Editors |
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v | |
Contributors |
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vii | |
Foreword: The Complex Terrain of Intellectual Property Governance |
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xxv | |
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Introduction |
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1 | (6) |
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PART I Patents and the Health Sector |
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7 | (136) |
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Chapter 1 TRIPS and Post-TRIPS Trade Agreements and Their Impact on Innovation |
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9 | (22) |
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9 | (6) |
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2 Trade as a Lever for More Extensive Protection Beyond the TRIPS Baseline |
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15 | (7) |
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3 Post-TRIPS Flexibilities in Patent Law |
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22 | (7) |
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3.1 Parallel Importing and TRIPS |
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22 | (3) |
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3.2 The EU Manufacturing Waiver |
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25 | (4) |
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4 Mounting Evidence That Multilateralism Is Preferable to FT AS for Innovation |
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29 | (2) |
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Chapter 2 In Between Breakthrough and Incremental Innovation: Rethinking Pharmaceuticals' Eligibility for IP Protection |
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31 | (30) |
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31 | (2) |
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2 Specifics of Pharmaceutical Innovation |
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33 | (4) |
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2.1 Pharmaceutical Innovation in the EU Regulatory Legislation |
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33 | (1) |
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2.2 Rationales for Incentivizing Primary and Secondary Innovation |
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34 | (3) |
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37 | (3) |
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4 Supplementary Protection Certificates |
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40 | (7) |
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4.1 Purposes of the SPC System |
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40 | (2) |
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42 | (5) |
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5 Regulatory Exclusivities |
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47 | (9) |
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5.1 Pharmaceutical Regulatory Framework in the EU |
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47 | (1) |
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5.2 Data and Market Protection for Reference Medicinal Products |
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48 | (3) |
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51 | (4) |
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55 | (1) |
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5.5 Paediatric Data and Market Exclusivity |
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56 | (1) |
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56 | (5) |
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Chapter 3 Human Enhancement and Patent Law |
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61 | (24) |
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61 | (3) |
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2 The Concept of HE and HET |
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64 | (4) |
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68 | (10) |
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4 Should HET Be Considered an `Ordinary' Invention? |
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78 | (4) |
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82 | (3) |
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Chapter 4 Do We Need Patent Protection for Biopharmaceuticals? |
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85 | (14) |
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85 | (4) |
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2 Why Do Biopharmaceuticals Need to Be Legally Separated from Chemical (Small Molecule) Medicinal Products? |
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89 | (1) |
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3 Categories of Biopharmaceuticals |
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90 | (3) |
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4 Why Do We Need Patent Protection for Biopharmaceuticals? |
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93 | (4) |
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97 | (2) |
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Chapter 5 Changing Approach to the Regulatory Testing Exemption in Patent Law: The European Union Perspective |
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99 | (24) |
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99 | (3) |
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2 Rationale for the Regulatory Testing Exemption: How Does It Impact Innovation? |
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102 | (2) |
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3 The Regulatory Testing Exemption in the EU: An Overview |
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104 | (5) |
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3.1 Article 10(6) of the Directive 2001/83/EC |
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104 | (1) |
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3.2 An Overview of the EU Bolar Exemption under the Current National Legislations |
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105 | (3) |
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3.3 An Overview of National Case Law |
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108 | (1) |
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4 Key Tendencies in the Approach to the Regulatory Testing Exemption in the EU |
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109 | (12) |
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4.1 The Regulatory Review Exemption Is Not Only Limited to the Abridged or Hybrid Procedure |
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109 | (4) |
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4.2 Extending the Regulatory Review Exemption to Registering Medicinal Products Abroad |
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113 | (2) |
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4.3 The Regulatory Testing Exemption Covers Third-Party Actions under the `Practical Requirements' |
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115 | (5) |
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4.4 The Regulatory Testing Exemption Includes Storage |
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120 | (1) |
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121 | (2) |
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Chapter 6 Rethinking SPC Protection: Manufacturing Waiver as an Incentive for the Generic Sector or a Disincentive to Innovators? |
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123 | (20) |
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Justyna Ozegalska-Trybalska |
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123 | (2) |
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2 Towards Extending Patent Protection by SPC and Limiting It by Manufacturing Waiver |
