Pharmaceutical Industry Antitrust Handbook PDF Download
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Author:
Publisher: American Bar Association
ISBN: 9781604425628
Category : Antitrust law
Languages : en
Pages : 484
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Book Description
Author:
Publisher: American Bar Association
ISBN: 9781604425628
Category : Antitrust law
Languages : en
Pages : 484
Get Book
Book Description
Author:
Publisher:
ISBN: 9781641052139
Category : Antitrust law
Languages : en
Pages : 455
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Book Description
Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
ISBN: 9403501146
Category : Law
Languages : en
Pages : 520
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Book Description
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: Roy Levy
Publisher: DIANE Publishing
ISBN: 1428953639
Category : Antitrust law
Languages : en
Pages : 226
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Book Description
Author: Pierre Kobel
Publisher: Springer
ISBN: 3319558137
Category : Law
Languages : en
Pages : 497
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Book Description
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: United States. Congress. Senate. Committee on the Judiciary
Publisher:
ISBN:
Category : Antitrust law
Languages : en
Pages : 752
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Book Description
Author:
Publisher: American Bar Association
ISBN: 9781590317013
Category : Law
Languages : en
Pages : 172
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Book Description
Designed as an introduction and general guide to the federal (and, by extension, state) antitrust laws that govern the activities of the insurance industry, this handbook will help you properly advise insurance clients to whom the antitrust laws are new territory.
Author: Ann-Kathrin Lehnhausen
Publisher: Springer
ISBN: 3658165510
Category : Business & Economics
Languages : en
Pages : 85
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Book Description
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:
Publisher:
ISBN: 9781639052110
Category : Antitrust law
Languages : en
Pages : 0
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Book Description
"Representing a sizable portion of the American economy, few industries in the United States have received more attention from the press, legislators, and antitrust agencies than the health care industry, particularly in recent years. The health care industry is also one of the most complex and dynamic industries in the world. In the eleven years since the publication of the fourth edition of this handbook, individuals and companies in the industry have had to grapple with significant changes, including new laws and regulations, changes in managed care contracting, and a variety of significant economic pressures--and the antitrust agencies have promised to keep up with these changes and continue their robust enforcement in health care markets." --
Author: Gordon Blanke
Publisher: Kluwer Law International B.V.
ISBN: 9041127607
Category : Law
Languages : en
Pages : 1052
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Book Description
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.
