Dutch court surprises with swift decision on Newron’s SPC for Xadago

At a hearing at the District Court The Hague, Italian pharmaceutical company Newron defended its SPC for Parkinson’s treatment Xadago. Competitor Vivanta had launched at risk in the Netherlands. The court immediately issued a preliminary injunction.

Unlike in Germany, issuing a preliminary injunction at a hearing is uncommon in the Netherlands. The main decision in the PI case (case ID: C/09 693949 / KG ZA 25-1072) is expected in December.

Newron’s SPC derives from its EP 161 329, which expired in spring 2024. The Dutch Patent Office granted Newron SPC (NL) 300752 for the product safinamide, valid until 7 April 2029.

Italian pharmaceutical company Zambon markets the drug on behalf of Newron under the trade name Xadago, with safinamide as the active substance. According to its 2024 annual report, Newron received licence fees of €6.9 million from Zambon for Xadago last year, partly from existing SPCs in several European countries.

Competitor Vivanta is a Czech company belonging to the Indian MSN group. On 7 April 2025, Vivanta obtained Dutch marketing authorisation for generic safinamide products named Safinamide Vivanta. According to the court’s judgment, Vivanta arranged for inclusion of its products in the G-Standaard (Z-Index) from November 2025, had already offered its product to wholesalers, and intended to market it from 1 November 2025.

The District Court The Hague ruled that Vivanta must cease distribution in the Netherlands and announced penalties for non-compliance.

Patent disputes 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. Most recently, the Federal Patent Court upheld Newron’s patent.

Italian coordination for Newron

Lawyer Daniela Ampollini of Trevisan & Cuonzo and patent attorney Silvia Bertuccio of TCBM are coordinating the defence of Newron’s Parkinson’s drug Xadago.

The in-house counsel are Elena Barbanti for Newron, and Roberta Morelli and Rosella De Dominicis for Zambon.

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

Vivanta was represented by a CMS team led by Jeroen Boelens, Lauren Delleman and Susanne Bijvank, and including Jesper Vrielink.