Moderna has reached a settlement agreement with Alnylam Pharmaceuticals to resolve patent infringement lawsuits over COVID-19 vaccine technology, according to court filings submitted Thursday in Delaware federal court. The settlement ends a multi-year legal battle that centered on allegations that Moderna's COVID-19 vaccine improperly utilized Alnylam's patented lipid nanoparticle delivery system.
The companies jointly requested dismissal of Alnylam's claims with prejudice, meaning the lawsuits cannot be refiled. An Alnylam spokesperson confirmed the settlement but declined to provide details about the agreement's terms. Moderna representatives did not immediately respond to requests for comment regarding the settlement specifics.
Patent Dispute Background
Cambridge, Massachusetts-based Alnylam initially filed patent infringement claims against Moderna in 2022, alleging that Moderna's COVID-19 vaccine Spikevax utilized Alnylam's proprietary lipid nanoparticle (LNP) technology without authorization. The LNP technology serves as a crucial delivery mechanism for transporting genetic material into cells within mRNA vaccines.
As part of its legal action, Alnylam sought royalty payments from Moderna's COVID-19 vaccine revenues. According to Moderna's company reports, the biotechnology firm generated $3.1 billion in revenue last year, with the majority stemming from Spikevax sales.
Moderna consistently denied the infringement allegations throughout the litigation process and challenged the validity of Alnylam's patents. The company maintained that its vaccine technology did not infringe upon Alnylam's intellectual property rights.
Court Rulings Favor Moderna
Prior to the settlement, multiple court decisions had ruled in Moderna's favor. Delaware U.S. District Judge Colm Connolly issued rulings against Alnylam in separate cases last year. Most significantly, a U.S. appeals court upheld Judge Connolly's ruling for Moderna in June, reinforcing the lower court's determination that Alnylam's claims lacked merit.
The legal disputes were part of a broader pattern of patent litigation surrounding COVID-19 vaccine technology. Biotech companies have filed numerous lawsuits against major vaccine manufacturers, including Moderna, Pfizer, and BioNTech, over various technological components used in their COVID-19 shots.
Ongoing Patent Litigation Landscape
The settlement between Moderna and Alnylam represents just one resolution within a complex web of patent disputes in the COVID-19 vaccine space. Alnylam continues to pursue separate patent infringement cases against Pfizer and BioNTech regarding their COVID-19 vaccines, though Judge Connolly ruled against Alnylam in that dispute earlier this year.
Meanwhile, Moderna has initiated its own patent infringement lawsuit against Pfizer and BioNTech, which remains ongoing. This cross-litigation demonstrates the intricate intellectual property landscape surrounding mRNA vaccine technology and the competitive dynamics among leading vaccine manufacturers.
The resolved cases, formally designated as Alnylam Pharmaceuticals Inc v. Moderna Inc, were filed in the U.S. District Court for the District of Delaware under case numbers 1:22-cv-00335 and 1:23-cv-00580. Legal representation included McDermott Will & Emery attorneys for Alnylam and Cooley attorneys for Moderna.
