Court Bars Merck Keytruda SC in Eight Countries

On October 7, 2026, the specialized Dutch patent court of the Hague ruled that Merck infringed Halozyme’s MDASE patent EP 2,797,622 (EP622) with subcutaneous Keytruda SC. It ordered MSD BV to stop manufacturing, offering, placing on the market, using, importing, or stocking the product in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands, and barred facilitating infringement by affiliates, including use of the European Marketing Authorization. The court rejected Merck’s invalidity argument. A Merck spokesperson said: “We consider Halozyme's patent to be invalid globally and its allegation of infringement to be without merit” and “We are evaluating next steps but are confident in our overall legal position and believe that, ultimately, we will prevail in the courts.” Halozyme’s Mark Snyder said the company was “very pleased the Dutch court recognized the validity and infringement of Halozyme's MDASE patent EP622” and that the technology took “years of rigorous research.” Patients still have IV Keytruda. Halozyme won a German preliminary injunction on December 4, 2025, and is suing in New Jersey over 15 patents from 2011. Keytruda Qlex/SC uses Alteogen’s berahyaluronidase alfa; Halozyme Enhanze partners are unaffected. Stock rose 2%; H.C. Wainwright’s Mitchell Kapoor reiterated Buy and a $115 target.