GSK turns its guns on Moderna in mRNA jab patent dispute

GSK has filed a pair of lawsuits against Moderna, claiming infringement of patents covering mRNA vaccines for COVID-19 and respiratory syncytial virus (RSV).

According to court documents, the lawsuits focus on Moderna's use of lipid nanoparticle encapsulation of mRNA vaccines, a technology used to protect the mRNA molecules as they are delivered to cells in the body.

The suits allege that nanoparticles used in Moderna's Spikevax COVID-19 shot and recently approved mResvia vaccine for RSV – which competes with GSK's $1.7 billion blockbuster Arexvy – infringe various patents held by GSK. Specifically, they refer to "lipid mRNA vaccine formulation technology" that predates the COVID-19 pandemic by more than a decade and stems mainly from an R&D team led by renowned vaccine specialist Christian Mandl.

The Mandl team was originally employed by Novartis, but GSK acquired rights to their work and intellectual property when it acquired Novartis' global vaccine business in 2015. Only by tapping into this earlier work was Moderna able to bring its mRNA vaccines to market so swiftly, the suits claim.

It is not the first time that GSK has flexed its legal muscles in defence of its lipid nanoparticle patent estate, as the company levelled similar accusations against Pfizer and BioNTech over their COVID-19 vaccine Comirnaty earlier this year. Both the Moderna and Pfizer/BioNTech actions are being heard in a Delaware district court.

The lawsuits contribute to an ongoing bun fight between various parties involved in mRNA vaccines, which raked in billions of dollars in revenues during the pandemic. Moderna and Pfizer/BioNTech are also suing each other, for example, while GSK alliance partner CureVac has been trading blows with BioNTech, also over nanoparticle delivery patents.

"Moderna has reaped billions of dollars in revenue from infringing GSK's patents-in-suit, and continues to benefit, without ever obtaining a license," according to one of the latest complaints.

"GSK brings this suit to recover a reasonable royalty for Moderna's infringing sales of mRNA vaccines that apply the Mandl team's inventions."

Sales of COVID-19 vaccine are in steep decline from their pandemic levels, but mResvia is one of Moderna's key growth prospects, with some analysts suggesting it could become a $1.5 billion product at its peak.

GSK, meanwhile, has also sued Pfizer over its rival RSV vaccine Abrysvo, although, that is not an mRNA shot and the lawsuit is focusing on infringement of compositions and methods that are covered by Arexvy patents.

At stake is an RSV vaccination market that has been estimated to be worth somewhere between $5 billion and $10 billion worldwide.