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Full-Text Articles in Law

Regulatory Competitive Shelters, Yaniv Heled Sep 2015

Regulatory Competitive Shelters, Yaniv Heled

Yaniv Heled

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 RCSs and distinguishes them from other, more traditional kinds of government-instituted properties. The Article then proceeds to describe a particular brand of RCSs established in federal statutory frameworks whose aim—much like patents—is to create incentives for technological innovation. Identifying several common motifs of such RCS regimes, the Article offers a taxonomy of these RCSs and describes the mechanisms by which RCSs instituted under such regimes …


On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled Oct 2014

On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled

Yaniv Heled

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 notion of “patenting humans”--that mobilized certain members of Congress to pass legislation prohibiting the issuance of patent claims “directed to or encompassing a human organism.” The values underlying this legislation may well have been agreeable, even admirable. Yet, the actual motivation for it was misguided; its execution, deeply flawed; its potential outcomes, hazardous

This Article reviews the history and background of this prohibition. It fleshes …


Patent Trolls As Parasites, Yaniv Heled Oct 2014

Patent Trolls As Parasites, Yaniv Heled

Yaniv Heled

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 setting realistic expectations in the fight against them. It may also explain the difficulty in designing perfect solutions against patent trolls and why we must not be discouraged by this fact in our efforts to curb their harmful effects.


Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled Oct 2014

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

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 (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …


Response To 'Pervasive Sequence Patents Cover The Entire Human Genome', Shine Tu, Yaniv Heled Oct 2014

Response To 'Pervasive Sequence Patents Cover The Entire Human Genome', Shine Tu, Yaniv Heled

Yaniv Heled

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 a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.


Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel Dec 2012

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

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 in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …