Dutch court blocks Merck's subcutaneous Keytruda in eight European countries

· Health · Netherlands · United States

A Dutch court has ordered Merck to stop manufacturing and selling its subcutaneous formulation of Keytruda in eight European countries, ruling that the injectable version infringed a patent held by Halozyme. The decision is a setback for Merck, which has been developing the under-the-skin version to extend Keytruda's franchise as competition in cancer immunotherapy intensifies. Halozyme licenses the drug-delivery technology used in subcutaneous formulations. The ruling could disrupt Merck's European rollout of the product and give Halozyme leverage in negotiations with other partners. Keytruda is one of the world's top-selling cancer drugs, making the outcome closely watched across the oncology sector.

Why it matters：The ruling tests how far drug-delivery patents can block follow-on formulations of blockbuster biologics, affecting Merck's European strategy and other companies planning subcutaneous versions of infused medicines.

Key points

  • A Dutch court ordered Merck to halt manufacturing and marketing of subcutaneous Keytruda in eight European countries.
  • The court ruled Merck infringed a patent held by Halozyme, which licenses drug-delivery technology.
  • The decision is a setback for Merck, which is counting on the subcutaneous version to extend Keytruda's franchise.

Sources (original reporting)

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