Halozyme Wins Dutch Court Injunction Against Merck's Keytruda SC

The Dutch court rejected Merck’s arguments regarding the invalidity of the patent EP 2,797,622, siding with Halozyme’s claims of infringement. Under the injunction, Merck’s distribution hub, MSD BV, is prohibited from importing, stocking, or marketing Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands. The ruling also bars the company from facilitating further infringement through its affiliates or European marketing authorizations. Patients currently relying on the intravenous version of the therapy will remain unaffected, as that formulation falls outside the scope of the patent dispute.

This outcome strengthens Halozyme’s global campaign to protect its drug delivery innovations. The company previously secured a preliminary injunction in Germany in December 2025, which also halted the rollout of Keytruda SC in that market. Beyond Europe, the legal battle continues in the United States, where Halozyme has filed a lawsuit in New Jersey federal court alleging that Merck’s subcutaneous formulation—marketed domestically as QLEX—infringes on 15 separate patents. Halozyme clarified that the MDASE technology at the center of these disputes is distinct from its separate ENHANZE licensing program, ensuring that current partners and their fee structures remain insulated from the ongoing litigation.