By Tristan Manalac
The European Patent Office has decided that a hotly contested mRNA patent held by Moderna pertaining to its COVID-19 vaccine is invalid, Reuters reported on Tuesday.
The patent in question covers betacoronavirus vaccines that use at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide, according to its claims document listed in the European Patent Register. While the patent battle is over the use of this technology to produce COVID-19 vaccines, the claims document also seeks to protect its use for other viral respiratory infections, including MERS and SARS.
Several biopharma companies have lodged their opposition to these claims, including BioNTech and Pfizer—Moderna’s chief competitors in the coronavirus vaccine market—as well as Sanofi, according to the patent’s listing on the register.
A BioNTech spokesperson in a statement to Fierce Pharma said that the company “welcomes” the European Patent Office’s decision, adding that it “is an important one as we believe that this and others of Moderna’s patents do not meet the requirements for grant and should never have been granted.”
Moderna told Endpoints News that it disagrees with the verdict and that it plans on appealing the decision. The company has two months to file its challenge.
Tuesday’s ruling from the European Patent Office is the latest development in the fierce patent battle over the mRNA technologies underpinning the COVID-19 vaccines. In August 2022, Moderna filed lawsuits against Pfizer and BioNTech, alleging that the partners’ vaccine Comirnaty infringed on patents filed from 2010 to 2016 and covering the core mRNA technology that underpins Moderna’s own vaccine Spikevax.
At the time, Moderna said that it would not enforce these patents in the more than 90 low- and middle-income countries participating in the GAVI COVAX Advance Market Commitment alliance.
Pfizer and BioNTech hit back at Moderna in December 2022, filing a countersuit to dismiss the initial lawsuit. In August 2023, the partners took the fight to the U.S. Patent and Trademark Office and sought to have Moderna’s patent protections invalidated.
In their 87-page petition, the pharma partners contend that Moderna’s patents are “unimaginably broad,” claiming ownership of knowledge that existed before the priority date of 2015. Pfizer and BioNTech contend that using injected mRNA to induce protein production has been in scientific practice since the 1990s and that Moderna’s patents “coopt an entire field of mRNA technology.”