“This study examines whether the conduct that the FTC challenged represented isolated instances or is more typical, and whether the 180-day exclusivity and the 30- month stay provisions of the Hatch-Waxman Amendments are susceptible to strategies to delay or deter consumer access to generic alternatives to brand-name drug products. The study focuses solely on the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect the brand-name drug product. The study does not address other procedures for generic entry, and it does not address the patent restoration features of HatchWaxman.
To accomplish the study, the Commission subpoenaed documents and information from brand-name and generic drug manufacturers, and examined instances since 1992 in which generic applicants filed an application with FDA seeking to enter the market with a generic version of a drug product prior to expiration of the brandname drug products’ patents. An increasing number of generic applicants have sought entry prior to patent expiration. During the 1980s, only 2 percent of generic applications sought entry this way, but from 1998 to 2000, approximately 20 percent of the generic applications sought entry prior to patent expiration. ”