Moderna filed patent infringement lawsuits against Pfizer and BioNTech on August 26, 2022, in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany. The biotechnology company claims that Pfizer and BioNTech's COMIRNATY vaccine infringes three foundational patents covering its mRNA-1273 vaccine technology platform.
Core Patent Claims
Moderna's lawsuit centers on three patents (US patent numbers 10,898,574, 10,702,600, and 10,933,127) filed between 2011 and 2016, predating its collaboration with the National Institutes of Health (NIH). The company alleges that Pfizer and BioNTech unlawfully copied two critical components of their patented mRNA technology platform: the mRNA chemical modification, particularly N1-methylpseudouridine (m1ψ) to enhance immune evasion and maintain protein production, and the design encoding the complete spike protein.
According to Moderna's assertions, both vaccines share striking similarities: they use the same mRNA technology encoding for the SARS-CoV-2 spike protein, both mRNA formulations are encapsulated in lipid nanoparticles, require intramuscular administration with two-dose regimens, and demonstrated exceptional efficacy in clinical trials—95% for BNT162b2 and 94.5% for mRNA-1273.
Technical Analysis of Vaccine Platforms
The patent dispute involves complex technical considerations regarding mRNA structural components. While Moderna has not fully disclosed the structural components of its vaccines, both companies incorporated m1ψ modified nucleotides into their mRNA formulations. Pfizer/BioNTech's BNT162b2 includes a 35-nucleotide sequence derived from the 5'-untranslated region of the highly expressed human α-globin gene.
Notably, the BNT162b2 vaccine produces approximately 3.3 times as many spike proteins as Moderna's mRNA-1273 vaccine, explaining why BNT162b2 requires lower doses (30 μg) compared to mRNA-1273 (100 μg). This difference raises questions about whether the increased translation efficiency results from m1ψ incorporation or from using the α-globin-derived sequence.
Legal Strategy and Scope
Moderna is seeking monetary damages for sales and activities in the United States and outside the 92 low- and middle-income countries included in the Gavi COVAX Advance Market Commitment, effective from March 8, 2022. Sales under US government contracts are excluded from the damages claim. Importantly, Moderna is not seeking an injunction to block or remove the COMIRNATY vaccine from the market.
The lawsuit's timing coincided with Pfizer and BioNTech's regulatory application in Europe for an updated booster vaccine covering Omicron variants. BioNTech stated it will "vigorously defend against all allegations of patent infringement."
Broader Patent Landscape
The mRNA vaccine patent landscape extends beyond Moderna's lawsuit. Multiple companies have filed patent infringement actions over various components of mRNA vaccine technology. Arbutus Biopharma Corporation sued Moderna over lipid nanoparticle (LNP) technology patents, while Alnylam Pharmaceuticals launched separate patent infringement proceedings against both Moderna and Pfizer over lipid components used in their LNP formulations.
CureVac, whose mRNA vaccine showed only 47% efficacy in late-stage trials, filed suit against BioNTech in Germany in July 2022, seeking compensation for infringement of four patent claims concerning mRNA payload features and lipid formulation used in BioNTech's coronavirus vaccine.
Expert Legal Perspectives
Legal scholars have raised questions about Moderna's patent pledge made in October 2020, when the company committed not to enforce its patents during the pandemic. Jorge L. Contreras, an intellectual property professor at the University of Utah, argues there are "compelling legal and policy reasons" for Moderna's action to fail, stating that "Moderna's existing 2020 patent pledge prevents it from prosecuting a patent infringement suit against Pfizer and BioNTech."
Jeremy Sheff, an IP professor at St. John's University, noted the risks for Moderna: "It's a huge risk for Moderna to litigate the validity of its broad foundational patents, such as its '574 patent, with a big player like Pfizer. Pfizer's play is to use that invalidity risk to extract a license not only for this vaccine, but for other mRNA therapeutics too."
Implications for mRNA Technology Development
The patent disputes reflect the complex intellectual property landscape surrounding mRNA technology, which life sciences and pharmaceutical companies now view as viable for treating and preventing various diseases. The litigation outcomes could significantly impact future mRNA therapeutic development and licensing arrangements.
Christopher B. Seaman, a law professor at Washington and Lee University, suggests that patent validity challenges may involve questions of inventorship and ownership, particularly regarding potential co-inventorship by federal researchers for the patents in question.
The resolution of these patent disputes will likely influence the broader mRNA technology ecosystem, potentially affecting licensing terms and development strategies for future mRNA-based therapeutics beyond COVID-19 vaccines.
