Erika Lietzan

University of Missouri School of Law

Missouri Avenue & Conley Avenue

Columbia, MO MO 65211

United States

SCHOLARLY PAPERS

26

DOWNLOADS
Rank 14,435

SSRN RANKINGS

Top 14,435

in Total Papers Downloads

6,208

SSRN CITATIONS

11

CROSSREF CITATIONS

3

Scholarly Papers (26)

1.

The Drug Innovation Paradox

Missouri Law Review, Forthcoming, University of Missouri School of Law Legal Studies Research Paper No. 2017-12
Number of pages: 75 Posted: 07 Apr 2017 Last Revised: 11 Aug 2022
Erika Lietzan
University of Missouri School of Law
Downloads 1,033 (39,350)
Citation 1

Abstract:

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new drugs, patents, data exclusivity, clinical trials, medical innovation, health policy, empirical research, history of medicine, patent policy, patent term restoration

2.

The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling

68 American University Law Review 823 (2019), University of Missouri School of Law Legal Studies Research Paper No. 2019-02
Number of pages: 103 Posted: 20 Sep 2018 Last Revised: 11 Aug 2022
Seán M. O'Connor and Erika Lietzan
George Mason University - Antonin Scalia Law School and University of Missouri School of Law
Downloads 681 (69,391)
Citation 2

Abstract:

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cannabis, marijuana, medical marijuana, FDA, food and drug law, health law, regulatory law, administrative law

3.
Downloads 564 (87,945)
Citation 1

Distorted Drug Patents

95 Washington Law Review 1317 (2020), University of Missouri School of Law Legal Studies Research Paper No. 2019-20
Number of pages: 68 Posted: 30 Sep 2019 Last Revised: 11 Aug 2022
University of Missouri School of Law and Colorado College - Department of Economics & Business
Downloads 538 (92,254)

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patents, pharmaceuticals, patent term restoration, innovation, access to medicines, clinical research, empirical research

Distorted Drug Patents

95 Washington Law Review 1317 (2020), University of Missouri School of Law Legal Studies Research Paper No. 2019-20
Number of pages: 68 Posted: 30 Sep 2019
University of Missouri School of Law and Colorado College - Department of Economics & Business
Downloads 26 (885,720)
Citation 1

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patents, pharmaceuticals, patent term restoration, innovation, access to medicines, clinical research, empirical research

4.

The Law of 180-Day Exclusivity

Food & Drug Law Journal, Forthcoming, University of Missouri School of Law Legal Studies Research Paper No. 2016-17
Number of pages: 104 Posted: 31 May 2016 Last Revised: 24 Jun 2016
Erika Lietzan and Julia Post
University of Missouri School of Law and Covington & Burling LLP
Downloads 512 (99,199)
Citation 1

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Generics, Brand Drugs, Hatch-Waxman, Antitrust, Intellectual Property, Patents, Biosimilars, Authorized Generics, New Drugs, FDA, PTO

5.

The History and Political Economy of the Hatch-Waxman Amendments

49 Seton Hall Law Review 53 (2018), University of Missouri School of Law Legal Studies Research Paper No. 2018-20
Number of pages: 76 Posted: 15 Mar 2018 Last Revised: 19 Dec 2018
Erika Lietzan
University of Missouri School of Law
Downloads 469 (110,265)
Citation 1

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drugs, patents, generic drugs, patent term restoration, patent term extension, public choice

6.

The Myths of Data Exclusivity

20 Lewis & Clark L. Rev. 91 (2016), University of Missouri School of Law Legal Studies Research Paper No. 2015-22
Number of pages: 74 Posted: 02 Sep 2015 Last Revised: 18 Sep 2016
Erika Lietzan
University of Missouri School of Law
Downloads 403 (132,026)
Citation 1

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pharmaceuticals, drugs, generic drugs, access to medicines, biologics, biosimilars, intellectual property, patents, exclusivity, data protection

7.

