[Edaily Reporter Kim Jinsoo ] While MSD (Merck) and Halozyme, partners of Alteogen Inc.(196170), are engaged in a patent dispute over technology related to the subcutaneous (SC) formulation of the world’s top-selling drug “Keytruda,” a Dutch district court has also ruled in MSD’s favor.
(Photo: Keytruda Qurex website) According to industry sources on the 23rd, the District Court of The Hague in the Netherlands dismissed Halozime’s application for a preliminary injunction against MSD.
Halozime had requested that “Keytruda Qurex”—the subcutaneous (SC) formulation of the anticancer drug Keytruda—be excluded from the drug price lists in Denmark and Sweden to block its sale until a decision is reached in the expedited main proceedings (VRO), but the court did not grant this request.
At the heart of the dispute is Halozyme’s European patent “EP 2 797 622.” This patent, set to expire in December 2032, is reportedly valid in the Netherlands, Denmark, Sweden, and other countries. MSD received EU marketing authorization for “Keytruda SC,” a product combining Keytruda with Alteogen Inc.’s ALT-B4, but Halozyme claimed that this infringes on its patent.
MSD registered Keytruda SC in the drug pricing databases of various countries through its subsidiaries in Sweden and Denmark, and once sales became possible in Sweden, Halozyme argued that this constituted a binding commitment by MSD or created a legitimate expectation, which would result in direct harm.
However, MSD refuted Halozyme’s claim that it intended to launch the product as quickly as possible in other EU countries, calling it “baseless and inaccurate.”
In response, Judge H.F.R. van Heemstra ruled that even if MSD’s statement were inaccurate, it was merely a litigious position taken to counter Halozyme’s claims and could not be considered an enforceable commitment under Dutch civil law. The court also noted that Halozyme had less extreme options available, such as seeking a preliminary injunction based on the merits of the patent case, and could have directly confirmed MSD’s intent to make such a commitment.
This decision by the Dutch District Court is significant in that it marks another victory for MSD in the ongoing legal battles across Europe. Previously, in 2025, the Munich Regional Court granted Halozime a preliminary injunction blocking the launch of Keytruda SC in Germany, and MSD filed patent invalidation lawsuits against Halozime in Germany, the Netherlands, France, and the United Kingdom.
In the United States as well, Halozyme is litigating in the U.S. District Court for the District of New Jersey, alleging that the subcutaneous injection formulation of Keytruda (known as Qlex in the U.S.) infringes on 15 patents. Oral arguments in the expedited trial are scheduled for July 31.
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