Moderna, a biotechnology company pioneering messenger RNA therapies and vaccines, has filed a lawsuit against Pfizer and BioNTech in the U.S. District Court for the District of Massachusetts and the Düsseldorf Regional Court in Germany.
Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, infringes patents Moderna filed between 2010 and 2016 for Moderna’s basic mRNA technology.
Moderna said in a press statement on its website Friday that the breakthrough technology was critical to the development of Spikevax, Moderna’s proprietary mRNA COVID-19 vaccine.
“Pfizer and BioNTech copied this technology, without Moderna’s permission, to create Comirnaty,” the statement read in part.
“We are filing these lawsuits to protect the innovative mRNA technology platform we pioneered, invested billions of dollars in creating and patenting during the decade leading up to the COVID-19 pandemic,” said Moderna Chief Executive Officer Stéphane Bancel.
“This foundational platform, which we started 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 hit. As we work to combat future health challenges, Moderna is leveraging our mRNA technology platform to develop drugs that can treat and prevent infectious diseases such as influenza and HIV, as well as autoimmune and cardiovascular diseases, and rare cancers.”
It added: “Consistent with its commitment to equitable global access, Moderna pledged in October 2020 not to enforce its COVID-19-related patents as long as the pandemic continued. In March 2022, as the collective fight against COVID-19 entered a new phase and the supply of vaccines in many parts of the world was no longer a barrier to entry, Moderna updated its pledge. 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 in the GAVI COVAX Advance Market Commitment, Moderna expected companies like Pfizer and BioNTech to respect their intellectual property rights. and would consider a commercially reasonable license if they applied for one for other markets. Pfizer and BioNTech have failed to do so.”
“We believe that Pfizer and BioNTech have unlawfully copied Moderna’s inventions and continued to use them without permission,” said Shannon Thyme Klinger, Moderna’s chief legal officer. “Outside of AMC 92 countries, where vaccine delivery is no longer a barrier to entry, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s continued use of Moderna’s proprietary technologies. Our mission to create a new generation of transformative medicine for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.”
It also noted that “Moderna recognizes the need to ensure continued access to these life-saving vaccines, and is not seeking to remove Comirnaty from the market or request a ban to prevent their future sale. Moderna is not seeking damages in connection with Pfizer’s sales to AMC 92 countries, nor is it seeking damages for Pfizer’s sales where the U.S. government would be responsible for any damages.Consistent with Moderna’s patent promise, the company is not seeking damages for activities that took place before March 8, 2022.”
Moderna believes Pfizer and BioNTech have copied two key features of Moderna’s proprietary technologies that are critical to the success of mRNA vaccines. When COVID-19 emerged, neither Pfizer nor BioNTech had the level of Moderna’s experience developing mRNA vaccines for infectious diseases, and they knowingly followed Moderna’s lead in developing their own vaccine.
“First, Pfizer and BioNTech took four different vaccine candidates into clinical trials, including options that would have left Moderna’s innovative path. However, Pfizer and BioNTech eventually decided to go ahead with a vaccine that has the exact same chemical mRNA modification in its vaccine as Spikevax®. Scientists at Moderna began developing this chemical modification that prevents an unwanted immune response from being triggered when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015.
“Second, and again, despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they developed a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.
“None of the patent rights Moderna plans to enforce relate to any intellectual property generated during Moderna’s partnership with the National Institutes of Health to fight COVID-19. That collaboration only started after the patented technologies discussed here proved successful in clinical trials in 2015 and 2016,” it said.