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Articles 1 - 30 of 373

Full-Text Articles in Health Law and Policy

Table Of Contents, Seattle University Law Review Sep 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


Helsinn Healthcare S.A. V. Teva Pharmaceuticals Usa, Inc.: “Sale” Keeps Its Old Meaning Under The Leahy–Smith America Invents Act, Sherrie Holdman Aug 2019

Helsinn Healthcare S.A. V. Teva Pharmaceuticals Usa, Inc.: “Sale” Keeps Its Old Meaning Under The Leahy–Smith America Invents Act, Sherrie Holdman

Minnesota Journal of Law, Science & Technology

No abstract provided.


Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill Jul 2019

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous ...


That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn May 2019

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect ...


A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen May 2019

A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen

Brooklyn Journal of Corporate, Financial & Commercial Law

The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 ...


The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall Apr 2019

The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall

Timothy S. Hall

This article explores some of the potential pitfalls associated with collection of detailed individual biometric or health-related information, and demonstrates that current laws and regulations are not well designed to protect users of these devices and apps from unauthorized use or misuse of their data. Health information is among the most sensitive, intimate, and potentially damaging personal information one may possess, and health policymakers have made health information privacy a priority for decades for good reason. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was one of the major health policy legislative achievements of the 1990s. However, HIPAA ...


Table Of Contents, Seattle University Law Review Feb 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


Dirty Little Secrets: Fracking Fluids, Dubious Trade Secrets, Confidential Contamination, And The Public Health Information Vacuum, Elliot Fink Jan 2019

Dirty Little Secrets: Fracking Fluids, Dubious Trade Secrets, Confidential Contamination, And The Public Health Information Vacuum, Elliot Fink

Fordham Intellectual Property, Media and Entertainment Law Journal

While the carbon energy industry has frequently claimed that hydraulic fracturing processes and ingredients are proprietary and protected by trade secret laws, their large scale and volume nationwide and the well-documented dangers that they pose to public health have brought fracking under scrutiny. When individuals have been adversely impacted in their own backyards, weak federal and state laws and regulation have generally left these impacted citizens with little to no recourse and part of this problem stems from questionable uses of privacy law, specifically dubious claims of trade secrecy. Focusing specifically on Pennsylvania as a model of insufficient state regulation ...


Health Care Costs And The Arc Of Innovation, Neel U. Sukhatme, Maxwell Gregg Bloche Jan 2019

Health Care Costs And The Arc Of Innovation, Neel U. Sukhatme, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze.

Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s ...


When Biopharma Meets Software: Bioinformatics At The Patent Office, Saurabh Vishnubhakat, Arti K. Rai Jul 2018

When Biopharma Meets Software: Bioinformatics At The Patent Office, Saurabh Vishnubhakat, Arti K. Rai

Saurabh Vishnubhakat

Scholars have spilled much ink questioning patent quality. Complaints encompass concern about incoming applications, examination by the U.S. Patent and Trademark Office (“USPTO”), and the USPTO’s ultimate output. The literature and some empirical data also suggest, however, that applications, examination, and output may differ considerably based on technology. Most notably, although definitions of patent quality are contested, quality in the biopharmaceutical industry is often considered substantially higher than that in information and communications technology (ICT) industries.

This Article presents the first empirical examination of what happens when the two fields are combined. Specifically, it analyzes the creation and ...


The Global Person: Pig-Human Embryos, Personhood, And Precision Medicine, Yvonne Cripps Jul 2018

The Global Person: Pig-Human Embryos, Personhood, And Precision Medicine, Yvonne Cripps

Indiana Journal of Global Legal Studies

Chimeras, in the form of pig-human embryos engineered by CRISPR-Cas9 and other biotechnologies, have been created as potential sources of organs for transplantation. Against that background, and in an era of "precision medicine," this Article examines the concept of the global genetically modified person and asks whether humanness and personhood are being eroded, or finding new boundaries in intellectual property and constitutional law.


