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Third Time Lucky For GSK-Teva ‘Skinny Label’ Review?

AAM Weighs In As Part Of Bid For ‘En Banc’ Appeals Court Rehearing

 
• By Dave Wallace

An amicus brief filed by the AAM has backed Teva’s bid to have the US Court of Appeals for the Federal Circuit rehear litigation with GSK that revolves around skinny-label generics that carve out patented indications. But after a pair of controversial prior decisions in the originator’s favor, will the third time be the charm?

Hand Holding Up Three Fingers On Green Background
The AAM is hoping for a favorable appeals court ruling at the third attempt • Source: Alamy

The long-running saga of US litigation between Teva and GlaxoSmithKline over skinny-label generics that carve out patented indications has taken another turn, as the US Court of Appeals for the Federal Circuit has been asked to rehear the litigation “en banc” – before the entire bench – after a pair of split decisions by a panel of three judges came down on the side of GSK.

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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.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

More from Generics Bulletin

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.

What’s Next? Five Things To Look Out For In May

 
• By Dean Rudge

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.