Dimethyl fumarate - EPO

On Jan 29, 2018, European Patent Office revoked Forward Pharma A/S's EP 2801355 patent in an opposition proceedings filed by several parties. The '355 patent covers a PH-controlled release pharmaceutical composition for oral use that contains dimethyl fumarate (DMF), the active ingredient in Biogen's MS drug Tecfidera.

EP’355 independent claims:

1. A pH controlled release pharmaceutical composition for oral use which consists of dimethylfumarate as the active substance, wherein the composition is provided with an enteric coating wherein the daily dosage is from 480 to 720 mg active substance given in one to three doses for use in the treatment of psoriatic arthritis, neurodermatitis, inflammatory bowel disease, or an autoimmune disease.

9. A pH controlled release pharmaceutical composition for oral use in the treatment of psoriatic arthritis, neurodermatitis, inflammatory bowel disease, or an autoimmune disease which consists of dimethylfumarate as the active substance, provided with an enteric coating wherein the daily dosage is 480 mg active substance given in one to three doses.

Total 11 parties (Zaklady Farmaceutyczne Polpharma;  G. L. Pharma; Strawman Limited; Zentiva; Hexal AG; Laboratorios Liconsa, Interquim S.A ; Biogen MA Inc; Actavis; Generics [UK] Limited and STADA Arzneimittel AG) filed post grant oppositions in Feb 2016. The EPO Opposition Division held oral hearing on Jan 29, 2018 & announced its decision to revoke the patent. The Opposition Division will issue detailed reasons for the decision in written form in due course, and following receipt and review of these, Forward plans to appeal the Opposition Division’s decision to the Technical Board of Appeal.

According to Jan 2017 news, Biogen entered into a settlement and license agreement with Forward Pharma. Upon the effectiveness of the settlement and license agreement, Biogen will provide Forward Pharma a cash payment of $1.25 billion. Biogen will only be obligated to pay Forward Pharma royalties in countries other than the U.S. if Forward Pharma obtains patent rights covering treatment of a human for multiple sclerosis by orally administering 480 mg per day of DMF in the opposition proceeding against Forward Pharma’s European patent EP 2801355.