Label Ruling Upends Generic Medicine Makers
The effects of the ‘skinny label’ decision are being felt across pharma. MaryAnne Armstrong of Birch, Stewart, Kolasch & Birch revisits GSK v Teva, in an article for WIPR – World IP Review.
In August 2021, the Court of Appeal for the Federal Circuit (CAFC), in a per curiam opinion, quietly decided one of the most important pharma cases in recent years in GlaxoSmithKline v Teva Pharmaceuticals USA (Fed Cir 2021).
The decision resulted in a $235 million infringement verdict for GSK. In addition, a dozen amicus curiae briefs were filed for consideration with the per curiam decision, from parties including both brand companies, generic drug companies and NPOs.
The decision in GSK v Teva effectively redefined the understanding of skinny label exceptions to infringement.