How Can Firms Avoid Falling Into GSK-Teva ‘Skinny Label’ Trap?
Industry Must Tread Carefully, Suggests Troy Groetken Of McAndrews, Held & Malloy
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.
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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.
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.
A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.