Law Commons^™

Intellectual Property And “The Lost Year” Of Covid-19 Deaths, Madhavi Sunder, Haochen Sun

Georgetown Law Faculty Publications and Other Works

Protecting intellectual property (IP) is a question of life and death. COVID-19 vaccines, partially incentivized by IP, are estimated to have saved nearly 20 million lives worldwide during the first year of their availability in 2021. However, most of the benefits of this life-saving technology went to high- and upper-middle-income countries. Despite 10 billion vaccines being produced by the end of 2021, only 4 percent of people in low-income countries were fully vaccinated. Paradoxically, IP may also be partly responsible for hundreds of thousands of lives lost in 2021, due to an insufficient supply of vaccines and inequitable access during …

New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg

Articles

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Compulsory Licensing Of Patents In Times Of Public Health Emergency, Kelsey Truglio

Touro Law Review

In March 2020, the United States shut down to avoid the continued spread of the COVID-19 virus as it spread globally. In December 2020, the first COVID-19 vaccines were granted emergency usage authorization in the United States. Wealthy nations were able to quickly purchase and hoard vaccines for public distribution, leaving many third-world countries and developing nations struggling to continue to survive the pandemic without vaccination.

Compulsory licensing should be allowed on otherwise patented or patentable new technology in times of global health emergency, regardless of which entity creates the technology. This will enable governments of countries spanning all wealth …

How To Build More Equitable Vaccine Distribution Technology, Laura M. Moy, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic and the distribution of vaccines that promise to bring it to an end have spotlighted inequities in our nation’s healthcare system. But the vaccine distribution problem illustrates a peculiar fact of our digital era: just how hard it is to ensure equitable delivery of services via the internet. This is especially the case when distributing a scarce critical resource as quickly as possible on a massive scale.

In this Brookings Institution article, Professors Laura Moy and Yael Cannon argue that digital infrastructure is a critical determinant of health, and call for the restructuring of online vaccine appointment …

New Innovation Models In Medical Ai, Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg

Law & Economics Working Papers

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those that relate to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of …

Intellectual Property As A Determinant Of Health, Ana S. Rutschman

Vanderbilt Journal of Transnational Law

Public health literature has long recognized the existence of determinants of health, a set of socioeconomic 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 …

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

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, …

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

All Faculty Scholarship

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 …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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.

The Internet Of Bodies, Andrea M. Matwyshyn

William & Mary Law Review

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 …

The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall

Timothy S. Hall

This article explores some of the potential pitfalls associated with collection of detailed individual biometric or health-related information, and demonstrates that current laws and regulations are not well designed to protect users of these devices and apps from unauthorized use or misuse of their data. Health information is among the most sensitive, intimate, and potentially damaging personal information one may possess, and health policymakers have made health information privacy a priority for decades for good reason. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was one of the major health policy legislative achievements of the 1990s. However, HIPAA …

Health Care Costs And The Arc Of Innovation, Neel U. Sukhatme, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze.

Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s excessive spending, …

Intellectual Property And Public Health: A White Paper, Katharine A. Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, The University of Akron School of Law's Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants, and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Celebrating Wisconsin Entrepreneurs: Lessons Learned From Wisconsin Entrepreneurs And Businesses, And Future Prospects For A Healthcare Sector That Is Healthcare Reform, Daniel S. Sem, Si Gou, Taleb Aljabban

Marquette Intellectual Property Law Review

Wisconsin has a rich history of entrepreneurial activity, which is often not appreciated beyond its well-recognized strength in the beer and cheese industries. However, Wisconsin’s entrepreneurial nature has been called into question. Recently, Wisconsin was ranked fiftieth in the United States for startup activity by the Kauffman Foundation. In contrast, Wisconsin ranks at the top of the country for startups that are local and established business with more longevity. The first half of this article will review some of the challenges and opportunities that have faced Wisconsin entrepreneurs, and will provide an overview of over 150 Wisconsin companies (Table 1), …

Reaching For Mediocrity: Competition And Stagnation In Pharmaceutical Innovation, Son Le, Neel U. Sukhatme

Georgetown Law Faculty Publications and Other Works

Patents might incentivize invention but they do not guarantee firms will invest in projects that maximize social utility. We model how risk-neutral firms’ ability to obtain substantial private returns on marginal new technologies causes them to “reach for mediocrity” by investing in socially-suboptimal projects, even in the presence of competition and new entrants. Focusing primarily on pharmaceutical innovation, we analyze various policy interventions to solve this underinvestment problem. In particular, we describe a new approach to patents – a value based patent system, which ties patent protection to the underlying invention’s social value – and show how it incentivizes socially-optimal …

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …

Patent Law's Reproducibility Paradox, Jacob S. Sherkow

Articles & Chapters

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …

Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii

Articles

Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …

The Experiences Of Trips-Compliant Patent Law Reforms In Brazil, India, And South Africa And Lessons For Bangladesh, M. Monirul Azam

Akron Intellectual Property Journal

This study analyzes the policy options used by Brazil, India, and South Africa in their transitions to a TRIPS-compliant patent law and their introduction of pharmaceutical patents. This comparative review can be used to explore possible policy options that can also be utilized by LDCs, including Bangladesh.

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Akron Intellectual Property Journal

On October 26, 2012, The University of Akron School of Law's Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants, and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall

Akron Intellectual Property Journal

This article explores some of the potential pitfalls associated with collection of detailed individual biometric or health-related information, and demonstrates that current laws and regulations are not well designed to protect users of these devices and apps from unauthorized use or misuse of their data. Health information is among the most sensitive, intimate, and potentially damaging personal information one may possess, and health policymakers have made health information privacy a priority for decades for good reason. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was one of the major health policy legislative achievements of the 1990s. However, HIPAA …

Bioprospect Theory, James Ming Chen

Akron Intellectual Property Journal

Conventional wisdom treats biodiversity and biotechnology as rivalrous values. The global south is home to most of earth's vanishing species, while the global north holds the capital and technology needed to develop this natural wealth. The south argues that intellectual property laws enable pharmaceutical companies and seed breeders in the industrialized north to commit biopiracy. By contrast, the United States has characterized calls for profit-sharing as a threat to the global life sciences industry. Both sides magnify the dispute, on the apparent consensus that commercial exploitation of genetic resources holds the key to biodiversity conservation.

Both sides of this debate …

Ip And Health Care: New Drugs Pricing And Medical Mistakes, Jay Dratler Jr.

Akron Intellectual Property Journal

I propose to address briefly two important IP questions from an economic perspective: patented drug pricing in an international context and trade secret protection for health care outcomes. The first will involve some algebra; the second involves a bit of common sense that so far seems to have eluded us.