HealthLawProf Blog

Brief of 14 Professors of Law as Amici Curiae in Support of the Petition for Rehearing En Banc in GlaxoSmithKline v. Teva Pharmaceuticals, Fed. Cir. No. 18-1976

Charles Duan (Cornell University), Brief of 14 Professors of Law as Amici Curiae in Support of the Petition for Rehearing En Banc in GlaxoSmithKline v. Teva Pharmaceuticals, Fed. Cir. No. 18-1976, SSRN (2021):

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit considered whether labeling and marketing materials for a generic drug could induce infringement of a patent on a method of using that drug, despite the label and those materials having carved out indications relating to that method pursuant to FDA procedures and the Hatch-Waxman Act. In an original opinion from 2020 and a revised opinion in 2021, a panel of the court affirmed a jury finding of inducement.

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Towards Racial Justice: The Role of Medical-Legal Partnership

Medha D. Makhlouf (Pennsylvania State University), Towards Racial Justice: The Role of Medical-Legal Partnerships, 50 J. L. Med. & Ethics (forthcoming 2022):

Medical-legal partnerships (MLPs) integrate knowledge and practices from law and health care in pursuit of health equity. However, the MLP movement has not reached its full potential to address racial health inequities, in part because its original framing was not explicitly race conscious. This article aims to stimulate discussion of the role of MLPs in racial justice. It calls for MLPs to name racism as a social determinant of health and to examine how racism may operate in the field. This work sets the stage for the next step: operationalizing racial justice in the MLP model, research, and practice.

Patent Eligibility of Disease Diagnosis

Shahrokh Falati (New York Law School), Patent Eligibility of Disease Diagnosis, 21 North Carolina J. L. Tech. 3 (2020):

The U.S. Supreme Court effectively redefined the scope of patent eligible subject matter when it decided Mayo. This decision focused on medical diagnostic technology and has had a profound effect on the biotechnology and personalized medicine industries in the United States. Subsequent back-to-back decisions by the Supreme Court in Myriad and Alice have made it unequivocally clear that there is now wholesale broadening of the judicially created exceptions to statutory laws governing patent eligible subject matter. This has caused havoc in the biopharmaceutical industry by not only making it a near impossibility to obtain a patent in certain fields, but also by vastly increasing the number of medical diagnostic patents being invalidated based on Section 101 of Title 35 of the U.S. Code. This major change in law has had unintended consequences, discouraging research and development necessary for new medical diagnostic and therapeutic methods to come to market. This article analyzes the patent eligibility legal landscape and focuses on emerging medical diagnostic technologies to explain why the Supreme Court’s recent rulings were made in error. I end by discussing how Congress could either abolish, as unnecessary, the non-statutory, Supreme Court-created, exceptions to Section 101, or to amend the statute. Only by doing so can our laws once again encourage and reward creative thinkers and entrepreneurs who take risk and innovate new medical diagnostic technologies in the U.S.

Medicare for All, Health Justice, and the Laboratories of Democracy

Elenore Wade (George Washington University), Medicare for All, Health Justice, and the Laboratories of Democracy, Georgetown J. Poverty L. Pol’y (forthcoming 2022):

A growing majority of Americans support the implementation of a national single-payer healthcare program, also known as Medicare for All, which would shift payments for healthcare services to a single public payer and provide care based on need rather than ability to pay. However, legislators, scholars, and advocates have suggested state governments rather than the federal government should take the lead by implementing state-based single-payer programs. Dozens of single-payer proposals have been introduced in state legislatures across the country, and proposed legislation in Congress would remove the federal roadblocks to state-based single-payer’s implementation. Proponents of state-based single-payer rely on the conventional wisdom that states—as the storied “laboratories of democracy”—can prove the concept of single-payer to other states, who will adopt it in time.

