Pharmaceutical Industry Antitrust Handbook


Pharmaceutical Industry Antitrust Handbook
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Pharmaceutical Industry Antitrust Handbook


Pharmaceutical Industry Antitrust Handbook
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Author :
language : en
Publisher: American Bar Association
Release Date : 2009

Pharmaceutical Industry Antitrust Handbook written by and has been published by American Bar Association this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Antitrust law categories.




Pharmaceutical Industry Antitrust Handbook


Pharmaceutical Industry Antitrust Handbook
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Author :
language : en
Publisher:
Release Date : 2018

Pharmaceutical Industry Antitrust Handbook written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with Antitrust law categories.




Antitrust In Pharmaceutical Markets Geographical Rules Of Origin


Antitrust In Pharmaceutical Markets Geographical Rules Of Origin
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Author : Pierre Kobel
language : en
Publisher: Springer
Release Date : 2017-09-20

Antitrust In Pharmaceutical Markets Geographical Rules Of Origin written by Pierre Kobel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-20 with Law categories.


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.



Patent Settlements In The Pharmaceutical Industry Under Us Antitrust And Eu Competition Law


Patent Settlements In The Pharmaceutical Industry Under Us Antitrust And Eu Competition Law
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Author : Amalia Athanasiadou
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2018-08-14

Patent Settlements In The Pharmaceutical Industry Under Us Antitrust And Eu Competition Law written by Amalia Athanasiadou and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-14 with Law categories.


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.



Pharmaceutical Antitrust


Pharmaceutical Antitrust
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Author : Mélanie Thill-Tayara
language : en
Publisher:
Release Date : 2023-11-24

Pharmaceutical Antitrust written by Mélanie Thill-Tayara and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-24 with categories.


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.



Insurance Antitrust Handbook


Insurance Antitrust Handbook
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Author :
language : en
Publisher: American Bar Association
Release Date : 2006

Insurance Antitrust Handbook written by and has been published by American Bar Association this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Law categories.


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.



Drug Industry Antitrust Act


Drug Industry Antitrust Act
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Author : United States. Congress. Senate. Committee on the Judiciary
language : en
Publisher:
Release Date : 1961

Drug Industry Antitrust Act written by United States. Congress. Senate. Committee on the Judiciary and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1961 with Antitrust law categories.




Research Handbook On International Competition Law


Research Handbook On International Competition Law
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Author : Ariel Ezrachi
language : en
Publisher: Edward Elgar Publishing
Release Date : 2012-01-01

Research Handbook On International Competition Law written by Ariel Ezrachi and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-01 with Law categories.


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.



Eu Law Of Competition And Trade In The Pharmaceutical Sector


Eu Law Of Competition And Trade In The Pharmaceutical Sector
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Author : Pablo Figueroa (Lawyer)
language : en
Publisher:
Release Date : 2019

Eu Law Of Competition And Trade In The Pharmaceutical Sector written by Pablo Figueroa (Lawyer) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Antitrust law categories.


This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry. Key features include: Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level Coverage of various key developments including 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-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter. This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.



Competition And Innovation In The Eu Regulation Of Pharmaceuticals


Competition And Innovation In The Eu Regulation Of Pharmaceuticals
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Author : Claudia Desogus
language : en
Publisher:
Release Date : 2011

Competition And Innovation In The Eu Regulation Of Pharmaceuticals written by Claudia Desogus and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Drugs categories.


This book deals with parallel trade of pharmaceuticals from a law and economics perspective. Traditionally, restrictions to parallel trade were regarded negatively because they ran against the rules of the EU internal market. However, in recent judgments (Bayer, Glaxo, and Syfait), EU courts questioned some of the legal principles underpinning the EU policy on parallel trade in the field of pharmaceuticals. This shift suggested that there might be scope for improvement of such policy. However, how and to what extent this change should be performed remained partially unclear. Through the analysis of the impact that parallel trade of pharmaceuticals has on consumer welfare, both in a static and in a dynamic sense, this book examines whether the current legal approach to parallel trade of pharmaceuticals reflects the findings of economic theory, whether it should change, and, if so, on what basis this adjustment should take place. The analysis not only provides a policy assessment, but also offers some insights on one of the issues debated within the process of modernization of EU competition law: how judges should integrate economic reasoning in the antitrust assessment of corporate practices. The book will be particularly useful both for practitioners and legal scholars who want deepen their understanding of the EU pharmaceutical market and of the most recent EU judicial developments in that field, as well as of their implications for EU competition law in a 'modernized' context.