3320 research outputs found
Sort by
Towards an Effective Merger Review Policy: A Defence of Rebuttable Structural Presumptions
Full text linkWe discuss the design of an effective merger review policy for the 21st century. We argue that the practice of the past decades is inadequate and propose a move towards much stronger rebuttable structural presumptions. These presumptions establish that all mergers above certain thresholds are illegal unless the merging parties can prove that merger-specific efficiencies will be shared with consumers and yield tangible welfare gains. These presumptions are grounded on solid economics and also acknowledge the real-world limitations in enforcement resources and information asymmetries between companies and regulators. We outline how to establish such presumptions in practice, defending the implementation of an ex-ante system that selects in advance (rather than per transaction) which companies and markets are subject to the presumption. Finally, we outline which merger-related efficiencies can rebut the presumption
Compounding Inequities Through Drug IP and Unfair Competition
Full text linkIn 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 as Ozempic and Wegovy) and tirzepatide (sold as Mounjaro and Zepbound), and injectable estrogen (sold as Depo-Estradiol). However, a corresponding uptick in litigation brought by innovator drug companies against compounding pharmacies alleging intellectual property (IP) infringement and unfair competition threatens the ability of compounding pharmacies to meet critical patient needs during such shortages. Compounding pharmacies serve smaller, local groups of patients and physicians and are less capable of withstanding the threats and costs of litigation. Without legal clarity about these risks, patients face real harms.
Drugs that are in shortage must be compounded, or else patients risk forgoing essential healthcare. While the U.S. Food and Drug Administration (FDA) permits such compounding during shortages, the Patent Act and Lanham Act do not exempt patent and trademark infringement by compounders. This conflict between FDA and IP law creates an incentive for drug manufacturers to deter compounding through the threat of IP litigation. This Article deconstructs the undertheorized IP and unfair competition risks of drug compounding in three ways. It documents the FDA’s authority to regulate compounding and highlights vulnerabilities created by recent and proposed regulations. It also analyzes ongoing litigation against compounding pharmacies for patent and trademark infringement, as well as allegations of unfair competition. Finally, it proposes two practical mechanisms to curtail these liabilities: a patent use exception that creates statutory immunity for pharmacies compounding patented drugs during active shortages, and widespread adoption of name suffixes that indicate the origin of compounded drugs—similar to nonproprietary name suffixes that are used to distinguish biosimilar products from a reference biologic. Both mechanisms would address the conflict between the FDA and IP regimes that affect compounding while protecting patients’ access to life-saving healthcare by promoting the availability of safe, effective, and high-quality drugs during shortages
AI Regulation: Competition, Arbitrage & Regulatory Capture
Full text linkThe commercial launch of ChatGPT in November 2022 and the fast development of Large Language Models catapulted the regulation of Artificial Intelligence to the forefront of policy debates. A vast body of scholarship, white papers, and other policy analyses followed, outlining ideal regulatory regimes for AI. The European Union and other jurisdictions moved forward by regulating AI and LLMs. One overlooked area is the political economy of these regulatory initiatives–or how countries and companies can behave strategically and use different regulatory levers to protect their interests in the international competition on how to regulate AI.
This Article helps fill this gap by shedding light on the tradeoffs involved in the design of AI regulatory regimes in a world where: (i) governments compete with other governments to use AI regulation, privacy, and intellectual property regimes to promote their national interests; and (ii) companies behave strategically in this competition, sometimes trying to capture the regulatory framework. We argue that this multi-level competition to lead AI technology will force governments and companies to trade off risks of regulatory arbitrage versus those of regulatory fragmentation. This may lead to pushes for international harmonization around clubs of countries that share similar interests. Still, international harmonization initiatives will face headwinds given the different interests and the high-stakes decisions at play, thereby pushing towards isolationism. To exemplify these dynamics, we build on historical examples from competition policy, privacy law, intellectual property, and cloud computing
Fears, Faith, and Facts in Environmental Law
Full text linkEnvironmental law has long been shaped by both the particular nature of environmental harms and by the actors and institutions that cause such harms or can address them. This nation’s environmental statutes remain far from perfect, and a comprehensive law tailored to the challenges of climate change is still elusive. Nonetheless, America’s environmental laws provide lofty, express protective purposes and findings about reasons for their enactment. They also clearly state health and environmental goals, provide tailored criteria for action, and utilize procedures and diverse regulatory tools that reflect nuanced choices.
