Intellectual Property Law Commons^™

Formulating Public Pharma, Shweta Kumar

IPIPC Papers & Reports

In 2022, prices for both brand-name and generic drugs in the U.S. were nearly three times as high as prices in comparably industrialized nations, with the cost of insulin products in particular being nearly ten times as high. As a result, 3 out of 10 American adults cannot afford to take their medication as prescribed. Furthermore, in 2024 the U.S. experienced its worst drug shortage in over a decade, with more than 300 drugs in short supply. Generic drugs are particularly vulnerable to shortage, as manufacturers have poor economic incentives to produce drugs with slim profit margins. While the Biden …

Intellectual Property, Genetic Resources, And Associated Traditional Knowledge, N.S. Gopalakrishnan, Srividhya Ragavan, Narendran Thiruthy

Faculty Scholarship

The recently concluded WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge mandates disclosure requirements in patent applications, thereby creating an obligation to attribute the use of genetic resources and traditional knowledge. The WIPO member countries thus have an opportunity to modify their national patent laws, so that they can effectively control genetic resources and traditional knowledge. This article examines the choices that the biodiversity-rich countries have when designing their national legal systems to implement the treaty.

Patent Law’S Role In Protecting Public Health, Sean B. Seymore

Notre Dame Law Review

Innumerable inventions implicate public health—including drugs, vaccines, dietary supplements, and sewage treatment plants. Over the past century, the Patent Office and the courts have modulated the ability to obtain or enforce patents for these inventions—whether in response to a public health crisis or to protect the credulous public from unscrupulous inventors. While normative and policy-based arguments can justify these interventions, they’ve disrupted the delicate balance of two competing policy objectives in patent law—enhancing public welfare and promoting innovation. This Article offers a new approach for courts to protect public health in patent cases—by making public health an affirmative defense to …

Patent Law's Role In Protecting Public Health, Sean B. Seymore

Vanderbilt Law School Faculty Publications

Innumerable inventions implicate public health-including drugs, vac- cines, dietary supplements, and sewage treatment plants. Over the past cen- tury, the Patent Office and the courts have modulated the ability to obtain or enforce patents for these inventions-whether in response to a public health crisis or to protect the credulous public from unscrupulous inventors. While normative and policy-based arguments can justify these interventions, they've disrupted the delicate balance of two competing policy objectives in patent law- enhancing public welfare and promoting innovation. This Article offers a new approach for courts to protect public health in patent cases-by making public health an …

Compounding Inequities Through Drug Ip And Unfair Competition, Shweta Kumar

IPIPC Papers & Reports

In 2024, the United States experienced its worst drug shortage in over a decade—more than 300 drugs are in shortage, leaving patients without access to lifesaving medicines. Luckily, drug manufacturers are not the only source of drugs. Through drug compounding, licensed pharmacists can create medications that are not commercially available due to discontinuations, shortages, or other supply chain issues. The recent slew of severe drug shortages has forced patients and physicians to rely on compounding pharmacies to make critical drugs for patients—particularly vulnerable patient populations, including pediatric, disabled, and transgender patients—such as mixed amphetamine salts (sold as Adderall), semaglutide (sold …

U'Wa Indigenous People Vs. Columbia: Potential Applications Of The Escazu Agreement, Ariana Lippi

Sustainable Development Law & Policy

Though the case is ongoing, and results are still to be seen, it in many ways sets a precedent for indigenous communities in Latin America seeking redress for environmental and cultural injustices. With Colombia’s recent ratification of The Escazú Regional Agreement (the Agreement herein) in 2022, this case presents a unique opportunity for implementation of the Agreement and greater accountability within existing domestic legislation.

Natural Resources In The Arctic: The Equal Distribution Of Uneven Resrouces, Ganeswar Matcha, Sudarsanan Sivakumar

Sustainable Development Law & Policy

This paper analyses the governance machine in place at the Arctic and examines the application of the principles of “common heritage of mankind” at the Arctic. This paper also offers some tentative propositions aimed at protecting Out Bound investment rights and how the World Trade Organization or other countries, like the U.S., can intercede in the Arctic investment sphere and attempt to regulate along with the United Nations Convention for the Law of the Sea.

