Supplementary Protection Certificates for Medicinal Products

Hardback

Supplementary Protection Certificates for Medicinal Products

9781035309955 Edward Elgar Publishing
Georgia A. Roussou, PPD Inc. and Max Planck Institute for Innovation and Competition, Munich, Germany
Publication Date: April 2023 ISBN: 978 1 03530 995 5 Extent: c 288 pp
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.

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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.
Critical Acclaim
‘The proposal for the SPC system (rather than simple patent term extension) referred to “the simplicity of the system” and called what was proposed “balanced simple transparent.” None of that proved true and, in my opinion at least, was obviously wrong at the time. Dr Roussou traces its complex history with battles between research based and generic pharma brilliantly. She valiantly attempts the impossible task of not just describing but also explaining the tortured reasoning of the CJEU on a flood of cases – which to some, me included, suggests the Court has no proper understanding of patent law (what is a “protected product”) nor regulatory law (very narrow and precise). She tackles the fuzzy interaction with competition law, the policy implications for pharma research, what’s to be done about the UPC and SPCs and where the system should go next. Not everyone will agree with her (I don’t on a number of points), but all will agree she has produced a valuable and provocative book.’
– Sir Robin Jacob, University College London, UK
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