Label ruling upends generic medicine makers

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.

When a generic wants to enter the market with a drug covered by an Orange Book-listed patent, its Abbreviated New Drug Application (ANDA) is required to contain a certification as to any patent listed in the Orange Book that: