321 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. 

Course Frequency*
Course Areas of Practice

Sections

Spring 2017
2017
Course Number Course Credits Evaluation Method Instructor Meeting Day/Times Room

321.01 3 Arti K. Rai MW 9:00-10:20 AM 3000

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. 

Pre/Co-requisites
None
Enrollment Restrictions
None
2016
Spring 2016
Course Number Course Credits Evaluation Method Instructor Meeting Day/Times Room

321.01 3 Barak D. Richman, Arti K. Rai MTh 9:00-10:20 AM 3000

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. 

Pre/Co-requisites

The course has no prerequisites. However, students will be expected to be quick studies on a variety of legal subjects.

Enrollment Restrictions
None
2013
Fall 2013
Course Number Course Credits Evaluation Method Instructor Meeting Day/Times Room

321.01 3 Arti K. Rai Tu/Th 1:30-2:51 pm Room 4172
This course will explore systematically the central intellectual property and regulatory questions raised by innovation in the life science industries (i.e. the biopharmaceutical and medical device industry). Students will learn that life sciences research and development is particularly complex because of the mix of public and private funding that supports such R&D and because of the intricate regulatory structure that surrounds drugs, biologics, and other interventions that require FDA approval. Although a background in the biological sciences is not required, students should be prepared to learn basic principles of molecular biology.

Pre/Co-requisites
None
Enrollment Restrictions
None

*Please note that this information is for planning purposes only, and should not be relied upon for the schedule for a given semester. Faculty leaves and sabbaticals, as well as other curriculum considerations, will sometimes affect when a course may be offered.