GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY.  According to the complaint, AVREXY and ABRYSVO were approved by the U.S. Food and Drug administration in May 2023 for use in adults over age 60, becoming the world’s first approved RSV immunizations for adults.

GSK describes the four asserted patents, U.S. Patent Nos. 8,563,002, 11,261,239, 11,629,181, and 11,655,284, as claiming inventions relating to compositions used in RSV vaccines, and methods for preparing those compositions.  GSK specifically describes AREXVY as “an injection that contains lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) as the antigen component.”  In its complaint, GSK claims that Pfizer “knowingly uses GSK’s claimed inventions in ABRYSVO without permission” and that Pfizer “began the project that led to ABRYSVO no earlier than 2013, at least seven years after GSK started its own RSV program.”

GSK seeks findings of infringement, a permanent injunction, lost profits and/or royalties, and attorneys’ fees.

Stay tuned for more coverage of this case and other big molecule litigations!

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