U.S. Supreme Court

Don’t Be Too Alarmed by the New SCOTUS Antibody Ruling

Timothy Bonis Leave a comment

Amgen v. Sanofi is an important case, but it won’t transform patent law on its own.

By Timothy Bonis

Last April, the Supreme Court ruled in Amgen v. Sanofi, a closely watched patent case where the justices upheld the invalidation of two monoclonal antibody patents for lack of enablement. The ruling has attracted significant interest for two reasons.

First, Amgen involved genus claims in biological and chemical fields, which some experts believe the Federal Circuit has made unduly hard to obtain. This viewpoint, most prominently expressed by Mark Lemley, Sean Seymore, and Dmitry Karshtedt in The Death of The Genus Claim (2021), informed much of the debate about Amgen, although it has been challenged by scholars like Christopher Holman.

Second, Amgen dealt with monoclonal antibody patents, which now represent some of the most valuable intellectual property. (The global market for monoclonals in 2022 was $210B.) Moreover, the scope of antibody patent claims has been narrowed markedly by heightened standards for enablement and written description introduced over the past two decades; antibody inventors once received broad protection through functional claims, but the Patent and Trademark Office (PTO) has raised its requirements, partially in response to repeated invalidations of antibody genus claims at the Federal Circuit (see Chiron v. Genentech, 2004, Centocor v. Abbott, 2011, and AbbVie v. Janssen, 2014).

The decision in Amgen continues the trend of narrowing antibody patents and the perceived trend of limiting genus claims. Thus, how impactful Amgen will be on its own remains uncertain. Does it add new constraints to the patentability of antibodies, small molecules, and chemicals, or does it merely recapitulate the Federal Circuit’s previous rulings? This post reviews that debate. Part I examines how scholars and attorneys have reacted to Amgen, focusing on whether they think the case will have a legal and practical impact. Part II synthesizes these perspectives, arguing that Amgen’s direct impact will be limited. A companion piece summarizing the ruling’s significance for the industry and innovation will follow.

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Strasbourg, France - April 13, 2018: the Hemicycle of the Parliamentary Assembly of the Council of Europe, PACE.

The Parliamentary Assembly of the Council of Europe: Responding to Public Health Emergencies by Upholding Human Rights, Democracy, and the Rule of Law

The Petrie-Flom Center Staff Leave a comment

By Anita Gholami

The Parliamentary Assembly of the Council of Europe, which brings together parliamentarians from 46 member States, has been a vigilant guardian of respect for the European Convention on Human Rights and other international standards throughout the COVID-19 pandemic. The Assembly has adopted a number of resolutions and recommendations seeking to equip parliaments in our European member States and beyond with the relevant tools and expertise to uphold human rights, democracy and the rule of law. It has been an important forum for enabling States to address the fault lines in national public health systems, bridge gaps in global health security and policy, and strengthen collective efforts to build back better.

In June 2023, the Assembly adopted Resolution 2500 (2023) on “Public health emergency: the need for a holistic approach to multilateralism and health care.” The report supports the ongoing processes taking place at the international level to transform global health governance. It considers that States must build on the principles of equity and the protection of human rights and fundamental freedoms during public health emergencies, and thus makes specific and productive reference to the Principles and Guidelines on Human Rights and Public Health Emergencies (“the Principles”).

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Shot of a landline telephone receiver hanging upside down.

Addressing Ghost Networks in Mental Health Care

Hannah Rahim Leave a comment

By Hannah Rahim

Many mental health provider directories for private and public insurance plans contain inaccurate or outdated provider information, which creates a misleading illusion of accessible care. These ghost networks result in many patients being unable to access essential mental health care. To tackle this issue, federal and state governments should strengthen the regulation of insurance networks and insurers should address underlying causes of inadequate networks.

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hospital equipment

Scarcity Is Not an Excuse to Discriminate: Age and Disability in Health Care Rationing

The Petrie-Flom Center Staff Leave a comment

By Silvia Serrano Guzmán

On July 4, 2023 the Constitutional Court of Colombia handed down a landmark decision on one of the most difficult dilemmas faced during the COVID-19 pandemic: the rationing of intensive care in situations of scarcity. Although the need for prioritization was a reality almost globally, many countries had no such regulation in place, which frequently led to the adoption of fragmented and discriminatory triage protocols.

