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Pharmaceutical Pay For Delay Reexamined
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Book Synopsis Regulation, Innovation and Competition in Pharmaceutical Markets by : Margherita Colangelo
Download or read book Regulation, Innovation and Competition in Pharmaceutical Markets written by Margherita Colangelo and published by Bloomsbury Publishing. This book was released on 2023-04-20 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anti-competitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debates. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.
Book Synopsis Competition Law and Policy in the Japanese Pharmaceutical Sector by : Akira Negishi
Download or read book Competition Law and Policy in the Japanese Pharmaceutical Sector written by Akira Negishi and published by Springer Nature. This book was released on 2022-02-08 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com
Book Synopsis The Economics of US Healthcare: Competition, Innovation, Regulation, and Organizations by :
Download or read book The Economics of US Healthcare: Competition, Innovation, Regulation, and Organizations written by and published by Stigler Center. This book was released on 2023-05-01 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This eBook was born out of a general diagnosis that the US healthcare sector is not only one of the most studied industries in economics but also one of the areas where the field can make the most progress. Indeed, the American healthcare industry has many features that are particularly attractive to economists. It is one of (if not the) largest sectors of the US economy, accounting for almost 20% of the national Gross Domestic Product and employing tens of millions of workers. Firms range from large conglomerates to small providers, and there is strong government-private sector interaction, with federal, state, and local governments shaping policy. The industry also has many failures, is undergoing tremendous change, and produces a wealth of data (even if not always perfectly formatted). The field, however, is far from saturated. Healthcare is such a complex and intricate sector, one where details matter so much that it is almost its own subfield of economics. These high barriers to entry prevent scholars from researching healthcare topics and weaken the cross-pollination of ideas, an increasing hallmark of many other areas. This is problematic, not the least, because any major advances in healthcare economics literally save lives (and billions of dollars). This project aimed to help lower these barriers and kick-start broader collaborations.
Book Synopsis Antitrust Policy in Health Care Markets by : Roger D. Blair
Download or read book Antitrust Policy in Health Care Markets written by Roger D. Blair and published by Cambridge University Press. This book was released on 2022-10-31 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health care costs in the United States are much higher than in other countries. These cost differences can be explained in part by a lack of competition in the United States. Some markets, such as pharmaceuticals and medical equipment, have elements of monopoly. Other markets, such as health insurance, have elements of monopsony. Many other markets may be subject to collusion on prices, such as generic drugs, or wages, such as the nurse labor market. Lawful monopoly and monopsony are beyond the reach of antitrust laws, but collusion is not. When appropriate, vigorous antitrust enforcement challenging anticompetitive conduct can aid in reducing health care costs. This book addresses monopoly, monopsony, cartels of sellers and buyers, horizontal and vertical merger policy, and antitrust enforcement through private suits as well as the efforts of the antitrust Agencies. The authors demonstrate how enforcing antitrust laws can ultimately promote competition and reduce health care costs.
Book Synopsis The Antitrust Enterprise by : Herbert HOVENKAMP
Download or read book The Antitrust Enterprise written by Herbert HOVENKAMP and published by Harvard University Press. This book was released on 2009-06-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: After thirty years, the debate over antitrust's ideology has quieted. Most now agree that the protection of consumer welfare should be the only goal of antitrust laws. Execution, however, is another matter. The rules of antitrust remain unfocused, insufficiently precise, and excessively complex. The problem of poorly designed rules is severe, because in the short run rules weigh much more heavily than principles. At bottom, antitrust is a defensible enterprise only if it can make the microeconomy work better, after accounting for the considerable costs of operating the system. The Antitrust Enterprise is the first authoritative and compact exposition of antitrust law since Robert Bork's classic The Antitrust Paradox was published more than thirty years ago. It confronts not only the problems of poorly designed, overly complex, and inconsistent antitrust rules but also the current disarray of antitrust's rule of reason, offering a coherent and workable set of solutions. The result is an antitrust policy that is faithful to the consumer welfare principle but that is also more readily manageable by the federal courts and other antitrust tribunals.
