STAT+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda

Merck, as it prepares a new version of its cancer blockbuster Keytruda, gets a boost in its patent dispute with Halozyme Therapeutics.

Jun 4, 2025 - 17:40
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STAT+: Merck gets lift from U.S. patent office in battle over injectable form of Keytruda

In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.

The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year, lapses in 2028.

At issue before the PTO are certain enzymes called Mdase that Halozyme developed to enable the administration of drugs by injection. Last November, Merck petitioned the PTO to reconsider seven patents that were awarded to Halozyme, arguing they were overly broad and should not have been granted. The filing came a few months after the PTO granted one patent in particular.

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