Jurisdynamics Network authors on SSRN

This page summarizes the most recent SSRN abstracts posted by the authors of the Jurisdynamics Network. The Network's authors are serious, productive scholars as well as stimulating bloggers, and we hope you will read and download these papers. This page has its own RSS feed, which you are invited to download by clicking here:  . To receive updates as these authors post new scholarship, please use the following form:

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%SOURCENAMEESCAPED%, New: Vaccine Development, the China Dilemma and International Regulatory Challenges, https://www.ssrn.com/abstract=4289910 (November 30, 2022)

Since the World Health Organization declared COVID-19 a global pandemic in March 2020, countries, intergovernmental bodies, nongovernmental organizations and individual experts have called for the development of new global frameworks and adjustments to international regulatory standards. As the pandemic has become more successfully contained—at least in the Global North—demands for emergency relief measures have given way to debates on the development of new standards to provide a more effective response during the inter-pandemic period and in the post-COVID era.

One challenging and inevitable debate concerns the role of China in such development. Among the important issues are whether China will support the development of new international regulatory standards, whether its participation will create additional complications, how its role will evolve in the near future and how best to engage with the country in the international regulatory system. Improving global pandemic ...
%SOURCENAMEESCAPED%, REVISION: A Critical Appraisal of the COVID-19 TRIPS Waiver, https://www.ssrn.com/abstract=3945304 (November 17, 2022)

In October 2020, India and South Africa submitted an unprecedented proposal to the Council for Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization, calling for a temporary waiver to combat the global pandemic. This waiver aimed to suspend Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement and related enforcement under Part III to facilitate the "prevention, containment or treatment of COVID-19." Lasting for a finite period to be determined by the General Council, the waiver would cover not only patents, but also other forms of intellectual property rights.

This chapter offers a critical appraisal of the COVID-19 TRIPS waiver proposal, which was revised in May 2021 but was not adopted at the Twelfth WTO Ministerial Conference in Geneva in June 2022. It begins by identifying the arguments for and against the waiver, including those questioning its necessity, expediency and effectiveness. Both sets of arguments are important and ...
%SOURCENAMEESCAPED%, REVISION: The Costs of Critical Habitat or Owl’s Well That Ends Well, https://www.ssrn.com/abstract=3691269 (November 16, 2022)

When the Fish and Wildlife Service designated land in four counties of Arizona as “critical habitat” necessary for the protection of the endangered cactus ferruginous pygmy‐owl, property values dropped considerably. When the owl was later delisted, property values jumped back up. We use difference-in-difference and synthetic control designs to identify this effect with Zillow property value data. The results provide an estimate of the costs of this critical habitat designation, and they are considerable, contrary to the regulators’ position that critical habitat protection imposes no incremental costs beyond the original endangered species listing.
%SOURCENAMEESCAPED%, New: Can the Right to Science Reduce the Tensions Between Intellectual Property and Human Rights?, https://www.ssrn.com/abstract=4273521 (November 16, 2022)

The right to science—or, more formally, the right to enjoy the benefits of scientific progress and its applications—is one of the most underexplored rights in the Universal Declaration of Human Rights (UDHR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). Referred to as being "[t]ucked away at the tail end" of the UDHR and the "most obscure of all the international human rights treaty provisions," this right did not become the subject of an authoritative interpretation by the U.N. Committee on Economic, Social and Cultural Rights (CESCR) until April 2020, amid the COVID-19 pandemic.

Taking note of the release of General Comment No. 25 and the considerable frustrations over the tensions and conflicts between intellectual property and human rights during the COVID-19 pandemic, this chapter closely examines the right to science as incorporated in Article 27(1) of the UDHR and Article 15(1)(b) of the ICESCR. The new interpretive comment is of ...
%SOURCENAMEESCAPED%, New: Pre-planning Transformation to Avoid Collapse--Is It Possible?, https://www.ssrn.com/abstract=4276783 (November 14, 2022)

Although societal collapse has been part of human history for millennia, a growing fear is that social, economic, technological, and environmental systems have become so globally interconnected, and their resilience so under threat, that the next collapse could be global in scale. Drawing from the collapse and social-ecological resilience studies literatures, we conceptualize two stages of collapse-avoidance governance—the pre-trigger adaptive governance stage during which policies draw on systems resilience to avoid the initiation of the collapse spiral, and the post-trigger transformative governance stage during which policies are implemented to steer out of the collapse spiral through fundamental change of systems regimes. Even under continued good collapse-avoidance governance it is possible for a variety of reasons that adaptive governance policies fail to avoid triggering of the collapse spiral, in which case policies to facilitate transformation will likely need to be ...
%SOURCENAMEESCAPED%, REVISION: Catastrophic Uncertainty and Regulatory Impact Analysis, https://www.ssrn.com/abstract=4217679 (November 8, 2022)

Cost-benefit analysis embodies techniques for the analysis of possible harmful outcomes when the probability of those outcomes can be quantified with reasonable confidence. But when those probabilities cannot be quantified (“deep uncertainty”), the analytic path is more difficult. The problem is especially acute when potentially catastrophic outcomes are involved, because ignoring or marginalizing them could seriously skewing the analysis. Yet the likelihood of catastrophe is often difficult or impossible to quantify because such events may be unprecedented (runaway AI or tipping points for climate change) or extremely rare (global pandemics caused by novel viruses in the modern world). OMB’s current guidance to agencies on unquantifiable risks is now almost twenty years old and in serious need of updating. It correctly points to scenario analysis as an important tool but it fails to give guidance on the development of scenarios. It then calls for a qualitative analysis of the ...
%SOURCENAMEESCAPED%, REVISION: Deferring Intellectual Property Rights in Pandemic Times, https://www.ssrn.com/abstract=4062300 (November 7, 2022)

In the intellectual property arena, policymakers and commentators have advanced different proposals to combat the COVID-19 pandemic. One pathbreaking proposal that has become highly controversial calls for a waiver of more than thirty provisions in the WTO TRIPS Agreement, covering copyrights, industrial designs, patents and the protection of undisclosed information. Although the WTO membership did not adopt the proposed waiver in the end, the debate surrounding this unprecedented proposal underscores our need to explore ways to adjust the international intellectual property system in pandemic times.

This article briefly recounts the strengths and weaknesses of the proposal for the COVID-19 TRIPS waiver. It then identifies the negotiation and implementation challenges confronting efforts to adopt and eventually operationalize the proposed instrument. Drawing on the literature on international treaty negotiations, including those in the intellectual property area, this article ...
%SOURCENAMEESCAPED%, REVISION: Regional Comprehensive Economic Partnership, https://www.ssrn.com/abstract=4242367 (November 2, 2022)

In November 2020, the Association of Southeast Asian Nations (ASEAN) and its five neighbors (Australia, China, Japan, New Zealand and South Korea) signed the Regional Comprehensive Economic Partnership (RCEP) Agreement. The Agreement entered into force on January 1, 2022. Chapter 11, which is devoted to intellectual property, contains 14 sections: (A) general provisions and basic principles; (B) copyright and related rights; (C) trademarks; (D) geographical indications; (E) patents; (F) industrial designs; (G) genetic resources, traditional knowledge and folklore; (H) unfair competition; (I) country names; (J) enforcement of intellectual property rights; (K) cooperation and consultation; (L) transparency; (M) transition periods and technical assistance; and (N) procedural matters. This short essay provides an overview of the intellectual property provisions in the RCEP Agreement.
%SOURCENAMEESCAPED%, REVISION: The COVID-19 TRIPS Waiver and the WTO Ministerial Decision, https://www.ssrn.com/abstract=4150090 (November 1, 2022)

In October 2020, India and South Africa submitted an unprecedented proposal to the WTO, calling for the partial suspension of the TRIPS Agreement to facilitate the "prevention, containment or treatment of COVID-19." Although this proposal immediately received considerable support from other WTO members, civil society organizations and individual experts, it faced strong opposition from some developed countries—most notably the European Union, the United Kingdom, Switzerland and, to some extent, also the United States.

