In a lawsuit filed on Tuesday in the U.S. federal court in Delaware, British pharmaceutical giant GlaxoSmithKline (GSK.L) accused Moderna (MRNA.O) of infringing its patent rights related to messenger RNA (mRNA) technology. GSK alleges that Moderna’s popular COVID-19 vaccine, Spikevax, and its RSV injectable, mResvia, unlawfully utilize GSK’s patented lipid nanoparticles (LNP) technology, which is crucial for transferring fragile mRNA into the human body.
The legal dispute centers around GSK’s claim that Moderna’s LNP technology, essential to the vaccines’ success, violates several of its patents. This new lawsuit expands GSK’s ongoing litigation in the mRNA space, which includes a similar action against Pfizer (PFE.N) and BioNTech filed in April in the same court over their COVID-19 vaccine, Comirnaty. GSK is seeking unspecified financial damages in the latest lawsuits.
Moderna, based in Massachusetts, has been informed of the lawsuits. A company spokesperson indicated that Moderna intends to vigorously defend itself in court. Meanwhile, GSK has stated it is open to licensing the patented technology on “commercially reasonable terms” to ensure continued patient access to the vaccines.
This lawsuit further broadens the network of U.S. court cases over patent royalties involving mRNA technology used in vaccines from Pfizer, BioNTech, and Moderna. Notably, Moderna filed a patent infringement lawsuit against Pfizer in 2022, marking a long-standing battle between pharmaceutical giants over the lucrative mRNA vaccine market.
Moderna’s Spikevax generated $6.7 billion in revenue last year, while Pfizer and BioNTech’s Comirnaty brought in $11.2 billion. However, both companies have seen a significant drop in vaccine sales in 2023 as demand for COVID-19 vaccines wanes.
Additionally, GSK has previously sued Pfizer over its RSV vaccine, Abrysvo, as part of its broader patent protection strategy. Moderna’s RSV vaccine was approved by the U.S. Food and Drug Administration (FDA) in May.
GSK asserts that the patents involved in the recent lawsuits cover foundational technology developed in 2008, which the company acquired when it partially purchased Novartis’ (NOVN.S) vaccine business in 2015. According to GSK, these patents form the basis for much of Moderna’s mRNA vaccine portfolio, positioning the legal battle as a significant showdown in the pharmaceutical industry’s race to protect breakthrough vaccine technologies.