S. Sean Tu

West Virginia University College of Law

Professor of Law

101 Law School Drive

Morgantown, WV West Virginia 26506

United States

http://https://www.law.wvu.edu/faculty-staff/faculty/s-sean-tu

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital

Visiting Professor

1620 Tremont St.

Suite 3012

Boston, MA 02120

United States

http://https://www.portalresearch.org/sean-tu.html

Georgetown University - The O'Neill Institute for National and Global Health Law

Scholar

600 New Jersey Avenue, NW

Washington, DC 20001

United States

http://https://oneill.law.georgetown.edu/experts/s-sean-tu/

SCHOLARLY PAPERS

46

DOWNLOADS
Rank 8,870

SSRN RANKINGS

Top 8,870

in Total Papers Downloads

9,610

SSRN CITATIONS
Rank 45,087

SSRN RANKINGS

Top 45,087

in Total Papers Citations

12

CROSSREF CITATIONS

7

Ideas:
“  FDA and Patent Law  ”

Scholarly Papers (46)

1.

Patent Law: An Open-Source Casebook (Entire Book)

Patent Law: An Open-Source Casebook (Fall 2023)
Number of pages: 1085 Posted: 06 May 2021 Last Revised: 27 Aug 2023
Indiana University Maurer School of Law, University of San Diego School of Law, University of Texas - McCombs School of Business, University of Minnesota Law School, University of Richmond - School of Law, George Washington University - Law School, UC Law, San Francisco, University of Iowa - College of Law, Southern Methodist University - Dedman School of Law and West Virginia University College of Law
Downloads 2,696 (9,368)

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patent law, patents, patent system, casebook, open source, history of patent law, economics of patent law, patent document and its claims, subject matter eligibility, utility, disclosure, anticipation, obviousness, infringement, defenses, remedies

2.

Luck/Unluck of the Draw: An Empirical Study of Examiner Allowance Rates

2012 Stan. Tech. L. Rev. 10
Number of pages: 45 Posted: 06 Oct 2011 Last Revised: 19 Jun 2020
S. Sean Tu
West Virginia University College of Law
Downloads 1,285 (29,618)
Citation 5

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patent, patents, patent law, patent reform, intellectual property, examiner, patent examination, USPTO

3.

Limits of Using Artificial Intelligence and GPT-3 in Patent Prosecution

54 Texas Tech Law Review 255 (2022), WVU College of Law Research Paper No. 2021-014
Number of pages: 20 Posted: 09 Aug 2021 Last Revised: 21 Sep 2022
S. Sean Tu, Amy Cyphert and Sam Perl
West Virginia University College of Law, West Virginia University - College of Law and Carnegie Mellon University
Downloads 522 (99,585)
Citation 1

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patent, artificial intelligence, GPT-3, patent prosecution, utility, enablement

4.

What Litigators Can Teach the Patent Office About Pharmaceutical Patents

WVU College of Law Research Paper No. 2021-015, Washington Law Review, Vol. 99, No. 1673, 2022
Number of pages: 59 Posted: 11 Aug 2021 Last Revised: 05 Aug 2022
S. Sean Tu and Mark A. Lemley
West Virginia University College of Law and Stanford Law School
Downloads 498 (105,578)
Citation 3

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5.

Three New Metrics for Patent Examiner Activity: Office Actions per Grant Ratio (OGR), Office Actions per Disposal Ratio (ODR), and Grant to Examiner Ratio (GER)

WVU College of Law Research Paper No. 2019-003, 100 Journal of the Patent and Trademark Office Society 277 (2018)
Number of pages: 37 Posted: 22 Jan 2018 Last Revised: 14 Jun 2021
S. Sean Tu
West Virginia University College of Law
Downloads 451 (118,763)

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Intellectual property, patent, patent law, patent examiner, patent statistics, patent prosecution, United States Patent and Trademark Office, USPTO, PTO, patentability, examination

6.

Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office

Berkeley Technology Law Journal, Vol. 38, p. 1 (2023), WVU College of Law Research Paper No. 2022-005
Number of pages: 50 Posted: 10 Feb 2022 Last Revised: 01 Nov 2023
S. Sean Tu and Christopher M. Holman
West Virginia University College of Law and University of Missouri - Kansas City School of Law
Downloads 365 (151,273)
Citation 1

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patent, antibody, USPTO, PTO, written description, enablement, patent examiner, prosecution, litigation

7.

Patent Examination and Litigation Outcomes

Stanford Technology Law Review, Vol. 17, p. 507, 2014, WVU Law Research Paper No. 2014-3
Number of pages: 43 Posted: 25 Jun 2014 Last Revised: 17 Jan 2019
S. Sean Tu
West Virginia University College of Law
Downloads 331 (168,226)
Citation 3

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patent, patents, patent law, patent reform, intellectual property, examiner, patent examination, USPTO

8.

Why Pharmaceutical Patent Thickets Are Unique

Texas Intellectual Property Law Journal, Forthcoming, Rutgers Law School Research Paper, WVU College of Law Research Paper No. 2023-25
Number of pages: 32 Posted: 19 Sep 2023 Last Revised: 22 Mar 2024
Michael A. Carrier and S. Sean Tu
Rutgers Law School and West Virginia University College of Law
Downloads 320 (174,411)

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patents, thickets, pharmaceuticals, drugs, high technology, continuations, Humira

9.

Antibody Claims and the Evolution of the Written Description / Enablement Requirement

IDEA 63(1):84 (2023)
Number of pages: 54 Posted: 07 Dec 2022 Last Revised: 14 Jan 2023
S. Sean Tu and Christopher M. Holman
West Virginia University College of Law and University of Missouri - Kansas City School of Law
Downloads 295 (189,982)
Citation 1

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antibody, patent, USPTO, patent examination, examiner, prosecution, written description, enablement, 35 USC 112(a)

10.

Use of Artificial Intelligence to Determine Copyright Liability for Musical Works

WVU College of Law Research Paper, No. 2020-012, 123 West Virginia Law Review 835 (2021)
Number of pages: 38 Posted: 01 Oct 2020 Last Revised: 15 May 2023
S. Sean Tu
West Virginia University College of Law
Downloads 275 (204,196)

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artificial intelligence, copyright, copyright liability, machine learning, substantial similarity, music

11.

Patent Examination and Examiner Interviews

WVU College of Law Research Paper No. 2021-001, Florida State Law Review Online (September 2021)
Number of pages: 25 Posted: 10 Nov 2020 Last Revised: 21 Sep 2021
S. Sean Tu
West Virginia University College of Law
Downloads 264 (212,723)

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patents, patent examiner, patent examination, prior art, examiner interview, patent prosecution, PTO

12.

Patenting Fast and Slow: Examiner Rejections and Applicant Traversals to Non-Prior Art Rejections

WVU College of Law Research Paper No. 2020-005, 2021 Michigan State Law Review 411 (2021)
Number of pages: 57 Posted: 02 Mar 2020 Last Revised: 28 Sep 2022
S. Sean Tu
West Virginia University College of Law
Downloads 236 (237,547)

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patents, patent examiner, patent prosecution, prior art, prior art rejections, patent quality, applicant response, applicant behavior, PTO, empirical

13.

Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v. Hikma Type Litigation

12 NYU Journal of Intellectual Property & Entertainment Law, 1 (Fall 2022), WVU College of Law Research Paper No. 2022-017
Number of pages: 54 Posted: 06 Sep 2022 Last Revised: 24 Jan 2023
S. Sean Tu and Charles Duan
West Virginia University College of Law and American University Washington College of Law
Downloads 226 (247,701)

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patent, patent litigation, generic, drug, drugs, brand, manufacturer, pharmaceutical, skinny label, health

14.

