Supplementary Protection Certificates Handbook

Paperback | May 8, 2018

byDaniel Alexander, Charlotte May, Sebastian Moore

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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 currentlyremain 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 the application and grant of these rights or their enforcement. The work provides the relevantbackground 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 SPC Regulations.

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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 Supp...

Daniel Alexander is a QC at 8 New Square. With over 20 years' experience of litigation and advice in intellectual property cases, his practice covers all areas of intellectual property. Cases have involved medical and plant biotechnology (including SPCs), pharmaceuticals, chemical process design, telecommunications and mobile phones. ...

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Format:PaperbackDimensions:336 pages, 9.69 × 6.73 × 0.01 inPublished:May 8, 2018Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199665230

ISBN - 13:9780199665235

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Table of Contents

1. Introduction2. The Origins of the SPC Regulations and Interpretation3. The Fundamental Tenets of the SPC Regulations and Their Impact4. Other Definitions and Terms5. Obtaining an SPC6. Scope of Protection and Infringement7. Formalities in an SPC Application, Entitlement and Grant8. Duration of the SPC, Expiry and Revival9. Invalidity10. The Transitional Provisions11. Paediatric Extensions12. Plant Protection Certificates13. Patent Extensions Outside of EuropeAppendices