Moderna is suing Pfizer and its German partner BioNTech for patent infringement in the development of the first COVID-19 vaccine approved in the United States, alleging they copied technology Moderna developed years before the pandemic.
The lawsuit, which seeks indeterminate damages, was filed in the U.S. District Court in Massachusetts and the Düsseldorf Regional Court in Germany, Moderna said in a press release Friday.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented in the decade before the COVID-19 pandemic,” the CEO said. of Moderna, Stéphane Bancel, in the press release.
Moderna Inc. alone, and the partnership of Pfizer Inc. and BioNTech SE were two of the first groups to develop a vaccine against the novel coronavirus.
Just ten years old, Cambridge, Massachusetts-based Moderna had been an innovator in messenger RNA (mRNA) vaccine technology that enabled the unprecedented speed of COVID-19 vaccine development.
An approval process that previously took years was completed in months, thanks in large part to the breakthrough in mRNA vaccines, which teach human cells how to make a protein that will trigger an immune response.
The German company BioNTech was also working in this field when it joined forces with the American pharmaceutical giant Pfizer.
The United States Food and Drug Administration granted emergency use authorization for the COVID-19 vaccine first to Pfizer/BioNTech in December 2020, then a week later to Moderna.
Moderna alleges that Pfizer/BioNTech, without permission, copied mRNA technology that Moderna patented between 2010 and 2016, long before COVID-19 emerged in 2019 and exploded into global consciousness in early 2020.
At the start of the pandemic, Moderna said it would not enforce its COVID-19 patents to help others develop their own vaccines, especially for low- and middle-income countries. But in March 2022, Moderna said it expected companies such as Pfizer and BioNTech to respect its intellectual property rights. He said he would not seek damages for any activity until March 8, 2022.
Patent litigation is not uncommon in the early stages of new technologies.
Pfizer and BioNTech already face multiple lawsuits from other companies that claim the partnership’s vaccine infringes their patents. Pfizer/BioNTech said they would vigorously defend their patents.
Germany’s CureVac 5cv.DE, for example, also filed a lawsuit against BioNTech in Germany in July. BioNTech responded in a statement that its work was original.
Moderna has also been sued for patent infringement in the US and has an ongoing dispute with the US National Institutes of Health over mRNA technology rights.
In Friday’s statement, Moderna said Pfizer/BioNTech had appropriated two types of intellectual property.
One involved an mRNA structure that Moderna says its scientists began developing in 2010 and were the first to validate in human trials in 2015.
“Pfizer and BioNTech tested four different vaccine candidates in clinical trials, which included options that would have avoided Moderna’s innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the exact same chemical modification of mRNA from its vaccine,” Moderna said in its statement.
The second alleged offense involves the coding of a full-length spike protein that Moderna says its scientists developed while creating a vaccine against the coronavirus that causes Middle East Respiratory Syndrome (MERS).
Although the MERS vaccine was never commercialized, its development helped Moderna rapidly deploy its COVID-19 vaccine.
(Reporting by Daniel Trotta; editing by Caroline Humer and Edwina Gibbs)