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 Areas of Practice
Evaluation Methods
  • Reflective Writing
  • Research paper, 25+ pages
  • Class participation
Degree Requirements
Course Requirements - JD
Course Requirements - JD-LLM-LE
Course Requirements - LLMLE
Course Type
  • Lecture
Learning Outcomes
  • Knowledge and understanding of substantive and procedural law

Spring 2021

2021
Course Number Course Credits Evaluation Method Instructor Meeting Days/Times Room

321.01 3
  • Reflective Writing
  • Research paper, 25+ pages
  • Class participation
Arti K. Rai M/W 9:20 AM-10:45 AM

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

Spring 2020

2020
Course Number Course Credits Evaluation Method Instructor Meeting Days/Times Room

321.01 3
  • Reflective Writing
  • Research paper, 25+ pages
  • Class participation
Arti K. Rai MW 9:20-10:45 am 4045

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

Spring 2019

2019
Course Number Course Credits Evaluation Method Instructor Meeting Days/Times Room

321.01 3
  • Reflective Writing
  • Research paper, 25+ pages
  • Class participation
Arti K. Rai M/W 10:55-12:20 PM 4055

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

Spring 2018

2018
Course Number Course Credits Evaluation Method Instructor Meeting Days/Times Room

321.01 3 Arti K. Rai MW 8:55-10:20 AM 4042

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

Spring 2017

2017
Course Number Course Credits Evaluation Method Instructor Meeting Days/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

Spring 2016

2016
Course Number Course Credits Evaluation Method Instructor Meeting Days/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
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.