On April 24, 2025, Halozyme, Inc. (“Halozyme”), a biotechnology company notably developing innovative drug delivery technologies, filed a patent infringement lawsuit against pharmaceutical giant Merck Sharp & Dohme Corp. (“Merck”) in the U.S. District Court for the District of New Jersey. 

Halozyme alleges that Merck has used its proprietary subcutaneous drug delivery technology based on human hyaluronidase, also referred to “MDASE” hyaluronidase technology, to develop a subcutaneous formulation of Merck’s cancer medicine Keytruda, without its permission. According to Halozyme, Merck is infringing upon no less than 15 patents protecting its MDASE technology. 

Halozyme further claims that Merck is knowingly infringing upon these patents, pointing out that it had previously approached Merck to start licensing discussions, but that Merck ultimately failed to secure a commercial license for the disputed technology and proceeded without it.

Keytruda’s subcutaneous formulation has completed phase 3 clinical testing and is slated for launch commercially in 2025. However, Halozyme’s legal action—particularly if the court grants injunctive relief—could jeopardize these plans and delay market entry.

Reference Materials:

1. HALOZYME, INC. v. MERCK SHARP & DOHME CORP. 2:2025cv03179 | U.S. District Court for the District of New Jersey | Justia (consulted on May 11, 2025)；
2. Halozyme Therapeutics, Inc. - Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation (consulted on May 11, 2025)；
3. Halozyme sues Merck over subcutaneous Keytruda (consulted on May 11, 2025).