Download or read book The False Promise of Breaking Patents to Lower Drug Prices written by Adam Mossoff and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The patent system is at the center of heated policy debates about drug prices, as some scholars and policy organizations claim that patents are a principal cause of rising drug prices. They propose price controls be imposed on drug patents to lower drug prices, and they claim federal agencies are authorized to do so by two federal statutes: § 1498 and the march-in power in § 203 of the Bayh-Dole Act. These price-control theories of § 1498 and the Bayh-Dole Act allege that Congress has already authorized federal agencies to break patents by imposing price controls on sales of patented products in the marketplace. This Article explains that these statutes do not authorize agencies to impose price controls on drug patents, as evidenced by their plain text and by longstanding judicial and agency interpretations of these two statutes. The price-control theories of § 1498 and the Bayh-Dole Act contradict the text and function of both statutes. Section 1498 is an eminent domain statute, applying only when a patent is “used by and for the United States.” This is not the case of a private company authorized by the government to sell a patented drug at a lower price than the drug innovator who owns the patent. Section 203 in the Bayh-Dole Act specifies only four delimited conditions when an agency may “march in” and license a patent without authorization by a patent owner. All address circumstances when a product is not available at all in the marketplace; price is not a specified condition. In sum, neither § 1498 nor the Bayh-Dole Act authorize a federal agency to impose price controls in private transactions in the marketplace between companies and consumers. There is a significant body of scholarship and policy work-product advancing the price-control theories of § 1498 and the Bayh-Dole Act, but these are policy arguments masquerading as statutory construction. It is time to lay these statutory myths to rest and to have a forthright policy debate.
Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceuticals Corporate Crime and Public Health written by Graham Dukes and published by Edward Elgar Publishing. This book was released on 2014-06-27 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Download or read book Science the Endless Frontier written by Vannevar Bush and published by Princeton University Press. This book was released on 2021-02-02 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The classic case for why government must support science—with a new essay by physicist and former congressman Rush Holt on what democracy needs from science today Science, the Endless Frontier is recognized as the landmark argument for the essential role of science in society and government’s responsibility to support scientific endeavors. First issued when Vannevar Bush was the director of the US Office of Scientific Research and Development during the Second World War, this classic remains vital in making the case that scientific progress is necessary to a nation’s health, security, and prosperity. Bush’s vision set the course for US science policy for more than half a century, building the world’s most productive scientific enterprise. Today, amid a changing funding landscape and challenges to science’s very credibility, Science, the Endless Frontier resonates as a powerful reminder that scientific progress and public well-being alike depend on the successful symbiosis between science and government. This timely new edition presents this iconic text alongside a new companion essay from scientist and former congressman Rush Holt, who offers a brief introduction and consideration of what society needs most from science now. Reflecting on the report’s legacy and relevance along with its limitations, Holt contends that the public’s ability to cope with today’s issues—such as public health, the changing climate and environment, and challenging technologies in modern society—requires a more capacious understanding of what science can contribute. Holt considers how scientists should think of their obligation to society and what the public should demand from science, and he calls for a renewed understanding of science’s value for democracy and society at large. A touchstone for concerned citizens, scientists, and policymakers, Science, the Endless Frontier endures as a passionate articulation of the power and potential of science.
Download or read book WIPO Technology Trends 2019 Artificial Intelligence written by World Intellectual Property Organization and published by WIPO. This book was released on 2019-01-21 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first report in a new flagship series, WIPO Technology Trends, aims to shed light on the trends in innovation in artificial intelligence since the field first developed in the 1950s.
Download or read book Corporate Crime in the Pharmaceutical Industry Routledge Revivals written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Download or read book The Public Domain written by James Boyle and published by Createspace Independent Publishing Platform. This book was released on 2017-11-25 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this insightful book you will discover the range wars of the new information age, which is today's battles dealing with intellectual property. Intellectual property rights marks the ground rules for information in today's society, including today's policies that are unbalanced and unspupported by any evidence. The public domain is vital to innovation as well as culture in the realm of material that is protected by property rights.
Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.
Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.
Download or read book Enhancing the Regulatory Decision Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Download or read book Transition and Coherence in Intellectual Property Law written by Niklas Bruun and published by Cambridge University Press. This book was released on 2021-01-07 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is for students and scholars of intellectual property law, practitioners seeking creative arguments from across the field, and policymakers searching for solutions to changing social and technological issues. The book explores the tensions between two fundamentally competing demands made of IP law.
Download or read book Bulletin of the Atomic Scientists written by and published by . This book was released on 1955-04 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Bulletin of the Atomic Scientists is the premier public resource on scientific and technological developments that impact global security. Founded by Manhattan Project Scientists, the Bulletin's iconic "Doomsday Clock" stimulates solutions for a safer world.
Download or read book An Economic Review of the Patent System written by Fritz Machlup and published by . This book was released on 1958 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: At head of title: 85th Cong., 2d sess. Committee print. Bibliography: p. 81-86.