By December 2021, it was quite clear that the COVID-19 TRIPS waiver proposal would not receive enough support to achieve consensus within the WTO membership. Around that time, the European Union, India, South Africa and the United States, with the support of the WTO, launched quadrilateral consultations to find a compromise solution. The "Quad proposal" that was eventually developed through these high-level consultations became the blueprint from which WTO ...
%SOURCENAMEESCAPED%, REVISION: A New Approach to the Geopolitics of Chinese Internets, https://www.ssrn.com/abstract=4258574 (October 26, 2022)

Written for a special issue on "The Geopolitics of Chinese Internets," this introductory essay summarizes how our understanding of Chinese internets – in the plural – has shifted in the past two decades. The incumbent approach sees "Chinese tech" as a unitary and statist monolith, an incomplete view whose utility has declined. By contrast, the articles in this special issue collectively substantiate a novel geopolitical approach that analyzes "Chinese internets" as internally diverse and externally border-crossing; as both public (governmental and non-governmental) and private (e.g., corporate); as discursive and policy entanglements beyond the dichotomy of multistakeholderism and multilateralism; and as global, regional, and local formations that are connected to, but not entirely constrained by, their national counterparts. Pluralist and multilayered, this new approach to analyzing Chinese techno-geopolitics shall provide a better fit for contemporary internet research involving ...
%SOURCENAMEESCAPED%, REVISION: Tragic Allocation Challenges in the COVID-19 Era, https://www.ssrn.com/abstract=3826983 (October 25, 2022)

Human society is facing its worst nightmare—a global pandemic caused by a highly infectious, resilient, and enigmatic virus. Questions that have occupied moral philosophers for ages transform into urgent practical predicaments for doctors, ethicists, and healthcare policymakers facing impossible situations. Societies, grown accustomed to the notion of plentifulness, are forced to grapple with the prospect of scarcity, particularly that of life-saving resources, such as ventilators, ICU beds, health human resources, medication, and vaccines. Leading health ethicists and other professionals have already penned articles addressing the reemerging dilemmas regarding the allocation of scarce life-saving resources. Although several papers discussing these matters have been published in the most prominent medical journals, they lacked a broader interdisciplinary perspective. In this Article, we illuminate the difficult questions ahead from a somewhat different angle – that of legal ...
%SOURCENAMEESCAPED%, REVISION: Adapting Private Law for Climate Change Adaptation, https://www.ssrn.com/abstract=4245201 (October 21, 2022)

The private law of torts, property, and contracts will and should play an important role in resolving disputes regarding how private individuals and entities respond to and manage the harms of climate change that cannot be avoided through mitigation (known in climate change policy dialogue as “adaptation”). While adaptation is commonly presented as a problem needing legislative solutions, this Article presents a novel and overdue case for private law to take climate adaptation seriously.

To date, the role of private law is a significant blind spot in scholarly discussions of climate adaptation. Litigation invoking common law doctrines in climate adaption disputes has not yet taken off the way that the wave of high-profile lawsuits against sources of emissions causing climate change has, but it is inevitable that it will, making it ripe for attention in legal scholarship. The Article begins in Part I by highlighting several features of climate change and adaptation that will ...
%SOURCENAMEESCAPED%, REVISION: Retribution Against Catholic Dioceses by Revival: The Evolution and Legacy of the New York Child Victims Act Claims Revival Window, https://www.ssrn.com/abstract=3796138 (October 20, 2022)

This article considers the evolution of limitations relief for time-barred child sexual abuse tort claims in New York culminating with the claims revival window enacted in 2019 as part of the New York Child Victims Act (NYCVA). The story of child sexual abuse litigation against Catholic dioceses and the legal and political history of the NYCVA exposes the important but largely unexplored balance of competing policy objectives that limitations laws strike. How child sexual abuse claimants achieved retribution by revival in the NYCVA reveals the fragility of limitations laws and the importance of coherent and consistent policy for revival of other types of time-barred claims in the future.
%SOURCENAMEESCAPED%, REVISION: China, the TRIPS Waiver and the Global Pandemic Response, https://www.ssrn.com/abstract=3975151 (October 18, 2022)

In October 2020, India and South Africa submitted an unprecedented proposal to the Council for Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization, calling for a temporary waiver to combat the global pandemic. This waiver aimed to suspend Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement and related enforcement obligations to facilitate the "prevention, containment or treatment of COVID-19." Although China was neither a proponent nor a cosponsor of the waiver proposal, it supported the initiative.

To document China's role in the global pandemic response, this chapter closely examines China's position in the waiver debate. It begins by discussing how the country's changing pharmaceutical landscape and its growing ambition to become an intellectual property power paved the way for its middle-of-the-road position. The chapter then identifies two additional, complementary factors that contributed to this position: complex international ...
%SOURCENAMEESCAPED%, New: Contextualizing Corruption: Foreign Financing Bans and Campaign Finance Law, https://www.ssrn.com/abstract=4248221 (October 18, 2022)

Current federal law prohibits foreign nationals (excluding permanent residents) from funding independent express expenditures. Bluman v. FEC, a decision of the U.S. District Court for the District of Columbia authored by then-Judge Brett Kavanaugh, upheld this prohibition by relying on cases excluding foreign nationals from participating in acts of democratic self-governance. The Supreme Court summarily affirmed Bluman. The decision, however, sits on shaky foundations. It relies on a series of “political community” cases which are themselves remnants of an earlier, more xenophobic age. As many commentators have noted, Bluman also is in significant tension with the sweeping condemnation of speaker-based distinctions announced by the Supreme Court in Citizens United v. FEC. Finally, the decision runs seriously afoul of the current Court’s general refusal to accept as legitimate (much less compelling) any state interest in regulating campaign speech on the basis of its effect on voters ...
%SOURCENAMEESCAPED%, New: Climate-Induced Wildfires and Strengthening Resilience in Electricity Infrastructure, https://www.ssrn.com/abstract=4201501 (September 26, 2022)

In recent times, climate-induced disasters have overwhelmed many parts of the world destroying human and non-human communities and ecosystems. In this article, we focus on a unique type of infrastructure – electricity grids. We collate the latest climate science, relate it to electricity infrastructure and shine the light on the ways in which electricity infrastructure has been impacted by climate-induced wildfires in Australia and California. The two jurisdictions are comparable in many respects but illustrate different approaches to grid governance. They also conceptualize risk management differently, with Australia focusing on resilience as a standalone concept and California viewing resilience as only one aspect of climate change adaptation. We investigate the resilience strategies of both jurisdictions and identify the strategies, including technological, that are needed to build resilience in the sector.
%SOURCENAMEESCAPED%, New: The Arkansas LL.M. Program: Forty Years of Leadership, https://www.ssrn.com/abstract=4226175 (September 25, 2022)

The University of Arkansas School of Law has been a leader in agricultural law education for over forty years through its innovative LL.M. Program in Agricultural and Food Law. This essay memorializes the history of this signature Program and charts its progress through the decades as agricultural law issues evolved and the discipline expanded to incorporate food law and policy. Arkansas has played a unique role in the development of both the discipline of agricultural law and the newer field of food law and policy. This essay chronicles that development.
%SOURCENAMEESCAPED%, REVISION: Two Decades of TRIPS in China, https://www.ssrn.com/abstract=3965395 (September 25, 2022)

China became the 143rd member of the World Trade Organization on December 11, 2001. Written in commemoration of the 20th anniversary of China's accession to the international trading body, this chapter reviews the intellectual property developments in China since the country joined the WTO.

