Digital Commons Network^™

Modification Patents Across Multiple Ndas In Pharmaceutical Protections, Robin C. Feldman, Ramy Alsaffar, Tanziuzzaman Sakib

Faculty Scholarship

Introduction Our study examines modification patents across multiple New Drug Applications (NDAs), employed by pharmaceutical companies to extend patent protections. Ours is the only comprehensive study of modification patents by Active Pharmaceutical Ingredient (API) across multiple NDAs, the approach of current regulatory initiatives, investigating how these patents extend drug protections and impede generic entry.

Methods We examine 1028 modification patents, categorizing them as chemical variations, formulation changes, treatment methods, or device/agent. We tabulated additional granted protection time, correlations with new NDAs, and litigation from potential generics.

Results On average, 5 modification patents protected each drug, extending granted protection periods by …

Early-Term Abortion Bans And Sex Selection After Dobbs V Jackson, William Jergins, Xin Liang Brown

Faculty Scholarship

Following the 2022 US Supreme Court decision Dobbs v Jackson, many states adopted early-term abortion (ETA) bans that prohibit abortions before the age of viability and often before sex determination is technologically feasible. We analyze the effect of ETA bans on the sex ratio at birth among first-generation Chinese, Korean, and Indian (CKI) immigrants using difference-in-differences and triple differences methodolo- gies. While our estimates across higher parity children sometimes indicate a decrease in the sex ratio at birth, they are also generally small and statistically insignificant, which is consistent with continued access to sex selection under ETA bans. In contrast, …

Strongly Confined Bismuth Antimonide Quantum Dots, Min Khadka, Rajendra Subedi, Qiaohui Zhou, Xin Lu, Joelin A. Agyei-Mensah, Miguel José-YacamáN, Guillaume Lang, Etienne Herth, Gregory Guisbiers

Faculty Scholarship

Bismuth antimonide (Bi1–xSbx) has emerged as a highly promising material for quantum applications due to its complex band structure. In this study, spherical Bi1–xSbx quantum dots (QDs), with a diameter of around 8 ± 2 nm, were successfully synthesized by pulsed laser ablation in liquids. The energy bandgap was determined at 2.02 ± 0.27 eV, which is significantly higher than the bulk value (∼0.025 eV). The strong confinement nature of the dots was confirmed by the Raman peak shifts. The chemical composition of the Bi1–xSbx QDs was measured to be around 77 ± 2 at. % of Bi and 23 …

Climate Lies And Unjust Profits, Vanessa Casado-Pérez, Yotam Kaplan, Yael Lifshitz, Niv Meyerson

Faculty Scholarship

The climate crisis has reached a perilous tipping point. Our entrenched reliance on fossil fuels remains unchecked, as fossil fuel corporations wield their power to block meaningful reform and entrench their profits. The political horizon offers little relief—an incoming administration is poised to dismantle vital environmental protections, stripping away the few safeguards that stand between us and climate catastrophe.

In this grim landscape, communities across the nation are turning to the courts with renewed urgency, seeking justice and reform through climate litigation. Yet past efforts have fallen short, stymied by two formidable barriers. First, by centering on greenhouse gas emissions …

Reflections On The Use And Misuse Of Economic Analysis In Copyright, Glynn Lunney

Faculty Scholarship

Economic analysis has long been used to justify copyright regulation. Long before the Statute of Anne, the Stationer’s Guild told the story of the copying competitor, who in the absence of regulation, would copy every original book and offer it for less. In the story, the coping competitor would, in the absence of regulation, deprive the original author of an opportunity to recoup their authorship investment, and so lead to a world where no books at all would be published. To ensure sufficient incentives for authorship, some degree of copyright regulation was thought essential. At the same time, in the …

Prompting As A New Medium: Greenbergian Medium Specificity And The Iterative Unpredictability Of Ai Art, Samantha Shapiro, James Hutson

