Pfizer-BioNTech, Regeneron sued for patent infringement with COVID-19 products

Patents on file
Regeneron, Pfizer and BioNTech are sued by Allele Biotech over patent infringement of fluorescent protein used to develop their COVID-19 vaccine and antibody cocktail. (Shutterstock)

As Regeneron grabs the limelight for treating President Donald Trump with its experimental COVID-19 antibody cocktail, the company now finds itself alongside vaccine developers Pfizer and BioNTech on the defensive in a lawsuit that claims their coronavirus products infringe upon a patent.

Allele Biotechnology and Pharmaceuticals filed two lawsuits against the three drugmakers on Monday. The San Diego firm alleges that Pfizer and BioNTech, with its investigational COVID-19 vaccine BNT162, and Regeneron’s REGN-COV2, were developed using Allele’s mNeonGreen fluorescent protein without the company’s permission.

To compensate for the alleged infringement, Allele is seeking damages that amount to no less than a reasonable royalty, the company said in its complaint. It’s not immediately clear how much Allele is seeking.

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In a statement, Regeneron said it disagrees with Allele’s claims of infringement and that it will “vigorously defend our position against this lawsuit.” Pfizer didn’t immediately respond to a request for comment.

Pfizer and BioNTech’s lead candidate, an mRNA shot dubbed BNT162b2 that’s supported by the Trump’s Administration’s Operation Warp Speed, entered a phase 3 efficacy trial in July as the second U.S. program to do so. The pair said on Tuesday that they have started a rolling submission to the European Medicines Agency, which allows for the agency to review an application as clinical data come through.

RELATED: Trump takes Regeneron's antibodies, Gilead's remdesivir, dexamethasone in first days of COVID-19 hospital stay

As for Regeneron, the company a few days ago unveiled encouraging data from the first 275 patients in a phase 1/2/3 study of REGN-COV2, which combines two types of antibodies against the virus, showing it could help non-hospitalized patients clear the virus and improve in symptoms. The drug made headlines this past week as President Trump received a high dose of the cocktail as part of his COVID-19 treatment.

But Allele claims that the Regeneron drug was developed with the help of mNeonGreen, pointing to several academic papers published in Science and co-authored by Regeneron employees that include information on how antibodies against SARS-CoV-2’s spike protein were tested with the fluorescent protein.

In medical research, fluorescent proteins are injected into living cells so that scientists can visualize the molecular changes to determine the cells’ response to treatments. Among them, mNeonGreen is one of the brightest and most stable monomeric fluorescent proteins to date, and therefore allows for rapid detection of changes, according to Allele. “This research tool is even more critical in a global pandemic where the need for a vaccine to save lives has never been more crucial,” the company said in its complaint.

According to Allele, it “sought on multiple occasions to discuss Regeneron’s taking a license to that patent” but got no reply.

RELATED: Regeneron's COVID-19 antibody cocktail curbs virus, speeds recovery in early data

In Pfizer and BioNTech’s case, Allele said development and testing of the pair’s BNT162 vaccine candidate was made possible “only through use of mNeonGreen,” but the partners never reached out for a license, according to the complaint.

The tech earned the companies “an immediate $445 million in grants and over $4 billion in sales of the vaccine to date,” the complaint said, likely referring to the government contracts the pair has secured, including a $1.95 billion supply deal with the U.S. government.

Editor's Note: Kyle Blankenship also contributed to reporting.

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