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Vol 21 No 11 Nov/Dec 2016

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Criminal Injuries Compensation Claims

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Supplementary Protection Certificates (Patent Extensions): Law and Practice

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ISBN13: 9781843344117
To be Published: January 2025
Publisher: Woodhead Publishing Ltd
Country of Publication: UK
Format: Paperback
Price: £52.50



Supplementary Protection Certificates (SPCs) (patents extensions) for pharmaceutical and veterinary products were introduced in Europe in 1993. In 1996, a similar regime was introduced for agrochemical (crop protection) products.

SPCs extend the period of protection given by a patent for a maximum of five years after the patent has expired. They were intended to compensate patent holders for the loss of exclusivity caused by the requirement in the pharmaceutical and agrochemical industries to obtain regulatory approval before a product can be marketed.

Supplementary Protection Certificates are of enormous commercial significance to the pharmaceutical and biotechnology industries, since they provide additional monopoly protection at a time when many products are reaching peak sales. This book provides a practical, unifying and comprehensive guide to the law as it now stands

  • provides a comprehensive, practical guide to the EU Regulations
  • drawing on the caselaw from the EU Member States and the European Court of Justice, the book will contain an examination of the kinds of products that may be protected by SPCs and the limitations of the European SPC regime
  • the new system for the grant of six month paediatric extensions to SPCs for medicinal products will be described in detail

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Subjects:
Intellectual Property Law
Contents:
Introduction
Historical background: patent term erosion and the need for SPCs
The SPC regulation for pharmaceutical and veterinary products
The scheme of the regulation in outline
The SPC regulation for plant protection products
Scope of protection of SPCs: what are covered, what are not covered
Applying for SPCs: administrative aspects
SPCs in practice: the caselaw in detail
Analysing the raediatric regulation and paediatric extensions.