Halozyme Wins Preliminary Injunction Against Merck's Keytruda SC in Germany

Core Viewpoint - Halozyme Therapeutics has secured a preliminary injunction from a German court against Merck, preventing the distribution of Keytruda SC in Germany due to patent infringement concerns related to Halozyme's MDASE™ technology [1][2]. Legal Developments - The Munich Regional Court identified imminent infringement of Halozyme's European Patent No. 2 797 622 (EP 622) by Merck's Keytruda SC, leading to the injunction [2]. - Merck has initiated separate nullity proceedings against the patent in August 2025, which are currently pending [2]. - Halozyme is confident that the injunction will withstand any potential appeal by Merck [2]. Patient Access - Patients will still have access to the intravenous (IV) version of Keytruda, which is not affected by the injunction or Halozyme's patent [3]. Company Statements - Halozyme expressed satisfaction with the court's decision, emphasizing the validity of its MDASE patents and its commitment to defending them [4]. - The company is also pursuing patent infringement claims against Merck in the U.S. federal district court, alleging that the subcutaneous formulation of Keytruda marketed as QLEX infringes 15 of Halozyme's patents [4]. Patent and Technology Overview - The MDASE™ patents are distinct from Halozyme's ENHANZE licensing program, meaning the outcome of the lawsuit will not affect ENHANZE or its associated revenues [5]. - Halozyme's MDASE technology is based on extensive research into human hyaluronidases, which facilitate rapid subcutaneous drug delivery [4]. Company Profile - Halozyme is a biopharmaceutical company focused on innovative drug delivery solutions, with its ENHANZE technology having impacted over one million patients globally [6][7]. - The company is also developing Hypercon™, a microparticle technology aimed at enhancing drug concentration and delivery methods [8].