Halozyme wins order blocking Merck's injected Keytruda in some European markets

• The court found Merck infringed Halozyme's MDASE patent covering rapid, high-volume under-the-skin drug delivery technology
• Sales are blocked in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands
• Halozyme has also sued Merck in the US alleging infringement of 15 patents and previously won a preliminary injunction in Germany last year

Summary: Halozyme Wins Injunction Against Merck's Injectable Keytruda in Europe

Key Development:

A Dutch patent court in The Hague ruled in favor of Halozyme against Merck, ordering the pharmaceutical giant to halt manufacturing and sales of its subcutaneous (injectable) version of Keytruda in eight European markets.

Affected Markets:

The injunction covers Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands.

Patent Dispute Details:

• The court found Merck infringed on Halozyme's patent covering MDASE technology, which enables rapid, high-volume subcutaneous drug delivery
• This marks Halozyme's second European victory, following a preliminary injunction granted in Germany last year that already blocked Keytruda SC's launch there
• Halozyme has also filed suit against Merck in the U.S., alleging infringement of 15 patents filed since 2011

Market Implications:

The ruling represents a significant setback for Merck's growth strategy. The company has been relying on Keytruda SC—a simpler-to-administer subcutaneous formulation—to sustain revenue growth as patents on the original intravenous version expire later this decade. The injectable version offers competitive advantages through easier administration compared to traditional IV infusions.

Company Responses:

Halozyme's Chief Legal Officer Mark Snyder expressed satisfaction with the court's recognition of patent validity and infringement. Merck has not yet commented on the ruling.

Bottom Line:

This decision could force Merck to negotiate licensing agreements with Halozyme or develop alternative formulations, potentially impacting Keytruda's commercial trajectory in key European markets and affecting Merck's long-term revenue projections for its blockbuster cancer drug.