Digital Commons Network^™

Case Law On American Indians, Thomas P. Schlosser

American Indian Law Journal

No abstract provided.

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …

Cafo’S Are A Public Health Crisis:The Creation Of Covid-19, Helena Masiello

University of Miami Law Review

Concentrated Animal Feeding Operations (“CAFO’s”) are largely unregulated by State or Federal Laws in the United States. As a result of this lack of oversight, they are a breeding ground for deadly infectious diseases. The COVID-19 epidemic has demonstrated the threat that diseases pose to the United State like H1N1, SARS, and Ebola.
The USDA needs to regulate CAFOs under the mandate given to them by congress in the AHPA to ensure that they are not the epicenter of the next wave of deadly infectious diseases. Scientists have been warning about the disease potential of CAFOs for the last decade, …

You Need To Calm Down: Examining The Origin And Eliminating The Future Of The “Gay Panic” Defense, Laura R. Conboy

Buffalo Law Review

No abstract provided.

Sinking Mink: An Argument For Ending The Mink Industry In Nova Scotia, Sarah Frame

Dalhousie Law Journal

Nova Scotia produces more mink pelts than any other province, but its fur farming industry imposes costs disproportionate to its benefits. These costs include the substantial financial aid given to mink farms, the toxic algae blooms in some lakes, the frequent spread of viruses from mink to humans and wildlife, the regular and wasteful mass culls of diseased mink, and the animal suffering caused by captivity, neglect, and abuse. Federal and provincial legislation does not and cannot provide meaningful protection to mink because of innate species characteristics and the cruelties inherent in the fur industry. Due to the association between …

Manipulating The Prescription Drug Market: Spiking Prices, Inducing Demand, And Costs To The Public, Katherine Drabiak, J.D.

DePaul Journal of Health Care Law

In 2016, Mylan made headlines when it spiked the price of its EpiPen AutoInjector by 400%, raising the price from an average of $57 to $500. Critics called the price hike “outrageous, “brutal” and “corrupt.” Public outcries fueled a demand for a Congressional investigation, and Mylan negotiated a settlement with the United States Department of Justice over alleged violations of the False Claims Act. Although competition self-corrected and similar products entered the marketplace, this case – and other similar cases involving generic drugs and insulin – highlighted the skyrocketing costs of prescription drugs in the United States. In 2019, United …

Artificial Intelligence/ Machine Learning-Based Medical Devices: Regulatory And Patentability Challenges, May Lee

Penn State Journal of Law & International Affairs (2012 - Present)

No abstract provided.

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Penn State Journal of Law & International Affairs (2012 - Present)

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to (1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory …

Session 2: Diversity Perspectives: In-House Counsel, Debbie Akhbari

SITIE Symposiums

This expert panel addressed diversity perspectives in the legal field. Moderated by Debbie Akhbari, six panelists shared their stories. The panelists were Leticia Hernández, Bernadette Lopez, Elida Moran, Catherine Romero, Rachel Seals, and Katina Thornock. Each panelist's stories have been broken into its own section in the summary of proceedings.

Many diverse candidates have incorrect assumptions made about them, resulting in doors being closed by those in positions of power. This panel shared their personal stories and encouraged students and newer attorneys to keep “knocking on those doors” and for those in positions of power to open those doors. Through …

A New Architecture For Global Health Emergency Preparedness And Response—The Imperative Of Equity, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Even before COVID-19 emerged in Wuhan, China, in December 2019, the prevailing global narrative was inequity—in health, income, race, and socioeconomic status. COVID-19 amplified all these inequities. Early in the pandemic, low-income countries were left without key medical resources, such as diagnostic tests, personal protective equipment, and ventilators. By 2021, inequitable vaccine distribution captured global attention and outrage. This year, high-income countries have bought the lion’s share of Paxlovid, a highly effective antiviral treatment. Vaccine inequities remain with only 16% of people in low-income countries having received at least 1 vaccine dose vs 80% of people across high-income countries. This …

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Student Scholarship

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to(1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory licensing …

Surrogacy And Parenthood: A European Saga Of Genetic Essentialism And Gender Discrimination, Mélanie Levy

Michigan Journal of Gender & Law

This paper tells a story of shifting normativities, from tradition to modernity and back, regarding the recognition of legal parenthood in non-traditional families created through crossborder surrogacy. The cross-border nature of the surrogacy is often forced as most domestic legal frameworks in Europe still restrict the creation of non-traditional families through assisted reproductive technologies. Once back home, these families struggle to have birth certificates recognized and establish legal parenthood. The disjuncture between social reality and domestic law creates a situation of legal limbo. In its recent case law, the European Court of Human Rights has pushed for domestic authorities to …

Copyright Protection For Works In The Language Of Life, Nina Srejovic

IPIPC Papers & Reports

In 2001, the DNA Copyright Institute sought to capitalize on the fear of human cloning by offering celebrities the opportunity to use copyright to secure exclusive rights in their DNA. At the time, a Copyright Office spokesperson pointed out that a person’s DNA “is not an original work of authorship.” That statement is no longer self-evident. A scientist claims to have used CRISPR technology to create a pair of twin girls with human-altered DNA that may provide immunity to HIV infection and improved cognitive function. Through gene therapy, doctors can “author” changes to patients’ DNA to cure disease. Scientists “edit” …

Adirondack Land Use Under The “Forever Wild” Clause After Protect!, Todd Thomas

Buffalo Environmental Law Journal

No abstract provided.

Rethinking Patents Within The Natural Law, Nicholas A. D'Andrea

Notre Dame Law Review

Though one scholar has directly suggested an implementation of Thomas Aquinas’s natural law concepts to United States patent law, that proposal has not been analyzed in light of modern patent law subject matter eligibility jurisprudence. In Part I of this Note, I trace the origins of natural law and natural rights in patents through English and United States legal history. In Part II, I outline the philosophical principles of natural law and natural rights necessary for understand-ing patent law. In Part III, I highlight the deemphasis of property rights in patent law, including in cases such as Alice and Oil …

Copyright Protection For Works In The Language Of Life, Nina Srejovic

Washington Law Review

In 2001, the DNA Copyright Institute sought to capitalize on the fear of human cloning by offering celebrities the opportunity to use copyright to secure exclusive rights in their DNA. At the time, a Copyright Office spokesperson pointed out that a person’s DNA “is not an original work of authorship.” That statement is no longer self-evident. A scientist claims to have used CRISPR technology to create a pair of twin girls with human-altered DNA that may provide immunity to HIV infection and improved cognitive function. Through gene therapy, doctors can “author” changes to patients’ DNA to cure disease. Scientists “edit” …

To My Children In Equal Shares: The Flaw Of Estate Planning When Property Is Devised To Beneficiaries As Tenants In Common, Camille M. Davidson

ACTEC Law Journal

No abstract provided.

Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed

Michigan Journal of Gender & Law

Transgender youth are increasingly able to access gender-affirming healthcare. Because gender-affirming care such as hormone therapy is clinically shown to reduce gender dysphoria and ease physical and social transition, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary for the treatment of dysphoria. However, an important dimension of gender-affirming care remains under-insured and overpriced: fertility preservation (FP). Several studies indicate that hormone therapies and certain gender-affirming surgeries can have negative, long-term impacts on future fertility. Although these impacts can be mitigated through approved FP methods such as sperm cryopreservation and oocyte cryopreservation, such methods are rarely affordable …

Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke

Michigan Journal of Gender & Law

Pregnant transgender people’s experiences vary: they may identify as male or non-binary and may seek gender-affirming medical care to different degrees. This variety in gender identities and bodies puts additional pressure on CJEU’s pregnancy discrimination case law—a case law that is, as this Article argues, already flawed. Building on a critique of the CJEU’s decision in Dekker, this Article discusses three alternative approaches to addressing pregnancy discrimination in EU law. The first two approaches are different ways of construing pregnancy discrimination as sex discrimination. First, the Article discusses a gender-stereotyping approach to direct sex discrimination, and, second, an indirect sex …

Shadow Contracts, Jessica S. Jeffers, Anne M. Tucker

The University of Chicago Business Law Review

This project explores side letters in private market funds. Side letters, separate agreements between a fund and an investor, act as an invisible amendment to the main contract. This article introduces a new use case for side letters: impact investments, where funds target social, as well as financial, returns. Using a hand-collected data set, we examine the scope and role of side letters in this growing space. Side letters as “shadow contracts” demonstrate the Easterbrook/Fischel theories in action, namely that parties “write their own tickets,” tailoring agreement terms to their specific needs within the framework of corporate governance rules. Expressing …

Racial Trauma In Civil Rights Representation, Angela Onwuachi-Willig, Anthony V. Alfieri

Articles

Narratives of trauma told by clients and communities of color have inspired an increasing number of civil rights and antiracist lawyers and academics to call for more trauma-informed training for law students and lawyers. These advocates have argued not only for greater trauma-sensitive practices and trauma-centered interventions on behalf of adversely impacted individuals and groups but also for greater awareness of the risks of secondary or vicarious trauma for lawyers who represent traumatized clients and communities. In this Article, we join this chorus of attorneys and academics. Harnessing the recent civil rights case of P.P. v. Compton Unified School District, …

The Racist Roots Of The War On Drugs And The Myth Of Equal Protection For People Of Color, André Douglas Pond Cummings, Steven A. Ramirez

University of Arkansas at Little Rock Law Review

By 2021, the costs and pain arising from the propagation of the American racial hierarchy reached such heights that calls for anti-racism and criminal justice reform dramatically expanded. The brutal murder of George Floyd by the Minneapolis police vividly proved that the social construction of race in America directly conflicted with supposed American values of equal protection under law and notions of basic justice. The racially-driven War on Drugs (WOD) fuels much of the dissonance between American legal mythology—such as the non-discrimination principle and the impartial administration of the rule of law—and the reality of race in the United States. …

Constitutional Law—Fourteenth Amendment And Fetal Personhood—Established Injustice: American Abortion Jurisprudence And The Irreducible, Geoffrey "Chip" Gross

University of Arkansas at Little Rock Law Review

No abstract provided.

