Pharmaceutical Patents under the SPC Regulation

Author: Ulla Callesen Klinge
Publisher: Edward Elgar Publishing
ISBN: 9781803927374
Published In: October 2022
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

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.

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.

7. Subject Matter of Protection (Art.

4) and Effects of the Certificate (Art.

8. Conclusion on the Law as it is