blue brain hovers over bright blue circle.

Is OI the New AI? Questions Surrounding “Brainoware”

By Adithi Iyer

The idea of artificial intelligence is just seeping into our collective consciousness, but as we watch new developments in the space, the true “new kid on the block” may be a new type of infused human-technology intelligence — one derived from a blob of cells no larger than a grain of rice. These new units of computational prowess are brain organoids, grown in-lab and capable of producing very basic, but real-time, neurological activity. Brain organoids are a specific, and arguably the most interesting, subset of organoid models that are just beginning to enter legal debates.

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Culturing cells in tissue culture plates.

R&D Mini-Me? New Legal Questions for Organoids

By Adithi Iyer

I have written previously about the not-so-distant possibility and promise of regenerative medicine, an area concerned with therapies that encourage the body to repair or heal itself. Cell-mediated and tissue-based technologies hold promise in inducing self-repair from within the body, and they’re making their way to market in traditional medicine. Much has been made of recently discussed CAR-T cell therapies for cancer, which have been around since 2017, and in-human sickle cell treatment Casgevy. Such applications of regenerative medicine and tissue engineering are wide-spanning and range across the bench-to-bedside pathway.

One application of regenerative medicine gaining some ground in the R&D space is the organoid. Organoids are lab-grown masses of cells and tissue that assemble to form miniature organs or organ systems in vitro. They come, too, in different forms and types, and while some organoid applications are heavily modified for specific functions, many are meant to recreate and model the naturally occurring organ systems we would find in our own bodies.

Organoids may sound especially futuristic, but are currently used regularly in labs for different research and therapeutic applications. A functional “organ” model not attached to a human body could offer the opportunity to model diseases and test treatments in real time without the need for an animal model (like the mice used today), especially in preclinical and early clinical trials for new drugs. Organoids generate information and data, and a single organoid model can even be hooked up to a “system” with other organoids to model systems and interrelated processes at once. The production of these models occurs in-lab, often involving stem cells that can divide and organize into tissues and organs on their own.

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cell with pipette and needle.

Are Embryos Children? The Alabama Supreme Court Says Yes

By Joelle Boxer

This month, the Alabama Supreme Court held that the term “children” in a state statute includes embryos, or “extrauterine children.”

As fertility treatments like in vitro fertilization (IVF) involve the creation of multiple embryos, not all of which are implanted, the implications of this ruling could be far-reaching. Four million births each year in the U.S. are via IVF, an important pathway to parenthood for couples with infertility, LGBTQ couples, and single parents.

This article will examine the Alabama Supreme Court’s decision in LePage v. Mobile Infirmary Clinic and its consequences for Americans building their families through fertility services.

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Birmingham, Alabama - February 8, 2020: University of Alabama at Birmingham UAB Hospital title and logo on brick facade.

The Beginning of a Bad TRIP – Alabama’s Embryonic Personhood Decision and Targeted Restrictions on IVF Provision

By Katherine L. Kraschel

Last week, the Alabama Supreme Court called frozen embryos created via in vitro fertilization (IVF) “extrauterine children” and referred to the cryotanks where they are stored as  “cryogenic nurser(ies).” The Court sided with couples who claim the accidental destruction of frozen embryos created through IVF and cryopreserved ought to be treated equally to the death of a child. 

The case, LePage v. Center for Reproductive Medicine, involves plaintiffs seeking punitive damages from an Alabama fertility clinic for the “wrongful death” of their embryos that were destroyed when a patient in the hospital where they were stored removed them from the cryotank. While the lower Alabama Courts concluded that the cryopreserved embryos were not a person or child under the state’s law, the Alabama Supreme Court disagreed and held that the state’s Wrongful Death of a Minor Act “applies to all unborn children, regardless of their location,” and that the  plaintiff’s wrongful death claims could proceed. 

Thoughtful scholars have argued that existing state laws do not sufficiently redress mistakes and accidents that occur in the process of fertility care, pregnancy, and birth. However, the ends do not justify the means in this case; likening frozen embryos to children is not a legally sound mechanism to hold fertility clinics accountable for negligently storing embryos. It illustrates how sympathetic stories can be used to further the agendas of those who seek to equate embryos and fetuses  to “people” under the law and undercut the critical role modern fertility care plays in (re)defining the bonds that create families, and particularly, many LGBTQ+ and single parent families. 

Specifically, lawmaking in fertility care stands to fuel the movement to create fetal personhood rights and a federal abortion ban. It may also signify an inflection point in regulating assisted reproduction reminiscent of pre-Dobbs targeted restrictions on abortion provider (TRAP) laws that sought to limit abortion provision by imposing restrictions. TRAP laws’ new sibling – targeted restrictions on IVF Provision – or TRIP laws, as I call them, stand to rob patients of their ability to build their families by compelling physicians to provide less effective, more expensive care. TRIP laws will erect barriers and exacerbate long standing racial disparities in accessing fertility care, and they will disproportionately impact members of the LGBTQ+ community who wish to build families through fertility treatments.  The Alabama decision is severe, but it should serve as a warning to state legislators with a new responsibility to safeguard reproductive health care without the floor of Roe’s protections – proceed with extreme care and regard for “unintended” consequences of regulating fertility care.  Read More

Newspapers and Laptop.

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

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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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

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

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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Person hands keys into another person's outstretched hand.

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

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

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

Double exposure of abstract digital world map on laptop background.

Harmonizing Africa’s Data Governance: Challenges and Solutions

By Donrich Thaldar

The establishment of a single data market across African nations promises significant socio-economic advantages, facilitating unrestricted and fluid data exchange. This concept has captured the attention of political leaders and has been prominently featured in the African Union’s (AU) Digital Transformation Strategy for Africa, as well as the AU’s Data Policy Framework. Further, entities like Smart Africa are actively championing the cause of creating an African single data market.

To transform the vision of an African single data market into reality, and to unlock its potential benefits for the continent’s populace, establishing regulatory alignment is paramount. This necessitates the integration of markets, the implementation of uniform online payment systems, the standardization of taxation and duties, and cross-border trade facilitation. This article delves into two critical legal dimensions of cross-border trade facilitation: data privacy and data ownership.

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