The Concept Of Originality And Creativity In The Humanities, The Social Sciences And The Natural Sciences, Madelene Sta. Maria, Christopher Cruz, Maria Judy San Juan, Charisse Tan, Rajiv Amarnani

Asia-Pacific Journal of IP Management and Innovation

The study was conducted to determine how 21 experts in the discipline clusters of humanities, the social sciences and the natural sciences defined originality and creativity in terms of how these concepts are understood and realized in the production of works in their respective disciplines, what related copyright issues emerge related to these concepts, and how these two concepts are related. Through thematic qualitative analysis of in-depth interview data, findings suggest that while there may be converging ideas about originality and creativity among the discipline clusters, the way this concept is operationalized by each discipline significantly vary. The study is …

Does Size Matter? Nanoscale Particle Size As An Indicator Of Inherency In Nanopharmaceutical Patent Validity, Kirsten Fehlan

Georgia State University Law Review

Scientific and technological advances in nanopharmaceuticals bring the doctrine of inherent obviousness to a head. On the one hand, nanotechnology promises to offer novel ways to target and treat traditionally incurable diseases by operating at a scale that is comparable to the scales that most biological systems use. On the other hand, nanotechnology inventions that result in improved pharmacokinetic properties are susceptible to validity challenges based on inherent obviousness.

Inherency and obviousness are two independently recognized and well-understood principles in United States patent law. Inherency refers to a claimed limitation or feature that is either necessarily present in, or the …

Lawyering The Indian Child Welfare Act, Matthew L.M. Fletcher, Wenona T. Singel

Michigan Law Review

This Article describes how the statutory structure of child welfare laws enables lawyers and courts to exploit deep-seated stereotypes about American Indian people rooted in systemic racism to undermine the enforcement of the rights of Indian families and tribes. Even when Indian custodians and tribes are able to protect their rights in court, their adversaries use those same advantages on appeal to attack the constitutional validity of the law. The primary goal of this Article is to help expose those structural issues and the ethically troublesome practices of adoption attorneys as the most important Indian Child Welfare Act (ICWA) case …

Paper Mills Research Report [English], Committee On Publication Ethics, Stm

Copyright, Fair Use, Scholarly Communication, etc.

Executive summary

The subject of paper mills is currently being widely discussed by many stakeholders across the research publishing landscape. This report aims to give an overview of this topic, to explain how paper mills work, why they work and what we can collectively do about it. We have also undertaken a study of data submitted from a variety of investigations by leading publishers to get a sense of the scale of the problem. This paper concludes that the submission of suspected fake research papers, also often associated with fake authorship, is growing and threatens to overwhelm the editorial processes …

The Effects Of “No Pro Homo” Policies On Lgbtq+ Perceptions In The American South, Isabella L. Brocato

Honors Theses

Five states in the American South currently have “no pro homo” policies in place, while an increasing number of bills targeting discussions about sexuality and gender identity in public schools are being introduced to House floors around the country. Although there is extensive research on the ways in which these policies put the physical and mental well-being of LGBTQ+ students at risk, there is little to no research about how they shape public perceptions of the LGBTQ+ community collectively. With inspiration from Kenneth and Mamie Clark’s social science study cited in Brown v. Board of Education (1954), this study works …

Understanding The Metacognitive "Space" And Its Implications For Law Students' Learning, Jennifer A. Gundlach, Jessica R. Santangelo

Hofstra Law Review

An introduction is presented in which the editor discusses articles in the issue on topics including broad range of lawyering skills and professional values through experiential learning.

Extraction Of Personal Data: A New Form Of Colonialism Or Continuation Of A Colonial Practice? Adult Native American Adoptees Resist Assimilation And Rebuild Erased Identities, Leonard Mukosi

American Indian Law Journal

A new form of colonialism, distinctive of the 21st century is reported to be taking shape: data colonialism. Data colonialism interprets the contemporary capture and processing of personal data by governments or data corporations as an evolution of historical colonialism. Scholars who advance this theory do not juxtapose the contents, form, let alone the physical violence of historical colonialism with the contemporary practices of appropriation of personal data. Instead, they only refer to historic colonialism in the context of its function within the development of economies on a global scale. The main argument made in this paper is that; to …