Digital Commons Network^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

Operationalizing Indigenous-Led Impact Assessment, Dayna Scott, Jennifer Sankey, Laura Tanguay

Commissioned Reports, Studies and Public Policy Documents

Recent years have ushered in an explosion of interest and expertise in place-based, Indigenous-led impact assessment models. Across Canada and beyond, Indigenous communities have been developing and engaging with alternative approaches to “environmental assessment” (EA) or “impact assessment” (IA) in response to proposed developments in their homelands. These efforts are borne out of deep dissatisfaction and frustration; Indigenous peoples have repeatedly pointed to the inability of settler law on EA to protect their constitutionally recognized Aboriginal and Treaty rights, and to meaningfully engage with Indigenous laws, values, and perspectives regarding the socio-ecological risks posed by resource development projects. The inability …

Against Integrity: A Feminist Theory Of Moral Rights, Creative Agency & Attribution, Carys Craig, Anupriya Dhonchak

All Papers

This Chapter explores insights that feminist theories can bring to the study and development of moral rights protections in copyright law. It begins by explaining why certain facets of conventional moral rights theory are ill-suited to—indeed inconsistent with—a feminist approach in both concept and effect. In particular, to the extent that strong moral rights of integrity and association limit dialogic engagement with, and transformation of, protected works, they risk suppressing critical and counter-hegemonic expression, and support an individualized and romanticized conception of the (patriarchal) author-figure. Employing alternative feminist conceptions of situated selfhood, relationality and dialogic authorship, the Chapter then explores …

In Your Face: Whether Photographs Should Be Considered Biometric Information, Alessandra M. Conte

UIC Review of Intellectual Property Law

No abstract provided.

America’S Hidden Citizens: The Untold Stories Of The Unconscionable Deportations Of Its International Adoptees, Halley Cody

Seattle University Law Review

This Note addresses how the U.S. should rectify the harms it has perpetrated on non-citizen adoptees by amending the current deportation statutes to prevent their deportation. Part I addresses the history of adoption in the U.S. and related effects on immigration law. Part II highlights the stories of Adam Crapser and Philip Clay, who were adopted by American families who failed to naturalize them as minors, and who were subsequently deported after they sustained criminal records. Part III examines the policy goals behind deportation as a consequence of criminal convictions, as well as remedies instituted to prevent unwarranted deportation and …

On The Appeal Of Drug Patent Challenges, Charles Duan

American University Law Review

Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.

This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation …

Public Health Product Hops, Michael S. Sinha

American University Law Review

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Industry advocates, however, maintain that product hops represent essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they …

Social Construction Of Race Undergirds Racism By Providing Undue Advantages To White People, Disadvantaging Black People And Other People Of Color, And Violating The Human Rights Of All People Of Color, Adjoa A. Aiyetoro

University of Colorado Law Review

No abstract provided.

Zeroing In On Net-Zero: From Soft Law To Hard Law In Corporate Climate Change Pledges, Daniel C. Esty, Nathan De Arriba-Sellier

University of Colorado Law Review

One hundred and ninety-seven nations endorsed a target of net-zero greenhouse gas (GHG) emissions by midcentury in the 2021 Glasgow Climate Pact. As countries around the world have begun to develop their plans for deep decarbonization, it has become evident that the private sector will need to deliver much of what is required for the transition to an environmentally sustainable economy. The commitment to net-zero emissions by the year 2050 has therefore cascaded to the corporate world, leading hundreds of major companies to make their own net-zero GHG pledges. What constitutes a meaningful net-zero corporate pledge, however, remains unclear—and what …

U.S. Disaster Policy: Oversight Challenges And The Promise Of Multi-Level Governance, Nancy J. Knauer

