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Trick Or Treat? How A U.S. Patent Over A Method For Processing Sugarcane Wrongly Alarmed The Colombian Panela Industry, Carter Ostrowski 2021 University of Cincinnati College of Law

Trick Or Treat? How A U.S. Patent Over A Method For Processing Sugarcane Wrongly Alarmed The Colombian Panela Industry, Carter Ostrowski

University of Cincinnati Law Review

No abstract provided.


Legal And Ethical Implications Of U.S. And Canadian Vaccine Contracts: The Impact Of Vaccine Nationalism On The Global Pandemic Response, Ryan S. Tahiri 2021 University of Miami School of Law

Legal And Ethical Implications Of U.S. And Canadian Vaccine Contracts: The Impact Of Vaccine Nationalism On The Global Pandemic Response, Ryan S. Tahiri

University of Miami Inter-American Law Review

This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These “pre-purchases,” many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations …


An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao 2021 Brooklyn Law School

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …


Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck 2021 Brooklyn Law School

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …


Scientific Experts In Wto Dispute Settlement, David A. Wirth 2021 Boston College Law School

Scientific Experts In Wto Dispute Settlement, David A. Wirth

Boston College Law School Faculty Papers

Engaging with scientific expertise is necessary to insure the effectiveness of WTO dispute settlement in areas such as the SPS Agreement. In rejecting the Uruguay Round texts and basic principles concerning the processing of policy-relevant science for lay decision makers, panels and the Appellate Body have counterproductively tended to undermine the scientific integrity, institutional legitimacy, and ultimately the speed and efficacy of WTO dispute settlement.


High Time For A Change: How The Relationship Between Signatory Countries And The United Nations Conventions Governing Narcotic Drugs Must Adapt To Foster A Global Shift In Cannabis Law, Alexander Clementi 2021 Brooklyn Law School

High Time For A Change: How The Relationship Between Signatory Countries And The United Nations Conventions Governing Narcotic Drugs Must Adapt To Foster A Global Shift In Cannabis Law, Alexander Clementi

Brooklyn Journal of International Law

Since the early 1970’s, the inclusion of cannabis and its byproducts in the United Nations Single Convention on Narcotic Drugs has mandated a strict prohibition on cultivation and use of the substance, which has led to a largely global practice of criminalization and imprisonment of anyone found to be in its possession. Yet recently, mostly in response to growing public health concerns, countries like Uruguay, Portugal, The Netherlands, Canada, and the United States have enacted laws which seek to decriminalize or even legalize cannabis use and possession. Yet, cannabis remains classified as a Schedule IV narcotic under the Single Convention, …


The War On Drugs And Its Legal Effects On Black Americans, Alexia L. Howard-Mullins 2021 Eastern Washington University

The War On Drugs And Its Legal Effects On Black Americans, Alexia L. Howard-Mullins

2022 Symposium

The differences in treatment between Black and white Americans in the past fifty years has been a topic of thought in the minds of political and sociological scholars since the inception of the War on Drugs in 1971. These differences in treatment may lead to discrimination legally, resulting in longer prison sentences and a higher proportion of Black Americans in prison. This study analyzes the results of the War on Drugs that led to disproportionate imprisonment of Black Americans, including mandatory sentencing laws, drug classifications, and discrimination within law enforcement and the legal system. This study will use primary sources …


A Solution To The Hard Problem Of Soft Law, Keagan Potts 2021 University of Michigan Law School

A Solution To The Hard Problem Of Soft Law, Keagan Potts

Michigan Journal of Environmental & Administrative Law

Administrative Agencies often rely on guidance documents to carry out their statutory mandate. Over the past few decades, the Food and Drug Administration (FDA) has been criticized for using soft law guidance documents to exercise powers beyond those authorized by Congress. Since attacks on the use of guidance documents persist and agencies need soft law to respond quickly and flexibly to rapid technological growth, it is essential to develop a solution that preserves this crucial regulatory mechanism and prevents its abuse. The most likely alternative to soft law guidance is formal regulation, which must be developed through the notice-and-comment process. …


Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman 2021 University of Georgia School of Law

Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman

Georgia Law Review

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …


Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs 2021 Texas A&M University School of Law

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs

Faculty Scholarship

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …


The Dope On Marijuana Consumption And Impaired Driving, Samuel D. Hodge, Jr., Lauren Williams 2021 Temple University

The Dope On Marijuana Consumption And Impaired Driving, Samuel D. Hodge, Jr., Lauren Williams

Cleveland State Law Review

Marijuana is the most frequently used psychotropic drug in the United States, following alcohol consumption. Its use is becoming socially acceptable as more and more states legalize recreational consumption. Nevertheless, marijuana is still a drug, and individuals must understand that it has adverse health effects and potential therapeutic benefits.

