Digital Commons Network^™

The Reckoning: The Return Of Genomic Results To 1444 Participants Across The Emerge3 Network, Ellen W. Clayton, Kathleen A. Leppig, Et Al.

Vanderbilt Law School Faculty Publications

The goal of Electronic Medical Records and Genomics (eMERGE) Phase III Network was to return actionable sequence variants to 25,084 consenting participants from 10 different health care institutions across the United States. The purpose of this study was to evaluate system-based issues relating to the return of results (RoR) disclosure process for clinical grade research genomic tests to eMERGE3 participants.

Science Fiction And The Law: A New Wigmorian Bibliography, Jorge L. Contreras

Utah Law Faculty Scholarship

In 1908, Dean John Henry Wigmore compiled a list of novels that no lawyer could “afford to ignore”. Wigmore’s list, taken up by Professor Richard Weisberg in the 1970s, catalogs one hundred novels, stories and dramatic works from Antigone to The Merchant of Venice to Native Son, each of which portrays or offers insight into the legal system or the practice of law. Weisberg’s updated list also includes a compilation of critical studies in the then-emerging law and literature movement. This article undertakes a similar bibliographic exercise with respect to law and the literature of science fiction. While science fiction, …

The Normative Molecule: Patent Rights And Dna, Saurabh Vishnubhakat

Faculty Scholarship

Throughout the biotechnology age, fears about the distortionary effects of property and other legal institutions upon the health and self-determination of individuals and societies have accompanied more popularly sensational fears about unscrupulous choices within the scientific community itself. Still, for most of that time the prevailing legal regime both in the United States and in Europe remained generally permissive of ownership of, and exclusionary power over, the fruits of much biomedical research, though this leniency took different forms and came about in different ways. In particular, the policy of the United States Patent and Trademark Office to grant patents on …

Frontiers In Precision Medicine Iv: Artificial Intelligence, Assembling Large Cohorts, And The Population Data Revolution, Adam Bress, Rich Albrechtsen, Monika Baker, Jorge L. Contreras, Zachary Fica, Austin Gamblin, Chelsea Ratcliff, Bianca E. Rich, Matt A. Szaniawski, Alyssa Thorman, Chad Vansant-Webb, Willard Dere

Utah Law Faculty Scholarship

Large cohort studies and more recently electronic medical records (EMR) are being used to collect massive amounts of genetic information. Implementation of artificial intelligence has become increasingly necessary to interpret this data with the goal of augmenting patient care. While it is impossible to predict what the future holds, policy makers are challenged to create guiding principles and responsibly roll out these new technologies. On March 22, 2019, the University of Utah hosted its fourth annual Precision Medicine Symposium focusing on artificial intelligence, assembling large cohorts, and the population data revolution. The symposium brought together experts in medicine, science, law …

Addiction As Disease, Teneille R. Brown

Utah Law Faculty Scholarship

The opioid addiction epidemic is the most overwhelming public health crisis our country has faced. It is now creating a legal crisis, as the its poisonous fruits spill over into the criminal, tort, and family courts. The epidemic costs the U.S. economy about $500 billion every year, and the pressure is crippling our legal systems. This Article is an attempt to relieve some of that pressure, by advocating for a comprehensive public health campaign based upon a new model of addiction. Research shows that the prevalent “moral choice” model of addiction has facilitated stigma and discouraged treatment, by viewing affected …

Liability Rules For Health Information, Jorge L. Contreras, Francisca Nordfalk

Utah Law Faculty Scholarship

The recent trend toward propertization of health data could pose significant challenges to biomedical research and public health. Property rule systems can result in sizable up-front costs in the acquisition of consent from individual data subjects, as well as the ongoing risk that data subjects will retract consent or object to unanticipated data uses, thus compromising existing data resources and analyses. We argue that property-based approaches to health data should be rejected in favor of liability rule frameworks for the protection of individual privacy interests. We demonstrate that liability rule frameworks for data governance are not only desirable from a …

How Does A Radical Lesbian Feminist Who Just Knows How To Holler Somehow Become A Noted Legal Scholar, Nancy Polikoff

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Patent Protection For Crispr: An Elsi Review, Jacob S. Sherkow

Articles & Chapters

The revolutionary gene-editing technology, CRISPR, has raised numerous ethical, legal, and social concerns over its use. The technology is also subject to an increasing patent thicket that raises similar issues concerning patent licensing and research development. This essay reviews several of these challenges that have come to the fore since CRISPR’s development in 2012. In particular, the lucre and complications that have followed the CRISPR patent dispute may affect scientific collaboration among academic research institutions. Relatedly, universities’ adoption of “surrogate licensors” may also hinder downstream research. At the same time, research scientists and their institutions have also used CRISPR patents …

Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow

Other Publications

Several research institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved. But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of licensing agreements with commercial enterprises. With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or "surrogate" company formed by the institution …

Molecular Measurement Of Toxicity In Fish; Case Examples And Policy Implications, Jessica A. Freedman

Senior Honors Projects

Stormwater and oil are common urban contaminants that can be harmful to fish species. One way of recognizing exposed and impaired fish is by monitoring gene expression and gene induction. This study focused on the identification and validation of reference genes for measuring contaminant-induced changes in gene expression due to urban influence. In this study, reference genes (which are genes used to normalize data and remain consistent in varying exposures regardless of organism and tissue type) were established. Six genes were identified as reference genes (ef1a, wdtc1, mtm1, spop, rxrba and tuba1) from a longer list of potential …

Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow

Other Publications

New gene-editing technologies, like CRISPR, promise revolutionary advances in biology and medicine. However, several patent disputes in the USA and UK may have complicated who can use CRISPR. What does this mean for the future of gene editing?

Diagnostics Need Not Apply, Rebecca S. Eisenberg

Articles

Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …

Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow

Articles & Chapters

Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.

Genome-editing technology based on clustered, regularly interspaced, short palindromic repeats (CRISPR) and CRISPR associated protein 9 (Cas9) has generated great excitement in both academia and industry. But a potential patent dispute between two sets of inventors has left the biotech community pondering its fate. Understanding several facets of patent law and history may provide some lessons about the probable — and best — outcome for the dispute.

The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman

Faculty Works

Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …

Science And The New Rehabilitation, Meghan J. Ryan

Faculty Journal Articles and Book Chapters

Rehabilitation’s making a comeback. Long thought to be an outdated approach to punishment, rehabilitation is reemerging in the wake of scientific advances. Not only have these advances in the fields of pharmacology, genetics, and neuroscience brought new rehabilitative possibilities, but the media’s communication of these advances to the general public have set the stage for rehabilitation’s reprise. The media constantly pummels the general public with reports of scientific breakthroughs like functional magnetic resonance imaging, prepping the public to be more accepting of deterministic viewpoints and to be more open to the possibility of transforming individuals. The rehabilitation that is emerging, …

The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely

Articles & Chapters

The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply …

Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott

Articles & Chapters

Myriad took no prisoners on its way to the top of the molecular diagnostics field. That strategy is unlikely to endure.

Myriad Genetics began in 1991 as a small University of Utah startup interested in the then-novel arena of diagnostic genetic testing. After winning a highly publicized race to sequence the BRCA1 and BRCA2 breast cancer genes, the company obtained patents on the gene sequences and methods of using them to determine cancer risk. The patents were broad and interlocking, covering BRCA genomic DNA, cDNA, methods of diagnosis and systems detecting mutations. Myriad also filed for diagnostic 'toolbox' patents, including …

Finding Fault?: Exploring Legal Duties To Return Incidental Findings In Genomic Research, Elizabeth R. Pike, Karen H. Rothenberg, Benjamin E. Berkman

Faculty Scholarship

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must …

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

Understanding Insurance Anti-Discrimination Laws, Ronen Avraham, Kyle D. Logue, Daniel Schwarcz

Articles

Insurance companies are in the business of discrimination. Insurers attempt to segregate insureds into separate risk pools based on the differences in their risk profiles, first, so that different premiums can be charged to the different groups based on their differing risks and, second, to incentivize risk reduction by insureds. This is why we let insurers discriminate. There are limits, however, to the types of discrimination that are permissible for insurers. But what exactly are those limits and how are they justified? To answer these questions, this Article (a) articulates the leading fairness and efficiency arguments for and against limiting …

