STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

stat+:-merck-suffers-a-setback-in-europe-over-its-new-keytruda-formulation

By Ed Silverman

Oct. 7, 2026

Pharmalot Columnist, Senior Writer

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

In a setback for Merck, a Dutch court ruled that the company infringed on a patent pertaining to a subcutaneous formulation of its Keytruda cancer treatment and was ordered to halt manufacturing and marketing of the medication in several European countries, including France, Italy, Sweden, Switzerland, and the Netherlands.

The ruling came as part of a widening patent infringement dispute with Halozyme Therapeutics over the best-selling cancer treatment. Patients requiring Keytruda will still have access to the existing intravenous version, which is not affected by the patent dispute or court order.

In a statement, Merck said it “strongly” disagreed with the court’s decision.

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