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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company’s leading multiple sclerosis treatment.
In a statement released on Jan. 17, 2017 Biogen said it will pay Forward Pharma $1.25 billion to settle a patent dispute over Biogen’s leading multiple sclerosis treatment Tecfidera (dimethyl fumarate). The companies have been engaged in an ongoing patent dispute involving dimethyl fumarate, the active ingredient in Tecfidera and Forward’s lead candidate, FP187. Both formulations treat multiple sclerosis with a 480 mg dose of dimethyl fumarate.
In a statement, Forward said the US Patent Office declared an interference between the two companies in 2015 in regards to their individual dimethyl fumarate patents. Forward applied for a patent covering its multiple sclerosis drug before Biogen, the company noted. The patent office has yet to decide in the dispute. If Biogen loses the interference and obtains an exclusive license for the drug, the company said it would pay Forward a 10% royalty of global sales of Tecfidera from 2021–2028, and a 20% royalty beyond 2029. Tecfidera global revenue reached $3.6 billion in 2015.
John Scotti, an analyst at Evercore ISI, noted that the settlement between Biogen and Forward Pharma is essentially a “~1.25 billion insurance policy, which provides [Biogen intellectual property] for Tecfidera beyond 2023 regardless of whether or not [Biogen] wins or loses the interference/IPR.” Scotti said regardless of the outcome of the patent dispute, it is likely that Tecfidera will remain branded beyond 2023. “If [Biogen] were to lose the interference without this insurance policy, it would have been possible that [Biogen] would have had to pay both back payments on Tecfidera as well as royalties >10%,” Scotti wrote.
Source: Biogen, Forward Pharma, Evercore ISI