Professor Ryan Abbott


Professor of Law and Health Sciences
MD, JD, MTOM, PhD

Academic and research departments

School of Law.

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Publications

Ryan Abbott (2024)Reflections on Thaler v Comptroller-General and the Use of Artificial Intelligence in Research and Development, In: European intellectual property review Sweet and Maxwell
Ryan Abbott, Alex F. Sarch (2019)Punishing Artificial Intelligence: Legal Fiction or Science Fiction, In: SSRN Electronic Journal

Whether causing flash crashes in financial markets, purchasing illegal drugs, or running over pedestrians, AI is increasingly engaging in activity that would be criminal for a natural person, or even an artificial person like a corporation. We argue that criminal law falls short in cases where an AI functionally commits a crime and there are no practically or legally identifiable upstream criminal actors. This Article explores potential solutions to this problem, focusing on holding AI directly criminally liable where it is acting autonomously and irreducibly. Conventional wisdom holds that punishing AI is incongruous with basic criminal law principles such as the capacity for culpability and the requirement for a guilty mind. Drawing on analogies to corporate and strict criminal liability, as well as familiar imputation principles, we show AI punishment cannot be categorically ruled out with quick theoretical arguments. AI punishment could result in general deterrence and expressive benefits, and it need not run afoul of negative limitations such as punishing in excess of culpability. Ultimately, however, punishing AI is not justified, because it might entail significant costs and it would certainly require radical legal changes. Modest changes to existing criminal laws that target persons, together with potentially expanded civil liability, are a better solution to AI crime.

Ryan Abbott (2022)Rational Robots: A Response to Interesting, Renegotiated, and Relational Robots, In: Jerusalem review of legal studies25(1)pp. 40-53 Oxford University Press
Ryan Abbott (2022)Intellectual property and artificial intelligence: an introduction, In: Ryan Abbott (eds.), Research Handbook on Intellectual Property and Artificial Intelligencepp. 2-21 Edward Elgar Publishing
Ryan Abbott, Rita Matulionyte, Paul Nolan (2021)A brief analysis of DABUS, Artificial Intelligence, and the future of patent law, In: Intellectual property forum125pp. 10-16

Artificial Intelligence ("AI") is really doing some very exciting things these days - from making music that sounds vaguely like Katy Perry made it, to writing books that are almost worth reading for novelty's sake. AI is doing some less practical things like dominating people at conventional board games, but it has also been engaged in scientific developments. For instance, in November 2020, the company DeepMind created an AI that outperformed human teams at predicting 3D protein folding structure from a 2D sequence. This was interesting for a number of reasons. From a medical point of view, predicting protein folding can be a critical component of drug discovery. From a legal point of view, this sort of activity is exciting because of its legal implications - including with respect to intellectual property. For instance, cases in which traditionally inventive activity is undertaken by an AI has led to challenges in acquiring a patent over such useful inventions.

Donald D. Chang, Ryan Abbott, Harris A. Eyre (2021)Converging Technologies Between the Space Mars Mission and Earth Global Mental Health, In: Harris A. Eyre, Michael Berk, Helen Lavretsky, Charles Reynolds (eds.), Convergence Mental Health: A Transdisciplinary Approach to Innovation Oxford University Press

The possibility of Space travel to Mars in our lifetime has reignited interest in aerospace medicine and mental health aspects of prolonged travel. The extended duration, tight quarters, and social aspect of Space travel have significantly but incompletely understood impact on the mental health of astronauts. As society looks to innovation to address mental health issues in Space, mental health on Earth remains a persistent and unmet need. There are ongoing efforts to advance technology to mitigate what is currently one of the largest burden of disease worldwide. How does one reconcile the challenges of mental health in longterm Space travel with that in the earthbound population? Fortunately, these apparently separate challenges are reliant on technologies that offer promising opportunities for crosspollination and bidirectional sharing of ideas. In fact, there is a rich history of Space technologies helping to address challenges on Earth so there is a precedent for this translation.

RB Abbott, R Bader, L Bajjali, TA Elsamen, T Obeidat, H Sboul, M Shwayat, I Alabbadi (2012)The price of medicines in Jordan: The cost of trade-based intellectual property, In: Journal of Generic Medicines9(2)pp. 75-85 Sage

Jordan dramatically strengthened the level of intellectual property protection it provides for pharmaceutical products in consequence of joining the World Trade Organization in 2000 and signing a Free Trade Agreement with the United States in 2001. This study assesses the impact of higher levels of intellectual property protection on access to medicines by quantifying the effects on the private retail pharmaceutical market of delayed market entry of generic products. Adjusted for increased sales volume and inflation, from 1999 to 2004 there was a 17% increase in total annual expenditure for medicines in Jordan. When assessing originator medicines that were marketed in both 1999 and 2004, and for which there were generic equivalents, the weighted average price of originator medicines increased while the weighted average price of equivalent generic medicines decreased. Delayed market entry of generics due to enhanced intellectual property protection is estimated to have cost Jordanian private consumers approximately 18 million U.S. dollars in 2004. Jordan should consider amending its current regulatory scheme on data protection and amending the Unfair Competition and Trade Secrets Law of 2000. Jordan should also consider increased spending on public health to offset the adverse impact on consumers of strengthening its intellectual property protection relevant to pharmaceutical products. © 2012 The Author(s).

