Nancy Chen is an IPilogue Writer and a second-year JD/MBA Candidate at the University of Toronto.
In 2020, COVID-19’s emergence prompted scientists across the world to race against time to develop a vaccine, with the pharmaceutical giants Moderna, Pfizer and BioNTech (“Pfizer/BioNTech”) leading the way. Two years later, as the world adapts to the new normal and vaccine supply is no longer a preeminent issue, Moderna seeks to take legal action against Pfizer/BioNTech for unlawfully infringing upon Moderna’s patented mRNA technology in the making of their COVID vaccine. The patent infringement lawsuit was filed on August 26, 2022 in the United States District Court for the District of Massachusetts as well as the Regional Court of Düsseldorf in Germany.
According to the complaint filed before the District of Massachusetts, Moderna was founded in 2010 “on the promise of developing mRNA technology to create a new generation of transformative medicines.” The company has since been singularly focused on developing all aspects of mRNA medicine, cumulating several patents in the process.
Moderna claimed that because of their extensive experience researching mRNA technology and using their patented mRNA platform, they were “uniquely positioned” to respond to the COVID-19 pandemic. As a result, Moderna’s mRNA vaccine, Spikevax, successfully reached clinical trials within just two months after the publication of the genetic sequence of the virus. Other competitors were predicting that vaccine development could take years.
In a news release, Moderna stated that they believed Pfizer/BioNTech unlawfully copied two key features of Moderna’s patented technologies in the development of their mRNA vaccine, Comirnaty. Specifically, Comirnaty contains the exact same chemical modification as Spikevax and it was developed using Moderna’s patented approach “to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”
Moderna also stated that Pfizer/BioNTech did not have the same level of experience as Moderna in developing mRNA vaccines, and despite testing four different vaccine candidates that did not use Moderna’s patented technology, they ultimately knowingly copied Moderna’s platform.
Pfizer/BioNTech addressed the allegations in a written statement, stating that these lawsuits were unexpected given that Comirnaty was based on BioNTech’s own proprietary mRNA technology. They intended to “vigorously defend against all allegations of patent infringement.”
In recognition of the need for ensuring vaccine access, Moderna stated that it will not seek to remove Comirnaty from the market or prevent future sales of this vaccine. The company will also not seek compensatory damages from sales occurring before March 8, 2022, the date the company considers to be the end of the pandemic. Sales to the U.S. government or to a list of 92 low and middle-income countries in the Gavi COVAX Advance Market Commitment will also be excluded from damages.
It is, however, seeking monetary damages of up to three times the amount of compensatory damages found in relation to all other instances of infringement including reasonable royalties and/or lost profits, together with interest, costs, expenses, disbursements.
Patent lawsuits typically take years to resolve and this particular action is further complicated by public policy considerations. Pfizer/BioNTech has a solid defense by arguing reasonable reliance on Moderna’s public pledge to not enforce patents while the pandemic continues. Although Moderna perhaps made this promise in the hopes of an end date to the pandemic, this date will likely be contested given the ongoing nature of COVID-19.
The outcome of this legal dispute will have implications for the future uses of mRNA technology, which boasts the potential for future vaccines against a myriad of diseases such as influenza and HIV. If Moderna succeeds, there may be a chilling effect in biotech development which may be detrimental in the event of another pandemic. It would be interesting to see how courts construe public promises and their validity against patent rights, or if broken promises may affect a company’s goodwill in the eyes of the public.