This chapter begins by highlighting the developments relating to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in the first decade of China's WTO membership. It then discusses the country's "innovative turn" in the mid-2000s and the ramifications of its changing policy positions. The chapter continues to examine the US–China trade war, in particular the second TRIPS complaint that the United States filed against China in March 2018. This chapter concludes with observations about the impact of the TRIPS Agreement on China, China's impact on that agreement and how the changing Chinese intellectual property landscape has altered the developing ...
%SOURCENAMEESCAPED%, New: Relevance, Redundancy, and Regularization: Penalized Regression and the Quest for the ℓ₀ Quasi-Norm, https://www.ssrn.com/abstract=4188299 (September 13, 2022)

The vector of a linear model’s coefficients represents the clearest guide to causal inference. Collinearity among variables, however, undermines the interpretation of that model. A wildly large positive coefficient on one variable may be offset by a comparably large negative coefficient on a collinear variable. Neither the size nor the sign of those coefficients can be trusted.

Instability arising from collinearity and high variance can be remedied through regularized or penalized regression. These methods can select model features in graduated or categorical fashion. Enforcing ℓ2 (Ridge) and ℓ1 (Lasso) regularization can blunt or even eliminate irrelevant or redundant variables. Methods incorporating the ℓ1 norm can induce sparsity. The resulting vector of nonzero standardized coefficients delivers the ℓ0 quasi-norm as the best mathematical representation of the model’s causal inferences.

In addition to Lasso, Ridge, and ElasticNet (a hybrid of Lasso and Ridge), this ...
%SOURCENAMEESCAPED%, New: No Country for Old Men (or Women): The Impact of Migration on Pension Funding Adequacy and Sustainability, https://www.ssrn.com/abstract=4185168 (August 11, 2022)

Retirement security is of paramount importance to working people. Adequate retirement income is also a leading concern for private and public pension systems. Pension funding adequacy measures the ability of pension scheme assets to meet a system’s liabilities. Pension managers accumulate assets primarily from employee contributions. Assets then grow through investment returns. Liabilities consist mainly of benefits promised and paid to pensioners.

In several countries, even within the European Union, a substantial percentage of the population receives pension income much lower than pre-retirement income or even the poverty line. At the same time, pension funding adequacy is threatened by reduced fertility in most European countries. Economic crises during the first quarter of the twenty-first century — the great recession, a sovereign debt crisis, the Covid-19 pandemic — have decreased individual and family income. These crises have reduced pension payments.

When the ...
%SOURCENAMEESCAPED%, REVISION: Adapting To a 4°C World, https://www.ssrn.com/abstract=4053843 (August 8, 2022)

The Paris Agreement’s goal to hold warming to 1.5°-2°C above pre-industrial levels now appears unrealistic. Profs. Robin Kundis Craig and J.B. Ruhl have recently argued that because a 4°C world may be likely, we must recognize the disruptive consequences of such a world and respond by reimagining governance structures to meet the challenges of adapting to it. In this latest in a biannual series of essays, they and other members of the Environmental Law Collaborative explore what 4°C might mean for a variety of current legal doctrines, planning policies, governance structures, and institutions.
%SOURCENAMEESCAPED%, New: Inequality and Regulation: Designing Rules to Address Race, Poverty, and Environmental Justice, https://www.ssrn.com/abstract=4178655 (August 5, 2022)

Inequality is a burning issue in our society but plays only a limited rule in the design of regulations. This article rejects arguments in favor of this neglect and forges a vision for moving forward. It argues in favor of features of the existing system that promote inequality: the controversial practice of using uniform valuations of life and health, regardless of income; and the use of disparate impact analysis in rulemaking. Rather than focusing on arguments for using regulation as a possible form of income redistribution or remedy for existing racial disparities, the article argues that justice requires devoting equal resources to prevent equal harms.

The reality is that low-income communities and communities of color often are the ones suffering the greatest harms (and not just by chance). By using far more granular approaches to determining who is exposed to risks and how vulnerable they are to harm, agencies could do far more to implement this principle, identify the ...
%SOURCENAMEESCAPED%, New: Catastrophic Uncertainty and Regulatory Impact Analysis, https://www.ssrn.com/abstract=4170257 (July 29, 2022)

Cost-benefit analysis embodies techniques for the analysis of possible harmful outcomes when the probability of those outcomes can be quantified with reasonable confidence. But when those probabilities cannot be quantified (“deep uncertainty”), the analytic path is more difficult. Decision science does not yet provide consensus solutions to the analysis of uncertain catastrophic outcomes. But it has advanced beyond the vague guidance provided by OMB since 2003, which may not have been state-of-the-art even then. This paper surveys these developments and explains how they might best be incorporated into agency practice in considering possible catastrophic risks
%SOURCENAMEESCAPED%, New: Common Law Zones: An Illustrated Review, https://www.ssrn.com/abstract=4141500 (June 28, 2022)

Governments across the globe have created special jurisdictions offering common law rules and practices imported from abroad, the better to attract foreign investment and stimulate local economic growth. Four such common law zones have launched in recent years: the United Arab Emirates’ Dubai International Financial Centre, in 2004; the Abu Dhabi Global Market, also in the UAE, in 2015; Kazakhstan’s Astana International Financial Centre, in 2018; and the first Honduran ZEDE, in 2020. Each of these common law zones has faced the challenge of transplanting foreign rules and practices into a jurisdiction set apart from that of its host government, which instead follows some mix of Napoleonic Civil Code, Sharia, and/or Soviet legal traditions. The first three zones have answered that challenge by importing the common law of England (and sometimes also Wales) and entrusting its interpretation to courts that, while set apart from the local legal system, remain under the control of ...
%SOURCENAMEESCAPED%, REVISION: From Transparency to Justification: Toward Ex Ante Accountability for AI, https://www.ssrn.com/abstract=4099657 (June 21, 2022)

At present, policymakers tend to presume that AI used by firms is legal, and only investigate and regulate when there is suspicion of wrongdoing. What if the presumption were flipped? That is, what if a firm had to demonstrate that its AI met clear requirements for security, non-discrimination, accuracy, appropriateness, and correctability, before it was deployed? This paper proposes a system of “unlawfulness by default” for AI systems, an ex-ante model where some AI developers have the burden of proof to demonstrate that their technology is not discriminatory, not manipulative, not unfair, not inaccurate, and not illegitimate in its legal bases and purposes. The EU’s GDPR and proposed AI Act tend toward a sustainable environment of AI systems. However, they are still too lenient and the sanction in case of non-conformity with the Regulation is a monetary sanction, not a prohibition. This paper proposes a pre-approval model in which some AI developers, before launching their systems ...
%SOURCENAMEESCAPED%, REVISION: Increased Copyright Flexibilities for User-Generated Creativity, https://www.ssrn.com/abstract=3916671 (June 3, 2022)

The arrival of the Internet, social media and other new communication technologies has presented individuals with an unprecedented ability to create new copyrighted works to benefit society. Moving from consumers to prosumers, these individuals have generated contents such as digitally altered images, music remixes, video mash-ups, synchronized animations, machinimas, parodies and satires, and a dazzling array of fanworks. To unleash the potential provided by this new group of creators, policy makers and commentators have advanced a wide array of proposals to reform copyright law.

