German Federal Patent Court upholds Newron’s patent for Xadago

Last week, the Federal Patent Court confirmed the validity of Newron’s EP 2 474 521 (case ID: 3 Ni 24/23 (EP)). The patent protects a high-purity form of safinamide used to treat Parkinson’s disease.

The original medication safinamide is sold under the brand name Xadago. Patent holder Newron has licensed distribution to Zambon. According to its 2024 annual report, Newron received licence fees of €6.9 million from Zambon for Xadago last year. These fees stem partly from existing SPCs in several European countries.

Hamburg-based pharmaceutical company Alfred E. Tiefenbacher attempted to invalidate the patent at the Federal Patent Court. The key issue was inventive step. The chamber under presiding judge Walter Schramm upheld the patent but the court has not yet published its reasoning. The plaintiff may appeal the decision.

Infringement proceedings are ongoing in parallel. Recently, Munich Regional Court granted a preliminary injunction against competitor Puren in September.

Further success for Newron

Alfred E. Tiefenbacher retained its long-standing advisor Malte von Seebach of Hamm & Wittkopp for the case at the Federal Patent Court.

Oswin Ridderbusch

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

For coordination of the European proceedings, the company relies on a team from Trevisan & Cuonzo/TCBM, led by Daniela Ampollini and Silvia Bertuccio. They also manage parallel proceedings in other European countries, as well as proceedings concerning the safinamide SPCs, including in the UK.

In-house counsel from both Newron and Zambon attended the hearing. Elena Barbanti is IP Director of Newron. General Counsel Rosella De Dominius and Patent Director Roberta Morelli represented Zambon.