Ryan Abbott (2019)Everything is Obvious, In: UCLA Law Review66(1)pp. 1-52 UCLA School of Law (United States)

For more than 60 years, “obviousness” has set the bar for patentability. Under this standard, if a hypothetical person skilled in the art would find an invention obvious in light of existing relevant information, then the invention cannot be patented. The skilled person is defined as a non-innovative worker with a limited knowledge-base. The more creative and informed the skilled person, the more likely an invention will be considered obvious. The standard has evolved since its introduction, and it is now on the verge of an evolutionary leap. Inventive machines are increasingly being used in research, and once the use of such machines becomes standard, the person skilled in the art should be a person using an inventive machine, or just an inventive machine. Unlike the skilled person, the inventive machine is capable of innovation and considering the entire universe of prior art. As inventive machines continue to improve, this will increasingly raise the bar to patentability, eventually rendering innovative activities obvious. The end of obviousness means the end of patents, at least as they are now.

I Alabbadi, R Abbott, D Jaber (2014)Jordanian stakeholder attitudes toward generic substitution, In: Journal of Generic Medicines11(1-2)pp. 24-34 SAGE Publications Ltd

About 10% of Jordan's gross domestic product is spent on health care, almost one-third of which is spent on pharmaceuticals. Jordan's pharmaceutical spending is a substantially higher percentage of gross domestic product than that of other developed countries. Generic substitution is a mechanism that could lower pharmaceutical spending costs in Jordan, but Jordan's domestic law currently forbids pharmacists in the private market from dispensing generic equivalents to branded medicines without a physician's approval. This article provides the results of a study that surveyed prominent organizational stakeholders (n=17, RR 100%) in Jordan's health care system and evaluates their opinions about generic substitution. The study finds there is abroad base of support for allowing and encouraging generic substitution in the private sector, and for mandating generic substitution in the public sector. Given that generic substitution may help to reduce health care costs and improve access to medicines, policymakers should consider legal and policy changes to facilitate generic substitution. The research suggests that key players in Jordan's health care system will support such proposals. © The Author(s) 2014.

Donald D. Chang, Eric A. Storch, Lance Black, Michael Berk, Neal Pellis, Helen Lavretsky, Jeffrey Sutton, Kylie Ternes, Marc Shepanek, Erin Smith, Ryan Abbott, Harris A. Eyre (2020)Promoting Tech Transfer Between Space and Global Mental Health, In: Aerospace medicine and human performance91(9)pp. 737-745 Aerospace Medical Association

INTRODUCTION: Numerous issues in mental health benefit from technological innovation. An example involves the mental health challenges of long-duration spaceflight (such as a Mars mission), including prolonged confinement, microgravity, and different sunlight exposure lengths. Persisting on Earth are global mental health challenges stemming from disease burdens, limited interview-based diagnostic systems, trial-and-error treatment approaches, and suboptimal access. There is potential for cross-pollinating solutions between these seemingly disparate challenges using a range of emerging technologies such as sensors, omics, and big data. In this review, we highlight the bidirectional value of mental health technology transfer aimed to address issues both on Earth and in space.METHODS: We prepared a systematic review of studies pertaining to mental health technological innovation and space medicine.RESULTS: For Earth mental health technologies translatable to long-duration space missions, we cite several example technologies, including device-based psychotherapy and social support, conversational agents aka chatbots, and nutritional and physical activity focused mental health. Space technologies translatable to Earth mental health include remote sensing devices, global navigation satellite systems, satellite communications, chronotherapies, and nutritional advances.DISCUSSION: There is a rich history of space technologies informing Earth technological trends, including general health care on Earth, and vice versa. To avoid the traditional happenstance approach that results in delays, missed opportunities, and increased cost, and to improve outcomes for both Earth and space utilization of these technologies, we propose increased dialogue and training opportunities to enhance innovation and outcomes.Chang DD, Storch EA, Black L, Berk M, Pellis N, Lavretsky H, Sutton J, Ternes K, Shepanek M, Smith E, Abbott R, Eyre HA. Promoting tech transfer between space and global mental health. Aerosp Med Hum Perform. 2020; 91(9):737745.

Ryan Abbott (2020)Artificial intelligence, big data and intellectual property: protecting computer generated works in the United Kingdom, In: T Aplin (eds.), Research Handbook on Intellectual Property and Digital Technologiespp. 322-337 Edward Elgar Publishing Ltd
R Abbott (2015)FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, In: Journal of Law and the Biosciences3(1)pp. 248-252 Oxford University Press
Harris A. Eyre, Andrew Robb, Ryan Abbott, Malcolm Hopwood (2019)Mental Health Innovation Diplomacy: An Under-recognised Soft Power, In: Australian and New Zealand Journal of Psychiatry Sage Publishing
Ryan Abbott, J Lack, D Perkins (2018)Managing disputes in the life sciences, In: Nature Biotechnology36(8)pp. 697-700 Nature Publishing Group

Life science company decision-makers can effectively manage disputes using appropriate dispute resolution techniques without resorting to expensive, complex, and uncertain litigation.

Jacob S. Sherkow, Ryan Abbott (2018)Fortune and Hindsight: Gene Patents’ Muted Effect on Medical Practice, In: British Medical Bulletin126(1)pp. 37-45 Oxford University Press (OUP)

Introduction: Physicians have long worried about gene patents’ potential to restrict their medical practices. Fortune and hindsight have proven these worries exaggerated both in the U.K. and elsewhere. Neither current nor future medical practices appear to be impinged by gene patents, although they may be subject to future intellectual property disputes. Sources of Data: Qualitative and quantitative (survey) studies of gene patents’ effects on medical practice; recent developments in patent law. Areas of Agreement: Traditional gene patents do not appear to have restricted medical practice in the U.K., although their effect elsewhere has been more nuanced. Areas of Controversy: Whether patents will restrict the spread of newer medical technologies is unresolved. Areas Timely for Developing Research: Continuing survey data on practitioners’ views concerning patents’ role in the distribution of newer technologies would be beneficial.

