Dutch Court Rules Merck's Keytruda Subcutaneous Injection Infringes Patent, Sales Banned in Eight Countries
nashnova research
A Dutch court ruled that Merck's subcutaneous Keytruda infringes a Halozyme Therapeutics patent, banning production and sales across eight European markets — a direct blow to Merck's strategy for extending Keytruda's commercial life.
What exactly did the court rule?
The Hague patent court found that Keytruda SC — the subcutaneous formulation — infringes Halozyme's European patent EP 2,797,622.
The injunction covers eight countries: Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands.
A key distinction: the ban applies only to the subcutaneous version. Keytruda IV — the intravenous formulation — is not covered and remains on the market.
What is the broader context?
This is not an isolated case. Halozyme is pursuing global patent enforcement against Merck; last December, a German court issued a preliminary injunction on the same patent.
At the center of the dispute is Halozyme's Enhanze drug-delivery technology — a platform that converts traditional IV drugs into subcutaneous formulations. EP622 protects that technology.
This means → the technical pathway Merck used to develop Keytruda SC does not belong to Merck at the patent level.
Why does Merck need a subcutaneous version so badly?
The reason is straightforward: Keytruda IV's market exclusivity is approaching expiration. Once it lapses, biosimilars will flood in.
The subcutaneous version is Merck's key strategy for extending the product's life cycle — offering patients a more convenient dosing method to fend off generic competition.
In plain terms = the old version is about to "expire," and the new version was meant to buy more time. That path is now blocked across core European markets.
What does this mean for the market?
With injunctions stacking across multiple European countries, Merck's life-extension strategy faces a material obstacle in its core markets.
After the news broke, Merck's share price fell in pre-market trading.
This reflects investor anxiety over Keytruda's revenue outlook — the drug is Merck's single largest revenue source, and any ruling that threatens its lifecycle directly moves the stock.
We are very pleased that the Dutch court has confirmed the validity and infringement of Halozyme's MDASE patent EP622 and issued an injunction preventing Merck from launching Keytruda SC in multiple European markets.
Mark Snyder
Chief Legal Officer, Halozyme Therapeutics
(Statement following the ruling)
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