Full Description
Supplementary Protection Certificates are of great importance to the pharmaceutical industry as a method of increasing the length of market exclusivity for successful medicines to compensate for delays in marketing a product which results from compliance with the regulatory requirements. Providing a comprehensive commentary to the Supplementary Protection Certifcate Regulations (the SPC Regulations), this practical handbook highlights the various issues and uncertainties in the SPC Regulations which have not only been illustrated by EU wide case law but by cases which currently remain undetermined. The invaluable analysis provided by this work enables practitioners to make informed and strategic decisions in relation to these important rights, whether they are involved in theapplication and grant of these rights or their enforcement. The work provides the relevant background to the SPC Regulations in order to define their underlying purpose and to analyse problematic elements of this, before going on to provide an EU wide commentary on the individual provisions of the SPCRegulations.
Contents
1. Introduction ; 2. The Origins of the SPC Regulations and Interpretation ; 3. The Fundamental Tenets of the SPC Regulations and Their Impact ; 4. Other Definitions and Terms ; 5. Obtaining an SPC ; 6. Scope of Protection and Infringement ; 7. Formalities in an SPC Application, Entitlement and Grant ; 8. Duration of the SPC, Expiry and Revival ; 9. Invalidity ; 10. The Transitional Provisions ; 11. Paediatric Extensions ; 12. Plant Protection Certificates ; 13. Patent Extensions Outside of Europe ; Appendices
