| | xix | |
| | xxi | |
| | xxvii | |
| Introduction | | xxxvii | |
| |
| The Drafting History of the European Biotechnology Directive |
| |
| | 3 | (3) |
| The Drafting History and Implementation of the Directive |
| | 6 | (11) |
| The European patent system |
| | 6 | (1) |
| The rationale for the Directive |
| | 7 | (3) |
| 1989-1995: The politicization of biotech patents and the mobilization of European civil society |
| | 10 | (1) |
| Potential clashes with ethical principles and other instruments |
| | 11 | (1) |
| Concerns raised by EPO decisions |
| | 12 | (1) |
| | 13 | (1) |
| 1995-1998: The second draft of the Directive |
| | 14 | (1) |
| Overview of the Directive |
| | 14 | (2) |
| The implementation of the Directive |
| | 16 | (1) |
| The Genealogy of Article 6(2)(c) |
| | 17 | (9) |
| The `human body' and the `human embryo' |
| | 17 | (5) |
| The subsequent emergence of hESC technology |
| | 22 | (2) |
| Questions concerning the patentability of hESC technology |
| | 24 | (2) |
| | 26 | (3) |
| II MORALITY, RESEARCH, AND ETHICS |
| |
| Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe |
| |
| | 29 | (3) |
| The Human Embryo: Moral and Legal Status |
| | 32 | (4) |
| | 36 | (8) |
| | 40 | (2) |
| | 42 | (1) |
| | 43 | (1) |
| | 44 | (7) |
| Requirements for embryo use in research |
| | 45 | (1) |
| | 45 | (2) |
| | 47 | (2) |
| Requirements for embryo destruction |
| | 49 | (2) |
| Procedural and Ethical Safeguards |
| | 51 | (4) |
| Stages of embryonic development |
| | 51 | (1) |
| | 52 | (1) |
| | 53 | (2) |
| | 55 | (3) |
| Human Embryonic Stem Cell Research in Central and Eastern Europe: A Comparative Analysis of Regulatory and Policy Approaches |
| |
| | 58 | (3) |
| | 58 | (1) |
| Informational differentiation |
| | 58 | (1) |
| Information technology use |
| | 59 | (1) |
| | 59 | (1) |
| Cultural differences concerning approach to information |
| | 59 | (1) |
| | 60 | (1) |
| Diversity as a primary discovery |
| | 61 | (1) |
| Societal Perception of Biomedical Sciences |
| | 61 | (6) |
| | 67 | (1) |
| | 68 | (7) |
| | 68 | (2) |
| | 70 | (1) |
| | 71 | (1) |
| | 72 | (1) |
| | 72 | (1) |
| | 73 | (1) |
| | 74 | (1) |
| | 74 | (1) |
| | 75 | (1) |
| | 75 | (1) |
| | 75 | (1) |
| Informed consent of the donor |
| | 75 | (1) |
| | 75 | (1) |
| | 76 | (1) |
| Only hESC lines are allowed to be exported and imported |
| | 76 | (1) |
| Embryo implantation after research use is prohibited |
| | 76 | (1) |
| | 76 | (1) |
| hESC Research and the Convention on Human Rights and Biomedicine |
| | 76 | (1) |
| | 77 | (1) |
| hESC Policy in CEE Countries |
| | 78 | (3) |
| | 80 | (1) |
| | 80 | (1) |
| | 81 | (1) |
| | 81 | (1) |
| | 82 | (1) |
| The Concepts of Regulation, Transparency, and Control vs Limitless Liberalism or the Rhetoric of Restriction |
| | 83 | (1) |
| | 84 | (1) |
| Morality Provisions in Law Concerning the Commercialization of Human Embryos and Stem Cells |
| |
| | 85 | (1) |
| Morality as a Constraint on Patenting Stem Cells |
| | 86 | (8) |
| Problem 1: No substantive definition of morality |
| | 87 | (2) |
| Problem 2: No procedural guidance on determining immorality |
| | 89 | (3) |
| The move towards stipulative prohibitions |
| | 92 | (2) |
| What is Wrong with Commercializing Stem Cells? |
| | 94 | (15) |
| | 95 | (4) |
| | 99 | (6) |
| | 105 | (2) |
| Not all embryos are created (or destroyed) equally |
| | 107 | (2) |
| Treating Stem Cells with Respect and Dignity |
| | 109 | (2) |
| | 111 | (6) |
