Law and Economics Workshop
WS 2009 - 2010 (6)
Scott Hemphill
Columbia Law School
Generic Drug Challenges Prior to Patent Expiration
(C. Scott Hemphill and Bhaven N. Sampat)
Tuesday, February 2, 2010
4:10 – 6:00 p.m.
Solarium (Room FA2) – Falconer Hall
84 Queen’s Park
The Hatch-Waxman Act established the modern U.S. regime for competition between brand-name and generic drugs. We examine a feature of the Act that has generated significant controversy, yet received little systematic attention. “Paragraph IV” challenges are a mechanism for generic drug makers to challenge the patents of brand-name drug makers, with a view to securing early market entry. This article reports initial results from a larger empirical project investigating the determinants of Paragraph IV challenges and their effects. We examine the growth of patent portfolios by brand-name drug makers and Paragraph IV challenges by generic firms, and explore the disparate roles of “flagship” patents, such as product and composition patents, and peripheral patents in affecting the likelihood of a Paragraph IV challenge. Our findings have significant implications for ongoing debates about the regulation of brand-name and generic drug makers.
Scott Hemphill is an associate professor of law at Columbia Law School. His research and teaching focus on the balance between competition and innovation set by antitrust law, intellectual property, and sector-specific regulation. Recent work examines competition in the pharmaceutical industry, regulation of broadband Internet access providers, and intellectual property protection for original fashion designs. Prior to joining Columbia's faculty, Hemphill clerked for Judge Richard Posner and Supreme Court Justice Antonin Scalia
CO-SPONSORED BY THE CENTRE FOR INNOVATION LAW & POLICY WORKSHOP SERIES.
For more workshop information, please contact Nadia Gulezko at n.gulezko@utoronto.ca.
