GlaxoSmithKline (GSK) has sued Pfizer and BioNTech, accusing the COVID-19 jab manufacturers of infringing patents related to mRNA technology in the experimental shots. 

“GSK Biologicals is the sole owner and assignee of numerous United States patents directed to formulations comprising lipids and messenger ribonucleic acid (‘mRNA’) molecules encoding an immunogen, and methods of administering the same,” the lawsuit read.

“In 2008, more than a decade before the SARS-CoV-2 (2019) coronavirus disease (COVID-19) pandemic, Andrew Geall, an accomplished formulation scientist and the named inventor of the Patents-in-Suit, joined a team of talented researchers working under the leadership of vaccinologist Christian Mandl (the ‘Mandl team’) focused on developing mRNA vaccines. These individuals discovered formulations comprising lipids and mRNA molecules encoding a viral immunogen that provide protection from viral infection. The Mandl team described the inventions now claimed in the Patents-in-Suit, in patent applications filed in 2010,” it continued.

Per Reuters:

A Pfizer spokesperson said in a statement that the company is “confident in our IP position around Comirnaty” and intends to “vigorously defend” against GSK’s claims. A BioNTech spokesperson declined to comment on the complaint.

A GSK spokesperson said the company believes its patents “provided the foundational technology used in Pfizer and BioNTech’s COVID-19 mRNA vaccines,” and that it is “willing to license these patents on commercially reasonable terms and to ensure continued patient access” to the shots.

The lawsuit adds to a web of high-stakes U.S. court cases involving Pfizer, BioNTech and Moderna over patent royalties for technology used in their vaccines, including a case brought by Moderna against Pfizer in 2022.

Pfizer made $11.2 billion from sales of Comirnaty last year, while Moderna earned $6.7 billion in revenue from its vaccine Spikevax. Sales of both vaccines declined significantly last year from 2022.

Bloomberg Law reports:

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.

Read the lawsuit HERE.

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