Pharmaceutical Patents under the SPC Regulation

Ulla Callesen Klinge (Autor)

Buch | Hardcover

286 Seiten

2022
Edward Elgar Publishing Ltd (Verlag)
978-1-80392-737-4 (ISBN)

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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.

Ulla Callesen Klinge, PhD (Law), European Patent Attorney, M. Sc. (Chem. Eng.)

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

Erscheinungsdatum	05.10.2022
Reihe/Serie	Elgar Intellectual Property Law and Practice series
Verlagsort	Cheltenham
Sprache	englisch
Maße	169 x 244 mm
Themenwelt	Recht / Steuern ► EU / Internationales Recht
	Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht
	Recht / Steuern ► Wirtschaftsrecht ► Urheberrecht
ISBN-10	1-80392-737-2 / 1803927372
ISBN-13	978-1-80392-737-4 / 9781803927374
Zustand	Neuware