Moderna’s U.K. Vaccine Patent Pledge Cut Short by Boilerplate

By Jorge L. Contreras

On July 2, 2024, the High Court of the United Kingdom issued a decision in Moderna’s mRNA vaccine patent litigation against Pfizer and BioNTech. As I previously discussed in October of 2020, Moderna pledged not to enforce its patents against makers of COVID-19 vaccines during the pandemic. Then, in 2022, Moderna sued competing vaccine makers Pfizer and BioNTech.  Pfizer/BioNTech responded that Moderna’s pledge authorized them to practice the asserted patents, at least until the end of the World Health Organization (WHO)-declared pandemic, which occurred in May 2023. Last week, however, the U.K. court found that the “forward-looking statement” boilerplate routinely appended to press releases of U.S. public companies permitted Moderna to revoke its pledge before the end of the pandemic, and that Moderna successfully did so in March 2022.

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Artificial Intelligence Plus Data Democratization Requires New Health Care Framework

By Michael L. Millenson

The latest draft government strategic plan for health information technology pledges to support health information sharing among individuals, health care providers and others “so that they can make informed decisions and create better health outcomes.”

Those good intentions notwithstanding, the current health data landscape is dramatically different from when the organizational author of the plan, the Office of the National Coordinator for Health IT, formed two decades ago. As Price and Cohen have pointed out, entities subject to federal Health Insurance Portability and Accountability Act (HIPAA) requirements represent just the tip of the informational iceberg. Looming larger are health information generated by non-HIPAA-covered entities, user-generated health information, and non-health information being used to generate inferences about treatment and health improvement.

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Q&A: George Church on Genomics of Cognitive Enhancement

Interviewed by William Leonard Pickard

George Church, PhD, is the Robert Winthrop Professor of Genetics at Harvard Medical School, Professor of Health Sciences and Technology at Harvard University and the Massachusetts Institute of Technology. He is a founding member of the Wyss Institute for Biologically Inspired Engineering at Harvard.

His research efforts include the first direct genome sequencing method, collaborating in initiating the Human Genome Project, and creating the Personal Genome Project. He co-founded over 50 biotechnology companies as spin-offs from the Church Lab, including Veritas Genetics, Rejuvenate Bio, and Nebula Genomics. Church began Colossal Biosciences to de-extinct the woolly mammoth.

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New Portable MRI Revolutionizing Brain Research Demands Ethical and Legal Innovation

by Francis X. Shen, Susan M. Wolf, and Frances Lawrenz

The advent of highly portable MRI will transform brain research, but urgently requires ethical and legal guidance.

Rather than participants traveling to the MRI scanner, now the scanner can travel to them. This advance could enable research with remote and marginalized communities that have not previously been able to participate, and in doing so address the lack of representativeness and diversity in human neuroscience research.

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Cell Therapies and their Legal Discontents

In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.

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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

 

 

 

By Suzan Slijpen, Mauritz Kop & I. Glenn Cohen

 

 

 

1. Introduction: A Fragmented AI in Healthcare Regulatory Landscape

In the past few years, we have witnessed a surge in artificial intelligence-related research and diagnostics in the medical field. It is possible that in some fields of medicine in the future AI tools used in diagnostics will generally perform far better than a human clinician. Prime examples of this can be found in radiology, particularly in the detection -and even the prediction- of malignant tumors.

Although the actual development of a clinically usable, deployable deep-learning algorithm is a challenge in and of itself, we have moved from an early period where there was not enough guidance as to ethical and other issues to an era where many guidelines have proliferated. While one might ordinarily say “let a thousand flowers bloom,” the fact that they partially overlap, sometimes diverge, and are often written at different levels of generality make it difficult for well-meaning companies to keep up. This is specifically the case for innovative firms who aim to bring their product into the European market.

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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