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| Acknowledgments | |
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| Introduction | |
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| Traditional Medical Knowledge, Biological Diversity and Intellectual Property Rights | |
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| The Concept of Traditional Medical Knowledge and the Impact of Biotechnology | |
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| A Definition of Traditional Medical Knowledge | |
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| Traditional and Indigenous Knowledge | |
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| Traditional Medical Knowledge | |
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| General Characteristics of Traditional Medical Knowledge | |
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| Traditional Knowledge Holders | |
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| Creation and Preservation | |
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| Ownership | |
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| The Role of Natural Resources in Pharmaceutical R&D | |
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| Overview | |
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| Pharmaceutical Biotechnology | |
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| Bioprospecting Research Project | |
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| The Value of Pharmaceutical Biotechnology and Traditional Medical Knowledge | |
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| The Value of Pharmaceutical Biotechnological R&D | |
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| The Value of Traditional Medical Knowledge | |
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| The Convention on Biological Diversity | |
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| Biological Diversity | |
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| Loss of Biodiversity | |
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| Consequences of Biodiversity Loss | |
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| Main Objectives of the CBD | |
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| Conservation and Sustainable Use | |
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| Access to Biological Resources and Benefit Sharing | |
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| National Sovereignty | |
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| The Tragedy of the Commons | |
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| The Role of Property Rights in Access and Benefit-Sharing Regulation | |
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| Article 8(j) CBD | |
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| The Elements of Traditional Knowledge Protection | |
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| Relationship with the Objectives | |
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| Form of Protection | |
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| Protection by Intellectual Property Rights | |
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| Positive and Negative Approaches to Protection | |
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| Trade-Related Intellectual Property Rights and Traditional Medical Knowledge | |
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| The TRIPS Agreement | |
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| Introduction | |
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| The International Legal Developments | |
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| The Economic Rationale of Intellectual Property Protection | |
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| Objectives of the TRIPS Agreement | |
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| Promotion of Free Trade | |
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| Promotion of Economic Development | |
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| Intellectual Property Rights and Developing Countries | |
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| General Principles of Non-Discrimination | |
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| National Treatment | |
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| Most-Favoured-Nation Clause | |
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| The International Legal and Economic Framework of Patents | |
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| Historical Development of Today's Patent Laws | |
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| Overview on TRIPS Rules on Patents | |
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| Patentable Subject Matter | |
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| Rules on Biotechnological Inventions and Biological Resources | |
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| Disclosure | |
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| The Economic Underlyings of Patenting | |
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| The Incentive-to-Invent Theory | |
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| Patent Scope | |
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| The Interaction Between Traditional Medical Knowledge, the TRIPS Agreement and the CBD | |
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| Traditional Knowledge in the TRIPS Context | |
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| Intellectual Property Rights and the CBD | |
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| Article 8(j) CBD - Preservation of and Respect for the Knowledge, Innovations and Practices of Traditional Communities | |
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| Conservation and Sustainable Use of Biodiversity | |
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| Article 15 CBD - Access to Genetic Resources and Fair and Equitable Benefit Sharing | |
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| Article 16 CBD - Access to and Transfer of Technology | |
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| Summary of the Main Results of Part 1 | |
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| The Status Quo - Protection of Traditional Medical Knowledge and Biotechnological Inventions Undercurrent Patent Law | |
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| Patentability Criteria in the US and the EU | |
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| Legal Foundations for (Biotechnological) Patents in the US and the EU | |
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| Sources of US Patent Law | |
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| The Constitution | |
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| Federal Statutes and Regulations | |
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| Case Law | |
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| European Patent Law | |
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| The European Patent Convention | |
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| The Biotechnology Directive | |
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| National Laws and Court Decisions | |
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| Substantive Patent Requirements | |
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| Products of Nature | |
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| US Patent Law | |
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| European Patent Law | |
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| Novelty | |
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| The State of the Art in US Patent Law | |
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| The European Approach to Novelty | |
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| Inventive Step and Non-Obviousness | |
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| US Patent Law - Non-Obviousness | |
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| European Patent Law - Inventive Step | |
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| Utility and Industrial Application | |
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| US-Utility | |
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| EU - Industrial Application | |
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| Specification | |
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| Disclosure of the Invention | |
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| US Patent Law | |
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| Europe | |
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| Patent Claims | |
