Health Law and Policy 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 …

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 …

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 …

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, …

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 …

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 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 …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

The Marijuana Insurgency: Federalism And Social Reframing In Policy Reform, Matthew P. Cavedon

Seattle University Law Review

After fifty years of federal prohibition, marijuana reform efforts have won political and legal success. These victories hold lessons for anyone seeking to resist federal law without being able to directly affect it.

Victory can come from reframing an issue. For marijuana reform, social reframing—not formal legal analysis or material factors—provides the best explanation for how advocates achieved change. Their unconventional political tactics, akin to those used by insurgents in wartime, undercut federal prohibition by winning hearts and minds.

This is an analysis of the sociology of legal change. It is also the story of how ordinary Americans retook personal …

What Is In Your Tampon? Increasing Transparency In Menstrual Products, Elianna Spitzer

Seattle University Law Review

The average person who menstruates will bleed for an average of five days, every twenty-four to thirty-eight days, over several decades and could use thousands of disposable menstrual products in their lifetime. Menstrual products line retail shelves. They can be found in homes, bags, and bodies—but until 2021, manufacturers were not required to disclose the ingredients used to make these products to consumers at all. In fact, they still are not federally required to disclose menstrual product ingredients on product packaging. Instead, in recent years, changes to menstrual product labels have largely been the result of state legislation. In 2019, …

Shareholder Primacy Versus Shareholder Accountability, William W. Bratton

Seattle University Law Review

When corporations inflict injuries in the course of business, shareholders wielding environmental, social, and governance (“ESG”) principles can, and now sometimes do, intervene to correct the matter. In the emerging fact pattern, corporate social accountability expands out of its historic collectivized frame to become an internal subject matter—a corporate governance topic. As a result, shareholder accountability surfaces as a policy question for the first time. The Big Three index fund managers, BlackRock, Vanguard, and State Street, responded to the accountability question with ESG activism. In so doing, they defected against corporate legal theory’s central tenet, shareholder primacy. Shareholder primacy builds …

Verses Turned To Verdicts: Ysl Rico Case Sets A High-Watermark For The Legal Pseudo-Censorship Of Rap Music, Nabil Yousfi

Seattle University Law Review

Whichever way you spin the record, rap music and courtrooms don’t mix. On one side, rap records are well known for their unapologetic lyrical composition, often expressing a blatant disregard for legal institutions and authorities. On the other, court records reflect a Van Gogh’s ear for rap music, frequently allowing rap lyrics—but not similar lyrics from other genres—to be used as criminal evidence against the defendants who authored them. Over the last thirty years, this immiscibility has engendered a legal landscape where prosecutors wield rap lyrics as potent instruments for criminal prosecution. In such cases, color-blind courts neglect that rap …

Addressing Ip And Technology Challenges To Pandemic Protection: A Need For Global Coordination To Promote National Security, Cynthia M. Ho

Faculty Publications & Other Works

This Artie!£ argues that effective national security mandates protection against the spread of infectious diseases, which requires addressing intellectual property (IP) and technology obstacles. Without modification, IP laws can bar the manufacture of needed treatments by anyone besides the IP owner and its licensees. Although there was some recognition during the COVID-19 pandemic that existing IP laws should be modified, there was strong resistance not only by IP-owning companies, but also by individual countries that impeded the ability to manufac­ture needed vaccines during the height of the pandemic. Many global leaders have recognized that future pandemics are inevitabw and that …

We Shall Overcome: The Evolution Of Quotas In The Land Of The Free And The Home Of Samba, Stella Emery Santana

Seattle University Law Review

When were voices given to the voiceless? When will education be permitted to all? When will we need to protest no more? It’s the twenty-first century, and the fight for equity in higher education remains a challenge to peoples all over the world. While students in the United States must deal with the increase in loans, in Brazil, only around 20% of youth between the ages of twenty-five and thirty-four have a higher education degree.

The primary objective of this Article is to conduct an in-depth comparative analysis of the development, implementation, and legal adjudication of educational quota systems within …

Pacific Islands And The U.S. Military: The Legal Borderlands Of The Environmental Movement, Sonia Lei

Seattle University Law Review

Climate change remains an urgent, ongoing global issue that requires critical examination of institutional polluters. This includes the world’s largest institutional consumer of petroleum: the United States military. The Department of Defense (DoD) is a massive institution with little oversight, a carbon footprint spanning the globe, a budget greater than the next ten largest nations combined, and overly generous exemptions to environmental regulations and carbon reduction targets. This Comment examines how this lack of accountability and oversight plays out in the context of three Pacific islands that have hosted U.S. military bases for decades. By considering the environmental impact of …

The Consumer’S Choice To Boycott, Agnes Bresee

Seattle University Law Review

In the wake of employees losing their jobs upon voicing their political opinions concerning Israel, Harvard and Columbia law students’ job offers being rescinded upon expressing support for Palestine, and the names and social media profiles of individuals who support Palestine being collected and listed on Canary Mission, such backlash may leave many Americans wondering what form of resistance to settler-colonialist apartheid is acceptable in the twenty-first century. Recently, the movement to collectively boycott brands like Starbucks, which sued its Worker’s Union for a tweet expressing support for Palestine; Disney, which donated money to Israel; and McDonald’s, where a location …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

A Different Approach To Agency Theory And Implications For Esg, Jonathan Bonham, Amoray Riggs-Cragun

Seattle University Law Review

In conventional agency theory, the agent is modeled as exerting unobservable “effort” that influences the distribution over outcomes the principal cares about. Recent papers instead allow the agent to choose the entire distribution, an assumption that better describes the extensive and flexible control that CEOs have over firm outcomes. Under this assumption, the optimal contract rewards the agent directly for outcomes the principal cares about, rather than for what those outcomes reveal about the agent’s effort. This article briefly summarizes this new agency model and discusses its implications for contracting on ESG activities.