| |
| A Comparative Analysis of the National Implementation of the Directive's Morality Clause |
| |
| | 117 | (2) |
| The Introduction of Article 6(2)(c) in National Law |
| | 119 | (10) |
| The legal background to Article 6(2)(c) |
| | 119 | (1) |
| The transposition process |
| | 120 | (2) |
| Amendments to Article 6(2)(c) in National Law |
| | 122 | (1) |
| | 122 | (1) |
| | 123 | (1) |
| | 124 | (5) |
| National Approaches to the Patenting of hESC Inventions |
| | 129 | (5) |
| Institutional strategies to ethical evaluation in patent law |
| | 129 | (1) |
| | 130 | (2) |
| | 132 | (1) |
| National decisions on hESC inventions |
| | 132 | (2) |
| | 134 | (8) |
| The Construction of the Directive's Moral Exclusions under the EPC |
| |
| | 142 | (1) |
| The Approach Taken in this Chapter---WARF did not Replace an Approach Starting from Basic Principle |
| | 143 | (1) |
| The Vienna Convention on the Law of Treaties (1969) |
| | 144 | (1) |
| Text, Context, and Purpose of Exceptions |
| | 145 | (1) |
| EPC Rules: the Directive as a Supplementary Guide |
| | 146 | (1) |
| The Practice of National Patent Offices |
| | 147 | (2) |
| The Technical Board of Appeal's Methodology for the Construction of the Moral Exclusion Clauses |
| | 149 | (2) |
| Implications for the Edinburgh and WARF Cases: Rule 23d(c) |
| | 151 | (1) |
| The Relevance of the Term `Uses' |
| | 152 | (4) |
| | 152 | (1) |
| | 153 | (1) |
| | 154 | (2) |
| The General Moral Exclusion Rule 53(a) |
| | 156 | (1) |
| `Ordre Public' and Morality |
| | 156 | (4) |
| Determination of European norms |
| | 158 | (1) |
| | 159 | (1) |
| Considerations on the EPO's Application of Article 53(a) EPC |
| | 160 | (2) |
| The Scope of the Rule 23d(c) EPC Exclusion |
| | 162 | (1) |
| The Test Case: WARF Before the Enlarged Board of Appeal |
| | 163 | (7) |
| | 164 | (1) |
| | 165 | (1) |
| | 165 | (2) |
| Industrial or commercial purposes |
| | 167 | (1) |
| The relationship with Article 53 EPC and the TRIPS Agreement |
| | 168 | (1) |
| | 169 | (1) |
| | 170 | (4) |
| Towards Systemic Legal Conflict: Article 6(2)(c) of the EU Directive on Biotechnological Inventions |
| |
| | 174 | (1) |
| The Rise of Institutional Moral Activism in European Patent Law |
| | 175 | (2) |
| The Broad Exclusionary Interpretation of Article 6(2)(c) |
| | 177 | (3) |
| Moral Parameters in EU Legislation |
| | 180 | (7) |
| EU Directive on Human Tissue and Cells |
| | 180 | (3) |
| EU Regulation on Advanced Therapies |
| | 183 | (4) |
| The Jurisprudence of European Courts |
| | 187 | (6) |
| Definitional vs moral tests |
| | 187 | (2) |
| `Industrial and commercial' |
| | 189 | (2) |
| Reassessing the scope of Article 6(2)(c) |
| | 191 | (2) |
| | 193 | (5) |
| | 193 | (2) |
| | 195 | (3) |
| Refocusing the Debate on Patents and Morality |
| | 198 | (4) |
| | 202 | (1) |
| Human Dignity, Human Rights, and Article 6(1) of the EU Directive on Biotechnological Inventions |
| |
| | 203 | (1) |
| Moral and Philosophical Foundations of Human Dignity |
| | 204 | (5) |
| Human Dignity in International Human Rights Instruments |
| | 209 | (3) |
| European Human Rights Instruments |
| | 212 | (1) |
| The European Convention on Human Rights and Biomedicine (ECHRB) |
| | 213 | (4) |
| The Protocol on the Prohibition of Cloning Human Beings |
| | 215 | (1) |
| The European Charter of Human Rights |
| | 216 | (1) |
| Human Dignity in National Constitutions |
| | 217 | (2) |
| Human Dignity and the Rights of the Embryo in European Courts |
