Dutch Court Rejected Merck Mavenclad Patent Extension
The ruling confirms that secondary medical uses of established drugs do not qualify for supplemental patent protection.
Updated on Oct. 1, 2026 in Biotech
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The District Court of The Hague has dismissed Merck's appeal to secure a supplementary protection certificate for its drug Mavenclad. The court determined that because the active ingredient, cladribine, was previously authorized for other medical treatments, it does not meet the necessary criteria for new protection.
Why it matters
This decision reinforces a restrictive standard for pharmaceutical intellectual property in the European Union, limiting the ability of companies to extend patent exclusivity for existing active ingredients repurposed for new therapeutic uses.
The ruling applied the interpretation of Article 3(d) of the SPC Regulation established in the 2020 Santen ruling, which mandates that prior marketing authorization of an active ingredient bars subsequent certificates. The court declined to refer the case to the Court of Justice of the European Union, citing existing legal clarity.
The players
Merck
A multinational pharmaceutical and chemical company focusing on healthcare, life science, and electronics.
District Court of The Hague
A judicial body in the Netherlands responsible for adjudicating complex patent and intellectual property disputes.
Court of Justice of the European Union
The judicial branch of the European Union that ensures EU law is interpreted and applied consistently across all member states.
German Federal Patent Court
A specialized German court that hears patent disputes and legal referrals concerning industrial property rights.
The details
The court focused on the definition of 'first marketing authorization' for the active ingredient, cladribine. By applying the CJEU's Santen ruling—a decision that restricted the scope of supplementary protection certificates to cases involving the first authorization of a product—the court concluded that Mavenclad's prior use in leukemia treatments invalidated the company's claim for extended exclusivity. The court denied a request for a preliminary reference, noting that the case law is settled regarding these protections.
Timeline
2012: The CJEU issued the Neurim case judgment.
2017: Marketing authorization was granted for Mavenclad.
2020: The CJEU established the Santen ruling.
2026: The District Court of The Hague issued the ruling.
The Tech Race
This ruling aligns with a series of restrictive judicial interpretations across Europe, including a similar rejection by the United Kingdom Court of Appeal. It follows the precedent established by the 2020 Santen ruling, narrowing the competitive runway for companies seeking to monetize legacy molecules through new secondary indications.
The decision provides legal clarity for the pharmaceutical market by preventing extensions on older active ingredients used in new therapies. This may accelerate the availability of generic or alternative treatments for patients once primary patent protections for those molecules expire.
The takeaway
The court's decision establishes a firm boundary against using supplemental certificates to extend patent life for existing drugs. Stakeholders should monitor the German Federal Patent Court's upcoming guidance from the CJEU to see if veterinary-human overlap cases offer a different legal path.
Further reading
For broader analysis on pharmaceutical patent law, visit Biotech.
Source note: This article includes information reported by Pinsent Masons.
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