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Halozyme Wins Injunction Stopping Manufacture and Sale of Merck's Keytruda SC in Multiple European Markets

HALO
  • The specialized Dutch patent court in The Hague ruled that Merck infringed Halozyme's MDASE patent EP 2,797,622 (EP622) & ordered Merck's MSD BV to cease manufacturing, offering, importing, or stocking Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, & the Netherlands.
  • The court rejected Merck's arguments regarding the invalidity of EP622 & forbade MSD from facilitating infringement through its affiliates or by allowing the use of its European Marketing Authorization.
  • Patients will retain access to the intravenous (IV) version of Keytruda, which is not covered by Halozyme's patent or the injunction order.
  • This ruling is part of Halozyme's global enforcement of MDASE patents against Merck's Keytruda SC, following a preliminary injunction granted by a German court in December 2025 to stop Keytruda SC distribution in Germany.
  • Halozyme has also filed a patent infringement lawsuit against Merck in U.S. federal district court in New Jersey, alleging that Keytruda SC (marketed as QLEX in the U.S.) infringes 15 patents related to MDASE technology.
  • The MDASE patents are distinct from Halozyme's ENHANZE licensing program, meaning the outcome of these enforcement actions will not impact licensee rights or fees for ENHANZE.
  • Halozyme continues to develop & license other drug delivery technologies, including Hypercon (renamed Aerocon) & proprietary auto-injector products like Hylenex & XYOSTED.