek relief for: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey.
Today’s actions expand on Arbutus and Genevant’s ongoing enforcement proceeding in the U.S. District Court for the District of Delaware, seeking fair compensation for Moderna’s alleged infringement of six U.S. patents in the manufacture and sale of Spikevax®. A jury trial is currently scheduled for September 2025.
It is well established in the scientific literature that the most significant technological hurdle to developing and deploying medicines using mRNA is engineering a safe and effective way to deliver the mRNA to human cells. Scientists at Arbutus and Genevant have spent years developing and refining LNP delivery technology, which has been licensed for various applications to many different third parties, including Moderna. Arbutus and Genevant’s LNP technology relies on microscopic particles built from four carefully selected types of fat-like molecules to shelter and protect mRNA molecules and to enable them to travel through the human body to a target cell and through the target cell’s membrane before releasing the mRNA. Without this crucial delivery technology, mRNA would quickly degrade in the body and be ineffective.
About Genevant Sciences
Genevant Sciences is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant’s scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant’s LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit www.genevant.com.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) for the treatment of chronic hepatitis B (cHBV). Through its ownership stake in and license agreement with Genevant, Arbutus is also focused on maximizing opportunity for its in-house developed Lipid Nanoparticle (LNP) delivery technology. For more information, visit www.arbutusbio.com.
Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include, but are not limited to, statements about: Arbutus’ plans with respect to the ongoing patent litigation matters.
Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
FAQ
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