Dutch court blocks Merck's Keytruda SC in eight European markets

A Dutch patent court in The Hague has issued a cross-border injunction against Merck, ordering the company to halt the manufacture, sale, and import of the subcutaneous version of Keytruda (Keytruda SC) in eight European markets. The affected countries include Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands.

The ruling follows a finding that Merck infringed on a Halozyme patent regarding MDASE technology, which enables rapid, high-volume subcutaneous drug delivery. Merck has expressed strong disagreement with the decision, stating it considers Halozyme’s patent to be invalid globally and the infringement allegations to be without merit.

While the injunction presents a setback for Merck’s efforts to transition patients to the easier-to-use subcutaneous formulation as original intravenous patents expire, analysts note the ruling is not a final judgment on patent validity. Separate invalidity proceedings are currently underway in Denmark, France, Sweden, and Switzerland. The outcome of these proceedings could potentially overturn the injunction.