This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
In this thoroughly updated second edition, Matthias Herdegen provides a comprehensive and contemporary assessment of the regulation of biotechnology processes and products from an international and comparative perspective, complete with analysis of intricate legal and ethical debates.
Undertaking the global project of improving intellectual property demands a critical and dynamic evaluation of its parameters and impacts. This innovative book considers what it means to improve intellectual property globally, exploring various aspects and perspectives of the international intellectual property debate and contemplating the possibilities for reform.
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.
Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.
This book examines patent law and policy in biotechnology across the full lifecycle of the patent, focusing on the patent bargain and the public interest. It considers the central issues of how to strike an effective balance of rights, and whether public interest is adequately safeguarded - two issues that are particularly important in areas of rapidly emerging technology.
This forward-looking book provides an in-depth analysis of the major transformations of the right to health in Latin America over the past decades, marked by the turn towards the pharmaceuticalisation of health care. Everaldo Lamprea-Montealegre investigates how health-based litigation has deepened inequalities in the global South, exploring the practices of key actors that are reclaiming the right to health in the region.