Arbutus Biopharma Corp. and Genevant Sciences GmbH filed a patent-infringement lawsuit Monday in Delaware federal court against
Filing the lawsuit “was necessary because Moderna has not meaningfully engaged in licensing discussions,” Genevant and Arbutus said in a conference call and webcast hosted by Roivant Sciences Ltd., Genevant’s principal shareholder.
Arbutus and Genevant said that were it not for “the rapid, widespread availability of cutting-edge mRNA-based vaccines like Moderna’s,” the impact of the Covid-19 pandemic “would be immeasurably worse.” The technology at issue delivers to cells instructions on how to make the spike protein that prompts the body’s immune system to gird itself, according to a complaint filed in the U.S. District Court for the District of Delaware.
Moderna denied the claims “and will vigorously defend itself against Genevant’s claims in court,” a spokesperson said in a statement. “Our Covid-19 vaccine is a product of Moderna’s many years of pioneering mRNA platform research and development, including creation of our own proprietary lipid nanoparticle delivery technology, which has been pivotal to combat the Covid-19 pandemic.”
The suit had been expected since early December, when Moderna’s ModernaTX unit lost an appeal of a patent tribunal’s findings that upheld the validity of two of the six Arbutus patents at issue in Monday’s lawsuit.
On Dec. 1, the U.S. Court of Appeals for the Federal Circuit affirmed findings by the Patent Trial and Appeal Board that Moderna didn’t have standing to appeal the ruling on one patent because it hadn’t developed its vaccine until after it filed the appeal—the pandemic also hadn’t yet begun by then. The Federal Circuit also affirmed the board’s finding that Moderna hadn’t proven the second patent covers an obvious invention.
The Federal Circuit issued its mandates reflecting those respective rulings on Jan. 25 and Jan. 10.
Moderna had sought help from the Federal Circuit, the nation’s top patent court, because, it claimed, the two Arbutus patents could leave its vaccine, called Spikevax, vulnerable to infringement suits.
Genevant, formed in 2018 by Roivant and Arbutus, licenses Arbutus’ lipid nanoparticle, or LNP, technology and patent portfolio. It says it has “deep expertise in delivery systems for mRNA”—or messenger ribonucleic acid—"and other nucleic acids.”
Genevant and Arbutus aren’t seeking an injunction or anything else that might “impede the sale, manufacture, or distribution of Moderna’s Covid-19 vaccine.” They said they expect Moderna will respond within the next several months and that the dispute could take at least two years.
Moderna last week said orders for its vaccine rose to $19 billion for 2022 sales, up from $18.5 billion announced in January.
Moderna’s vaccine went “from lab bench to arms in record speed,” the suit says, because Moderna used “breakthrough technology Arbutus had already created and patented—a revolutionary lipid nanoparticle delivery platform that took the scientists of Arbutus years of painstaking work to develop and refine.”
Five of the patents at issue cover particle compositions and expire in April 2029. One covers a lipid vesicle formulation and expires in July 2023.
Arbutus said that without its LNPs, “the mRNA in Moderna’s vaccine would degrade before ever reaching the cells it needs to enter and the vaccine would not work.”
Moderna, the suit says, obtained licenses several years before the pandemic for use of Arbutus’ LNP patents “for certain mRNA products directed to specific viral targets,” but the licenses didn’t grant Moderna rights for use in products targeting the virus that causes Covid-19 and that Moderna’s vaccine targets.
The suit targets Moderna’s mRNA-1273 Covid-19 mRNA LNP vaccine and any related booster shot.
Moderna also said in its statement that it “has notified the U.S. government about the accusation of infringement against sales to the U.S. government, so that the U.S. government can protect its rights in defending against any alleged liability to Genevant.”
Cause of Action: Patent infringement.
Relief: Damages of at least a reasonable royalty on all infringing sales “or other dispositions” of Moderna’s Spikevax; enhanced damages for willful infringement; attorneys’ fees; costs and expenses; pre- and post-judgment interest.
Attorneys: Arbutus and Roivant are represented by Shaw Keller LLP, Williams & Connolly LLP, and Durie Tangri LLP.
The case is Arbutus Biopharma Corp. v. Moderna Inc., D. Del., No. 22-cv-252, complaint filed 2/28/22.
—With assistance from