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The Risks Associated with a Pandemic Treaty: Between Global Health Security and Cosmopolitanism

Clare Wenham (London School of Economics & Political Science), Mark Eccleston-Turner (Kings College London), Maike Voss (German Alliance on Climate Change and Health), The Risks Associated with a Pandemic Treaty: Between Global Health Security and Cosmopolitanism, SSRN (2021):

In November 2021, the World Health Assembly (WHA) is hosting a special session to discuss the proposed plans for a pandemic treaty. Despite the fact that there are scant details concerning the treaty, the proposal has gained considerable support in both the academic community, and at the international level. While we agree that in the wake of the numerous governance failures during COVID-19, we need to develop appropriate global solutions to be able to prevent, detect, respond to, and recover from future global health crises, and that such mechanisms should be rooted in global equity. However, we disagree that this pandemic treaty, currently, is the most appropriate way in which to achieve this. Indeed, notions of global community, solidarity, fairness are far removed from the reality that we have seen unfolding in the actions of states responding to the pandemic. This is the crux of the tension with the proposed treaty: the balance between the ideal cosmopolitan worldview held by those in power in global health, and the practice of national security decision making witnessed in the last 18 months. Indeed, we do not believe that a pandemic treaty will deliver what is being extolled by its proponents, and it will not solve the multiple problems of global cooperation in global health that supporters believe it will.

Moral Status in Bioethics

Ezio Di Nucci (University of Copenhagen), Moral Status in Bioethics, The Rowman & Littlefield Handbook of Bioethics (forthcoming 2022):

What does the “bio” stand for, in bio-ethics? You’d think such a fundamental question would have been settled with the establishment of the field – isn’t that what names are for? – but actually, in good old philosophical tradition, that is still one of the most debated questions within bioethics, for the simple reason that the answer would settle the hard question of who – which beings or things – is deserving of moral consideration; and therefore also who isn’t, which is possibly even more controversial. This means, ironically, that the field is still trying to find out what its own name means (or at least what it refers to, which isn’t necessarily the same, if you remember your Frege). Then again, if you are a philosopher you are used to these wild levels of uncertainty, so no big deal.

Intellectual Property and Health Care at the Multilateral Level during a Pandemic COVID-19

Daria Soldatenko (Moscow State Institute of International Relations), Intellectual Property and Health Care at the Multilateral Level during a Pandemic COVID-19, SSRN (2021):

The current stage of development of the world economic system is characterized by a high degree of intellectualization of international economic relations. This phenomenon is mostly reflected in the context of the international movement of intellectual property objects (hereinafter - IP), which received a new impetus during the COVID-19.

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Towards Ending the Information Poverty Among Persons with Print Disabilities: A Proposed Draft (Amendment) Bill for Disability Diversification of the National Library of Nigeria

Bizibrains Okpeh (Nigerian Bar Association), Towards Ending the Information Poverty Among Persons with Print Disabilities: A Proposed Draft (Amendment) Bill for Disability Diversification of the National Library of Nigeria, SSRN (2021):

Globally, there is less information available or accessible to persons with print disabilities (PWPDs), or otherwise the print disabled. These are persons who are blind or have visual impairments or perceptual or reading disabilities, which cannot be improved to give visual function substantially equivalent to that of persons who have no such impairments or disabilities and so are unable to read printed works to substantially the same degree as persons without impairments or disabilities, or are otherwise unable, through physical disability, to hold or manipulate a book or to focus or move the eyes to the extent that would be normally acceptable for reading, regardless of any other disabilities.

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Pharmaceutical Patents and Evergreening

Hazel V. J. Moir (Australian National University), Pharmaceutical Patents and Evergreening, SSRN (2021):

This paper investigates the motivations which trigger evergreening patents for pharmaceuticals and explores the characteristics of such patents, particularly their low degree of inventiveness. It starts by considering the economics of the pharmaceutical industry – the cost of developing new medicines; who pays for this research and development (R&D); what pharmaceutical revenue is spent on and how profits are used. Attention is then turned to the patent system and the leading role the pharmaceutical industry has played in designing the critical features that allow secondary patents (Section 2). Section 3 reviews in detail different types of evergreening patents, commenting on the doctrines (patent policies) which give rise to such patents. The paper concludes by looking at the impact that the industry’s focus on evergreening patents has on the incentive to develop new medicines that address unmet health needs. Given the incentive structure in patent policy the industry has managed to achieve, it is far more profitable to extend market monopolies for existing medicines, and develop variants of these, than it is to undertake riskier research to develop totally new medicines. Numerous voices have called for substantial reforms to reset the incentive structure for the pharmaceutical industry, but to date governments throughout the democratic world have been impervious to these.

