Law Commons^™

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

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We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …

Did The America Invents Act Change University Technology Transfer?, Cynthia L. Dahl

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University technology transfer offices (TTOs) are the gatekeepers to groundbreaking innovations sparked in research laboratories around the U.S. With a business model reliant on patenting and licensing out for commercialization, TTOs were positioned for upheaval when the America Invents Act (AIA) transformed U.S. patent law in 2011. Now almost ten years later, this article examines the AIA’s actual effects on this patent-centric industry. It focuses on the five key areas of most interest to TTOs: i) first to file priority; ii) broadening of the universe of prior art; iii) carve-out to the prior commercial use defense; iv) micro-entity fees; and …

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

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Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Self-Actualization And The Need To Create As A Limit On Copyright, Christopher S. Yoo

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Personhood theory is almost invariably cited as one of the primary theoretical bases for copyright. The conventional wisdom views creative works as the embodiment of their creator’s personality. This unique connection between authors and their works justifies giving authors property interests in the results of their creative efforts.

This Chapter argues that the conventional wisdom is too limited. It offers too narrow a vision of the ways that creativity can develop personality by focusing exclusively on the results of the creative process and ignoring the self-actualizing benefits of the creative process itself. German aesthetic theory broadens the understanding of the …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

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The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

The Law Of Employee Data: Privacy, Property, Governance, Matthew T. Bodie

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The availability of data related to the employment relationship has ballooned into an unruly mass of personal characteristics, performance metrics, biometric recordings, and creative output. The law governing this collection of information has been awkwardly split between privacy regulations and intellectual property rights, with employees generally losing on both ends. This Article rejects a binary approach that either carves out private spaces ineffectually or renders data into isolated pieces of ownership. Instead, the law should implement a hybrid system that provides workers with continuing input and control without blocking efforts at joint production. In addition, employers should have fiduciary responsibilities …