Faculty Scholarship

This article argues that AI prompting should be understood not as a tool, technique, or accessory to image generation, but as a medium in its own right. Drawing on Clement Greenberg’s theory of medium specificity, it contends that a medium becomes legible through the operations peculiar to itself, namely, the constraints, affordances, and formal procedures that distinguish it from neighboring arts. Existing scholarship has asked whether prompting counts as art, whether prompt engineering constitutes a creative skill, and whether the prompt itself can be aesthetic; however, these accounts often stop short of a sustained theory of prompting as medium. This …

Plea Bargain Skepticism When Companies Kill People, Peter R. Reilly

Faculty Scholarship

In 2018 and 2019, two Boeing 737 MAX airplanes fell from the sky, killing 346 people—one of the deadliest corporate crimes in U.S. history. Instead of taking the case to trial, the United States Department of Justice (“DOJ”) addressed the matter by using two different alternative dispute resolution vehicles. First, Boeing was given a three-year deferred prosecution agree-ment. That deal was canceled when DOJ determined the company had breached it. Next, Boeing was given a plea bargain. This Article argues that federal courts, which are empowered to approve or reject plea deals, should be skeptical when the government turns to …

Poor Esg: Regressive Effects Of Climate Stewardship, Zohar Goshen, Assaf Hamdani, Alex Raskolnikov

Faculty Scholarship

The rise of inequality and global warming are the two ultimate challenges of our time. After decades of congressional failure to address climate change, the private sector has stepped in and adopted a set of environmental, social, and governance (ESG) policies as a market-based solution to a public policy failure. ESG advocates hope that corporate executives would save our planet. Where Congress failed, ESG will succeed.

This Article argues that if ESG-driven climate stewardship ever achieves the scale necessary to have a real impact on global warming, it will hurt the poor. Legislative interventions to combat climate change are nearly …

U.S. Shareholder Activism: Convergence With Japan, Nobuhisa Ishizuka

Faculty Scholarship

To many observers long accustomed to slow, incremental change, the current boom in shareholder activism in Japan comes as a surprise. The opening for U.S.-style activists was created by market conditions that eventually resulted in policy changes that attracted significant numbers of foreign investors. However, even the current market would not have emerged without a parallel evolution in U.S. hedge-fund tactics, which gradually shifted over a number of years to a sophisticated and more nuanced approach, one based on partnership and dialogue with target companies, in contrast to adversarial relationships and public campaigns. This article attempts to place current trends …

Metrics Not Thresholds: How To Regulate Ai And Other Expert Methods For Use In Criminal Investigations And Proceedings, Rebecca Wexler

Faculty Scholarship

Should regulators set performance thresholds for AI tools used in the criminal legal system? This Article draws on U.S. evidence law for guidance. Its answer is ... don’t. Instead of gatekeeping with ex ante performance thresholds, regulators should require or incentivize metrics of reliability that can be clearly communicated to end-user decisionmakers.

The Federal Reserve’S Fiscal Agent Mandate And The Problem For Central Bank Independence, Lev Menand, Joshua Younger

Faculty Scholarship

The Federal Reserve is among the most powerful organs of government. It is tasked primarily with maintaining the growth of monetary and credit aggregates consistent with long-run maximum employment and price stability. This mandate is widely known and the subject of extensive public debate. But another mandate lies within the statute that is largely overlooked — to serve as fiscal agent of the United States. This distinct responsibility is older, and also important. This Article offers a comprehensive assessment of where the Fed’s two mandates overlap and occasionally sharply conflict: in the market for U.S. government debt. First, it identifies …

How Ai Destroys Institutions, Woodrow Hartzog, Jessica Silbey

Faculty Scholarship

Civic institutions—the rule of law, universities, and a free press—are the backbone of democratic life. They are the mechanisms through which complex societies encourage cooperation and stability, while also adapting to changing circumstances. The real superpower of institutions is their ability to evolve and adapt within a hierarchy of authority and a framework for roles and rules, while maintaining legitimacy for the knowledge produced and the actions taken. Purpose-driven institutions built around transparency, cooperation, and accountability empower individuals to take intellectual risks and challenge the status quo. This happens through the machinations of interpersonal relationships within those institutions, which broaden …

