1. Generics Bulletin
  2. >>Legal & IP

Appeals Court Rehearing Rejected In Teva-GSK Skinny-Label Saga

Split Federal Circuit Refuses ‘En Banc’ Rehearing Of Labeling Carve-Out Case

 
• By Dave Wallace

Teva will not get a third hearing at the US Court of Appeals for the Federal Circuit in its long-running dispute with GSK over skinny-label generics, after the appeals court rejected a petition for the full bench to re-examine the case.

Federal Circuit closeup_683614828_1200.jpg
The appeals court refused to rehear the case on labelling carve-outs

Teva has lost the latest round in its long-running battle with GlaxoSmithKline over skinny-label generics, after the US Court of Appeals for the Federal Circuit refused to re-examine previous rulings in the litigation, which revolves around generic labels that carve out patented indications and which industry representatives have suggested could pose a threat to the skinny-label regime in the US.

In a 6-3 split decision, the Federal Circuit denied Teva’s petition for it to rehear the litigation “en banc” – before the entire bench – after a pair of successive split decisions by a

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

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.”

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.

More from Generics Bulletin

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.

Teva’s Uzedy Continues Surge As Olanzapine LAI Filing Nudges Closer

 
• By Dean Rudge

Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.

Dr Reddy’s Gears For Tariffs Scenario To Ensure No US Supply Disruption

 
• By Anju Ghangurde

Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.