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.
Reverse Payments
Reverse Payments - 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 Payments write by Daryl Lim. This book was released on 2014. Reverse Payments available in PDF, EPUB and Kindle. On its face, the United States Supreme Court's opinion in Federal Trade Commission (FTC) v. Actavis seemed to contain the elements of a straightforward antitrust indictment: a dominant drug company paid potential rivals millions of dollars not to compete at the cost of public access to cheaper medicine. The interests of these rivals, once aligned with those of the public, have been twisted to align with its former rival and current paymaster. According to an FTC report, these settlements cost consumers $3.5 billion a year. The Court likened these settlements to cases involving market division arrangements, hardcore offenses normally weeded out under a per se standard of illegality. However, it ultimately opted for a rule of reason approach. Lower courts were to balance benefits and anticompetitive harms, taking into consideration the size and scale of the payment in relation to the patent owner's anticipated litigation costs and any auxiliary services it received from the generic drug company. Large and unexplained payments could be used as a proxy for market power and anticompetitive harm, sparing lower courts the need for complex, costly and time-consuming inquiries into issues of patent validity and infringement.While the Hatch-Waxman Act makes it lucrative for generic challenges to induce settlements, the fact that the European Union faces similar issues in cases such as Lundbeck, Les Laboratoires Servier and others even without similar legislation is evidence that reverse payments occur outside the setting of the Act. Looking ahead, parties to a reverse payment will need to negotiate with a view that their agreement will be scrutinized by antitrust agencies and courts. Since at least 2005, settlements have evolved beyond cash payments to include other forms of consideration. Courts must now articulate how cross-licensing, service agreements and offers to delay authorized generic launches are to be assessed. Carelessly applied, Actavis could open litigation floodgates, dampening R&D by current and prospective patent owners. With the prospect and payoffs of settlement now tightened, generics could also be less willing to develop cheaper alternatives or challenge patents to bring such alternatives to market. In the United States where patent litigation is considerably higher than in Europe, these risks are more real and the consequences more dire. Beyond reverse payments, Actavis provides a rare and precious opportunity to move the dialogue on the interface between the patent and antitrust laws beyond mere platitudes. Most patent and antitrust stakeholders agree that both regimes seek to promote competition and innovation. An enduring disagreement remains, however, as to how these goals should be operationalized. The fierce rift between the majority and dissent vividly illustrates this: should we give primacy to visible marketplace rivalry or allow more latitude for private ordering between the settling parties? The true legacy of Actavis lies in the promise of catalyzing those from the patent and antitrust spheres into moving towards a realistic compromise on how the rules that affect them both should look like and function. Through debate, experimentation and refinement innate in the common law, future cases can craft pieces that will form a coherent analytical framework for the interface between patent and antitrust laws. The effort must be supported by constituents clear-headed enough to look beyond traditional prejudices, who are able to translate economic insights into workable legal rules, and who recognize that failure would mean that law at the interface will look a lot like the current state of American politics - divided, dysfunctional and a hotbed for empty rhetoric.
Patent Settlements in Europe and the Lundbeck Case
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.
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?
