Newron defends SPC for Parkinson’s drug Xadago against Puren

The original medication is safinamide, sold under the brand name Xadago. Newron holds the patent and 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.

The case concerns EP 2 474 521, which protects a high-purity form of safinamide used to treat Parkinson’s disease. The purity of safinamide is central to the invention. This active ingredient increases dopamine concentration in the brain. Dopamine levels are reduced in Parkinson’s patients’ brains but are crucial for movement control.

PI upheld

Munich Regional Court issued an ex-parte PI against Puren on 17 June 2025 (case ID: 21 O 7785/25). Puren lodged an objection. In mid-September, Munich Regional Court under presiding judge Georg Werner heard the case and upheld the PI. The court has not yet published its written reasoning.

On Tuesday 30 September, the Federal Patent Court will hear arguments on the validity of the German part of EP 521 (case ID: 3 Ni 24/23). Alfred E. Tiefenbacher is the plaintiff. The Federal Patent Court’s preliminary opinion suggests the patent is valid. The 3rd Senate under presiding judge Walter Schramm will hear the case.

Meanwhile, Newron’s SPC application for safinamide in Germany is under appeal at the Federal Patent Court (case ID: 14 W (pat) 23/24).

The case primarily concerns second medical use claims. Enforcing second medical use patents is currently contentious, as absolute substance protection is due to expire for some commercially important drugs.

Düsseldorf Higher Regional Court established criteria for preparation-free use (‘herrichtungsfreie Gebrauch’) in the Fulvestrant ruling. The UPC local division Düsseldorf referenced these criteria in the Sanofi/Regeneron decision, but then considered various other aspects.

Furthermore, Munich Regional Court issued the nilotinib decision on preparation-free use (case ID: 21 O 14559/24). These proceedings are now before Munich Higher Regional Court. The Xarelto proceedings in Munich also address aspects of this discussion.

Trevisan & Cuonzo for Newron

Armin Kühne of Noerr and patent attorney Markus Rieck of Fuchs Patentanwälte are representing Puren Pharma.

Trevisan & Cuonzo/TCBM, led by Daniela Ampollini and Silvia Bertuccio, are coordinating proceedings for Newron Pharmaceuticals and Zambon. They are also managing parallel proceedings in other European countries, as well as proceedings for the safinamide SPCs, including in the UK.

In the German infringement and nullity proceedings, Newron has retained Vossius & Partner. The team includes patent attorney Oswin Ridderbusch and lawyers Kai Rüting and Leonie Dißmann-Fuchs.

Malte von Seebach of Hamm & Wittkopp regularly represents Alfred E. Tiefenbacher.