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Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled Nov 2015

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Yaniv Heled

No abstract provided.


Regulatory Competitive Shelters As Incentives For Innovation In Agrobiotech, Yaniv Heled J.S.D. Nov 2015

Regulatory Competitive Shelters As Incentives For Innovation In Agrobiotech, Yaniv Heled J.S.D.

Yaniv Heled

No abstract provided.


Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge Nov 2015

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

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.


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 …


Alter Rules Of Liability, Yaniv Heled Oct 2014

Alter Rules Of Liability, Yaniv Heled

Yaniv Heled

No abstract provided.


On Presidents, Agencies, And The Stem Cells Between Them: A Legal Analysis Of President Bush's And The Federal Governments Policy On The Funding Of Research Involving Human Embryonic Stem Cells, Yaniv Heled Oct 2014

On Presidents, Agencies, And The Stem Cells Between Them: A Legal Analysis Of President Bush's And The Federal Governments Policy On The Funding Of Research Involving Human Embryonic Stem Cells, Yaniv Heled

Yaniv Heled

On August 9, 2001, President George W. Bush announced his policy on research involving human embryonic stem cells and proclaimed that federal funding would be allocated only to research involving human embryonic stem cell lines produced prior to his announcement (the Directive). Immediately thereafter, the National Institutes of Health (NIH) announced that it would act in accordance and full compliance with the Directive and took action to implement it. Since then, the Directive has dictated the nature and extent of scientific research involving human embryonic stem cells. Yet, astonishingly, despite being the subject of a boisterous debate, the Directive’s legality …


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

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

Yaniv Heled

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 (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …


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.


The Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled Oct 2014

The Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled

Yaniv Heled

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 requirements to screen and test sperm and egg donors for genetic diseases. The only nationwide standards for genetic screening and testing of donated reproductive tissue are guidelines created by professional organizations, but compliance with those guidelines is voluntary so they cannot be enforced effectively. Furthermore, the few reported cases involving children born from genetically-compromised reproductive tissue illustrate the court system’s failure to afford such children …


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 …


Healthcare Reform Creates Pathway For Biosimilar Biologics, Frederick Rein, Scott Warren, Yaniv Heled Oct 2014

Healthcare Reform Creates Pathway For Biosimilar Biologics, Frederick Rein, Scott Warren, Yaniv Heled

Yaniv Heled

No abstract provided.


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.


Why Deny Parents New Technology?, Yaniv Heled Oct 2014

Why Deny Parents New Technology?, Yaniv Heled

Yaniv Heled

No abstract provided.


Why Primary Patents Covering Biologics Should Be Unforceable Against Generic Applicants Under The Biologics Price Competition And Innovation Act, Yaniv Heled Dec 2013

Why Primary Patents Covering Biologics Should Be Unforceable Against Generic Applicants Under The Biologics Price Competition And Innovation Act, Yaniv Heled

Yaniv Heled

No abstract provided.


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 …