Book Synopsis Pharmaceuticals, Corporate Crime and Public Health by : Graham Dukes
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.
Book Synopsis Strengthening Forensic Science in the United States by : National Research Council
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.
Book Synopsis Disease Control Priorities, Third Edition (Volume 6) by : King K. Holmes
Download or read book Disease Control Priorities, Third Edition (Volume 6) written by King K. Holmes and published by World Bank Publications. This book was released on 2017-11-06 with total page 1027 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Book Synopsis Generic drug entry prior to patent expiration an FTC study by :
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:
Book Synopsis Patents in the Knowledge-Based Economy by : National Research Council
Download or read book Patents in the Knowledge-Based Economy written by National Research Council and published by National Academies Press. This book was released on 2003-08-11 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.
Book Synopsis Blocking Patents in European Competition Law by : Angelika S. Murer
Download or read book Blocking Patents in European Competition Law written by Angelika S. Murer and published by Kluwer Law International B.V.. This book was released on 2021-12-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: In practice and jurisprudence in European competition law, it is especially difficult to define the boundaries of patent abuse as an offence. In this thoroughly researched book, the author answers the question of when and how an application for a blocking patent can amount to an abuse of a dominant position under Article 102 TFEU. Drawing on legal literature and European Union (EU) case law, the presentation analyses a constellation of blocking patenting strategies and proposes potential remedies where abuse is involved. With detailed descriptions of the characteristics of potentially abusive and non-abusive behaviour regarding applications for blocking patents, the book provides the following and more: a comprehensive analysis of the case law of the EU courts on the abuse of a dominant position in cases which involve intellectual property rights; insights on how patenting strategies affect competition with a particular focus on the application of blocking patents; an overview of the developments in doctrine and practice which led to the current understanding of the seemingly conflictual goals of competition and intellectual property law; and insights on the difficulties of defining relevant markets and establishing whether an undertaking holds a dominant position. The book illustrates the mechanisms of blocking patenting strategies with examples from the pharmaceutical industry because blocking strategies have particular relevance in applying for patents in that context. A test scheme for analysing the application of a blocking patent under Article 102 TFEU is included. Additionally, the book provides an outlook on the topic of patents and shortages of supply in light of the COVID pandemic. Practitioners and policymakers requiring an understanding of the conceptual framework of the abuse concept within EU competition law and how it relates to patent strategies will welcome this invaluable book. They will not only be able to set the conduct of applying for blocking patents into the Article 102 TFEU context but also have decisive tools to approach questions on the intersection of patent law and competition law in the EU.
Book Synopsis Federal Public Land and Resources Law by : George Cameron Coggins
Download or read book Federal Public Land and Resources Law written by George Cameron Coggins and published by . This book was released on 2002 with total page 1272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This casebook is an authoritative introduction to the study of public land and resources law. Case studies, case notes, and examples illustrate points under consideration. Thought-provoking questions generate classroom discussion and hone students' legal reasoning. Representative topics include authority on public lands, wildlife resource, preservation, resource, and history of public land law.
Book Synopsis A Patent System for the 21st Century by : National Research Council
Download or read book A Patent System for the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2004-10-01 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. patent system is in an accelerating race with human ingenuity and investments in innovation. In many respects the system has responded with admirable flexibility, but the strain of continual technological change and the greater importance ascribed to patents in a knowledge economy are exposing weaknesses including questionable patent quality, rising transaction costs, impediments to the dissemination of information through patents, and international inconsistencies. A panel including a mix of legal expertise, economists, technologists, and university and corporate officials recommends significant changes in the way the patent system operates. A Patent System for the 21st Century urges creation of a mechanism for post-grant challenges to newly issued patents, reinvigoration of the non-obviousness standard to quality for a patent, strengthening of the U.S. Patent and Trademark Office, simplified and less costly litigation, harmonization of the U.S., European, and Japanese examination process, and protection of some research from patent infringement liability.
Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
