Patent Settlements in Europe and the Lundbeck Case - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Patent Settlements in Europe and the Lundbeck Case write by Jonas Frank. This book was released on 2017. Patent Settlements in Europe and the Lundbeck Case available in PDF, EPUB and Kindle. The paper studies the Lundbeck patent settlement antitrust case of the European Commission from an economic perspective. The Commission concludes that the agreements in Lundbeck involving reverse payments from the originator to generics have violated competition law. The paper shows that this decision is the correct one. More broadly the paper analyzes problem areas of patent settlement assessment in Europe. It assesses what we can learn from the U.S. patent settlement debate with particular focus on the differences in regulatory frameworks of the pharmaceutical sector which are relevant for patent settlement assessment. The recommendation is presented that, instead of taking into account the wide range of factors and effects which are important for the correct assessment of these agreements, we should rather aim at a more pragmatic approach. The paper suggests that a presumption of the illegality of reverse payments in patent settlements and a safe harbor rule for agreements without reverse payments can be a feasible approach.
Reverse Payment Patent Settlements in the European Union and the United States
Reverse Payment Patent Settlements in the European Union and the United States - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Reverse Payment Patent Settlements in the European Union and the United States write by Damien Geradin. This book was released on 2015. Reverse Payment Patent Settlements in the European Union and the United States available in PDF, EPUB and Kindle. In recent years, reverse patent settlement agreements -- whereby a patent holder pays or gives other forms of value to an infringer in order to avoid or to settle patent litigation -- have raised considerable debate in the pharmaceutical field in both the United States and the European Union, with the antitrust authorities and courts reaching different conclusions as to their compatibility with competition rules. In the United States, the Supreme Court addressed this matter in the Actavis case, in which it determined that reverse patent settlements should be assessed under the “rule of reason.” In contrast, the European Commission in its Lundbeck decision considered that reverse patent settlements were per object restrictions of EU competition law and therefore the effects of such agreements did not need to be analyzed. This decision is, however, being appealed before the General Court of the EU. In its more recent Servier decision, the Commission has modified its approach as, while it declared that the reverse patent settlements in question were per object restrictions, it also demonstrated that these agreements had anticompetitive effects. Against this background, we contrast the approaches taken in the US and the EU with respect to reverse patent agreements, and assess which approach makes the most sense. We also address a number of important questions, which are being looked at by lower courts in the US and may also be relevant in the EU.
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 - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law write by Amalia Athanasiadou. This book was released on 2018-08-14. Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law available in PDF, EPUB and Kindle. 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.
Competition and Patent Law in the Pharmaceutical Sector
Competition and Patent Law in the Pharmaceutical Sector - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Competition and Patent Law in the Pharmaceutical Sector write by Giovanni Pitruzzella. This book was released on 2016. Competition and Patent Law in the Pharmaceutical Sector available in PDF, EPUB and Kindle. Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Multi-dimensional Approaches Towards New Technology
Multi-dimensional Approaches Towards New Technology - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Multi-dimensional Approaches Towards New Technology write by Ashish Bharadwaj. This book was released on 2018-07-23. Multi-dimensional Approaches Towards New Technology available in PDF, EPUB and Kindle. This open access edited book captures the complexities and conflicts arising at the interface of intellectual property rights (IPR) and competition law. To do so, it discusses four specific themes: (a) policies governing functioning of standard setting organizations (SSOs), transparency and incentivising future innovation; (b) issue of royalties for standard essential patents (SEPs) and related disputes; (c) due process principles, procedural fairness and best practices in competition law; and (d) coherence of patent policies and consonance with competition law to support innovation in new technologies. Many countries have formulated policies and re-oriented their economies to foster technological innovation as it is seen as a major source of economic growth. At the same time, there have been tensions between patent laws and competition laws, despite the fact that both are intended to enhance consumer welfare. In this regard, licensing of SEPs has been debated extensively, although in most instances, innovators and implementers successfully negotiate licensing of SEPs. However, there have been instances where disagreements on royalty base and royalty rates, terms of licensing, bundling of patents in licenses, pooling of licenses have arisen, and this has resulted in a surge of litigation in various jurisdictions and also drawn the attention of competition/anti-trust regulators. Further, a lingering lack of consensus among scholars, industry experts and regulators regarding solutions and techniques that are apposite in these matters across jurisdictions has added to the confusion. This book looks at the processes adopted by the competition/anti-trust regulators to apply the principles of due process and procedural fairness in investigating abuse of dominance cases against innovators.
