Bibliothèque de L'IMIST/CNRST

Includes bibliographical references and index.

The patentability of genetic diagnostics in US law and policy / Rochelle C. Dreyfuss -- Patentability of pharmaceutical innovations : the European perspective / Rainer Moufang -- Patentability of medical methods in Japan / Nari Lee -- Patent term restoration and non-patent exclusivity in the US / Margo A. Bagley -- Clinical data, data exclusivity and private investment protection in Europe / Christian R. Fackelmann -- Patent term extension in Japan : an academic and comparative perspective / Ryoko Iseki -- Recent UK case law on supplementary protection certificates / Richard Arnold -- Patent term extension in Japan : focusing on the Pacif Capsule decision / Toshiaki Imura -- Strategic patenting by the pharmaceutical industry : towards a concept of abusive practices of protection / Hanns Ullrich -- Anticompetitive marketing in the context of pharmaceutical switching in Europe / Bengt Domeij -- AstraZeneca and the EU sector inquiry : when do patent filings violate competition law? / Josef Drexl.

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.