- Halozyme (HALO, Financial) files a patent infringement lawsuit against Merck over MDASE technology used in Keytruda SC formulation.
- The litigation comes as Merck plans to launch SC Keytruda in 2025, post phase 3 trials.
- Halozyme's ENHANZE® licensing program remains unaffected by this lawsuit.
Halozyme Therapeutics (NASDAQ: HALO) has initiated a legal battle against pharmaceutical giant Merck, alleging that Merck's subcutaneous Keytruda formulation infringes on multiple patents owned by Halozyme. Filed in the U.S. District Court in New Jersey, the lawsuit is centered on the unauthorized use of Halozyme's MDASE technology, a pioneering advancement in subcutaneous drug delivery.
Keytruda, Merck's flagship cancer medication, has completed phase 3 clinical testing and is slated for a 2025 market release. Halozyme claims that despite being aware of the MDASE patents, Merck proceeded with developing the SC formulation without a license. Halozyme seeks both damages and injunctive relief to halt the product's launch.
Halozyme's MDASE technology, developed through extensive research entailing nearly 7,000 modifications to human hyaluronidases, offers rapid, high-volume subcutaneous drug delivery, significantly improving patient treatment experiences. The company emphasizes that this legal action will not disrupt its ENHANZE® licensing program or its associated revenue streams.
Halozyme's robust patent portfolio reflects its commitment to safeguarding its intellectual assets. The outcome of this lawsuit could lead to potential damages or forced licensing agreements for Merck, presenting a significant financial upside for Halozyme, while reinforcing its reputation for defending its proprietary technologies.
