Moderna has filed a brief in the United States District Court for the District of Delaware seeking the dismissal of a patent infringement lawsuit that pertains to the production and sale of its COVID-19 mRNA vaccine Spikevax. 

The lawsuit against the U.S-based pharmaceutical giant was filed by Arbutus Biopharma Corporation and Genevant Sciences, which had sued Moderna, claiming that six of their patents involved in the production and sale of Modern’s COVID-19 vaccine were infringed by Moderna.

According to the lawsuit, Arbutus claims that it had developed the lipid nanoparticle encasing used to deliver the Moderna vaccine’s mRNA into human cells which  it has since licensed its patents to Genevant. They claim that Moderna has been practising the patented inventions without its permission through the manufacture and distribution of Spikevax. 

However, Moderna had claimed immunity from any lawsuit for infringement of patent rules, saying that its contract with the US Federal government to produce and supply the vaccine protects it from legal suits over patent rights. 

Moderna claims US government contract included authorization to use patents

Moderna, in its brief, states that the US government gave its “authorization and consent” for Moderna to infringe any third-party patents when manufacturing the vaccine based on a contract it originally signed in 2020 for the production and supply of 100 million doses of its vaccine.

Provisions in the contract stipulate that any claimant of patent infringement should sue or take up the case with the U.S. government, Moderna stated. 

According to Moderna’s legal brief, its contract with the US Government is covered by a US Federal Statute, 28 USC 1498(a), which provides that whenever an invention covered by a U.S. patent “is used or manufactured by or for the United States without a license,” the owner of the patent must sue the government for damages in the United States Court of Federal Claims, rather than the manufacturer, per se. 

“Modern argues that it has a compulsory license from the US government to use third party patents on its COVID 19 vaccine,  under 28 USC 1498(a), so patent holders should sue the federal government for compensation for nonvoluntary use, and not Moderna,” noted Jamie Love, head of Knowledge Ecology International, an NGO which has been advocating for the wider use of such “compulsory licensing” by countries that wish to support wider generic production of COVID vaccines and treatments, as well as pharmaceuticals more generally.

This is not the first time that such a lawsuit has been filed in a US court against Moderna for patent infringement related to its COVID-19 vaccine. In March 2022, Alnylam Pharmaceuticals sued both Moderna and Pfizer, in separate lawsuits, claiming that the companies used a delivery technology for their shots that was invented by Alnylam over a decade ago. 

All three plaintiffs- Arbutus, Alnylam and Genevant– have been clear that they do not seek to halt vaccine production or sales, but only seek damages for the infringements. 

Medicines access advocates are watching the Moderna cases closely to see what kind of precedent they may set for wider use of “compulsory licensing” of patented drugs – which developed countries such as the US have generally discouraged in order to protect IP both at home and abroad.    

“Moderna’s filing is an important reminder of existing flexibilities that the U.S. government can leverage to expand vaccine access,” wrote KEI in a brief on the legal case. “Apparently, at least when doing so is consistent with a company’s legal or financial interests, they are willing to embrace such flexibility.”

Image Credits: Jernej Furman/Flickr, Gavi .