Response to ‘Pervasive Sequence Patents Cover the Entire Human Genome’

Genome Medicine, Vol. 6, No. 14, 2014, George Mason Law & Economics Research Paper No. 14-07, San Diego Legal Studies Paper No. 14-148, Loyola-LA Legal Studies Paper No. 2014-19, Georgia State University College of Law, Legal Studies Research Paper No. 2014-16
Number of pages: 4 Posted: 01 Mar 2014 Last Revised: 14 May 2014
West Virginia University College of Law, University of Missouri - Kansas City School of Law, George Mason University - Antonin Scalia Law School, University of San Diego School of Law, Villanova University Charles Widger School of Law, University of Utah - S.J. Quinney College of Law, Georgia State University College of Law, University of Baltimore - School of Law and Loyola Law School Los Angeles
Downloads 217 (257,301)
Citation 1

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gene patents, human genome, Myriad Genetics, patent claims, patent scope

15.

Patenting Fast and Slow: Examiner and Applicant Use of Prior Art

Cardozo Arts & Entertainment Law Journal, Volume 38(2): 391-434 (2020), WVU College of Law Research Paper 2020-004
Number of pages: 44 Posted: 02 Mar 2020 Last Revised: 15 Oct 2020
S. Sean Tu
West Virginia University College of Law
Downloads 212 (262,930)

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patents, patent examiner, patent prosecution, prior art, prior art rejections, patent quality, applicant response, applicant behavior, PTO

16.

Free Speech in the Balance: Judicial Sanctions and Frivolous SLAPP Suits

Loyola Los Angeles Law Review, Volume 54(2): 623-674 (2021), WVU College of Law Research Paper No. 2020-003
Number of pages: 44 Posted: 14 Feb 2020 Last Revised: 28 May 2021
S. Sean Tu and Nicholas Stump
West Virginia University College of Law and West Virginia University - College of Law
Downloads 209 (266,433)

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free speech, defamation, attorney sanctions, judicial sanctions, Rule 11, SLAPP, Anti-SLAPP, Robert Murray, John Oliver, Media, Journalism, Free speech, first amendment, frivolous

17.

Overqualified and Underrepresented: Gender Inequality in Pharmaceutical Patent Law

Brigham Young University Law Review, Vol. 48, p. 137, Temple University Legal Studies Research Paper No. 2021-44, WVU College of Law Research Paper No. 2022-001
Number of pages: 60 Posted: 11 Nov 2021 Last Revised: 11 Mar 2023
S. Sean Tu, Paul R. Gugliuzza and Amy Semet
West Virginia University College of Law, Temple University - James E. Beasley School of Law and SUNY, University of Buffalo
Downloads 157 (342,626)

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gender, patent, patent litigation, pharmaceutical, diversity, inequality, patent prosecution, PTO

18.

Patent Law: An Open-Source Casebook (Cover, Preface, and Table of Contents)

Patent Law: An Open-Source Casebook (Fall 2023)
Number of pages: 17 Posted: 30 Apr 2021 Last Revised: 27 Aug 2023
University of Texas - McCombs School of Business, University of Minnesota Law School, University of Richmond - School of Law, Indiana University Maurer School of Law, George Washington University - Law School, UC Law, San Francisco, University of Iowa - College of Law, University of San Diego School of Law, Southern Methodist University - Dedman School of Law and West Virginia University College of Law
Downloads 130 (398,343)
Citation 1

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patents, patent law, casebook, open source, patent claims, subject matter eligibility, utility, disclosure, anticipation, obviousness, infringement, defenses, remedies

19.

Invalidated Patents and Associated Patent Examiners

Vanderbilt Journal of Entertainment & Technology Law, No. 18
Number of pages: 31 Posted: 01 Feb 2016 Last Revised: 18 Jan 2019
S. Sean Tu
West Virginia University College of Law
Downloads 124 (413,033)
Citation 1

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Patent, patents, examiner, patent examiner, USPTO, litigation

20.

Brief of 42 Professors of Law, Economics, Business, and Medicine as Amici Curiae in Support of the Petition

Supreme Court brief in Teva Pharmaceuticals v. GlaxoSmithKline (2022), Rutgers Law School Research Paper, WVU College of Law Research Paper No. 2022-015
Number of pages: 22 Posted: 11 Aug 2022 Last Revised: 21 Nov 2022
Rutgers Law School, American University Washington College of Law and West Virginia University College of Law
Downloads 122 (418,016)

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skinny labels, generics, Hatch Waxman, method-of-use patents

21.

