- Biogen Idec and Danish firm, Forward Pharma, are fighting over patent rights for dimethyl fumarate (DMF), which Biogen Idec markets as Tecfidera for treatment of multiple sclerosis (MS).
- Forward Pharma is basing its patent claim on the fact that it purchased Aditech Pharma in 2005. Forward claims that it acquired rights to slow-release dimethyl fumarate (DMF) through this acquisition.
- Forward's competitor product, FP187, also uses DMF, but has a "slow-release structure" that Forward claims is superior to Tecifdera's.
Forward's challenge of Biogen Idec's DMF patent represents a formidable threat to the company. Biogen's launch of Tecfidera in March 2013 as first-line treatment for adults with relapsing-remitting MS (RRMS) was very successful—resulting in almost-immediate blockbuster status. With sales of $1.2 billion for the first half of this year, Tecfidera has emerged as one of the most important new treatment options for MS. Newly available phase III data confirms its utility and efficacy. One trial even showed that Tecfidera-treated patients with RRMS had a 44% reduction in their annualized relapse rate, compared with placebo patients.
The stakes are high. About 85% of people with MS has the RRMS variant. Revenues for DMF-based treatments will only rise in the coming years. The patent stand-off is off to a slow start so far, but bound to amp up quickly. A settlement may be in the works—stay tuned.