Dutch court blocks subcutaneous Keytruda in eight European markets

A Dutch patent court in The Hague ruled that Merck/MSD’s subcutaneous version of Keytruda infringes Halozyme’s European patent for drug-delivery technology, and ordered MSD BV to stop manufacturing, selling, importing, stocking or otherwise supplying it in eight countries:
Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.

The court rejected Merck’s challenge to the patent’s validity. Halozyme said the ruling blocks the subcutaneous product in those markets; Germany had faced a separate restriction, bringing the total to nine European countries with reported barriers.

The order applies to subcutaneous Keytruda, not the established intravenous formulation, which remains unaffected.

Merck strongly disputes the ruling, says it considers Halozyme’s patent invalid and the infringement allegation unfounded, and is evaluating its next steps. The dispute could affect the rollout of a more convenient injection, but the ruling may be contested.