But the news is far from good. Despite the ambitious nature of the nation’s environmental laws, the environment and environmental law in the United States today face many pressing challenges, among them climate change, political vacillations, and a currently antiregulatory Supreme Court that uses unpredictable linguistic games and fact-free exaggerations to reject protective actions. This six-justice antiregulatory majority on the Supreme Court has, in 2022 and 2023, begun to embrace its newfound power and act to further its preferred views of the world, politics, and environmental policy. As discussed below, these antiregulatory justices don’t like agencies, don’t like deference, don’t trust Congress, and find statutes wanting. These justices seem confident in their analytical rigor and integrity, yet often paint skewed views of regulatory actions, trod sloppily over what statutes actually say and do—especially in their neglect of laws’ protective designs and choices—and instead focus almost exclusively on resultant costs claimed by those opposed to the laws’ protective goals.
This article, based on a 2023 Distinguished Lecture at Florida State University College of Law, focuses on the role and possible corrective power of facts, science, and other sorts of “effects claims” in environmental law policymaking. After briefly identifying the fact and science-linked problems motivating this article, I turn to several predictable sorts of fears that both shape our environmental laws and motivate resistance norms that threaten environmental progress. I next turn to the double-edged sword of faith—not in the religious sense, but in the sense of trust or confidence in people and institutions that affect environmental outcomes. Different sorts of faith are displayed by, and motivate, both environmental interests and those seeking to shelve or weaken environmental laws.
This article argues that more rigorous documentation and testing of facts, science, and other effects observations, assertions, and predictions—which this article labels as “effects claims”— and overt challenges to conjecture, dissembling, and exaggerations, could force all to engage with evidence and empirical judgments made salient by legally binding choices reflected in this nation’s environmental statutes. The focus should be on facts, science, and tested effects claims linked to each statute’s particular express goals and action criteria. This increased reliance on and documentation of facts should include development of scientific evidence, assessments of technological and business practice capacities, and on-the-ground observations about environmental ills and effects claims about such risks, harm-creating actions, and regulatory responses. More factually-tethered regulatory actions, built on such documented and tested effects claims, could reduce wild oscillations, check judicial overreach, and even build trust and lock in progress. Law—especially environmental law—as mostly a word-based power game must be de-emphasized
Anti-Press Bias: A Response to Andersen Jones and West\u27s Presuming Trustworthiness
Full text linkProfessors RonNell Andersen Jones and Sonja R. West’s Presuming Trustworthiness is a deeply depressing read. That is what makes it so good. The article is a clear-eyed, data-driven approach to assessing just how endangered the legal status of the free press is. Given the universality of the agreement that a free press is central to democracy, Andersen Jones and West’s message is vital. Presuming Trustworthiness should raise alarms.
In response, I hope this essay can serve as a bullhorn. I want to amplify what Andersen Jones and West’s research and data bear out. Not only has the Supreme Court ceased presuming the press’s trustworthiness, but certain Justices’ rhetoric intimates that any presumption has swung in the opposite direction. These Justices’ words suggest an anti-press bias.
This anti-press bias has serious consequences. Beyond the disadvantage it would pose to future press litigants, anti-press bias is already eroding legal protections for the institutional press and hobbling democracy. The United States is ill-equipped to bear such harms. At the hands of the Supreme Court, they are self-inflicted and unnecessary wounds
Authoritarian Privacy
Full text linkPrivacy laws are traditionally associated with democracy. Yet autocracies increasingly have them. Why do governments that repress their citizens also protect their privacy? This Article answers this question through a study of China. China is a leading autocracy and the architect of a massive surveillance state. But China is also a major player in data protection, having enacted and enforced a number of laws on information privacy. To explain how this came to be, the Article first turns to several top-down objectives often said to motivate China’s privacy laws: advancing its digital economy, expanding its global influence, and protecting its national security. Although each has been a factor in China’s turn to privacy law, even together they tell only a partial story.
