- Two biotech companies on Monday sued Moderna in U.S. federal court over claims the COVID-19 vaccine maker infringed on six patents they hold that describe technology important to the delivery of messenger RNA shots into the body.
- The 51-page lawsuit, filed by Arbutus Biopharma and partner Genevant Sciences in the U.S. District Court for the District of Delaware, alleges that Moderna used their technology in its coronavirus vaccine and repeatedly refused to "engage meaningfully" in licensing negotiations.
- In a statement emailed to BioPharma Dive, Moderna denied Arbutus and Genevant's allegations and said it would defend itself in court. The company added that its vaccine is the product of years of mRNA research and development, including the creation of proprietary delivery technology different than Arbutus and Genevant's.
Arbutus and Genevant's lawsuit escalates a yearslong dispute with Moderna that's already wound its way through a federal patent appeal board and a federal appeals court.
At issue are microscopic fat-like particles that Arbutus scientists developed to shield messenger RNA delivered into the body — inventions awarded several U.S. patents which Arbutus and partner Genevant allege Moderna infringed with its COVID-19 vaccine Spikevax.
In court documents, the two cited several disclosures in scientific publications describing early studies of what would become Spikevax, including one coauthored by National Institutes of Health scientists that was published in The New England Journal of Medicine. The papers, Arbutus and Genevant claim, show Moderna's vaccine uses so-called lipid nanoparticles that are covered by six separate patents they hold.
Moderna, for its part, claims to have created its own lipid nanoparticle technology, though the exact composition of the fatty shell used in Spikevax hasn't been disclosed. Moderna has also notified the U.S. government of Arbutus and Genevant's claims so it "can protect its rights in defending against any alleged liability to Genevant."
(Moderna previously disputed rights claimed by the U.S. government with respect to Spikevax, but has since decided not pursue issuance of the patent in question, which did not relate to lipid nanoparticles.)
Arbutus and Moderna have clashed several times before. Prior to the pandemic, Moderna had sub-licensed rights to some of Arbutus' technology though a Canadian company called Acuitas Therapeutics, an agreement Arbutus challenged claiming it violated a license granted to Acuitas. A 2018 settlement between Arbutus and Acuitas left intact four sublicenses to Moderna for specific vaccines against certain viruses, but not for use against SARS-CoV-2.
Soon after, Moderna challenged Arbutus' patents through a review process run by an arm of the U.S. Patent Office. While Moderna successfully invalidated one Arbutus patent, the Patent Trial and Appeal Board, or PTAB, partially rejected its efforts to overturn another and upheld the claims contained within a third last July.
That decision was affirmed by the U.S. Court of Appeals for the Federal District, which in December 2021 rejected Moderna's appeal of the PTAB's decision.
Against this backdrop, Arbutus and Genevant claim they were "forced" to sue for damages due to "Moderna's intransigence" in discussing a license for lipid nanoparticles covered by Arbutus and Genevant's patents.
Arbutus and Genevant are not seeking an injunction on sales of Spikevax, which last year earned Moderna nearly $19 billion, and acknowledge Moderna's essential role in developing a vaccine that's saved tens of thousands of lives during the pandemic.
But they're hoping to win a judgement that Moderna infringed six of their patents and to secure damages no less than a "reasonable royalty" on Moderna's sales. Mani Foroohar, an analyst at SVB Leerink who covers Moderna, expects a single-digit royalty could be expected should the court rule against Moderna, which would still equate to a significant sum.
A trial, however, could take a long time. Arbutus and Genevant expect litigation could take at least two years, a timeline that Foroohar described as "optimistic."
Genevant was formed by Arbutus and another company called Roivant Sciences in 2018 and licensed Arbutus' lipid nanoparticle technology.