Embryonic Stem Cell Patents: European Patent Law and Ethics

Stem cell research, and particularly embryonic stem cell research, whilst 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, whilst 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 analyses 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.

PART I: BACKGROUND ; 1. The Drafting History of the European Biotechnology Directive ; PART II: MORALITY, RESEARCH AND ETHICS ; 2. Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe ; 3. Human Embryonic Stem Cell Research in Central and Eastern Europe: A Comparative Analysis of Regulatory and Policy Approaches ; 4. Morality Provisions in Law Concerning the Commercialisation of Human Embryos and Stem Cells ; PART III: EUROPEAN PATENT LAW ; 5. A Comparative Analysis of the National Implementation of the Directive's Morality Clause ; 6. The Construction of the Directive's Moral Exclusions under the EPC ; 7. Towards Systemic Legal Conflict: Article 6(2)(c) of the Biotech Directive ; 8. Human Dignity, Human Rights and Article 6(1) of the Biotech Directive ; 9. Jurisdictional and Institutional Aspects of Stem Cell Patenting in Europe (EC and EPO): Institutional and Jurisdictional Tensions of Stem Cells Patenting in Europe ; 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 ; PART IV: WIDER ISSUES ; 11. An Ethics Committee for Patent Offices ; 12. The Research Exemption in Patent Law and its Application to hES Cell Research ; 13. Human Embryos, Patents and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception ; 14. Stem Cells Patenting and Competition Law