Tear Down The Wall: Why Requiring The Fda And The Pto To Share Information Will Improve The Decision-Making Of Both Agencies, Robin C. Feldman, Gideon Schor

Faculty Scholarship

An invisible wall separates the U.S. Food and Drug Administration (FDA) from the U.S. Patent and Trademark Office (PTO). This wall blocks inter-agency communication, depriving the PTO of information relevant to patent applications and depriving the FDA of information relevant to drug-approval applications. Consequently, it is too easy for a drug company to tell the PTO ‘our drug is new’ (in hopes of speeding a patent grant) while telling the FDA ‘our drug is not new’ (in hopes of speeding drug approval). Better communication between the FDA and PTO would increase agency accuracy by preventing inconsistent representations, and would increase …

Ultra Vires Review In Administrative Law For Dummies, Jack M. Beermann

Faculty Scholarship

Richard W. Murphy, Ultra Vires Review of Federal Agency Action Made Simple(r), 2025 Utah L. Rev. 1201 (2025).

Non-statutory review, ultra vires review, and Leedom v. Kyne, the leading case on non-statutory review, all have one thing in common—when I come across them, my eyes glaze over, and I pretend it never happened, hoping they will all go away. It’s like an allergic reaction. I’ve avoided talking about them, writing about them, and covering them in my Administrative Law course like the plague. Leave it to Richard (“Chip”) Murphy, famous for his entertaining and informative annual reviews of …

Grading Machines: Can Ai Exam-Grading Replace Law Professors?, Kevin L. Cope, Jen Frankenreiter, Scott Hirst, Eric A. Posner, Daniel Schwarcz, Dane Thorley

Faculty Scholarship

In the past few years, large language models (LLMs) have achieved significant technical advances, such that legal-advocacy organizations are increasingly adopting them as complements to—or substitutes for—lawyers and other human experts. Several studies have examined LLMs' performance in taking law school exams, finding mixed results. Yet there have been no published studies systematically analyzing LLMs' competence at one of law professors' chief responsibilities: grading law school exams. This paper presents results of an analysis of how LLMs perform in evaluating student responses to legal analysis questions of the kind typically administered in law school exams. The underlying data come from …

The Racial Implications For Black Claimants At The Federal Arbitration Act's Centennial, Michael Z. Green

Faculty Scholarship

On February 12, 1925, when President Calvin Coolidge signed into law an Act to make arbitration agreements "valid, irrevocable, and enforceable," no person could have expected that this new statute would ever apply to claims by Black litigants. A century later, that law, now referred to as the Federal Arbitration Act (FAA), has evolved to encompass disputes involving a broad array of claimants and processes where businesses enforce pre-dispute agreements to arbitrate. In examining whether Black claimants (businesses, consumers, and importantly, workers) may benefit from using arbitration, this Article investigates how the FAA, as enacted, never intended to address their …

Tokenized Real Estate: The Law And Tech Of Digital Deeds, Christopher K. Odinet, Andrea Tosato

Faculty Scholarship

The advent of blockchain technology has generated bold claims that non-fungible tokens (NFTs) can fundamentally transform real estate. Proponents assert that digital assets can tokenize real property interests: the concept of using digital tokens to represent ownership rights in physical property. Their goal is to allow buyers and sellers to transfer real estate through simple blockchain transactions, thereby eliminating traditional intermediaries, reducing costs, and accelerating deal velocity. This Essay provides the first comprehensive legal analysis examining whether American law actually supports such a direct tokenization of real estate rights.

