Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Viatris Celebrates As US Court Refuses Tecfidera Review

Originator Biogen Is ‘Disappointed With Decision’ And ‘Evaluating Next Steps’

Executive Summary

Viatris has welcomed a decision by the US Court of Appeals for the Federal Circuit not to rehear litigation with Biogen over Tecfidera, after a split decision by the court last year confirmed a patent invalidity ruling that allowed generics to launch in 2020. Biogen told Generics Bulletin it was disappointed with the decision and is evaluating its next steps.

You may also be interested in...



European Regulator Pulls Marketing Authorizations For Tecfidera Generics

In a blow to several generics firms – albeit one telegraphed by a decision handed down nine months ago – the European Commission has ordered the removal of marketing authorizations for generic versions of Biogen’s MS brand, Tecfidera.

Blow For EU Tecfidera Rivals As Biogen Triumphs In Legal Battle

Developers of generic dimethyl fumarate have received a setback after a CJEU ruling in Biogen’s favor gave Tecfidera EU regulatory marketing protection until at least February 2024.

US Supreme Court Preview: ‘Skinny’ Labels, FTC, And FCA – But No Tecfidera As Biogen Loses Bid

Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

GB151742

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel