The Hague upholds sales ban on Vivanta’s generic safinamide product

At a November hearing, the District Court The Hague issued a provisional injunction ordering the Czech company Vivanta to cease distribution of its generic safinamide products in the Netherlands and announced penalties for non-compliance. Vivanta complied and withdrew its products from the Dutch market.

Just before Christmas, the court followed up with a main decision in the PI case. The judges held the SPC prima facie valid and ruled that generic safinamide products potentially infringed it. They upheld the injunction prohibiting the marketing of generic safinamide products in the Netherlands and ordered the recall of already supplied generics as well as removal from the G-Standaard listing. The court also required Vivanta to disclose obligations regarding customers, suppliers and stock in a limited scope (case ID: C/09 693949 / KG ZA 25-1072).

Vivanta has since filed an appeal against the PI with the Court of Appeal The Hague.

Newron’s winning streak

Newron is engaged in a multi-jurisdictional battle defending its Parkinson’s treatment Xadago — so far with considerable success. In the Netherlands, the Italian pharmaceutical company is defending its SPC (NL) 300752, which derives from EP 161 329. While the latter expired in spring 2024, the SPC for safinamide remains valid until 7 April 2029.

Italian pharmaceutical company Zambon markets the drug on behalf of Newron. According to its 2024 annual report, Newron received licence fees of €6.9 million from Zambon for Xadago that year, partly from existing SPCs in several European countries.

Competitor Vivanta, a Czech company belonging to the Indian MSN group, obtained Dutch marketing authorisation for generic safinamide products named Safinamide Vivanta on 7 April 2025. The company arranged for inclusion of its products in the G-Standaard (Z-Index) from November 2025 and had already offered its product to wholesalers, intending to market it from 1 November 2025. The District Court The Hague halted these plans with its first provisional injunction.

Patent disputes over safinamide are also pending in other European countries. For example, infringement proceedings based on Newron’s EP 2 474 521 are ongoing in Germany, where the Munich Regional Court granted a preliminary injunction against competitor Puren in September last year. In October, the Federal Patent Court upheld Newron’s patent. However, in the UK, Newron failed in its attempt to defend a crucial safinamide patent EP 1 613 296 in early 2024.

Italian lead

In the Netherlands, the team from Hoyng ROKH Monegier consisting of Peter van Schijndel, Akiva Friedmann and Rosalie ten Wolde led the proceedings for the Italian patent holder.

The coordination of Newron’s defence in Europe lies with litigator Daniela Ampollini of Trevisan & Cuonzo and patent attorney Silvia Bertuccio of TCBM. The in-house counsel are Elena Barbanti for Newron, and Roberta Morelli and Rosella De Dominicis for Zambon.

Vivanta was represented by an Amsterdam-based CMS team led by Jeroen Boelens, Lauren Delleman and Susanne Bijvank, and including Jesper Vrielink.