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125 | (2) |
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3 Derogation from Exclusivity: A Characteristic of the Manufacturing Waiver |
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127 | (5) |
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4 Derogation from Exclusivity or Exemption from Conferred Rights? |
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132 | (3) |
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5 Reviewing Arguments: A Chance of Increasing Competitiveness or Risk of Affecting Innovation? |
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135 | (8) |
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PART II Patents and Plants |
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143 | (66) |
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Chapter 7 Rethinking IP Protection for Plants? Revisiting the Exclusivity-Access Balance Through the Type-Token Ontology |
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145 | (16) |
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145 | (1) |
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2 Plant Breeding Techniques |
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146 | (2) |
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148 | (6) |
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3.1 Plant Breeder's Rights |
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148 | (1) |
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3.1.1 Eligible Subject Matter: Plant Varieties |
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149 | (1) |
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3.1.2 Substantive Protection Criteria |
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149 | (1) |
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150 | (1) |
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151 | (1) |
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3.2.1 Eligible Subject Matter: Plants |
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151 | (3) |
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3.2.2 Substantive Protection Criteria |
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154 | (1) |
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154 | (1) |
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4 Looking at the Exclusivity/Access Balance Through the Type/Token Lens |
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154 | (4) |
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4.1 Plant Breeder's Rights Law |
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155 | (2) |
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157 | (1) |
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5 Re-assessing the Exclusivity/Access Balance |
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158 | (1) |
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159 | (2) |
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Chapter 8 Non-patent Legal Factors of Marketability in Plant Biotechnology in Europe |
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161 | (20) |
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161 | (2) |
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2 The Goal of Patent Protection |
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163 | (1) |
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3 Patent Protection of Plants in Europe |
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164 | (4) |
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4 Plant Patents in Europe |
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168 | (2) |
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168 | (1) |
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169 | (1) |
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5 GMO Legislation in the EU |
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170 | (8) |
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5.1 Overview of the GMO Legislation |
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170 | (3) |
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5.2 New Plant Breeding Techniques and the Legal Status of Their Products |
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173 | (5) |
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178 | (3) |
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Chapter 9 The Farm-Saved Seed under the Community Plant Variety Rights System in the Light of the "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991 and Article 39(1) (a) TFEU |
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181 | (28) |
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Juan Antonio Vives-Valles |
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182 | (4) |
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1.1 The Community Plant Variety Rights System Within the UPOV System |
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182 | (1) |
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1.2 The FSS, a Controversial Exception |
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183 | (3) |
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2 The "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991 |
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186 | (1) |
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3 The FSS under the CPVR system |
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187 | (4) |
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3.1 "[ Safeguarding Agricultural Production" as the Grounds of the FSS under the CPVR System |
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187 | (3) |
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3.2 "[ Safeguarding Agricultural Production" as a Limitation of the FSS under the CPVR System |
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190 | (1) |
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4 The Grounds of the FSS under the CPVR System: Between the "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991 and Article 39(1)(a) TFEU |
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191 | (10) |
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4.1 The Grounds of the FSS in the CPVR System and the "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991 |
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191 | (2) |
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4.2 The Grounds of the FSS in the CPVR System as an Implementation in the Secondary EU Law of Article 39(1) (a) TFEU |
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193 | (1) |
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4.3 A Comprehensive Interpretation of the FSS under the CPVR System |
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194 | (7) |
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5 Further Considerations on the FSS under the CPVR System |
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201 | (5) |
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5.1 Extension of the Scope of the FSS under the CPVR System Beyond the Limits Set by the "Recommendation Relating to Article 15(2)" and the Logic of the EU Law |
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201 | (3) |
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5.2 Undue Influence of the List of Species in Article 14(2) of the Basic Regulation on National Lists of Species under the FSS |
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204 | (1) |
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5.3 The Evolution of the CAP and the FSS under the CPVR System |
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205 | (1) |
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206 | (3) |
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PART III Patents and Artificial Intelligence |
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209 | (58) |
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Chapter 10 AI Patents: Is There a Need to Rethink Patent Law? |
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211 | (24) |
