Yaniv Heled

Georgia State University College of Law

Associate Professor

85 Park Pl NE

Atlanta, GA 30303

United States

SCHOLARLY PAPERS

25

DOWNLOADS
Rank 18,565

SSRN RANKINGS

Top 18,565

in Total Papers Downloads

3,319

SSRN CITATIONS

4

CROSSREF CITATIONS

3

Scholarly Papers (25)

1.

Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?

18 Michigan Telecommunications and Technology Law Review 419, Georgia State University College of Law, Legal Studies Research Paper No. 2011-17
Number of pages: 61 Posted: 29 Jun 2011 Last Revised: 21 Feb 2014
Yaniv Heled
Georgia State University College of Law
Downloads 530 (64,625)
Citation 3

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biologics, pharmaceuticals, patents, statutory exclusivities, market exclusivity, data exclusivity, generics, biologics price competition, hatch, waxman, BPCIA, PPACA, FDA

2.

Intellectual Property and Public Health – A White Paper

Akron Intellectual Property Journal, Vol. 7, 2013, U of Akron Legal Studies Research Paper No. 13-11, Northeastern University School of Law Research Paper No. 152-2013, Seton Hall Public Law Research Paper No. 2259089, Georgia State University College of Law, Legal Studies Research Paper No. 2014-22
Number of pages: 23 Posted: 02 May 2013 Last Revised: 19 Jun 2014
University of New Hampshire School of Law, Michigan State University - College of Law, University of Akron - School of Law, Regent University School of Law, University of Louisville - Louis D. Brandeis School of Law, Georgia State University College of Law, Brooklyn Law School, University of Akron - School of Law, University of Akron - School of Law, New York University School of Law, Northeastern University - School of Law, University of Kansas - School of Law and Case Western Reserve University School of Law
Downloads 508 (68,168)

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public health, intellectual property, TRIPS, patent, healthcare, health, big data, innovation, health care, pharmaceuticals, alternatives, Hatch-Waxman, prizes, collectively governed systems, clinical trials, black box, transparency, Obamacare, privacy, human rights

3.

Patent Trolls as Parasites

JURIST - Forum, April 2014, Georgia State University College of Law, Legal Studies Research Paper No. 2014-33
Number of pages: 4 Posted: 04 May 2014 Last Revised: 16 Oct 2014
Yaniv Heled
Georgia State University College of Law
Downloads 378 (96,864)

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4.

Why Primary Patents Covering Biologics Should be Unenforceable Against Generic Applicants under the Biologics Price Competition and Innovation Act

Annals of Health Law, Vol. 21, 2011, Georgia State University College of Law, Legal Studies Research Paper No. 2012-12
Number of pages: 13 Posted: 28 Mar 2012 Last Revised: 30 Jul 2013
Yaniv Heled
Georgia State University College of Law
Downloads 273 (137,919)

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biologics, pharmaceuticals, Price Competition and Innovation Act, FDA, data exclusivity, exclusivities, patents, Hatch-Waxman, BPCIA, primary patents, secondary patents, PTO, Food and Drug Administration, Patent and Trademark Office, market exclusivity, generic exclusivity

5.

The Regulation of Genetic Aspects of Donated Reproductive Tissue - The Need for Federal Regulation

Columbia Science and Technology Law Review, Vol. 11, 2010
Number of pages: 66 Posted: 14 Aug 2010 Last Revised: 28 Jul 2013
Yaniv Heled
Georgia State University College of Law
Downloads 219 (171,096)

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sperm, egg, semen, ova, ovum, insemination, IVF, ART, FDA, tissue, donation, gene, genetic disease, DNA, Public Health Service Act, PHSA, biologics, communicable disease, bioethics

6.

On Patenting Human Organisms or How the Abortion Wars Feed into the Ownership Fallacy

Cardozo Law Review, Vol. 36, 2014, Forthcoming, Georgia State University College of Law, Legal Studies Research Paper No. 2014-06
Number of pages: 61 Posted: 30 Mar 2014 Last Revised: 21 May 2014
Yaniv Heled
Georgia State University College of Law
Downloads 206 (181,238)

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Ownership fallacy, human organism, human being, patents, abortion, Thirteenth Amendment, patenting humans, OTA, Weldon Amendment, directed to or encompassing, chimera, cloning, humanzee, shemale, humouse, innovation, biomedicine, technology

7.

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, Faculty, 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 178 (206,617)
Citation 1

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

8.

On Presidents, Agencies, and the Stem Cells between Them: A Legal Analysis of President Bush’s and the Federal Government’s Policy on the Funding of Research Involving Human Embryonic Stem Cells

Administrative Law Review, Vol. 60, p. 65, 2008, Georgia State University College of Law, Legal Studies Research Paper
Number of pages: 62 Posted: 15 Jul 2010 Last Revised: 18 Apr 2013
Yaniv Heled
Georgia State University College of Law
Downloads 172 (212,789)

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9.

