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Halozyme wins Dutch ruling against Merck's subcutaneous Keytruda: the eight markets where Keytruda SC is now blocked

The Hague found Merck's under-the-skin Keytruda infringes Halozyme's EP 2,797,622 patent, upheld the patent and barred the product in eight markets. Intravenous Keytruda is unaffected.

Published in ET: Feed time in ET: Legal HALO
  • The District Court of The Hague found Merck's subcutaneous Keytruda infringes Halozyme's patent EP 2,797,622 and rejected Merck's invalidity arguments, Halozyme said on October 7, 2026.
  • MSD BV must stop making, marketing, importing and stocking Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands; intravenous Keytruda is unaffected.
  • Germany has been covered by a separate preliminary injunction since December 4, 2025, while in the US the patent board invalidated Halozyme's US 11,952,600 patent in May 2026.
HALO Halozyme wins Dutch ruling against Merck's subcutaneous Keytruda: the eight markets where Keytruda SC is now
MoveSurge publish 08:30:25 ET
MoveSurge publish
08:30:25 ET
110.56 110.21 109.86 109.51 110.32 08:30 08:30 08:48
Real 1-minute OHLC candles around publish time. Chart times are New York ET; validated market data captured by MoveSurge.

Reaction by asset (real prices)

Asset2m beforeAt release+1m+10m+1m %+10m %
HALO 111.40 111.40 111.40 111.81 0.00% +0.37%

Halozyme Therapeutics (Nasdaq: HALO) said on Wednesday, October 7, 2026 that the District Court of The Hague found Merck's subcutaneous Keytruda infringes Halozyme's European patent EP 2,797,622 and ordered Merck's Dutch subsidiary, MSD BV, to stop manufacturing, offering, marketing, importing and stocking the product in eight markets: Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. The court also rejected Merck's argument that the patent is invalid. The news first reached the MoveSurge news feed at 08:30:25 ET, before the market opened; HALO was at $111.40 when a second report crossed at 09:27:33 ET, three minutes before the opening bell, and traded 0.88% higher at $112.38 fifteen minutes later. The MoveSurge reaction reading, taken ten minutes after that report, had HALO 0.37% higher at $111.81.

The order applies only to the under-the-skin version of Keytruda, which Merck sells in the US as Keytruda Qlex. Intravenous Keytruda is outside both the patent and the injunction, so patients in those countries keep access to the drug. The court also barred MSD BV from facilitating infringement by its affiliates, including by letting them use its European marketing authorization, the regulatory approval the subcutaneous product is sold under.

Merck's own shares barely moved: MRK was 0.1% higher a minute after a later report of the ruling reached the MoveSurge news feed at 09:39:19 ET.

Merck's subcutaneous Keytruda, court by court

CourtDatePatentOutcome
Munich Regional CourtDecember 4, 2025EP 2,797,622Preliminary injunction against Keytruda SC in Germany
US Patent Trial and Appeal BoardMay 12, 2026US 11,952,600All remaining claims held invalid for lack of enablement and written description
District Court of The Hague, preliminary reliefJuly 2026EP 2,797,622Halozyme's request to bar the product in Denmark and Sweden before the main case rejected
District Court of The Hague, main proceedingsAnnounced October 7, 2026EP 2,797,622Infringement found, validity upheld, injunction in eight markets

How one Dutch case reached eight countries

A European patent is a bundle of national patents, one for each country where it is validated. Merck's subsidiary opened the Dutch case itself, asking the court to declare that it did not infringe EP 2,797,622 and to revoke the Dutch part of the patent. Halozyme answered with cross-border infringement counterclaims covering every country where the patent is in force except Germany, which has its own proceedings. Because MSD BV is the Dutch company that holds Merck's central European marketing authorization, a single Dutch judgment against it could reach Belgium, France, Italy and the other markets in the order.

The July hearing on preliminary relief went the other way. The same court refused to bar the product from Denmark and Sweden while the main case was pending, finding that a statement in Merck's pleadings was not a binding promise Halozyme could rely on. The main proceedings, heard at the end of July, have now produced the injunction Halozyme failed to get on an interim basis. EP 2,797,622 runs until December 2032.

The US patent fight runs on a different track

In the US, Merck has attacked Halozyme's patents on modified hyaluronidase, the enzyme family Halozyme calls MDASE, at the Patent Trial and Appeal Board. On May 12, 2026 the board invalidated US Patent No. 11,952,600, finding that its claims were not supported by enough description to show how to make and use the full range of enzymes they covered. Merck filed review petitions against 14 more Halozyme patents between November 2024 and November 2025; the board instituted 13 of them and denied the last on May 15, 2026, and Merck filed three further petitions in March 2026. The American and European rulings concern different patents with different claims, so the US board's decisions do not bind the European courts.

What did the Dutch court rule in Halozyme v. Merck?

The District Court of The Hague found that Merck's subcutaneous Keytruda infringes Halozyme's European patent EP 2,797,622, rejected Merck's invalidity arguments and ordered MSD BV to stop making, marketing, importing and stocking the product in eight markets. Halozyme announced the ruling on October 7, 2026.

Which countries does the Keytruda SC injunction cover?

Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. Germany has been covered separately by a preliminary injunction from the Munich Regional Court since December 4, 2025.

Is intravenous Keytruda affected by the ruling?

No. The patent and the injunction cover only the subcutaneous formulation, so intravenous Keytruda remains available in all of those countries.

How did Halozyme stock react to the Keytruda ruling?

HALO was at $111.40 when a report of the ruling reached the MoveSurge news feed at 09:27:33 ET, three minutes before the open, and traded 0.88% higher at $112.38 fifteen minutes later. Merck shares were little changed.

Sources

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