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Supplementary Protection Certificates for Medicinal Products

Supplementary Protection Certificates for Medicinal Products

Author: Georgia A. Roussou
Publisher: Edward Elgar Publishing
ISBN: 9781035309955
Published In: April 2023
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

Details

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.

With rigorous analysis of the relevant case law, Supplementary Protection Certificates for Medicinal Products provides a unique and holistic insight into the interaction of the SPC system with the unified patent court, as well as with the principles laid down by competition law. Accompanied by specific proposals suggesting legislative change, the analysis of doctrinal issues demonstrates how the regulatory concerns regarding the instrumentalization of the SPC regulation can be resolved.

Providing a vertical overview of the regulatory issues related to the provision for SPCs for medicinal products, this comprehensive book will be an essential read for scholars in the fields of biotechnology and pharmaceutical law and intellectual property law. With insights into the interaction of the SPC system with the unified patent system, it will also appeal to both legal practitioners and policymakers in the field.

1. Supplementary protection certificates for medicinal products: an introduction

2. The long road to the enactment of the SPC Regulation

3. Legal analysis of the SPC Regulation (i): the meaning of the term “protected by a basic patent” under Art.

3 (a) SPC Regulation

4. Legal analysis of the SPC Regulation (ii): the meaning of the term “product” in the light of Art.

1 (b) and 3 (d) of the SPC Regulation

5. Interaction between the SPC Regulation and the unified patent system

6. The application of competition law in cases of supplementary patent protection

7. The future of SPC regulation

Bibliography

Index