Moderna announced in August 2022 that it is filing patent infringement lawsuits against Pfizer and BioNTech. In a statement released on 26th August, Moderna suggested that the Covid-19 vaccine Comirnaty “infringes patents Moderna filed between 2010 and 2016″. These cover Moderna’s “foundational mRNA technology”. This technology, “critical to the development” of Moderna’s Spikevax Covid-19 vaccine, is said to have been copied “without Moderna’s permission, to make Comirnaty”.
Moderna’s CEO Stephane Bancel said that these lawsuits would “protect” the technology platform that Moderna “pioneered”. He reflected that “billions of dollars” had been invested in the decade before the 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”.
Bancel stated that this mRNA technology platform was critical to further development into medicines against “infectious disease” as well as “autoimmune and cardiovascular diseases and rare forms of cancer”.
Moderna’s statement suggests that Pfizer and BioNTech “copied two key features” of patented technologies. These, it emphasises, are “critical to the success of mRNA vaccines”. Moderna insists that neither company had sufficient experience in mRNA vaccines, and therefore “knowingly followed Moderna’s lead”. Although Pfizer and BioNTech took several vaccine candidates to testing, they moved forward with a vaccine that “has the same exact mRNA chemical modification to its vaccine as Spikevax”. Moderna says that its scientists began to develop this in 2010 and validated it in human trials in 2015.
Moderna goes on to accuse Pfizer and BioNTech of copying the “approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus”. It traces its claim to this approach when scientists created a coronavirus vaccine against MERS, years ago.
Expectations and exceptions
In October 2020 Moderna pledged not to “enforce its Covid-19 related patents” in order to align with a “commitment to equitable global access”. However, this pledge was “updated” in March 2022 when, according to Moderna, “vaccine supply was no longer a barrier to access in many parts of the world”. This update made exceptions for “any Covid-19 vaccine used in the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC 92)” but “expected” other companies to “respect its intellectual property rights”. Pfizer and BioNTech “failed to do so”, insist Moderna.
Chief Legal Office Shannon Thyme Klinger believes that Pfizer and BioNTech “unlawfully copied Moderna’s inventions” and have gone on to use them without requesting permission. Therefore, Moderna “expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use” of the technology.
“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.”
Moderna will not seek to remove Comirnaty from the market or an injunction to prevent future sale. Furthermore, it is “not seeking damages” related to sales to AMC 92 countries or sales where the US Government would be responsible. It is also not seeking damages for “activities occurring before March 8, 2022”.
To hear from representatives from Moderna, Pfizer, and BioNTech at the World Vaccine Congress in Europe get your tickets here.