Our investigation reveals a stark disconnect between technological capability and legal …

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Medical-Legal Partnership As Value-Based Primary Care: Interprofessional Teamwork For Health-Related Social Needs, Jin K. Park, Andrew F. Beck, Keegan D. Warren, William M. Sage

Faculty Scholarship

Today’s primary care physicians are being asked to address patients’ health-related social needs (HRSN) as part of their routine care practices. An aging population, with a growing complement of intersecting medical and social needs, increases this burden on primary care. Medical-legal partnerships (MLP) are interprofessional collaborations that combine clinical and legal expertise to address HRSN involving housing, public benefits, employment, and other domains remediable by civil legal assistance. A value-based approach to integrating MLP into the health system may help primary care practices more effectively address HRSN and, in turn, better balance revenue and expenses. At the practice and healthcare …

Advice For Nonactualists: Embrace Metaphysically Vague Ficta, Jeffrey C. Goodman

Faculty Scholarship

I here critically discuss “the Selection Problem”, a vexing problem for metaphysicians who are realists about fictional entities and who further claim that such entities are identified with nonactualia. The Selection Problem arises due to the fact that the nonactualist is forced to defend the view that ficta are somehow discovered, or selected, by authors who then present them to us so we may entertain their exploits. But how exactly does an author manage this when there are a vast number of eligible candidates to be found in the relevant nonactual realms? I argue that the realist who is also …

False Conflict: Colorblindness And Section 2 Of The Voting Rights Act, W. Kerrel Murray

Faculty Scholarship

If friends and foes of section 2 of the Voting Rights Act of 1965 agree on one thing, it is the irrepressible conflict between section 2’s attention to race and constitutional colorblindness.  They’re wrong.  Rightly understood, section 2’s design is remarkably compatible with colorblind constitutionalism’s letter and spirit.

To show how, this Article first returns to section 2’s origins and the preexisting approach its text codifies.  That approach had an underappreciated ethos:  When intentional discrimination’s effects sufficiently distort a political system, an electoral rule’s results might impugn its unconstitutionality, even if the rule had been adopted without discriminatory purpose.  Drawing …

Bad Faith Disregard Of Benefits And Science In Federal Environmental Deregulation, Michael B. Gerrard

Faculty Scholarship

Since the beginning of the Reagan administration in 1981, federal agencies have used cost-benefit analysis when making important policy decisions, especially when issuing regulations. In the years since then the methodologies have been refined and enshrined in White House guidance. The second Trump administration has upended these practices by often ignoring the benefits of regulations and only considering the costs. In doing so it often claims that there are such uncertainties about the benefits that they should be disregarded. It uses these claims in support of repealing or softening regulations that prior administrations found would save thousands of human lives.

Thinking Constructively About International Law, Monica Hakimi

Faculty Scholarship

The international order that has defined the post-World War II period is being radically transformed, presenting a once-in-a-generation opportunity to reconstitute its basic foundations. The pressing questions for international lawyers are about the roles their enterprise can and should play going forward. I argue in this Article that most lack the analytic framework they need even to begin tackling these questions. Worse, most seem mired in an old theory about law that corrupts how they approach their enterprise. My goals in the Article are to expose the prevalence of this bad theory and to present the grounds for discarding it, …

Generative Artificial Intelligence With A Human Touch: Building Hana, Conrad Johnson

Faculty Scholarship

This Essay examines how generative artificial intelligence (GenAI) can be integrated into legal education and public interest law practice in a way that meaningfully enhances — rather than diminishes — human judgment, professional responsibility, and access to justice. Drawing on the experience of Columbia Law School’s Lawyering in the Digital Age Clinic, the Essay situates GenAI within an experiential pedagogy that emphasizes competence, ethical awareness, and collaborative problem-solving. It argues that law students and lawyers must move beyond a passive or uncritical use of GenAI tools; toward a deeper understanding of how these systems operate, the risks they pose, and …

Uncomfortably Reminiscent: Odonnell V. Harris County In History And Memory, Kellen R. Funk

