Moderna’s Lawsuit Against Pfizer/BioNTech: What Does This Mean for Their Vaccine’s future?

On August 26, Moderna filed a lawsuit against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany. The foundation of Moderna’s lawsuit against Pfizer/BioNTech is the assertion that their COVID-19 vaccine, Comirnaty®, infringes on Moderna’s patents for foundational mRNA technology.

Related Article: Pfizer’s Bivalent RSV Candidate Demonstrates 85% Efficacy in Phase 3 Trials

Moderna Goes Back On its Early Pandemic Pledge

In October 2020, Moderna pledged that it would not enforce any of its patents related to COVID-19 against other companies developing vaccines. 

In a statement, released in October 2020, the company said, “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19-related patents against those making vaccines intended to combat the pandemic.”

However, that sentiment changed when the pandemic entered a new phase in March this year. With the supply of vaccines no longer a pressing issue, Moderna amended its pledge that it would only refrain from enforcing its patents in low and middle-income countries. Moderna filed suits asserting that Pfizer and BioNTech unlawfully copied two critical aspects of Moderna’s mRNA technology.

Will Pfizer’s Vaccine Become Unavailable?

Both Moderna’s and Pfizer/BioNTech’s vaccines use mRNA technology. Moderna’s filing alleges that Pfizer/BioNTech copied two critical aspects of their vaccine, Spikevax, in creating their own. 

The first alleged violation is a chemical reaction found in both vaccines. This reaction prevents a patient’s immune system from attacking the mRNA before it deploys the vaccine. Moderna claims they began developing this reaction in 2010 and validated it in 2015 clinical trials. Furthermore, Moderna asserts that out of other vaccine candidates that would have steered Pfizer/BioNTech clear of their patent, the companies decided on the one that violated Moderna’s patent. 

The second alleged violation centers on Moderna’s claims that Pfizer/BioNTech copied their encoding method of the spike protein found in the vaccine. According to Moderna, they developed this approach for Middle East Respiratory Syndrome (MERS) years before the emergence of COVID-19. 

Despite the lawsuit, Moderna is not seeking the removal of Pfizer/BioNTech’s vaccine from the market. Instead, they want payment from the companies. In a statement, Moderna’s Chief Legal Officer, Shannon Thyme Klinger, said, “Outside of AMC 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.”

This is not the first lawsuit facing either company centered around COVID-19 Vaccine Technology. In March of this year, Alnylam Pharmaceuticals filed separate lawsuits against Pfizer and Moderna for allegedly violating their patents on biodegradable lipids.CureVac filed another lawsuit against BioNTech recently. They also claim BioNTech unfairly appropriated their mRNA intellectual property for their COVID-19 vaccine.

Though Pfizer has not released a public statement, BioNTech responded in a press release to Moderna’s lawsuit. The company resoundly rebukes Moderna’s claims, asserting that their work was original.

Whether Moderna’s Lawsuit Against Pfizer/BioNTech will be settled in court or privately remains to be seen. 

Author

Max Heirich