GSK Sues Pfizer and BioNTech Over Alleged COVID-19 Patent Infringement

Courthouse_iStock, Mariakray

Pictured: Sign above the entrance to a U.S. courthouse/iStock, Mariakray

GSK on Thursday sued Pfizer and BioNTech, alleging that the pharma partners have infringed patents related to the mRNA technology of their COVID-19 vaccine Comirnaty, according to Reuters.

In its complaint, filed with the U.S. District Court of Delaware, GSK claims Pfizer and BioNTech made use of “seminal” mRNA research from Christian Mandl, who in 2008—with a team of researchers—successfully addressed long-standing hurdles regarding the use of mRNA molecules as vaccines.

“The Mandl team successfully overcame the many challenges and discovered the novel lipid and mRNA formulations and methods for their use to raise an immune response against immunogens,” GSK’s filing noted, adding that the company obtained exclusive rights to the Mandl research in 2015, when it bought a “substantial portion” of Novartis’ vaccines unit.

Despite its ownership, GSK alleges that Pfizer and BioNTech knowingly used the Mandl research to develop Comirnaty. BioNTech has cited the work of Mandl’s team in its patent applications, while Pfizer has likewise pointed to the Mandl research in at least one of its presentations.

Pfizer and BioNTech’s “mRNA vaccines exploit the fundamental technologies invented by the Mandl team,” GSK wrote in its lawsuit, noting that the defendants “did not acquire a license to practice the GSK inventions before or since commercializing” their COVID-19 shots.

As compensation for the alleged patent infringement, GSK is seeking damages including an on-going license fee as well as related attorney fees and other expenses.

A Pfizer spokesperson in a statement to Reuters said that the company is “confident in our IP position around Comirnaty” and that it will “vigorously defend” its position against GSK. BioNTech declined to provide comment.

Thursday’s lawsuit adds to Pfizer and BioNTech’s legal troubles surrounding Comirnaty. The partners are also locked in a patent battle with Moderna, which in August 2022 claimed infringement on certain patented mRNA technology. Moderna’s lawsuit focuses on the specific chemical modifications to the mRNA molecule used in Comirnaty, as well as the process of encoding the full-length spike protein contained in a lipid nanoparticle.

Pfizer and BioNTech fired back in August 2023 and asked the U.S. Patent Trademark Office for an inter partes review, claiming that some of Moderna’s patents were invalid for being too broad and for seeking to claim ownership of established knowledge.

Last week, the U.S District Court of Massachusetts granted Pfizer and BioNTech’ motion to pause Moderna’s lawsuit until after the resolution of the inter partes proceedings.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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