| | 219 | (4) |
| European Court of Justice |
| | 220 | (2) |
| The ECtHR on the Rights of the Human Embryo |
| | 222 | (1) |
| The Future of General Moral Exclusions on Biotech Patents |
| | 223 | (3) |
| | 226 | (2) |
| Institutional and Jurisdictional Aspects of Stem Cell Patenting in Europe (EC and EPO): Tensions and Prospects |
| |
| | 228 | (1) |
| | 229 | (2) |
| Biotech Patents in European Community Law: Delimiting the Competence of the Community vis-a-vis its Member States |
| | 231 | (16) |
| The principles defining Community legislative competence |
| | 232 | (2) |
| Uniformity vs differentiation in European Community law |
| | 234 | (2) |
| Morality and ordre public: the margin of appreciation and the role of the ECJ |
| | 236 | (1) |
| Guidance from ECJ case law in the context of free movement of goods and services |
| | 237 | (5) |
| Guidance from ECJ case law on secondary Community law |
| | 242 | (3) |
| Morality in the Biotech Directive: judicial expansionism or restraint? |
| | 245 | (2) |
| The European Patent Organisation and its Jurisdiction and Competences in Biotech Patents |
| | 247 | (14) |
| The nature of the European Patent Organisation and the European Patent Convention |
| | 247 | (1) |
| Relationship with the Contracting States and with national law: harmonization through emulation |
| | 248 | (1) |
| | 249 | (1) |
| | 249 | (1) |
| Legislative and rule-making powers |
| | 249 | (1) |
| | 250 | (3) |
| The EPO's competence to rule on questions of morality |
| | 253 | (1) |
| The competence of the EPO in questions of morality prior to the Biotech Directive |
| | 253 | (2) |
| The taking over of the Biotech Directive: competence and jurisdiction |
| | 255 | (2) |
| The margin of appreciation for the EPO |
| | 257 | (4) |
| | 261 | (1) |
| Prospects: Will the Community Patent Offer a Solution? |
| | 262 | (6) |
| | 268 | (4) |
| A Transnational Institution Confronted with a Single Jurisdiction Model: Guidance for the EPO's Implementation of the Directive from a Private International Law Perspective |
| |
| | 272 | (1) |
| Starting Points---Taking a Somewhat Broader Approach |
| | 273 | (2) |
| | 275 | (5) |
| The Paris Convention 1883 |
| | 275 | (1) |
| | 275 | (1) |
| | 276 | (1) |
| | 276 | (1) |
| The Brussels Convention and the Brussels I Regulation |
| | 277 | (1) |
| Territoriality---exclusive jurisdiction |
| | 278 | (1) |
| The European Patent Convention 1973 |
| | 279 | (1) |
| A tailormade system---no real departure from principle |
| | 279 | (1) |
| Interim conclusion on the issue of jurisdiction |
| | 280 | (1) |
| | 280 | (8) |
| The Paris Convention 1883 |
| | 281 | (1) |
| Law of the country where protection is claimed |
| | 281 | (1) |
| | 282 | (1) |
| | 282 | (1) |
| The law of the country where protection is claimed again |
| | 283 | (1) |
| Domestic law in the United Kingdom |
| | 283 | (1) |
| | 284 | (1) |
| The lex protectionis in the case law |
| | 284 | (2) |
| Issues covered by the lex protectionis |
| | 286 | (1) |
| Interim conclusion on the issue of choice of law |
| | 287 | (1) |
| Moral and Ethical Issues---Public Policy |
| | 288 | (6) |
| Article 6 of the Directive |
| | 289 | (1) |
| The value of the recitals |
| | 289 | (2) |
| | 291 | (1) |
| Mandatory rules and public policy |
| | 291 | (1) |
| Regles d' application immediate |
| | 292 | (1) |
| How to determine the nature of the rules? |
| | 292 | (1) |
| Interim conclusion on public policy, mandatory rules, and morality |
