Context: In February 2022, nucleic acid delivery company Genevant Sciences and clinical-stage biopharmaceutical company Arbutus Biopharma Corporation sued Moderna for allegedly infringing six U.S. patents in the District of Delaware (February 28, 2022 Genevant press release). In that suit, the companies alleged that Moderna used their “revolutionary” lipid nanoparticle (LNP) delivery platform “without payment or a license” – the system, they claim, was developed “with great effort and at great expense, and without which Moderna’s COVID-19 vaccine would not have been successful.” A jury trial in that suit is scheduled for September this year.
What’s new: Expanding on that campaign, Genevant and Arbutus yesterday filed five more lawsuits against Moderna, alleging that the company’s Spikevax and mRESVIA vaccines (among others) are infringing their mRNA-related patents in 30 different countries. The companies have filed lawsuits in the Federal Court of Canada, the Tokyo District Court, Switzerland’s Federal Patent Court, and the Unified Patent Court (UPC). Genevant and Arbutus are seeking monetary relief and injunctions against Moderna’s infringing vaccinations in every jurisdiction.
Direct impact: Moderna has been on the receiving end of lawsuits over its COVID-19 vaccine several times since the launch of its product – including, most recently, by GlaxoSmithKline and Northwestern University. But the company also celebrated significant wins in its European, UK and U.S. disputes in 2024, which may put it on firmer territory as it heads into this newest case.
Wider ramifications: Genevant and Arbutus’s suits are two of very few pharma patent cases at the UPC – although they join a major one filed against BioNTech/Pfizer in January – indicating that it is still a path of uncertainty and great hesitancy for pharma patentees. If this case proceeds, the ultimate decision could have a big impact on how future UPC pharma patent infringement cases are treated.
Arbutus Biopharma is a clinical-stage biopharmaceutical company focused on infectious diseases based in Pennsylvania. It is currently developing imdusiran (AB-729) for the treatment of chronic hepatitis B (cHBV). Arbutus Biopharma owns a stake in and is currently licensing LNP delivery technology from Genevant (which is a joint company with Roivant Sciences).
The patents-in-suit include:
- Canada Patent No. 2721333 (“Novel lipid formulations for nucleic acid delivery”).
- Japanese Patent No. 5475753 (“Lipid formulations for nucleic acid delivery”).
- EP2279254 (“Novel lipid formulations for nucleic acid delivery”).
- EP4241767 (“Novel lipids and compositions for the delivery of therapeutics”).
Together, the UPC actions are seeking 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, Liechtenstein, and Turkey.
The companies are seeking permanent injunctions in all five suits, and provisional injunctions in both the UPC actions.
As part of the campaign, Genevant and Arbutus have submitted evidence from testing of commercial Moderna product samples sourced from the U.S. and Europe, indicating that the samples contain LNP that infringe on their patents.
In a statement yesterday, the plaintiffs noted that 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. 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, they emphasized:
“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.”
Counsel
In the U.S., David Berl at Williams & Connolly is lead counsel for Genevant. He is joined by Williams & Connolly’s Adam Harber, Jessica Palmer Ryen, Shaun P. Mahaffy, and Thomas S. Fletcher, as well as Karen Elizabeth Keller and John W. Shaw at Shaw Keller LLP, Daralyn J. Durie, Eric C. Wiener and Lydia B. Cash at Morrison Foerster, and Denis R. Hurley.
Arbutus Biopharma is also represented by John W. Shaw and Karen Elizabeth Keller, as well as Shaw Keller LLP’s Nathan Roger Hoeschen and Kira A. Davis at Morrison Foerster.
Meanwhile, Moderna is being represented by Morris, Nichols, Arsht & Tunnell LLP’s Brian P. Egan, Jack B. Blumenfeld, and Kirkland & Ellis’s James F. Hurst, Jeanna M. Wacker, Mark C. McLennan, and Patricia A. Carson.
Moderna’s Spikevax has been targeted in LNP patent infringement suits before. In October, GlaxoSmithKline and Northwestern University filed parallel actions alleging Moderna’s COVID-19 vaccine infringed their LNP patent portfolios in the District of Delaware (October 17, 2024 ip fray article).
But 2024 was also a positive year for Moderna after the European Patent Office in May upheld the validity of one of its key patents in its dispute against Pfizer, while the High Court of Justice for England & Wales (EWHC) also ruled in favour of Moderna in its dispute against Pfizer two months later, finding that the defendant was infringing a Moderna patent with its COVID-19 vaccine Comirnaty. Then, in October, it celebrated a major win in its dispute against Alnylam Pharmaceuticals (where Moderna was a defendant) when the latter admitted defeat and asked the court to dismiss the case without prejudice.