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Halozyme wins court order to block Merck's injected Keytruda in select European markets - Finance news and analysis from Global Banking & Finance Review
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Halozyme wins court order to block Merck's injected Keytruda in select European markets

Published by Global Banking & Finance Review

Posted on October 7, 2026

2 min read

· Last updated: October 7, 2026

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Halozyme Blocks Merck's Injectable Keytruda in 8 European Markets After Patent Ruling

Patent Dispute and Market Impact

Oct 7 (Reuters) - Biopharma company Halozyme said on Wednesday that a Dutch patent court ruled in its favor against Merck, ordering the drugmaker to halt the manufacture and sale of injectable Keytruda in eight European markets.

Details of the Dutch Court Ruling

Here are some details:

Patent Infringement Findings

• Halozyme said a specialized Dutch patent court in The Hague found that Merck had infringed one of its patents covering MDASE, Halozyme's technology for rapid, high-volume under-the-skin drug delivery.

Markets Affected by the Injunction

• The court ordered Merck to stop the production and sale of injectable Keytruda in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.

Keytruda SC and Growth Strategy

• The drugmaker has been counting on the simpler-to-use subcutaneous version of the drug, known as Keytruda SC, to help drive growth as key patents on its original intravenous version expire later in the decade.

Merck's Response and Next Steps

Merck's Statement

• "We strongly disagree with the Dutch court's decision to grant a cross-border injunction. We consider Halozyme's patent to be invalid globally and its allegation of infringement to be without merit," a Merck spokesperson said in a statement.

Future Actions

• The company said it is evaluating next steps.

Additional Legal Proceedings

U.S. Patent Lawsuit

• Halozyme has also sued Merck for patent infringement in the US, alleging the under-the-skin formulation of Keytruda infringes 15 patents that Halozyme has filed since 2011.

German Injunction

• The company sued Merck in Germany and was granted a preliminary injunction last year, stopping Merck's launch of Keytruda SC in Germany.

Reporting Credits

(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)

Key Takeaways

  • A Dutch patent court in The Hague ruled on October 7, 2026 that Merck infringed Halozyme’s EP 2 797 622 MDASE patent and ordered a cross‑border injunction across eight markets: Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands. (Sources: Turner‑0search0, Turner‑0search11)
  • Merck’s arguments challenging the validity of the patent were rejected in this ruling. The injunction prohibits manufacturing, marketing, importing and facilitating Keytruda SC via MSD’s EU marketing authorization; however, the intravenous version of Keytruda remains available. (Sources: Turner‑0search0, Turner‑0search11)
  • This decision follows a prior preliminary injunction in Germany in December 2025, and Halozyme is pursuing parallel litigation in the U.S., alleging infringement of multiple MDASE patents by Merck’s subcutaneous Keytruda (marketed as QLEX). (Sources: Turner‑0search5, Turner‑0search4, Turner‑0search0)

Frequently Asked Questions

Why did Halozyme win a court order against Merck?
A Dutch patent court found that Merck had infringed Halozyme's patent covering its drug delivery technology, ordering a halt of Keytruda SC sales in select markets.
Which countries are affected by the court order blocking Keytruda SC?
The court order affects Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands.
What technology is at the center of the Halozyme and Merck dispute?
The dispute centers on Halozyme's MDASE technology for rapid, high-volume under-the-skin drug delivery.
Is Merck planning to appeal the Dutch court decision?
Merck has stated that it strongly disagrees with the decision and is evaluating its next steps.
Has Halozyme taken legal action against Merck in other countries?
Yes, Halozyme has sued Merck for patent infringement in the US and Germany, with a preliminary injunction granted in Germany last year.

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