On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against Moderna and certain affiliates. Genevant and Arbutus are seeking injunctions and damages or royalties in respect of Moderna’s Spikevax® Covid-19 mRNA vaccine, and also potentially Moderna’s RSV vaccine mRESVIA®, which Moderna “has represented use the same LNP technology” as claimed in Genevant/Arbutus’ patents.
The five lawsuits were filed in the following jurisdictions:
- Canada (File No. T-704-25), alleging infringement of CA2721333;
- Japan (Case No. 2025 (Wa) 70079), alleging infringement of JP5475753;
- Switzerland, alleging infringement of EP2279254;
- Unified Patent Court (UPC) (Case 10280/2025), alleging infringement of EP2279254; and
- UPC (Case 10284/2025), alleging infringement of EP4241767.
Together, the enforcement actions target 30 countries, with the UPC actions seeking relief in: 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.
The Court filings follow litigation between the parties underway in the US District Court for the District of Delaware (1:22-cv-00252), which is scheduled for trial in September 2025. In those proceedings, Genevant and Arbutus allege that Moderna infringes six US patents relating to LNP technology: 11141378, 8058069, 8492359, 8822668, 9364435 and 9504651.
The five lawsuits were commenced in the same week as two US Moderna patents to Spikevax® were invalidated by the PTAB. The PTAB invalidation followed IPRs filed by Pfizer and BioNTech in 2023 (IPR2023-01358 and IPR2023-01359) against two patents to the Moderna coronavirus vaccine (US10702600 and US10933127) respectively. According to Pfizer/BioNTech media releases, the decision was delivered by PTAB on 6 March 2025 and is currently under seal. The PTAB decision is appealable to the Federal Circuit.
Moderna sued Pfizer and BioNTech in the District Court of Massachusetts in 2022 alleging infringement of 3 patents. The PTAB decision relates to 2 of the in-suit patents.