Incentivizing Sustainability In American Enterprise: Lessons From Finnish Model, Vasa T. Dunham

Sustainable Development Law & Policy

The disparate climate performances of Finland and the United States, two of the wealthiest countries in the world, bring to light the question of how corporate responsibility has been inspired in each jurisdiction. Having established the urgency of the climate crisis and the importance of corporate behavior in optimizing a given country’s approach to protection of the global environment, an examination of each nation’s legal frameworks may shed light on features of the corporate regime that are effective in advancing sustainability goals and those that are not.22 Part I of this paper establishes a comparative framework by providing background on …

Editor's Note, Shade Streeter, Reagan Ferris

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.

No Need To Reinvent The Wheel: The Positive Relationship Between Green Technology And Patent Enforcement, Addison S. Fowler

Villanova Environmental Law Journal (1991 - )

No abstract provided.

A History Of Corporate Law Federalism In The Twentieth Century, William W. Bratton

Seattle University Law Review

This Article describes the emergence of corporate law federalism across a long twentieth century. The period begins with New Jersey’s successful initiation of charter competition in 1888 and ends with the enactment of the Sarbanes-Oxley Act in 2002. The federalism in question describes the interrelation of state and federal regulation of corporate internal affairs. This Article takes a positive approach, pursuing no normative bottom line. It makes six observations: (1) the federalism describes a division of subject matter, with internal affairs regulated by the states and securities issuance and trading regulated by the federal government; (2) the federalism is an …

Reconciling Disjunct Cryptocurrency Securities Enforcement With Purchaser Expectations, Jacob E. Simmons

Seattle University Law Review

The Southern District of New York’s July 2023 decision in SEC v. Ripple Labs, Inc. has been touted as a monumental win for cryptocurrency purchasers and related businesses. The Ripple court held that, except institutional investor transactions, all sales of Ripple’s XRP token were not investment contracts, a class of security subject to federal securities law. The court’s ruling meant that Ripple could not be held liable for the unregistered trading of XRP beyond its sales to institutional investors. Ripple adds new insights to a pervasive policymaking dilemma addressed in this Note: is the Securities and Exchange Commission’s (SEC) regulatory …

Stakeholder Capitalism’S Greatest Challenge: Reshaping A Public Consensus To Govern A Global Economy, Leo E. Strine Jr., Michael Klain

Seattle University Law Review

The Berle XIV: Developing a 21st Century Corporate Governance Model Conference asks whether there is a viable 21st Century Stakeholder Governance model. In our conference keynote article, we argue that to answer that question yes requires restoring—to use Berle’s term—a “public consensus” throughout the global economy in favor of the balanced model of New Deal capitalism, within which corporations could operate in a way good for all their stakeholders and society, that Berle himself supported.

The world now faces problems caused in large part by the enormous international power of corporations and the institutional investors who dominate their governance. These …

Foreseeability And Duty In Washington Negligence Law: Leaving The Road Less Traveled By, Leo Linder

Seattle University Law Review

Washington negligence law is a confusing labyrinth of foreseeability that not even Ariadne’s string could guide plaintiffs out of. Foreseeability is implicated in four distinct analyses, several of which overlap considerably. Doctrines that were once questions of law are now questions of fact, and vice versa. Something needs to change.

Washington has taken the novel approach of bifurcating the duty element into two parts—duty’s mere existence, which is a question of law for the court to determine; and duty’s scope, which is a question of fact handed off to the jury to determine. Foreseeability impacts both of these assessments, but …

Henderson And The Objective Observer Standard: The Future Of Race-Conscious Standards Post-Students For Fair Admissions, Gabriela Dionisio

Seattle University Law Review

On June 29, 2023, the Supreme Court of the United States decided Students for Fair Admissions v. President & Fellows of Harvard College, which struck down race-conscious admissions policies. Within just a year after its ruling, Students for Fair Admissions has already had a sweeping impact, reaching beyond higher education. Although the Supreme Court did not indicate whether Students for Fair Admissions applies to sectors beyond higher education, law firms, and other employers have already modified their diversity policies and initiatives, erasing race and company diversity considerations. Given those dramatic changes, there is growing fear that Students for Fair Admissions …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Same Crime, Different Time: Sentencing Disparities In The Deep South & A Path Forward Under The Fourteenth Amendment, Hailey M. Donovan