The Problem with Relying on Profit-Driven Models to Produce Pandemic Drugs

Journal of Law & Biosciences, vol. 7, 2020, Saint Louis U. Legal Studies Research Paper No. 2020-17, Georgia State University College of Law, Legal Studies Research Paper No. 2021-03
Number of pages: 23 Posted: 16 Jul 2020 Last Revised: 12 Feb 2021
Georgia State University College of Law, Saint Louis University - School of Law and Emory University School of Law
Downloads 129 (268,805)
Citation 1

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COVID-19, coronavirus, SARS-CoV-2, pandemic, pharmaceuticals, vaccines, healthcare markets, incentives, for-profit, public health, innovation, remdesivir, Food and Drug Administration, FDA, Gilead, Ebola, SARS, MERS, preparedness, private public partnerships, PPPs, emergency response

10.

Why Healthcare Companies Should Be(Come) Benefit Corporations

60(1) Boston College Law Review __,2019, Forthcoming, Emory Legal Studies Research Paper, Georgia State University College of Law, Legal Studies Research Paper No. 2018-15
Number of pages: 74 Posted: 05 Jun 2018 Last Revised: 11 Jan 2019
Georgia State University College of Law, Emory University School of Law and Georgia State University - College of Law
Downloads 113 (295,827)

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healthcare, incentives, benefit corporations, pharmaceuticals, public health, healthcare reform, non-profit, for profit, hybrid corporations, non for profit, business entities, corporate form

11.

The Need for the Tort Law Necessity Defense in Intellectual Property Law

University of Chicago Legal Forum, forthcoming, Georgia State University College of Law, Legal Studies Research Paper No. 2021-16, Emory Legal Studies Research Paper No. 21-12
Number of pages: 22 Posted: 10 Jul 2020 Last Revised: 30 Jun 2021
Georgia State University College of Law, Saint Louis University - School of Law and Emory University School of Law
Downloads 104 (313,312)

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COVID-19, coronavirus, necessity, lesser-evil, lesser harm, defense, privilege, intellectual property, IP, Lake Erie, Vincent v. Lake Erie, respirators, 3d printing, pharmaceuticals, public health, public necessity, private necessity, imminent harm, torts, common law, emergency

12.

Regulatory Competitive Shelters

76 Ohio St. L.J. 299 (2015), Georgia State University College of Law, Legal Studies Research Paper No. 2015-15
Number of pages: 58 Posted: 26 Apr 2015 Last Revised: 11 Jun 2015
Yaniv Heled
Georgia State University College of Law
Downloads 93 (336,891)

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Regulatory Competitive Shelters; regulatory exclusivity; data exclusivity; market exclusivity; generic exclusivity; Food and Drug Administration; Environmental Protection Agency; generic; follow-on; patents; innovation

13.

Genetic Paparazzi: Beyond Genetic Privacy

82 Ohio State Law Journal 409 (2021)
Number of pages: 54 Posted: 14 Apr 2020 Last Revised: 09 Jun 2021
Yaniv Heled and Liza Vertinsky
Georgia State University College of Law and Emory University School of Law
Downloads 85 (356,212)

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14.

Follow-On Biologics Are Set Up to Fail

University of Illinois Law Review, No. 113, 2018, Georgia State University College of Law, Legal Studies Research Paper No. 2018-24
Number of pages: 26 Posted: 26 May 2018 Last Revised: 27 Sep 2018
Yaniv Heled
Georgia State University College of Law
Downloads 75 (383,217)
Citation 1

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biologics, biosimilars, pharmaceuticals, follow-on, generics, innovation, biopharmaceuticals, competition, antitrust

15.

The Biologics Price Competition and Innovation Act At 10–A Stocktaking

7Texas A&M University Journal of Property Law 81 (2021), Georgia State University College of Law, Legal Studies Research Paper No. 2021-10
Number of pages: 30 Posted: 29 Jul 2020 Last Revised: 06 Apr 2021
Yaniv Heled
Georgia State University College of Law
Downloads 65 (413,901)

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Biologics, biopharmaceuticals, pharmaceuticals, Food and Drug Administration, FDA, pricing, competition, Biologics Price Competition and Innovation Act, BPCIA, BPCI Act, follow-on, access to medicine, generics, biosimilars, interchangeables, interchangeability, biosimilarity, automatic substitution

16.