Ryan Abbott (2020)The Reasonable Robot: Artificial Intelligence and the Law Cambridge University Press

Today, artificial intelligence (AI) and people do not compete on a level playing field. From a safety perspective, AI may be the best choice for driving a vehicle, but laws often prohibit driverless vehicles. At the same time, a person may be better at packing boxes at a warehouse, but a business may automate because AI receives preferential tax treatment. Or, AI may be better at helping businesses to innovate, but these same businesses may not want to use AI if doing so restricts future intellectual property rights. In The Reasonable Robot, Ryan Abbott argues that the law should not discriminate between people and AI when they are performing the same tasks, a legal standard that will help to eliminate market distortions and to ensure that decisions are made on the basis of efficiency. This work should be read by anyone interested in the rapidly evolving relationship between AI and the law.

Ryan Abbott, DD Chang, HA Eyre, CA Bousman, D Merrill, H Lavretsky (2017)Pharmacogenetic Decision Support Tools: A New Paradigm for Late-Life Depression?, In: American Journal of Geriatric Psychiatry26(2)pp. 125-133 Elsevier

Clinicians still employ a “trial-and-error” approach to optimizing treatment regimens for late-life depression (LLD). With LLD affecting a significant and growing segment of the population, and with only about half of older adults responsive to antidepressant therapy, there is an urgent need for a better treatment paradigm. Pharmacogenetic decision support tools (DSTs), which are emerging technologies that aim to provide clinically actionable information based on a patient’s genetic profile, offer a promising solution. Dozens of DSTs have entered the market in the past fifteen years, but with varying level of empirical evidence to support their value. In this clinical review, we provide a critical analysis of the peer-reviewed literature on DSTs for major depression management. We then discuss clinical considerations for the use of these tools in treating LLD, including issues related to test interpretation, timing, and patient perspectives. There are no primary clinical trials in LLD cohorts. However, in adult populations, newer generation DSTs show promise for the treatment of major depression. Further independent and head-to-head clinical trials are required to further validate this field.

RB Abbott, KK Hui, RD Hays, MD Li, T Pan (2007)A randomized controlled trial of Tai Chi for tension headaches, In: Evidence-based Complementary and Alternative Medicine4(1)pp. 107-113 Hindawi Publishing Corporation

This study examined whether a traditional low-impact mind-body exercise, Tai Chi, affects health-related quality-of-life (HRQOL) and headache impact in an adult population suffering from tension-type headaches. Forty-seven participants were randomly assigned to either a 15 week intervention program of Tai Chi instruction or a wait-list control group. HRQOL (SF-36v2) and headache status (HIT-6™) were obtained at baseline and at 5, 10 and 15 weeks post-baseline during the intervention period. Statistically significant (P < 0.05) improvements in favor of the intervention were present for the HIT score and the SF-36 pain, energy/fatigue, social functioning, emotional well-being and mental health summary scores. A 15 week intervention of Tai Chi practice was effective in reducing headache impact and also effective in improving perceptions of some aspects of physical and mental health. © 2006 The Author(s).

RB Abbott, KK Hui, RD Hays, J Mandel, M Goldstein, B Winegarden, D Glaser, L Brunton (2011)Medical student attitudes toward complementary, alternative and integrative medicine, In: Evidence-based Complementary and Alternative Medicine2011985243 Hindawi Publishing Corporation

While the use of complementary, alternative and integrative medicine (CAIM) is substantial, it continues to exist at the periphery of allopathic medicine. Understanding the attitudes of medical students toward CAIM will be useful in understanding future integration of CAIM and allopathic medicine. This study was conducted to develop and evaluate an instrument and assess medical students' attitudes toward CAIM. The Complementary, Alternative and Integrative Medicine Attitudes Questionnaire (CAIMAQ) was developed by a panel of experts in CAIM, allopathic medicine, medical education and survey development. A total of 1770 CAIMAQ surveys (51 of US medical schools participated) were obtained in a national sample of medical students in 2007. Factor analysis of the CAIMAQ revealed five distinct attitudinal domains: desirability of CAIM therapies, progressive patient/physician health care roles, mind-body-spirit connection, principles of allostasis and a holistic understanding of disease. The students held the most positive attitude for the mind-body-spirit connection and the least positive for the desirability of CAIM therapies. This study provided initial support for the reliability of the CAIMAQ. The survey results indicated that in general students responded more positively to the principles of CAIM than to CAIM treatment. A higher quality of CAIM-related medical education and expanded research into CAIM therapies would facilitate appropriate integration of CAIM into medical curricula. The most significant limitation of this study is a low response rate, and further work is required to assess more representative populations in order to determine whether the relationships found in this study are generalizable. Copyright © 2011 Ryan B. Abbott et al.

R Abbott, M Cohen (2013)Medico-legal issues in cardiology, In: Cardiology in Review21(5)pp. 222-228 Lippincott, Williams & Wilkins

The aim of this article is to educate physicians about the current litigation climate in cardiology and cardiac surgery, with a focus on the most frequently litigated areas of practice, including failure to diagnose and treat myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, and the use of tissue plasminogen activator. Empirical research on cardiology malpractice is presented, along with a sampling of up-to-date cases designed to illustrate common issues and important themes. The principles for reducing legal liability are also discussed, including the informed consent process, spoliation of records, and the role of documentation. Finally, practical recommendations are provided for cardiologists and cardiac surgeons to limit their legal liability. © 2013 Lippincott Williams & Wilkins.

R Abbott, H Lavretsky (2013)Tai Chi and Qigong for the Treatment and Prevention of Mental Disorders, In: Psychiatric Clinics of North America36(1)pp. 109-119

Tai Chi and Qigong are traditional Chinese exercises that are widely practiced for their health benefits and as martial arts. Evidence suggests that these practices may be effective at treating a range of physical health conditions, and at improving health-related quality of life. There is growing interest in the use of Tai Chi and Qigong to treat mental disorders, because they are noninvasive, exercise-based therapies, and because patients with mental disorders frequently use complementary and alternative medicine. Evidence is promising that these treatments may be effective in reducing depressive symptoms, stress, anxiety, and mood disturbances. © 2013 Elsevier Inc. All rights reserved.