An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009

Food and Drug Journal, Vol. 65, No. 4, 2010
Number of pages: 149 Posted: 17 Feb 2013
Erika Lietzan, Jeffrey Elikan and Krista Carver
University of Missouri School of Law, Covington & Burling and Covington & Burling
Downloads 381 (140,161)
Citation 1

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biosimilars, BPCIA, biologics, Hatch-Waxman

8.

The Uncharted Waters of Competition and Innovation in Biological Medicines

44 Florida State University Law Review 883 (2017), University of Missouri School of Law Legal Studies Research Paper No. 2016-27
Number of pages: 61 Posted: 06 Oct 2016 Last Revised: 29 May 2018
Erika Lietzan
University of Missouri School of Law
Downloads 290 (188,034)

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Generic Drugs, Biosimilars, Patents, Antitrust, Coverage, Reimbursement, Substitution, Marketplace Dynamics, Competition, Medicare, Medicaid

9.

Solutions Still Searching for a Problem: A Call for Relevant Data to Support 'Evergreening' Allegations

33 Fordham Intell. Prop. Media & Ent. L.J. 788 (2023)., University of Missouri School of Law Legal Studies Research Paper: 2022-09
Number of pages: 85 Posted: 26 Sep 2022 Last Revised: 24 Jun 2023
University of Missouri School of Law and Colorado College - Department of Economics & Business
Downloads 227 (239,864)

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drugs, patents, evergreening, exclusivity, policymaking

10.

Biosimilar Law and Regulation: An Essential Guide

FDLI Monograph Series, Volume 2, Number 5, June 2011
Number of pages: 228 Posted: 20 Feb 2013
Erika Lietzan
University of Missouri School of Law
Downloads 204 (266,102)

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biosimilars, BPCIA, FDA, biologics

11.

Paper Promises for Drug Innovation

26 George Mason Law Review 168 (2018) , University of Missouri School of Law Legal Studies Research Paper No. 2018-17
Number of pages: 48 Posted: 23 Jan 2018 Last Revised: 15 Apr 2019
Erika Lietzan
University of Missouri School of Law
Downloads 203 (266,102)
Citation 3

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drugs, biologics, medicine, generic drugs, biosimilars, patents, exclusivity, new uses, repurposing, innovation policy

12.

The "Evergreening" Metaphor in Intellectual Property Scholarship

53 Akron Law Review 805 (2019), University of Missouri School of Law Legal Studies Research Paper No. 2020-08
Number of pages: 68 Posted: 20 Feb 2020 Last Revised: 10 Aug 2020
Erika Lietzan
University of Missouri School of Law
Downloads 182 (293,557)

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drugs, patents, generic drugs, FDA, evergreening, antitrust

13.

Ignoring Drug Trademarks

56 Wake Forest Law Review 945 (2021), University of Missouri School of Law Legal Studies Research Paper 2021-30
Number of pages: 77 Posted: 16 Jun 2021 Last Revised: 11 Aug 2022
Erika Lietzan
University of Missouri School of Law
Downloads 168 (314,675)

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FDA, brand drugs, generic drugs, drug patents, trademark law, brand names, pharmacy law, healthcare finance, history of pharmacy, history of medicine, evergreening, Medicare, Medicaid, food and drug law

14.

A Second Look at the CREATES Act: What's Not Being Said

The Federalist Society Review, Volume 17, Issue 3, Forthcoming , University of Missouri School of Law Legal Studies Research Paper No. 2016-26
Number of pages: 14 Posted: 29 Sep 2016 Last Revised: 25 Oct 2016
Erika Lietzan
University of Missouri School of Law
Downloads 147 (351,958)

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Generic Drugs, Biosimilars, Antitrust, Patent, Legislation, FDA, Drug Pricing, Innovation Policy, Biologics

15.

Access Before Evidence and the Price of the FDA's New Drug Authorities

53 U. RICH. L. REV. 1243 (2019) , University of Missouri School of Law Legal Studies Research Paper No. 2019-02
Number of pages: 68 Posted: 05 Mar 2019 Last Revised: 26 May 2019
Erika Lietzan
University of Missouri School of Law
Downloads 119 (414,142)
Citation 2

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fecal microbiota, FDA, new drugs, tissues, blood, Hatch Waxman, orphan drugs, cost-benefit analysis, innovation

16.

