Erika Lietzan

University of Missouri School of Law

Missouri Avenue & Conley Avenue

Columbia, MO MO 65211

United States

SCHOLARLY PAPERS

23

DOWNLOADS
Rank 13,444

SSRN RANKINGS

Top 13,444

in Total Papers Downloads

5,245

SSRN CITATIONS

4

CROSSREF CITATIONS

4

Scholarly Papers (23)

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 986 (32,840)
Citation 1

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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
Sean M. O'Connor and Erika Lietzan
George Mason University - Antonin Scalia Law School, Faculty and University of Missouri School of Law
Downloads 604 (63,382)
Citation 2

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

3.
Downloads 513 ( 77,804)

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 498 (79,923)

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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 15 (770,690)

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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 478 (84,723)
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 447 (91,744)
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 373 (112,891)
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 333 (127,994)

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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 261 (164,508)

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

9.

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 172 (241,446)

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biosimilars, BPCIA, FDA, biologics

10.

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 166 (248,712)
Citation 1

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

11.

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 157 (260,660)

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

12.

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 135 (293,686)

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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

13.

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 131 (300,446)

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

14.

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 95 (374,848)
Citation 2

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

15.

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 95 (374,848)

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

16.

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 77 (425,135)

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

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

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 64 (468,749)

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transparency, trade secrets, clinical data, data protection

19.

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 28 (643,672)

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

20.

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 24 (672,099)

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preemption, FDA, products liability

21.

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 22 (687,344)

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advisory committees, FDA, conflicts of interest

22.

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 14 (753,449)

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

23.

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