Yaniv Heled

Georgia State University College of Law

Associate Professor

85 Park Pl NE

Atlanta, GA 30303

United States

  • Georgia State University College of Law

    • Email
    • Tel: 404-413-9092
SCHOLARLY PAPERS

29

DOWNLOADS

5,302

TOTAL CITATIONS

9

Scholarly Papers (29)

Actions:
Email selected abstracts
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 640 (83,614)
Citation 3

Abstract:

Loading...

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
Ryan G. Vacca, James Ming Chen, Jay Dratler, Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank Pasquale, Elizabeth A. Reilly, Jeffrey Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance and Katharine A. Van Tassel
University of Missouri at Columbia - University of Missouri 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, Cornell 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 577 (95,395)

Abstract:

Loading...

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 435 (134,439)

Abstract:

Loading...

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 311 (194,821)

Abstract:

Loading...

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.

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

The Regulatory Review (2021), Emory Legal Studies Research Paper No. 21-17
Number of pages: 7 Posted: 28 Jul 2021 Last Revised: 17 Dec 2021
Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky
Georgia State University College of Law, Villanova University - Charles Widger School of Law and University of Maryland Carey School of Law
Downloads 229 (265,476)

Abstract:

Loading...

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

6.

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
S. Sean Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin and Lee Petherbridge
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 228 (266,535)
Citation 1

Abstract:

Loading...

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

7.

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 220 (275,727)

Abstract:

Loading...

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

8.

Genetic Paparazzi: Beyond Genetic Privacy

82 Ohio State Law Journal 409 (2021), Georgia State University College of Law, Legal Studies Research Paper No. 2022-04
Number of pages: 55 Posted: 14 Apr 2020 Last Revised: 28 Mar 2022
Yaniv Heled and Liza Vertinsky
Georgia State University College of Law and University of Maryland Carey School of Law
Downloads 213 (284,307)

Abstract:

Loading...

9.

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

2021 University of Chicago Legal Forum 127, Georgia State University College of Law, Legal Studies Research Paper No. 2021-16, Emory Legal Studies Research Paper No. 21-12
Number of pages: 17 Posted: 10 Jul 2020 Last Revised: 22 Feb 2022
Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky
Georgia State University College of Law, Villanova University - Charles Widger School of Law and University of Maryland Carey School of Law
Downloads 211 (286,840)
Citation 1

Abstract:

Loading...

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

10.

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 211 (286,840)

Abstract:

Loading...

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

11.

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
Yaniv Heled, Liza Vertinsky and Cassady V. Brewer
Georgia State University College of Law, University of Maryland Carey School of Law and Georgia State University - College of Law
Downloads 207 (291,925)

Abstract:

Loading...

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

12.

A Theory of Genetic Dimensions in the Law

99 Indiana Law Journal 1341 (2024), U of Maryland Legal Studies Research Paper No. 2024-11
Number of pages: 61 Posted: 08 Aug 2023
Yaniv Heled, Liza Vertinsky and Ana Santos Rutschman
Georgia State University College of Law, University of Maryland Carey School of Law and Villanova University - Charles Widger School of Law
Downloads 195 (308,400)

Abstract:

Loading...

Genetics, DNA, Genomics, Genetic Privacy, Genetic Information, Genetic Property, Genetic Interests, Genetic Dimensions, Gene Therapy, Myriad Genetics, Moore v. Regents, Greenberg v. Miami, Maryland v. King, Genetic Identity, Genetic Objects, Gina, Genetic Discrimination, Genetic Testing, Sequencing

13.

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
Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky
Georgia State University College of Law, Villanova University - Charles Widger School of Law and University of Maryland Carey School of Law
Downloads 188 (318,926)
Citation 1

Abstract:

Loading...

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

14.

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 175 (340,053)

Abstract:

Loading...

15.

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 142 (407,287)
Citation 1

Abstract:

Loading...

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

16.

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 130 (433,958)

Abstract:

Loading...

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

17.

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 119 (464,274)

Abstract:

Loading...

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

18.

Regulatory Reactivity: FDA and the Response to COVID-19

76:2 Food and Drug Law Journal 318 (2021), Georgia State University College of Law, Legal Studies Research Paper No. 2021-24
Number of pages: 20 Posted: 28 Aug 2020 Last Revised: 14 Mar 2022
Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky
Georgia State University College of Law, Villanova University - Charles Widger School of Law and University of Maryland Carey School of Law
Downloads 117 (470,279)

Abstract:

Loading...

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

19.

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 109 (495,643)
Citation 1

Abstract:

Loading...

