After decades of research, COVID-19 proved that mRNA technology can be effective in human healthcare. Life sciences and pharmaceutical companies now see mRNA as a viable technology for treating or preventing diseases. Just like we saw with CRISPR–Cas9 technology, mRNA stakeholders will be looking to defend and/or strengthen their legal positions in this space.
There have been a few legal actions and licensing deals (for example, in 2021 Sanofi paid $3.2 billion for Translate Bio). We expect to see more in the coming months.
This article summarises the cases we are aware of and the law firms involved.
Some of the patent cases
Allele Biotechnology
Allele Biotechnology sued Pfizer and BioNTech in the US in 2020 but the dispute was later settled (see here).
Legal representatives
Williams & Connolly and Noonan Lance Boyer & Banach acted for Pfizer while Paul Hastings acted for BioNTech.
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals brought patent infringement actions against Pfizer and Moderna in the US in March 2022 (see here, here and here). Moderna said the actions are “unfounded” and it will seek to dismiss them (see here).
Legal representatives
McDermott Will & Emery is acting for Alnylam Pharmaceuticals.
Arbutus Biopharma
Acuitas Therapeutics filed an action for non-infringement against Genevant Sciences and Arbutus Biopharma in the US in March 2022 (see here). Pfizer’s COMIRNATY® vaccine uses Acuitas Therapeutics’ lipid nanoparticle (LNP) technology for mRNA delivery. In 2018, Arbutus Biopharma Corporation and Acuitas Therapeutics settled a licensing dispute (which involved Moderna) over the LNP technology in Canada (see here).
Legal representatives
Paul Weiss Rifkind Wharton & Garrison is acting for Acuitas Therapeutics in this non-infringement action.
Shaw Keller, Durie Tangri and Williams & Connolly are acting for Arbutus Biopharma Corporation and Genevant Sciences.
CureVac
CureVac sued BioNTech in Germany for patent infringement in July 2022. BioNTech and Pfizer responded with an action for a declaration of non-infringement in the US District Court for the District of Massachusetts.
Legal representatives
Willkie Farr & Gallagher is representing Pfizer while Paul Hastings acts for BioNTech.
BioNTech and Pfizer
BioNTech and Pfizer issued proceedings against CureVac in the UK's Patents Court on September 2, 2022. We understand they are seeking a declaration of non-infringement.
Pfizer and BioNTech issued invalidity proceedings against Moderna in September 2022.
Legal representatives
Powell Gilbert is representing BioNTech while Taylor Wessing acts for Pfizer.
Moderna
Moderna sued Pfizer and BioNTech in the United States and Germany alleging that they used its mRNA platform technology for their COMIRNATY® vaccine. Read about the US case here. Moderna also launched proceedings against both companies in the UK in August 2022.
Legal representatives
Patent stars Amy Wigmore, Emily Whelan, and William Lee of WilmerHale are among the lawyers leading Moderna’s litigation in the US against Pfizer and BioNTech. Freshfields Bruckhaus Deringer acts for Moderna in the UK.
We have not yet confirmed the lawyers for the German litigation.
*This article was first published on August 30, 2022. We will amend it as soon as we receive updates.