This chapter explores how and why copyright law should be reformed to increase flexibilities for user-generated creativity. Based on recent legislative reforms and the Author's personal experience in the copyright reform process, the chapter outlines two distinct but mutually non-exclusive options: (1) the creation of copyright exceptions for user-generated creativity; and (2) the limits to statutory ...
%SOURCENAMEESCAPED%, REVISION: Intellectual Property, Global Inequality and Subnational Policy Variations, https://www.ssrn.com/abstract=3760413 (May 27, 2022)

The North-South divide has been frequently invoked in the debate on intellectual property, innovation and global inequality. While developed countries in the Global North complained about the inadequate protection and enforcement of intellectual property rights in developing countries, the Global South lamented the unfair distribution of benefits within the international intellectual property regime. Developing countries were also frustrated that they bore the brunt of globalization and the detrimental effects of strong intellectual property protection and enforcement.

The arrival of middle-income countries, in particular those with considerable and ever-growing strengths in the intellectual property area, has called into question the North-South Debate. First, that debate is both dated and oversimplified. It overlooks the many complications raised by Brazil, China, India and other fast-growing emerging countries. With increasing abilities to compete effectively against ...
%SOURCENAMEESCAPED%, REVISION: Transplanting Anti-suit Injunctions, https://www.ssrn.com/abstract=3937716 (May 16, 2022)

When adjudicating high-value cases involving the licensing of patents covering industry standards such as Wi-Fi and 5G (standards-essential patents or SEPs), courts around the world have increasingly issued injunctions preventing one party from pursuing parallel litigation in another jurisdiction (anti-suit injunctions or ASIs). In response, courts in other jurisdictions have begun to issue anti-anti-suit injunctions, or even anti-anti-anti suit injunctions, to prevent parties from hindering the proceedings in those courts. Most of these activities have been limited to the United States and Europe, but in 2020 China emerged as a powerful new source of ASIs in global SEP litigation.

The comparative law literature uses the notion of legal transplant to describe the introduction of a foreign legal concept, rule, or procedure. Taking the view that the emergence of ASIs in China represents a new form of transplant from Western legal systems, this article analyzes the ...
%SOURCENAMEESCAPED%, REVISION: The Legal Industry's Second Chance to Get It Right, https://www.ssrn.com/abstract=3773197 (May 12, 2022)

The legal industry's reaction to the COVID-19 pandemic and how it's response can drive the recovery following the COVID-19 pandemic.
%SOURCENAMEESCAPED%, New: Some Observations on Separation of Powers and the Wisconsin Constitution, https://www.ssrn.com/abstract=4096476 (May 3, 2022)

In recent years the Wisconsin Supreme Court has decided several high-profile cases concerning the separation of powers under the state constitution. In the abstract, questions concerning the separation of powers do not seem inherently partisan, largely because the partisan balance of government will shift over time. Yet, as has been the case with many of its recent decisions, the justices’ votes have broken along what most observers regard as partisan lines, and the opinions have featured heated prose including accusations of result orientation and methodological illegitimacy.

This article is the initial product of an effort to read, and attempt to synthesize, the entirety of the Wisconsin Supreme Court’s output relating to separation of powers dating back to the state’s founding. It advances no single thesis and makes no grand claims. It instead seeks to identify some threads running through the caselaw, including with respect to the court’s approaches to interpreting the ...
%SOURCENAMEESCAPED%, REVISION: Modalities, Challenges, and Possibilities: An Introduction to the Pharmaceutical Innovation Symposium, https://www.ssrn.com/abstract=3705735 (April 19, 2022)

On October 25, 2019, the Texas A&M Journal of Property Law and the Center for Law and Intellectual Property at Texas A&M University School of Law jointly organized the "Pharmaceutical Innovation, Patent Protection, and Regulatory Exclusivities" Symposium. Although none of the organizers and participants could predict what was to come in the next few months, there was a wide consensus that the rapid changes in the pharmaceutical landscape and our continuous struggle to strike a proper balance between proprietary protection and public access in the public health arena deserves scholarly, policy and regulatory attention.

To inform readers about the inspirations and motivations behind the Symposium, this introductory article begins by exploring the different modalities of protection--in particular the role of patents and regulatory exclusivities in providing the needed incentives to pharmaceutical developers. It then identifies three sets of challenges that affect the ...
%SOURCENAMEESCAPED%, REVISION: The Long and Winding Road to Effective Copyright Protection in China, https://www.ssrn.com/abstract=3960557 (April 19, 2022)

In November 2020, China adopted the Third Amendment to the Copyright Law, providing a major overhaul of its copyright regime. This amendment entered into effect on June 1, 2021. The last time the regime was completely revamped was in October 2001, when the Copyright Law was amended two months before China joined the World Trade Organization. While U.S. policymakers and industry groups have had mixed reactions to the recent amendment, the new law presents an opportunity to take stock of the progress China has made in the copyright reform process.

Written for the Symposium on "Hindsight Is 2020: A Look at Unresolved Issues in Music Copyright," this article begins by mapping the long and winding road to effective copyright protection in China, especially in relation to U.S. rights holders. It then focuses on the recent amendment, highlighting five sets of upgrades or changes while offering some overarching observations. The article concludes by identifying five road tips to help ...
%SOURCENAMEESCAPED%, REVISION: The U.S.-China Forced Technology Transfer Dispute, https://www.ssrn.com/abstract=4014481 (April 13, 2022)

The past few years have seen not only a trade war between China and the United States involving tariffs on close to $750 billion worth of goods, but also multiple complaints filed by both countries before the WTO Dispute Settlement Body. A key driver behind these ongoing tensions and conflicts concerns the challenges confronting U.S. technology companies—both online and offline. Although the inadequate protection and enforcement of intellectual property rights in China has been the subject of a perennial debate since the mid-1980s, the recent concerns have raised new issues that have been lumped together under the umbrella of "forced technology transfer."

Written for the Seton Hall Law Review Symposium on "Intellectual Property and Technology in the New Global Age," this article closely examines the U.S.-China forced technology transfer dispute. It begins by offering a critical assessment of the complaint filed by the United States in March 2018, which alleged violations of ...
%SOURCENAMEESCAPED%, REVISION: US-China Intellectual Property Trade Wars, https://www.ssrn.com/abstract=3925290 (April 13, 2022)

More than two decades ago, the literature on the Chinese intellectual property system was filled with commentaries on the trade threats exchanged between the United States and China in relation to the inadequate protection and enforcement of intellectual property rights in the latter. At that time, China has not yet joined the World Trade Organization. In the past few years, we once again have been confronted with multiple rounds of trade threats—this time as part of a trade war, which has thus far involved tariffs on close to $750 billion worth of goods. Although the current U.S.-China trade war implicates many items ranging from agricultural produce to electronic goods to financial services, inadequate protection and enforcement of intellectual property rights in China remains one of the few oft-cited justifications.

This chapter begins by recounting the trade threats exchanged between the two countries in the early 1990s in relation to the lack of intellectual property ...
%SOURCENAMEESCAPED%, REVISION: Intellectual Property, Cultural Heritage and Human Rights, https://www.ssrn.com/abstract=3950888 (April 11, 2022)

The relationship between intellectual property and human rights in the cultural heritage context is both complex and challenging. Although these two sets of rights frequently align, they also compete against each other. The resulting tensions and conflicts affect not only the relevant cultural groups but all of us. Even more challenging, there has so far been no consensus on how to protect cultural heritage. Nor are there generally agreed definitions of "culture" and "cultural heritage." Although a diverse array of conventions, protocols, declarations, laws, policies and guidelines has been established to protect cultural heritage and cultural diversity, many of these normative documents include definitions that were drafted on a text-by-text basis. It is therefore difficult to generalize definitions across a variety of contexts, including those at the intersection of intellectual property and human rights.

