By Daniel Trotta
(Reuters) – 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.
Shares of Pfizer fell 1.4% before the bell, while BioNTech fell about 2%.
The lawsuit, which seeks unspecified monetary damages, was filed in the U.S. District Court in Massachusetts and the District Court in Dusseldorf, 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 leading up to the COVID-19 pandemic,” said Moderna CEO Stephane Bancel.
Moderna Inc, on its own, and the partnership of Pfizer Inc and BioNTech SE were two of the first groups to develop a vaccine for the new coronavirus.
Just over a decade ago, Moderna, based in Cambridge, Massachusetts, pioneered the messenger RNA (mRNA) vaccine technology that enabled the unprecedented speed in vaccine development for COVID-19.
An approval process that previously took years was completed in months, thanks in large part to the discovery of mRNA vaccines, which teach human cells how to produce a protein that will trigger an immune response.
Germany-based BioNTech also worked in this area when it partnered with US pharmaceutical giant Pfizer.
The US Food and Drug Administration granted emergency use authorization for the COVID-19 vaccine first to Pfizer/BioNTech in December 2020 and then a week later to Moderna.
Moderna’s COVID vaccine — its only commercial product — brought in $10.4 billion in revenue this year, while Pfizer’s vaccine brought in about $22 billion.
Moderna alleges that Pfizer/BioNTech, without permission, copied mRNA technology that Moderna had patented between 2010 and 2016, long before COVID-19 appeared in 2019 and exploded into global consciousness in the early 2020s.
Early in the pandemic, Moderna said it would not enforce its COVID-19 patents to help others develop their own vaccines, particularly for low- and middle-income countries. However, in March 2022, Moderna said it expects companies such as Pfizer and BioNTech to respect its intellectual property rights. It said it will not seek compensation for any activity before March 8, 2022.
Patent litigation is not uncommon in the early stages of new technology.
Pfizer and BioNTech already face multiple lawsuits from other companies that say the collaboration’s vaccine infringes their patents. Pfizer/BioNTech has stated that it will vigorously defend their patents.
Germany’s CureVac, 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 United States and has an ongoing dispute with the US National Institutes of Health over rights to mRNA technology.
In Friday’s statement, Moderna said Pfizer/BioNTech 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 put four different vaccine candidates through clinical trials, which included options that would have strayed from Moderna’s innovative path. Pfizer and BioNTech, however, ultimately decided to move forward with a vaccine that has the same exact chemical modification of mRNA with its vaccine,” Moderna said in its statement.
The second alleged violation involves encoding a full-length spike protein that Moderna says its scientists developed while creating a vaccine for the Middle East respiratory syndrome (MERS) coronavirus.
Although the MERS vaccine never made it to market, its development helped Moderna quickly launch its vaccine for COVID-19.
Pfizer said the company had not been served and was unable to comment at this time.
(Reporting by Daniel Trotta Editing by Caroline Humer and Edwina Gibbs)