The Federal Circuit’s October 2020 split decision in
GSK v. Teva[i] made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any manufacturer of a marketed “AB‑rated” generic drug liable for induced infringement of patents covering any of the brand products’ FDA‑approved indications – even where the generic’s labeling “carved out” such an indication to escape infringement under the “section viii” provision of Hatch-Waxman.[ii]
GSK v. Teva is now headed to a Federal Circuit panel rehearing (not
en banc review) on February 23, and the industry and practitioners are watching closely. But recent developments suggest that the Federal Circuit might now avoid the hotly-debated legal question of whether a generic with a fully “carved-out” indication might induce infringement solely by touting its “AB-rating.” Rather, there are signs that the majority mi