GlaxoSmithKline (GSK) has initiated a lawsuit against Pfizer in an attempt to put a halt to their Respiratory Syncytial Virus (RSV) vaccine for adults. GSK asserts that Pfizer’s vaccine, known as Abrysvo, infringes on four of their patents. The news of this lawsuit comes as we approach the RSV season, which usually kicks off in fall and lasts into spring. The two vaccines in question, GSK’s Arexvy and Pfizer’s Abrysvo are both designed to treat the lower respiratory tract disease caused by RSV in adults aged 60 and older.
GSK’s claim was filed in the Delaware District federal court and argues that their research into an RSV vaccine began before Pfizer’s. They reference their work in the early 2000s, which according to scientists at the National Institute for Allergy and Infectious Diseases (NIH), primarily targeted a protein the virus uses to infect cells, known as RSV F. Research shows that a prefusion form of this protein is effective at eliciting protective antibodies—information which GSK believes Pfizer utilized in the development of its own vaccine’s double-prefusion form of the F protein.
Interestingly, GSK’s case makes no mention of the NIH research but simply claims that their own RSV investigation was initiated earlier. In their legal documents, GSK states that Pfizer commenced its research in 2013, seven years after GSK had begun developing a vaccine. GSK insists that its team was centered on the prefusion form of the protein, RSVPreF, noting that prior vaccines using the RSVPostF induced only limited or no efficacy. GSK’s scientists sought to develop an RSVPreF antigen that targets the RSV Predation conformation present on the virus before it attaches to the cell surface.
GSK alleges that Pfizer was aware of at least one of the patents associated with their recombinant RSV antigens and filed oppositions to these patents with the European Patent Office in 2019 and 2022, leading to the current legal battle.
In addition to older adults, Pfizer’s Abrysvo has tested to vaccinate pregnant mothers, allowing the infant to receive protection through the accumulated antibodies. The FDA approval for Abrysvo as a maternal vaccine is due later this month. However, GSK’s lawsuit is specifically targeted at Pfizer’s vaccine in its use for adults over 60 and does not aim to undermine its use in infants. Nonetheless, the complaint does assert that GSK views the use of Pfizer’s vaccine in infants as an infringement and will seek appropriate damages.
Fierce competition between both companies is expected as they are, thus far, the only two to have developed approved vaccines against RSV, a disease that poses significant risks to adults over 60.
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