US patent office rules in Biogen’s favour on Tecfidera

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

US patent office rules in Biogen’s favour on Tecfidera

Home/Policies & Legislation | Posted 28/02/2020 0 Post your comment

Biogen has won a patent challenge from Mylan over multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

US biotech company Biogen has won a patent challenge from Mylan over Tecfidera, Biogen’s patented treatment for relapsing MS. The small molecule drug is an immunomodulator and has been used to treat MS since 2013. It is Biogen’s top selling drug, bringing in over 30% of total revenue in 2019.

Biogen’s patent on Tecfidera (’514) is due to expire in 2028 and Mylan claimed that the patent is invalid, which would allow them to bring a generic drug to market. However, the Patent Trial and Appeal Board (part of the US Patent and Trademark Office) have ruled in Biogen’s favour, stating that Mylan did not sufficiently demonstrate their claim and dismissed the challenge.

Mylan have responded stating that the company strongly disagrees with the decision and will investigate grounds for appeal. ‘Mylan continues to believe, based on the law and the facts, that Biogen’s ‘514 patent is invalid and will continue its challenges in both the district court and the Federal Circuit to remove this patent from blocking generics competition to Tecfidera’, a spokesperson said.

This is more good news for Biogen, who recently resumed work on their Alzheimer’s drug aducanumab. Initial data from phase II trials indicated it would not meet the primary endpoint, however, new data with higher doses has shown an improvement in symptoms. As a result, the US Food and Drug Administration has approved a re-dosing study for patients enrolled on previous trials, which could begin in March 2020, and Biogen is preparing for the potential launch of the drug in the US.

Related articles
FDA approves MS and prostate generics

Samsung Bioepis expands biosimilars agreement with Biogen

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.