PTAB Releases Orange Book-Listed Patent Study

By Andrew Williams — Pharmaceutical patent owners have been one of the more vocal groups decrying the creation and existence of inter partes reviews and other PTAB post-issuance proceedings. And for good reason. Congress enacted the Hatch-Waxman statute to create an abbreviated approval pathway for generic small molecule drugs. In so doing, it crafted a fine balance between the interests of branded pharmaceutical NDA holders and generic drug-product manufacturers. As part of this balance, Congress established a procedure by which ANDA filers could challenge the validity of patents that cover the drug product and methods of its use in district…Original Article