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Articles 1 - 11 of 11
Full-Text Articles in Law
Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman
Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman
All Faculty Scholarship
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 …
The Intellectual Property Of Covid-19, Ana Santos Rutschman
The Intellectual Property Of Covid-19, Ana Santos Rutschman
All Faculty Scholarship
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
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 …
Intellectual Property As A Determinant Of Health, Ana Santos Rutschman
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 …
Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman
Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman
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The COVID-19 pandemic has shed renewed light on the importance of research and development (R&D) on biopharmaceutical products needed to prevent or lessen the burden posed by outbreaks of infectious diseases. Among these, the need for new vaccines has become of paramount importance. While a race to develop different types of vaccines unfolds at unusual speed, there are still significant shortcomings in the ecosystem that leads to the production and dissemination of vaccines targeting infectious diseases like COVID-19.
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
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This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
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Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …
The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman
The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman
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Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.
From Venetian Glass To Contemporary Intellectual Property: Revisiting Tailored Patent Regimes (Book Review), Ana Santos Rutschman
From Venetian Glass To Contemporary Intellectual Property: Revisiting Tailored Patent Regimes (Book Review), Ana Santos Rutschman
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This piece reviews Stefania Fusco's “Murano Glass Vase" and "Lessons from the Past." In Murano Glass Vase, Fusco recounts the history of the glassmaking industry in Venice, framing it as the natural experiment from which the patent system sprang into the world. Fusco emphasizes the mix of exclusionary rights and trade secrecy that formed the backbone of Venetian innovation policy against the backdrop of a heavily regulated and protectionist economy. In “Lessons from the Past,” Fusco draws on original research performed at the Venetian State Archives to further the Murano narrative by looking at how the Venetian government fueled an …
Steps Towards An Alignment Of Intellectual Property In South-South Exchanges: A Return To Trips, Ana Santos Rutschman
Steps Towards An Alignment Of Intellectual Property In South-South Exchanges: A Return To Trips, Ana Santos Rutschman
All Faculty Scholarship
Some of the most instrumental players in shaping the course of intellectual property policies in the South are the so-called BRIC countries. The acronym BRIC originally encompassed Brazil, Russia, India and China. In 2011, South Africa formally joined the BRIC countries, which are now referred to either by the original acronym or by BRICS. While categorizations like BRICS attract a fair amount of criticism, with questions surrounding the criteria used to aggregate disparate economies, the concept of emerging economies in the South seeking to advance similar development agendas has become accepted currency in multiple fields, from institutional cooperation to financial …
Steps Towards And Alignment Of Intellectual Property In South-South Exchanges: A Return To Trips, Ana Santos Rutschman
Steps Towards And Alignment Of Intellectual Property In South-South Exchanges: A Return To Trips, Ana Santos Rutschman
All Faculty Scholarship
Some of the most instrumental players in shaping the course of intellectual property policies in the South are the so-called BRIC countries. The acronym BRIC originally encompassed Brazil, Russia, India and China. In 2011, South Africa formally joined the BRIC countries, which are now referred to either by the original acronym or by BRICS. While categorizations like BRICS attract a fair amount of criticism, with questions surrounding the criteria used to aggregate disparate economies, the concept of emerging economies in the South seeking to advance similar development agendas has become accepted currency in multiple fields, from institutional cooperation to financial …