Central to China’s privacy turn is the party-state’s use of privacy law to shore up its legitimacy amid rampant digital abuse. China’s whiplashed transition into the digital age has given rise to significant vulnerabilities and dependencies for ordinary citizens. Through privacy law, China’s leaders have sought to interpose themselves as benevolent guardians of privacy rights against other intrusive actors—individuals, firms, even state agencies and local governments. So framed, privacy law can enhance perceptions of state performance and potentially soften criticism of the center’s own intrusions. China did not enact privacy law in spite of its surveillance state; it embraced privacy law in order to maintain it. The Article adds to our understanding of privacy law, complicates the conceptual relationship between privacy and democracy, and points towards a general theory of authoritarian privacy
A Short History of the Interpretation-Construction Distinction
Full text linkThis document collects for ease of access and citation three of my posts on the New Private Law Blog, which chart the conceptual history of the interpretation-construction distinction. The posts begin with Francis Lieber’s 1939 introduction of the concepts, then describes Samual Williston’s 1920 account of the distinction in the first edition of Williston on Contracts, and concludes with Arthur Linton Corbin’s 1951 reconceptualization in the first edition of Corbin on Contracts. The posts identify two different conceptions of the distinction. Under the first (Lieber and Williston), construction supplements interpretation. Under the second (Corbin), the two activities complement one another. The complementary conception is the better one
Modernizing the Power of the Purse Statutes
Full text linkTwo foundational statutes limit the executive branch’s important and necessary work in executing the budget against the backdrop of congressional control: the Antideficiency Act, dating back to the post-Civil War era, and the Impoundment Control Act, which emerged from the Nixon years. This Article, originally written as an invited contribution to The George Washington Law Review’s annual issue on administrative law, calls these the Power of the Purse statutes. While these statutes have been generally successful in responding to the problems that first prompted them, this Article illustrates gaps in the statutes that have become apparent in an era of expanded presidential control and proposes reforms to fix them. The reforms largely—although not entirely—map onto legislation proposed by Democrats in recent years. This Article argues that these proposals are commonsense reforms that ought to be supported by bipartisan majorities—as underscored by, among other things, their support from a remarkably bipartisan coalition of civil society organizations during both the Trump and Biden Administrations and the enactment of several of the reforms with bipartisan support through consecutive Consolidated Appropriations Acts. This Article thus reframes both the problems and the proposals as institutional rather than partisan and urges that the reforms ought to become law
The Taylor Swift Effect and International Law
Full text linkTaylor Swift’s Eras Tour has come to an end, but the Taylor Swift Effect will remain a powerful force with influence well beyond even Swift herself. Often used to describe Swift’s economic impact through her fandom, it has become shorthand for the broader network effect that amplifies and extends the reach of her discography and cultural influence. As this article discusses, the Taylor Swift Effect has real implications for international relations and international law at a time when many nations are withdrawing from constructive international engagement, with devastating consequences in terms of global rights, liberties, and norms.
This article explores the Taylor Swift Effect in the context of international law, beginning with the connection between Swift’s music and norms and principles of international law and expanding upon this foundation to consider broader applications. Just as international law has many smaller-scale layers to its generation and dissemination, the Taylor Swift Effect can turn how individual fans react to and internalize Swift’s music into global movements with the power for collective change. As Swift sings in New Romantics, “life is just a classroom,” and an assessment of where her discography and actions highlight the potential and shortcomings of international law is both insightful and overdue
The Trade Origins of Privacy Law
Full text linkThe desire for trade propelled the growth of data privacy law across the world. Countries with strong privacy laws sought to ensure that their citizens’ privacy would not be compromised when their data traveled to other countries. Even before this vaunted Brussels Effect pushed privacy law across the world through the enticement of trade with the European Union, Brussels had to erect privacy law within the Union itself. And as the Union itself expanded, privacy law was a critical condition for accession.
But this coupling of privacy and trade leaves a puzzle: how did the U.S. avoid a comprehensive privacy law yet retain access to trade? The Article explains U.S. exceptionalism as resting on its enormous economic leverage, which enabled it to negotiate sui generis regimes to ensure access to foreign data.
Even those accepting this historical account as account might yet argue that privacy should not be subjected to trade law disciplines. “Privacy is not bananas,” as the great Spiros Simitis famously proclaimed. But food safety is also a human right, and trade law has shown that we can protect human health even when we consume food produced abroad. Similarly, we can protect privacy even while enabling trade in digital services. Trade disciplines need not undermine privacy, but rather help ensure that claims of privacy protection are not merely disguised protectionism