What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? By Kevin E. Noonan — The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the Hatch-Waxman Act has been on-going for over thirty years. As part of this regime, Congress has provided a pathway for generic drug companies to obtain FDA approval for less than all the indications a branded drug has obtained, using a “carve out” strategy resulting in a so-called “skinny label.” This has raised the possibility of “off-label” use, where physicians prescribe the generic drug for an indication…
