1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Generics

Generic Manufacturers Face Uphill Climb After Federal Circuit’s ‘Skinny Label’ Decision

 
• By Brenda Sandburg

Split appeals court denies en banc review of GSK v. Teva ruling, but suggests the district court could consider GSK’s patent declarations in determining whether Teva’s label is evidence of inducement to infringe. Teva plans to file petition for Supreme Court review.

Skinny stamp
Appeals court declines to rehear 'skinny label' case on generic label carve-outs • Source: Alamy

Generic manufacturers could face a rise in litigation now that the US Court of Appeals for the Federal Circuit has shot down Teva Pharmaceuticals USA Inc.’s request for a full court rehearing of its “skinny label” case. The company is now looking to the US Supreme Court to take up the dispute that has roiled the generic drug industry.

In a 6-3 decision, the Federal Circuit denied Teva’s petition, letting stand a three-judge panel’s decision that Teva’s labeling for a generic version of Coreg (carvedilol), which carved out the patented indication, induced infringement of GlaxoSmithKline plc’s patents

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Generics

More from Biosimilars & Generics