UK pharmaceutical giant GlaxoSmithKline (NYSE: GSK) has taken US-based Pfizer Inc., (NYSE: PFE) to court, alleging that Pfizer’s recently approved respiratory syncytial virus (RSV) vaccine, Abrysvo, infringes upon the patents of GSK’s own RSV vaccine, Arexvy. According to the docket filed with the US District Court of Delaware, Abrysvo is claimed to infringe upon four patents related to the antigen used in Arexvy.
Background on RSV Vaccine Approvals
Arexvy was the first RSV vaccine to gain global approval when the FDA granted it in May 2023, indicated to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years and older. Pfizer’s Abrysvo received approval for an identical indication less than one month later. Unlike Arexvy, Abrysvo is also under development for pediatric use. In May, an FDA Advisory Committee voted to support the approval of the vaccine as a preventive measure for RSV in infants through maternal immunization, with an approval decision expected in August.
GSK’s Legal Claim and Pfizer’s Response
GSK’s case specifically pertains to Abrysvo’s use in the age group over 60 years old and seeks damages and an injunction on the sale of Pfizer’s product. GSK’s lawsuit emphasizes that Pfizer did not commence work on its RSV vaccine program until 2013, approximately 7 years after GSK initiated its own program. Pfizer has released a statement denying the infringement allegations and has pledged to contest the case vigorously.-Fineline Info & Tech
