Shortly after winning a stay on a COVID-19 vaccine patent lawsuit brought by Moderna, Pfizer and its German partner BioNTech are being dragged into another round of mRNA litigation by GSK.
GSK on Thursday filed a lawsuit in Delaware federal court accusing Pfizer and BioNTech of infringing five patents related to the mRNA technology behind the partners’ COVID shot Comirnaty. The relevant mRNA research was conducted “more than a decade” before the COVID-19 pandemic and was picked up by GSK in 2015 when the company acquired a “substantial portion” of Novartis’ global vaccine business, according to the lawsuit.
GSK claims Pfizer and BioNTech subsequently “reaped billions of dollars in revenue from infringing GSK’s Patents-in-Suit and continue to benefit, without ever obtaining a license.”
Now, the British drugmaker is seeking a “reasonable royalty” from Pfizer and BioNTech, as well as a compulsory ongoing licensing fee for the partners’ alleged use of GSK’s patented mRNA technology.
A GSK spokesperson confirmed over email that the company filed suit and said it’s “committed to taking appropriate action where necessary to protect the company’s intellectual property.” She described the GSK patents in question as “foundational” to Pfizer and BioNTech’s mRNA vaccines.
GSK would be “willing to license these patents on commercially reasonable grounds” to make sure patients continue to enjoy access to Pfizer and BioNTech’s shots, the spokesperson added.
Pfizer, for its part, remains “confident” in its intellectual property (IP) position and intends to “vigorously defend against [GSK’s] claims,” a company spokesperson said in a statement.
The latest lawsuit in Delaware marks the opening of a new front in GSK’s vaccine patent litigation against Pfizer.
Last August, GSK claimed in a separate court filing that Pfizer’s respiratory syncytial virus (RSV) shot Abrysvo violated four patents related to its own RSV immunization Arexvy. GSK argued that Pfizer began the project that led to Abrysvo no earlier than 2013—at least seven years after GSK kickstarted its own RSV program.
Separately, Pfizer and BioNTech have been locking horns with Moderna over mRNA IP for nearly two years.
The kerfuffle started in late August of 2022 when Moderna filed lawsuits in the United States and Germany contending that Pfizer and BioNTech copied “key features” of its patented mRNA technology. Pfizer and BioNTech filed a countersuit and demanded a jury trial in December of that same year, with lawyers for the partners arguing that Moderna was attempting to put itself in the “single, starring role” of the response to the COVID-19 pandemic.
More recently, Pfizer and BioNTech last summer pressed the U.S. Patent and Trademark Office’s (PTO’s) Patent Trial and Appeals Board to invalidate a pair of Moderna patents around mRNA vaccine production.
Earlier this month, Massachusetts federal judge Richard G. Stearns granted a stay on the case to provide more time for the Patent Trial and Appeal Board to review Pfizer and BioNTech’s patent challenges.
COVID-19 vaccine revenues have fallen precipitously for both Pfizer-BioNTech and Moderna over the last two years.
In 2023, Comirnaty brought in $11.2 billion in sales, a steep 70% decline from the $37.8 billion generated by the shot in 2022.