Dutch court blocks Merck’s subcutaneous Keytruda in eight European markets
On Oct. 7, 2026, a Dutch patent court found that Merck infringed Halozyme’s EP622 MDASE patent and ordered MSD BV to stop making, supplying, marketing or importing the subcutaneous Keytruda formulation across eight European markets. The court rejected Merck’s challenge to the patent’s validity. Intravenous Keytruda is outside the order, while Halozyme is pursuing related litigation against Merck in Germany and the United States.
Why it matters
The ruling prevents Merck from commercializing the subcutaneous formulation in the affected markets unless the decision is changed, while leaving its intravenous product available there. For Halozyme, the decision reinforces its ability to enforce the MDASE patent, but the materials do not quantify any resulting revenue change.
Key facts
- 1The Dutch court held that Merck infringed Halozyme’s EP 2,797,622 patent and directed MSD BV to halt activities involving the subcutaneous Keytruda product in eight European markets. prnewswire.com
- 2The ruling does not restrict patients’ access to intravenous Keytruda. prnewswire.com
- 3Halozyme previously obtained a preliminary injunction against Merck’s launch of the same formulation in Germany on December 4, 2025. prnewswire.com
- 4Merck’s intravenous Keytruda generated $7.9 billion in Q2, while the subcutaneous version contributed $463 million. biospace.com
Open questions
- The materials do not establish whether Merck has formally appealed the Dutch ruling or obtained any stay of the order.
Summary written by AlphAI AI Desk from 20 of 20 sources. Not investment advice. Figures are as stated by the linked sources.