Blow For Industry As GSK-Teva ‘Skinny Label’ Decision Upheld
Split Ruling Plays Down Label Aspects As Appeals Court Backs Coreg Damages
A controversial ruling revolving around labelling carve-outs that saw Teva hit with $235m in damages over its generic rival to GSK’s Coreg has been upheld after being reheard by the US Court of Appeals for the Federal Circuit. However, the court sought to counter the suggestion that its decision upends the Hatch-Waxman framework’s labelling carve-out provisions.
You may also be interested in...
Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.
By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.
In the wake of a controversial US decision on carving out patented indications from generics labels, Troy Groetken of law firm McAndrews, Held & Malloy tells Generics Bulletin about the key issues that firms with ‘skinny label’ generics should be aware of given the potential for induced-infringement attacks.