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| Claim Categories | |
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| Claim Drafting | |
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| Concluding Remarks | |
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| Biotechnological Patents on Pharmaceutical Drugs Developed in Bioprospecting Research Projects | |
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| The Patentability of Biotechnological Inventions Using Traditional Medical Knowledge | |
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| Natural Products Doctrine | |
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| Traditional Medical Knowledge as Invalidating Prior Art | |
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| The Neem Patents | |
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| Analysis of the Prior Art Assessment in the Neem Proceedings | |
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| The Standard of Disclosure | |
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| Non-Obviousness in Bioprospecting Research Projects | |
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| US Patent Law: The Standard of Non-Obviousness in the Aftermath of KSR | |
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| The Inventive Step Requirement in Europe: Neem and Hoodia | |
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| Analysis of the Results | |
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| The Importance of Patents for Pharmaceutical R&D | |
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| The Predictability of the Outcomes of Patent Proceedings | |
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| The Rights of the Providers of Traditional Medical Knowledge | |
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| The Patentability of Traditional Medical Knowledge | |
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| Products of Nature | |
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| Novelty and Non-Obviousness | |
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| Formal Requirements | |
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| The Owner of the Patent: The Concept of Joint Inventorship | |
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| Legal Definition of joint Inventorship | |
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| Requirements for Joint Inventorship in US Patent Law | |
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| Joint Inventorship Under the EPC | |
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| Joint Inventorship of Traditional Knowledge Groups and Pharmaceutical Companies | |
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| Analysis of the Results | |
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| The Public Good Problem | |
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| Suboptimal Rate of Innovation | |
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| Free-Riding | |
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| Allocation of Resources | |
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| Implementation of the CBD | |
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| Prior Informed Consent | |
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| Benefit Sharing | |
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| Disclosure of the Origin of the Source | |
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| Summary of the Main Results of Part 2 | |
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| Protecting and Rewarding Traditional Medical Knowledge Contributions Under Property and Liability Regimes | |
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| The Property Rights-based Approach to Protection | |
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| The Construction of Traditional Knowledge Rights | |
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| Novel Interpretation of Existing Norms | |
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| Invention | |
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| Novelty and Inventive Step | |
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| Sui Generis Systems - Definition of New Rights for Indigenous Peoples | |
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| Implementation of Article 8(j) CBD Through Traditional Knowledge Rights | |
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| Interpretation and Infringement | |
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| Literal Infringement | |
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| The Doctrine of Equivalents | |
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| Implications for the Right of Traditional Knowledge Providers | |
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| Economic Analysis - The Effects of Patents in Cumulative Innovation Scenarios | |
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| Optimal Allocation of Rights and Division of Profits | |
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| Hold-Up and Anticommons | |
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| Conclusion | |
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| Co-Operation Between Indigenous Groups and Pharmaceutical Companies and Joint Inventorship | |
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| Modification of the Requirements | |
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| The Rights of Joint Inventors | |
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| Use of the Patented Invention | |
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| Sharing of Profits | |
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| Discussion | |
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| Conclusion on the Property Rights Approach | |
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| Benefit-Sharing Agreements and Liability Rules | |
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| Mandatory Benefit-Sharing Agreements as Conditions to Patentability | |
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| Benefit Sharing Under a Liability-Based Approach | |
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| Conditions of a Compensatory Liability Regime | |
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| Determination of the Value | |
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| Statutory Rules | |
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| Collective Rights Organizations | |
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| Impact of Benefit Sharing on Retail Costs of Pharmaceuticals | |
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| Conclusion on Benefit Sharing | |
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| Prior Informed Consent and Disclosure Requirements | |
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| The Content and Scope of the Requirements | |
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| Prior Informed Consent Requirement | |
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| Disclosure Requirements | |
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| Effects and Costs of Prior Informed Consent and Disclosure Requirements | |
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| The Sanction in Case of Non-Compliance | |
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| The Effects of Disclosure Requirements | |
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| The Effects of Prior Informed Consent | |
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| Compatibility with TRIPS | |
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| Prior Informed Consent | |
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| Disclosure Requirements | |
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| Substantive or Formal Requirements | |
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| Article 29 TRIPS | |
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| Article 62 TRIPS | |
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| Conclusion on Disclosure and Prior Informed Consent Requirements | |
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| Summary of the Results of Part 3 | |
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| Conclusion. The Results of the Analysis and the Implications for Future Discussions | |
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| Bibliography | |
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| List of Cases | |
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| About the author | |
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| About the series | |