Case study: Moderna vs Pfizer lawsuit – BioNtech

On August 26, 2022, Moderna filed a lawsuit against Pfizer and BioNTech for patent infringement regarding three US patents: 10,898,574 (Delivery and formulation of engineered nucleic acids), 10,702,600 (Betacoronavirus mRNA vaccine), and 10,933,127 (Betacoronavirus mRNA vaccine). Moderna claims to be the first company to discover the use of mRNA encoding for the full-length coronavirus spike protein in an effective nano lipid particle formulation, which generates highly effective neutralizing antibodies against the coronavirus. Moderna’s research demonstrates that their coronavirus vaccine, which targets the spike protein, is a successful vaccine design and has been granted patent exclusivity.

Moderna states that Pfizer and BioNTech have provided over 472 million doses of COVID-19 vaccine for use in the United States. Pfizer reported $7.8 billion in revenue from the sale of Comirnaty vaccine in the US in 2021 and expects an additional $32 billion in global revenue in 2022.

Previously, on October 8, 2020, Moderna voluntarily pledged not to enforce its patent rights related to COVID-19 vaccines. However, realizing that access to COVID-19 vaccines was no longer a barrier in many parts of the world by early 2022, on March 7, 2022, Moderna announced its desire for companies like Pfizer and BioNTech to respect Moderna’s intellectual property rights and consider a fair commercial licensing arrangement. Nonetheless, Moderna continues to commit to not enforcing its patent rights for any COVID-19 vaccine used in 92 low- and middle-income countries as per the COVAX-GAVI (AMC) commitment.