321 The Law and Policy of Innovation: the Life Sciences
This course addresses the key legal and policy regimes that shape the introduction of new products, processes, and services in the life science industries. Innovation in biopharmaceuticals, medical devices, and health care delivery is central to the heavily regulated life sciences sector, and the sector therefore provides valuable insights into the intersection of law and regulatory policy with scientific innovation. In particular, this course will focus on how intellectual property law, FDA law, product liability regimes, and antitrust law shape life sciences innovation. Evaluation will be based on class participation and a final exam.
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JD elective
LLM-LE (JD) elective
IntlLLM-SJD-EXC elective
IntlLLM Business Cert
IntllLLM IP Cert
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Spring 2026
| Course Number | Course Credits | Evaluation Method | Instructor | ||
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| 321.01 | 3 |
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Arti K. Rai | ||
This course addresses the key legal and policy regimes that shape the introduction of new products, processes, and services in the life science industries. Innovation in biopharmaceuticals, medical devices, and health care delivery is central to the heavily regulated life sciences sector, and the sector therefore provides valuable insights into the intersection of law and regulatory policy with scientific innovation. In particular, this course will focus on how intellectual property law, FDA law, product liability regimes, and antitrust law shape life sciences innovation. Evaluation will be based on class participation and a final exam. Degree RequirementsPre/Co-requisitesNone |
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Spring 2023
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 |
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Arti K. Rai | ||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2022
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 |
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Arti K. Rai | ||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2021
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 |
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Arti K. Rai | ||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2020
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 |
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Arti K. Rai | ||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2019
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 |
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Arti K. Rai | ||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2018
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 | Arti K. Rai | |||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2017
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 | Arti K. Rai | |||
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. Degree RequirementsPre/Co-requisitesNone |
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Spring 2016
| Course Number | Course Credits | Evaluation Method | Instructor | ||
|---|---|---|---|---|---|
| 321.01 | 3 | Barak D. Richman, Arti K. Rai | |||
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-requisitesThe course has no prerequisites. However, students will be expected to be quick studies on a variety of legal subjects. |
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