321.01 The Law and Policy of Innovation: the Life Sciences

This course analyzes the legal and policy regimes that shape the introduction of new products, processes, and services in the life science industries. Innovation in biopharmaceuticals, medical devices, health services, and health care delivery is central to the heavily regulated life sciences sector, and thus the sector offers a window into multiple intersections of scientific innovation, regulatory policy, and law.  Innovation in this sector is also shaped by multiple bodies of law (e.g. intellectual property law, FDA law, federal and state-based insurance and professional regulation, antitrust, tax), each with its own private and public constituencies, and therefore offers an opportunity to assess how different bodies of law approach the common issue of innovation.  Although this course focuses on innovation in the life science industries, this focus will produce lessons for innovation policy in other regulated and less-regulated industries. 

Spring 2021

Course Number Course Credits Evaluation Method Instructor
Course Credits
Reflective Writing
Research paper, 25+ pages
Class participation
Arti K. Rai
Sakai site: https://sakai.duke.edu/portal/site/LAW.321.01.Sp21
Email list: LAW.321.01.Sp21@sakai.duke.edu