Supplementary Protection Certificates (patent Extensions)

Supplementary Protection Certificates (SPCs) (patents extensions) for pharmaceutical and veterinary products were introduced in Europe in 1993. This book uses examples of the impact of SPCs to illustrate the legal concepts described. It discusses the system for the grant of six month paediatric extensions to SPCs for medicinal products.

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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.This book provides a single, comprehensive and practical guide to the EU Regulations, drawing on caselaw from the EU Member States and the European Court of Justice. It uses examples of the impact of SPCs to illustrate the legal concepts described.
The book is the first to describe and discuss the system for the grant of six month paediatric extensions to SPCs for medicinal products.Dr Duncan Curley trained and qualified in the intellectual property department of a 'magic circle' law firm in London, eventually becoming a partner at the international law firm of McDermott, Will & Emery. He set up his own law firm - Innovate Legal - in June 2007, specialising in advice to companies operating in the pharmaceutical and biotech sectors. Dr Curley has appeared in a number of high profile cases throughout his career, including Lenzing v Courtaulds (judicial review of a decision by the European Patent Office), Bespak v 3M (patent revocation proceedings concerning metered dose inhalers) and BioProgress v Stanelco (patent dispute concerning drug encapsulation technology). He is the author of over fifty published articles and his first book - "Intellectual Property Licences and Technology Transfer" (published by Chandos) - is the leading practical textbook on the impact of European competition law on technology licensing and the block exemption.