Seattle University Law Review

The United States has the highest incarceration rate of any country in the world. The American obsession with crime and punishment can be tracked over the last half-century, as the nation’s incarceration rate has risen astronomically. Since 1970, the number of incarcerated people in the United States has increased more than sevenfold to over 2.3 million, outpacing both crime and population growth considerably. While the rise itself is undoubtedly bleak, a more troubling truth lies just below the surface. Not all states contribute equally to American mass incarceration. Rather, states have vastly different incarceration rates. Unlike at the federal level, …

Ai, New Technologies, And Corporate Governance: Three Phenomena, Martin Petrin

Seattle University Law Review

Artificial intelligence (AI) and other new technologies are increasingly influencing the operations, business models, and structures of companies. This Article focuses on three emerging phenomena that impact significant aspects of corporate governance and regulation: (1) perforation and blurring of firm boundaries through the ubiquitous use of externally provided AI services; (2) businesses engaging in strategic access and leveraging of critical resources held by third parties without owning them; and (3) the unusual hybrid role of online platforms between market facilitators and markets themselves. The Article explores how these phenomena challenge traditional views of firms as separate units, with technology leading …

A Blueprint To Reclaim Legal Education From External Rankers, Scott Rempell

Seattle University Law Review

The U.S. News & World Report (U.S. News) law school rankings have impacted the perceptions and behaviors of everyone in the rankings ecosystem for decades. Commentators have almost universally condemned these ordinal rankings, yet they continue to influence the legal education market, often in highly detrimental ways.

The influence of these rankings stems from legitimate market demands, for reasons that the psychology of choice literature makes clear. People want (or need) to efficiently acquire and digest information that could help them make consequential decisions. At a time when consumers of law school information did not have such choice-making assistance, U.S. …

Real-World Consequences For Online Actions: The Case For Expanding Employee Harassment Protection Via Employers’ Rights Of Action, Alexander Barnes

Seattle University Law Review

This Note argues for expanding employers’ access to legal remedies that allow them to recoup the costs of protecting their employees from swatting, doxing, and other online harassment arising from their employees’ professional activity. Part I provides a brief description and history of the online harassment problem and its potentially deadly dangers. Part II describes employers’ legal responsibility to take action to protect their employees from harassment aimed at their employees within the scope of their employment. Part III explores common legal remedies that are currently available to employers, using the state of Washington as an example. Part III also …

The Need For Corporate Guardrails In U.S. Industrial Policy, Lenore Palladino

Seattle University Law Review

U.S. politicians are actively “marketcrafting”: the passage of the Bipartisan Infrastructure Law, the CHIPS and Science Act, and the Inflation Reduction Act collectively mark a new moment of robust industrial policy. However, these policies are necessarily layered on top of decades of shareholder primacy in corporate governance, in which corporate and financial leaders have prioritized using corporate profits to increase the wealth of shareholders. The Administration and Congress have an opportunity to use industrial policy to encourage a broader reorientation of U.S. businesses away from extractive shareholder primacy and toward innovation and productivity. This Article examines discrete opportunities within the …

Securities Regulation And Administrative Deference In The Roberts Court, Eric C. Chaffee

Seattle University Law Review

In A History of Securities Law in the Supreme Court, A.C. Pritchard and Robert B. Thompson write, “Securities law offers an illuminating window into the Supreme Court’s administrative law jurisprudence over the last century. The securities cases provide one of the most accessible illustrations of key transitions of American law.” A main reason for this is that the U.S. Securities and Exchange Commission (SEC) is a bellwether among administrative agencies, and as a result, A History of Securities Law in the Supreme Court is a history of administrative law in the Supreme Court of the United States as well.

