Biotech
Friday, August 26th, 2022 8:37 am EDT
Moderna on Friday sued rival COVID-19 vaccine developers Pfizer and BioNTech, alleging that it pioneered and patented the messenger RNA technology used in their top-selling shot.
The suit, filed Friday in U.S. and German courts, claims that Pfizer and BioNTech’s vaccine, known as Comirnaty, infringes on patents issued to Moderna between 2010 and 2016.
“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 CEO Stéphane Bancel, in a statement.
Moderna isn’t seeking to have Comirnaty removed from the market, or an injunction against future sales. Instead, the company wants compensation for all alleged use of its intellectual property by Pfizer and BioNTech in developed countries after March 2022.
Early in the pandemic when vaccine supply was limited, Moderna pledged not to pursue patent claims in developed nations or any low- and middle-income countries. It recently changed that stance, however. While the company won’t ever pursue legal action in the 92 countries that are covered in the international vaccine alliance Covax, Moderna argued that vaccine supply hasn’t been a barrier to access for much of the world since March.
Afterwards, the company “expected companies such as Pfizer and BioNTech to respect its intellectual property rights” and “consider a commercially reasonable license” from Moderna. “Pfizer and BioNTech have failed to do so,” the company said.
Moderna believes Pfizer and BioNTech used its patent-protected technologies in two ways. One involves a chemical modification that both vaccines have and keep the shots from stimulating an unwanted immune response in humans. Moderna alleges its scientists began developing that modification in 2010 and, in 2015, were the first to test it in people.
Moderna also claims Pfizer and BioNTech “copied” the company in designing a shot that teaches the body to recognize the full-length “spike” protein on the novel coronavirus. Moderna alleged that its scientists developed that approach when they created a vaccine for another coronavirus, Middle East Respiratory Syndrome, or MERS, years before the pandemic.
These discoveries and other research “enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck,” Bancel added, in the statement.
In a statement, Pfizer said it was surprised by the lawsuit because its vaccine was based on proprietary intellectual property owned by BioNTech. “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit,” the statement said.
The history of intellectual property disputes among RNA drug developers suggests the lawsuit won’t amount to a significant payout, according to SVB Securities analyst Mani Foroohar. The most likely outcome “would be modest royalties paid by both companies, with little net favorable financial impact for anyone but the law firms involved,” Foroohar wrote in a note on Friday.
Moderna itself has been the target of lawsuits over vaccine-related intellectual property. Arbutus Biopharma and Genevant Sciences claimed that Moderna’s vaccine violated six of their patents related to the delivery technology involved in the shot.
Meanwhile, the biotech also got in a dust-up with the National Institutes of Health over whether its scientists deserved to be named on a Moderna-owned vaccine patent.
Moderna and Pfizer remain locked in a race to get more vaccines to market. Both are seeking Food and Drug Administration authorization of updated booster shots that target the currently circulating versions of omicron.
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