Professor Ryan Abbott


Professor of Law and Health Sciences
MD, JD, MTOM

Academic and research departments

School of Law.

Biography

Biography

Professor Abbott is highly regarded for his scholarship, teaching, and professional activities. His legal research has focused in three areas: the impact of autonomous machines and technological advances, intellectual property issues in the biotechnology and pharmaceutical industries, and the use of informational regulation and market-based mechanisms by health regulatory agencies. His work on autonomous machines has included recent publications in the UCLA Law Review, George Washington Law Review, Harvard Law and Policy Review, and the Boston College Law Review on autonomous machines and accident law, tax policy, and intellectual property, respectively. His work with health regulatory agencies has included publications in the Duke Law Journal and the Iowa Law Review. His monograph, "The Reasonable Robot: Autonomous Machines and the Law" is forthcoming with Cambridge University Press in 2019.

Professor Abbott has worked as General Counsel and Medical Director of a mid-stage biotechnology company, and has been Of Counsel at law firms where he specialized in intellectual property litigation and transactional matters for pharmaceutical and medical device clients. He has served as a consultant for international organizations, academic institutions and non-profit enterprises including the World Health Organization (WHO) and the World Intellectual Property Organization (WIPO). Professor Abbott has also worked as an expert witness which has included testifying in U.S. federal court.

Professor Abbott is a licensed and board certified physician, attorney, and acupuncturist in the United States, as well as a solicitor (non-practicing) in England and Wales. He is a graduate of the University of California, San Diego School of Medicine (M.D.) and the Yale Law School (J.D.), as well as a Summa Cum Laude graduate from Emperor's College (M.T.O.M.) and a Summa Cum Laude graduate from University of California, Los Angeles (B.S.). Professor Abbott has been the recipient of numerous research fellowships, scholarships and awards, and has served as Principal Investigator of clinical research studies at the University of California. He is a registered patent attorney with the U.S. Patent and Trademark Office and a member of the California and New York State Bars. He is also a Senior Fellow of the Higher Education Academy (SFHEA).

Research interests

Professor Abbott has a variety of research interests that reflect his multi-disciplinary background. He writes on a range of topics related to health law, intellectual property, as well as law and technology. He has published significant works on health care financing, access to medicines, and big data. He has also completed clinical studies in medicine, and legal research projects related to traditional knowledge, integrative health, and emerging technologies. For further information and downloadable papers, please see SSRN.

Prospective students interested in pursuing research matching his scholarly and research interests are welcome to make informal enquiries.

Departmental duties

Director of Research (Impact)

Select Videos of Professor Abbott

Inaugural Lecture: The Reasonable Robot—Autonomous Machines and the Law. 20 Mar 2014. Watch.

Debate with Richard Epstein. "FDA Involvement in Off-Label Drug Use." 13 Jan 2014. Watch.

Select Media Coverage

TRT World, Rise of the Robots: Part I (Watch) and Part II (Watch).

BBC, Free Thinking Radio 3. Robots, Makt Myrkranna. Listen.

Scott Graham. "Patent Law at the AI Crossroads." Law.com. April 1, 2016. View.

"Measles Outbreak: Expert Weighs in on Vaccine Debate." ABC7. February 4, 2015. (Video). Watch.

“Perineal Self-Acupressure for Constipation?” New England Journal of Medicine Journal Watch (Audio). May 7, 2015. Listen.

Basken, Paul. “Supreme Court's Ruling on Gene Patents Opens New Avenues for University Research.” The Chronicle of Higher Education. 17 Jun. 2013. View.

Wharton, David. "Pac-12 Football Coaches Hush-Hush About Hurt Players." Los Angeles Times, 20 Sep. 2012: C1. Print. View.

My publications

Publications

Abbott R, Ayres I (2014) Evidence and extrapolation: Mechanisms for regulating off-label uses of drugs and devices, Duke Law Journal 64 (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.
Abbott R, Ayres I (2014) Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?, FDLI's Food and Drug Policy Forum 4 (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, reimbu

