Dutch court blocks Merck’s Keytruda SC across eight European markets

A specialist court in The Hague found that Merck infringed Halozyme’s MDASE patent and issued a cross-border injunction against Keytruda SC in eight European markets. The order applies to MSD BV, Merck’s European authorization holder and distribution center, while intravenous Keytruda is outside the scope of the ruling. Merck said it disagrees with the decision, considers the patent invalid and is assessing its response.

The injunction prevents Merck from manufacturing and commercializing the subcutaneous Keytruda formulation in the covered markets unless the ruling changes. Halozyme said its MDASE patent dispute with Merck does not alter ENHANZE licensees’ ability to use ENHANZE or their associated license fees.

  • 1The Hague patent court ruled that Merck infringed Halozyme patent EP 2,797,622.
  • 2The injunction restricts Keytruda SC activities in eight European markets.
  • 3The Dutch court rejected Merck’s challenge to the validity of the EP622 patent.
  • 4The order does not affect the intravenous version of Keytruda.
  • 5Halozyme previously obtained a preliminary German injunction on December 4, 2025.
  • 6Merck said it strongly disagreed with the ruling and was evaluating its next steps.
  • The outcome of any Merck appeal or other response to the Dutch injunction is not yet known.
  • The financial effect of the injunction on either company was not disclosed.

Sources