Dutch Court Blocks Keytruda SC Sales in Eight Countries
The injunction halts the distribution of the subcutaneous cancer drug, impacting operations across key European markets.
Updated on Oct. 30, 2026 in Biotech
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The District Court of The Hague has issued a cross-border injunction blocking the sale and distribution of Keytruda SC in eight European countries. The ruling upholds a patent held by Halozyme and prohibits Merck Sharp & Dohme from manufacturing or selling the subcutaneous injection form of its cancer drug in these markets.
Why it matters
This injunction halts the rollout of a key product line for Merck Sharp & Dohme, illustrating the significant legal risks manufacturing hubs face when incorporating third-party patent technology into new drug delivery formats.
The ruling impacts the distribution of Keytruda SC, a subcutaneous formulation, across Belgium, Denmark, France, Ireland, Italy, the Netherlands, Sweden, and Switzerland. The court determined the European patent held by Halozyme is valid, rejecting a non-infringement claim.
The players
Merck Sharp & Dohme
A pharmaceutical company that produces Keytruda and maintains a major manufacturing hub in the Netherlands.
Halozyme
A biotechnology firm that develops drug delivery technologies and holds the European patent upheld by the court.
The details
The court based its decision on the BSH v Electrolux ruling from the Court of Justice of the EU to determine jurisdiction over cross-border patent claims. Judges evaluated the role of the Netherlands as a manufacturing and distribution hub for the drug, effectively linking the location of production to market authorization rights. The injunction remains active unless a national court in one of the affected jurisdictions rules the underlying patent invalid.
Timeline
- 2026-10-30
The District Court of The Hague issued the cross-border patent injunction.
The Tech Race
The ruling follows the legal standard set by the BSH v Electrolux case, which governs how courts establish jurisdiction over cross-border patent enforcement. It creates a significant hurdle for Merck Sharp & Dohme as it attempts to scale the subcutaneous version of its flagship cancer therapy.
Patients and healthcare providers in the eight affected countries will face immediate supply disruptions for the subcutaneous version of Keytruda. The product will remain unavailable in these markets unless the injunction is overturned by a national court.
The takeaway
The court's decision forces a sudden pause in the European distribution strategy for Keytruda SC. Industry participants should monitor upcoming national court filings in the affected jurisdictions to see if any local judges challenge the validity of the underlying Halozyme patent.
Further reading
For more on the regulatory and patent challenges facing new medical delivery methods, visit the Biotech section.
Source note: This article includes information reported by Pinsent Masons.
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