German Federal Patent Court grants SPC for safinamide

On 27 April 2026, the 14th Senate of the Federal Patent Court, presided over by Dörte Otten-Dünnweber, granted an SPC for the period between 8 April 2024 and 7 April 2029 (14 W (pat) 23/24). The presiding judge also works at the UPC.

The German Patent and Trademarks Office had initially rejected the application for an SPC. The decision of the Federal Patent Court overturns this and grants the SPC. The SPC application 12 2015 000 058.4 applies to the basic patent EP 1 613 296 (DE 60 2004 021 790), which expired in April 2024.

Dörte Otten-Dünnweber

In its ruling, the Federal Patent Court also deals with the interpretation of the CJEU’s Yeda decision and deems it not applicable in this case. Specifically, the active ingredient safinamide is protected both alone and in combination with other Parkinson’s drugs. The Federal Patent Court also clarifies that EP 296 protects the use of safinamide even without a combination and applies the two-stage test from the CEUJ decision Teva/Gilead.

New treatment approach

The background to the dispute is a new Parkinson’s therapy using Newron and Zambon’s  drug Xadago. These drugs attempt to slow down the changes in the brain of Parkinson’s patients, which progress chronically.

Parkinson’s disease is caused by the degeneration of dopaminergic neurones in the brain. As a result, the brains of those affected produce too little dopamine. Consequently, more and more nerve cells die off, so that nerve impulses are transmitted increasingly poorly. This results in the motor symptoms typical of Parkinson’s, such as tremors, muscle stiffness and unsteadiness when walking. Medication is used to compensate for this lack of dopamine in the brain. Treatment usually begins with levodopa, although the positive effect diminishes over time. Combination therapies such as Xadago then follow.

Parallel infringement proceedings are pending in Germany and the Netherlands, where Newron and Zambon have been successful to date.

Vossius and Trevisan

Newron assembled a substantial team for the pan-European proceedings. For the German cases, the company works with Vossius & Partner. The team includes patent attorney Oswin Ridderbusch (lead) and lawyers Kai Rüting and Leonie Dißmann-Fuchs.

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. They also manage parallel proceedings in other European countries, as well as proceedings concerning the safinamide SPCs, including in the UK.

Update 6.5.2026: Back in February, the Commercial Section of the Court of First Instance of Valencia had already lifted a preliminary injunction filed by Newron and Zambon against Vivanta and Mabo-Farma. The Spanish court, presided over by Jacinto Talens Sedgu (preliminary injunctive relief LEC 727 1179/2025), thereby overturned the PI issued in November 2025 without a hearing.