Intellectual Property And Public Health: A White Paper, Katharine A. Van Tassel Mar 2018

Intellectual Property And Public Health: A White Paper, Katharine A. Van Tassel

Katharine Van Tassel

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 ...


Serving Pets In Poverty: A New Frontier For The Animal Welfare Movement, Amanda Arrington, Michael Markarian Feb 2018

Serving Pets In Poverty: A New Frontier For The Animal Welfare Movement, Amanda Arrington, Michael Markarian

Sustainable Development Law & Policy

No abstract provided.


How Fast Is Too Fast? Osha’S Regulation Of The Meat Industry’S Line Speed And The Price Paid By Humans And Animals, Israel Cook Feb 2018

How Fast Is Too Fast? Osha’S Regulation Of The Meat Industry’S Line Speed And The Price Paid By Humans And Animals, Israel Cook

Sustainable Development Law & Policy

No abstract provided.


The Farts Heard ‘Round The World: Where Cow-Tapping Falls On The International Agenda Of Sustainable Development, Alexandra C. Nolan Feb 2018

The Farts Heard ‘Round The World: Where Cow-Tapping Falls On The International Agenda Of Sustainable Development, Alexandra C. Nolan

Sustainable Development Law & Policy

No abstract provided.


This Is Not The Bee’S Knees: A Critical View Of The Government’S Lack Of Policy To Conserve The Pollinators, Savannah Pugh Feb 2018

This Is Not The Bee’S Knees: A Critical View Of The Government’S Lack Of Policy To Conserve The Pollinators, Savannah Pugh

Sustainable Development Law & Policy

No abstract provided.


Legislative Efforts To Increase State Management For Imperiled Species Should Be Rejected, Stephanie Kurose Feb 2018

Legislative Efforts To Increase State Management For Imperiled Species Should Be Rejected, Stephanie Kurose

Sustainable Development Law & Policy

No abstract provided.


Anthropogenic Noise And The Endangered Species Act, Carolyn Larcom Feb 2018

Anthropogenic Noise And The Endangered Species Act, Carolyn Larcom

Sustainable Development Law & Policy

No abstract provided.


Cruelty To Human And Nonhuman Animals In The Wild-Caught Fishing Industry, Kathy Hessler, Rebecca Jenkins, Kelly Levenda Feb 2018

Cruelty To Human And Nonhuman Animals In The Wild-Caught Fishing Industry, Kathy Hessler, Rebecca Jenkins, Kelly Levenda

Sustainable Development Law & Policy

No abstract provided.


The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith Feb 2018

The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith

Sustainable Development Law & Policy

Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.


Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely Feb 2018

Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely

Sustainable Development Law & Policy

No abstract provided.


About Sdlp Feb 2018

About Sdlp

Sustainable Development Law & Policy

No abstract provided.


Editor's Note, Luke Trompeter, Ingrid Lesemann Feb 2018

Editor's Note, Luke Trompeter, Ingrid Lesemann

Sustainable Development Law & Policy

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 Feb 2018

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

Katharine Van Tassel

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 ...


Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel Feb 2018

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Katharine Van Tassel

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 ...


Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman Jan 2018

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

All Faculty Scholarship

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding ...


2017 Annual Survey: Recent Developments In Sports Law, Jordan Lysiak, Katherine Hampel Jan 2018

2017 Annual Survey: Recent Developments In Sports Law, Jordan Lysiak, Katherine Hampel

Marquette Sports Law Review

None


Index: Sports Law In Law Reviews And Journals, Jordan Lysiak Jan 2018

Index: Sports Law In Law Reviews And Journals, Jordan Lysiak

Marquette Sports Law Review

None


Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim Jan 2018

Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim

Washington University Law Review

Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma ...


Index: Sports Law In Law Reviews And Journals, Jordan Lysiak Jan 2018

Index: Sports Law In Law Reviews And Journals, Jordan Lysiak

Marquette Sports Law Review

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