A specialized Dutch patent court has blocked Merck & Co. from manufacturing, selling, or stocking its subcutaneous version of the cancer drug Keytruda in eight European countries, including France and Italy. The October 7, 2026 ruling found Merck infringed Halozyme Therapeutics Inc.'s MDASE drug-delivery patent. The decision deals a major setback to Merck's strategy to transition patients to the injectable formulation before key intravenous patents expire.
The Dutch patent court ruling
- ▪The Dutch patent court found that Merck & Co. infringed a patent covering MDASE, Halozyme Therapeutics Inc.'s technology for rapid, high-volume under-the-skin drug delivery
- ▪A specialized Dutch patent court in The Hague ruled in favor of Halozyme Therapeutics Inc. against Merck & Co. on October 7, 2026
- ▪The Dutch court's October 7, 2026 injunction blocks Merck & Co. from manufacturing, selling, or stocking subcutaneous Keytruda in Belgium, Denmark, France, Ireland, Italy, the Netherlands, Sweden, and Switzerland
Halozyme statements
- ▪Halozyme Therapeutics Inc. issued a statement on October 7, 2026, noting that it has several suits underway against Merck & Co.
- ▪Mark Snyder, the chief legal officer of Halozyme Therapeutics Inc., stated that the company was pleased the Dutch court recognized the validity and infringement of Halozyme's MDASE patent
Other patent disputes between the companies
- ▪Halozyme Therapeutics Inc. has sued Merck & Co. in the United States, alleging that the under-the-skin formulation of Keytruda infringes 15 patents filed by Halozyme since 2011
- ▪Halozyme Therapeutics Inc. previously sued Merck & Co. in Germany and was granted a preliminary injunction in 2025 that stopped Merck's launch of subcutaneous Keytruda in Germany
Debatable claims
- ▪Subcutaneous reformulations of blockbuster drugs primarily serve to delay generic competition
- ▪European courts should not block Merck's subcutaneous Keytruda over patent disputes
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