This chapter begins by mapping the contours of the international human ...
%SOURCENAMEESCAPED%, New: Distributed Self-Government in Protocol Communities: An Introduction and Index of Examples, https://www.ssrn.com/abstract=4058722 (March 20, 2022)

We live in exciting times for governance. Large and powerful institutions used to come in only a few standardized types, such as nation-states and commercial corporations. But the advent of distributed organizations, built on computer code and fueled by digital cash, has supercharged the evolution of social coordination systems. Richly capitalized global communities worth hundreds of billions of U.S. dollars now spring up seemingly overnight. They die just as quickly, too—taking high hopes and huge fortunes with them. This article introduces the fascinations of distributed-protocol communities and analyzes the self-governance of several of the largest and most innovative. It defines seven measures of governance and grades the performance of each of ten protocols on a scale of safe, caution, or danger. The resulting Distributed Governance Index organizes and summarizes the latest developments in the evolution of distributed-protocol communities and provides a framework for continuing ...
%SOURCENAMEESCAPED%, REVISION: Legal Pragmatism and Presidential Power: A Case Study, https://www.ssrn.com/abstract=3839787 (March 15, 2022)

This essay explores the differences between legal pragmatism and formalism as working forms of legal thought. After a short overview of pragmatism and a discussion of Louis Brandeis as an exemplar, it turns to the evolving caselaw regarding presidential removal. This issue has led to notable faceoffs between formalists and pragmatist, from Taft v. Holmes and Brandeis, to Roberts and Thomas v. Kagan. Because of their preference for bright-line rules, formalists have tended to oversimplify Founding era history and post-Founding practice. Pragmatist judges have provided more nuanced historical accounts and have tried to come to grips with the tradeoffs involved in issues of institutional design. The choice between these styles of thought is not inherently tied to differences in ideology or substantive constitutional views. Legal pragmatism has the potential, however, to connect judicial decisions to issues that are meaningful to the public, to provide more transparency into the ...
%SOURCENAMEESCAPED%, REVISION: Intellectual Property Paradoxes in Pandemic Times, https://www.ssrn.com/abstract=4001504 (March 8, 2022)

The COVID-19 pandemic has presented many paradoxes that raise complex law and policy questions with no satisfactory answers. Policymakers and commentators have already identified many contradictions, ironies and hard-to-reconcile positions at the intersection of international law and global health. This short essay turns to paradoxes in the intellectual property field.

The discussion will focus on three paradoxes, all of which relate to each other. The first paradox concerns the difficult policy choices that governments have to make in order to combat COVID-19, including those in the intellectual property field. The second paradox pertains to the simultaneous vulnerability and robustness of the international intellectual property system. The final paradox relates to the need for both stronger and weaker intellectual property standards to combat the global pandemic.
%SOURCENAMEESCAPED%, New: Negligence Without Harm, https://www.ssrn.com/abstract=4038781 (February 24, 2022)

The colloquial phrase “no harm, no foul” captures one of the most fundamental tenets of negligence law: the tort is incomplete and there can be no legal redress without proof of actual harm. Mere exposure to risk, even when it is foreseeable and unreasonable, is not actionable. The Article dares to challenge this time-honored, deep-rooted, and highly impactful legal axiom.

Part I restates the traditional quadripartite structure of the tort of negligence, highlights the implications of the harm requirement, and briefly reviews and characterizes past attempts to circumvent it.

The Article then launches a three-pronged attack on this traditional structure:

(1) Part II uncovers the internal normative incoherence of existing negligence doctrine (where breach of a legal duty does not in itself have legal repercussions) and offers “negligence without harm” as a coherent alternative.

(2) Part III provides a fairness-based case for abolishing the harm ...
%SOURCENAMEESCAPED%, REVISION: Israel (2014 Report), https://www.ssrn.com/abstract=3973555 (February 22, 2022)

This is the Israeli report to the Tort and Insurance Law Yearbook. It critically evaluates notable developments which took place in Israeli tort law in 2014. Part A discusses new legislation and Part B discusses case law on the relation between negligence and breach of statutory duty, the structure of the tort of negligence, liability in negligence for pure economic loss, the truth defense in defamation law, road accidents, and collateral benefits.
%SOURCENAMEESCAPED%, REVISION: Israel (2013 Report), https://www.ssrn.com/abstract=3973549 (February 22, 2022)

This is the Israeli report to the Tort and Insurance Law Yearbook. It critically evaluates notable developments which took place in Israeli tort law in 2013. Part A discusses legislation and legislative bills on liability for sexual harassment and road accidents. Part B discusses Supreme Court decisions on the structure of the tort of negligence, alienation of affections, liability for failure to prevent third-party crime, mitigation of damages, and assignment of a cause of action in tort. Part C reviews new Israeli tort law literature.
%SOURCENAMEESCAPED%, New: Staying within the Guardrails, https://www.ssrn.com/abstract=4033777 (February 18, 2022)

Cost-benefit analysis has been central to the process of issuing new regulations since 1981. Today, it's under assault from both ends of the political spectrum. This essay offers some thoughts about how cost-benefit analysis can still play a useful but more restricted role in the future. Rather than serving as the controlling standard for regulatory agencies it can be more usefully seen as an important part of a multi-factor analysis of regulatory effects. In that role, it can serve as a reality check on regulations that, in the pursuit of other goals, impose costs that are grossly disproportionate to a regulation's positive effects.
%SOURCENAMEESCAPED%, REVISION: Ranking Legal Publications: The Israeli Inter-University Committee Report, https://www.ssrn.com/abstract=3422168 (February 14, 2022)

The Report offers a global ranking of academic legal publications, covering more than 900 outlets, and using a four-tier categorization. The ranking is based on a combined quantitative and qualitative methodology. The Report was composed in the context of the Israeli academic system, but the methodology and the results are not jurisdiction-specific.

Evaluating academic publications is a never-ending challenge. Such evaluation is an integral part of internal hiring, promotion, and tenure procedures, and of external funding decisions and institutional rankings. The proper way to evaluate academic publications has been the subject of fierce debate. The traditional method for academic evaluation is specific review of each publication, assessing its originality, rigor, and significance. This method, known as "peer-review", is often difficult to perform and might be subjective and biased. These concerns have generated an increased interest in the use of quantitative indicators in ...
%SOURCENAMEESCAPED%, REVISION: Environmental Law, Disrupted by COVID-19, https://www.ssrn.com/abstract=3985629 (January 25, 2022)

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it transmitted and spreads, who is vulnerable, how is it dangerous, and what are effective treatments—to help governments respond. In many places, including the United States, governments slowed the spread of the virus by relying primarily on the blunt tool of physical distancing, typically in the form of stay-at-home orders. Physical distancing, whether engaged in voluntarily as a result of ...
%SOURCENAMEESCAPED%, REVISION: The Comparative Law and Economics of Counterfeits and Post-Sale Confusion, https://www.ssrn.com/abstract=3987126 (January 4, 2022)

Post-sale confusion is a concept used to protect trademark holders even when no consumer confusion exists at the point of sale. Instead, protection is granted based on the fact that future purchasers or other consumers will be confused after the sale and such confusion will harm trademark holders. Despite the widespread criticisms of this doctrine, with many commentators calling for either its abolition or substantial reform, courts continue to grant such protection.