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

20.

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
Burcu Kilic, Brook K. Baker, Cynthia M. Ho, Yuan Qiong Hu, Luke McDonagh, Yaniv Heled and Pratyush Nath Upreti
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 Queen's University Belfast, School of Law
Downloads 101 (523,561)

Abstract:

Loading...

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

21.

An Institutional Solution to Build Trust in Pandemic Vaccines

31 Harvard Public Health Review 2021
Number of pages: 3 Posted: 21 Jun 2021
Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky
Georgia State University College of Law, Villanova University - Charles Widger School of Law and University of Maryland Carey School of Law
Downloads 86 (579,767)

Abstract:

Loading...

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.

Righting a Reproductive Wrong: A Statutory Tort Solution to Misrepresentation by Reproductive Tissue Providers

Houston Law Review, Vol. 60, No. 1, 2022
Number of pages: 50 Posted: 09 Nov 2022 Last Revised: 30 May 2023
Yaniv Heled, Hillel Y. Levin, Timothy D. Lytton and Liza Vertinsky
Georgia State University College of Law, University of Georgia School of Law, Georgia State University - College of Law and University of Maryland Carey School of Law
Downloads 80 (605,249)

Abstract:

Loading...

assisted reproductive technology, sperm bank, tort liability, abortion politics, fraud

23.

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 74 (631,770)

Abstract:

Loading...

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

24.

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 72 (641,158)

Abstract:

Loading...

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

25.

A Wrong Without a Remedy: Leaving Parents and Children with a Hollow Victory in Lawsuits against Unscrupulous Sperm Banks

Chicago-Kent Law Review, Vol. 96, No. 1, 2021
Number of pages: 14 Posted: 25 Jan 2022 Last Revised: 11 Feb 2023
Yaniv Heled, Timothy D. Lytton and Liza Vertinsky
Georgia State University College of Law, Georgia State University - College of Law and University of Maryland Carey School of Law
Downloads 65 (680,706)

Abstract:

Loading...

assisted reproductive technology, sperm bank, tort liability, abortion politics, fraud

26.

Comments on Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, National Institute of Standards and Technology (NIST), United States Department of Commerce, Notice of Proposed Rulemaking. 86 FR 35. Agency/Docket Number: 201207-0327

Saint Louis U. Legal Studies Research Paper No. 2021-24, Emory Legal Studies Research Paper No. 21-21
Number of pages: 8 Posted: 17 Aug 2021 Last Revised: 17 Dec 2021
Joshua D. Sarnoff, Liza Vertinsky, Yaniv Heled, Ana Santos Rutschman and Cynthia M. Ho
DePaul University College of Law, University of Maryland Carey School of Law, Georgia State University College of Law, Villanova University - Charles Widger School of Law and Loyola University of Chicago School of Law
Downloads 60 (702,069)
Citation 1

Abstract:

Loading...

Bayh-Dole, Patents, Regulations, March-In, Pricing

27.

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 54 (736,557)

Abstract:

Loading...

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

28.

Genetic Paparazzi

Consuming Genetic Technologies: Ethical and Legal Considerations, Cambridge Univ. Press, forthcoming
Number of pages: 9 Posted: 18 Jul 2014 Last Revised: 12 Dec 2022
Yaniv Heled and Liza Vertinsky
Georgia State University College of Law and University of Maryland Carey School of Law
Downloads 43 (809,802)

Abstract:

Loading...

DNA, genetics, privacy, information, law

29.

The Theory of Genetic Dimensions in the Law, Polygenic Risk Scores, and Reproductive Decision-Making

38.3 Harv. J. L. & Tech. (forthcoming 2025)
Number of pages: 27 Posted: 20 Nov 2024
Yaniv Heled and Liza Vertinsky
Georgia State University College of Law and University of Maryland Carey School of Law
Downloads 10 (1,132,625)

Abstract:

Loading...

Genetics, Theory of Genetic Dimensions, polygenic risk scores, PRS, reproduction, IVF, assisted reproductive technology, ART, embryo selection, genetic interests, wrongful birth, wrongful life, preimplantation genetic diagnosis, polygenic, preimplantation genetic testing, PGT, in-vitro fertilization, PGT-P, GWAS, fertility, embryo transfer, reproductive negligence, sperm, egg donation, surrogacy, , legal causation, reproductive health, schizophrenia, genetic object, physical-chemical dimension, informational dimension, functional dimension, taxonomic dimension, Group-identity-conferring dimension, Individual-identity-conferring dimension, Reproductive dimension, ToGi, ToGi Framework