Category: Professional Regulation

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Bioethics, Psychedelic Therapy Abuse, and the Risk of Ethics Washing

The Petrie-Flom Center Staff Leave a comment

By Tehseen Noorani and Neşe Devenot

Introduction

The academic discipline of bioethics is becoming a prominent arena for the discussion of ethics abuses in psychedelic therapy. With this being a relatively new topic of research for bioethics, it may be opportune to consider blind spots in the discipline’s own gaze and operations, which can otherwise hinder effective engagement with the issues at hand. We write in the wake of an extensive search by Gather Well Psychedelics, a psychedelic therapy training organization, to contract professional bioethicists to conduct an ethics audit of their organization. We ask, what challenges arise for bioethicists offering professional services when taking on commissions to work for organizations such as Gather Well that are emerging out of the psychedelic underground?

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Introductory Editorial — Critical Psychedelic Studies: Correcting the Hype

The Petrie-Flom Center Staff Leave a comment

By Neşe Devenot

Since the 2022 publication of “Preparing for the Bursting of the Psychedelic Hype Bubble,” a JAMA Psychiatry Viewpoint by David Yaden and colleagues, a wave of scholarship and commentaries has emphasized the ethical importance of nuanced science communication about the still-nascent field of psychedelic medicine.

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Newspapers and Laptop.

AI, Copyright, and Open Science: Health Implications of the New York Times/OpenAI Lawsuit

Adithi Iyer Leave a comment

By Adithi Iyer

The legal world is atwitter with the developing artificial intelligence (“AI”) copyright cage match between The New York Times and OpenAI. The Times filed its complaint in Manhattan Federal District Court on December 27 accusing OpenAI of unlawfully using its (copyrighted and paywalled) articles to train ChatGPT. OpenAI, in turn, published a sharply-worded response on January 8, claiming that its incorporation of the material for training purposes squarely constitutes fair use. This follows ongoing suits by authors against OpenAI on similar grounds, but the titanic scale of the Times-OpenAI dispute and its application of these issues to media in federal litigation makes it one to watch. While much of the buzz around the case has centered on its intellectual property and First Amendment implications, there may be implications for the health and biotech industries. Here’s a rundown of the major legal questions at play and the health-related stakes for a future decision.

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The NCAA May Pay a Healthy Sum to Student Athletes

Bobby Stroup Leave a comment

By Bobby Stroup

Right now in a Los Angeles courtroom, the fate of the NCAA hangs in the balance. Perhaps as a way to preempt the outcome, on December 6, NCAA President Charlie Baker sent a letter proposing some schools should be allowed to compensate student athletes for using their name, image and likeness (NIL). President Baker is right to try and get ahead of the student-athlete compensation issue, but NIL payments are not the only issue at play. Health care will also be a critical part of future student-athlete compensation conversations.

The NCAA describes the compensation lawsuits as beginning in 2009, yet exploring this topic reveals the debate is not so novel. The NIL terminology is newer, but limiting this to an NIL problem is overly narrow. The challenge of student-athlete compensation is a broader issue that started at the founding of the organization. This issue is rooted in more than a century of health policy, and understanding that history is essential to understanding future NCAA negotiations.

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Torso of doctor in white coat with hands displaying in between them a rendering of an antibody.

The SCOTUS Antibody Ruling Has an Uncertain Impact for Drug Makers and Patients

Timothy Bonis Leave a comment

How Amgen v. Sanofi will affect innovation and the pharmaceutical industry.

By Timothy Bonis

Millions of patients rely on monoclonal antibodies. The global market in 2022 was $210B with a compound annual growth rate of 11 percent. Monoclonal antibody patents are now some of the world’s most valuable intellectual property.

Monoclonal antibody patent law has been in turmoil for the past two decades. The Court of Appeals for the Federal Circuit (the “Federal Circuit”) has repeatedly raised the standards for antibody patents, forcing patentees to rethink how they protect their inventions. In April 2023, the increasingly stringent standards of the Federal Circuit were affirmed by the Supreme Court. In Amgen v. Sanofi, the justices unanimously upheld the invalidation of two antibody patents, potentially transforming patent law across biotech.

This post reviews the emerging post-Amgen literature, distilling the ruling’s likely impact on innovation and the pharmaceutical industry. A companion post addresses the ruling’s legal significance.

This post has three parts. Part I describes monoclonal antibodies and why Amgen is important. Parts II and III address innovation, first by discussing whether Amgen is reflective of modern antibody science and second by exploring how the ruling may affect the pharmaceutical industry.

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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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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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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

President Joe Biden at desk in Oval Office.

What’s on the Horizon for Health and Biotech with the AI Executive Order

Adithi Iyer Leave a comment

By Adithi Iyer

Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. This is perhaps unsurprising— the health sector touches almost every other aspect of American life, and of course continues to intersect heavily with technological developments. AI is particularly paradigm-shifting here: the technology already advances existing capabilities in analytics, diagnostics, and treatment development exponentially. This Executive Order is, therefore, as important a development for health care practitioners and researchers as it is for legal experts. Here are some intriguing takeaways:  Read More

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The Privatization of Cancer

Daniel G. Aaron 2 Comments

By Daniel G. Aaron

Cancer is fearsome, unstoppable even. So the story goes. Yes, you can secure some extra time with loved ones, and — if you are lucky —  maybe your cancer is susceptible to drugs or surgery. But for most people, cancer sounds like a death sentence. The proper response is to throw drugs and radiation at it.

Cancer seems so unstoppable that many have started rifling through their cosmetic products and foods to eliminate all possible carcinogens. Despite the fact we have regulatory regimes to ensure our food, makeup, the air, and drinking water are free of carcinogens, people don’t trust them. There is an intuitive sense that products are not well regulated, leaving individuals to moderate their own cancer risk. In fact, the majority of Americans do not hold strong trust in our health agencies like FDA and CDC.

In my forthcoming article, I argue that our cancer regulatory regimes inadequately protect the public. I believe deregulation is one form of the “privatization of cancer.”

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