GSK Sues Pfizer, BioNTech for Share of Billions in Vaccine Sales

GlaxoSmithKline filed a federal lawsuit seeking to recoup a share of the tens of billions of dollars in revenue Pfizer and BioNTech have reported from sales of their Covid-19 vaccines, which GSK alleges infringe five patents related to mRNA vaccine technology.

The complaint relates to patents discovered by researchers who began working on mRNA vaccines in 2008, the rights to which GSK later acquired. The mRNA vaccines that were later produced by Pfizer and BioNTech for Covid have continued to generate billions in revenue for the two companies for years after their initial release.

Two GSK units—GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC—allege multiple versions of Pfizer Inc. and BioNTech SE’s Covid-19 vaccine, Comirnaty, infringe US Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467, according to a complaint filed Thursday in the US District Court for the District of Delaware.

Pfizer and BioNTech “have reaped billions of dollars in revenue from infringing GSK’s patents-in-suit and continue to benefit, without ever obtaining a license,” the complaint says. GSK seeks a reasonable royalty for infringement and a compulsory ongoing licensing fee.

The patents cover formulations that include lipids, or fats, and mRNA molecules that encode an immunogen, a substance that triggers an immune response. The technology is used to create vaccines that instruct cells to produce a protein that will stimulate an immune response and can be applied against a variety of diseases.

The patented formulations were discovered by a team of researchers who found a way to protect mRNA molecules and deliver them into human cells effectively, which was a significant challenge in the field, according to the complaint.

The researchers worked at Novartis AG subsidiaries when they began working on mRNA vaccines in 2008, the complaint says. Inventions including rights to what would become the asserted patents were transferred to GSK in 2015, when GSK Biologicals acquired a substantial portion of Novartis’ global vaccines business.

The ‘693 and ‘694 patents were issued in May 2023 and cover lipid and mRNA formulations for vaccines, and methods of administering them. The ‘534 and ‘401 patents—issued in June and September 2023, respectively—focus on advancements in mRNA formulations. The ‘467 patent, issued last October, is related to methods and compositions for mRNA vaccines.

All of the patents will expire in July 2031, Bloomberg Law estimates.

Pfizer reported more than $8 billion in US revenue from 2022 sales of the targeted vaccines, and more than $2 billion in US revenue in 2023, the suit says—it reported more $48 billion in global revenue from the targeted vaccines in those two years. BioNTech reported more than €12 billion ($12.8 billion) in revenues from the accused shots in 2022, and more than €3 billion in 2023, according to the complaint.

“We are confident in our IP position around Comirnaty and intend to vigorously defend against these claims,” a Pfizer spokesperson said in a statement.

A BioNTech spokesperson acknowledged the lawsuit’s filing but said BioNTech “will not comment on the company’s legal strategy.”

Richards, Layton & Finger PA; and Desmarais LLP represent GSK.

The case is GlaxoSmithKline Biologicals SA v. Pfizer Inc., D. Del., No. 24-cv-512, complaint filed 4/25/24.