Novartis AG v. Glenmark Arnznemittel GmbH, preliminary relief judge District Court The Hague, 27 August 2025, Case no. ECLI:NL:RBDHA:2025:16044
The preliminary relief judge in The Hague held that Novartis’ SPC for eltrombopag (Revolade®) was infringed when Glenmark arranged for its generic eltrombopag to be included in the ‘G-Standaard’ as of 1 September 2025, even though the SPC remains in force until 14 September 2025.
The G-Standaard is the Dutch database containing information on all medicinal products (including medicines, medical devices and homeopathic remedies) that are or may become available in pharmacies. It is maintained by the Dutch Royal Dutch Pharmacists Association (KNMP) and published by Z-Index.
Established case law regards inclusion in the G-Standaard as an ‘offering’ within the meaning of Article 53 of the Dutch Patent Act, and therefore as an infringing act. Glenmark’s argument that the listing covered only the final two weeks of the protection period, and that European developments such as the stockpiling waiver and the proposed extension of the Bolar exemption permit preparatory steps, was dismissed: inclusion in the G-Standaard falls outside these exceptions, and Novartis retains full exclusivity for the entire duration of the SPC.
A copy of the judgment (in Dutch) can be read here.
