The lawsuits claim that Moderna used and profited from crucial mRNA technology in its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.
GSK on Tuesday filed two lawsuits against Moderna, alleging that the vaccine developer has used protected mRNA technology for its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.
The lawsuits, filed separately in the U.S. District Court for the District of Delaware, are seeking a judgement declaring that Moderna has committed infringement, “either literally or under the doctrine of equivalents” for several patents that “provide the foundation for Moderna’s mRNA vaccine portfolio.”
GSK is also seeking damages to compensate for the alleged infringement as well as a “compulsory ongoing licensing fee” for the claimed technologies.
“Moderna has reaped billions of dollars in revenue from infringing GSK’s Patents-in-Suit, and continues to benefit, without ever obtaining a license,” the legal complaint contends. “GSK brings this suit to recover a reasonable royalty for Moderna’s infringing sales of mRNA vaccines” that use these protected technologies.
Spikevax earned around $6.7 billion in 2023, compared with more than $18 billion in 2022.
Meanwhile, GSK’s RSV lawsuit on Tuesday targets the recently approved mResvia, which won the FDA’s nod in May 2024. Late-stage data showed that the mRNA vaccine was 83.7% effective against lower respiratory tract disease. Moderna plans to make the shot available by the 2024/2025 RSV season.
Jefferies analyst Peter Welford in an August 2024 note to investors said that mResvia’s entry into the market has done little to threaten GSK’s own RSV vaccine Arexvy, with Moderna’s shot holding “negligible” market share at the time.
With Tuesday’s lawsuit, GSK is upping its legal campaign to claim rights over crucial COVID-19 patents. In April 2024, the British drugmaker filed a similar complaint against Pfizer and BioNTech over their alleged infringement of protected mRNA vaccine technologies. At the time, GSK claimed that the defendants “exploit fundamental technologies” owned by GSK, without acquiring a license to practice these inventions “before or since commercializing.”
In its Moderna suit, GSK is seeking compensation for the damages it allegedly suffered due to the infringement, as well as an ongoing license fee.
GSK’s latest lawsuit adds to a complex legal battle over COVID-19 vaccines, including an August 2022 patent infringement suit from Moderna against Pfizer and BioNTech. The mRNA specialist at the time focused on two key technologies—the process of encoding the full-length spike protein encased in a lipid nanoparticle and certain chemical alternations to the mRNA molecule in the vaccine.
Pfizer and BioNTech hit back a year later, challenging the validity of Moderna’s patents with the U.S. Patent and Trademark Office.
