Moderna is filing patent infringement lawsuits against American pharma giants Pfizer and its German partner BioNTech in the development of the first mRNA-based Covid-19 vaccine approved in the United States.
Moderna, which is headquartered in Cambridge, Massachusetts, is alleging that the two companies copied the technology it had developed years before the pandemic. The lawsuit, which seeks undetermined monetary damages, has been filed in the US District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
Moderna believes that Pfizer and BioNTech’s vaccine, Comirnaty, infringes patents it filed between 2010 and 2016. The groundbreaking technology was critical to the development of Moderna’s own mRNA-based COVID-19 vaccine, Spikevax.
In a statement, Moderna chief executive officer Stéphane Bancel, said: “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.
“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.”
Moderna said in a release that consistent with its commitment to equitable global access, it pledged not to enforce its COVID-19-related patents while the pandemic continued in October 2020.
In March 2022, when the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge. It made 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 (AMC 92), 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.
Moderna’s Chief Legal Officer, Shannon Thyme Klinger, added: “We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission.
“Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate for Comirnaty’s ongoing use of Moderna’s patented technologies. Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.”
He added that recognising the need to ensure continued access to these lifesaving vaccines, Moderna is not seeking to remove Comirnaty from the market and is not asking for an injunction to prevent its future sale. Moderna is also not seeking damages related to Pfizer’s sales to AMC 92 countries and is not seeking damages for Pfizer’s sales where the US Government would be responsible for any damages.
Moderna has alleged that Pfizer and BioNTech copied two key features of its patented technologies which are critical to the success of mRNA vaccines.
First, Pfizer and BioNTech decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax despite having other options. 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.
Second, and despite having different options again, 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.
Pfizer said it was surprised by the action and that the vaccine was based on its own proprietary mRNA technology. A spokesperson added: “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
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