COVID-19 Lockdown Defiance, Public ‘Indiscipline’, and Criminalisation of Vulnerable Populations in Ghana

Festival Godwin Boateng (Columbia University), Saviour Kusi (Independent), Samuel Ametepey (Independent), COVID-19 Lockdown Defiance, Public ‘Indiscipline’, and Criminalisation of Vulnerable Populations in Ghana, SSRN (2021):

Behavioural economics has provided much source of inspiration for public policy in the COVID-19 era. Such is evidently the state of discussion in Ghana, where Ghanaians' so-called stubborn resistance to positive behavioural change is increasingly the target of public and popular criticisms. This paper argues that further to legitimising the police violence and extrajudicial sanctions meted out to ‘undisciplined’ violators of the restrictions, the indiscipline narrative leaps too quickly from an account of the personal morality/attitudes of Ghanaians to the collective action of mass-defiance of the restrictions without taking adequate account of the range of structural constraints that made it difficult for the majority of the people to comply with the restrictions. The mass defiance of the restrictions is best understood in the context of the unequal outcomes of the broader policy processes and practices, and the historical-institutional power dynamics around them that put some people in criminogenic situations in the country. It is important that media and policy analyses of public defiance of the restrictions and social problems in the country generally move beyond the simplistic notion of indiscipline to dissect how deliberate bias against the needs of the majority operates, and is institutionalised in policy and practice in ways that undermine their commitment to rules and regulations.

Intellectual Property Protection in Agriculture: Plant Variety Protection and Farmers’ Rights in Bangladesh

Md Uddin (Independent), Intellectual Property Protection in Agriculture: Plant Variety Protection and Farmers’ Rights in Bangladesh, SSRN (2021):

Since agriculture has a significant amount of contribution to the national economy of Bangladesh, it is important to assess the role of intellectual property (IP) in the agriculture sector of the country. In this regard, this chapter will focus on how plant breeding, commercial exchange of seeds, farmers’ traditional knowledge as well as farmers’ rights issues are dealt with under IPRs or similar protection mechanisms. Accordingly, in addition to considering concerned international treaties and agreements as background, the study considers national patent law, plant variety protection law, and biodiversity protection related law of Bangladesh. The study finds that new plant varieties are protectable under national patent law and the plant variety protection Act. Farmers’ traditional knowledge, as well as farmers’ rights, are possible to defend under the plant variety protection Act and Biodiversity Act of the country. However, the study recommends updating the country’s century-old patent law in the light of the recent development of patent-related international negotiations, which must consider poor farmers’ interests as well as national interest that vested on country’s agricultural growth. The study further recommends that the government of Bangladesh should also focus on appropriate enforcement of the national plant variety protection Act and Biodiversity Act for the purpose of ensuring that specified farmers’ rights are properly observed and upheld.

Utilising Public Health Flexibilities in the Era of COVID-19: An Analysis of Intellectual Property Regulation in The OAPI and MENA Regions of Afric

Yousuf A. Vawda (University of KwaZulu-Natal), Bonginkosi Shozi (University of KwaZulu-Natal), Utilising Public Health Flexibilities in the Era of COVID-19: An Analysis of Intellectual Property Regulation in The OAPI and MENA Regions of Africa, S. Centre Research Paper 141 (2021):

The paper explores the unique approaches to IP protection in the countries belonging to the Organisation Africaine de la Propriété Intellectuelle/African Intellectual Property Organization (OAPI) and the Middle East and North Africa (MENA) regions; the limited extent to which legal and policy frameworks with regard to TRIPS flexibilities have been adopted and implemented in pursuit of access to medicines in those countries; and makes recommendations in order to optimise the use of the flexibilities in advancing public health objectives. In the context of the COVID-19 pandemic, the impact of IP rights on access, and some approaches to countering the challenges to access are also discussed.

