Pfizer must hand over COVID-19 vaccine knowledge
Moderna alleges that rivals’ vaccine infringes patents filed covering a foundational mRNA technology | Big pharma firm must “specifically describe” awareness of Moderna's work in the mRNA vaccine sphere before the end of the month.
Pfizer and BioNTech must supply Moderna with details concerning how and when it gained knowledge of mRNA vaccine before the end of September, a US judge has ruled.
Judge Richard Stearns delivered the order on Friday, September 14, at the US District Court of Massachusetts, marking the latest development in the dispute over the groundbreaking technology.
Moderna filed a patent infringement suit against Pfizer and the German drug manufacturer, in Massachusetts and the Regional Court of Düsseldorf in Germany in August 2022, prompting the pair to countersue.
Moderna believes that Pfizer and BioNTech's COVID-19 vaccine Comirnaty infringes patents filed between 2010 and 2016 covering Moderna's foundational mRNA technology—which also proved critical to the development of Moderna's own mRNA COVID-19 vaccine, Spikevax.
Pfizer and BioNTech copied this technology, without Moderna's permission, to make Comirnaty, according to the suit.
Knowledge and dates requested
Moderna accuses Pfizer and BioNTech of copying two key features of Moderna's patented technologies, which 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,” said the pharma company.
Judge Stearns issued an order granting Moderna its motion to compel the defendants to “specifically describe” their knowledge of Moderna's work in the mRNA vaccine sphere.
“If defendants had nothing more than mere awareness of Moderna and the nature of its business (eg, if they did not have any further knowledge about the details of Moderna's work or its usage of 1-methylpseudouridine in developing an mRNA vaccine), they may state so in their responses.
“Defendants shall also, at the same time, supplement their responses…to identify the date on which they first became aware of patents or applications related to the patents-in-suit,” he wrote.
In a statement issued at the time the suit was filed, Moderna alleged that Pfizer and BioNTech took four different vaccine candidates into clinical testing, which “included options that would have steered clear of Moderna's innovative path”.
“Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as 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,” added the statement.
Different options
Moderna further argued that “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 years before COVID-19 first emerged.”
Commenting on the suit, Moderna chief legal officer Shannon Thyme Klinger, said: "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 Moderna 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."
