GSK Says Pfizer Infringed Five Patents Relating to Comirnaty COVID Vaccine

GlaxoSmithKline filed a four-count civil action for patent infringement in the United States District Court for the District of Delaware late last week seeking damages for Pfizer and BioNTech’s infringing manufacture, use, sale and marketing of both the original “monovalent” and “bivalent” Comirnaty COVID-19 vaccines.

The COVID-19 vaccine was quickly rolled out compared to other vaccines in the past and many pharmaceutical companies benefited financially. However, GlaxoSmithKline Biologicals SA, GSK Biologicals and GlaxoSmithKilne LLC (GSK LLC), (collectively GSK) contend their competitors, Pfizer Inc. and Pharmacia & Upjohn Co. LLC (collectively Pfizer) and BioNTech SE, BioNTech Manufacturing GMBH and BioNTech US Inc. (collectively BioNTech) developed their vaccines with GSK’s patented inventions created about a decade earlier.

The background of the complaint dates to 2008, when Formulation Scientist Andres Geall joined a research team under the leadership of Vaccinologist Christian Mandl to develop mRNA vaccines for GSK. Known as the “Mandl team,” they discovered formulations that were comprised of lipids and mRNA encoding a wide range of immunogens. The Mandl team described the inventions that are claimed in U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467, which were filed in 2010. Though the Mandl team was originally employed by Novartis, GSK acquired a substantial portion of Novartis’ global vaccine business in 2015, including the Mandl team’s inventions.

According to the complaint, Pfizer was only able to develop Comirnaty thanks to the Mandl team’s unique approach to vaccine design, including “the ability to employ the technology as a platform to formulate and administer mRNA encoding a wide range of immunogens” and “the speed with which a new vaccine candidate can be made and tested.” In 2013, said the complaint, the Mandl team responded to an influenza outbreak in China by creating a new mRNA vaccine candidate in just eight days. Prestigious scientific journals have also recognized the Mandl team’s contributions, GSK added.

“Defendants have repeatedly touted the speed at which they produced their original COVID-19 vaccine and were later able to modify it to address new viral strains but have consistently failed to acknowledge how they applied the Mandl team’s revolutionary platform to do so,” said the complaint.

It added: “Defendants have reaped billions of dollars in revenue from infringing GSK’s Patents-in-Suit and continue to benefit, without ever obtaining a license.”

GSK is alleging direct infringement, either literally or under the doctrine of equivalents; induced infringement; contributory infringement; and willful infringement. GSK is also asking that the case be declared exceptional for the purposes of awarding attorney fees, costs and expenses.

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