Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-based biotech violated multiple patents with its duo of approved mRNA vaccines.
GSK sued Moderna over the shots in Delaware federal court Tuesday, claiming the mRNA specialist ignored GSK-owned patents related to lipid mRNA vaccine formulation technology.
The lawsuits specifically concern Moderna’s COVID-19 vaccine, Spikevax, and its more recently approved mRNA shot for respiratory syncytial virus (RSV), mRESVIA. GSK claims Moderna is marketing the products in violation of its intellectual property without licenses.
In the lawsuits, GSK’s legal team said the company hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales as well as “all damages adequate” to make up for the mRNA outfit’s alleged infringement.
GSK confirmed the filing of the lawsuits in an email Tuesday, with a spokesperson adding that the company is “committed to taking appropriate action where necessary” to protect its intellectual property.
GSK “believes these patents provided the foundational technology used in both Moderna’s COVID-19 and RSV mRNA-based vaccines,” the spokesperson said. “We are willing to license these patents on commercially reasonable terms and to ensure continued patient access.”
Moderna, for its part, told Fierce Pharma it’s aware of the litigation and plans to defend itself.
Vaccines like Moderna’s Spikevax and mRESVIA rely on lipid nanoparticles to deliver mRNA, which “can degrade quickly” and need "to be protected from the moment of preparation through formulation, storage, handling, administration, and even inside the body following administration,” according to GSK’s lawsuit.
GSK’s legal team argues Moderna didn’t start investigating lipid encapsulation and delivery for RNA vaccines until after the foundational work on the approach—which GSK acquired in 2015 after purchasing much of Novartis’ vaccine business—became public.
GSK further contends that Moderna got its hands on technical know-how tied to the company’s mRNA vaccine platform by “hiring several former Novartis and GSK employees with first-hand knowledge.”
The Moderna lawsuits echo similar claims made by GSK when it sued Pfizer and BioNTech for allegedly infringing upon the company’s mRNA patents back in April.
At the time, Pfizer voiced confidence in its patent position and vowed to “vigorously defend against” the allegations.
Meanwhile, GSK last August filed a separate lawsuit against Pfizer over the companies’ dueling RSV immunizations, Arexvy and Abrysvo. In the complaint, GSK argues Pfizer kicked off the project that led to Abrysvo no earlier than 2013, which it claims was at least seven years after its own RSV program.
Up until recently, the RSV vaccine arena was seen as a potential $10 billion-plus opportunity for large drugmakers to compete over. But, after a recent narrow Centers for Disease Control and Prevention recommendation on suggested immunization schedules, those early estimates may prove overly ambitious.
As for COVID vaccines, sales of Pfizer and Moderna’s shots have fallen precipitously after reeling in astronomical revenues at the pandemic’s height.
For all of 2023, Moderna’s Spikevax brought home $6.7 billion compared to Comirnaty’s $11.2 billion. Both numbers marked a more than 60% plunge versus 2022 sales.