Moderna, the Cambridge, Mass.-based manufacturer of one of two COVID-19 vaccines granted full approval by the U.S. Food and Drug Administration, announced Friday that it is suing Pfizer and BioNTech – manufacturers of the other approved vaccine – for patent infringement.
“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna's foundational mRNA technology,” used to create its Spikevax vaccine, said the company in a statement.
This year, the FDA gave Comirnaty full approval before Spikevax.
According to Moderna, complaints against Pfizer and BioNTech will be filed in the U.S. and in Germany, where BioNTech is headquartered. These complaints allege that the companies copied “groundbreaking technology [that] was critical to the development of Moderna’s own mRNA COVID-19 vaccine,” without permission.
“Moderna believes Pfizer and BioNTech copied two key features of Moderna’s patented technologies,” said Friday’s announcement.
Although Pfizer and BioNTech took four different vaccine candidates into clinical testing, they untimely proceeded with a candidate “that has the same exact mRNA chemical modification to its vaccine as Spikevax,” said Moderna. Second, Moderna alleges that Pfizer and BioNTech copied an “approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus,” that Moderna scientists created for Middle East Respiratory Syndrome (MERS) “years before COVID-19 first emerged.”
However, Moderna clarified that it does not want Comirnaty removed from the market or any injunction against future sales of the vaccine. Additionally, it said that it is not pursuing monetary damages for the sale of vaccines to 92 low- and middle-income countries or damages for Pfizer’s sales where the U.S. Government would be responsible for any damages.
“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. He said that Moderna plans to apply mRNA technology more in the future to develop medicines that address influenza, HIV, cardiovascular disease, cancer and more.
In October 2020, just months after the pandemic was declared, Moderna pledged not to enforce its COVID-19 related patents while the pandemic continued. Consistent with the pledge, Moderna is not seeking damages for activities occurring before March 8 of this year.
“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,” said the company, adding that, “Moderna 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.”
So far, Pfizer and BioNTech have failed to do so, according to Moderna.
“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,” said Moderna Chief Legal Officer Shannon Thyme Klinger.
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