As the salad days of pandemic vaccine sales wane, two mRNA camps are taking a legal stand on the global stage—and duking it out in the name of drug delivery.
In response to an August lawsuit from Moderna alleging patent infringement related to its COVID-19 vaccine technology, Pfizer and BioNTech have hit back with a countersuit, demanding a jury trial and refuting Moderna’s claims of infringement.
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In Moderna’s original suit, the company accused Pfizer and BioNTech of stepping on Moderna’s patents filed between 2010 and 2016 and sought to “protect” its innovative mRNA technology that it “pioneered, invested billions of dollars into creating, and patented” during the decade proceeding the pandemic, CEO Stéphane Bancel said in a statement at the time.
Pfizer and BioNTech denied each of Moderna’s claims, noting that Moderna is stretching its “already overbroad” and arguably “invalid” patents and is trying to “claim credit for others’ work.” The companies argue that Moderna, in its original lawsuit, tried to rewrite the well-known story of the COVID-19 pandemic to put itself in the “single, starring role” by ignoring the contributions of other players, including scientists at Pfizer and the National Institute of Health (NIH).
The scathing countersuit went on to attest that Pfizer and BioNTech independently developed their vaccine by using innovation from their scientists and decades of research conducted by others.
“Unlike Moderna, however, Pfizer and BioNTech are not seeing a financial windfall for the work of others,” the companies’ attorneys said in the filing. “Moderna’s patent claims far exceed its actual contributions to the field, and its present lawsuit will discourage further development of the remarkable science that made accelerated COVID-19 vaccines possible in the first place.”
While Moderna’s lawsuit claimed that the two mRNA vaccines are similar enough to warrant a patent claim, due to the use of mRNA and lipid nanoparticles in both, Pfizer and BioNTech claim that their vaccine is “undeniably different” from their competitor's. The companies noted that their vaccine uses a different mRNA structure than the one present in Moderna’s vax, as well as different lipids.
Aside from denying the copying claims, Pfizer’s suit was quick to point out Moderna’s 2020 pledge that it would not enforce its COVID-19-related patents during the pandemic. But now, Moderna has been “quietly expanding its patent portfolio” and is breaking the promises to “leverage fundamental research” done by others for financial gain, the countersuit says.
Pfizer seeks judicial determinations that the company has not violated Moderna’s patent claims. It wants a judgement to be entered officially declaring that the companies did not step on any of Moderna’s patents, and then that Moderna’s complaint be dismissed with prejudice.
The three companies, who all reaped billions from their respective vaccines, are still deep in other vaccine related lawsuits, including one by CureVac that accuses BioNTech of infringing on its intellectual property.
Moderna did not immediately reply to Fierce Pharma’s request for comment.