CR BARNETT, RA ABBOTT, CJ BAILEY, PR FLATT, C IOANNIDES (1992)CYTOCHROME-P450-DEPENDENT MIXED-FUNCTION OXIDASE AND GLUTATHIONE-S-TRANSFERASE ACTIVITIES IN SPONTANEOUS OBESITY-DIABETES, In: BIOCHEMICAL PHARMACOLOGY43(8)pp. 1868-1871 PERGAMON-ELSEVIER SCIENCE LTD
MH Cohen, SR Natbony, RB Abbott (2013)Complementary and alternative medicine in child and adolescent psychiatry: Legal considerations, In: Child and Adolescent Psychiatric Clinics of North America22(3)pp. 493-507 Elsevier

The rising popularity of complementary and alternative medicine (CAM) in child and adolescent psychiatry raises unique ethical and legal concerns for psychiatrists and other conventional health care providers. This article explores these concerns and provides clinical advice for promoting patient health and safety while minimizing the psychiatrist's risk. Although any departure from the conventional standard of care is a potential risk, the risk of malpractice liability for practicing integrative medicine in child and adolescent psychiatry is low. CAM is most safely recommended from a legal standpoint when there is some published evidence of safety and efficacy. © 2013 Elsevier Inc.

R Abbott, KK Hui (2015)Perineal Self-Acupressure’s Mechanism of Action, In: Journal of General Internal Medicine30(4)pp. 399-399 Springer New York LLC
R Abbott, I Ayres, E Hui, KK Hui (2014)Effect of Perineal Self-Acupressure on Constipation: A Randomized Controlled Trial, In: Journal of General Internal Medicine30(4)pp. 434-439 Springer New York LLC

BACKGROUND: The efficacy of perineal self-acupressure in treating constipation is uncertain. OBJECTIVE: We aimed to evaluate whether perineal self-acupressure would improve patient reports of quality of life and bowel function at 4 weeks after training. DESIGN: A randomized, parallel group trial was conducted. SETTING: The study took place at the UCLA Department of Medicine. PATIENTS: One hundred adult patients who met Rome III criteria for functional constipation participated. INTERVENTION: The control group received information about standard constipation treatment options, while the treatment group received training in perineal self-acupressure plus standard treatment options. MEASUREMENTS: Primary outcome was the Patient Assessment of Constipation Quality of Life (PAC-QOL). Secondary outcomes included patient assessments of bowel function (as measured by a modified Bowel Function Index (BFI)), and health and well-being (as measured by the SF-12v2). RESULTS: The mean PAC-QOL was improved by 0.76 in the treatment group and by 0.17 in the control group (treatment-effect difference, 0.59 [95 % CI, 0.37 to 0.81]; p < 0.01). The mean modified BFI was improved by 18.1 in the treatment group and by 4.2 in the control group (treatment-effect difference, 13.8 [95 % CI, 5.1 to 22.5]; p < 0.01). The mean SF-12v2 Physical Component Score was improved by 2.69 in the treatment group and reduced by 0.36 in the control group (treatment-effect difference, 3.05, [95 % CI, 0.85 to 5.25]; p < 0.01); and the mean SF-12v2 Mental Component Score was improved by 3.12 in the treatment group and improved by 0.30 in the control group (treatment-effect difference, 2.82, [95 % CI, −0.10 to 5.74]; p < 0.07). LIMITATION: The trial was not blinded. CONCLUSION: Among patients with constipation, perineal self-acupressure improves self-reported assessments of quality of life, bowel function, and health and well-being relative to providing standard constipation treatment options alone. © 2014, Society of General Internal Medicine.

Ryan Abbott, Brinson S. Elliott (2023)Putting the Artificial Intelligence in Alternative Dispute Resolution: How AI Rules Will Become ADR Rules, In: Amicus curiae : journal of the Society for Advanced Legal Studies4(3)pp. 685-706 Institute of Advanced Legal Studies

This article argues that the evolving regulatory and governance environment for artificial intelligence (AI) will significantly impact alternative dispute resolution (ADR). Very recently, AI regulation has emerged as a pressing international policy issue, with jurisdictions engaging in a sort of regulatory arms race. In the same way that existing ADR regulations impact the use of AI in ADR, so too will new AI regulations impact ADR, among other reasons, because ADR is already utilizing AI and will increasingly utilize AI in the future. Appropriate AI regulations should thus benefit ADR, as both regulatory approaches in both fields share many of the same goals and values such as promoting trustworthiness.

