Core Viewpoint - Halozyme Therapeutics has filed a patent infringement lawsuit against Merck, alleging that Merck's development of subcutaneous Keytruda infringes on Halozyme's patented MDASE technology [1][2][5] Company Overview - Halozyme is a biotechnology company that specializes in subcutaneous drug delivery using human hyaluronidase, with a focus on improving patient outcomes through innovative drug delivery solutions [1][6] - The company has developed the ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of therapeutic drugs, and has partnered with major pharmaceutical companies to enhance patient experiences [6][8] Patent Infringement Details - Halozyme claims that Merck has used its MDASE technology without permission to develop subcutaneous Keytruda, which has completed phase 3 clinical testing and is expected to launch in 2025 [2][3] - The lawsuit seeks damages and injunctive relief to prevent Merck from launching SC Keytruda, as Halozyme believes Merck is aware of the infringement [5][6] Research and Development - Halozyme's patents stem from extensive research involving nearly 7,000 modifications to human hyaluronidases, which enable rapid subcutaneous administration of therapeutic drugs [4] - The company's innovations in hyaluronidases represent significant advancements in the field, providing a roadmap for enhancing drug delivery mechanisms [4] Legal Context - Halozyme's Chief Legal Officer stated that Merck's actions indicate a clear infringement of Halozyme's patents, and the lawsuit aims to enforce these rights without affecting Halozyme's existing ENHANZE® licensing program [5][6]
Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation