Intellectual Property Law Commons^™

Paving A Path To Independent Tiny Living: An Introduction To Roadblocks, Jaclyn Troutner

Sustainable Development Law & Policy

“Tiny living” is a growing trend in which small-scale, ecoconscious housing is used as an alternative means for homeownership. Tiny homes are smaller than the average detached home with the appearance and character of a traditional freestanding residential home. They are one-story, single-occupant dwellings and usually constructed on a trailer base for towing. State-of-the-art building techniques provide a lower environmental burden and utility cost per square foot. Due to their smaller size, tiny homes are cheaper with an average price of $52,000, opening a wider door to home ownership. The typical design is to include all the standard amenities and …

Rulemaking Doubletake: An Opportunity To Repair And Strengthen The National Environmental Policy Act, Rachel Keylon

Sustainable Development Law & Policy

Introduction

In the middle of the twentieth century, there was a turning point in the United States and around the world in the understanding of the human relationship with the natural environment and natural resources. It was a shift from a perspective of natural resources endlessly available for exploitation to a perspective that natural resources are finite, and conservation and preservation are necessary to ensure that these resources are available for future generations. The accumulation of chronic environmental degradation, such as the unchecked proliferation of pesticides and other toxic chemicals, pollution to the nation’s waters, loss of land to erosion, …

About Sdlp

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Because our publication focuses on reconciling the tensions found within our ecosystem, it spans a broad range of environmental issues such as sustainable development; trade; renewable energy; environmental justice; air, water, and …

Editor's Note, Juliette Jackson, Bailey Nickoloff

Sustainable Development Law & Policy

Dear Readers,

For more than two decades, the Sustainable Development Law and Policy Brief (SDLP) remains true to its mission of providing innovative solutions to some of the most important legal issues related to environmental law, energy law, and natural resources law. We are honored to be the Editors-in-Chief during these unprecedented times in our history, as we witnessed a historical presidential election and now enter the third year of the COVID-19 global pandemic. Despite these unparalleled times, the SDLP staff brought our readership another great issue.

In this issue, our authors provide an in-depth analysis into current regulations and …

New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg

Articles

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

The Doha Declaration At Twenty: Interpretation, Implementation, And Lessons Learned On The Relationship Between The Trips Agreement And Global Health, Eric M. Solovy

Northwestern Journal of International Law & Business

No abstract provided.

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Compulsory Licensing Of Patents In Times Of Public Health Emergency, Kelsey Truglio

Touro Law Review

In March 2020, the United States shut down to avoid the continued spread of the COVID-19 virus as it spread globally. In December 2020, the first COVID-19 vaccines were granted emergency usage authorization in the United States. Wealthy nations were able to quickly purchase and hoard vaccines for public distribution, leaving many third-world countries and developing nations struggling to continue to survive the pandemic without vaccination.

Compulsory licensing should be allowed on otherwise patented or patentable new technology in times of global health emergency, regardless of which entity creates the technology. This will enable governments of countries spanning all wealth …

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …

Artificial Intelligence In Canadian Healthcare: Will The Law Protect Us From Algorithmic Bias Resulting In Discrimination?, Bradley Henderson, Colleen M. Flood, Teresa Scassa

Canadian Journal of Law and Technology

In this article, we canvas why AI may perpetuate or exacerbate extant discrimination through a review of the training, development, and implementation of healthcare-related AI applications and set out policy options to militate against such discrimination. The article is divided into eight short parts including this introduction. Part II focuses on explaining AI, some of its basic functions and processes, and its relevance to healthcare. In Part III, we define and explain the difference and relationship between algorithmic bias and data bias, both of which can result in discrimination in healthcare settings, and provide some prominent examples of healthcare-related AI …

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Table Of Contents

Seattle University Law Review

Table of Contents

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

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 …

Coronavirus, Compulsory Licensing, And Collaboration: Analyzing The 2020 Global Vaccine Response With 20/20 Hindsight, Arjun Padmanabhan

Student Scholarship

In December 2019, COVID-19, a novel strain of the SARS-2 Virus, appeared in Wuhan, China. Within a year, over ninety million people had been infected, and two million had died. Amid all the death and desolation, humanity's ingenuity and willpower emerged in history's greatest vaccine race. The global community sought to find novel ways to protect innovation and intellectual property while still collaborating to roll out a vaccine in record time. Despite the presence of compulsory licensing provisions like 28 U.S.C. § 1498 and the Bayh-Dole Act in the U.S., and the TRIPS Agreement at the international level, the journey …

Waive Ip Rights & Save Lives, Srividhya Ragavan

Faculty Scholarship

In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries. The waiver was proposed as a tool to kick-start prevention, containment and treatment of COVID-19. While there is an imminent need to meet a growing supply-demand gap for all medical products, COVID-19 related products are urgently required in poorer nations to contain the pandemic. The waiver has an additional role to play in the larger trade schema. In enabling vaccination of populations across the globe, the waiver would be critical …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Proceedings Of The 2020 Lee E. Teitelbaum Utah Law Review Symposium, Utah Law Review

Utah Law Review

In the autumn of 2020, the Utah Law Review, in cooperation with the S.J. Quinney College of Law Center for Law and Biomedical Sciences, convened a twoday virtual symposium exploring “The Law and Ethics of Medical Research.” On November 13th, leading scholars from across the country joined us for a panel discussion titled “Sharing Medical Research Data: Privacy and Confidentiality.” On November 20th, a second set of distinguished scholars and practitioners gathered virtually for three more panel discussions: “Clinical Trials—Legal and Ethical Issues in the Age of COVID-19,” “Intellectual Property and Medical Research,” and “Medical Research as a Public Health …

Lessons Learned From The Hiv/Aids Pandemic And Access To Medicines For Covid-19 Treatment, Thalia Le

Independent Study Project (ISP) Collection

There is an imminent need to address the healthcare disparities in accessing all COVID-19 medicinal products in developing countries. While logistical issues like inadequate production facilities such as the lack of vaccines administration capacity, storage issues, gap between supply and demand as well as vaccine hesitancy can certainly play a part in impeding COVID19 medicines distribution, patent monopolies and intellectual property protection laws further exacerbated the problem, especially when vaccines were at its early stages of authorization. Historical and contemporary case studies of efforts to challenge patents on HIV AVRs treatment provide a useful lens through which we may glean …

Trademarks And The Covid-19 Pandemic: An Empirical Analysis Of Trademark Applications Including The Terms "Covid," "Coronavirus," "Quarantine," "Social Distancing," "Six Feet Apart," And "Shelter In Place", Irene Calboli

Faculty Scholarship

True to its nature as a (hopefully) once in a lifetime event, the COVID-19 pandemic has led to a tsunami of trademark applications. These include the terms “COVID,” “Coronavirus,” and other medical and pandemic-management related terms. This unprecedented number of applications has been highlighted by several commentators in general terms in the past months. This Article examines these applications in detail. Notably, the Article presents the first and most complete survey of the applications filed between the onset of the pandemic and the end of 2020, which include the following terms: “COVID,” “Coronavirus,” “Quarantine,” “Social Distancing,” “Six Feet Apart,” and …

Opening Session, Annette Clark, Steven Bender

SITIE Symposiums

This year's conference focuses on the social good, highlighting three access barriers fundamental in law and society - access to legal services (and more generally, justice), access to health and health care during the COVID-19 pandemic, and access to financial services for the unbanked or underbanked.

Trade Marking ‘Covid’ And ‘Coronavirus’ In The Usa: An Empirical Review, Irene Calboli

Faculty Scholarship

Famous and sensational events often lead to several entities filing trade mark applications that include terms related to these events. The most recent example of this phenomenon is the COVID-19 pandemic, which has led to large numbers of (largely controversial) filings worldwide.

In this article, I review the applications including the terms ‘COVID’ and ‘Coronavirus’ filed with the United States Patent and Trademark Office (USPTO) in 2020 based on the data available and recorded by the end of January 2021. These data offer significant information related to the type of products for which the applications were filed, the type of …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Covid-19 As An Example Of Why Genomic Sequence Data Should Remain Patent Ineligible, Jorge L. Contreras

Utah Law Faculty Scholarship

The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no …

New Innovation Models In Medical Ai, Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg

Law & Economics Working Papers

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those that relate to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of …