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Thursday, October 8, 2026

Dutch court blocks subcutaneous Keytruda sales in eight European countries

Life Sciences Thursday, October 8, 2026 · Updated Oct 8, 2026 07:33

A Netherlands court sided with Halozyme in its patent dispute with Merck, barring sales of the subcutaneous Keytruda Qlex in eight European countries.

Why it matters: The ruling complicates Merck's European rollout of the under-the-skin Keytruda formulation and strengthens Halozyme's hand in any licensing negotiation.

Data as of Court decision announced October 7, 2026; reported by BioPharma Dive and STAT October 7

A Dutch court has blocked sales of Merck’s subcutaneous cancer immunotherapy Keytruda Qlex in eight European countries, siding with Halozyme in an intellectual property dispute. Halozyme said the court ruled that Merck’s drug infringed patents covering Halozyme technology that rapidly delivers large biologic molecules through under-the-skin injections. The Netherlands case is part of a broader offensive: Halozyme won a legal proceeding in Germany and is challenging Merck in a U.S. court.

The contrast with Merck’s rivals sharpens the point. Bristol Myers Squibb and Roche both partnered with Halozyme to develop subcutaneous versions of their cancer immunotherapies, Opdivo and Tecentriq, rather than building around the technology. TD Cowen analyst Brendan Smith wrote that the decision “strengthens Halozyme’s position and could improve the potential path toward a future license or other economic resolution.”

Subcutaneous formulations matter because they move treatment out of infusion centers, and Keytruda is the world’s top-selling drug. A multi-country sales block in Europe is a genuine commercial obstacle, not a procedural footnote, even though the case is one front in a wider patent war with the U.S. case still pending.

Sources

  1. Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial · BioPharma Dive · 2026-10-07
  2. Merck suffers a setback in Europe over its new Keytruda formulation · STAT · 2026-10-07