GERMANY — In a pivotal development, the European Patent Office has dealt a significant blow to Moderna by invalidating the patent for its mRNA-based COVID-19 vaccine, Spikevax.
This decision triggered a nearly 4% decline in the company’s shares on Tuesday. The invalidated patent, European patent no. 3,718,565 B1, is a cornerstone in Moderna’s COVID-19 vaccine technology, covering betacoronavirus vaccines utilizing RNA polynucleotides.
Moderna spokesperson Christopher Ridley expressed disagreement with the decision, stating, “we continue to believe in the strength and validity of the ‘565 patent and will appeal.”
Beyond its application to COVID-19 vaccines, the nullified patent seeks to safeguard the technology’s utilization in other viral respiratory infections, including MERS and SARS.
This setback is part of Moderna’s broader legal battles in the mRNA technology domain, including ongoing lawsuits against Pfizer/BioNTech for alleged unlawful copying of its mRNA inventions in developing the COVID-19 vaccine Comirnaty.
Moderna’s legal challenges extend to disputes with Alnylam Pharmaceuticals and Arbutus Biopharma, contributing to the complexity of its legal landscape.
Competitors, including BioNTech, Pfizer, and Sanofi, have opposed Moderna’s claims, further intensifying the legal disputes.
While Moderna has secured favorable rulings in some cases, such as against Alnylam, the European Patent Office’s decision introduces uncertainty to the company’s legal standing.
These legal battles unfold amid declining demand for COVID vaccines, resulting in a reported 50% decline in third-quarter sales for Moderna.
The undisclosed legal costs associated with these lawsuits underscore the magnitude of the battle. Meta’s payment of US$67 million to the law firm WilmerHale in 2022, the same firm representing Moderna, exemplifies the substantial financial strain incurred.
The potential payout for Moderna, if successful in its legal endeavors, would be based on vaccine sales during the pandemic.
The company’s original lawsuit against Pfizer/BioNTech seeks damages rather than the removal of Comirnaty.
With Comirnaty’s sales surpassing US$35 billion in 2022 alone, a favorable outcome for Moderna could not only cover legal costs but also bolster its position in defending its patents in the future.
Despite the challenges and falling revenues from vaccine sales, Moderna remains optimistic, anticipating sales of at least 50 million doses in the US this fall.
This projection supports the expectation of total Spikevax sales reaching at least US$6 billion for the year.