The U.S. FDA granted Emergency Use Authorization for the Pfizer-BioNTech vaccine in December 2020. A week later, authorities approved Moderna’s vaccine’s emergency use. Now, Moderna is suing Pfizer for stealing the mRNA technology.
Pfizer and its partner BioNTech are being sued by Moderna for allegedly violating its patents by using its technology to create the COVID-19 vaccine.
Moderna said it believed the Pfizer-BioNTech vaccine breached proprietary mRNA technology that it had started developing years before the outbreak took hold and filed complaints in both the U.S. and Germany on Friday.
Moderna claimed that Pfizer and BioNTech stole its “groundbreaking technology” without authorization in order to create their own coronavirus vaccine.
“Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path,” the company alleged in a press release on Friday.
“Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification as [Moderna vaccine] Spikevax.”
Moderna said that its experts started developing the technology in 2010, and that five years later, it was the first business to test the technology on humans.
“Again, 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,” the firm added. “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 ‘surprised’ by lawsuit
A Pfizer representative told Fortune on Friday that Moderna’s lawsuit had come as a surprise.
“Pfizer-BioNTech has not yet fully reviewed the complaint, but we are surprised by the litigation given the Pfizer-BioNTech COVID-19 vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the spokesperson said.
“We remain confident in our intellectual property supporting the Pfizer-BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
On Friday, Moderna CEO Stéphane Bancel announced that the company was bringing the 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.”
He also stated that Moderna was employing its mRNA technology to produce medications for both infectious diseases such as HIV and noncommunicable diseases such as cancer.
Vaccine patents
In October 2020, before any COVID vaccinations were utilized outside of clinical testing, Moderna committed not to enforce its COVID-19-related patents for the duration of the pandemic.
In March of this year, the corporation shifted stance, claiming that the pandemic had reached a “new phase” in which vaccine supply was no longer causing accessibility concerns in many regions of the world.
At the time, Moderna stated that it wouldn’t enforce patents in 92 low- and middle-income nations, but that it anticipated other companies in other markets to “respect its intellectual property rights.” It also stated that if competing vaccine makers sought it, it would provide “commercially reasonable” licenses to utilize its technology.
Moderna stated in its suits against Pfizer and BioNTech on Friday that it was not demanding the removal of its COVID vaccine from the market or an injunction to restrict its future sale.
The business also stated that the damages sought had nothing to do with sales to the 92 nations excluded from its patent guarantee, and that it would not pursue any damages where the United States government would be held culpable.
All damages sought by Moderna would be for sales made after March 8, 2022, when the firm modified its COVID vaccination patent policy.
Competitive space
Although messenger RNA (mRNA) vaccines have been researched for many years, the technology was not made available to the general public until the COVID-19 vaccinations were introduced.
mRNA technology is used in the Moderna and Pfizer-BioNTech vaccines to stimulate an immune response that shields recipients against the virus.
In 2020 Phase III clinical studies, both vaccines showed effectiveness rates of about 95%. Both, however, were created to counter the virus’s original strain and are therefore less effective against its later variants.
The BA.4 and BA.5 Omicron subvariants, the predominant strains of the virus in the United States, are the focus of all the firms‘ efforts to create vaccines.
Sales of Pfizer’s COVID-19 vaccine brought in $37 billion last year.
807 million COVID vaccinations totaling $17.7 billion were distributed by Moderna in 2021.
The U.S. FDA granted Emergency Use Authorization for the Pfizer-BioNTech vaccine in December 2020. A week later, authorities approved Moderna’s vaccine’s emergency use.
According to Our World in Data, the Pfizer-BioNTech vaccine is the most often administered COVID-19 shot in the United States, with Moderna second on the list.
According to a New York Times analysis, the Oxford-AstraZeneca vaccine, that does not employ mRNA technology, is the most extensively used globally. According to the Times, Pfizer-BioNTech is the second most extensively used vaccination in the world, followed by Moderna.
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