Moderna sues Pfizer/BioNTech for patent infringement over COVID vaccine

Washington, Aug. 26 (BUS) – 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 to copy technology Moderna developed years before the pandemic.

Moderna said in a press release Friday that the lawsuit, which seeks unspecified monetary damages, has been filed with the US District Court in Massachusetts and the Düsseldorf Regional Court in Germany.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we created, invested billions of dollars in creating, and patented in the decade leading up to the COVID-19 pandemic,” Stefan Bancel, our CEO, said in the statement.

Moderna Inc (MRNA.O), on its own, a partnership of Pfizer Inc (PFE.N) and BioNTech SE (22UAy.DE) were among the first groups to develop a vaccine for the novel coronavirus.

Just a decade ago, Moderna, based in Cambridge, Massachusetts, was an innovator in mRNA vaccine technology that enabled unprecedented speed in COVID-19 vaccine development.

The approval process that once took years has been completed in months, thanks in large part to a breakthrough in mRNA vaccines, which teach human cells how to make a protein that triggers an immune response.

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

The FDA granted emergency use authorization for the COVID-19 vaccine first to Pfizer/BioNTech in December 2020, then one week later to Moderna.

Moderna alleges that Pfizer/BioNTech, without permission, copied mRNA technology Moderna patented between 2010 and 2016, long before COVID-19 emerged in 2019 and exploded into global consciousness in early 2020.

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Early in the pandemic, Moderna said it would not apply 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 like Pfizer and BioNTech to respect their intellectual property rights. It said it would not seek compensation for any activity 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 their patents. Pfizer/BioNTech said it would vigorously defend its patents.

For example, German company CureVac 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 the rights to its mRNA technology.

In a statement Friday, Moderna said Pfizer/Bioantek seized two types of intellectual property.

One involved an mRNA structure that Moderna says its scientists began developing in 2010 and were the first to be validated in human trials in 2015.

“Pfizer and BioNTech have taken four different vaccines into clinical trials, which included options that would deviate from Moderna’s innovative path. However, Pfizer and BioNTech eventually decided to go ahead with a vaccine that had the same chemical modification of the mRNA as their vaccine,” she said. Moderna in its statement.

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

Although the MERS vaccine was never released to the market, its development helped Moderna quickly launch a COVID-19 vaccine.

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