Blow to Moderna as EU nixes mRNA vaccine patent

The European Patent Office has said it has invalidated a patent held by Moderna on mRNA-based COVID-19 vaccines, the latest development in an increasingly acrimonious dispute between the company and rivals BioNTech and Pfizer.

Moderna has lawsuits on the go against BioNTech in several jurisdictions, including the US, Germany, the UK, the Netherlands, Belgium, and Ireland, claiming that its Comirnaty vaccine infringes patents covering its own Spikevax shot, including EU patents EP3590949 (the ‘949 patient) and EP3718565 (‘565), which make claims for mRNA vaccines intended to treat respiratory diseases.

BioNTech and Pfizer have since countersued, seeking to dismiss Moderna’s suit and further claiming that its patents are invalid and not infringed, and make claims that “far exceed its contributions to the field.”

The parties have all said they are not seeking damages for the period during the COVID-19 emergency, but need to exert their intellectual property rights now that the pandemic is over and normal commercial conditions have been established.

At the heart of the dispute are claims covering a chemical modification to prevent an unwanted immune response in patients and allow larger doses of mRNA to be delivered, covered by ‘565, as well as a proprietary lipid nanoparticle formulation covered by ‘949.

The EPO has now invalidated the ‘565 patent, a decision which BioNTech said was “important" as it "believe[s] that this and others of Moderna’s patents do not meet the requirements for grant and should never have been granted.” The patent has also been contested by Sanofi, which was also developing an mRNA-based COVID-19 vaccine that was discontinued as the pandemic started to abate.

Moderna said in a statement that it disagreed with the EPO’s decision and would lodge an appeal. Shares in the company lost 2.3% of their value in the wake of the announcement.

The lawsuits were filed at the peak of COVID-19 vaccine sales - when billions of dollars were generated each quarter for the companies - but there are signs that the bonanza will not continue as the market transitions from a government-led to a traditional private commercial model.

Moderna and Pfizer/BioNTech have both slashed their COVID-19 sales forecasts for the year in the last few weeks, with Moderna expecting demand to further slacken in 2024, before the market stabilises in 2025 and beyond at a lower level.