Delegated Corporate Voting And The Deliberative Franchise, Sarah C. Haan

Seattle University Law Review

Starting in the 1930s with the earliest version of the proxy rules, the Securities and Exchange Commission (SEC) has gradually increased the proportion of “instructed” votes on the shareholder’s proxy card until, for the first time in 2022, it required a fully instructed proxy card. This evolution effectively shifted the exercise of the shareholder’s vote from the shareholders’ meeting to the vote delegation that occurs when the share-holder fills out the proxy card. The point in the electoral process when the binding voting choice is communicated is now the execution of the proxy card (assuming the shareholder completes the card …

Robo-Voting: Does Delegated Proxy Voting Pose A Challenge For Shareholder Democracy?, John Matsusaka, Chong Shu

Seattle University Law Review

Robo-voting is the practice by an investment fund of mechanically voting in corporate elections according to the advice of its proxy advisor— in effect fully delegating its voting decision to its advisor. We examined over 65 million votes cast during the period 2008–2021 by 14,582 mutual funds to describe and quantify the prevalence of robo-voting. Overall, 33% of mutual funds robo-voted in 2021: 22% with ISS, 4% with Glass Lewis, and six percent with the recommendations of the issuer’s management. The fraction of funds that robo-voted increased until around 2013 and then stabilized at the current level. Despite the sizable …

Capitalism Stakeholderism, Christina Parajon Skinner

Seattle University Law Review

Today’s corporate governance debates are replete with discussion of how best to operationalize so-called stakeholder capitalism—that is, a version of capitalism that considers the interests of employees, communities, suppliers, and the environment alongside (if not before) a company’s shareholders. So much focus has been dedicated to the question of capitalism’s reform that few have questioned a key underlying premise of stakeholder capitalism: that is, that competitive capitalism does not serve these various constituencies and groups. This Essay presents a different view and argues that capitalism is, in fact, the ultimate form of stakeholderism. As such, the Essay urges that the …

The Limits Of Corporate Governance, Cathy Hwang, Emily Winston

Seattle University Law Review

What is the purpose of the corporation? For decades, the answer was clear: to put shareholders’ interests first. In many cases, this theory of shareholder primacy also became synonymous with the imperative to maximize shareholder wealth. In the world where shareholder primacy was a north star, courts, scholars, and policymakers had relatively little to fight about: most debates were minor skirmishes about exactly how to maximize shareholder wealth.

Part I of this Essay discusses the shortcomings of shareholder primacy and stakeholder governance, arguing that neither of these modes of governance provides an adequate framework for incentivizing corporations to do good. …

The Esg Information System, Stavros Gadinis, Amelia Miazad

Seattle University Law Review

The mounting focus on ESG has forced internal corporate decision-making into the spotlight. Investors are eager to support companies in innovative “green” technologies and scrutinize companies’ transition plans. Activists are targeting boards whose decisions appear too timid or insufficiently explained. Consumers and employees are incorporating companies sustainability credentials in their purchasing and employment decisions. These actors are asking companies for better information, higher quality reports, and granular data. In response, companies are producing lengthy sustainability reports, adopting ambitious purpose statements, and touting their sustainability credentials. Understandably, concerns about greenwashing and accountability abound, and policymakers are preparing for action.

In this …

On The Value Of History: A Review Of A.C. Pritchard & Robert B. Thompson’S A History Of Securities Law In The Supreme Court, Joel Seligman

Seattle University Law Review

A.C. Pritchard and Bob Thompson have written a splendid history of securities law decisions in the Supreme Court. Their book is exemplary because of its detailed use of the long unpublished papers of Supreme Court justices, including those of Harry Blackmun, William O. Douglas, Felix Frankfurter and Lewis F. Powell, primary sources which included correspondence with other Justices and law clerks as well as interviews with law clerks. The use of these primary sources recounted throughout the text and 67 pages of End Notes deepens our understanding of the intentions of the Justices and sharpens our understanding of the conflicts …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Religious Freedom And Diversity Missions: Insights From Jesuit Law Deans, Anthony E. Varona, Michèle Alexandre, Michael J. Kaufman, Madeleine M. Landrieu

Seattle University Law Review

This Article is a transcript of a panel moderated by Anthony E. Varona, Dean of Seattle University School of Law. During the panel, Jesuit and religious law school deans discussed what law schools with religious missions have to add to the conversation around SFFA and the continuing role of affirmative action in higher education.