Düsseldorf court to hear Tecfidera PI appeal as Biogen fights to stop generics

Düsseldorf Higher Regional Court will hear the appeals against preliminary injunctions granted to stop competitors entering the German market with generic versions of Biogen’s MS drug Tecfidera (case IDs: I-2 U 32/25, I-2 U 33/25, I-2 U 34/25 and I-2 U 36/25).

In a first attempt, Biogen lost the PI proceedings due to doubts over the patent’s validity in view of pending oppositions at the EPO. However, after the EPO Opposition Division upheld the patent, Biogen then again filed PI proceedings against several generic companies. At the end of 2024 and beginning of this year Düsseldorf Regional Court granted Biogen’s requests for preliminary injunctions to prevent various generic manufacturers from entering the market.

Biogen claims the generic products infringe EP 2 653 873. EP 873 is a formulation patent derived from Tecfidera’s original basic patent. It protects a pharmaceutical composition comprising dimethyl fumarate or monomethyl fumarate, plus one or more pharmaceutically acceptable excipients. The formulation, administered in a 480mg daily dose, now forms the basis of Tecfidera.

Today’s appeal hearing involves the main competitors  Glenmark, Stadapharm, Aliud Pharma and Hexal.

In June, the Paris Judicial Court ruled that the French part of EP 873 was invalid due to lack of inventive step (case ID: 23/02356). The court found that Mylan and Viatris had thus not infringed the patent. Biogen must now pay Mylan and Viatris €300,000 plus legal costs.

In early 2025, Biogen also suffered defeat in the Dutch proceedings.

Rospatt for Biogen

Benoit Strowel of Hoyng ROKH Monegier represented Biogen in the French case. However, for the German proceedings, Biogen opted for a team led by Thomas Musmann and Hetti Hilge of Rospatt, as well as Sandra Pohlman of df-mp.

Denis Schertenleib, name partner of litigation boutique Schertenleib, represents Mylan and Viatris in France.

The Paris judges’ panel comprised Jean-Christophe Gayet (First Deputy Vice-Chairman), Anne Boutron (Vice-Chairwoman) and Linda Boudour, assisted by Lorine Mille (court clerk during debates) and Stanleen Jabol (court clerk for documents).

In today’s hearing at Düsseldorf Higher Regional Court, Hexal relies on lead partner Matthias Sonntag from Gleiss Lutz. Glenmark retained a Düsseldorf-based team of Taylor Wessing led by Alexander Rubusch. A team around Daniel Hoppe from Bonabry represented Stadapharm and Aliud Pharma. The firm split off from Preu Bohlig in 2024.

Long list of opponents

The EPO Opposition Division upheld the patent in late 2024. Df-mp represents Biogen in the EPO proceedings.

The opponents are as follows:

• Neuraxpharm represented by Ter Meer Steinmeister & Partner
• Generics/Mylan represented by Elkington + Fife
• Polpharma represented by Hendrik Wichmann of Wuesthoff & Wuesthoff
• Hexal represented by Michael Best and Johannes Steinbauer from Kraus & Lederer
• Zentiva represented by Grünecker
• G. L. Pharma represented by Sonn
• Stada represented by Thomas Kernebeck
• Teva represented by D Young
• Adalvo represented by Maiwald
• Accord Healthcare represented by Brand Murray Fuller
• Glenmark Pharmaceuticals represented by Schlich
• Kraus & Lederer as strawman
• Biogaran represented by Casalonga
• Dr Schön, Neymeyr & Partner as strawman
• betapharm represented by Maiwald

The opponents have appealed and the Boards of Appeal will hear these on 25 to 27 November 2025 (case ID: T1462/24-3.3.04).

Update 18.7.25: Following the oral hearing, the court rejected the application for PIs against Glenmark, Aliud, Stadapharm and Hexal. The panel of the 2nd Civil Senate around presiding judge Stephan Fricke expressed doubts about the validity of the patent notwithstanding the fact that it had recently been upheld by the EPO Opposition Division.

This article was updated on 18.7.25 to include information regarding the decision of the Higher Regional Court Düsseldorf.