Embryonic Stem Cell Patents: European Patent Law and Ethics

Overview

Stem cell research, and particularly embryonic stem cell research, while offering the prospect of developing theories for serious life-threatening diseases, also raises a number of difficult and controversial moral questions. This is reflected in a variety of moral perspectives and regulatory regimes, already adopted or in the process of being developed, in EU Member States. In particular the "moral exclusion" clause in Article 6 of the EC Directive on the legal protection of biotechnological inventions has ...

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Overview

Stem cell research, and particularly embryonic stem cell research, while offering the prospect of developing theories for serious life-threatening diseases, also raises a number of difficult and controversial moral questions. This is reflected in a variety of moral perspectives and regulatory regimes, already adopted or in the process of being developed, in EU Member States. In particular the "moral exclusion" clause in Article 6 of the EC Directive on the legal protection of biotechnological inventions has created much uncertainty in this field.

This collection of original essays provides comprehensive analysis of the EU patent system as applied to biotechnological inventions and particularly stem cell research, dealing with the overlapping EPC, EU, international and national law regimes bearing on the exclusion of patents in a morally fragmented and contested field. In this multidisciplinary study, the editors aim to clarify the legal scope of Article 6, which they deem essential for the fostering of research and investment in Europe, while ensuring that such research is conducted within clear ethical limits which address the concerns of society.

As well as a complete overview of the application of the European patent law in the field of human embryonic stem cells, topics covered include legal and philosophical accounts of the boards of the European Court of Justice and European Patent Offices' reasoning in the leading litigated cases, as well as the institutional tensions between national and transnational European research and patent regimes. With its broad research in the fields of patent law, ethics and philosophy, the book analyzes a wide range of issues in a way no other book has previously done and suggests solutions to unblock the current stalemate surrounding the patentability of human embryonic stem cell related inventions. The book will be welcomed by a broad readership, including experts and academics in both ethical and legal disciplines as well as policy makers and regulators in the field of embryonic stem cell research in Europe.

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Editorial Reviews

From the Publisher
"The book edited by Plomer and Torremans should be a compulsory reading for everyone interested in stem cell patenting in Europe. The essays of this book present the most thorough and complete analysis of the statutory and case law situation in this field in Europe."
—Joseph Straus, IP Max Planck Institute Munich

"There is more discussion in this text on stem-cell patents that an enthusiast could ever dream about"
—Anna Feros, European Intellectual Property Review

"A valuable read for students of IP, medical law, and for practitioners seeking a deeper understanding of rules they are working within. A fascinating and insightful collection"
—Leanne Bell, Medical Law Review

"An important read for any person interested in stem cell..patenting..Plomer and Torremans are to be complimented on a well-chosen set of essays,clearly written and logically presented"
—Ashley W. Roughton, Journal of Intellectual Property Law and Practice

"Plomer and Torremans collection helpfully concentrates the mind on a number of key questions"
—Roger Brownsword, Modern Law Review

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Product Details

  • ISBN-13: 9780199543465
  • Publisher: Oxford University Press, USA
  • Publication date: 2/8/2010
  • Pages: 440
  • Product dimensions: 6.30 (w) x 9.20 (h) x 1.40 (d)

Meet the Author

Edited by Aurora Plomer, Chair in Law and Bioethics, Director of Sheffield Institute of Biotechnology Law and Ethics, University of Sheffield, and Paul Torremans, City Solicitors' Educational Trust Professor of Intellectual Property Law, School of Law, University of Nottingham; Professor of Private International Law, Faculty of Law, University of Ghent

Professor Dr Aurora Plomer is Chair in Law and Bioethics and the Director of Sheffield Institute of Biotechnology Law and Ethics at The University of Sheffield. She has a dual background in Philosophy and Law. She is the Coordinator of a European FP6 funded project: Stem Cell Patents: European Patent Law and Ethics.

Professor Dr Paul Torremans is City Solicitors' Educational Trust Professor of Intellectual Property Law at the School of Law of the University of Nottingham and Professor of Private International Law at the Faculty of Law of the University of Ghent (Belgium).

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Table of Contents

PART I: BACKGROUND
1: Gerard Porter: The Drafting History of the European Biotechnology Directive
PART II: MORALITY, RESEARCH AND ETHICS
2: Rosario M. Isasi and Bartha M. Knoppers: Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe
3: Josef Kure: Human Embryonic Stem Cell Research in Central and Eastern Europe: A Comparative Analysis of Regulatory and Policy Approaches
4: Adrian Viens: Morality Provisions in Law Concerning the Commercialisation of Human Embryos and Stem Cells
PART III: EUROPEAN PATENT LAW
5: Åsa Hellstadius: A Comparative Analysis of the National Implementation of the Directive's Morality Clause
6: Paul Torremans: The Construction of the Directive's Moral Exclusions under the EPC
7: Aurora Plomer: Towards Systemic Legal Conflict: Article 6(2)(c) of the Biotech Directive
8: Aurora Plomer: Human Dignity, Human Rights and Article 6(1) of the Biotech Directive
9: Antonina Bakardjieva Engelbrekt: Jurisdictional and Institutional Aspects of Stem Cell Patenting in Europe (EC and EPO): Institutional and Jurisdictional Tensions of Stem Cells Patenting in Europe
10: Paul Torremans: A Transnational Institution Confronted with a Single Jurisdiction Model: Guidance for the EPO's Implementation of the Directive from a Private International Law Perspective
PART IV: WIDER ISSUES
11: Elodie Petit: An Ethics Committee for Patent Offices
12: Asa Hellstadius: The Research Exemption in Patent Law and its Application to hES Cell Research
13: Gerard Porter: Human Embryos, Patents and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception
14: Antonina Bakardjieva Engelbrekt: Stem Cells Patenting and Competition Law
PART I: BACKGROUND
1. The Drafting History of the European Biotechnology Directive, Gerard Porter
PART II: MORALITY, RESEARCH AND ETHICS
2. Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe, Rosario M. Isasi and Bartha M. Knoppers
3. Human Embryonic Stem Cell Research in Central and Eastern Europe: A Comparative Analysis of Regulatory and Policy Approaches, Josef Kure
4. Morality Provisions in Law Concerning the Commercialisation of Human Embryos and Stem Cells, Adrian Viens
PART III: EUROPEAN PATENT LAW
5. A Comparative Analysis of the National Implementation of the Directive's Morality Clause, Åsa Hellstadius
6. The Construction of the Directive's Moral Exclusions under the EPC, Paul Torremans
7. Towards Systemic Legal Conflict: Article 6(2)(c) of the Biotech Directive, Aurora Plomer
8. Human Dignity, Human Rights and Article 6(1) of the Biotech Directive, Aurora Plomer
9. Jurisdictional and Institutional Aspects of Stem Cell Patenting in Europe (EC and EPO): Institutional and Jurisdictional Tensions of Stem Cells Patenting in Europe, Antonina Bakardjieva Engelbert
10. A Transnational Institution Confronted with a Single Jurisdiction Model: Guidance for the EPO's Implementation of the Directive from a Private International Law Perspective, Paul Torremans
PART IV: WIDER ISSUES
11. An Ethics Committee for Patent Offices, Elodie Petit
12. The Research Exemption in Patent Law and its Application to hES Cell Research, Asa Hellstadius
13. Human Embryos, Patents and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception, Gerard Porter
14. Stem Cells Patenting and Competition Law, Antonina Bakardjieva Engelbert

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