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

All Faculty Scholarship

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Neuroscience And The Future Of Personhood And Responsibility, Stephen J. Morse

All Faculty Scholarship

This is a chapter in a book, Constitution 3.0: Freedom and Technological Change, edited by Jeffrey Rosen and Benjamin Wittes and published by Brookings. It considers whether likely advances in neuroscience will fundamentally alter our conceptions of human agency, of what it means to be a person, and of responsibility for action. I argue that neuroscience poses no such radical threat now and in the immediate future and it is unlikely ever to pose such a threat unless it or other sciences decisively resolve the mind-body problem. I suggest that until that happens, neuroscience might contribute to the reform of …

What Real-World Criminal Cases Tell Us About Genetics Evidence, Deborah W. Denno

Faculty Scholarship

This Article, which is part of a symposium on "Law and Ethics at the Frontier of Genetic Technology," examines an unprecedented experimental study published in Science. The Science study indicated that psychopathic criminal offenders were more likely to receive lighter sentences if a judge was aware of genetic and neurobiological explanations for the offender’s psychopathy. This Article contends that the study’s conclusions derive from substantial flaws in the study’s design and methodology. The hypothetical case upon which the study is based captures just one narrow and unrepresentative component of how genetic and neurobiological information operates, and the study suffers from …

Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Journal Articles

This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …

Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations, Karen H. Rothenberg, Lynn W. Bush

Faculty Scholarship

Transformative innovations in medicine and their ethical complexities create frequent confusion and misinterpretation that color the imagination. Placed in historical context, theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped -- and been shaped by -- personal and professional relationships. The drama of these human interactions is powerful and has the potential to generate fear, create hope, transform identity, and inspire empathy -- a vivid source to observe the complex implications of translating research into clinical practice through …

Reexamining Models Of Disability And Applying Rationality, Morality, And Ethics To Support Disability Rights In Context Of Genetics, Gary C. Norman

Articles in Law Reviews & Journals

The author discusses genetic and assistive reproduction science and technology in light of their impact on people with disabilities. Specifically, he focuses on the prism of the models through which disability is recognized. If applied in a manner such that the best facets of both models of disability can bear forth, then the position of the author, a person with a vision disability, is that his colleagues in the disability civil rights movement should not reflexively excoriate genetic and assisted reproduction science and technology. However, safeguarding people with disabilities, who are a discrete and insular minority across the globe, against …

From Eugenics To The "New" Genetics: "The Play's The Thing", Karen H. Rothenberg

Faculty Scholarship

Genetics occupies a place in the public imagination with which few areas of science can compete. It is popularly understood to be the “science of life,” concerned with the essence of humanity: a subject that generates both awe and fear. These divergent emotions are encapsulated in the “promise versus peril” debate: the promise of an end to human disease is countered by the peril embodied in the discriminatory capacity of genetic essentialism. This debate has become ingrained in popular culture, and its dramatic potential has been effectively realized in theatre.

Plays have always been written and performed as expressions of …

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research, Michael J. Malinowski

Journal Articles

No abstract provided.

Human Identity: The Question Presented By Human-Animal Hybridization, Jospeh Vining

Other Publications

What makes each of us, as individuals, human to one another, or, more generally, what makes an individual creature human? We have not often had to ask the question because of the species line based on reproductive capacity and incapacity, although "degrees of humanness" were explored in the various eugenic programs of the last century. Now the biotechnological possibility of fusing human and other forms of life is presenting the question in a new and serious way. If the traditional biological means of defining species are no longer reliable, what other criteria might determine what is "human" and what is …

Necessary Subjects: The Need For A Mandatory National Donor Gamete Registry, Naomi R. Cahn

GW Law Faculty Publications & Other Works

This brief article calls for a mandatory national donor gamete registry. It first discusses the history of secrecy in the adoption context before turning to issues involving confidentiality in the donor context. After analyzing the issues involved in maintaining the secrecy of donor gametes, the article ultimately recommends the establishment of a national information registry, similar to that in place in numerous other countries, to keep track of children both through donor egg, embryo, and sperm, as well as the identities of the gamete providers. Participation in the registry would be mandatory for anyone involved in supplying donor gametes. Once …