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Works of Yaniv Heled

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Associate Professor of Law and Co-Director, Center for Intellectual Property

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About Yaniv Heled

Positions

Present	Assistant Professor of Law, Georgia State University College of Law ‐ Center for Intellectual Property
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Disciplines

Law, Food and Drug Law, Intellectual Property Law, Science and Technology Law, and Bioethics and Medical Ethics

Research Interests

Intellectual Property Law, Law & Biology (Biolaw), Autonomous Vehicles Law, Food & Drug Law, Law & Technology, and Bioethics

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	LL.B. and undergraduate diploma in biology, Tel Aviv University
Institution Organization Student Type Student Title Degree Time Period to Options Currently enrolled Affiliate my profile with this Institution
	LL.M., Columbia University ‐ School of Law
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	J.S.D., Columbia University ‐ School of Law
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Faculty Profile

ORCID

http://orcid.org/0000-0002-1529-0966

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Contributions to Books
Articles
Popular Press

Contributions to Books (2)

Genetic Paparazzi (Yaniv Heled and Liza S. Vertinsky) Consumer Genetic Technologies: Ethical and Legal Considerations (2021)

Biologics, Biosimilars and Other Idiosyncrasies (Yaniv Heled) Contemporary Issues in Pharmaceutical Patent Law (2017)

Articles (24)

Righting a Reproductive Wrong: A Statutory Tort Solution to Misrepresentation by Reproductive Tissue Providers (Timothy Lytton, Hillel Y. Levin, Yaniv Heled, et al.) Houston Law Review (2022)

Fraud, misrepresentation, and other unfair trade practices plague the market for human reproductive tissue. The sale of sperm, eggs, and embryos is virtually unregulated in almost all states, and courts have been inhospitable to victims. ...

The Biologics Price Competition and Innovation Act at 10—A Stocktaking (Yaniv Heled) Texas A&M Journal of Property Law (2021)

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (a.k.a. “Obamacare”). The purpose of BPCIA was to ...

A Wrong Without a Remedy: Leaving Parents and Children With a Hollow Victory in Lawsuits Against Unscrupulous Sperm Banks (Yaniv Heled, Timothy D. Lytton and Liza S. Vertinsky) Chicago-Kent Law Review (2021)

For over six years, parents of children conceived with sperm purchased from the Atlanta-based sperm bank Xytex have sued the company for debilitating genetic conditions allegedly originating from the sperm. These lawsuits rely on a ...

An Institutional Solution to Build Trust in Pandemic Vaccines (Yaniv Heled, Ana Santos Rutschman and Liza S. Vertinsky) Harvard Public Health Review (2021)

Genetic Paparazzi: Beyond Genetic Privacy (Yaniv Heled and Liza Vertinsky) Ohio State Law Journal (2021)

The domain of accessible information about celebrities, political leaders, and other public figures is expanding as technology evolves, placing new stresses on already uneasy legal boundaries around their privacy. The availability of cheap, fast, and ...

Regulatory Reactivity: FDA and the Response to COVID-19 (Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky) Food and Drug Law Journal (2021)

The immense pressures created by the COVID-19 pandemic have exposed ingrained shortcomings in the regulatory and administrative apparatus for addressing public health crises, shortcomings that are particularly salient in the context of FDA's emergency response. ...

The Need for the Tort Law Necessity Defense in Intellectual Property Law (Yaniv Heled, Ana Santos Rutschman and Liza S. Vertinsky) University of Chicago Legal Forum (2021)

The COVID-19 pandemic has laid bare inherent tensions between the protection of intellectual property (IP) and the health of individuals touched by life-threatening medical conditions. A few examples have even made front page news. Hospitals ...

The Problem With Relying on Profit-Driven Models to Produce Pandemic Drugs (Yaniv Heled, Ana Santos Rutschman and Liza Vertinsky) Journal of Law & Biosciences (2020)

The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced ...

The Case for Disclosure of Biologics Manufacturing Information (Yaniv Heled) Journal of Law, Medicine and Ethics (2019)

Why Healthcare Companies Should Be(come) Benefit Corporations (Yaniv Heled, Liza Vertinsky and Cass Brewer) Boston College Law Review (2019)

Our healthcare system is broken. Despite spending far more on healthcare per capita than any other country, health outcomes in the United States are relatively poor. There is a pervasive disconnect within the healthcare system ...

Follow-On Biologics Are Set Up to Fail (Yaniv Heled) Illinois Law Review Online (2018)

Regulatory Competitive Shelters in the Area of Personalized Medicine (Yaniv Heled) Boston University Journal of Science and Technology Law (2015)

Regulatory Competitive Shelters (Yaniv Heled) Ohio State Law Journal (2015)

This Article identifies an array of seemingly disparate federal exclusivity regimes as belonging to an increasingly prevalent and relatively new class of highly valuable government benefits, which it names “regulatory competitive shelters” (RCSs). It characterizes ...

Regulatory Competitive Shelters as Incentives for Innovation in Agrobiotech (Yaniv Heled) Michigan State Law Review (2015)

On Patenting Human Organisms or How the Abortion Wars Feed Into the Ownership Fallacy (Yaniv Heled) Cardozo Law Review (2014)

The idea of ominous technologies that put human individuals or parts of their bodies under someone else's control has been stirring emotions and terrifying people for centuries. It was a recent offshoot of this idea--the ...

Patent Trolls as Parasites (Yaniv Heled) JURIST (2014)

This short commentary piece suggests that patent trolls may be better understood when viewed as analogous to biological parasites. Understanding patent trolls in this manner may help in explaining the patent troll phenomenon and in ...

Response to "Pervasive Sequence Patents Cover the Entire Human Genome" (Shine Tu, Christopher M. Holman, Adam Mossoff, et al.) All Faculty Scholarship (2014)

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of ...

Response to 'Pervasive Sequence Patents Cover the Entire Human Genome' (Shine Tu and Yaniv Heled) Genome Medicine (2014)

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of ...

Intellectual Property and Public Health – A White Paper (Ryan G. Vacca, Jim Chen, Jay Dratler, et al.) Akron Intellectual Property Journal (2013)

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest ...

Patents v. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both (Yaniv Heled) Michigan Telecommunications & Technology Law Review (2012)

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products ...

Why Primary Patents Covering Biologics Should Be Unforceable against Generic Applicants under the Biologics Price Competition and Innovation Act (Yaniv Heled) Annals of Health Law and Life Sciences (2012)

Healthcare Reform Creates Pathway for Biosimilar Biologics (Frederick H. Rein, Scott A. Warren and Yaniv Heled) ipFrontline (2010)

The Regulation of Genetic Aspects of Donated Reproductive Tissue - The Need for Federal Regulation (Yaniv Heled) Columbia Science & Technology Law Review (2010)

It is estimated that egg and sperm donations account for more than 60,000 births every year in the United States. However, surprisingly, and despite common misconceptions, there are no federal requirements and barely any state ...

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