Supplementary Protection Certificates (Patent Extensions) book cover

Supplementary Protection Certificates (Patent Extensions)

Law and Practice

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. SPCs 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.

Paperback, 200 Pages

Published: May 2015

Imprint: Chandos Publishing

ISBN: 978-1-84334-411-7

Contents

  • 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 case law in detail; Analysing the raediatric regulation and paediatric extensions.

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