Boards of Appeal revoke Biogen’s dosage patent for Tecfidera

Biogen’s multiple sclerosis drug Tecfidera now faces competition in the UK and EU countries including Germany, France, and Spain, following the expiration of marketing exclusivity.

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.

In September 2025, the European General Court ruled that Biogen was several weeks too late to extend market exclusivity for Tecfidera by one year. The EP 2 653 873 and associated supplementary protection certificates should have prevented generic products from entering these markets. EP 873 would have been valid until 2028, with the associated SPC extending until 2029.

The Boards of Appeal decision to revoke Biogen’s patent has disrupted these plans. In October 2024, the EPO’s Opposition Division maintained the patent with amendments. Fifteen opponents appealed the decision. The Technical Board of Appeal heard these appeals from 25 to 27 November 2025. The Technical Board comprised Chair Magdalena Pregetter, Silke Albrecht and Lukas Bühler (case ID: T1462/24-3.3.04).

At the hearing’s conclusion, the TBA revoked EP 873, overturning the first-instance decision. The Board ruled that EP 873 violates the added matter prohibition. When this outcome became apparent, Biogen and its lawyers attempted to force a submission to the Enlarged Board of Appeal, but the TBA rejected this. Whilst Biogen could still appeal directly to the EBA citing procedural defects, experts say reversing the decision would be both difficult and time-consuming.

Markets are open

Biogen claims the generic products infringe EP 873 and had continued to fight for market exclusivity through PI proceedings in multiple European countries, including Germany, the Netherlands, and France.

In Germany for example, following the oral hearing in July, Düsseldorf Higher Regional Court rejected the application for PIs against Glenmark, Aliud, Stadapharm and Hexal. The court expressed doubts about the validity of the patent notwithstanding the fact that it had recently been upheld by the EPO Opposition Division.

In its first attempt, Biogen lost the PI proceedings due to doubts over the patent’s validity given pending EPO oppositions. However, after the EPO Opposition Division upheld the patent, Biogen filed fresh PI proceedings against several generics companies. Düsseldorf Regional Court granted Biogen’s requests for preliminary injunctions at the end of 2024 and beginning of this year, preventing various generics manufacturers from entering the market.

Financial consequences

Even if Biogen ultimately succeeds in having the EPO grant the patent, the decision temporarily blocks all ongoing infringement and PI proceedings. According to analysts, Biogen could now face damages claims from generics companies due to the enforcement of PIs.

A possible new barrier for generic products could be Biogen’s EP 4 137 819, a divisional application from the same family. An examination proceeding is currently pending with the EPO.

Experts believe that, should generic products enter the European market, manufacturers would not face liability for damages, even if Biogen were to succeed at the Enlarged Board of Appeal and EP 873 were subsequently granted. In the UK, the path is now completely clear for generic Tecfidera products.

Representatives for 15 The opponents

Fifteen opponents challenged the granting of EP 873. Most generics manufacturers fought openly, though there were also two straw-man oppositions. The generics manufacturers largely retained their long-standing advisors.

• • Neuraxpharm represented by Ingo Ortel and Bernd Aechter from Ter Meer Steinmeister & Partner
  • Viatris/Generics represented by Richard Gillard and Richard Cooke from Elkington + Fife
  • Polpharma represented by Hendrik Wichmann and Thomas Sonnenhauser from Wuesthoff & Wuesthoff
  • Hexal represented by Michael Best and Johannes Steinbauer from Kraus & Lederer
  • Zentiva represented by Steven Zeman and Christoph Latzel from Grünecker
  • G. L. Pharma represented by Rudolf Griss from Sonn
  • Stada represented by Thomas Kernebeck
  • Teva represented by Laura Jennings and Neil Nachshen from D Young
  • Adalvo represented by Derk Vos from Maiwald
  • Dr Reddy’s/betapharm (as intervenor) represented by Andreas Ledl from Maiwald
  • Biogaran represented by Jean-Baptiste Lecoeur from Casalonga
  • Glenmark Pharmaceuticals represented by Andrew Clements from Schlich
  • Christoph Schön from Schön Neymeyr & Partner as strawman
  • Kraus & Lederer as straw man
  • Accord Healthcare represented by Brand Murray Fuller in first instance

Df-mp for Biogen

Sandra Pohlman, patent attorney from Munich-based IP firm df-mp, represents Biogen in the EPO and German proceedings. Df-mp attorneys Richard Page and Erin Becker provided support. Pohlman was also present in the Dutch proceedings.

In the Netherlands, Biogen relies on a team from Hoyng ROKH Monegier. For the German proceedings, Biogen retained Düsseldorf-based IP litigation firm Rospatt. A London-based team from Herbert Smith Freehills Kramer, led by Sebastian Moore and Emily Bottle, coordinates the disputes across Europe.