Moderna, a pharma giant that makes a COVID-19 vaccine, is suing Pfizer and Pfizer’s German partner BioNTech.
It says that its main competitors copied its technology to make their vaccine and that Pfizer and BioNTech’s shot “has the same exact mRNA chemical modifications” as theirs.
Moderna said on Friday that Pfizer and BioNTech’s vaccine Comirnaty breaks patents that Moderna filed for Spikevax’s technology several years ago.
The company filed patent infringement lawsuits in a U.S. district court in M.A. and a German court.
The two-shot vaccines made by Moderna and Pfizer are based on mRNA technology, a brand new way to make vaccines.
Four vaccine alternatives, including several that would have avoided Moderna’s novel course, were tested in clinical trials by Pfizer and BioNTech.
In the past, most vaccines were made using parts of a virus or a virus that had been killed to stimulate an immune response.
With proprietary mRNA technology, the vaccine uses messenger RNA made in a lab to send genetic instructions to direct our cells to produce a protein or part of a protein that activates an immune response.
Moderna, based in Cambridge, Massachusetts, had only been around for ten years. Still, it was already a leader in the messenger RNA (mRNA) vaccine technology that made it possible to make the COVID-19 vaccine so quickly.
The typically lengthy approval process was finished in just a few months, largely thanks to mRNA vaccines.
“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,” the CEO of Moderna, Stephane Bancel, said in a news release.
Two of the first groups to make a vaccine for the new coronavirus were Moderna and Pfizer and BioNTech working together. This led to a windfall of revenue for the companies.
In December 2020, the U.S. Food and Drug Administration gave emergency use authorization for the COVID-19 vaccine to Pfizer/BioNTech. A week later, Moderna also got emergency use authorization for the vaccine.
Moderna’s only commercial product, the COVID vaccine, brought in $10,4 billion, while Pfizer’s vaccine brought in about $22 billion this year.
Pam Eisele, a spokeswoman for Pfizer, said the company had not thoroughly reviewed Moderna’s lawsuit. Still, they were surprised because their vaccine is based on technology that both BioNTech and Pfizer created.
She also said that the company was sure of its intellectual property and would fight to defend itself against the claims.
In October 2020, Moderna promised not to enforce its COVID-19-related patents as long as the pandemic continued.
Moderna revised its commitment in March of this year, as the global effort to combat COVID-19 reached a new stage and vaccine availability was no longer a barrier to access in many regions of the world.
Moderna said it would keep its promise not to enforce its COVID-19-related patents in low- and middle-income countries. Still, it expects rival companies like Pfizer to respect its intellectual property rights.
Moderna is not trying to get the Pfizer and BioNTech vaccine taken off the market or stop future sales. But they are seeking monetary damages.
Jacob Sherkow, a law professor at the University of Illinois College of Law specializing in biotech intellectual property issues, says that if the company wins, the royalty is usually a “high single-digit” percentage of sales.
Analysts on Wall Street think that the fight will go on for years.
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References:
https://apnews.com/article/moderna-covid-vaccine-lawsuit-pfizer-c1c25964c5ac3d945be0831363683d49
https://www.reuters.com/legal/moderna-sues-pfizerbiontech-patent-infringement-over-covid-vaccine-2022-08-26/
https://www.npr.org/sections/health-shots/2022/08/26/1119608060/moderna-sues-pfizer-over-covid-19-vaccine-patents