Hardback

Pharmaceutical Patents under the SPC Regulation

9781803927374 Edward Elgar Publishing
Ulla Callesen Klinge, PhD (Law), European Patent Attorney, M. Sc. (Chem. Eng.)
Publication Date: October 2022 ISBN: 978 1 80392 737 4 Extent: c 296 pp
Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.

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Contents
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Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.

Key Features:

• Broad, practitioner-oriented approach offers a useful source of reference alongside practical guidance
• Analysis of SPC case law in light of developments in pharmaceutical technology, including both legal and technical aspects of the cases
• Examination of the lack of clarity in interpretation of the legislation and how this might be exploited by stakeholders

Pharmaceutical Patents under the SPC Regulation is an indispensable practical resource for patent law practitioners, including patent attorneys and attorneys-at-law in the SPC field. It will also prove useful to national patent authorities, legislators, and academics working at the intersection between pharmaceuticals and legal research.
Critical Acclaim
‘This book provides an excellent account of the current legal frameworks applying to SPCs, as well as a splendid explanation of why and how new technological developments challenge these. It includes a highly coveted analysis of case law and practice in Europe and provides clear and pragmatic tools to reflect and guide future practice.’
– Timo Minssen, Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark

‘Modern pharmaceuticals pose significant challenges to the established SPC system in Europe. It is a highly topical question whether the European SPC Regulation is still fit for purpose. Pragmatic advice, improved legal certainty, but also wider policy proposals are needed. This book includes a comprehensive and competent analysis of case law and practice in Europe and provides clear and pragmatic tools to reflect and guide future practice. This is no surprise, given the author’s experience as a well-known European Patent Attorney in the field. The entire sector is thoroughly analysed and discussed in detail while at the same time always keeping in mind the high-level perspective and not getting lost in details. In short: This book belongs on the desk of every practitioner in the field and is at the same time interesting for academics.’
– Matthias Leistner, Ludwig-Maximilians-Universität München, Germany
Contents
Contents: Preface PART I INTRODUCTION AND CONTEXT 1. Introduction to Pharmaceutical Patents under the SPC Regulation 2. The Pharmaceutical Industry and the Surrounding Legal and Economic Environment PART II LEGAL ANALYSIS OF THE SPC REGULATION AS IT IS 3. Background and Purpose of the SPC System 4. Definition of “Product” and “Medicinal Product” 5. Eligibility for Protection of (Medicinal) Products under the SPC System 6. Conditions for Obtaining a Certificate (Art. 3) 7. Subject Matter of Protection (Art. 4) and Effects of the Certificate (Art. 5) 8. Conclusion on the Law as it is PART III LEGAL ANALYSIS OF THE SPC REGULATION WITH REGARD TO MODERN PHARMACEUTICAL INNOVATION 9. SPC protection for biotechnological medicinal products 10. Secondary innovation PART IV GENERAL FINDINGS AND FUTURE PROPOSALS 11. General Findings and Future Proposals Bibliography Index
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