| | 293 | (1) |
| Recognition and Enforcement of Foreign Judgments |
| | 294 | (1) |
| What Can We Derive from this Analysis? |
| | 295 | (6) |
| | 296 | (1) |
| No single concept of ethics and morality |
| | 297 | (1) |
| Alternatives open to the EPO |
| | 298 | (1) |
| | 298 | (2) |
| The ideal solution---pushing it one bit further |
| | 300 | (1) |
| The Enlarged Board of Appeal's Decision in WARF |
| | 301 | (1) |
| | 302 | (3) |
| |
| An Ethics Committee for Patent Offices? |
| |
| | 305 | (1) |
| | 306 | (3) |
| From an ideal of personal growth to an ideal of social stability |
| | 306 | (1) |
| From a field of uncertainty to a field of foreseeability |
| | 307 | (1) |
| From a consensual approach to an adjudicative approach |
| | 308 | (1) |
| National and Research Ethics Committees |
| | 309 | (9) |
| National ethics committees |
| | 309 | (5) |
| Research ethics committees |
| | 314 | (4) |
| The Integration of an Ethics Committee into the Patent Evaluation Process: A Judicious Concept? |
| | 318 | (4) |
| | 322 | (1) |
| The Research Exemption in Patent Law and its Application to hESC Research |
| |
| | 323 | (3) |
| The Scope of the Experimental Use Exemption |
| | 326 | (7) |
| | 326 | (1) |
| | 327 | (3) |
| | 330 | (3) |
| The Experimental Use Exemption in Biotechnological Research |
| | 333 | (6) |
| | 333 | (1) |
| | 333 | (2) |
| Extension of the experimental use exemption? |
| | 335 | (4) |
| The Experimental Use Exemption in hESC Research |
| | 339 | (3) |
| | 339 | (1) |
| | 339 | (3) |
| | 342 | (1) |
| Human Embryos, Patents, and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception |
| |
| | 343 | (3) |
| Divergent Views on the TRIPS Morality Exception |
| | 346 | (6) |
| The `necessity of a ban on commercial exploitation' view |
| | 346 | (1) |
| The `prohibition of commercial exploitation is not necessary' view |
| | 347 | (1) |
| The `EPO morality jurisprudence' view |
| | 348 | (1) |
| The `WTO jurisprudence on exceptions' view |
| | 349 | (3) |
| The Interpretation of TRIPS Article 27.2 |
| | 352 | (14) |
| General principles of interpretation |
| | 352 | (2) |
| | 354 | (3) |
| Context, object, and purpose |
| | 357 | (2) |
| Interpreting Article 27.2: The necessity of a ban on commercial exploitation |
| | 359 | (1) |
| | 360 | (1) |
| | 360 | (1) |
| The distinction between legality and morality in TRIPS |
| | 361 | (1) |
| The appropriateness of a two-tier `necessity' test |
| | 362 | (1) |
| A legal test for Article 27.2 of TRIPS |
| | 363 | (1) |
| Article 6(2)(c) of the EU Biotechnology Directive |
| | 363 | (1) |
| Morality and the EPC framework |
| | 364 | (1) |
| Prohibitions on the preliminary steps of manufacture |
| | 364 | (1) |
| TRIPS Article 27.3(b): The exclusion of `animals' from patentability |
| | 365 | (1) |
| | 366 | (3) |
| Stem Cells Patenting and Competition Law |
| |
| | 369 | (3) |
| IP Rights and Abuse of Dominant Position |
| | 372 | (25) |
| Origins of the essential facilities doctrine and its present status in the US |
| | 373 | (3) |
| Refusal to license and IP law in the European Community |
| | 376 | (11) |
| The market for stem cells |
| | 387 | (3) |
| Patented stem cells as essential facility? |
| | 390 | (3) |
| Anti-commons problem in stem cell patenting? Patent thickets, access to research tools, and possible solutions from a competition perspective |
| | 393 | (4) |
| | 397 | (2) |
| Bibliography | | 399 | (22) |
| Index | | 421 | |
