Biosimilars: Impact of Differences With Hatch–Waxman

Abstract

A comparison of the Hatch-Waxman Act for approval of small-molecule pharmaceuticals with the Biological Price Competition and Innovation Act for approval of biosimilars provides insight into the market entry and patent litigation for biosimilars. Key differences between the two statutes include a longer period of statutory exclusivity for biosimilars, no 30-month stay for a reference product sponsor upon initiation of litigation, and no 180-day market exclusivity period for the first filer of an application for approval of a biosimilar in the absence of interchangeability. These differences will focus the incentive to settle any patent litigation on the risk of invalidity and/or noninfringement of the reference product sponsor's patents. A biosimilar applicant should develop the best case for invalidity and/or noninfringement of these patents, identify third-party patents and develop a freedom to operate strategy, and file for patents on production, formulation, or use of the biosimilar.