Marijuana can influence a user’s judgment and impair a person’s driving abilities. A significant problem with its consumption and driving is that there is no statistical link to show what level of marijuana in the blood causes impairment. Roadside tests for the appropriate blood alcohol content to show intoxication are well …


Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley 2021 Washington University in St. Louis School of Law

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1


Association Of Self-Reported High-Risk Allergy History With Allergy Symptoms After Covid-19 Vaccination, Dean M. Hashimoto, Lily Li, Lacey B. Robinson, Rajesh Patel, Et al 2021 Boston College Law School

Association Of Self-Reported High-Risk Allergy History With Allergy Symptoms After Covid-19 Vaccination, Dean M. Hashimoto, Lily Li, Lacey B. Robinson, Rajesh Patel, Et Al

Boston College Law School Faculty Papers

Allergic history in individuals with confirmed anaphylaxis to a messenger RNA (mRNA) COVID-19 vaccine is common. However, the risk factors for allergy symptoms after receiving the vaccine are unknown.


Estate Planning For Cannabis Business Owners: An Introduction, Bridget J. Crawford, Jonathan G. Blattmachr 2021 Elisabeth Haub School of Law at Pace University

Estate Planning For Cannabis Business Owners: An Introduction, Bridget J. Crawford, Jonathan G. Blattmachr

Elisabeth Haub School of Law Faculty Publications

As more states legalize cannabis sales, estate planners may increasingly be called upon to advise clients with interests in cannabis-related businesses. This essay seeks to assist estate planners in two ways. First, it aims to raise general awareness of cannabis business owners' unique concerns. Second, the essay provides an overview of some of the fundamental issues about which cannabis business owners are likely to seek estate planning advice: business formation matters, wealth transfers, the ability of trusts to own cannabis-related businesses, and gift, estate, and income tax considerations.

In most states that permit legal cannabis sales, there is limited (or …


Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli 2021 Texas A&M University School of Law

Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli

Faculty Scholarship

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspects to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights …


Alternative Solutions For Government Intervention In Climate Crisis Markets: Price Gouging And The Pandemic Egg Market Case Study, S. Byron Frazelle 2021 William & Mary Law School

Alternative Solutions For Government Intervention In Climate Crisis Markets: Price Gouging And The Pandemic Egg Market Case Study, S. Byron Frazelle

William & Mary Environmental Law and Policy Review

The cost of a thing is the amount of what I will call life which is required to be exchanged for it, immediately or in the long run.

The incredible, edible egg.


Fires in California, hurricanes along the Gulf, a worldwide pandemic—it is evident that the year 2020 was defined by great crises, most of which were direct results of or exacerbated by climate change. The effects of these crises on broader American society, in particular that of the COVID-19 pandemic, are just beginning to be realized. Nearly every aspect of American life has been impacted by the pandemic and …


The Public Health Turn In Reproductive Rights, Rachel Rebouché 2021 Temple University Beasley School of Law

The Public Health Turn In Reproductive Rights, Rachel Rebouché

Washington and Lee Law Review

Over the last decade, public health research has demonstrated the short-term, long-term, and cumulative costs of delayed or denied abortion care. These costs are imposed on people who share common characteristics: abortion patients are predominantly low income and disproportionately people of color. Public health evidence, by establishing how law contributes to the scarcity of services and thereby entrenches health disparities, has vividly highlighted the connections between abortion access, race, and income. The contemporary attention to abortion law’s relationship to inequality is no accident: researchers, lawyers, and advocates have built an infrastructure for generating credible empirical studies of abortion restrictions’ effects. …


Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson 2021 Washington and Lee University School of Law

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …


Martinez-Cuevas V. Deruyter Brothers And Covid-19: Is It Time To Re-Examine Farmworker Labor Protections?, Margaret Todd, Sarah Everhart 2021 University of Maryland

Martinez-Cuevas V. Deruyter Brothers And Covid-19: Is It Time To Re-Examine Farmworker Labor Protections?, Margaret Todd, Sarah Everhart

Journal of Food Law & Policy

In the fall of 2020, in the midst of the COVID-19 global pandemic, a closely divided (5-4) Washington Supreme Court, in Martinez-Cuevas v. Deruyter Bros. Dairy Inc.1, held that dairy workers, despite a state wage and hour law2 specifically exempting agricultural workers, are entitled to overtime pay. The Court based its decision, in part, on the dangerous nature of the work performed by the dairy workers.3 Although the decision was specific to dairy workers in Washington, the majority of U.S. farmworkers are not entitled to overtime wages while working jobs that are generally considered dangerous and have been made more …


Iowa Land And Landowners: Fear Or Opportunity, Neil D. Hamilton 2021 Drake University, Des Moines

Iowa Land And Landowners: Fear Or Opportunity, Neil D. Hamilton

Journal of Food Law & Policy

Our relation to the land changed as modern agriculture changed. Today many issues involving the land seem to focus on fear and conflict, revealing a fragility of agriculture surprising for how it confounds the expected image of strength and stability. In many ways, our fragile relation to the land contrasts to the optimism of the relation in the past, in the years of settlement and expansion. Part of the change reflects the adverse impacts of modern agriculture catching up with us, and part stems from a society more willing to focus on issues of equity, inclusion, and inequality. The good …


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