The pharmaceutical company Moderna on Friday filed a lawsuit for patent infringement against Pfizer and German partner BioNTech in a court in Massachusetts (United States) and another in Düsseldorf (Germany). The firm argues that Pfizer and BioNTech’s Comirnaty Covid-19 vaccine infringes patents Moderna filed between 2010 and 2016, covering Moderna’s foundational mRNA technology. “Pfizer and BioNTech copied this technology, without Moderna’s permission,” the company said in a press release Friday.
The statement does not specify what Moderna is seeking in damages. The Covid-19 vaccine has become the pharmaceutical giant Pfizer’s main source of revenue, accounting for half of its turnover. For Moderna, it has been its first blockbuster product on the market.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic,” said Moderna Chief Executive Officer Stéphane Bancel in the statement.
Moderna believes that Pfizer and BioNTech copied two key features of their proprietary technologies that are critical to the success of mRNA vaccines. “When Covid-19 emerged, neither Pfizer nor BioNTech had Moderna’s level of experience with developing mRNA vaccines for infectious diseases, and they knowingly followed Moderna’s lead in developing their own vaccine,” the company argued.
RNA is an essential molecule for life. Both the Moderna vaccine and the Pfizer-BioNTech vaccine are based on this molecule, specifically a subtype known as messenger RNA. Messenger RNA vaccines use the body’s cells as bioreactors to produce copies of the coronavirus S protein that are localized by the immune system.
According to Moderna, Pfizer and BioNTech brought four different vaccine candidates to clinical trials, including options that would have “steered clear of Moderna’s innovative path.” However, Pfizer and BioNTech ultimately decided to proceed with a vaccine that has the same chemical modification of the mRNA as the Moderna vaccine Spikevax. Moderna scientists began developing this chemical modification that avoids provoking an undesirable immune response when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015, the company said.
“Second, and again despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before Covid-19 first emerged,” it continued.
The company said that due to its commitment to equitable global access to vaccines, in October 2020, it pledged not to enforce its Covid-19-related patents while the world was being gripped by the pandemic. In March 2022, when the fight against Covid entered a new phase and vaccine shortages were no longer a major problem, Moderna updated its pledge. The company said it made it clear that while it would never enforce its patents for any Covid-19 vaccine used in the 92 low- and middle-income countries, it expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. “Pfizer and BioNTech have failed to do so,” it said.
”This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective Covid-19 vaccine in record time after the pandemic struck. As we work to combat health challenges moving forward, Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer,” Bancel added in the statement.