This chapter interrogates the economic justifications for the doctrine of post-sale confusion. It begins by exploring those justifications in the trademark holder's domestic market. For analytical purposes, the discussion focuses on U.S. trademark law, including the different rationales advanced by the U.S. Court of Appeals for the Sixth Circuit in General Motors Corp. v. Keystone Automotive Industries, Inc. The analysis demonstrates that very limited economic justifications exist to support the doctrine of ...
%SOURCENAMEESCAPED%, REVISION: From Struggle to Surge: China's TRIPS Experience and Its Lessons for Access to Medicines, https://www.ssrn.com/abstract=3677329 (December 9, 2021)

The WTO TRIPS Agreement has imposed unprecedented burdens on countries in the developing world. In the public health arena, its high protection and enforcement standards have not only greatly jeopardized access to medicines—at both the domestic and international levels—but have also eroded the policy space and flexibilities developing countries need to devise solutions for public health challenges.

Although many developing and least developed countries continue to struggle with the high and arguably inappropriate TRIPS standards, large or populous emerging economies, such as Brazil, China, India, South Africa, and Thailand, have managed to adapt the TRIPS Agreement with some success. As economic and technological conditions improved, these emerging economies began to secure even greater benefits from the TRIPS-based intellectual property system, thereby initiating a self-reinforcing virtuous cycle.

Of all emerging economies, no country provides a better illustration for ...
%SOURCENAMEESCAPED%, New: Israel (2015 Report), https://www.ssrn.com/abstract=3973569 (December 8, 2021)

This is the Israeli report to the Tort and Insurance Law Yearbook. It critically evaluates notable developments which took place in Israeli tort law in 2015. Part A discusses legislation and legislative bills in various areas, including damages in non-civil procedures, infringement of designs, and road accidents. sexual harassment and road accidents. Part B discusses Supreme Court decisions on breach of statutory duty, the loss of a chance doctrine, defamation in the context of business disputes, enemy aliens' tort actions, and compensation to victims of X-ray treatment of tinea capitis.
%SOURCENAMEESCAPED%, New: Instrumental Comparative Tort Law, https://www.ssrn.com/abstract=3973401 (December 8, 2021)

This contribution to the JTL symposium on "The State of Tort Theory" aims to delineate the potential use of comparative tort law in practice and theory. It takes the view that comparative law is always a means, never an end in itself, demonstrates how it can be utilized by judges, legislatures, and legal scholars, and puts forward important caveats and qualifications.

Part 2 exemplifies the more traditional role of comparative law in interpreting and implementing shared or similar tort doctrines and in providing ideas, often accompanied by relevant empirical evidence, for domestic tort law gap-filling and reform. It explains the challenges that lawmakers and scholars who use comparative tort law for these purposes might face.

Part 3 maintains that comparative law is the cornerstone of unification endeavors. It starts with coordinated projects, such as the Restatements of Torts and the Principles of European Tort Law, demonstrating that unification is in itself an ...
%SOURCENAMEESCAPED%, New: Marshalling Copyright Knowledge to Understand Four Decades of Berne, https://www.ssrn.com/abstract=3980493 (December 8, 2021)

As part of the festschrift for Marshall Leaffer, this tribute focuses on what would have happened had he, like the fictional character Captain Buck Rogers, been frozen on his way to academia in 1978. What will he discover upon his return in 2021? Will he find the developments in the intervening decades interesting or surprising? What observations would he make had he not been frozen?

Because of Marshall's love for copyright law, his many important contributions to the field of international intellectual property law, and his longtime membership in the Association Littéraire et Artistique Internationale (ALAI), this article pays tribute by examining the past four decades of developments surrounding the Berne Convention for the Protection of Literary and Artistic Works.

This article begins by exploring three areas that are usually explored in relation to the Berne revision process: (1) the arrival of new Berne members; (2) the advent of new technologies; and (3) the ...
%SOURCENAMEESCAPED%, REVISION: 4° Celsius, https://www.ssrn.com/abstract=3806040 (December 7, 2021)

Conventional climate change wisdom tells governments to plan for a 2°C increase in global average temperature. However, increasingly robust science indicates that the planet is well on its way to at least 4°C of warming, possibly by the end of the 21st century or shortly thereafter. That much warming is a governance game changer, taking the multiple and interconnected complex systems that define U.S. society across thresholds and tipping points into cascades of transformational change. Critically, these systems potentially include the United States’ system of government—the key system that must successfully adapt to the coming changes in order for the country as a whole to have any chance of adapting peacefully, equitably, and productively to systemic transformation while still remaining a democracy.

This Article seeks to push U.S. climate change adaptation policy toward an entirely new mode of governance necessary to meet the challenges ahead. It does so by making five novel ...
%SOURCENAMEESCAPED%, REVISION: This Is the Way the World Ends, Not with a Bang but Bonds and Bullets, https://www.ssrn.com/abstract=3904934 (December 2, 2021)

This article explores instinctive frames of human decision-making in environmental and resource economics. Higher-moment asset pricing combines rational, mathematically informed economic reasoning with psychological and biological insights. Leptokurtic blindness and skewness preference combine in particularly challenging ways for carbon mitigation. At their worst, human heuristics may generate perverse decisions. Information uncertainty and the innate preference for bonds-and-bullets portfolios may impair responses to catastrophic climate change.
%SOURCENAMEESCAPED%, New: Being a 'First' - Over and Over Again, https://www.ssrn.com/abstract=3897378 (October 6, 2021)

This short essay discusses how someone who is often a "first" is perceived and provides advice for future "firsts."
%SOURCENAMEESCAPED%, New: The Specter of Malpractice: When Law Firm General Counsel and Risk Management Professionals Are Confronted with Potential Malpractice Claims and Ethics Violations, https://www.ssrn.com/abstract=3932534 (September 28, 2021)

Every day, law firm general counsel and other law firm risk management professionals face a very practical, very vexing problem. The problem is what to do when hearing that a serious ethical mistake or impropriety may have occurred—but without any concrete confirmation that something problematic has, in fact, happened. This essay discusses the most important initial steps and questions that the firm’s general counsel or other risk management professional must address in this confounding situation where the “specter of malpractice” is present. We call this the “specter of malpractice” because a malpractice claim has not yet fully materialized (and it is not entirely clear that one will materialize), but enough risk factors have surfaced to capture the risk management team’s attention. Included among these important and difficult questions are:

• Could this type of mistake constitute an ethics violation or a future malpractice claim?

• What duty does a firm’s general ...
%SOURCENAMEESCAPED%, New: Insulin Federalism, https://privwww.ssrn.com/abstract=3869876 (June 30, 2021)

In April 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb decreed interchangeable insulin poised for market entry within the next few years. This makes insulin the first biologic to achieve interchangeable biologic status. Insulin, relatively “simpler” than more complex biologics and with a substantial amount of real-world evidence supporting safety and efficacy, is a natural choice for interchangeable biologic status. The Association for Accessible Medicines (AAM) notes that brand-to-brand switches of insulin products regularly occur at the direction of providers, and “the risk of diminished safety or efficacy from a transition is minimal or not present” due to the nature of insulin products. Interchangeable status for insulin promises a tremendous impact on costs because it allows insulin to be dispensed at retail pharmacies, subject to state interchangeable biologic substitution laws.

