Dimethyl Fumarate (DMF) has been subject to litigation across Europe surrounding Biogen’s EP 2653873 patent—covering the use of DMF, the active ingredient in Tecfidera, for the treatment of Multiple Sclerosis.
Biogen has enforced its exclusivity rights and patents, and this has resulted in a delay in generic competition in several countries and high litigation costs for the generics.
Adalvo has been actively opposing the EP 2653873 patent, to ensure timely market entry for generic products. The recent decision by the EPO Technical Board of Appeal 3.3.04 to revoke Biogen’s patent for added matter in oral proceedings held on 25–26 November 2025 represents a significant step toward clearing the way for competition and high-quality, cost-effective patient access across Europe.
The revocation follows years of litigation and reflects the determination of multiple opponents—including Adalvo—to contest Biogen’s attempts to maintain exclusivity beyond what is lawfully justified. While Biogen may still seek a petition for review or may try to enforce pending divisional applications, the Board’s clear findings including a cost order against Biogen, show a strong signal against procedural abuse and delay tactics to avoid a timely decision.
Adalvo remains committed to ensuring fair competition and sustainable access to high-quality medicines in Europe.