Faculty Scholarship

In ODonnell v. Harris County, a federal trial court enjoined the misdemeanor bail system of Houston, Texas, freeing approximately 20,000 indigent defendants annually. To do this, the trial court drew upon Reconstruction era precedents establishing intensive federal oversight of state criminal proceedings. The court explicitly invoked the Civil War and Reconstruction transformation of the federal judiciary, comparing the County’s defenses to slavery era arguments. Conversely, when the en banc Fifth Circuit reviewed a similar order in Dallas, Texas, six years later, it rejected this historical framework, condemning such litigation as an impermissible “ongoing federal audit of state criminal proceedings.” …

On Predicting And Stopping Dystopia, Evan Selinger, Woodrow Hartzog

Faculty Scholarship

Is it reasonable to be dystopian about how the future will likely unfold? We think so. For some time, we have been arguing that facial recognition technology is a perfect tool of oppression, and that its pernicious affordances are leading society down a slippery slope toward the evisceration of privacy by obscurity. This is a soft form of “determinism”—the notion that while technology is not an unstoppable force and the future is not preordained, there nevertheless are identifiable factors, such as the invitingness of affordances, human nature, and incentives that drive technology in certain directions and make some social outcomes …

Beyond The Building: Leveraging A Library Renovation To Tell A Broader Story, Kristen S. Shuyler

Faculty Scholarship

A library renovation presents a unique communication challenge, requiring a thoughtful strategy that minimizes disruption while building anticipation. When James Madison University (JMU) decided to renovate and expand its flagship library, the JMU Libraries’ Communications & Outreach team pivoted from routine promotional efforts to a streamlined communication model designed to handle significantly increased, narrative-driven messaging related to the renovation. This article outlines the renovation project’s communication plan, describes our streamlining efforts, and highlights unexpected opportunities that emerged along the way—allowing us to share the library’s story in new ways and with broader audiences.

Access To Justice After Medina V Planned Parenthood South Atlantic, Daniel G. Aaron, Nicole Huberfeld

Faculty Scholarship

Access to justice is “the ability of all people to seek and obtain effective remedies through accessible, affordable, … and culturally competent institutions of justice.”¹ Historically, patients and physicians have worked together to protect the integrity of medical care as well as patients’ rights by challenging unlawful government actions in court. Yet the US Supreme Court recently issued decisions that may impede access to justice, potentially empowering federal, state, and local governments to interfere with evidence-based care. We explore constraints on access to justice that may arise after Medina v Planned Parenthood South Atlantic (PPSA) (606 US 357, 2025), …

The Business Of Ai-Producing Startups: Evidence From A Worldwide Survey, James Bessen, Stephen Michael Impink, Robert Seamans

Faculty Scholarship

We report results from a multi-year, worldwide survey of artificial intelligence (AI)-producing startups to describe the types of technologies, frameworks, data protection, and partnerships nascent firms use to develop their AI products. Analyses of our survey findings also inform how startups gather the resources to commercialize their AI applications in alignment with their entrepreneurial strategies, address competitive barriers, and respond to regulations. These data provide initial evidence of the perceived impact of these products on their customers’ tasks and industries, suggesting that these firms’ AI products not only reduce labor costs but augment human capabilities.

Nonlinear Bivariate Associations And Mononuclear Cell‐Type‐Specific Expression Level Differences In The Sting Signalling Pathway, David Kaplan

Faculty Scholarship

Understanding intracellular signalling pathways is crucial since they regulate essential functional activities. Bivariate relationships have been useful in delineating these pathways in clinical samples. In our previous studies, we have found many linear associations between pathway components, and we have interpreted these correlations as rheostatic regulators. Increases in an upstream component are correlated with a commensurate downstream increase. Here, we report a quantitative analysis of molecules in the STING pathway by assessing the variance in human peripheral blood mononuclear cell-type-specific molecular expression from patients with atherosclerotic coronary artery disease. The induction of the type I interferon track by this pathway …