The Case for Disclosure of Biologics Manufacturing Information

47 J.L. Med. & Ethics 54 (2019), Georgia State University College of Law, Legal Studies Research Paper No. 2020-11
Number of pages: 36 Posted: 12 Feb 2020 Last Revised: 03 Nov 2020
Yaniv Heled
Georgia State University College of Law
Downloads 49 (472,214)

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Pharmaceuticals, biologics, exclusivity, patents, trade secrets, manufacturing information, data, access to medicine, Food and Drug Administration, FDA, biosimilars, interchangeable biosimilars, Biologics Price Competition and Innovation Act, BPCIA, BPCI Act, competition, innovation

17.

Biologics, Biosimilars, and Other Idiosyncrasies

Contemporary Issues in Pharmaceutical Patent Law: Setting the Framework and Exploring Policy Options (Bryan Mercurio & Daria Kim, eds. Routledge 2017).
Number of pages: 22 Posted: 18 Apr 2018
Yaniv Heled
Georgia State University College of Law
Downloads 45 (488,959)

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pharmaceutical, biologic, biosimilar, patent, intellectual property, international intellectual property law, follow-on biologics, international trade agreements

18.

Amicus Curiae Submission on Eli Lily the Company vs. The Government of Canada

Submitted to the ICSID Case No. UNCT14/2
Number of pages: 11 Posted: 22 May 2018
Public Citizen, Northeastern University - School of Law, Loyola University of Chicago School of Law, University of London-School of Oriental and African Studies(SOAS), School of Law, LSE Law, Georgia State University College of Law and Institut d'Etudes Politiques de Paris, Sciences Po Law School
Downloads 35 (535,909)

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IP, patent, ISDS, investor-state arbitration, TRIPS, NAFTA, expropriation, fair and equitable treatment, utility, industrial application, promise doctrine, secondary patents, evergreening

19.

Regulatory Competitive Shelters as Incentives for Innovation in Agrobiotech

2015 Michigan State Law Review 553 , Georgia State University College of Law, Legal Studies Research Paper No. 2015-34
Number of pages: 7 Posted: 06 Nov 2015 Last Revised: 16 Dec 2015
Yaniv Heled
Georgia State University College of Law
Downloads 23 (606,784)

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Regulatory competitive shelters, RCS, regulatory exclusivities, agrobiotech, FIFRA, Generic Animal Drug and Patent Term Restoration Act, GADPTRA, genetically modified organisms, genetically modified animals, Federal Insecticide, Fungicide and Rodenticide Act, FDA, EPA, exclusivity

20.

Regulatory Competitive Shelters in the Area of Personalized Medicine

Boston University Journal of Science and Technology Law, Vol. 21, No. 2, 287 (2015), Georgia State University College of Law, Legal Studies Research Paper No. 2016-15
Number of pages: 12 Posted: 12 Jul 2016 Last Revised: 22 Oct 2016
Yaniv Heled
Georgia State University College of Law
Downloads 18 (641,360)

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Regulatory competitive shelters, RCSs, Regulatory exclusivities, personalized medicine, patents, patentability, subject mater eligibility, FDA, innovation

21.

An Institutional Solution to Build Trust in Pandemic Vaccines

31 Harvard Public Health Review 2021
Number of pages: 3 Posted: 21 Jun 2021
Georgia State University College of Law, Saint Louis University - School of Law and Emory University School of Law
Downloads 11 (693,104)

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Vaccines, COVID-19, Food and Drug Administration, FDA, Public Health, Vaccine Hesitancy, Emergency Use Authorization, EUA, chloroquine, hydroxychloroquine, convalescent plasma, coronavirus, pandemic, Office of Technology Assessment, OTA

22.

Genetic Paparazzi

Consuming Genetic Technologies: Ethical and Legal Considerations, Cambridge Univ. Press, forthcoming
Number of pages: 9 Posted: 18 Jul 2014 Last Revised: 24 Nov 2020
Yaniv Heled and Liza Vertinsky
Georgia State University College of Law and Emory University School of Law
Downloads 6 (731,981)

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DNA, genetics, privacy, information, law

23.

Regulatory Reactivity in FDA's Approval of the Alzheimer's Disease Drug Aducanubam (Aduhelm)

The Regulatory Review (2021)
Number of pages: 6
Georgia State University College of Law, Saint Louis University - School of Law and Emory University School of Law
Downloads 4

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Alzheimer's, Food and Drug Administration, FDA, pharmaceuticals, drugs, regulation, administrative law, health, Chevron

24.

Regulatory Reactivity: FDA and the Response to COVID-19

Food and Drug Law Journal (2021, Forthcoming)
Posted: 28 Aug 2020
Georgia State University College of Law, Saint Louis University - School of Law and Emory University School of Law

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FDA, Food and Drug Administration, COVID-19, hydroxychloroquine, convalescent COVID-19 plasma, vaccines, reactivity, administrative law

25.

A Theory of Genetic Interests

Posted: 17 Jun 2019
Yaniv Heled and Liza Vertinsky
Georgia State University College of Law and Emory University School of Law

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