AAM Steps Into GSK-Teva Case To Defend Carve-Outs

Ruling On Skinny Labels Must Not Become ‘Road Map’ For Originators

The AAM has stepped into controversial litigation between Teva and GSK over generic labelling carve-outs, urging the US Court of Appeals for the Federal Circuit to rehear the case to prevent the rules on so-called skinny labels from being subverted.

Chisel carve stone
Generics firms must be able to carve out indications, the AAM says • Source: Shutterstock

A controversial ruling by the US Court of Appeals for the Federal Circuit over generic labeling carve-outs should be reheard “en banc” by the full court, to correct a misinterpretation of the rules around so-called skinny labels, the Association for Accessible Medicines has urged in an amicus brief.

The case involving GlaxoSmithKline and Teva over Coreg (carvedilol) made waves earlier this year when a split appeals court decision...

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

More from Legal & IP

Zydus Trastuzumab Suit Dismissed In India For ‘Illusion Of Cause Of Action’

 
• By 

After nearly a decade of procedural delays, a Bombay High Court has finally tossed Zydus Cadila’s pre-emptive complaint against Roche over its Herceptin biosimilar, calling it an “illusion” of a real dispute.

Alchem Fined Over Buscopan API Cartel

 
• By 

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By 

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

US Federal Circuit Says It Will Not Rehear Viatris Invega Trinza Infringement Ruling

 
• By 

The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.

More from Generics Bulletin

Alchem Fined Over Buscopan API Cartel

 
• By 

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
• By 

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By 

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.