GSK targets Pfizer over newly approved RSV vaccine
GSK argues that its US rival knew of its patented technology seven years after research began | Blockbuster respiratory vaccines, world’s first of their kind, received US approval in May.
Biopharma firm GSK has sued its US rival Pfizer over their competing blockbuster respiratory vaccines, which both represent the world’s first respiratory syncytial virus (RSV) treatments for adults over 60.
GSK, the UK’s second largest pharma company, accuses New York-based Pfizer of infringing four patents related to the antigen element of its vaccine, Arexvy.
In a complaint filed in Delaware on Wednesday, August 2, GSK argued that Pfizer began work on its vaccine, Abrysvo, no earlier than 2013—at least seven years after GSK started its own research into the virus. However, GSK did not provide evidence of this in the lawsuit.
GSK noted that Pfizer’s Abrysvo was administered to a patient for the first time in July, in California. No details were given as to whether Arexvy has yet been administered.
The US Food and Drug Administration (FDA) approved both vaccines in May, with Pfizer’s version receiving approval a few weeks after GSK’s. This is the first time a vaccine has been successfully developed since research attempts began in the 1960s.
GSK’s Arexvy received European approval in June, while Pfizer’s Abrysvo received European approval the following month.
GSK alleged that Pfizer knew of its patented technology since at least 2019, when it began challenging the validity of European versions of the patents, according to the lawsuit.
In a statement emailed to LSIPR, a GSK spokesperson said: "Intellectual property protections are the foundation of research-based companies’ ability to drive innovation. This action does not impact GSK’s ability to launch its RSV vaccine, Arexvy, and we remain fully focused on making our RSV vaccine for older adults available in the US following its recent approval by the FDA."
RSV is a contagious virus that can lead to serious respiratory illness in people of all ages. In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis.
According to estimates from the Centers for Disease Control and Prevention cited in the lawsuit, between 60,000 and 160,000 older adults in the US are hospitalised. Approximately 6,000 to 10,000 of these die due to RSV infection.
The patents in dispute are US patent numbers 8,563,002, 11,261,239, 11,629,181, and 11,655,284. GSK filed the lawsuit at the US District Court for the District of Delaware.
Both companies are rolling out their vaccines in the US ahead of ‘RSV season’ in the autumn.
Counsel for GSK in the lawsuit are Chris Noyes, Robert Gunther, Lisa Pirozzolo and Stephanie Lin at WilmerHale; and Fred Cottrell, Kelly Farnan and Sara Metzler at Delaware law firm Richards, Layton & Finger.
LSIPR has contacted Pfizer for comment, without immediate response.
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