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INTRODUCTION 1320 I. A DANGEROUS STATUS QUO 1332 A. Sweeping Access: Federal Regulators' Information-Gathering Powers 1333 1. Premarket Approval 1336 2. Investigation 1338 B. Locked Vaults: Federal Regulators Keeping Corporate [...]

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict--indeed, have already begun to conflict--with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. [section] 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that [section] 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought to be invoked sparingly or not at all, even in extraordinary circumstances such as a pandemic. Yet that conventional wisdom is a recent one, and it conflicts with both history and theory. This Article considers the role of [section] 1498 in the context of national crises and emergencies like COVID-19, a context so far not addressed substantially in the literature on the statute. We find that government patent use is not nearly as exceptional as it is commonly made out to be, and indeed has been not only used but expanded through statutory amendment over the last century. Review of the development and use of the statute during both world wars and the post-September 11 period reveals widespread acceptance of government patent use as a tool for addressing imminent national problems, and it illuminates particular features of government patent use that become especially pertinent in times of crisis. In the United States, government patent use and national emergencies have a close and special relationship; each has shaped the other. Drawing from the lessons of history and analysis of the statute, we develop a novelframeworkfor comparing [section] 1498 to other policy tools, including prizes, research grants, and patent buyouts. Under this framework, four features of [section] 1498 stand out: speed of invocation, flexibility in the scope of its use, post-crisis determination of compensation, and use of an impartial adjudicator. Whenever these four features are advantageous--which will be true in most national emergency situations, as we demonstrate--the U.S. government should strongly consider government patent use over patent buyouts and other policy tools. We show the advantages of these four features in a case study: government patent use to expand supply and access to the COVID-19 treatment remdesivir. Accordingly, and contrary to the conventional view of [section] 1498, we conclude that government patent should be an ordinary tool of government policy., Table of contents Introduction I. Historical Role of Government Patent Use in Times of Crisis A. Origin of the Statute B. World War I C. World War II D. Bioterrorism [...]

For years, social media companies have sparred with lawmakers over how much independent access to platform data they should provide researchers. Sharing data with researchers allows the public to better understand the risks and harms associated with social media, including areas such as misinformation, child safety, and political polarization. Yet researcher access is controversial. Privacy advocates and companies raise the potential privacy threats of researchers using such data irresponsibly. In addition, social media companies raise concerns over trade secrecy: the data these companies hold and the algorithms powered by that data are secretive sources of competitive advantage. This Article shows that one way to navigate this difficult strait is by drawing on lessons from the successful governance program that has emerged to regulate the sharing of clinical trial data. Like social media data, clinical trial data implicates both individual privacy and trade secrecy concerns. Nonetheless, clinical trial data's governance regime was gradually legislated, regulated, and brokered into existence, managing the interests of industry, academia, and other stakeholders. The result is a functionally successful (albeit imperfect) clinical trial data-sharing ecosystem. Part II sketches the status quo of researchers' access to social media data and provides a novel taxonomy of the problems that arise under this regime. Part III reviews the legal structures governing sharing of clinical trial data and traces the history of scandals, investigations, industry protest, and legislative response that gave rise to the mix of mandated sharing and experimental programs we have today. Part IV applies lessons from clinical trial data sharing to social media data and charts a strategic course forward. Three primary lessons emerge: first, the benefits of research on otherwise secret data are cascading and unpredictable; second, law without institutions to implement the law is insufficient; and, third, data access regimes must be tailored to the different sorts of data they make available. [ABSTRACT FROM AUTHOR]

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari's theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit "public option" for pharmaceutical development. [ABSTRACT FROM AUTHOR]

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a "taking" of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US's most important state and federal health care programs. [ABSTRACT FROM AUTHOR]

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict--indeed, have already begun to conflict--with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of governmentpaid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought to be invoked sparingly or not at all, even in extraordinary circumstances such as a pandemic. Yet that conventional wisdom is a recent one, and it conflicts with both history and theory. This Article considers the role of § 1498 in the context of national crises and emergencies like COVID-19, a context so far not addressed substantially in the literature on the statute. We find that government patent use is not nearly as exceptional as it is commonly made out to be, and indeed has been not only used but expanded through statutory amendment over the last century. Review of the development and use of the statute during both world wars and the post-September 11 period reveals widespread acceptance of government patent use as a tool for addressing imminent national problems, and it illuminates particular features of government patent use that become especially pertinent in times of crisis. In the United States, government patent use and national emergencies have a close and special relationship; each has shaped the other. Drawing from the lessons of history and analysis of the statute, we develop a novel framework for comparing § 1498 to other policy tools, including prizes, research grants, and patent buyouts. Under this framework, four features of § 1498 stand out: speed of invocation, flexibility in the scope of its use, post-crisis determination of compensation, and use of an impartial adjudicator. Whenever these four features are advantageous--which will be true in most national emergency situations, as we demonstrate--the U.S. government should strongly consider government patent use over patent buyouts and other policy tools. We show the advantages of these four features in a case study: government patent use to expand supply and access to the COVID-19 treatment remdesivir. Accordingly, and contrary to the conventional view of § 1498, we conclude that government patent should be an ordinary tool of government policy. [ABSTRACT FROM AUTHOR]

Water as an effective promoter of the endo-selective opening of trisubstituted epoxides which allows related cascades leading to a variety of substituted ladder polyether structures is described. The property of water as a uniquely versatile medium and promoter of epoxide opening is confirmed by its ability to overcome the powerful electronic directing effect of a methyl substituent at either site of the epoxide when used in combination with a tetrahydropyran-templated nucleophile.

Ladder polyether natural products are a class of natural products denoted by their high functional-group density and large number of well-defined stereocenters. They comprise the toxic component of harmful algal blooms (HABs), having significant negative economic and environmental ramifications. However, their mode of action, namely blocking various cellular ion channels, also denotes their promise as potential anticancer agents. Understanding their potential mode of biosynthesis will not only help with developing ways to limit the damage of HABs, but would also facilitate the synthesis of a range of analogs with interesting biological activity. 1,3-Dioxan-5-ol substrates display remarkable 'enhanced template effects' in water-promoted epoxide cyclization processes en route to the synthesis of these ladder polyether natural products. In many cases, they provide near complete endo-to-exo selectivity in the cyclization of epoxy alcohols, thereby strongly favoring the formation of tetrahydropyran (THP) over tetrahydrofuran (THF) rings. The effects of various Brønsted and Lewis acidic and basic conditions are explored to demonstrate the superior selectivity of the template over the previously reported THP-based epoxy alcohols. In addition, the consideration of other synthetic routes are also considered with the goal of gaining rapid access to a plethora of potential starting materials applicable towards the synthesis of ladder polyethers. Finally, cascade sequences with polyepoxides are investigated, further demonstrating the versatility of this new reaction template., (Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)