The FDA has regulated insulin since it was first used to ...
%SOURCENAMEESCAPED%, New: Telling the Story on Your Timesheets: A Fee Examiner's Tips for Creditors' Lawyers and Bankruptcy Estate Professionals, https://www.ssrn.com/abstract=3853962 (June 3, 2021)

This essay discusses how much of a lawyer’s embedded assumptions and cognitive errors can come across in something as simple as a time entry on a bill. So much can be revealed about how a lawyer views himself or herself in society and about the lawyer’s relationship with the client that it’s worth examining what we can find when we look at legal bills.
%SOURCENAMEESCAPED%, New: Private Insurance Limits and Responses, https://privwww.ssrn.com/abstract=3808304 (March 23, 2021)

The COVID-19 pandemic exposed a number of existing flaws in the United States’ patchwork approach to paying for and providing access to medical care. Shelter-in-place orders, social distancing, and other public health strategies employed to address the pandemic spawned a global recession, causing rapid and high unemployment rates in many countries. The U.S. unemployment rate peaked in April 2020 at 14.7%, higher than in any previous period since World War II. The United States has long hewed an anachronistic policy of relying heavily on private employers to provide health insurance to a substantial portion of the population. Those who are not eligible for employer-sponsored insurance (ESI) must fend for themselves in the non-group market, unless they qualify for government-sponsored insurance or safety net programs. Companion Chapters in this volume describe the COVID-related challenges for Medicaid and the uninsured, while this Chapter focuses on the private insurance market. The ...
%SOURCENAMEESCAPED%, New: International Tax Transparency, https://privwww.ssrn.com/abstract=3753715 (February 8, 2021)

An imbalance exists between tax authorities and taxpayers when it comes to the latter’s financial information. Taxpayers have the information they need to calculate their tax liabilities and file their returns. Tax authorities, on the other hand, tend to have little beyond what is in the tax return. Thus it can be hard for tax authorities to detect non-compliance. The solution? Pass laws to force the taxpayer (or a third party) to provide more and better information to tax authorities. In other words, increase tax transparency. This Article discusses broad international trends that have been the principal catalyst for tax transparency measures such as the Foreign Account Tax Compliance Act, the Common Reporting Standard and Country-by-Country Reporting, which try to inhibit offshore tax evasion and non-compliant international tax avoidance. In a world where data is the “new oil,” tax advisers are increasingly called on to promote and protect their clients’ interests by advising on ...
%SOURCENAMEESCAPED%, REVISION: Debunking Intellectual Property Myths: Cross-Cultural Experiments on Perceptions of Property, https://privwww.ssrn.com/abstract=3312822 (January 28, 2021)

For decades the prevailing view in the United States and many Western countries has been that China does not appropriately respect intellectual property rights. These beliefs lie at the heart of President Donald Trump’s current trade war with China. Despite substantial geopolitical debate over differences between American and Chinese attitudes towards intellectual property rights, and despite the critical effects that such attitudes have on international economic markets and the function of the intellectual property system, empirical evidence of these attitudes is largely lacking. This Article presents original survey and experimental research that explores cross-cultural differences between American and Chinese attitudes towards intellectual property rights, personal property rights, and real property rights.

The results of the studies are somewhat counter-intuitive. First, Chinese participants are found to have more consistent preferences towards different types of property ...
%SOURCENAMEESCAPED%, REVISION: COVID-IP: Staring Down the Bayh-Dole Act with 2020 Vision, https://privwww.ssrn.com/abstract=3599621 (January 27, 2021)

As the human and economic toll of the COVID-19 coronavirus steadily escalates, there is extreme uncertainty about the timeframe for preventing, detecting, and treating it. There is also concern about the eventual costs associated with approved products and the barriers to access created by the patent system. Industry, government, and academic collaborations are leading the charge in the discovery race, partnerships which have triggered calls for the activation of the federal governments so-called “march-in rights” established in the Bayh-Dole Act. The Bayh-Dole Act dramatically altered the patent protections available to federally funded academic institutions and scientists and initiated a 40-year debate over appropriate incentives for innovation and the scope of the government’s authority.

The COVID-19 coronavirus pandemic provides an opportunity to reflect on the purpose and impact of the historic legislation as well as contemplate the implications for our public ...
%SOURCENAMEESCAPED%, REVISION: 21st Century Citizen Pharma: The FDA & Patient-Focused Product Development, https://privwww.ssrn.com/abstract=3131857 (January 27, 2021)

Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration (FDA). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA’s activity in drug, biologic, and medical device regulation over the course of the last one-hundred plus years. The most recent fundamental reframing of the agency’s authority and directive presented itself in the 21st Century Cures Act, reflecting an important role for patient perspectives in the regulatory process. This Article explores recent developments in patient-focused product development efforts at the FDA and offers modest insights on the increasing role of patients, and patient advocacy groups, in agency decision-making. The Article terms this era “21st century citizen pharma.”
%SOURCENAMEESCAPED%, REVISION: Three Framings of 'Faster' at the FDA and the Federal Right to Try, https://privwww.ssrn.com/abstract=3599624 (January 27, 2021)

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug status to postmarket studies and surveillance. I categorize these mechanisms into three areas: expansion, acceleration, and extension. The federal right to try can be characterized as an expansion, expanding patient access to investigational new drugs as an alternative mechanism to the FDA’s long-standing expanded ...
%SOURCENAMEESCAPED%, New: Tax Wars: How to End the Conflict over Taxing Global Digital Commerce, https://privwww.ssrn.com/abstract=3676641 (October 7, 2020)

In the last two years, dozens of governments have proposed or implemented unilateral tax measures to tax foreign-based technology companies. The new tax innovations include special withholding taxes, diverted profit taxes, minimum taxes, and digital services taxes. The rise of these unilateral measures threatens an international tax “war” among governments that could stifle new business models or even the spread of the global digital economy. This Article reviews the failure of international reform efforts to constrain aggressive international tax planning within the digital economy, and how the global digital tax conflict masks a growing dissatisfaction with how to tax value associated with global transactions. The best way to address these global developments is through a coordinated solution that creates an economic presence test (a Quantitative Economic Presence Permanent Establishment) and modifies the division of tax revenues between countries by allocating residual profits to ...
%SOURCENAMEESCAPED%, REVISION: Private Insurance Limits and Responses, https://privwww.ssrn.com/abstract=3675889 (August 21, 2020)

The COVID-19 pandemic exposed a number of existing flaws in the United States’ patchwork approach to paying for and providing access to medical care. Shelter-in-place orders, social distancing, and other public health strategies employed to address the pandemic spawned a global recession, causing rapid and high unemployment rates in many countries. The U.S. unemployment rate peaked in April 2020 at 14.7%, higher than in any previous period since World War II. The United States has long hewed an anachronistic policy of relying heavily on private employers to provide health insurance to a substantial portion of the population. Those who are not eligible for employer-sponsored insurance (ESI) must fend for themselves in the non-group market, unless they qualify for government-sponsored insurance or safety net programs. Companion Chapters in this volume describe the COVID-related challenges for Medicaid and the uninsured, while this Chapter focuses on the private insurance market. The ...
%SOURCENAMEESCAPED%, New: Tracking Transnational Terrorist Resourcing Nodes and Networks, https://privwww.ssrn.com/abstract=3601189 (June 9, 2020)

