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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]

The phannaceutical industry is among the most politically powerful business sectors in the United States today. This article describes how this industry has successfully entrenched its power, with attention to four sources of power: property power. vertical power over politics, ideational power, and material power. Attempts to reform the industry must grapple with these forms of power, which are not easily separated and which, in the current environment, tend to reinforce one another. [ABSTRACT FROM AUTHOR]

Rising inequality and increasing concentration of corporate power have brought renewed attention to questions of political economy, and to how law helps to construct private power and encase it from democratic rearrangement. This Article brings a political economy perspective to the law of commercial secrets, to show that changes in the scope and justification for trade secret law, operating in a context of rising importance of data and information, have set this law on a collision course with our democracy. An area of law that was once understood as focused on fair competition and commercial morality has been retheorized as a kind of "intellectual property," following prevailing neoliberal arguments about the economics of information. Earlier limits on the scope of the law have been dissolved, so that companies today can claim that almost any confidential corporate information is a trade secret. The law has also been constitutionalized, so that a legislature disclosing corporate information -- from the ingredients in cigarettes to the price of a drug -- now face powerful challenges from corporations on the basis of the Takings Clause. Some of the most basic functions of the modern regulatory state, including many mandated disclosures about commercial products to the public, would not have been possible if this view had reigned in earlier decades. Unsurprisingly, it did not. Several Supreme Court cases that have largely been forgotten show that courts even at the height of laissez faire were clear about the categorical priority of the public, and rejected trade secret claims when they conflicted with the public's right to know. These cases, and earlier logics of trade secrecy that see it as an expression of values of fair competition and commercial morality, together form what I call the "public history of trade secrets." Recalling this history can help us to defend a more democratic relation between the political and the economic in our age of informational capitalism. These cases also point to a clear legal principle that would, if recovered, reshape what legislatures and regulators are able to reveal to the public: The disclosure of corporate secrets can be made a condition of participation in markets whenever the information helps illuminate the nature of a product or service. Recognizing this would enable vastly more public insight into companies and their products -- for example, enabling states to mandate disclosure of the algorithms that shape our social media feeds, and the secret data companies hold about the risks and benefits of consumer products. [ABSTRACT FROM AUTHOR]

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue--Loturne 11, Issue 1--captures that event. The following article represents the second of four panels. This panel asked, "Should the U.S. government actively assert its own patents?" The panel was moderated by Christopher Morten, Deputy Director of NYU Law's Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical Technology Transfer at the U.S. Army Medical Research and Development Command, Professor Amy Kapczynski of Yale Law School, Donna Meuth, Associate General Counsel and Lead Attorney of the U.S. Intellectual Property Department of Eisai, and Zain Rizvi, a policy researcher at Public Citizen who focuses on pharmaceutical innovation and access to medicines. [ABSTRACT FROM AUTHOR]

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available. [ABSTRACT FROM AUTHOR]