Ryan Abbott, Elizabeth Rothman (2023)AI-Generated Output and Intellectual Property Rights: Takeaways from the Artificial Inventor Project, In: European intellectual property review
Erin Smith, Diab Ali, Bill Wilkerson, Walter D Dawson, Kunmi Sobowale, Charles Reynolds, Michael Berk, Helen Lavretsky, Dilip Jeste, Chee H Ng, Jair C Soares, Gowri Aragam, Zoe Wainer, Husseini K Manji, Julio Licinio, Andrew W Lo, Eric Storch, Ernestine Fu, Marion Leboyer, Ioannis Tarnanas, Agustin Ibanez, Facundo Manes, Sarah Caddick, Howard Fillit, Ryan Abbott, Ian H Robertson, Sandra B Chapman, Rhoda Au, Cara M Altimus, William Hynes, Patrick Brannelly, Jeffrey Cummings, Harris A Eyre (2020)A Brain Capital Grand Strategy: toward economic reimagination, In: Molecular psychiatry
Ryan Abbott (2022)We, the Robots? Regulating Artificial Intelligence and the Limits of the Law by SIMON CHESTERMAN, In: The international and comparative law quarterlypp. 1-2 Cambridge University Press
Ryan Abbott (2022)Build Back Brainier: Base Policies on Brain Science, In: William Hynes, Igor Linkov, Patrick Love (eds.), A Systemic Recovery OECD
Harris A. Eyre, Jessica Carson, Erin Smith, Helen Lavretsky, Charles Reynolds, Husseini K Manji, Walter D Dawson, Laura Booi, Mark Heinemeyer, Jeffrey L. Cummings, Ernestine Fu, Eric A. Storch, William Hynes, Eric J. Lenze, Retsina Meyer, Ian Macrae, Antonella Santuccione Chadha, Ryan Abbott, Sandra Bond Chapman, Ian H Robertson, Carol Graham, Brisa S. Fernandes, David G. Angeler, Adrienne Grzenda, Agustin Ibanez, Zoltan Sarnyai, Sofia Marcha, Michael Berk, Patrick Brannelly (2021)Boosting Brain Health After COVID-19: A Convergence Solution, In: Psychiatric Times MJH Life Sciences
Claire Gregg, RYAN ABBOTT (2022)DABUS Down Under – AI at Work in Australia and Around the World, In: Intellectual Property Forum129 IPSANZ

F or many, thoughts of artificial intelligence (" AI ") conjure Hollywood-esque images of once subservient robots taking revenge on their human masters and attempting to take over the world. In reality, AI has made a number of much more positive contributions to society, from medical diagnostics to autonomous vehicles to the creation of artistic works. While AI is not taking over the world any time soon, it is taking the world of innovation by storm and intellectual property law is struggling to keep up. For the last several years, the Artificial Inventor Project (" AIP ") 1 has shone a light on the inadequacies of the IP system in dealing with AI-generated inventions, as patent offices and courts around the world grapple with the concept of AI inventors within current legislative frameworks.

Sebastian F. Winter, David G. Angeler , Walter D Dawson, Virginia Bennett, Michael Freeman, William Hynes, Michael Berk, Zoltan Sarnyai, Chee H Ng, Ryan Abbott, Agustin Ibanez, Erin Smith, James T. Hackett, Eric Storch, Jorge Jraissati, Lynne Corner, Shou Chen, Andrew Carlo, Robert M. Bilder, Jair C. Soares, Christine Yu Moutier, Rym Ayadi, Antonella Santuccione Chadha, Facundo Manes, Karen Rommelfanger, Wolfgang H. Oertel, Dilip Jeste, Frederic Destrebecq, Ian H Robertson, Mark T. D’Esposito, Michael D. Matthews, Carol Graham, Harris A. Eyre (2022)BRAIN HEALTH-DIRECTED POLICYMAKING: Brookings Institution

Democracies are increasingly under siege. Beyond direct external (e.g., warfare) and internal (e.g., populism, extremism) threats to democratic nations, multiple democracy-weakening factors are converging in our modern world. Brain health challenges, including mental, neurologic, and substance use disorders, social determinants of health, long COVID, undesired effects of technology, mis- and disinformation, and educational, health, and gender disparities, are associated with substantial economic and sociopolitical impediments. Herein, we argue that thriving democracies can distinguish themselves through provision of environments that enable each citizen to achieve their full brain health potential conducive to both personal and societal well-being. Gearing policymaking towards equitable and quality brain health may prove essential to combat brain challenges, promote societal cohesion, and boost economic productivity. We outline emerging policy innovations directed at building “pro-democratic brain health” across individual, communal, national, and international levels. While extensive research is warranted to further validate these approaches, brain health-directed policymaking harbors potential as a novel concept for democracy strengthening.

R Abbott (2016)Hal the Inventor: Big Data and Its Use by Artificial Intelligence, In: CR Sugimoto, HR Ekbia, M Mattioli (eds.), Big Data is Not a Monolith(14)pp. 187-198 MIT Press
R Epstein, R Abbott (2014)Involvement in Off-Label Use: Debate Between Richard Epstein and Ryan Abbott, In: Southwestern Law Review44(1) Southwestern Law School
Ryan Abbott (2017)Patenting the Output of Autonomously Inventive Machines, In: Landslide10(1)pp. 16-22 American Bar Association

An innovation revolution is on the horizon. Artificial intelligence (AI) has been generating inventive output for decades, and now the continued and exponential growth in computing power is poised to take creative machines from novelties to major drivers of economic growth. A creative singularity in which computers overtake human inventors as the primary source of new discoveries is foreseeable.

R Abbott (2009)The Beijing Declaration: A Landmark for Traditional Medicine, In: ICTSD-Bridges13(1) International Centre for Trade and Sustainable Development

Last November in Beijing, government officials representing member states of the World Health Organisation adopted a declaration that provides a powerful endorsement of traditional medicine and may one day become the foundation for a legally binding resolution.

R Abbott (2013)Big data and pharmacovigilance: Using health information exchanges to revolutionize drug safety, In: Iowa Law Review99(1)pp. 225-292 Iowa Law Review

Data on individual patients collected through state and federal health information exchanges has the potential to usher in a new era of drug regulation. These exchanges, produced by recent health care reform legislation, will amass an unprecedented amount of clinical information on drug usage, demographic variables, and patient outcomes. This information could aid the Food and Drug Administration ("FDA") with post-market drug surveillance because it more accurately reflects clinical practice outcomes than the trials the FDA relies upon for drug approval. However, even with this data available, the market-driven impetus to use it to police drugs is weak. This is fixable; the post-market drug regulatory process needs new incentives to boost third party participation. While a variety of mechanisms could achieve this, the best option for generating robust results may be an administrative bounty proceeding that will allow third parties to submit evidence to the FDA to contest the claimed safety and efficacy profiles of drugs already on the market. This Article uses a case study of Merck's former blockbuster drug Vioxx to demonstrate how this system might work. In creating a new incentive that counters the powerful financial motivation of drug manufacturers to obscure or misrepresent safety profiles, the proposed bounty proceeding could lead to an improved balance of the risks and benefits of drugs used by the American public. More broadly, this Article illustrates how to create an incentive for the private sector to supplement regulatory activity in a complex field.

