Legal defenses and outcomes in Paragraph IV patent litigation

Abstract

Since 2006, there has been a dramatic increase in patent litigation filed between brand and generic pharmaceutical companies in the United States. The Federal Food, Drug, and Cosmetic Act (commonly referred to the Hatch Waxman Act) enables generic companies to apply to the FDA to enter the market before the brand product’s patents expire. In turn, the filing of an application permits the brand company to file patent infringement actions against the generic applicants. Known as “Paragraph IV” cases, these actions beg the question of which legal defenses generic companies use to defend the actions and to what degree these defenses are successful. Analyzing all Paragraph IV cases decided from 1 January 2009 to 31 December 2012, this paper identifies the case outcomes and analyzes the success of generic companies and their defenses.