Regional Court Munich issues ex parte PIs on SPC for parkinson drug Xadago

The ex parte PIs are a particularly heavy blow for Vivanta Generics, Stadapharm and Aliud Pharma. They already market their generics of drug Xadago with the active ingredient safinamide in Germany.

The dispute revolves around a new Parkinson’s therapy. These drugs attempt to slow down the changes in the brain of Parkinson’s patients, which progress chronically.

Newron and Zambon basic patent EP 1 613 296 already expired in April 2024. The German Patent and Trademarks Office had initially rejected the application for an SPC. This enabled the generic manufacturers to enter the market.

Suprisingly, on 27 April 2026, the 14th Senate of the Federal Patent Court, presided over by Dörte Otten-Dünnweber, granted an SPC for the period from 8 April 2024 through to 7 April 2029 (14 W (pat) 23/24).

Fundamental question on granting of SPC

Based on the SPC, the Munich Regional Court has now surprisingly issued PIs against Vivanta Generics (21 O 3953/26), Stadapharm (21 O 3955/26) and Aluid Pharma (21 O 3954/26) without an oral hearing. At least one of the manufacturers has already lodged an objection.

The Regional Court Munich I has scheduled the hearing with Vivanta Generics for 1 July 2026. According to research by JUVE Patent, no nullity proceedings have yet been filed against the SPC. However, this is likely just a matter of time, as the dispute between the parties revolves around a fundamental question regarding the granting of the SPC. The issue is whether an SPC based on one active ingredient is justified when the basic patent concerns a combination of three active ingredients. The Federal Patent Court had also dealt with the interpretation of the CJEU’s Yeda decision and decided that it was not applicable in this case.

Courts across Europe have ruled differently in the dispute over this SPC: In Sweden, the SPC has been legally invalidated. In Belgium, Spain and the UK, the SPC is currently declared null and void, but appeals are pending. In the Netherlands, however, the Dutch SPC is the subject of nullity proceedings.

Substantial team

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.

In Germany Vivanta Generics is working with its regular advisors around Daniel Hoppe from Bonabry.

Both Stadapharm and Aliud are working with lawyers Jan Phillip Rektorschek and Julia Fischer of Pentarc, together with patent attorney Alexander Wittkopp of Hamm & Wittkopp.