Ryan Abbott (2017)Autonomous Machines and their Inventions, In: Mitteilungenpp. 429-437 Wolters Kluwer

In some cases, a computer’s output constitutes patentable subject matter, and the computer rather than a person meets the requirements for inventorship. As such machines become an increasingly common part of the inventive process, they may replace the standard of the person skilled in the art now used to judge nonobviousness. Creative computers require a rethinking of the criteria for inventiveness, and potentially of the entire patent system.

R Abbott (2016)I Think, Therefore I Invent: Creative Computers and the Future of Patent Law, In: Boston College Law Review57(4)pp. 1079-1126 Boston CollegeLaw

Artificial intelligence has been generating inventive output for decades, and now the continued and exponential growth in computing power is poised to take creative machines from novelties to major drivers of economic growth. In some cases, a computer’s output constitutes patentable subject matter, and the computer rather than a person meets the requirements for inventorship. Despite this, and despite the fact that the Patent Office has already granted patents for inventions by computers, the issue of computer inventorship has never been explicitly considered by the courts, Congress, or the Patent Office. Drawing on dynamic principles of statutory interpretation and taking analogies from the copyright context, this Article argues that creative computers should be considered inventors under the Patent and Copyright Clause of the Constitution. Treating nonhumans as inventors would incentivize the creation of intellectual property by encouraging the development of creative computers. This Article also addresses a host of challenges that would result from computer inventorship, including the ownership of computer-based inventions, the displacement of human inventors, and the need for consumer protection policies. This analysis applies broadly to nonhuman creators of intellectual property, and explains why the Copyright Office came to the wrong conclusion with its Human Authorship Requirement. Finally, this Article addresses how computer inventorship provides insight into other areas of patent law. For instance, computers could replace the hypothetical skilled person that courts use to judge inventiveness. Creative computers may require a rethinking of the baseline standard for inventiveness, and potentially of the entire patent system.

R Abbott, I Ayres (2014)Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?, In: FDLI's Food and Drug Policy Forum4(5)pp. 1-12 Food and Drug Law Institute

A recurring issue for evidence-based regulation of medicine is deciding whether to extend governmental approval from an approved use with sufficient current evidence of safety and efficacy to a novel use where such evidence is currently lacking. This “extrapolation” problem can arise in several contexts: (i) diagnosis extrapolation occurs when physicians want to use an approved drug or device to treat a new condition; (ii) patient extrapolation occurs when physicians want to use an existing drug or device to treat a new population with a given condition; (iii) dosage extrapolation occurs when physicians want to use an existing drug or device for a new duration, schedule of use, or at a new dosage; (iv) treatment extrapolation occurs when physicians want to use a new drug or device that is related to an approved counterpart. The logic of pre-approval testing, and the precautionary principal (first, do no harm), would seem to counsel prohibiting extrapolation approvals until after traditional safety and efficacy evidence exists. We reject that approach as overly conservative and instead propose a more dynamic and evolving evidence-based regime based on Bayes’ Law fundamentally, the science of learning. To apply Bayesian decision-making, one needs to (i) form a “prior” belief based on existing evidence, (ii) gather additional information, and (iii) update the prior belief. A system that allows interim periods of use can provide physicians and patients with greater treatment options while providing regulators with valuable evidence about the safety and efficacy of the proposed extrapolation. Indeed, off label drug use is legal and sometimes the medical standard of care. In contrast, a precautionary requirement conditioning all approvals on pre-existing evidence for uses that constitute just slight extrapolations along just one of these four dimensions sacrifices probable short-term health benefits at the alter of precaution. Harm is not only associated with permitting access to unsafe products but also with restricting access to beneficial products. We call for policy changes in reporting, testing, and enforcement regulations to provide a more layered and dynamic system of regulatory incentives. Our proposals are Bayesian because they force policymakers to (i) assess and acknowledge the imperfect nature of their prior beliefs regarding off-label use, (ii) gather, when cost-effective, additional information, and (iii) take action in terms of approvals, reimbursements, and enforcement based on continual updating. We aim to put Bayesianism into regulatory practice.

R Abbott (2014)Post-Market Drug Regulation in the Age of Big Data: What Path to the Promised Land?, In: FDLI's Food and Drug Policy Forum4(10)pp. 1-14 Food and Drug Law Insititute

This article argues that an administrative bounty proceeding should be established to motivate third parties to submit data on drug safety and efficacy to the food and drug agency. The administrative bounty proceeding should be modeled after the Federal Claims Act qui tam regime, and the federal government should pay petitioner rewards based on a portion of the money that the government will save by avoiding adverse effects and medically ineffective therapies in patients with government health insurance.

R Abbott (2012)Overcoming Barriers to a Global Treaty on Medical Funding and R&D, In: Journal of the Brazilian Institute for Intellectual Property7pp. 70-76
R Abbott (2012)Treating the Health Care Crisis: Complementary and Alternative Medicine for PPACA, In: DePaul Journal of Health Care Law14(1)pp. 35-98 DePaul College of Law

The Patient Protection and Affordable Care Act (PPACA) intends to take American health care in a new direction by focusing on preventive medicine and wellness-based treatment. But, in doing so, it does not adequately take into account the potential contribution of complementary and alternative medicine (CAM). CAM is already used by a large and growing number of individuals in the United States, although to date there is limited scientific evidence to support the efficacy of most CAM treatments. This article proposes statutory reforms to PPACA to encourage CAM research and development (R&D), and the use of demonstrably effective CAM treatments. A hybrid system of limited intellectual property protection and government prizes based on regulatory approval may be the best option for incentivizing R&D on CAM, along with increased funding for research through the National Institutes of Health. PPACA should require health insurance plans to reimburse for evidence-based CAM and empower an existing government agency (NCCAM) to regulate CAM standards and to recommend evidence-based CAM services. Together these policy and funding mechanisms should help reduce U.S. healthcare costs and improve quality of life.

