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Mylan's Lantus Rival Faces Fresh Attack

Sanofi Tries To Stop Biosimilar Via Supreme Court PTAB Review

 
• By Brenda Sandburg

Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.

A law book with a gavel - Constitution
Sanofi Says Unconstitutional Status Of PTAB Judges Warrants Appeal of Lantus Ruling • Source: Shutterstock

A decision by the US Court of Appeals for the Federal Circuit that Patent Trial and Appeal Board (PTAB) judges were unconstitutionally appointed is continuing to have ripple effects, with Sanofi now arguing that it should be able to apply this ruling in appealing a finding that its Lantus (insulin glargine) patents are unpatentable. It plans to file a certiorari petition for US Supreme Court review of its argument.

In a November ruling in Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc

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Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By Dean Rudge

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

Glenmark’s UK Dapagliflozin Blocked On Appeal After Teva Readied Launch

 
• By Dean Rudge

Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.

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