Supplementary Protection Certificates Handbook
Published in 2013
Book
Paperback/Softback
336 pages
978-0-19-966523-5 (ISBN)
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 the
application 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 SPC
Regulations.
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 the
application 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 SPC
Regulations.
More details
Persons
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. Daniel Alexander's recent experience in relation to SPCs includes the disputes before the UK courts in Actavis v Sanofi; and Eli Lilly
v Human Genome Sciences.
Charlotte May is a barrister at 8 New Square. She was appointed as Standing Counsel to the Comptroller General of Patents and Trade Marks in December 2008, and has wide ranging experience in SPC related disputes in both the UK courts and the Courts of Justice of the European Union including Generics v Synaptech; Astellas Pharma Inc v Comptroller-General of Patents; E I DuPont v Comptroller-General of Patents, Neurim v Comptroller-General of Patents and Tulane Education Fund.
Sebastian Moore is a Partner in Intellectual Property at Herbert Smith Freehills. As well as running multi-jurisdictional pharmaceutical patent actions, he has advised a number of pharmaceutical and biotechnology companies on licensing and freedom to operate issues. He is a guest lecturer at the University of London and a tutor on the Oxford University Diploma in Intellectual Property Law and Practice. He has advised several multinational pharmaceutical and biotechnology companies in disputes
relating to SPCs including advising Sanofi in relation to its dispute with Actavis before national courts and the CJEU.
Jonathan Turnbull is a Senior Associate in Herbert Smith Freehill's Intellectual Property Team. Following his DPhil in Chemistry at Oxford University, he has assisted Sebastian Moore in running multi-jurisdictional pharmaceutical patent actions. He has also advised several multinational pharmaceutical and biotechnology companies on issues and disputes relating to SPCs and their licensing including their application to both small molecules, biological products and combination products,
including advising Sanofi in relation to its dispute with Actavis before national courts and the CJEU.
Gordon Wright is a Partner at Elkington and Fife LLP. Having worked over 20 years in the pharmaceutical industry, most recently as Head of Intellectual Property for Sanofi- Synthelabo in France, Gordon Wright handles mainly chemical and pharmaceutical subject matter. Gordon has an in-depth knowledge of IP topics specifically related to the pharmaceutical industry, including in particular SPCs, regulatory data exclusivity, product life cycle management, pharmaceutical trade marks, parallel
imports and arrangements, often taking a key part in structuring the deal and drafting the agreements.
v Human Genome Sciences.
Charlotte May is a barrister at 8 New Square. She was appointed as Standing Counsel to the Comptroller General of Patents and Trade Marks in December 2008, and has wide ranging experience in SPC related disputes in both the UK courts and the Courts of Justice of the European Union including Generics v Synaptech; Astellas Pharma Inc v Comptroller-General of Patents; E I DuPont v Comptroller-General of Patents, Neurim v Comptroller-General of Patents and Tulane Education Fund.
Sebastian Moore is a Partner in Intellectual Property at Herbert Smith Freehills. As well as running multi-jurisdictional pharmaceutical patent actions, he has advised a number of pharmaceutical and biotechnology companies on licensing and freedom to operate issues. He is a guest lecturer at the University of London and a tutor on the Oxford University Diploma in Intellectual Property Law and Practice. He has advised several multinational pharmaceutical and biotechnology companies in disputes
relating to SPCs including advising Sanofi in relation to its dispute with Actavis before national courts and the CJEU.
Jonathan Turnbull is a Senior Associate in Herbert Smith Freehill's Intellectual Property Team. Following his DPhil in Chemistry at Oxford University, he has assisted Sebastian Moore in running multi-jurisdictional pharmaceutical patent actions. He has also advised several multinational pharmaceutical and biotechnology companies on issues and disputes relating to SPCs and their licensing including their application to both small molecules, biological products and combination products,
including advising Sanofi in relation to its dispute with Actavis before national courts and the CJEU.
Gordon Wright is a Partner at Elkington and Fife LLP. Having worked over 20 years in the pharmaceutical industry, most recently as Head of Intellectual Property for Sanofi- Synthelabo in France, Gordon Wright handles mainly chemical and pharmaceutical subject matter. Gordon has an in-depth knowledge of IP topics specifically related to the pharmaceutical industry, including in particular SPCs, regulatory data exclusivity, product life cycle management, pharmaceutical trade marks, parallel
imports and arrangements, often taking a key part in structuring the deal and drafting the agreements.
Content
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