R Abbott, I Ayres (2014)Evidence and extrapolation: Mechanisms for regulating off-label uses of drugs and devices, In: Duke Law Journal64(3)pp. 377-435 Duke University School of Law

A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking. This "extrapolation" issue arises in the medicines context when an approved drug or device that is already being marketed is being considered (1) for new conditions (such as off-label diagnostic categories), (2) for new patients (such as new subpopulations), (3) for new dosages or durations, or (4) as the basis for approving a related drug or device (such as a generic or biosimilar drug). Although the logic of preapproval testing and the precautionary principle-first, do no harm-would counsel in favor of prohibiting extrapolation approvals until after traditional safety and efficacy evidence exists, such delays would unreasonably sacrifice beneficial uses. The harm of accessing unsafe products must be balanced against the harm of restricting access to effective products. In fact, the Food and Drug Administration's (FDA's) current regulations in many ways reject the precautionary principle because they largely permit individual physicians to prescribe medications for off-label uses before any testing tailored to those uses has been done. The FDA's approach empowers physicians, but overshoots the mark by allowing enduring use of drugs and devices with insubstantial support of safety and efficacy. This Article instead proposes a more dynamic and evolving evidence-based regime that charts a course between the Scylla and Charybdis of the overly conservative precautionary principle on one hand, and the overly liberal FDA regime on the other. Our approach calls for improvements in reporting, testing, and enforcement regulations to provide a more layered and nuanced system of regulatory incentives. First, we propose a more thoroughgoing reporting of off-label use (via the disclosure of diagnostic codes and "detailing" data) in manufacturers' annual reports to the FDA, in the adverse event reports to the FDA, in Medicare/Medicaid reimbursement requests, and, for a subset of FDA-designated drugs, in prescriptions themselves. Second, we would substantially expand the agency's utilization of postmarket testing, and we provide a novel framework for evaluating the need for postmarket testing. Finally, our approach calls for a tiered labeling system that would allow regulators and courts to draw finer reimbursement and liability distinctions among various drug uses, and would provide the agency both the regulatory teeth and the flexibility it presently lacks. Together, these reforms would improve the role of the FDA in the informational marketplace underlying physicians' prescribing decisions. This evolutionary extrapolation framework could also be applied to other contexts. © 2014 Ryan Abbott and Ian Ayres.

Ryan Abbott (2021)Machine Rights and Reasonable Robots, Remarks, In: Washburn law journal60(3)pp. 429-444 Washburn Law Journal
R Abbott (2018)The Reasonable Computer: Disrupting the Paradigm of Tort Liability, In: George Washington Law Review86(1)pp. 1-45

Artificial intelligence is part of our daily lives. Whether working as taxi drivers, financial analysts, or airport security, computers are taking over a growing number of tasks once performed by people. As this occurs, computers will also cause the injuries inevitably associated with these activities. Accidents happen, and now computer-generated accidents happen. The recent fatality caused by Tesla’s autonomous driving software is just one example in a long series of “computer-generated torts.” Yet hysteria over such injuries is misplaced. In fact, machines are, or at least have the potential to be, substantially safer than people. Self-driving cars will cause accidents, but they will cause fewer accidents than human drivers. Because automation will result in substantial safety benefits, tort law should encourage its adoption as a means of accident prevention. Under current legal frameworks, manufacturers (and retailers) of computer tortfeasors are likely strictly responsible for their harms. This article argues that where a manufacturer can show that an autonomous computer, robot, or machine is safer than a reasonable person, the manufacturer should be liable in negligence rather than strict liability. The negligence test would focus on the computer’s act instead of its design, and in a sense, it would treat a computer tortfeasor as a person rather than a product. Negligence-based liability would create a powerful incentive to automate when doing so would reduce accidents, and it would continue to reward manufactures for improving safety. In fact, principles of harm avoidance suggest that once computers become safer than people, human tortfeasors should no longer be judged against the standard of the hypothetical reasonable person that has been employed for hundreds of years. Rather, individuals should be measured against computers. To appropriate the immortal words of Justice Holmes, we are all “hasty and awkward” compared to the reasonable computer.

R Abbott, BN Bogenschneider (2018)Should Robots Pay Taxes? Tax Policy in the Age of Automation, In: Harvard Law & Policy Review12(1)pp. 145-175

Existing technologies can already automate most work functions, and the cost of these technologies is decreasing at a time when human labor costs are increasing. This, combined with ongoing advances in computing, artificial intelligence, and robotics, has led experts to predict that automation will lead to significant job losses and worsening income inequality. Policy makers are actively debating how to deal with these problems, with most proposals focusing on investing in education to train workers in new job types, or investing in social benefits to distribute the gains of automation. The importance of tax policy has been neglected in this debate, which is unfortunate because such policies are critically important. The tax system incentivizes automation even in cases where it is not otherwise efficient. That is because the vast majority of tax revenue is now derived from labor income, so firms avoid taxes by eliminating employees. More importantly, when a machine replaces a person, the government loses a substantial amount of tax revenue—potentially trillions of dollars a year in the aggregate. All of this is the unintended result of a system designed to tax labor rather than capital. Such a system no longer works once the labor is capital. Robots are not good taxpayers. We argue that existing tax policies must be changed. The system should be at least “neutral” as between robot and human workers, and automation should not be allowed to reduce tax revenue. This could be achieved by disallowing corporate tax deductions for automated workers, creating an “automation tax” which mirrors existing unemployment schemes, granting offsetting tax preferences for human workers, levying a corporate self-employment tax, or increasing the corporate tax rate. We argue the ideal solution may be a combination of these proposals.

