US patent office rules in Biogen’s favour on Tecfidera

Home/Policies & Legislation | Posted 28/02/2020 post-comment0 Post your comment

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

Multiple Sclerosis V14A24

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. 

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
PDUFA VI: FDA could promote generics competition
47 MD001813
Home/Policies & Legislation Posted 29/07/2022
House bill passes FDA funding fees but conflicts with Senate bill
User Fee V13H23
Home/Policies & Legislation Posted 15/07/2022
US Senate clarifies status of interchangeable biosimilar exclusivity
Interchangeability V18K30
Home/Policies & Legislation Posted 27/05/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010