Lewis & Clark Law Review

U.S. disaster preparedness and response policy now plays an increasingly central role in the lives of many Americans. The COVID-19 pandemic and the strong uptick in extreme weather events have placed a heightened burden on our emergency management resources. In 2021, it seemed that hardly a week went by without a new emergency declaration as we battled devastating wildfires and drought in the West and catastrophic flooding and storms in the East. To further complicate matters, these unrelenting weather-related disasters played out within the context of an unprecedented and multi-year public health crisis—the COVID-19 pandemic. This Article examines the history …

More Than The Minimum: Why States Should Enact Better Fmla Equivalents, Matt Heldt

Lewis & Clark Law Review

For many workers, taking time off from work for a serious health condition or to care for a family member’s serious health condition is complicated. Since 1993, the Family Medical Leave Act (FMLA) has provided job protection for workers who take leave. However, not all workers are covered. This Comment looks at where the FMLA comes up short, how some states are providing broader coverage and more robust benefits, and advocates for states to continue improving upon the FMLA baseline.

Juvenile Competency Restoration, David R. Katner

Lewis & Clark Law Review

Despite legal competence presumptions about juveniles facing delinquency charges, tens of thousands of forensic mental health evaluations challenge the status of court-involved children in the United States each year. Researchers now find mental health disorders prevalent among juveniles in the justice system, with up to 70% having a diagnosable mental health problem. It is inappropriate to think of adolescents as younger versions of adults whose behaviors can be viewed through the same lens as adult behaviors. The Article will explore some of the causes and conclusions about why many juveniles are not competent and why many of them may not …

Abortion Rights As (Inter)National Human Rights: Dobbs And The Noncompliance Of U.S. Abortion Policies Under International Human Rights Law, Sydney Chong Ju Padgett

Lewis & Clark Law Review

The current state of reproductive rights in the United States following Dobbs v. Jackson Women’s Health Organization constitutes yet another chapter in the saga of the United States’ hypocrisy in failing to uphold international human rights at the domestic level. International human rights law unequivocally provides that safe and legal abortion access is a fundamental human right. Yet, applying treaty body guidance to the cruel and irrational legislation enacted in Dobbs’ wake, it is clear: the United States has wholly and dangerously failed to comply with its international commitments to protect and uphold the fundamental rights at stake in regulating …

Opportunities For Transformation: Equity, Diversity, And Inclusion Across The Developmental Disabilities Network, Lydia Ocasio-Stoutenburg, Jacy Farkas

Developmental Disabilities Network Journal

No abstract provided.

On Women Professors Who Teach Legal Writing: Addressing Stigma And Women's Health, Amanda L. Stephens, Sean A. Vina

Faculty Articles

Since the late 1980s, legal writing (LW) professors have been disproportionately white women because the LW field has been stigmatized as "women's work. "As a result, these teaching positions typically have been low status and afforded with less pay and job security in comparison to tenure-track doctrinal law professor positions. Compounding--or intersecting--with the stigma of teaching LW are LW professors' social statuses as women and/or other marginalized statuses. These statuses intersect and influence how and what they teach and the legal academy's attitudes toward them.

Although previous scholarship has briefly addressed legal skill classes' stigmatization, no scholarship to date has …

The Marriage Nullity Process In The Reform Of Pope Francis With Special Reference To The Processus Brevior (Book), Roberto Rosas, Yeshica Umaña

Faculty Articles

Marriage in the Church is considered the greatest symbol of mystical life and has been instituted by God, representing the sacrament of the spousal union of Christ with the Church. Multiple canons include the Church's requirements and regulations for marriage since its institution as a sacrament. The last marital reform was introduced in the 18th century by Pope Benedict XIV and remained as legal norm until Pope Francis announced the publication of a new reform for the annulment of marriages within the Church on August 15, 2015.

Despite reactions against maintaining strictness in favor of marriage, Pope Francis emphasized that …

Revolutionizing Justice: Unleashing The Power Of Artificial Intelligence, Samuel D. Hodge Jr.

