Now that President Biden has officially announced that “the pandemic is over,” vaccine manufacturer Moderna has decided its high time to sue Pfizer and BioNTech over the patents it holds for the COVID vaccines. And the lawsuit promises to be the biggest legal battle yet over who owns key inventions used in mRNA technology.
Moderna’s lawsuits, filed against its biggest competitors, allege that Pfizer and BioNTech infringed patented mRNA technology used in the company’s proprietary COVID-19 vaccines. Ironically, all three companies already were involved in separate lawsuits over patents related to the technology, but the action by Moderna is the highest profile suit to date. And, given the glacial pace at which most patent cases progress in the U.S., the outcome is many years in the future.
Moderna was founded in 2010 based on the precept that messenger RNA, or mRNA, could be used to deliver genetic instructions to cells for making proteins.
Messenger RNA is a type of single-stranded RNA involved in protein synthesis and is made from a DNA template during the process of transcription. The role of mRNA is to carry protein information from the DNA in a cell’s nucleus to the cell’s cytoplasm (watery interior), where the protein-making machinery reads the mRNA sequence and translates each three-base codon into its corresponding amino acid in a growing protein chain.
When Moderna first released its COVID vaccine, many consumers expressed concern that the mRNA technology underlying the formulation had the potential to alter human existence at the genetic level. This concern also led to quite a few entertaining memes and bizarre social media exchanges.
The COVID vaccines used mRNA to coax cells into temporarily making coronavirus proteins, and the genetic technology proved faster to design and manufacture than traditional vaccines.
“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Moderna’s chief legal officer, Shannon Thyme Klinger, said in a statement.
A spokesperson for Pfizer said that the New York-based company and BioNTech, its German development partner on the COVID vaccine, have not had time to fully review the lawsuit, but that the companies “are surprised by the litigation.” Their vaccine “was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the spokesperson said.
Why It Matters. In October 2020, Moderna promised not to enforce its patents related to the COVID-19 vaccine during the pandemic. But global sales of the two mRNA COVID-19 vaccines are expected to reach more than $107 billion by the end of the year, with nearly two-thirds going to Pfizer and BioNTech, and these stakes were just too high for Moderna to forego patent infringement lawsuits in perpetuity.
When it filed, Moderna released a statement explaining that in March “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,” opening the door for legal action against Pfizer and BioNTech. And if Moderna eventually prevails against Pfizer and BioNTech, even a small royalty percentage could add substantially to the billions of dollars in profits it already has reaped from vaccine sales.