Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the messenger RNA vaccine giant for infringement, but when. Now, the other shoe has dropped.
Arbutus and Roivant’s Genevant Sciences on Monday filed (PDF) a lawsuit against Moderna in the U.S. District Court for the District of Delaware. In their suit, the companies seek damages for infringement on six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine.
The patents relate to nucleic acid-lipid particles and lipid vesicles, plus compositions and methods for their use, Arbutus and Genevant said in a release.
Crucially, the plaintiff companies don’t want to stop Moderna from making, selling or distributing its shot.
“We’re not seeking an injunction and … we do not wish to impede in any way Moderna’s COVID-19 vaccine from reaching as many people as possible,” Matthew Gline, CEO at Roivant, said Monday on a conference call with investors.
In fact, Genevant is collaborating with multiple companies and nonprofits “to develop vaccines against COVID-19 in territories around the world, including low- and middle-income countries, with the goal of eradicating COVID-19,” the companies said in Monday’s release.
Genevant’s global mRNA ambitions coincide with Moderna and BioNTech’s own efforts to expand vaccine production globally by setting up manufacturing in places like Africa. The World Health Organization is also working to extend mRNA technology to underserved countries by recreating Moderna’s COVID-19 vaccine using public information at its technology transfer hub in South Africa.
As for the lawsuit against Moderna, the plaintiffs are seeking damages “sufficient to compensate Arbutus and Genevant for Moderna’s infringement … in no event less than a reasonable royalty on all infringing sales or other dispositions of Accused Product,” Monday’s court filing says.
“We think the circumstances here are unique, and these factors support significant damages, potentially, frankly, well beyond what we have seen speculated in certain places publicly,” Pete Lutwyche, Ph.D., president and CEO of Genevant, said on the investor call.
Even a small slice of the pandemic pie would prove a major boon for Arbutus and Genevant. Moderna made $17.7 billion in full-year 2021 sales of its mRNA vaccine, the company reported last week. The biotech expects its shot to net roughly $22 billion this year.
In December, Moderna failed to ward off the threat of an infringement suit when the U.S. Court of Appeals for the Federal Circuit rejected the biotech’s bid to invalidate key Arbutus patents that could be linked to the delivery of its mRNA-based shot. The patents relate to lipid nanoparticles (LNPs), which protect and deliver genetic material such as mRNA as it travels through the body. LNPs are used in both Moderna and Pfizer-BioNTech’s COVID-19 shots.
Moderna did not immediately respond to Fierce Pharma’s request for comment on Genevant and Arbutus’ lawsuit.
Arbutus and Genevant, for their part, argue that delivering mRNA to human cells is “the most significant technological hurdle to developing and deploying” the class of medicines, the companies said in their release.
The plaintiffs expect Moderna to respond to the complaint within “the next several months,” Genevant’s Lutwyche said. “We expect litigation with Moderna could take at least two years,” the CEO added.
“I think the complaint speaks for itself in terms of our level of confidence in the evidence that we have,” Lutwyche said when asked about the prospect of an Arbutus-Genevant victory in court.