A New History and Discussion of 180-Day Exclusivity

Food and Drug Law Journal, Vol. 64, No. 2, 2009
Number of pages: 57 Posted: 18 Feb 2013
David Korn, Erika Lietzan and Shaw Scott
Pharmaceutical Research and Manufacturers of America (PhRMA), University of Missouri School of Law and Covington & Burling
Downloads 118 (416,826)

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Hatch-Waxman, 180-day exclusivity, generic drugs, ANDAs

17.

A Solution in Search of a Problem at the Biologics Frontier

2018 U. Ill. L. Rev. Online 19, University of Missouri School of Law Legal Studies Research Paper No. 2018-05
Number of pages: 17 Posted: 30 Nov 2017 Last Revised: 06 Feb 2018
Erika Lietzan
University of Missouri School of Law
Downloads 98 (479,424)

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Antitrust, Competition, Generic Drugs, Biosimilars, Patents, Exclusivity, Product Hopping, Incremental Innovation, Competition, Innovation

18.

A New Framework for Assessing Clinical Data Transparency Initiatives

Number of pages: 54 Posted: 11 Aug 2013 Last Revised: 18 Mar 2014
Erika Lietzan
University of Missouri School of Law
Downloads 83 (528,789)

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transparency, trade secrets, clinical data, data protection

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FDA, Patent, Antitrust, Drug Pricing, Generic Drugs, Public Health, Transparency, Open Government

20.

The Case of the Missing Device Patents, or: Why Device Patents Matter

XXXIII Fordham Intell. Prop. Media & Ent. L.J.409 (2023), University of Missouri School of Law Legal Studies Research Paper
Number of pages: 66 Posted: 22 Sep 2022 Last Revised: 08 Feb 2023
University of Missouri School of Law, Colorado College - Department of Economics & Business and Shook, Hardy & Bacon L.L.P.
Downloads 71 (578,096)

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patents, medical devices, innovation, FDA, intellectual property, drugs, drug patents

21.

Brief of 11 Professors as Amici Curiae in Support of Amgen in Amgen v. Sandoz

Number of pages: 55 Posted: 23 Mar 2017 Last Revised: 25 Mar 2017
Erika Lietzan
University of Missouri School of Law
Downloads 48 (697,720)

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biologics, medicines, innovation, patent litigation, economics, FDA, Hatch-Waxman, legislation

22.

Advisory Commitees at FDA: The Hinchey Amendment and 'Conflict of Interest' Waivers

Journal of Health Law, Vol. 39, No. 4, 2006
Number of pages: 35 Posted: 20 Feb 2013
Erika Lietzan
University of Missouri School of Law
Downloads 41 (743,198)

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advisory committees, FDA, conflicts of interest

23.

Thoughts on Preemption in the Wake of the Levine Decision

Journal of Health Care Law & Policy, Vol. 13, No. 225, 2010
Number of pages: 32 Posted: 18 Feb 2013
Erika Lietzan and Sarah E. Pitlyk
University of Missouri School of Law and Independent
Downloads 39 (757,114)

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preemption, FDA, products liability

24.

Outpatient Civil Commitment in North Carolina: Constitutional and Policy Concerns

Law and Contemporary Problems, Vol. 58, No. 2, 1995
Number of pages: 32 Posted: 21 Feb 2013
Erika Lietzan
University of Missouri School of Law
Downloads 27 (850,626)

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outpatient commitment, mental health, O'Connor v. Donaldson

25.

User Fee Programs: Design Choices and Processes

University of Missouri School of Law Legal Studies Research Paper
Number of pages: 79 Posted: 11 Dec 2023
Erika Lietzan
University of Missouri School of Law
Downloads 21 (904,639)

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26.

FDA Regulation of Biosimilars

FDA in the Twenty First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press 2015)
Posted: 17 Sep 2015
Erika Lietzan and Henry G. Grabowski
University of Missouri School of Law and Duke University - Department of Economics

Abstract:

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biosimilars, generic drugs, BPCIA, Hatch-Waxman, price competition, innovation, cost savings, pharmaceuticals, biotechnology