FDA Reexamination: Increased Communication Between the FDA and USPTO to Improve Patent Quality

WVU College of Law Research Paper No. 2022-014, Houston Law Review, Vol. 60, 2022 60 Hous. L. Rev. 403 (2022).
Number of pages: 63 Posted: 29 Jun 2022 Last Revised: 17 Jan 2023
S. Sean Tu
West Virginia University College of Law
Downloads 118 (428,527)

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patent, reexamination, USPTO, PTO, post-grant review, IPR, inter partes review, examination

22.

Effectiveness of Examiner Interviews

14 Landslide 24 (2022), WVU College of Law Research Paper No. 2022-006
Number of pages: 9 Posted: 25 Feb 2022 Last Revised: 06 Apr 2022
S. Sean Tu
West Virginia University College of Law
Downloads 111 (451,552)

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patent, examiner interview, interview, PTO, prosecution, patent prosecution, patent examiner

23.

Bigger and Better Patent Examiner Statistics

WVU College of Law Research Paper No. 2019-006, IDEA: The IP Law Review, Vol. 59, 2018
Number of pages: 21 Posted: 10 Jan 2019 Last Revised: 25 Jan 2019
S. Sean Tu
West Virginia University College of Law
Downloads 85 (535,685)

Abstract:

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Intellectual property, patent, patent law, patent examiner, patent statistics, patent prosecution, United States Patent and Trademark Office, USPTO, PTO, patentability, examination

24.

Understanding the Backlog Problems Associated with Requests for Continued Examination Practice

Duke Law & Technology Review, Vol. 13, No. 1, p. 216, 2015, WVU Law Research Paper No. 2015-10
Number of pages: 32 Posted: 05 Sep 2015 Last Revised: 25 Jan 2019
S. Sean Tu
West Virginia University College of Law
Downloads 77 (567,883)

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patent examination, examiner, RCE, continuation, patent application, Intellectual property, patent, patent law, patent statistics, patent prosecution, United States Patent and Trademark Office, USPTO, PTO, patentability

25.

Artificial Intelligence Cannibalism and the Law

Colorado Technology Law Journal, forthcoming, WVU College of Law Research Paper, No. 2023-23
Number of pages: 12 Posted: 09 Nov 2023 Last Revised: 14 Dec 2023
Amy Cyphert, Sam Perl and S. Sean Tu
West Virginia University - College of Law, Carnegie Mellon University and West Virginia University College of Law
Downloads 73 (585,302)

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Artificial Intelligence, algorithm, legal standards

26.

Funk Brothers: An Exercise in Obviousness

University of Missouri-Kansas City Law Review, Vol. 80, No. 3, 2011
Number of pages: 21 Posted: 21 Jul 2021 Last Revised: 11 Aug 2021
S. Sean Tu
West Virginia University College of Law
Downloads 50 (705,257)

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Patents, patentable subject matter, obviousness, 103, 101 gene patents

27.

Brief of Intellectual Property Law Professors and Scholars as Amici Curiae in Support of the Respondents

Supreme Court brief in Amgen, Inc., v. Sanofi, et al. (2023), WVU College of Law Research Paper, No. 2023-016, Duke Law School Public Law & Legal Theory Series No. 2023-40
Number of pages: 43 Posted: 19 Jul 2023 Last Revised: 09 Sep 2023
Oskar Liivak, Arti K. Rai and S. Sean Tu
Cornell University - Law School, Duke University School of Law and West Virginia University College of Law
Downloads 44 (743,964)

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Supreme Court of the United States, SCOTUS, amicus brief, Amgen Inc., v. Sanofi, patent law

28.

Characteristics of Patent Examiners Who Issue Litigated/Invalidated Patents

27 Intellectual Property Litigator 1 (2021), WVU College of Law Research Paper No. 2021-016
Number of pages: 8 Posted: 24 Sep 2021 Last Revised: 01 Apr 2022
S. Sean Tu
West Virginia University College of Law
Downloads 40 (772,154)

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Patent, patent litigation, patent examination, USPTO, invalidation, empirical

29.