Abbott R, Stevens C (2014) Redefining Medical Necessity: A Consumer-Driven Solution to the U.S. Health Care Crisis, Loyola Law Review 47 (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,
Abbott, R., M.D., J.D., Smith DE (2015) The New Designer Drug Wave: A Clinical, Toxicological, and Legal Analysis, Journal of Psychoactive Drugs 47 (5) pp. 368-371 Routledge
This article reviews clinical, toxicological, and legal issues related to designer drug abuse, with a focus on synthetic cathinones (bath salts). Synthetic cathinones are amphetamine-type central nervous system (CNS) stimulants that produce similar effects to amphetamine. Like amphetamine, synthetic cathinones can also result in neurological and cardiovascular side-effects consistent with sympathomimetic toxicity. The differential for a patient presenting with the signs and symptoms of synthetic cathinone toxicity is broad, and laboratory testing for synthetic cathinones is of limited value in acute management. If a diagnosis of cathinone-induced delirium is suspected, treatment efforts should focus on controlling agitation and then treating medical complications such as metabolic acidosis. Physicians should be aware of these new drugs, not only to optimally treat patients, but also to raise awareness of the dangers of designer drug use through patient counseling and community outreach programs. © Taylor & Francis Group, LLC.
Abbott R (2016) Hal the Inventor: Big Data and Its Use by Artificial Intelligence, In: Sugimoto CR, Ekbia HR, Mattioli M (eds.), Big Data is Not a Monolith 14 pp. 187-198 MIT Press
Abbott RB, Hui KK, Hays RD, Mandel J, Goldstein M, Winegarden B, Glaser D, Brunton L (2011) Medical student attitudes toward complementary, alternative and integrative medicine, Evidence-based Complementary and Alternative Medicine 2011 985243 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.
Abbott R, Ayres I, Hui E, Hui KK (2014) Effect of Perineal Self-Acupressure on Constipation: A Randomized Controlled Trial, Journal of General Internal Medicine 30 (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
Abbott RB, Hui KK, Hays RD, Li MD, Pan T (2007) A randomized controlled trial of Tai Chi for tension headaches, Evidence-based Complementary and Alternative Medicine 4 (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
Abbott R, Lavretsky H (2013) Tai Chi and Qigong for the Treatment and Prevention of Mental Disorders, Psychiatric Clinics of North America 36 (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.
Abbott F, Abbott R, Bannenberg W, Schürmann M (2009) Regional Assessment of Patent and Related Issues and Access to Medicines: Caricom Member States and the Dominican Republic, In: Health Research for Action Final Report- Main Report Vol 1 HERA
Abbott R (2014) Post-Market Drug Regulation in the Age of Big Data: What Path to the Promised Land?, FDLI's Food and Drug Policy Forum 4 (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.
Abbott R (2012) Overcoming Barriers to a Global Treaty on Medical Funding and R&D, Journal of the Brazilian Institute for Intellectual Property 7 pp. 70-76
Abbott R, Zhang W (2007) Meeting Report for the UCLA Center for East-West Medicine 2006 Annual Conference: Integration of Traditional Chinese Medicine and Western Medicine - Research and Clinical Applications, Chinese Journal of Integrative Medicine 13 (1) pp. 74-75
Abbott R, Bannenberg W (2009) Regional Assessment of Patent and Related Issues and Access to Medicines: Caricom Member States and the Dominican Republic, In: Health Research for Action: Final Report: Country Studies Vol 2 HERA
Abbott R (2014) Documenting Traditional Medical Knowledge, 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

Abbott R, Lavretsky H (2013) Tai Chi and Qi Gong for Treatment and Prevention of Mental Disorders, Psychiatr Clin North Am 36 (1) pp. 109-119 Elsevier
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.
Abbott R (2013) Big data and pharmacovigilance: Using health information exchanges to revolutionize drug safety, Iowa Law Review 99 (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.
Abbott R, Cohen M (2013) Medico-legal issues in cardiology, Cardiology in Review 21 (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.
Alabbadi I, Abbott R, Jaber D (2014) Jordanian stakeholder attitudes toward generic substitution, Journal of Generic Medicines 11 (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.
Abbott R (2014) Balancing Access and Innovation in India's Shifting IP Regime, Remarks, Whittier Law Review 35 pp. 341-341
Abbott R, Hui KK (2015) Perineal Self-Acupressure?s Mechanism of Action, Journal of General Internal Medicine 30 (4) pp. 399-399 Springer New York LLC
Abbott R (2009) The Beijing Declaration: A Landmark for Traditional Medicine, ICTSD-Bridges 13 (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.
Epstein R, Abbott R (2014) Involvement in Off-Label Use: Debate Between Richard Epstein and Ryan Abbott, Southwestern Law Review 44 (1) Southwestern Law School
Abbott R (2015) FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, Journal of Law and the Biosciences 3 (1) pp. 248-252 Oxford University Press
Abbott R (2012) Treating the Health Care Crisis: Complementary and Alternative Medicine for PPACA, DePaul Journal of Health Care Law 14 (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.
Abbott R (2016) The Sentinel Initiative as a Cultural Commons, In: Strandburg K (eds.), Governing Medical Research Commons Cambridge University Press
Abbott RB, Bader R, Bajjali L, Elsamen TA, Obeidat T, Sboul H, Shwayat M, Alabbadi I (2012) The price of medicines in Jordan: The cost of trade-based intellectual property, Journal of Generic Medicines 9 (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).
Cohen MH, Natbony SR, Abbott RB (2013) Complementary and alternative medicine in child and adolescent psychiatry: Legal considerations, Child and Adolescent Psychiatric Clinics of North America 22 (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.
Abbott R (2018) The Reasonable Computer: Disrupting the Paradigm of Tort Liability, George Washington Law Review 86 (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.
Abbott R, Bogenschneider B (2018) Should Robots Pay Taxes? Tax Policy in the Age of Automation, Harvard Law & Policy Review 12 (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.
Abbott R, Chang D, Eyre H, Bousman C, Merrill D, Lavretsky H (2017) Pharmacogenetic Decision Support Tools: A New Paradigm for Late-Life Depression?, American Journal of Geriatric Psychiatry 26 (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.
Abbott R, Lavretsky H, Chang D, Eyre H (2018) Mind-Body Practices Tai Chi and Qigong in the Treatment and Prevention of Psychiatric Disorders, In: Gerbarg P, Muskin P, Brown R (eds.), Complementary and Integrative Treatments in Psychiatric Practice American Psychiatric Press
Abbott R (2017) Autonomous Machines and their Inventions, Mitteilungen pp. 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.
Abbott R (2016) I Think, Therefore I Invent: Creative Computers and the Future of Patent Law, Boston College Law Review 57 (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.
Abbott R (2017) Patenting the Output of Autonomously Inventive Machines, Landslide 10 (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.
Sherkow Jacob S., Abbott Ryan (2018) Fortune and Hindsight: Gene Patents? Muted Effect on Medical Practice, British Medical Bulletin 126 (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.

Abbott Ryan (2018) Everything is Obvious, UCLA Law Review 66 (1) 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.
Abbott Ryan, Lack J, Perkins D (2018) Managing disputes in the life sciences, Nature Biotechnology 36 (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.