SMU Science and Technology Law Review

The practice of law is changing, and most lawyers are unprepared for this metamorphosis. This statement is not an exaggeration but the acknowledgment that artificial intelligence (“AI”) has altered the way lawyers do business. Instead of having a “battle of forms,” attorneys will now be confronted with the “battle of computers.” Linking artificial intelligence and the law, however, is a natural progression. Both operate in similar fashions: each examines and applies “historical examples in order to infer rules to apply to new situations.”

While many attorneys are unsure how to integrate this new technology into their practices, they already use …

Virtual Gaming, Actual Damage: Video Game Design That Intentionally And Successfully Addicts Users Constitutes Civil Battery, Allison Caffarone

Scholarly Works

In recent years, there has been increased academic interest in both the neurological effects of compulsive gaming and the potential tort liability of game developers who scientifically engineer games in order to addict users. Scholars from various disciplines are currently debating the scope and potential solutions to the problems associated with Gaming Disorder, now a globally recognized illness. This article contributes to this discussion by offering a multidisciplinary analysis of the scope of video game addiction, its neurological bases, and its relation to the legal rights and responsibilities of victims and game developers. In addition, this article explores the practical …

“The Cruelty Is The Point”: Using Buck V. Bell As A Tool For Diversifying Instruction In The Law School Classroom, Tiffany C. Graham

Scholarly Works

Instructors who are looking for opportunities to expose their students to the ways in which intersectional forms of bias impact policy and legal rules can use Buck v. Bell to explore, for instance, the impact of disability and class on the formation of doctrine. A different intersectional approach might use the discussion of the case as a gateway to a broader conversation about the ways in which race and gender bias structured the implementation of sterilization policies around the nation. Finally, those who wish to examine the global impact of American forms of bias can use this case and the …

Fda's Revolving Door: Reckoning And Reform, Laura Karas

Articles

Recent controversy over the FDA's approval of the Alzheimer's therapy Aduhelm (aducanumab) and the Duchenne muscular dystrophy therapy Exondys 51 (eteplirsen) called into question the impartiality and independence of high-level FDA regulators. Atypical associations between FDA regulators and pharmaceutical company sponsors, in addition to fierce internal disputes over the adequacy of the evidence, elicited criticism and triggered concern about potential undue influence at the FDA. The revolving door is one persistent source of undue influence that overshadows the discharge of FDA regulators' duties to the public. Exit from government to private-sector employment via the "revolving door" is a frequent occurrence …

Measuring Follow-On Innovation, Janet Freilich, Sepehr Shahshahani

Faculty Scholarship

How patents affect follow-on innovation is a key question for the patent system. We disaggregate follow-on innovation into activities that infringe patents and others that do not infringe but can be indirectly affected by patents. Replicating an important study using our disaggregated measure, we find that 87 percent of followon innovation is not patent infringement. Supplementing the study’s empirical strategy with data on patent expiration dates, we find that gene patents which are not close to expiration cause an increase in noninfringing follow-on research, but the effect disappears for patents close to expiration. Our nuanced measure helps better identify the …

Implementing Nature's Rights In Colombia: The Arato And Amazon Experiences, Camila Bustos, Whitney Richardson

Elisabeth Haub School of Law Faculty Publications

Nature's rights approaches are being developed as an alternative legal means to enable justice for nature and, oftentimes, humans, too. This study examines Colombia's two seminal court-ordered nature's rights approaches which recognize ecosystems-the Atrato River Basin (2016) and the Colombian Amazon (2018)-as a legal subject with rights to protection, maintenance, conservation, and restoration. Developed as remedies for human rights violations, both cases offer opportunities to explore variations in nature's rights approaches and the relationship between efforts to enable justice for humans and nature. We build on existing scholarly engagement with the cases by contributing a detailed archival study on their …

