Pfizer Faces Lawsuit from GSK Alleging Infringement of RSV Vaccine Patent

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GlaxoSmithKline filed a lawsuit against Pfizer in a U.S. court on Wednesday, accusing Pfizer of patent infringement for GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine.

GlaxoSmithKline claims that Pfizer’s RSV vaccine, Abrysvo, violates four of its patents associated with the antigen used in GlaxoSmithKline’s own vaccine.

In a strong-worded complaint filed in federal court in Delaware, GlaxoSmithKline stated, “Upon information and belief, Pfizer knowingly utilizes GlaxoSmithKline’s patented inventions in Abrysvo without permission.”

Both vaccines received approval from the U.S. Food and Drug Administration in May for use in adults aged 60 and above. Some doses of the vaccines are already available to the public at retail pharmacies like Walgreens.

RSV is a common respiratory infection that typically causes mild, cold-like symptoms, but can lead to more severe cases in older adults and children. According to CDC data, RSV causes 6,000 to 10,000 deaths among seniors and a few hundred deaths among children under the age of 5.

In the lawsuit, GlaxoSmithKline is demanding a jury trial and seeking monetary damages, including lost profits and royalties resulting from Pfizer’s alleged patent infringement. GlaxoSmithKline also seeks to prohibit Pfizer from manufacturing and selling Abrysvo in the U.S. for adults aged 60 and older.

It is important to note that GlaxoSmithKline is not attempting to limit the use of Abrysvo for preventing RSV in infants, as it is a separate vaccine specifically designed to protect newborns. The FDA is expected to make a final decision on the infant vaccine in August.

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A spokesperson for Pfizer expressed confidence in the company’s intellectual property position and stated that Pfizer will vigorously defend its right to provide its innovative RSV vaccine to patients.

The lawsuit highlighted that Pfizer began working on its RSV vaccine program in 2013, seven years after GlaxoSmithKline started its own program. The lawsuit also alleges that Pfizer was aware of GlaxoSmithKline’s patented technology since at least October 2019, when Pfizer commenced challenging the validity of European versions of the patents.

This is not the first time GlaxoSmithKline has engaged in a legal battle with Pfizer over patent rights. In 2016, GlaxoSmithKline sued Pfizer in an Irish court, alleging patent infringement related to GlaxoSmithKline’s meningitis vaccine.

Moderna also sued Pfizer and its German partner BioNTech for patent infringement regarding the Covid vaccine in August 2022. Pfizer and BioNTech countersued in December.

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