Gender Inequality in Pharmaceutical Patent Law

Landslide, Vol. 15 (2023), WVU College of Law Research Paper No. 2023-007
Number of pages: 9 Posted: 21 Mar 2023 Last Revised: 23 May 2023
S. Sean Tu and Tess Hardesty
West Virginia University College of Law and West Virginia University College of Law
Downloads 35 (809,214)

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patent law, pharmaceutical patents, patent litigators, patent attorneys, gender, gender representation, legal education, pipeline theory

30.

Fast versus Slow Examination: How Examiners Use Allowances or Rejections to Delay or Compact Patent Prosecution

Intellectual Property Litigator (September/October 2021), WVU College of Law Research Paper, 2021-018
Number of pages: 10 Posted: 24 Sep 2021 Last Revised: 26 Oct 2021
S. Sean Tu
West Virginia University College of Law
Downloads 31 (841,428)

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patent, patent examination, USPTO, rejections, anticipation, novelty, obviousness, 102, 103

31.

The Indeterminacy Critique and the Trespass Fallacy

Florida Law Review, Vol. 65, No. 35, 2013
Number of pages: 3 Posted: 16 Jun 2021 Last Revised: 11 Aug 2021
S. Sean Tu
West Virginia University College of Law
Downloads 11 (1,030,872)

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patent

32.

Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”

Clinical Pharmacology and Therapeutics, Vol. 115(1), p 22-24 (2024)
Posted: 22 Feb 2024
S. Sean Tu and Aaron Kesselheim
West Virginia University College of Law and Harvard University - Harvard Medical School

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skinny labeling, generic drugs, drug labeling, GlaxoSmithKline (GSK) v. Teva, method-of-use patents, patent thickets

33.

Inequitable Conduct and Invalidation of FDA-Regulated Product Patents

JAMA, Vol. 330(21), p. 2119-2121 (2023)
Posted: 22 Feb 2024
West Virginia University College of Law, West Virginia University College of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School and Harvard University - Harvard Medical School

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drug patents, USPTO, US Patent and Trademark Office, inequitable conduct, FDA, drug patent invalidation

34.

Ancillary Product Patents to Extend Biologic Patent Life

JAMA, Vol. 330(21), p. 2217-2119 (2023)
Posted: 22 Feb 2024
Rachel Goode, William Feldman and S. Sean Tu
Fresenius Kabi USA, Harvard University - Harvard Medical School and West Virginia University College of Law

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biologic patents, ancillary product patents, trade secret

35.

Biologic Patent Thickets and Terminal Disclaimers

JAMA, Vol. 331(4), p. 335-337 (2023)
Posted: 22 Feb 2024
S. Sean Tu, Rachel Goode and William Feldman
West Virginia University College of Law, Fresenius Kabi USA and Harvard University - Harvard Medical School

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patent thickets, biosimilar competition, terminal disclaimer, US Patent and Trademark Office, biologic patents

36.

Free Speech Challenges to the Inflation Reduction Act

JAMA, Vol. 330(13), p. 1229-1230 (2023), WVU College of Law Research Paper No. 2023-21
Posted: 09 Nov 2023
S. Sean Tu and Rebecca Tushnet
West Virginia University College of Law and Harvard Law School

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First Amendment, Inflation Reduction Act, free speech, speech

37.

The Prevalence of Drug Patent Term Extensions in the United States, 2000-2018

Nature Biotechnology, Vol. 41, p. 903-906 (2023), WVU College of Law Research Paper No. 2023-20
Posted: 09 Nov 2023
University of Cambridge, Faculty of Law, Brigham and Women's Hospital/Harvard Medical School, Harvard University and West Virginia University College of Law

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Patents, Patent Term Extension, Expiration

38.

Changes in the Number of Continuation Patents on Drugs Approved by the FDA between 2000-2015

JAMA, Vol. 330(5), p. 469-470 (2023), WVU College of Law Research Paper No. 2023-19
Posted: 09 Nov 2023
West Virginia University College of Law, Brigham and Women's Hospital/Harvard Medical School, Independent and Harvard University - Harvard Medical School

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Patents, patent, continuation, USPTO

39.

Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation

JAMA, Vol. 329(18), p. 1607-1608, 2023 doi:10.1001/jama.2023.3079, WVU College of Law Research Paper, No. 2023-014
Posted: 19 Jul 2023 Last Revised: 09 Sep 2023
West Virginia University College of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Brigham and Women's Hospital/Harvard Medical School, Harvard University - Division of Pharmacoepidemiology and Pharmacoeconomics and Independent

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Orphan Drug Act, pharmaceutical investment, statutory incentive, FDA, Orphan Drug Designations and Approvals

40.

Broad Patent Claims Come Before the Supreme Court in Amgen v. Sanofi

JAMA, Vol. 329(19), p. 1641-1642, 2023 doi:10.1001/jama.2023.5638, WVU College of Law Research Paper, No. 2023-015
Posted: 18 Jul 2023 Last Revised: 09 Sep 2023
West Virginia University College of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School and University of Cambridge, Faculty of Law

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Amen v Sanofi, patent law, enablement, SCOTUS

41.

A 'Method of Use' to Prevent Generic and Biosimilar Market Entry

New England Journal of Medicine, Vol. 388, p. 483-485, WVU College of Law Research Paper No. 2023-009
Posted: 08 May 2023
S. Sean Tu and Ameet Sarpatwari
West Virginia University College of Law and Harvard Medical School

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patent law, patent thicket, pharmaceutical patents, generic drugs, method of use patents

42.

Next-Generation Bioprinted Products: Products of Nature or Patentable Innovation?

IEEE Pulse, Vol. 14(1), p. 20, Link to full text at IEEE Pulse: https://ieeexplore.ieee.org/document/10070346, WVU College of Law Research Paper No. 2023-006
Posted: 21 Mar 2023
Jennie Zheng, S. Sean Tu and Stephen Maebius
Foley & Lardner LLP, West Virginia University College of Law and Foley & Lardner LLP

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bioprinting, bioink, patent law, patent eligibility, FDA,

43.

Recent Patent Reform Bills and Their Implications for Prescription Drugs

JAMA, Vol. 329(6), p. 459-460, Link to full text at JAMA: https://jamanetwork.com/journals/jama/fullarticle/2800700, WVU College of Law Research Paper No. 2023-005
Posted: 21 Mar 2023
West Virginia University College of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School and Brigham and Women's Hospital/Harvard Medical School

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pharmaceutical, FDA, patent, prescription drug, legislation

44.

Antibody Patent Evolution

WVU College of Law Research Paper No. 2022-020, IEEE Pulse, This article was published in IEEE Pulse. The version of record is available at: https://pubmed.ncbi.nlm.nih.gov/36301809/, Vol. 13, Issue 5, p. 33-37, 2022
Posted: 03 Nov 2022
Independent, Brigham and Women's Hospital/Harvard Medical School and West Virginia University College of Law

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therapeutic antibodies, antibody patents, USPTO, pharmaceutical patents, drug patents

45.

Product Hopping in the Drug Industry — Lessons from Albuterol

New England Journal of Medicine, Vol. 387, p. 1153-1156 (2022), WVU College of Law Research Paper No. 2022-019
Posted: 17 Oct 2022
West Virginia University College of Law, affiliation not provided to SSRN and Harvard University - Harvard Medical School

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Food and Drug Administration, FDA, generic drugs, albuterol, patents, brand-name drugs, pharmaceutical patents, drug patents

46.

Reference Check: A Simple Strategy to Improve Drug Patent Quality

WVU College of Law Research Paper No. 2022-012 Health Affairs Forefront https://www.healthaffairs.org/do/10.1377/forefront.20220615.404330
Posted: 28 Jun 2022 Last Revised: 20 Aug 2022
West Virginia University College of Law, University of Missouri School of Law and Brigham and Women's Hospital/Harvard Medical School

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USPTO, patent, pharmaceutical, orange book, patent examination, PTO