Moderna sues Pfizer, BioNTech over patent infringement of its Covid vaccine

Biotechnology major Moderna on Friday sued rival Pfizer and BioNTech over alleged infringement of its messenger RNA (mRNA) vaccine technology patents.

In the lawsuit filed in the US and Germany, Moderna alleged that Pfizer and BioNTech's Covid-19 vaccine 'Comirnaty' unlawfully infringes patents Moderna filed between 2010 and 2016 for its foundational mRNA technology, critical to the development of Moderna's own mRNA vaccine, 'Spikevax'.

"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 CEO Stephane Bancel.

The company said that Pfizer and BioNTech copied this technology, without Moderna's permission, to make Comirnaty.

In October 2020, Moderna pledged not to enforce its Covid-19 related patents while the pandemic continued.

In March 2022, when the collective fight against Covid-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge.

It made clear that while it would never enforce its patents for any Covid vaccine used in the 92 low- and middle-income countries, Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Pfizer and BioNTech have failed to do so.

"We believe that Pfizer and BioNTech unlawfully copied Moderna's inventions, and they have continued to use them without permission," said Moderna Chief Legal Officer Shannon Thyme Klinger.

"Outside of 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty's ongoing use of Moderna's patented technologies," Klinger added.

Moderna said it is not seeking to remove Comirnaty from the market and is not asking for an injunction to prevent its future sale.

In addition, Moderna said it is not seeking damages related to Pfizer's sales to 92 countries and is not seeking damages for Pfizer's sales where the US government would be responsible for any damages

Moderna believes Pfizer and BioNTech copied two key features of Moderna's patented technologies which are critical to the success of mRNA vaccines.

"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," said the company.

Pfizer/BioNTech have also been sued for patent infringement by CureVac.

Moderna is also facing lawsuits from biotechnology companies Arbutus Biopharma and Genevant Sciences.

Another biotechnology company, Alnylam, is suing both Pfizer/BioNTech and Moderna over a similar technology.