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Author : Anonim
Publisher : American Bar Association
Page : 484 pages
File Size : 50,9 Mb
Release : 2009
Category : Antitrust law
ISBN : 1604425628
Author : Roy Levy
Publisher : DIANE Publishing
Page : 226 pages
File Size : 51,8 Mb
Release : 1999
Category : Antitrust law
ISBN : 9781428953635
Author : Ann-Kathrin Lehnhausen
Publisher : Springer
Page : 85 pages
File Size : 51,5 Mb
Release : 2016-11-14
Category : Business & Economics
ISBN : 9783658165512
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.
Author : Amalia Athanasiadou
Publisher : Kluwer Law International B.V.
Page : 520 pages
File Size : 53,8 Mb
Release : 2018-08-14
Category : Law
ISBN : 9789403501147
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.
Author : Pierre Kobel,Pranvera Këllezi,Bruce Kilpatrick
Publisher : Springer
Page : 497 pages
File Size : 44,5 Mb
Release : 2017-09-20
Category : Law
ISBN : 9783319558134
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.
Author : Mélanie Thill-Tayara,George G. Gordon
Publisher : Unknown
Page : 0 pages
File Size : 45,8 Mb
Release : 2023-11-24
Category : Electronic
ISBN : 1954750102
In an era of unprecedented innovation in life sciences, where breakthroughs in pharmaceuticals, biotechnology, and healthcare are shaping global health and economies, "Pharmaceutical Antitrust: An Analysis of US and EU Law" is an indispensable guide. Edited by Mélanie Thill-Tayara and George Gordon, esteemed experts in antitrust law, this book offers a comprehensive examination of how competition laws are applied in the life sciences sector in the United States and the European Union. The book provides in-depth analysis of and practical insights regarding the effect of the complex interplay of IP, regulatory frameworks, and competition principles on issues related to marketing authorizations, exclusivities, patent acquisition and enforcement, mergers and acquisitions, collaboration agreements, pricing strategies, and distribution arrangements. Each chapter provides invaluable insights into the intricacies of antitrust, international cooperation among antitrust authorities, and the analysis of market dynamics within the pharmaceutical arena. This book is an indispensable companion for legal professionals, academics, regulators, and executives operating in the complex world of pharmaceuticals and antitrust law.
Author : United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Monopoly, and Business Rights
Publisher : Unknown
Page : 252 pages
File Size : 53,5 Mb
Release : 1989
Category : Competition, Unfair
ISBN : LOC:00005432054
Author : United States. Congress. Senate. Committee on the Judiciary
Publisher : Unknown
Page : 942 pages
File Size : 54,8 Mb
Release : 1961
Category : Antitrust law
ISBN : UCBK:C051765053
Author : United States. Congress. Senate. Committee on the Judiciary
Publisher : Unknown
Page : 60 pages
File Size : 40,7 Mb
Release : 2002
Category : Business & Economics
ISBN : STANFORD:36105050250302
Author : Anonim
Publisher : Unknown
Page : 455 pages
File Size : 49,6 Mb
Release : 2018
Category : Antitrust law
ISBN : 1641052139
Author : Herbert HOVENKAMP
Publisher : Harvard University Press
Page : 392 pages
File Size : 50,7 Mb
Release : 2009-06-30
Category : Law
ISBN : 0674038827
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.
Author : Pablo Figueroa,Alejandro Guerrero
Publisher : Edward Elgar Publishing
Page : 758 pages
File Size : 47,9 Mb
Release : 2019
Category : Business & Economics
ISBN : 9781785362613
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.
Author : Irina Haracoglou
Publisher : Edward Elgar Publishing
Page : 272 pages
File Size : 42,9 Mb
Release : 2008-01-01
Category : Law
ISBN : 9781848440111
This is an incredibly interesting book on an increasingly pertinent topic. . . the book is succinctly written and provides a comprehensive overview of EU law. . . providing a really useful analysis of the European cases concerned with the imposition of a duty to deal in relation to intellectual property. . . This book is a thoroughly enjoyable read, and perhaps because of its brevity the author retains her focus on the central issues being examined. I found it to be engaging and thought provoking. Jane Nielsen, Competition and Consumer Law Journal The book caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself. Journal of Intellectual Property Rights Using the example of research tools in biopharmaceutical research and innovation, this book examines the complexities of the relationship between two fundamental areas of law and policy intellectual property rights and competition law. It addresses a question that is certain to become paramount in other industries also: how to strike the balance between initial and follow-on innovation so as to ensure that access to essential research tools (or other fundamental elements to follow-on innovation) is not impeded. The book concludes by suggesting how competition law could be used to complement the patent balance. Competition Law and Patents caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself.
Author : United States. Congress. House. Committee on the Judiciary
Publisher : Unknown
Page : 938 pages
File Size : 53,6 Mb
Release : 1962
Category : Antitrust law
ISBN : LOC:00089184897
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.
Author : Margherita Colangelo
Publisher : Bloomsbury Publishing
Page : 257 pages
File Size : 54,9 Mb
Release : 2023-04-20
Category : Law
ISBN : 9781509965526
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.