US patent office upholds Biogen's patent for Tecfidera

The US Patent and Trademarks Office's Patent Trial and Appeal Board on Tuesday upheld the validity of a patent protecting Biogen's multiple sclerosis treatment Tecfidera (dimethyl fumarate)‎ following a challenge by hedge fund manager Kyle Bass. In the case, Bass challenged a patent focusing on a method for dosing patients with 480 milligrams per day of certain fumarates.

Commenting on the news, Mizuho analyst Salim Syed noted that the ruling could protect Tecfidera against generic competition until 2028, while the consensus was that the drug would face generic competition as early as 2023 or 2024. The analyst warned that Bass could appeal the ruling, a process that could last as long as 18 months. 

"We are still waiting for the interference ruling against [Forward Pharma]," Syed explained, adding "this will determine if [Biogen] owes [Forward] a 10 percent royalty on US sales. The analyst continued "there is no guarantee we will receive this ruling soon, but it's the same three-judge panel looking at this case, so base case thinking is it should come out soon." 

In January, Biogen reached a $1.25-billion settlement and licensing agreement with Forward Pharma under which it gained an irrevocable license to the latter's intellectual property. Meanwhile, Biogen cautioned that the deal did not resolve issues pending in an ongoing interference proceeding in the US or an opposition proceeding in Europe. 

Tecfidera was approved by the FDA for the treatment of multiple sclerosis in 2013 and authorised in Europe the following year.