Halozyme wins EU injunction on Keytruda SC

Syringe and cancer drug vial in clinic, illustrating EU injunction on subcutaneous PD-1 therapy tied to HALO

Key Points

01Dutch patent court rules Keytruda SC infringes Halozyme (HALO) patent
02Injunction halts Keytruda SC supply in eight European countries
03MSD BV barred from allowing use of its EU marketing authorization for Keytruda SC in ways that would infringe Halozyme’s patent
04Intravenous Keytruda not affected and remains available

Dutch court rules on Halozyme–Merck patent dispute

A specialized patent court in The Hague has determined that Merck’s (MRK) subcutaneous formulation of Keytruda, known as Keytruda SC, infringes Halozyme’s (HALO) European patent EP 2,797,622. The patent covers MDASE technology, which is used in subcutaneous drug delivery. Following its finding of infringement, the court issued an injunction targeting Merck’s (MRK) European operations connected to the product.

The decision focuses specifically on Merck’s central European marketing authorization holder and packaging and distribution hub, MSD BV. The court rejected Merck’s attempt to challenge the validity of the EP 2,797,622 patent, concluding that the patent remains in force and enforceable against Keytruda SC.

Scope of the injunction across European markets

Under the injunction, MSD BV must refrain from manufacturing, offering, placing on the market, using, importing, or stocking Keytruda SC for these purposes in eight European countries. The affected markets are Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. This order effectively stops the launch or further distribution of Keytruda SC in these territories through MSD BV.

The injunction also forbids MSD BV from otherwise distributing Keytruda SC in these countries. By targeting the central authorization holder and distribution hub, the court’s order addresses the key logistical and regulatory channels for the subcutaneous product in the region.

Restrictions on MSD BV’s role and authorizations

Beyond direct sales and distribution, the court explicitly bars MSD BV from facilitating infringement of the EP622 patent by its affiliates. This includes prohibiting MSD BV from allowing use of its European marketing authorization for Keytruda SC in ways that would infringe the patent. The ruling therefore extends beyond physical handling of the product to include regulatory and authorization-based support.

By addressing both the commercial and facilitative roles of MSD BV, the injunction is designed to limit potential workarounds that might enable Keytruda SC to reach the restricted markets through the same authorization framework.

Status of intravenous Keytruda and patient access

The court’s order applies only to the subcutaneous formulation of Keytruda. The intravenous version of Keytruda is not covered by the EP 2,797,622 patent and is not subject to the injunction. As a result, the IV formulation remains available to patients in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.

This distinction preserves access to Keytruda through its established intravenous route of administration in the affected countries, while limiting the rollout of the newer subcutaneous option where it is found to infringe Halozyme’s patent.

Key Takeaways

01The ruling confirms the enforceability of Halozyme’s EP622 patent against Merck’s subcutaneous Keytruda in key European markets.
02By targeting MSD BV’s manufacturing, distribution and authorization roles, the injunction restricts multiple pathways for Keytruda SC to enter eight European countries.
03Only the subcutaneous formulation is affected, leaving intravenous Keytruda available and preserving ongoing patient treatment options in the impacted markets.

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