Gender Violence As A Penalty Of Poverty, Deborah M. Weissman

Faculty Publications

The matter of gender violence, including intimate partner violence (IPV), has long been categorized as a particularly egregious crime. The consequences of IPV are profound and affect all members of the household, family members near and far, and the communities where they live. Gender violence impacts the national economy. Costs accrue to workplaces, health care institutions, and encumber local and state coffers. Survivors are deprived of income, property, and economic stability: conditions that often endure beyond periods of physical injuries. Offenders also experience economic hardship as a result of involvement with the legal system. They often face significant obstacles when …

The Real Problem With Plea Bargaining, Carissa Byrne Hessick

Faculty Publications

This Response critiques Jeffrey Bellin’s argument that plea‑bargaining reform should focus solely on problems uniquely caused by plea bargaining and instead contends that the practice has fundamentally reshaped American criminal justice in ways that extend far beyond Bellin’s narrow framework. The Response argues that plea bargaining exacerbates systemic issues—including harsh sentencing, coercive leverage, and inaccurate convictions—by insulating legislative excess, weakening trial incentives, and pressuring even innocent defendants to plead guilty. It further maintains that Bellin understates how plea bargaining distorts legislative behavior, affects statutory design, and suppresses political pressure for reform. Most importantly, the Response identifies plea bargaining’s central harm …

Multibillion-Dollar Tax Questions, James Alm, Jay A. Soled, Kathleen Delaney Thomas

Faculty Publications

Tax compliance in the United States historically hovers in the 80 percent range, costing the nation approximately half a trillion dollars annually in uncollected tax revenue. To foster greater tax compliance, the Internal Revenue Service (IRS) should employ whatever tools are at its disposal. Standard deterrence theory argues that increasing the audit rate and imposing stiffer penalties would foster greater tax compliance. There are political headwinds, however, that strongly suggest that these approaches are not currently viable. Instead, there is a low-cost method that could yield greater tax compliance. Drawing on recent and compelling social science research, the IRS should …

Physicians Spreading Medical Misinformation: The Uneasy Case For Regulation, Richard S. Saver

Faculty Publications

Physicians have played a surprisingly prominent role in the current “infodemic” of false and misleading medical claims. Yet, state medical boards, the governmental agencies responsible for professional licensure and oversight, have sanctioned remarkably few physicians. Pushing back against the widespread criticism of medical boards for insufficient action, this Article questions the overall suitability of licensure regulation to police medical misinformation. First, uncertainty exists about medical boards’ jurisdiction and legal authority. Many misinformation claims have involved physicians communicating publicly, not while treating patients. Given the primarily patient-centered legal and ethical frameworks governing the practice of medicine, serious challenges arise in making …

High Anxiety: Racism, The Law, And Legal Education, Elayne E. Greenberg

Washington and Lee Journal of Civil Rights and Social Justice

Conspicuously absent from the United States’ ongoing discourse about its racist history is a more honest discussion about the individual and personal stressors that are evoked in people when they talk about racism. What if they got it wrong? The fear of being cancelled -- the public shaming for remarks that are deemed racist -- has had a chilling effect on having meaningful conversations about racism. What lost opportunities!

This paper moves this discussion into the law school context. How might law schools rethink their law school curricula to more accurately represent the role systemic racism has played in shaping …

From Newark’S Little Italy To Congress: How The Italian American Values Of Family, Pride, And Hard Work Influenced Congressman Peter Rodino’S Legislation, Francesca Simone

Student Works

No abstract provided.

The Potential End To Space Diplomacy: How Biden Can Preserve It And Expand Cooperation, Padraig Delaney

Student Works

No abstract provided.

Critical Theory & Commercial Law In The Sunshine, Christopher D. Hampson

UF Law Faculty Publications

In recent years, Florida and other states have attempted to expel critical legal theory, critical race theory, and all things “woke” from their institutions of higher education. At a time of professional cautiousness and chilled speech, this Essay aims to bring these ideas into the sunshine. I provide a rough background on critical theory and how it helps make sense of commercial law, including Contracts and Bankruptcy, two courses I teach at the University of Florida. Critical theory can help students learn how to navigate complex systems of laws, analyze the policy implications of legal rules, and represent their future …