Halozyme sues Merck over subcutaneous Keytruda as licensing talks fall through

Title

Halozyme Files Patent Lawsuit Against Merck Over Subcutaneous Keytruda After Licensing Talks Collapse

Keywords

• Halozyme
• Merck
• Keytruda
• Subcutaneous drug delivery
• Patent infringement
• Licensing dispute
• MDASE technology
• Hyaluronidase
• Immunotherapy
• Biotech litigation

Key Facts

- Lawsuit Filed:
On April 24, 2025, Halozyme Therapeutics sued Merck in U.S. District Court in New Jersey, alleging that Merck’s subcutaneous formulation of Keytruda infringes several of Halozyme’s patents related to its MDASE subcutaneous delivery technology5.

- Patent Basis:
Halozyme claims its patents, filed since 2011, cover innovations in rapid, high-volume subcutaneous drug delivery using human hyaluronidase, a technology it says Merck used without authorization in developing subcutaneous Keytruda5.

- Damages and Injunction Sought:
Halozyme is seeking monetary damages and a court injunction to block Merck from further infringement and to halt the launch and commercial sale of subcutaneous Keytruda in the U.S.5.

- Failed Licensing Talks:
The lawsuit follows failed negotiations between the two companies over potential licensing of Halozyme’s proprietary technology for subcutaneous delivery5.

- Subcutaneous Keytruda Development:
Merck has completed phase 3 clinical testing of subcutaneous Keytruda (pembrolizumab), which demonstrated non-inferior efficacy and faster administration compared to the intravenous form41. The subcutaneous version is intended to improve patient convenience by reducing treatment times—from about 30 minutes for IV administration to 2–3 minutes for subcutaneous injection34.

- Industry Impact:
The dispute comes as Merck aims to expand access for its $25 billion-per-year blockbuster Keytruda by offering a quicker, more accessible subcutaneous option, following similar moves in the pharma industry4.

- Statements:
Halozyme’s CEO Dr. Helen Torley stated the lawsuit was necessary to protect the company’s innovation, emphasizing the patient benefits of their technology5.

Sources:

1. https://www.merck.com/news/mercks-investigational-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-demonstrates-noninferior-pharmacokinetics-compared-to-intravenous-iv-keytruda-pembrolizumab-in-pivotal/

3. https://www.fiercepharma.com/pharma/merck-lays-out-subcutaneous-keytruda-data-lung-cancer-amid-patent-brawl-halozyme

4. https://www.fiercepharma.com/pharma/chasing-roche-merck-scores-phase-3-trial-subcutaneous-keytruda

5. https://www.prnewswire.com/news-releases/halozyme-sues-merck-for-patent-infringement-over-subcutaneous-keytruda-formulation-302437331.html