Halozyme Therapeutics, a leading biotechnology company which is specialized in the development of innovative drug delivery systems, has raised serious infringement issue regarding the latest iteration of Merck’s blockbuster cancer treatment, Keytruda. A report published by the Wall Street Journal on Wednesday, March 5, 2025 says that Halozyme has formally accused Merck of infringing on its patents with the new version of the cancer immunotherapy drug.
Basically, the dispute moves around the use of Halozyme’s proprietary technology in drug delivery. Halozyme has developed a platform known as ENHANZE, which uses the enzyme hyaluronidase to facilitate the delivery of injectable biologic therapies. The technology helps in enhancing the absorption and distribution of drugs, enabling patients to receive their medications more efficiently with the help of fewer injections. The company has licensed this technology to multiple pharmaceutical partners, including Merck.
Keytruda, Merck’s most successful immuno-oncology drug, is used in the treatment of various cancers, including lung, melanoma, and head and neck cancers. The drug works by inhibiting the PD-1 protein, which prevents the immune system from attacking cancer cells. Keytruda has become one of the highest-grossing cancer drugs globally, generating billions of dollars in revenue for Merck.
Although Keytruda has been available in its original formulation for years, Merck has recently introduced a new version designed to improve its dosing and delivery system as per patient convenience and to reduce the frequency of treatment. This new formulation, which involves a subcutaneous (under-the-skin) injection rather than an intravenous infusion, is said to incorporate Halozyme’s ENHANZE technology.
The patent dispute has raised significant concerns in the biotech and pharmaceutical industries, especially given the high stakes involved. Keytruda’s success has made it one of the most critical cancer therapies in the world, and any disruption to its continued availability or distribution could have far-reaching effects for both Merck and its patients. On the other hand, Halozyme’s potential legal victory could lead to lucrative compensation or even the suspension of Merck’s new Keytruda formulation.
However, both Halozyme and Merck have yet to provide formal public comments on the matter and spokespeople for the companies declining to offer further details beyond confirming their awareness of the issue.
This case highlights the broader importance of intellectual property protection and the intense scrutiny surrounding the use of cutting-edge technologies in the rapidly evolving world of drug development. The outcome of this dispute will likely have long-term ramifications for both companies and the pharma industry at large.
