Moderna Sues Pfizer Over mRNA Vaccine Patent Infringement

Moderna filed patent infringement lawsuits against Pfizer and BioNTech over their mRNA vaccine technology, the company said in a statement on Friday.

The company believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016, covering Moderna’s foundational mRNA technology which was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax.

“Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty,” the statement reads.

The lawsuits were filed in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” said Moderna Chief Executive Officer Stéphane Bancel.

Key features

According to Moderna, “when COVID-19 emerged, neither Pfizer nor BioNTech had Moderna’s level of experience with developing mRNA vaccines for infectious diseases, and they knowingly followed Moderna’s lead in developing their own vaccine.”

Friday’s statement explains that although Pfizer and BioNTech took four different vaccine candidates into clinical testing, “which included options that would have steered clear of Moderna’s innovative path,” they “ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax.”

Moderna scientists had begun developing that breakthrough modification in 2010 and were the first to validate the usage of the particular vaccine in human trials in 2015.

“Second, and again despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus,” it adds.

Again, Moderna scientists developed this approach years before COVID-19 emerged, when they created their vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS).

The decision to sue Pfizer and BioNTech was triggered by their failure to respect Moderna’s intellectual property rights when the fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world.

In October 2020, Moderna had pledged not to enforce its COVID-19 related patents while the pandemic continued and recently updated its pledge to never enforce its patents for any COVID-19 vaccine used in the 92 low-income and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92).

Moderna’s new bivalent vaccine

Earlier in August, the U.K. became the first country to approve the world’s first bivalent COVID-19 vaccine, developed by Moderna.

The dual-strain vaccine is designed to tackle both the original virus and the newer Omicron variant and has been approved for adult booster doses after it was found to meet the U.K. regulator’s standards of safety, quality, and effectiveness.

Clinical trials showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. It was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.

In the post-pandemic world, Moderna will be using its mRNA technology platform to develop medicines that could treat and prevent infectious diseases such as influenza and HIV, as well as autoimmune diseases, cardiovascular diseases, and rare forms of cancer, Moderna CEO Bancel says.