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 …

Pathogen Genomes As Global Public Goods (And Why They Should Not Be Patented), Jorge L. Contreras

Utah Law Faculty Scholarship

During past viral outbreaks, researchers rushed to patent genomic sequences of the viruses as they were discovered, leading to disputes and delays in research coordination. Yet similar disputes did not occur with respect to the genomic sequence of SARS-CoV-2, the virus responsible for COVID-19. With respect to COVID-19, global research collaboration occurred rapidly, leading to the identification of new variants, the ability to track the spread of the disease, and the development of vaccines and therapeutics in record time. The lack of patenting of SARS-CoV-2 is likely due the U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. …

Trademarks And Censorship In The Time Of Covid-19, Xuan-Thao Nguyen

Articles

During the devastating year of 2020, China quickly conquered the novel coronavirus and roared back economically while the United States faced staggering deaths and economic losses. But underneath the divergent experience of the two countries is an untold story of trademark and censorship in the time of COVID-19. This Article observes that while the United States Supreme Court has lifted the ban on trademark registrations for unconstitutional viewpoint discrimination, opening the door for offensive COVID-19 trademark applications, China has transformed trademark law into the law for censorship as Chinese authorities press forward to achieve twin victories over the coronavirus and …

Intellectual Property And The Politics Of Public Good In Covid-19: Framing Law, Institutions, And Ideas During Trips Waiver Negotiations At The Wto, Sara E. Fischer, Lucia Vitale, Akinyi Lisa Agutu, Matthew M. Kavanagh

O'Neill Institute Papers

Context: To facilitate the manufacturing of COVID-19 medical products, in October 2020, India and South Africa proposed a waiver of certain WTO intellectual property (IP) provisions. After 18 months, a narrow agreement that did little for vaccine access passed the ministerial, despite the pandemic’s impact on global trade, which the WTO is mandated to safeguard.

Methods: The authors conducted a content analysis of WTO legal texts, key actor statements, media reporting, and the WTO’s procedural framework to explore legal, institutional, and ideational explanations for the delay.

Findings: IP waivers are neither legally complex nor unprecedented within WTO …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

Non-Patent Intellectual Property Barriers To Covid-19 Vaccines, Treatment And Containment, Sean Flynn, Erica Nkrumah, Luca Schirru

Joint PIJIP/TLS Research Paper Series

As the World Trade Organization considers a proposal to waive or otherwise address intellectual property barriers to the global response to the COVID-19 pandemic, most of the attention given by scholars and policy makers has been focused on patents. The original proposals by South Africa and India, as well as the groundbreaking support of the United States, however, explicitly applied to all forms of intellectual property. This paper documents many instances where non-patent forms of intellectual property create barriers to the global scale up of access to vaccines, treatments, and the ability to contain the virus through social distancing. Addressing …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Covid-19 As An Example Of Why Genomic Sequence Data Should Remain Patent Ineligible, Jorge L. Contreras

Utah Law Faculty Scholarship

The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no …

The Open Covid Pledge: Design, Implementation And Preliminary Assessment Of An Intellectual Property Commons, Jorge L. Contreras

Utah Law Faculty Scholarship

Early during the COVID-19 pandemic, a number of widely-publicized incidents gave rise to concerns that holders of patents and other intellectual property (IP) rights could hinder the development, manufacture and distribution of essential medical devices, protective equipment and biomedical products. The global response to these concerns was swift and included the issuance of compulsory licensing orders by several national governments, as well as the proposal of a technology pool by the World Health Organization (WHO). Alongside these efforts, a group of scientific, engineering and legal experts created a lightweight, open framework under which IP holders could voluntarily pledge not to …

Child-Proofing Global Public Health In Anticipation Of Emergency, Frederick M. Abbott

Scholarly Publications

No abstract provided.

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 …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

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 — Volume 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 …

Pledging Intellectual Property For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

COVID-19 differs from other recent public health crises with respect to its sudden onset, its rapid spread, the lack of any known vaccine or cure and resulting shortages of critical medical equipment. The convergence of these factors has prompted both governments and IPR holders around the world to seek ways to increase the availability of IPR necessary to combat the pandemic. Governmental compulsory licensing, IPR pools and voluntary IPR pledges have all been used in the past, though in situations that differ in important respects from the COVID-19 pandemic. Each is designed to result, to a greater or lesser degree, …

Facilitating Access To Cross-Border Supplies Of Patented Pharmaceuticals: The Case Of The Covid-19 Pandemic, Frederick M. Abbott

Scholarly Publications

The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that maybe achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment …

Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman

All Faculty Scholarship

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.