Dutch Court Halted Keytruda SC Sales Across Europe
The ruling impacts eight nations following a finding of patent infringement against Merck & Co.
Updated on Oct. 8, 2026 in Biotech
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A Dutch court in The Hague has issued an injunction prohibiting the sale and manufacturing of Merck & Co.'s Keytruda SC across eight European countries. The ruling determined that the drug's formulation infringes a patent held by Halozyme Therapeutics.
Why it matters
The decision disrupts the market for a subcutaneous, or under-the-skin, delivery version of the cancer drug Keytruda. It underscores the high stakes of intellectual property disputes regarding drug delivery technologies that allow patients to receive medication without lengthy intravenous infusions.
The court identified that Keytruda SC infringes European Patent No. 2 797 622. This patent covers MDASE technology, an enzyme-based method that modifies the subcutaneous space to facilitate the delivery of larger volumes of biologic drugs.
The players
Merck & Co.
A global pharmaceutical firm known for its portfolio of oncology biologics and the development of the checkpoint inhibitor Keytruda.
Halozyme Therapeutics
A biotechnology company specializing in drug delivery platforms that utilize enzymes to improve the administration of subcutaneous medications.
The details
The legal dispute centers on the use of MDASE technology — recombinant human hyaluronidase, an enzyme that temporarily breaks down hyaluronic acid in the skin to allow for larger drug injections. By degrading this structural component of the tissue, the technology enables the administration of high-volume biologics that would otherwise be difficult to inject subcutaneously. The court rejected arguments from Merck & Co. asserting that the patent held by Halozyme Therapeutics was invalid.
Timeline
October 7, 2026: The Dutch patent court issued the injunction against Merck & Co.
The Tech Race
This injunction serves as a critical checkpoint in the ongoing race to transition standard intravenous oncology treatments to subcutaneous platforms. It reinforces the market power of firms holding foundational patents on delivery mechanics against large-scale pharmaceutical incumbents.
Patients and healthcare providers in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands will face immediate changes to the availability of the subcutaneous version of Keytruda. The ruling halts the drug's distribution in these markets while the legal injunction remains in effect.
The takeaway
The court's decision signals that proprietary drug-delivery enzymes are being aggressively defended in European courts. Watch for subsequent legal filings or licensing agreements between Merck & Co. and Halozyme Therapeutics that might restore access to the drug.
Further reading
For more on the regulatory and patent landscape of medical innovations, visit the Biotech section.
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