The Colombian case reinforces that human rights and public health are not mutually exclusive. Importantly, this is reflected in the Principles and Guidelines on Human Rights & Public Health Emergencies (2023). Though the Principles did not exist during the litigation of the case, they will be of use in similar instances going forward, both for States working to develop human rights-compliant public health measures, as well as for courts reviewing such measures.

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3D illustration of a Renaissance marble statue of Zeus, king of the gods, who was also the god of the sky and thunder. Zeus in Greek mythology is known as Jupiter in Roman mythology.

Data Pseudonymization and POPIA

Donrich Thaldar Leave a comment

By Donrich Thaldar

Just as Zeus, the King of the Gods in Greek mythology, assumed various forms to conceal his true identity, so does modern data often undergo transformations to mask its origins. Zeus could become a swan, a bull, or even golden rain to achieve his purposes — all while maintaining his essence. Similarly, pseudonymization techniques aim to alter data enough to protect individual privacy without losing the core information necessary for research or analysis. This entails replacing data subjects’ identifying information in a dataset with unique codes, while keeping another dataset that links these data subjects’ identifying information with their allocated codes. Therefore, just as Zeus’ transformations were sometimes seen through by keen eyes, pseudonymized data can be re-identified by those having access to the linking dataset.

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Person hands keys into another person's outstretched hand.

We May Not ‘Own’ Our Bodies. Should We?

Adithi Iyer Leave a comment

By Adithi Iyer

As the provision of human tissue leaves the research realm and becomes a bona fide consumer transaction, our legal responses to these developments will be most effective when we know what we want to protect, and how.

Perhaps the most famous discussion around tissue “donation” comes from the story of Henrietta Lacks and her family. Ms. Lacks is the namesake and unknowing donor of HeLa cells, and subject of the Rebecca Skloot bestseller, The Immortal Life of Henrietta Lacks. In a settlement obtained just this past summer with manufacturing giant ThermoFisher, the Lacks estate (Ms. Lacks herself died of an aggressive cervical cancer in 1951) obtained a confidential payment for the unconsented taking of her cells for research. The settled case was built on an unjust enrichment claim, and while this wasn’t decided on the merits, it raises the question of whether a provision of tissue is a transfer of value. If so, what are our ownership stakes in that value? Read More

Person filling syringe from vial.

Public Health Emergencies and Human Rights Principles: A Solidarity Approach

The Petrie-Flom Center Staff Leave a comment

By Anne Kjersti Befring and Cecilia Marcela Bailliet

  1. Introduction

The COVID-19 pandemic posed a grave threat to humanity and revealed the need for a new approach to improve transnational cooperation within the global health system and new perspectives on solidarity addressing the cross-border spread of infection and distribution of vaccines.

The Principles and Guidelines on Human Rights and Public Health Emergencies (“the Principles”), developed by the Global Health Law Consortium and the International Commission of Jurists, set forth a human rights-based solidarity approach that can provide a basis for implementing the obligations of States and responsibilities of Non-State actors to achieve the goal of limiting the harmful effects of serious health crises.

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Hundred dollar bills rolled up in a pill bottle

Ketamine Is the New Viagra

Vincent Joralemon Leave a comment

By Vincent Joralemon

Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Johnson & Johnson’s ketamine-based formulation generated $183 million in Q3, surpassing Pfizer’s erectile dysfunction (ED) drug, which earned $110 million over the same period. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals. 

Yet, these two drugs have more in common than meets the eye, and the path Spravato has taken looks strangely similar to that of Viagra. By looking at the journey traversed by Viagra over the past twenty years, we can predict where Spravato (and other psychedelic therapies) are headed.

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Group of Diverse Kids Playing in a Field Together.

Securing a Place for Children’s Rights in Public Health Emergencies

The Petrie-Flom Center Staff Leave a comment

By Sheila Varadan, Ton Liefaard, and Jaap Doek

The Principles and Guidelines on Human Rights and Public Health Emergencies (Principles) make a significant contribution towards clarifying the scope of States’ legal obligations under international human rights law during public health emergencies. What is missing, however, is a specific and detailed discussion on the rights obligations and principles owed to children during public health emergencies. This leaves open the question of how States will guarantee respect for and protection of children’s rights in future public health emergencies, and what measures, if any, will be taken to ensure children are actively listened to and engaged with in the prevention of, preparedness for, and response to public health emergencies (PPRR).

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