RYAN ABBOTT (2022)Artificial Intelligence and Intellectual Property: An Introduction, In: RESEARCH HANDBOOK ON INTELLECTUAL PROPERTY AND ARTIFICIAL INTELLIGENCE Edward Elgar
Ryan Abbott, H Lavretsky, D Chang, H Eyre (2018)Mind-Body Practices Tai Chi and Qigong in the Treatment and Prevention of Psychiatric Disorders, In: P L Gerbarg, P R Muskin, R P Brown (eds.), Complementary and Integrative Treatments in Psychiatric Practice American Psychiatric Press
R Abbott (2014)Documenting Traditional Medical Knowledge, In: World Intellectual Property Organization World Intellectual Property Organization

Traditional medical knowledge is experiencing increased attention worldwide in light of global health care demand and the significant role of traditional medicine in meeting the public health needs of developing countries. Traditional medicines already comprise a multi-billion dollar, international industry, and the biomedical sector is increasingly investigating the potential of genetic resources and traditional knowledge. Documenting and protecting these medicines is becoming a greater priority. Traditional knowledge has historically been at odds with modern intellectual property systems designed to protect innovations such as new pharmaceutical drugs. However, as the financial value of many forms of traditional medicine becomes recognized, traditional knowledge holders and nations rich in genetic resources are arguing for greater protection through non-conventional systems of intellectual property protection. Traditional knowledge holders are increasingly demanding fair and equitable distribution of benefits from the commercialization of traditional medicine, as well as the prior informed consent of indigenous peoples to prevent misappropriation. Many problems associated with the protection of traditional medical knowledge lack clear solutions. In attempting to protect traditional medicine, traditional knowledge holders are confronted by a confusing and diverse group of national and international policies, regulatory systems designed primarily to accommodate pharmaceutical medicines, safety and efficacy concerns, and challenges to ownership. This text is designed to assist traditional medical knowledge holders, government representatives and third-party collaborators to think about issues of intellectual property law specifically related to traditional medical knowledge. It is not intended to provide legal advice, but rather to help stimulate thinking about traditional knowledge and to provide illustrative case studies. There is no generic way to protect traditional medical knowledge. Traditional knowledge holders should carefully consider identified community goals for the use of traditional medicine and the risks and benefits of documentation. Whether traditional medical knowledge is documented can have far reaching consequences on intellectual property protection, commercialization and promotion of traditional medicine, regulatory submissions and interactions with collaborators. It is important that traditional knowledge holders be adequately informed to safeguard their reputations and interests when interacting with third parties. Hopefully, this text will help traditional knowledge holders better understand the issues related to traditional medicine and intellectual property and make informed decisions about the best use of their knowledge.

R Abbott, C Stevens (2014)Redefining Medical Necessity: A Consumer-Driven Solution to the U.S. Health Care Crisis, In: Loyola Law Review47(4)pp. 943-943 Loyola of Los Angeles Law Review

The American health care system is plagued by high costs and poor public health outcomes, due in part to the overuse of costly diagnostic tests and treatments. In 2009, the Institute of Medicine estimated that unnecessary care wastes $750 billion, equivalent to about 30 percent of health care spending. Moreover, overtreatment can directly harm patients as a result of surgical complications, drug toxicity, and hospital-acquired infections. Yet while the problem of medical waste has long been recognized, solving the problem has proven elusive. In part, this difficulty is due to perverse economic incentives for physicians and hospitals, which still primarily receive reimbursement on a fee-for-service basis. Providers are financially motivated under this system to generate a higher volume of invasive procedures independent of their likely benefits. Patients generally lack the information needed to decline unnecessary services, even when they wish to actively share in medical decision-making, and a strong cultural bias pushes both patients and physicians to “do more,” even when evidence suggests that doing more may result in harm. In the 1990s, managed health care organizations attempted to rein in health care waste by stringently reviewing and prospectively denying payment for unnecessary tests and treatments, but that experiment was a political failure. Similarly, attempts to reduce overuse by shifting financial risk directly onto providers through capitated payment mechanisms have had limited success. The ability of these mechanisms to limit waste is compromised by the real or perceived incentive to also reduce spending on appropriate care. We propose a new conception of medical necessity that will reduce inappropriate care by allowing informed consumers to actively participate in decisions about their medical care. Where evidence-based guidelines are available, medical necessity should be determined on the basis of an objective, multi-level Matrix of Appropriateness rather than the subjective binary decision of an insurance company’s medical reviewer. Such Matrices have already been created by systematically combining published evidence with expert judgment to create clinically detailed, evidence based, multilevel medical necessity ratings for elective procedures based on individual patient characteristics. In our proposed system, if a patient desires a service proposed by a physician under clinical circumstances that receive low medical necessity ratings, the third-party payer would offer to cover the service but at a sliding co-payment scale imposing greater patient cost sharing based on the service’s appropriateness. This system would preserve patient choice while discouraging the overuse of costly treatments that provide little marginal value, reducing medical waste and improving the overall value of medical care.

R Abbott (2016)The Sentinel Initiative as a Cultural Commons, In: K Strandburg (eds.), Governing Medical Research Commons Cambridge University Press
R Abbott (2014)Balancing Access and Innovation in India's Shifting IP Regime, Remarks, In: Whittier Law Review35pp. 341-341