Intellectual Property / Patent / Copyright Medical Law Intellectual Property

Pharmaceutical Patents under the SPC Regulation

By Ulla Callesen Klinge
Edward Elgar Publishing October 2022

Specifications

ISBN-13
9781803927374
Publisher
Edward Elgar Publishing
Publication
October 2022
Format
Hardback
Jurisdiction
U.K. ? Countri(es) for reference only

Details

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.

Table of 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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