Download or read book Pharmaceutical Industry Antitrust Handbook written by and published by American Bar Association. This book was released on 2009 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Industry Antitrust Handbook written by and published by . This book was released on 2018 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Download or read book Antitrust in Pharmaceutical Markets Geographical Rules of Origin written by Pierre Kobel and published by Springer. This book was released on 2017-09-20 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gathers international and national reports from across the globe on key questions in the field of antitrust and intellectual property. The first part discusses the application of competition law in the pharmaceutical sector, which continues to be a focus for anti-trust authorities around the world. A detailed international report explores the extent to which the application of the competition rules in the pharmaceutical sector should be affected by the specific characteristics of those products and markets (including consumer protection rules, the need to promote innovation, the need to protect public budgets, and other public interest considerations). It provides an excellent comparative study of this complex subject, which lies at the interface between competition law and intellectual property law. The second part of the book gathers contributions from various jurisdictions on the topic of “What rules should govern claims by suppliers about the national or geographic origin of their goods or services?” This section presents an international report, which offers an unparalleled comparative analysis of this topic, bringing together common themes and contrasting the various national provisions dealing with indications of origin, amongst other things. The book also includes the resolutions passed by the General Assembly of the International League of Competition Law (LIDC) following a debate on each of these topics, which include proposed solutions and recommendations. The LIDC is a long-standing international association that focuses on the interface between competition law and intellectual property law, including unfair competition issues.
Download or read book The Pharmaceutical Industry written by Roy Levy and published by DIANE Publishing. This book was released on 1999 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Studies on Competition and Antitrust Issues in the Pharmaceutical Industry written by Ann-Kathrin Lehnhausen and published by Springer. This book was released on 2016-11-14 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.
Download or read book Drug Industry Antitrust Act written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 1961 with total page 942 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Industry Antitrust Act written by United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust and Monopoly and published by . This book was released on 1961 with total page 1182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considers S. 1552 and companion H.R. 6245, the Drug Industry Antitrust Act, to amend the Federal Food, Drug, and Cosmetic Act and Sherman Antitrust Act to establish drug company licensing procedures, to require FDA to certify the effectiveness of all new drugs, to require advertisements sent to physicians to contain FDA warnings on the drug, and to limit drug company rights to exclusive production of patented drugs.
Download or read book Drug Industry Antitrust Act written by United States. Congress. House. Committee on the Judiciary and published by . This book was released on 1962 with total page 938 pages. Available in PDF, EPUB and Kindle. Book excerpt: Committee Serial No. 32. Considers legislation to eliminate anticompetitive practices in the patenting, licensing, and marketing of drugs, and to require FDA standardization of drug names and stricter safety and efficacy standards for new drugs.
Download or read book The Cambridge Handbook of Antitrust Intellectual Property and High Tech written by Roger D. Blair and published by Cambridge University Press. This book was released on 2017-04-07 with total page 873 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Cambridge Handbook, edited by Roger D. Blair and D. Daniel Sokol, brings together a group of world-renowned professors in the fields of law and economics to assess the theory and practice of antitrust, intellectual property, and high tech. With the increased globalization of antitrust, a better understanding of how law and economics shape this interface will help academics, policymakers, and practitioners to understand the existing state of academic literature, its limits, and its relevance to real-world antitrust. The book will be an essential resource for anyone seeking to understand academic and policy considerations shaping the world of antitrust, intellectual property, and high tech.
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Download or read book Antitrust Health Care Handbook written by and published by American Bar Association. This book was released on 2004 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: The most complete and up-to-date single-volume reference on health care antitrust law.
Download or read book EU and US Antitrust Arbitration written by Gordon Blanke and published by Kluwer Law International B.V.. This book was released on 2011-01-01 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: EU and US Antitrust Arbitration is the first book that deals with how both of the world's leading antitrust systems, US and EU law, are treated in international arbitration. In forty-nine chapters written by renowned experts, this book provides an in-depth examination of all relevant topics, from drafting arbitration clauses, to arbitrability, provisional measures, the applicability of antitrust law in arbitrations, dealing with economic evidence and experts in relation to antitrust law, to relations with courts and regulators, remedies, and recognition and enforcement of arbitration awards dealing with antitrust issues. Both antitrust and merger control are covered. The perspectives of the arbitrator and the in-house andquot;userandquot; of arbitration are included. Two chapters outline and explain US antitrust law and EU antitrust law with special reference to matters particularly likely to arise in arbitration. One chapter is devoted to ICC antitrust arbitrations and another to the emerging area of EU State aids in arbitration. There are industry-specific chapters, such as on telecommunications and pharmaceuticals, and much else. In this substantial book, practitioners will find helpful and easy-to-understand guidance to their questions on antitrust arbitrations.
Download or read book Research Handbook on International Competition Law written by Ariel Ezrachi and published by Edward Elgar Publishing. This book was released on 2012-01-01 with total page 615 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Research Handbook on International Competition Law brings together leading academics, practitioners and competition officials to discuss the most recent developments in international competition law and policy. This comprehensive Handbook explores the dynamics of international cooperation and national enforcement. It identifies initiatives that led to the current state of collaboration and also highlights current and future challenges. The Handbook features twenty-two contributions on topical subjects including: competition in developed and developing economies, enforcement trends, advocacy and regional and multinational cooperation. In addition, selected areas of law are explored from a comparative perspective. These include intellectual property and competition law, the pharmaceutical industry, merger control worldwide and the application of competition law to agreements and dominant market position. Presenting an overview of the current state of cooperation and convergence as well as a comparative analysis of substance and procedure, this authoritative Handbook will prove an invaluable reference tool for academics, competition officials and practitioners who focus on international competition law.
Download or read book Pharmaceutical Innovation Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Download or read book Antitrust Issues in the Pharmaceutical Industry written by Jonathan Ian Gleklen and published by . This book was released on 2003 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by Oxford University Press. This book was released on 2012-04-12 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.
