1. Generics Bulletin
  2. >>Legal & IP

Federal Circuit Cements Viatris Victory Over Biogen On Key US Tecfidera Patent

US Appeals Court Split 2-1; Analyst Predicts ‘Case Is Likely Concluded’

 
• By Dean Rudge

As anticipated by the street, Viatris has prevailed over Biogen on the originator’s appeal of a district court ruling that invalidated a key US patent shielding its Tecfidera treatment for multiple sclerosis. However, the Federal Circuit was not aligned on its decision.

Court of Appeals for Federal Circuit Lafayette Park Across from White House Washington DC
The Federal Circuit did not overturn the June 2020 decision • Source: Shutterstock

A US district court in West Virginia “did not clearly err” in determining that Biogen’s key US patent 8,399,514 shielding its multiple sclerosis treatment Tecfidera (dimethyl fumarate) through 2028 was invalid for lack of written description, the US Court of Appeals for the Federal Circuit has ruled, cementing victory for ANDA sponsor Viatris’ Mylan.

“We hold that the district court did not clearly err in determining that Mylan has established its burden of showing, by clear and convincing evidence, that the asserted ’514 patent claims are invalid for lack of written description,” the Federal Circuit decided

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

J&J Hits Back Over Private-Label Stelara Biosimilar In US

 
• By Dave Wallace

After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By Dean Rudge

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

More from Generics Bulletin

Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By Dean Rudge

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.