Moderna Sues Pfizer, BioNTech Over Covid Vaccine Patent Infringement

Pharmaceuticals Moderna is suing Pfizer and its German partner BioNTech for patent infringement in developing the first Covid-19 vaccine approved in the United States, claiming they copied technology that Moderna developed years before the pandemic.

The lawsuit, which seeks indefinite monetary damages, is being filed in the United States District Court in Massachusetts and the Regional Court in Dusseldorf, Germany, Moderna said in a press release on Friday.

“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 prior to the Covid-19 pandemic,” said Moderna Chief Executive Stephane Bancel. , in a statement.

Moderna, on its own, and Pfizer’s partnership with BioNTech were two of the first groups to develop a vaccine for the coronavirus.

Just a decade old, Cambridge, Massachusetts-based Moderna was an innovator in messenger RNA (mRNA) vaccine technology that enabled unprecedented speed in disease vaccine development.

An approval process that once took years was completed in months, thanks in large part to advances in mRNA vaccines, which teach human cells to produce a protein that will trigger an immune response.

Germany-based BioNTech was also working in this field when it partnered with US pharmaceutical giant Pfizer.

The Food and Drug Administration (FDA), a body similar to Anvisa in the US, granted emergency use authorization for the Covid-19 vaccine first to Pfizer/BioNTech in December 2020 and, a week later, to Moderna.

Moderna alleges that Pfizer/BioNTech, without permission, copied the mRNA technology that Moderna had patented between 2010 and 2016, well before Covid-19 broke out in 2019 and exploded globally in early 2020.

Early in the pandemic, Moderna said it would not apply its patents on Covid-19 to help others develop their own vaccines, particularly for low- and middle-income countries. But in March 2022, Moderna said it expected companies like Pfizer and BioNTech to respect its intellectual property rights. She said she would not seek compensation for any activities before March 8, 2022.

Patent litigation is not uncommon in the early stages of a new technology.

Pfizer and BioNTech are already facing multiple lawsuits from other companies that say the partnership vaccine infringes on their patents. Pfizer/BioNTech said it will vigorously defend its patents.

Germany’s CureVac 5cv.DE, for example, also filed a lawsuit against BioNTech in Germany in July. BioNTech responded in a statement that their 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 (NIH) over the rights to the mRNA technology.

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 brought four different vaccine candidates into clinical trials, which included options that would have avoided Moderna’s innovative path. Pfizer and BioNTech, however, have decided to go ahead with a vaccine that has the exact same chemical modification of mRNA as their vaccine,” Moderna said in its statement.

The second alleged breach involves encoding a full-length Spike protein that Moderna says its scientists developed when creating a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS).

Although the MERS vaccine never made it to market, its development helped Moderna quickly launch its Covid-19 vaccine.

(Edited by Caroline Humer and Edwina Gibbs)