The U.S. biotechnology industry today faces a confluence of legislative, judicial and executive branch developments that will profoundly affect its business model for decades to come. Biotechnology, as an industry singularly dependant on its intellectual property assets, must consider the impact of the biggest proposed changes to the patent laws in over 50 years. In addition, Congress is poised to create an abbreviated FDA regulatory pathway for followon biologics while, at the same time, attempting to establish a framework that will fairly protect the intellectual property, including patents and clinical trial data, developed by biotechnology innovators. In this session, experts will identify key policy issues at the intersection of intellectual property and health care, and apply lessons learned from 25 years of generic drug regulation to explore the role of patents, clinical data protection provisions, and other policy tools to ensure continued incentives for biotechnology innovation.