GSK Sues Pfizer, Pharmacia & Upjohn & BioNTech for Infringing mRNA Vaccine Patents

Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc. infringe five U.S. patents directed to mRNA vaccine technology.  The Patents-In-Suit are U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467.  According to the Complaint, the five patents relate to “formulations comprising lipids and messenger ribonucleic acid (“mRNA”) molecules encoding an immunogen, and methods of administering the same.”

GSK seeks “damages for Defendants’ infringing manufacture, use, sale, marketing, offer for sale, and/or importation” of the following products: “(1) the original ‘monovalent’ (containing a single mRNA active ingredient) Comirnaty® COVID-19 vaccine; (2) the ‘bivalent’ (containing two different mRNA active ingredients) Comirnaty® COVID-19 original plus BA.1 variant vaccine; (3) the bivalent Comirnaty® COVID-19 original plus BA.4/5 variant vaccine; and (4) the monovalent Comirnaty® COVID-19 XBB.1.5 variant vaccine.”

GSK alleges that the named inventor Andrew Geall and a team of researchers working under Christian Mandl “discovered formulations comprising lipids and mRNA molecules encoding a viral immunogen that provide protection from viral infection… [and ] described the inventions now claimed in the Patents-in-Suit, in patent applications filed in 2010.”  GSK alleges that the Mandl team’s inventions have been credited with improving the “speed with which a new vaccine candidate can be made and tested.”

GSK alleges that Defendants had been aware of the Mandl team’s innovations for years before marketing the five accused products.  In particular, GSK alleges that Defendants hired business employees who had knowledge of the alleged innovations and also that Defendants have cited the Mandl team’s patent applications and related publications in Defendants’ own patent applications and publications.

GSK seeks a judgment of infringement of the five Patents-In-Suit, a finding of willful infringement, damages for past infringement, treble damages, attorneys’ fees, a compulsory ongoing license fee, and any other relief the Court deems just and proper.