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211 | (3) |
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2 AI Patents: Determining Invention and Its Patent Eligibility |
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214 | (8) |
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3 AI Patents and Innovation |
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222 | (7) |
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4 AI Patents and Public Interest |
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229 | (1) |
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230 | (5) |
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Chapter 11 Transparency in the Patent System: Artificial Intelligence and the Disclosure Requirement |
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235 | (18) |
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235 | (1) |
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2 The Disclosure Requirement in Patent Law |
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236 | (7) |
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2.1 Historical Background |
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237 | (2) |
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2.2 Current Role and Function |
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239 | (2) |
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2.3 Fixing the Disclosure Requirement |
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241 | (2) |
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3 Artificial Intelligence |
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243 | (3) |
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244 | (1) |
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245 | (1) |
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245 | (1) |
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246 | (4) |
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4.1 Al-Created Invention, Disclosed |
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247 | (1) |
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4.2 Inventive AI as the Invention, Disclosed |
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247 | (1) |
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4.3 Inventive Al/Working Requires AI, Disclosed, but Unexplainable |
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248 | (1) |
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4.4 Working Requires AI, Concrete Use of AI Undisclosed |
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248 | (1) |
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4.5 Working Requires AI, Invention Not Reproducible |
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249 | (1) |
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250 | (1) |
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251 | (2) |
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Chapter 12 Artificial Intelligence, Novelty and Inventive Step: What Is the Impact of AI on Patent Law? |
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253 | (14) |
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253 | (2) |
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2 What Is Artificial Intelligence? |
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255 | (3) |
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255 | (1) |
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2.1.1 Machine Learning and Deep Learning |
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255 | (1) |
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2.1.2 Evolutionary/Genetic Algorithms |
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256 | (1) |
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2.1.3 Artificial Neural Networks |
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257 | (1) |
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258 | (1) |
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3 Three Use Cases of AI and Patent Law |
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258 | (4) |
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258 | (1) |
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3.2 Product Design and Development |
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259 | (2) |
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261 | (1) |
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4 The Law on Novelty and Inventive Step |
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262 | (4) |
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262 | (1) |
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263 | (1) |
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4.3 Applying the Law to AI in General |
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264 | (1) |
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4.4 Applying the Law to the Use Cases |
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264 | (2) |
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5 Conclusions and Considerations |
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266 | (1) |
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PART IV Patents and ICT Sector |
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267 | |
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Chapter 13 Over-Enforcement Practices by Patent Assertion Entities in Europe: The Practice of National Courts |
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269 | (1) |
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1 Growing Concerns Regarding Over-Enforcement Practices by PAEs in Europe |
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270 | (25) |
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2 Identification of the Practices Adopted by PAEs |
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272 | (3) |
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3 The Response of National Courts to Over-Enforcement Practices of PAEs in Europe |
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275 | (15) |
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275 | (1) |
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3.2 Safeguards and Sanctions Imposed by National Courts |
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276 | (1) |
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3.2.1 Taking Advantage of Being an NPE |
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276 | (4) |
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3.2.2 Choice of Targeted Company |
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280 | (1) |
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3.2.3 Choice of Asserted Patents |
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281 | (2) |
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3.2.4 Frivolous Litigation |
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283 | (2) |
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3.2.5 Vague Demand Letters |
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285 | (1) |
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3.2.6 Threat of Injunction |
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286 | (1) |
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3.2.6.1 Preliminary Injunction |
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287 | (1) |
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3.2.6.2 Permanent Injunction |
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288 | (1) |
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289 | (1) |
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290 | (5) |
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290 | (2) |
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292 | (3) |
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Chapter 14 Standard Essential Patents: Between Open Access and Rewarding Innovation |
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295 | (22) |
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295 | (1) |
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2 The Legal Framework of the FRAND Declaration |
