Understanding Current Trends and Outcomes in Generic Drug Patent Litigation: An Empirical Investigation

Abstract

This thesis examines the role of patent litigation in the generic drug approval process. Generic drug companies wishing to enter a brand-name drug market early may challenge a brand-name’s patents by filing for an Abbreviated New Drug Application (ANDA) with a paragraph IV certification. While anecdotal evidence on the characteristics of paragraph IV lawsuits abound, there has yet to be a comprehensive study on these unique cases. Leveraging a new dataset of district court cases, this thesis presents an empirical investigation into some of the current trends in generic drug litigation from January 1, 2006 to August 1, 2011. Using several basic econometric specifications, I study the determinants of settlement and other outcomes in these cases, observing that factors such as declaratory judgment, the size of a pioneer company, the level of patent protection, and remaining exclusivity may be significant factors.

Keywords: ANDA, pharmaceuticals, Hatch-Waxman, paragraph IV certifications, patent litigation