Moderna agrees $950m settlement of mRNA jab litigation

Moderna has agreed to settle litigation with Arbutus Biopharma and Roivant's Genevant that claimed its blockbuster COVID-19 vaccine infringed patents, with an upfront payment of $950 million.

Arbutus and Genevant's complaint claimed that Moderna's mRNA-based Spikevax shot used lipid nanoparticle (LNP) delivery technology, which enables the safe and effective delivery of nucleic acid therapies and was developed by the plaintiffs.

The settlement could swell to a massive $2.25 billion if Moderna is unable to pass on a contingent payment, currently under consideration by an appeals court, to the US federal government, on the grounds that Spikevax was developed under federal contracts. Moderna said it believes the additional payment is "not considered probable."

The first payment is due to be paid by July, and will give Moderna a global non-exclusive license to the disputed LNP delivery technology, based on an amino cationic lipid known as SM-102, for use in mRNA vaccines for infectious diseases. Moderna has also agreed not to sue over the validity of certain Genevant/Arbutus patents.

According to Roivant, if the $1.3 billion payment is realised, the settlement "will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industry."

The outcome fires a warning over the bows of Pfizer and BioNTech, whose rival Comirnaty vaccine is also subject to patent litigation in the US, once again alleging (PDF) infringement of LNP patents.

Sales of both COVID-19 vaccines have declined massively since the end of the pandemic, from tens of billions of dollars a year, but Comirnaty is thought to have a two-thirds share of the remaining global market, with Spikevax making up most of the remainder.

"Nobel laureates, industry executives, and prominent researchers have long recognised that Arbutus scientists changed the drug development landscape when they invented LNP delivery technology, enabling nucleic acids, including mRNA, to be used for medicines and opening a new world of possibilities," said Lindsay Androski, Arbutus' chief executive.

"Today, Moderna has finally acknowledged the same," she added. "This is a transformative outcome for Arbutus as a company, but more importantly, it is a long-overdue recognition" of the researchers who made the rollout of COVID-19 vaccines possible.

Moderna's CEO, Stéphane Bancel, said the settlement "removes uncertainty and allows us to turn our full focus to Moderna's exciting near-term future," including the potential approvals of its combined COVID/flu vaccine – just recommended for approval in the EU – and trial readouts in its oncology pipeline.

The company also said that other COVID-19 vaccine-related litigation, which includes lawsuits with Pfizer/BioNTech, includes claims that "will exceed liabilities."