Astellas and Hoyng ROKH successfully defend Xtandi in the Netherlands

Generic drug companies cannot launch their enzalutamide products in the Netherlands. In the pan-European dispute over prostate cancer drug Xtandi, the District Court The Hague upheld a basic patent and SPC protecting the active ingredient enzalutamide.

The patent owner, The Regents of the University of California, and its exclusive sub-licensee Astellas so far have had considerable success throughout Europe in defending their Xtandi-related patents. The UK High Court and the German Federal Patent Court previously upheld patents relating to the active ingredient enzalutamide. Earlier this year, the Dutch court also upheld formulation patent EP 3 725 778.

The District Court The Hague has now dismissed nullity suits filed by Accord Healthcare and Sandoz against basic patent EP 1 893 196 and its Dutch SPC 300632 (case IDs: 23-903 and 23-904). EP 196 remains in force until 29 March 2026, with the respective SPC extending protection in the Netherlands until 25 June 2028.

Sandoz and Accord disputed the priority claims of EP 196, since the lead compound — then known as RD 162 — had already been published at a conference before the patent was filed. They argued that the slightly altered version of RD 162 as claimed in EP 196 B2 is not disclosed therein. The court did not follow this argument.

It is not yet known if the generic drug companies will appeal the decision. However, in the case of the formulation patent EP 778, Sandoz and Accord filed an appeal against the Dutch decision that was handed down earlier this year. In the UK, an appeal against the High Court ruling from October 2024 regarding EP 196 is pending.

The District Court The Hague has taken its time with its ruling on EP 196. After the oral hearing in June 2024, the court planned to hand down the decision in October of the same year but then postponed it several times until now.