Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law PDF Download
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Author: Amalia Athanasiadou Publisher: Kluwer Law International B.V. ISBN: 9403501146 Category : Law Languages : en Pages : 349
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: Amalia Athanasiadou Publisher: Kluwer Law International B.V. ISBN: 9403501146 Category : Law Languages : en Pages : 349
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: Herbert HOVENKAMP Publisher: Harvard University Press ISBN: 9780674038820 Category : Law Languages : en Pages : 392
Book Description
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: Wolf Sauter Publisher: Edward Elgar Publishing ISBN: 1802204415 Category : Law Languages : en Pages : 325
Book Description
This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Author: Angelika S. Murer Publisher: Kluwer Law International B.V. ISBN: 9403538155 Category : Law Languages : en Pages : 386
Book Description
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.
Author: Margherita Colangelo Publisher: Bloomsbury Publishing ISBN: 150996553X Category : Law Languages : en Pages : 257
Book Description
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.
Author: Ferdinand Wollenschläger Publisher: Kluwer Law International B.V. ISBN: 940350210X Category : Law Languages : en Pages : 439
Book Description
Private Enforcement of European Competition and State Aid Law Current Challenges and the Way Forward Edited by: Ferdinand Wollenschläger, Wolfgang Wurmnest & Thomas M.J. Möllers The overlapping European Union (EU) regimes of competition law and State aid law both provide mechanisms allowing private plaintiffs to claim compensation for losses or damages. It is thus of significant practical value to provide, as this book does, analysis and guidance on achieving enforcement of such claims, written by renowned authorities in the two fields. The book examines the two areas of law both from an EU perspective and from the perspectives of private enforcement in France, Germany, Italy, the Netherlands, Spain and the United Kingdom. In country reports for these major jurisdictions, as well as in more general and comparative chapters, the authors focus on such issues as the following: impediments to private enforcement; which entity is liable for damages; binding effect of decisions of competition authorities; limitation of actions; collective actions and pooling of claims; enforcement of the standstill obligation (Article 108(3) TFEU); remedies and information deficits; cooperation and coordination between national courts and the European Commission; transposition of the so-called Damages Directive (Directive 2014/104/EU) by the EU Member States; extent to which the strengthening of private enforcement of competition law has a spillover effect on State aid law; and prospects for harmonisation of State aid law. A concluding section identifies enforcement deficits and proposes ways to improve the existing legal framework. As an in-depth assessment of key obstacles and best practices in private enforcement actions, this highly informative and practical volume facilitates choice of the best forum for competition and State aid law cases. Academics and practitioners engaged with this important area of European law will appreciate the authors’ awareness of the economic need and legal particularities which could generate an effective European system of private enforcement of legitimate claims under EU competition and State aid law.
Author: Maciej Bernatt Publisher: Kluwer Law International B.V. ISBN: 9403502487 Category : Law Languages : en Pages : 1034
Book Description
International Competition Law Series#91 Enforcement of competition law often calls for a complex economic and legal assessment, and the review of those enforcement decisions usually falls to national courts. In this connection, however, European competition law and legal scholarship have offered scant guidance on how judicial review should and does function. This book, the first comprehensive, systematic, and comparative empirical study of judicial review of competition law public enforcement in the EU and the UK, provides a thorough understanding of the practical operation of the role of judicial review in competition enforcement. A country-by-country analysis, along with a detailed introduction and an incisive comparative summary, covers all publicly available judicial review judgments – 5,707 in all – of final public enforcement actions in relation to Articles 101 and 102 TFEU and relevant national provisions in the twenty-seven EU Member States and the UK rendered between 1 May 2004 and 30 April 2021. The data presented draws on a rich database built for the purpose of this study by twenty-eight national teams of competition law academics and practitioners. For each jurisdiction, the analysis focuses on such aspects as the following: structure of the national enforcement system; number of judgments rendered; success rate; types of appellants; competition rules subject to review; grounds of review; use of preliminary references; appeals involving leniency and/or settlements; and role of third parties. Numerous graphs, figures, and tables support the presentation. In the light it sheds on trends in judicial review of competition law enforcement on a comparative basis, and in its data-driven assessment of how the decentralised judicial review of EU competition law meets EU integration aims, this important study will be of inestimable value to competition lawyers, policymakers, and academics in developing a confident understanding of precisely how judicial review in this area operates in each of the EU Member States and the UK. In addition, the book provides a significant contribution not only with respect to EU and national competition laws but also, more broadly, to comparative administrative law scholarship in Europe.
Author: Giovanna Massarotto Publisher: Kluwer Law International B.V. ISBN: 9403511117 Category : Law Languages : en Pages : 291
Book Description
Competition enforcement authorities use settlements as a tool to ensure compliance with antitrust law. Companies can make commitments to remedy breaches, ensuring that they avoid litigation and potential fines and reputational damage. The author of this highly original and innovative book shows that, rather than fines or arguing principles of competition law in litigation, antitrust settlements (namely U.S. consent decrees and EU commitment decisions) hold the key to globally effective enforcement, particularly in the digital and blockchain era. Antitrust law does not necessarily need to be abolished, but rather should be fully exploited as an economic regulation led by antitrust settlements. In supporting her thesis, the author examines such elements of competition enforcement as the following: drawbacks of allowing the courts to regulate markets; whether antitrust settlements sacrifice antitrust deterrence; how settlements rapidly and surgically regulate markets; comparative analysis between U.S. consent decrees and EU commitment decisions; economic analysis on the adoption of antitrust settlements in both the U.S. and EU markets from 2013 to 2018; fundamental role of antitrust settlements in regulating the current digital markets; and comprehensive description on how to use antitrust settlements to regulate the data industry. With its thorough guidance on U.S. consent decrees and EU commitment decisions from their functioning to their characteristics and procedure—and its extensive treatment of the main antitrust remedies available and used in enforcing of antitrust law in both the U.S. and EU—the book provides both an economic and a legal analysis of the functioning and the scope of antitrust settlements. It assesses the influence of decisions on companies’ behavior and agencies’ practice, using economic analysis to show the procompetitive or anticompetitive effects of remedies, with special attention to digital markets. Because markets have become so dynamic and unpredictable that is difficult to preserve efficiency, the author says, there is a little room for law—economic regulation is a better fit. This book is a springboard to further investigate how a simple antitrust enforcement tool, having turned competition law into an economic regulation policy, can drive our economy, leading both the antitrust and regulatory interventions in tackling today’s market challenges.
Author: Amalia Athanasiadou
Author: Amalia Athanasiadou
Author: Giovanni Pitruzzella
Author: Herbert HOVENKAMP
Author: Wolf Sauter
Author: Angelika S. Murer
Author: Margherita Colangelo
Author: 
Author: Ferdinand Wollenschläger
Author: Maciej Bernatt
Author: Giovanna Massarotto