Ultra-Compelled: Abortion Providers' Free Speech Rights After NIFLA

Kimberley Harris (Texas Tech University), Ultra-Compelled: Abortion Providers' Free Speech Rights After NIFLA, Albany L. Rev. (forthcoming 2022):

Blocked by the Supreme Court’s holdings in Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey from enforcing blanket prohibitions on abortion, anti-abortion advocates have turned to a variety of measures to restrict access to abortions, including enacting onerous “informed consent” laws. These requirements compel speech from abortion providers by forcing them to distribute state-created, ideologically-tinged materials that contain false and misleading statements, convey oftentimes false, irrelevant, and ideological information specified by the legislature during pre-abortion counseling sessions, and perform, display, and narrate ultrasounds.
Circuit courts have split over whether these “informed consent” laws should be analyzed according to First Amendment jurisprudence or the undue burden standard of Casey. Although the Supreme Court has refused to provide guidance on this issue, they have not remained similarly silent when abortion opponents challenge mandatory disclosure laws; in National Institute of Family and Life Advocates v. Becerra (NIFLA), the Court upheld a First Amendment challenge to a California law requiring disclosures from crisis pregnancy centers.

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Post-Pandemic Recommendations: COVID-19 Continuity of Court Operations During a Public Health Emergency Workgroup

Samuel Thumma (Arizona Court of Appeals), Marcus W. Reinkensmeyer (Arizona Court of Appeals), Post-Pandemic Recommendations: COVID-19 Continuity of Court Operations During a Public Health Emergency Workgroup, 75 SMU L. Rev. F. 1 (2022):

In this report, the COVID-19 Continuity of Court Operations During a Public Health Emergency Workgroup (Plan B Workgroup) makes recommendations about best practices and technologies that should be retained or adapted post-pandemic. The recommendations in this final Plan B Workgroup whitepaper are based on experience and feedback from Arizona’s courts addressing pandemic and post-pandemic practices. Although the original report, issued on June 2, 2021, included a May 2021 Survey of Arizona’s Courts, this updated report also includes information from a July 2021 State Bar of Arizona Survey and a September 2021 State of Arizona Public Opinion Survey addressing those practices. The workgroup’s findings and recommendations, which remain unchanged, can be summarized in five major categories: (1) Increasing Access to Justice, (2) Expanding Use of Technology, (3) Jury and Trial Management, (4) Communication Strategies and Disaster Preparedness, and (5) Health, Safety, and Security Protocols.

Competence to Stand Trial Ingredients: The Role of Neuroscience

John T. Philipsborn (Independent), Melissa Hamilton (University of Surrey School of Law), Competence to Stand Trial Ingredients: The Role of Neuroscience, Univ. St. Thomas J. L. Pub. Pol’y (2021):

What follows is a discussion that is meant for judges, forensic mental health experts, and lawyers whose involvement in criminal cases means, when necessary, accessing the tools and knowledge to address, analyze, and respond to evidence of the accused’s alleged incompetence to stand trial. There is here a discussion of practice guidelines, caselaw, competence related orders, commentaries, and recommendations that should be pertinent when the accused’s competence to stand trial is questionable. Courts, and the lawyers who appear in such cases, should be aware of the information that can be offered by neuroscientists from the various fields involved in researching, assessing, and documenting brain structure and function. This writing, a combination of a literature review and a commentary that includes illustrative court orders, is offered by the combination of a practicing lawyer with more than forty years of criminal case litigation experience, some of it as counsel of record in competence adjudications and otherwise as a court qualified lawyer-expert on competence to stand trial, and by an academic who researches the use of forensic science in the law.

