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EP622 patent canceled in U.K. and invalidated in U.S., yet upheld and deemed infringed in the Netherlands.
MSD refutes the ruling, asserting global patent invalidity; Merck shares rise 0.6% despite the legal setback.
The global patent dispute surrounding Alteogen’s (196170) subcutaneous (SC) delivery platform, ALT-B4, has hit a new point of contention following contradictory rulings in Europe and the United States. In an unusual turn of events, a Dutch court has declared a patent valid and infringed by Keytruda SC—a patent that Halozyme had previously consented to cancel in the United Kingdom.
In the United States, MSD has secured a series of victories in invalidation trials against Halozyme’s MDASE-related patents. Within Europe, the legal landscape has become increasingly fragmented, with U.K. and Dutch courts reaching diametrically opposed conclusions regarding the same EP622 patent.
According to reports from Halozyme and foreign media on the 8th, the District Court of The Hague in the Netherlands ruled that MSD infringed upon Halozyme’s European patent EP 2,797,622 (EP622). The court also dismissed MSD’s claims that the patent was invalid.
Consequently, an injunction was issued against MSD BV—the entity holding the company’s European marketing authorizations—ordering it to cease the manufacturing, sale, importation, and inventory stocking of Keytruda SC across eight countries, including the Netherlands, Belgium, Denmark, France, Ireland, Italy, Sweden, and Switzerland.
EP622 Canceled in the U.K., Yet Upheld and Infringed in the Netherlands
In contrast, the Dutch court recognized the validity of the same European patent (EP622) as it pertains to the Netherlands, ruling that the application of ALT-B4 in Keytruda SC constitutes an infringement. This results in a scenario where, despite sharing a common origin, the same patent is considered defunct in the U.K. while remaining both valid and enforceable in the Netherlands.
These disparate outcomes stem in part from differences in the specific legal arguments and evidentiary processes presented in each jurisdiction. While the U.K. proceedings concluded before a full assessment of validity and infringement could be rendered due to the patent’s cancellation, the Dutch court conducted a substantive review of both the patent’s validity and the alleged infringement by ALT-B4.
Because European patents are effectively a bundle of national patents, judicial interpretations can vary from country to country. However, given the ongoing string of patent invalidations in the U.S. and the voluntary cancellation of the patent in the U.K., the Dutch ruling represents a significant departure from the recent trend of the global patent battle.
MSD Secures Winning Streak in the U.S. as Halozyme Patents Face Invalidation
The U.S. Patent Trial and Appeal Board (PTAB) has consistently ruled in favor of MSD in invalidation trials targeting Halozyme’s MDASE-related patents. The PTAB has repeatedly found these patents unpatentable, citing failures to meet written description and enablement requirements.
Earlier this month, in case PGR2025-00052, the PTAB issued a final written decision declaring all 17 claims of Halozyme’s U.S. Patent No. 12,264,345 to be unpatentable. With similar decisions in previous Post-Grant Reviews, Halozyme’s related patent portfolio continues to face systemic invalidation in the U.S. market.
The Dutch ruling stands in stark opposition to the outcomes seen in the U.S. and U.K. By affirming the patent’s validity and issuing an injunction covering eight European markets, the ruling presents a distinct disadvantage for both MSD and Alteogen.
MSD Responds with Immediate Refutation; Merck Shares Edge Up 0.6%
MSD has responded sharply to the decision. The company stated that it strongly disagrees with the Dutch court’s cross-border injunction, maintaining that Halozyme’s patent is invalid on a global scale and that the infringement claims are groundless. MSD is currently reviewing further legal options, including an appeal.
Despite the ruling, Merck’s stock price remained resilient. In New York trading on the 7th (local time), Merck closed at $142.79, up 0.60% from the previous session. Shares of Halozyme also rose by approximately 2%. Despite the injunction affecting eight European markets, the market impact on both companies was muted.
Patent disputes in Europe remain ongoing. MSD has been challenging the validity of EP622 in various European nations, and proceedings are currently underway in major markets including Germany. The Dutch ruling is also subject to subsequent legal procedures.
While the Dutch ruling is an unfavorable development for Alteogen and MSD, it is premature to conclude that this dictates the final outcome of the global patent conflict. With invalidation trends persisting in the U.S. and the same patent already canceled in the U.K., the muted market reaction on the day of the ruling suggests that investors are waiting for further developments. As national courts continue to reach conflicting conclusions on the same patent, the upcoming proceedings in the Netherlands and other European jurisdictions will be critical to watch.
