German Federal Patent Court Upholds Newron's Xadago Patent for Parkinson's Disease Treatment
Key Insights
The German Federal Patent Court confirmed the validity of Newron's EP 2 474 521 patent protecting a high-purity form of safinamide (Xadago) for Parkinson's disease (search) treatment.
Newron received €6.9 million in license fees from distribution partner Zambon (search) for Xadago in 2024, stemming partly from existing supplementary protection certificates across European countries.
Munich Regional Court granted a preliminary injunction against competitor Purem in September, while parallel infringement proceedings continue across multiple European jurisdictions.
The German Federal Patent Court has upheld Newron Pharmaceuticals (search)' key patent for Xadago (safinamide), a Parkinson's disease (search) treatment, following a validity challenge by Hamburg-based pharmaceutical company Alfred E. Tiefenbacher (search). The decision reinforces Newron's intellectual property position for the high-purity safinamide formulation across European markets.
Patent Validation Strengthens Market Position
The Federal Patent Court confirmed the validity of EP 2 474 521 under case ID 3 Ni 24/23 (EP), which protects a high-purity form of safinamide used to treat Parkinson's disease (search). The chamber, presiding under judge Walter Schramm, upheld the patent after Tiefenbacher challenged its inventive step. While the court has not yet published its detailed reasoning, the plaintiff retains the right to appeal the decision.
Patent holder Newron has licensed distribution rights to Zambon (search), generating significant revenue from the arrangement. According to Newron's 2024 annual report, the company received €6.9 million in license fees from Zambon for Xadago last year. These fees stem partly from existing supplementary protection certificates (SPCs) in several European countries.
Clinical Significance and Mechanism of Action
The patent centers on safinamide's purity, which is central to the invention's therapeutic value. This active ingredient increases dopamine concentration in the brain, addressing a critical need in Parkinson's disease (search) treatment. Dopamine levels are reduced in Parkinson's patients' brains but are crucial for movement control, making the high-purity formulation clinically significant for patient outcomes.
Ongoing Legal Proceedings
Parallel infringement proceedings are advancing across multiple jurisdictions. Munich Regional Court issued an ex-parte preliminary injunction against Purem on June 17, 2025, under case ID 21 O 7785/25. After Purem lodged an objection, Munich Regional Court under presiding judge Georg Werner heard the case in mid-September and upheld the preliminary injunction.
The case primarily concerns second medical use claims, which have become increasingly contentious as absolute substance protection expires for commercially important drugs. Düsseldorf Higher Regional Court established criteria for preparation-free use in the Fulvestrant ruling, while Munich Regional Court issued the nilotinib decision addressing similar aspects.
SPC Applications Under Review
Newron's SPC application for safinamide in Germany remains under appeal at the Federal Patent Court under case ID 14 W (pat) 23/24. The company is managing parallel proceedings in other European countries, including SPC proceedings in the UK, as part of a comprehensive intellectual property strategy.
Legal Representation
Newron has assembled extensive legal teams for the pan-European proceedings. For German cases, the company works with Vossius & Partner, including patent attorney Oswin Ridderbusch and lawyers Kai Rüting and Leonie Dißmann-Fuchs. Trevisan & Cuonzo/TCBM coordinates the European proceedings, led by Daniela Ampollini and Silvia Bertuccio.
Alfred E. Tiefenbacher (search) retained Malte von Seebach of Hamm & Wittkopp for the Federal Patent Court case, while Purem Pharma (search) is represented by Armin Kühne of Noerr and patent attorney Christian Fuchs of Fuchs Patentanwälte.
In-house counsel from both Newron and Zambon (search) attended the hearing, with Elena Barbanti serving as IP Director of Newron, and General Counsel Rosella De Dominius and Patent Director Roberta Morelli representing Zambon.