Vaccine Exemptions and Coverage

Brandyn Churchill (Vanderbilt University), Vaccine Exemptions and Coverage, SSRN (2021):

Falling vaccination rates, the re-emergence of previously eradicated diseases, and the COVID-19 pandemic have raised important questions regarding the degree to which parents can opt their children out of receiving required school vaccines. This paper provides novel evidence on how laws repealing these exemptions affect claimed exemptions, coverage rates, and information seeking behavior. First, I show that laws repealing non-medical exemptions reduced the share of kindergartners receiving an exemption by 2-3 percentage points, and this reduction was pronounced in states prohibiting all exemptions compared those continuing to allow religious objections. Indeed, these latter states experienced increased internet search activity for the phrase ‘religious exemption.’ Next, I show that while policies prohibiting all non-medical exemptions increased coverage of four school-entry vaccines (MMR, DTP, hepatitis B, and polio) by 1.7-2.9 percentage points, the estimates for laws repealing personal exemptions but allowing for religious objections were smaller in magnitude and often statistically insignificant.

No Future but a Shared Future

Lawrence O. Gostin (Georgetown University), Kevin A. Klock (Georgetown University), Sam Halabi (University of Missouri), Katie Gottschalk (University of Missouri), Katherine Ginsbach (Georgetown University), No Future but a Shared Future, Think Glob. Health (Nov. 28, 2021):

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to the pandemic. This meeting was followed by regional consultations convened in Africa, Latin America-Caribbean, and Southeast Asia. The O’Neill Institute/FNIH also held a consultation with civil society representatives. This article is a concise, edited excerpt of the report of those meetings, outlining the options for such an international instrument.

Legal Capacity for All: Including Older Persons in the Shift from Adult Guardianship to Supported Decision-Making,

Rebekah Diller (Benjamin N. Cardozo School of Law), Legal Capacity for All: Including Older Persons in the Shift from Adult Guardianship to Supported Decision-Making, 43 Fordham Urban L. J. 495 (2016):

For the last several decades, guardianship has been the subject of continual calls for reform, often spurred by revelations of guardian malfeasance and other abuses in the system. Recent developments in international human rights law pose a more fundamental challenge to the institution. Under Article 12 of the United Nations Convention on the Rights of Persons with Disabilities (CRPD), governments may not deprive individuals of their “legal capacity”—or right to make decisions and have those decisions recognized as legally binding—on the grounds of disability. In the wake of the CRPD, the concept of supported decision-making has gained growing acceptance as an alternative to guardianship. But, to date, supported decision-making has not taken hold to quite the same degree—in both the theoretical discussions and in practice—as an alternative for older adults who may be vulnerable to guardianship. This Article argues that the paradigm shift away from guardianship to a right to legal capacity can and should apply to older persons who would otherwise be at risk of guardianship. It offers a normative argument for supported decision-making rooted in the particular concerns of older adults facing the loss of their rights and then suggests a number of contexts in which a shift away from guardianship for older persons may be achieved most readily.

Religious Liberty in the Age of COVID

Antony Kolenc (University of North Texas), Religious Liberty in the Age of COVID, SSRN (2021):

In the age of COVID-19, two pressing questions arise: What limits does the U.S. Constitution place on the government suppression of religious liberty during a global health emergency, and what can believers do to secure their right to religious worship?

Growing Enlightenment: Sentencing Offenders With Autism Spectrum Disorder in Australia

Gabrielle Wolf (Deakin University), Growing Enlightenment: Sentencing Offenders With Autism Spectrum Disorder in Australia, 44 Univ. New South Wales L. J. 4 (2021):

The number of defendants raising an Autism Spectrum Disorder (‘ASD’) diagnosis in criminal proceedings is increasing. Australian courts treat this neurodevelopmental disorder as a mental impairment that they may take into account in sentencing. A few studies nonetheless exposed deficiencies in judicial officers’ understanding of ASD symptoms and their potential forensic relevance. Courts’ willingness to rely on expert evidence did not always lead to them sentencing offenders with ASD in a consistent or enlightened manner. Building on those investigations and drawing on research into ASD, this article examines sentencing decisions involving eight offenders with ASD in various Australian jurisdictions between 2014 and 2020. This analysis demonstrates that judicial officers’ knowledge about ASD and appreciation of its possible relevance to sentencing considerations are growing, but there remain gaps in both respects. The article speculates on possible reasons for this and proposes reforms to improve courts’ approaches to sentencing offenders with ASD.