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Athanasiadou, Amalia
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Athanasiadou, Amalia
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- PublicationAccès librePatent settlements in the pharmaceutical industry : under U.S. antitrust & EU competitionThis book examines patent settlements between originators and generic pharmaceutical manufacturers under U.S. antitrust and EU competition law. The main focus of analysis is on patent settlements involving reverse payments, commonly known as pay for delay settlements. Reverse payments are big value transfers from the originator to the generic pharmaceutical manufacturer, arguably aiming to delay generic entry to the market. This book comparatively analyses the legal treatment of reverse payment patent settlements by U.S. and European courts and outlines the applicable tests and the criteria used for their assessment. It also discusses the evolution in the form of patent settlements throughout the years and the development of other types of strategies allegedly aiming to delay generic entry to the market. The ultimate goal is to provide guidance to the pharmaceutical industry regarding the types of patent settlements and strategies which may be problematic from a U.S. antitrust and EU Competition law perspective, in order to assist it in structuring settlements which are both efficient and compliant. Cet ouvrage examine les accords amiables en matière de brevets entre les laboratoires de princeps et les fabricants de génériques, sous le droit antitrust des États Unis et le droit européen de la concurrence. L’analyse concerne principalement les accords amiables moyennant « paiements inversés » aussi connus sous le nom d’accords « pay for delay ». Les paiements inversés sont des transferts de grandes valeurs provenant des laboratoires de princeps envers les fabricants de génériques, dans le but de retarder l’entrée de pharmaceutiques génériques sur le marché. L’objectif principal de cette étude est l’analyse comparée du traitement juridique et des critères d’évaluation des paiements inversés par les cours américaines et les cours européennes. L’évolution de la forme des accords amiables en matière de brevets et le développement des autres types de stratégies, ayant pour but de retarder l’entrée des génériques sur le marché, sont aussi au centre de l’analyse. Cet ouvrage expose également les différents types d’accords amiables et d’autres stratégies qui peuvent être problématiques sous le droit antitrust des États Unis et le droit européen de la concurrence, afin d’assister l’industrie pharmaceutique à créer des accords amiables pour qu’ils soient à la fois efficaces et légitimes.
- PublicationMétadonnées seulementLundbeck v. Commission: the first decision of the European General Court on reverse payments(2016-10-10)On September 8, 2016, the General Court of the European Union published its decision on Lundbeck v. Commission, its first decision on patent settlements involving reverse payments. This commentary focuses on the main points of the Lundbeck decision: the role of the patent and of the presumption of patent validity in the antitrust analysis, the issue of potential competition and the importance of the size of the payments. It presents the General Court’s analysis and considerations which led to a finding of a restriction of competition by object and also discusses the influence of the U.S. Supreme Court’s decision in FTC v. Actavis on the General Court’s reasoning. Finally, it argues that the General Court’s decision does not amount to a class condemnation of all patent settlements involving reverse payments as restrictions by object and maintains that the standard set by the Lundbeck decision is not necessarily harsher than the one embraced by FTC v. Actavis.
- PublicationMétadonnées seulementFTC v. Actavis: Are Reverse Payment Settlements Antitrust Immune?The purpose of this article is to analyse the Supreme Court’s decision in FTC v. Actavis and to provide an overview of the legal debate on reverse payment settlements in the U.S. and the EU. First, the facts and the holdings of the District and the Appellate Court on the Actavis settlement are presented. Second, an analysis of the scope of the patent test, the presumptive illegality approach and the Actavis rule of reason follows. Third, the main legal issues arising from the Supreme Court’s decision in Actavis are discussed, focusing on the question of no-authorized generic commitments in the context of the Effexor XR Antitrust Litigation. Finally, the European Commission’s initiatives on reverse payment settlements and the Lundbeck case are briefly presented. The decision of the General Court of the European Union in the Lundbeck case will be the first to set the standard for the review of reverse payment settlements under European competition law. This article aims to stress the need for the European Union to benefit from the troubled U.S. experience on reverse payment settlements.