Moderna and Pfizer are set to wage legal battle over the technology that led to their respective covid-19 vaccines. Moderna is now suing Pfizer and its German partner BioNTech for the alleged infringement of patents related to the development of a viable mRNA vaccine platform that Moderna claims to have pioneered. Though the Massachusetts-based company is seeking financial compensation, the lawsuits aren’t expected to affect the current or future availability of Pfizer’s vaccines.
Moderna declared legal war in an announcement released Friday morning. It will be suing the companies in the United States District Court for the District of Massachusetts and in the Regional Court of Düsseldorf in Germany.
The basic science underlying mRNA vaccine development stretches back at least three decades. But Moderna claims that their scientists made the patented advances needed for these vaccines to become the effective tools against the covid-19 pandemic that they’ve become—advances that Pfizer/BioNTech allegedly lifted without proper credit and recompense.
Specifically, the company argues that Pfizer’s vaccine relies on a modification invented by Moderna that delays the body from responding to the mRNA located in the vaccine too quickly. Moderna also alleges that it has patent rights over mRNA vaccines that replicate the full spike protein of the SARS-CoV-2 coronavirus, based on its past work with MERS, a related coronavirus (mRNA vaccines work by inducing cells to produce a piece of the target germ, in this case, the spike protein). According to the company, the patents do not concern any of the research conducted in conjunction with the U.S. government via the National Institutes of Health, though there has been a separate patent dispute ongoing between the parties there as well.
“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 Stéphane Bancel in a statement.
These lawsuits have been brewing for a while. But early on, Moderna had pledged that it would not pursue any legal action related to its patents during the pandemic. In March 2022, the company changed its pledge to claiming that it would not sue for patents related to vaccines developed in low- to middle-income countries. And since covid-19 vaccines have become readily available in wealthier countries, Moderna argues that now is the right time to safeguard its intellectual property in these areas.
The lawsuits will not seek to block future sales of Pfizer’s vaccine (formally called Comirnaty in the U.S.) nor remove it from the market. And it won’t seek damages related to vaccines purchased by the U.S. government or those bought before March 2022, in keeping with its original pledge. With the government about to leave the marketplace for covid-19 vaccines, though, the lawsuits, if successful, could affect the profitability of Pfizer’s vaccines moving forward.
“Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty®’s ongoing use of Moderna’s patented technologies,” said Moderna Chief Legal Officer Shannon Thyme Klinger.
The legal battleground over this breakthrough vaccine technology is likely to only get more intense. As noted by the Verge, BioNTech is facing patent lawsuits from another mRNA-centric company, CureVac. And in addition to its standoff with the U.S. government, Moderna is being sued over aspects of its lipid nanoparticle delivery method by Genevant Sciences and Arbutus Biopharma, while both Moderna and Pfizer are being sued by the company Alnylam over their delivery method as well. While some of these lawsuits may settle out of court, it could very well take years for the dust to settle.