Hatch-Waxman Patent Litigation Toolkit | Practical Law
Resources for counsel involved in litigation arising under the Hatch-Waxman Act based on a generic drug manufacturer's filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), including background information on the Hatch-Waxman Act, pre-suit considerations for a patent owner's counsel, litigation documents and settlement issues. It also covers Biosimilars Litigation under the Biologics Price Competition and Innovation Act (BPCIA).