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Stage Set For Generics To Triumph With Skinny-Label Reversal

Latest Twist In Long-Running Litigation Sees Solicitor-General Back Teva Over GSK

 
• By Dave Wallace

With the US solicitor general offering support for Teva over GSK in long-running litigation over skinny-label carve-outs of generic indications, the stage could be set for a major reversal at the Supreme Court that would favor the generics industry.

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Could a reversal be on the cards for Teva? • Source: Shutterstock

Teva has seen its chances of success in a long-running US legal battle over “skinny-label” generics given a major boost, after the US solicitor general emphatically supported the firm’s position as it seeks a Supreme Court review of litigation over induced-infringement claims made by GlaxoSmithKline.

The case – which holds wider significance for all generics that carve out patented indications under the US “section viii” pathway – has over the years proceeded through the district and appeals courts, with GSK ultimately seeing reinstated an early jury finding of infringement and a $235m damages award from 2017, based on Teva’s generic version of Coreg (carvedilol) that carved out a congestive heart failure indication protected by GSK’s reissued US patent RE40,000

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