Number: RL33901
Title: Follow-On Biologics: Intellectual Property and Innovation Issues
Authors: Wendy H. Schacht and John R. Thomas, Resources, Science, and Industry Division 
Abstract: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of this report introduces innovation policy issues pertaining to follow-on biologics.
Pages: 27
Date: Updated October 31, 2008