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296 | (4) |
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2.1 FRAND Declarations for Standardization |
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296 | (1) |
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2.2 The Direct Contractual Effect of the FRAND Declaration |
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297 | (1) |
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2.3 The Effect of the FRAND Declaration under EU Competition Law |
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297 | (2) |
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2.4 Result: Two Ways to a FRAND License |
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299 | (1) |
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3 The FRAND Defense under Huawei v. ZTE in Germany |
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300 | (12) |
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3.1 Limited Guidance from the CJEU |
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300 | (1) |
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3.2 The Sisvel v. Haier Case in the Federal Court of Justice |
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301 | (1) |
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3.2.1 The Decision of the Dusseldorf Higher Regional Court in Sisvel v. Haier |
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301 | (2) |
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3.2.2 Sisvel v. Haier Before the Federal Court of Justice |
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303 | (2) |
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3.2.3 Parallel Case Between Sisvel and ZTE |
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305 | (1) |
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3.3 Case Law of the Diisseldorf Higher Regional Court and Regional Court |
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305 | (1) |
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3.3.1 Diisseldorf Higher Regional Court--Unwired Planet v. Huawei |
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305 | (2) |
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3.3.2 Diisseldorf Regional Court--MPEG LA v. Huawei and MPEG LA v. ZTE |
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307 | (2) |
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3.4 The Case Law of the Karlsruhe Higher Regional Court and Mannheim Regional Court |
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309 | (1) |
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3.4.1 Mannheim Regional Court and Karlsruhe Higher Regional Court--Pioneer v. Acer |
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309 | (1) |
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3.4.2 Mannheim Regional Court--Philips v. Archos |
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310 | (1) |
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3.4.3 Mannheim Regional Court--Philips v. Asus and IP Bridge v.HTC |
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311 | (1) |
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3.4.4 Karlsruhe Higher Regional Court--Philips v. Wiko |
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312 | (1) |
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4 Summary of the Current Practice in FRAND Cases in Germany |
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312 | (4) |
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4.1 Transparency Requirement for FRAND Offers |
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313 | (1) |
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4.2 Royalty Review, Not Royalty Setting |
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313 | (1) |
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4.3 FRAND Defines a Range |
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314 | (1) |
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4.4 Formalities of the FRAND Negotiation |
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314 | (1) |
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315 | (1) |
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316 | (1) |
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Chapter 15 Should Standard Essential Patents Be Licensed to Makers of Components or Manufacturers of Final Products? A View from Competition Law Perspective |
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317 | |
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317 | (3) |
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2 Licensing SEPs to Manufacturers of Components Versus Licensing SEPs to Manufacturers of Final Products: Industry Perspectives |
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320 | (4) |
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2.1 Qualcomm's `No License, No Chips' Licensing Model |
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320 | (2) |
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2.2 Licensing in the Automotive Industry |
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322 | (1) |
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2.3 Industry Responses to Component Level Licensing |
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323 | (1) |
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3 Approaches Towards Refusal to License Component Makers in Selected Jurisdictions |
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324 | (11) |
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3.1 Recent Developments in the US |
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325 | (1) |
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325 | (1) |
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325 | (2) |
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3.1.1.2 Qualcomm's Royalties as an Artificial Surcharge |
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327 | (1) |
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3.1.1.3 Qualcomm's `No License, No Chips' Policy |
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328 | (1) |
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3.1.1.4 Critique of the Court of Appeals' Decision |
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329 | (2) |
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3.1.2 DOJ Business Review Letter Concerning Avanci Patent Pool |
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331 | (1) |
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3.2 Developments in the EU |
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332 | (1) |
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3.2.1 Nokia v. Daimler (Mannheim Regional Court) |
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333 | (1) |
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3.2.2 Nokia v. Daimler (Dusseldorf Regional Court) |
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333 | (1) |
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3.2.3 Huawei v. Nokia (Dusseldorf Regional Court) |
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334 | (1) |
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3.2.4 Licensing Between SEP Holders and Component Makers |
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334 | (1) |
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4 Future Developments: Possible Solutions - Conclusions |
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335 | |
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335 | (1) |
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4.2 Licensing Makers of Final Products Does Not Always Raise Competition Concerns |
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335 | (1) |
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4.3 Setting-up a Dedicated Licensing Company |
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336 | (1) |
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4.4 Room for Competition Law in Enforcing FRAND Commitments |
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336 | |