On Monday, two biotech companies filed a lawsuit against Moderna in the U.S. District Court for the District of Delaware, accusing the vaccine manufacturer of patent infringement on its COVID-19 vaccine.
Arbutus Biopharma and Genevant Sciences sued Moderna over infringement claims on six patents concerning the manufacture and sale of Moderna’s Covid-19 vaccine.
Moderna released a statement to The Hill and denied these allegations of patent infringement.
“Moderna denies these allegations and will vigorously defend itself against Genevant’s claims in Court,” Moderna said in a statement to The Hill. “Our COVID-19 vaccine is a product of Moderna’s many years of pioneering mRNA platform research and development, including the creation of our own proprietary lipid nanoparticle delivery technology, which has been pivotal to combat the COVID-19 pandemic,” it added.
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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.
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.