On Friday, Moderna sued Pfizer and its German partner BioNTech for patent infringement in the production of the first COVID-19 vaccine authorized in the US, saying that they duplicated technology created by Moderna years before the pandemic.
The action, which seeks unspecified monetary damages, was filed in the United States District Court for the District of Massachusetts. According to a news release from Moderna, the claim will also be filed at the Regional Court of Duesseldorf in Germany.
“We are launching these cases to safeguard the breakthrough mRNA technology platform that we pioneered, invested billions of dollars in developing, and patented over the decade preceding the COVID-19 pandemic,” stated Moderna CEO Stephane Bancel in a news statement.
Moderna Inc (MRNA.O) and the cooperation of Pfizer Inc (PFE.N) and BioNTech SE (22UAy.DE) were the first to produce a vaccine for the new coronavirus, resulting in a revenue bonanza. The US Food and Drug Administration awarded emergency use authorization for the COVID-19 vaccine to Pfizer/BioNTech in December 2020, then to Moderna one week later.
Moderna’s sole commercial product, the COVID vaccine, generated $10.4 billion in sales this year, whereas Pfizer’s vaccine generated over $22 billion. Pfizer stated that it was confident about its intellectual property and that it would actively defend itself against the charges.
“We are surprised by the action given that the COVID-19 vaccine was developed by both BioNTech and Pfizer and was based on BioNTech’s patented mRNA technology,” a Pfizer spokeswoman said in an emailed statement.
BioNTech termed the lawsuit “unfortunate” and insisted that its work was unique. “We will fiercely defend against all charges of patent infringement,” the business stated in a statement. Moderna, situated in Cambridge, Massachusetts, was a pioneer in messenger RNA (mRNA) vaccine technology, which enabled the COVID-19 vaccine to be developed at an unparalleled pace.
A clearance procedure that previously took years was completed in months, due in large part to advances in mRNA vaccines, which educate human cells on how to manufacture a protein that will trigger an immune response. BioNTech was also involved in this arena when it joined with the pharmaceutical behemoth, Pfizer.
Pfizer/BioNTech allegedly duplicated mRNA technology that Moderna had copyrighted between 2010 and 2016, far before COVID-19 surfaced in 2019 and blasted into worldwide attention in early 2020, without authorization, according to Moderna.
Moderna stated that its case was not intended to prevent people from receiving vaccinations, and it reiterated its promise not to prosecute its COVID-19 patents in 92 low- and middle-income countries.
However, Moderna stated that it expects corporations such as Pfizer and BioNTech to respect its intellectual property rights, and it is demanding royalty payments based on sales after March 8, 2022, excluding sales to the US government or low-income nations.
Pfizer/BioNTech took two forms of intellectual property, according to Moderna’s statement on Friday. One included an mRNA structure that Moderna scientists developed in 2010 and were the first to validate in human trials in 2015.
“Pfizer and BioNTech advanced four vaccine candidates into clinical trials, including possibilities that would have avoided Moderna’s novel approach. Pfizer and BioNTech, on the other hand, finally opted to continue with a vaccine that has the same precise mRNA chemical alteration “explained Moderna.
The second claimed infringement includes the coding of a full-length spike protein created by Moderna scientists while developing a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS). Although the MERS vaccine was never commercialized, its research aided Moderna in the speedy rollout of its COVID-19 vaccine.
Pfizer shares were down 2% in Friday afternoon trade, while Moderna fell 3.3%. BioNTech’s American shares fell 3% after their German stock fell 1.6%.