In light of persistent terrorist attacks in Europe and elsewhere, the study of terrorist resourcing and financing has attracted renewed attention. How are terrorists’ networks financed? Who raises the financial “resources,” and how do they transfer them across borders? How does the global financial industry facilitate or impede these transfers? Answers to these and other questions can help law enforcement investigate, disrupt, and neutralize cross-border terrorist resourcing. Evidence and data on this phenomenon is scarce, of questionable quality, irreplicable, and can be difficult to come by. This study is the first comprehensive effort to collect, code, analyze, and compare available open-source case law data on transnational terrorist resourcing networks. Under the study’s methodology, the conventional yet strict focus on financing is broadened to resources, which includes forms other than cash, including trade-based fraud and online social networks. The analysis reveals common ...
%SOURCENAMEESCAPED%, REVISION: Taxing Global Digital Commerce, https://privwww.ssrn.com/abstract=3515446 (May 22, 2020)

This latest edition of the preeminent text on the taxation of cross-border digital commerce transactions — formerly titled Electronic Commerce and International Taxation (1999), Electronic Commerce and Multijurisdictional Taxation (2001) — revises, updates, and expands the book’s coverage. It includes a detailed and up-to-date analysis of digital VAT and global income tax developments, and explores the implications of digital commerce for the US state and local sales and use tax regime in the wake of the US Supreme Court decision in South Dakota v. Wayfair, Inc. (2018). Analysing the practical tax consequences of digital commerce from a multijurisdictional perspective and using examples to illustrate the application of different taxes to digital commerce transactions, the book offers in-depth treatment of such topics as: (a) the OECD and G20’s digital tax reforms under the Base Erosion and Profit Shifting project; (b) the new or proposed equalization levies, digital services taxes, ...
%SOURCENAMEESCAPED%, New: One Child Town: The Health Care Exceptionalism Case Against Agglomeration Economies, https://privwww.ssrn.com/abstract=3560171 (March 27, 2020)

This Article offers an extended rebuttal to the suggestion to move residents away from dying communities to places with greater economic promise. Rural America, arguably, is one of those dying places. A host of strategies aim to shore up those communities and make them more economically viable. But one might ask, “Why bother?” In similar vein, David Schleicher’s provocative 2017 Yale Law Journal article, Stuck! The Law and Economics of Residential Stagnation urged dismantling a host of state and local government laws operating as barriers to migration by Americans from failing economies to robust agglomeration economies. But Schleicher said little about the fate of the places left behind. Schleicher’s article drew a number of pointed responses, urging the value and preservation of Small Town America. But those arguments failed fully to meet the rational economic thesis, countering instead with more sentimental or humanitarian concerns. This article offers a way to reconcile ...
%SOURCENAMEESCAPED%, New: Measure for Measure: The Risks of Incorporating Citations Data into U.S. News Rankings, https://privwww.ssrn.com/abstract=3518770 (February 5, 2020)

This short essay responds to Paul Heald and Ted Sichelman’s article, Ranking the Academic Impact of 100 American Law Schools. Heald and Sichelman's work provides a rigorous analysis of law school faculties’ citation and download statistics. Their recommendation to incorporate these statistics into U.S. News & World Report’s annual law school rankings, however, appears misguided. Heald and Sichelman do not fully take into account the concerning gaming behavior and problem¬atic incentives related to faculty hiring that such incorporation would likely produce over time.
%SOURCENAMEESCAPED%, REVISION: The Internet of Bodies, https://www.ssrn.com/abstract=3452891 (November 4, 2019)

This Article introduces the ongoing progression of the Internet of Things (IoT) into the Internet of Bodies (IoB)—a network of human bodies whose integrity and functionality rely at least in part on the Internet and related technologies, such as artificial intelligence. IoB devices will evidence the same categories of legacy security flaws that have plagued IoT devices. However, unlike most IoT, IoB technologies will directly, physically harm human bodies—a set of harms courts, legislators, and regulators will deem worthy of legal redress. As such, IoB will herald the arrival of (some forms of) corporate software liability and a new legal and policy battle over the integrity of the human body and mind. Framing this integrity battle in light of current regulatory approaches, this Article offers a set of specific innovation-sensitive proposals to bolster corporate conduct safeguards through regulatory agency action, contract, tort, intellectual property, and secured ...
%SOURCENAMEESCAPED%, New: Broken, https://www.ssrn.com/abstract=3452930 (September 20, 2019)

This article argues that the CFAA as currently written is unsalvageable and requires a rewrite of its core provisions. Shifting paradigms to an approach driven by principles from computer security and epidemiology theory, this Article offers an attempted rewrite of the CFAA in a manner more attuned to the current security reality.
%SOURCENAMEESCAPED%, New: Cyber Harder, https://www.ssrn.com/abstract=3452936 (September 20, 2019)

The predecessor article to this essay, CYBER!, offered a fresh approach to security – the paradigm of reciprocal security. This essay continues where CYBER! concluded and offers elaborations on concrete policy suggestions for charting a new course for security in both the public and private sectors. It offers implementation suggestions for the five sets of security policy proposals arising from the reciprocal security paradigm advocated by CYBER!
%SOURCENAMEESCAPED%, New: CYBER!, https://www.ssrn.com/abstract=3452934 (September 20, 2019)

This Article challenges the basic assumptions of the emerging legal area of “cyber” or “cybersecurity.” It argues that the two dominant “cybersecurity” paradigms—information sharing and deterrence—fail to recognize that corporate information security and national “cybersecurity” concerns are inextricable. This problem of “reciprocal security vulnerability” means that in practice our current legal paradigms channel us in suboptimal directions. Drawing insights from the work of philosopher of science Michael Polanyi, this Article identifies three flaws that pervade the academic and policy analysis of security, exacerbating the problem of reciprocal security vulnerability—privacy conflation, incommensurability, and internet exceptionalism. It then offers a new paradigm—reciprocal security. Reciprocal security reframes information security law and policy as part of broader security policy, focusing on two key elements: security vigilance infrastructure and defense primacy. The Article ...
%SOURCENAMEESCAPED%, New: The Case for the Repeal of the Fifteenth Amendment in the Yale Law Journal, https://www.ssrn.com/abstract=2957111 (August 20, 2018)

In June 1903, in the depths of the Jim Crow system, the Yale Law Journal published an article by famed New York corporate lawyer John R. Dos Passos (whose son, with the same name, later became a famous modernist novelist and socialist). The article, entitled “The Negro Question,” argued that many African American citizens in southern state were not yet ready for voting rights. The article defended the restriction of rights in southern states since the end of Reconstruction among African-Americans. Dos Passos’ article has received virtually no attention in recent years. It is important evidence of the intellectual credibility of ideas of segregation and second-class citizenship at the turn of the twentieth century. It reveals the breadth of the entrenched opposition to the ideas of racial equality. And it invites further examination of how law reviews in the early twentieth century supported Jim Crow segregation.  
%SOURCENAMEESCAPED%, New: The End User's Predicament: User Standing in Patent Litigation, http://www.ssrn.com/abstract=2894922 (January 9, 2017)

The traditional parties in patent litigation are technologically savvy competitors. Yet recently, patent owners have begun hauling end users—including farmers, small cafés, and podcasters—into patent disputes. This Article shows that end users, unlike competitors, cannot take proactive measures to protect their interests in defending against patent enforcement. The standing doctrine impedes end users’ access to federal court to challenge a patent’s validity in a declaratory judgment action. At the same time, standing and timing requirements prevent end users from taking advantage of the new procedures created under the America Invents Act to challenge patents at the U.S. Patent and Trademark Office (“PTO”). This Article argues that although standing requirements impose a significant obstacle for competitors as well as end users, the unique characteristics of end users place them in a particular predicament. First, the U.S. Court of Appeals for the Federal Circuit requires that ...

  

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