Biogen's Tecfidera Settles Intellectual Patent Dispute

The Center for Biosimilars Staff

Biogen and Forward Pharma have reached a settlement in their Tecfidera (dimethyl fumarate) patent dispute over the active ingredient for the multiple sclerosis drug (MS) used treat people with relapsing forms of the disease.

Biogen will pay Forward $1.25 billion, as well as royalties in exchange for an irrevocable license to all intellectual property. The level of royalties will depend upon any interference proceeding the hearing decision., with the royalty rate ranging from 1% to 10% -- and could go as high as 20%, depending upon the resolution. Around 77% of Forward Pharma shareholders have already agreed to vote in favor of the deal, with a final vote scheduled for Feb. 1.

The intellectual property associated with the 480mg dose of oral dimethyl fumarate, the active compound in Tecfidera, has been the subject of the ongoing litigation through the Patent Trial and Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit, the European Patent Office, the Technical Board of Appeal and the Enlarged Board of Appeal, with a decision expected March 17.

Confidence Pays Off

Analysts predicted Biogen's success with the case, even though they will pay more than a billion dollars upfront to Forward Pharma. Early sales figures had cemented it as one of the "blockbuster" drugs, but fell after safety issues were discovered--and marketing took a hit when the consumer advertising campaign was cut after it did not produce an uptick in fulfilled prescriptions.