Tuesday, July 16, 2019

Dimethyl fumarate - EPO


EPO opposition / appeal decision:

Case number
Decision date
Online available
Patentee
Opponent(s)
Patent No.
Final Decision
T 1537/16
Apr 18, 2019
Jul 15, 2019
Forward pharma
Generics [UK] Limited
Biogen MA Inc.
Wohldorff GmbH
EP2379063
Decision under appeal is set aside

EP2379063 B1 (Forward pharma; Exp: Jan 08, 2030):

1. A pharmaceutical formulation in the form of an erosion matrix tablet comprising:
i) 10 % to 80 % by weight of one or more fumaric acid esters selected from di- (C1 -C5 )alkylesters of fumaric acid and mono-(C1 -C5 )alkylesters of fumaric acid, or a pharmaceutically acceptable salt thereof, as an active substance;
ii) 1-50 % by weight of one or more rate-controlling agents; and an enteric coating, wherein said enteric coating is applied at a level of 1.5 - 3.5 % by weight of the core,
wherein erosion of said erosion matrix permits controlled or sustained release of said active substance.

Order of Board of Appeal:
1. The decision under appeal is set aside.
2. The case is remitted to the Opposition Division with the order to maintain the patent on the basis of the first auxiliary request, filed with letter dated 5 February 2016 and a description to be adapted.

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