File #2800: "2020_Book_ThePatentabilityOfSyntheticBio.pdf"
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1|Acknowledgements|6
1|Contents|7
1|About the Author|9
1|Abbreviations|10
1|Chapter 1: Introduction|12
2|References|15
1|Chapter 2: Synthetic Biology|17
2|2.1 Synthetic Biology|17
3|2.1.1 Definition of Synthetic Biology|17
4|2.1.1.1 Origin of the Term|17
4|2.1.1.2 Range of Definitions|19
4|2.1.1.3 Radically New Technology or Extension of Earlier Practices|23
4|2.1.1.4 Negative Connotation|24
4|2.1.1.5 Engineering Principles|25
3|2.1.2 Difference from Other Technologies|26
4|2.1.2.1 Genetic Engineering|27
4|2.1.2.2 Metabolic Engineering|28
4|2.1.2.3 Synthetic Chemistry|28
4|2.1.2.4 Systems Biology|29
4|2.1.2.5 Other Related Disciplines|30
2|2.2 Techniques, Research Areas and Applications|30
3|2.2.1 Techniques Used in Synthetic Biology|30
4|2.2.1.1 Designing Techniques|31
4|2.2.1.2 Production Techniques|32
4|2.2.1.3 Standardisation|33
3|2.2.2 Current Research Areas|34
4|2.2.2.1 Minimal Genome|35
4|2.2.2.2 Synthetic Life|37
4|2.2.2.3 Xenobiology|41
3|2.2.3 Futuristic Research Areas|43
4|2.2.3.1 De-extinction|44
4|2.2.3.2 Protocells|46
3|2.2.4 Applications|47
4|2.2.4.1 Health|47
4|2.2.4.2 Food and Agriculture|49
4|2.2.4.3 Energy and Fuel|50
4|2.2.4.4 Environment|52
4|2.2.4.5 Data Processing and Storing|52
4|2.2.4.6 Others|54
3|2.2.5 Technical Background: The Chemical and Informational Content of DNA|55
2|2.3 Market and Players|59
3|2.3.1 Market|59
3|2.3.2 Players|60
4|2.3.2.1 Governments|60
4|2.3.2.2 Universities and Research Institutions|61
4|2.3.2.3 Companies|63
4|2.3.2.4 Public|64
4|2.3.2.5 DIY Movement|66
2|2.4 Risks, Concerns and Regulations|67
3|2.4.1 Risks and Concerns Connected to Synthetic Biology|67
4|2.4.1.1 Ethics|67
4|2.4.1.2 Safety|69
3|2.4.2 Synthetic Biology in the Normative and Regulatory Framework|73
2|References|75
1|Chapter 3: Norms and Patents in the Field of Synthetic Biology|89
2|3.1 Patent Norms Applicable to Synthetic Biology Inventions|89
2|3.2 The Patenting Landscape in the Field of Synthetic Biology|95
2|References|97
1|Chapter 4: The Patent Eligibility of Synthetic Biology Inventions|101
2|4.1 Patentable Subject Matter|101
3|4.1.1 Introduction|102
3|4.1.2 Inventions|103
4|4.1.2.1 Overview|103
4|4.1.2.2 Technical Requirement|106
5|European Normative Overview|106
5|European Case Law Overview|107
3|4.1.3 Discoveries|110
4|4.1.3.1 European Normative Overview|110
5|European Patent Convention|110
5|Biotech Directive|113
4|4.1.3.2 European Case Law Overview|116
5|European Patent Convention and the Pre-Directive Framework|116
5|Biotech Directive|119
3|4.1.4 Microorganisms|119
4|4.1.4.1 European Normative Overview|119
4|4.1.4.2 European Case Law Overview|121
3|4.1.5 Technical and Essentially Biological Processes|122
4|4.1.5.1 European Normative Overview|122
4|4.1.5.2 European Case Law Overview|123
3|4.1.6 The Laws and Product of Nature Doctrines|125
4|4.1.6.1 US Patent Norms|125
4|4.1.6.2 The Development of the Doctrines|126
4|4.1.6.3 The Laws of Nature Doctrine|127
4|4.1.6.4 The Product of Nature Doctrine Pre-Myriad|129
4|4.1.6.5 The Product of Nature Doctrine Post-Myriad|135
5|The Myriad Saga in the US|135
5|The Myriad Saga Around the World|142
5|Impact of the Myriad Decisions in Europe|144
3|4.1.7 Mathematical Methods|146
4|4.1.7.1 Overview|146
4|4.1.7.2 European Normative Overview|148
4|4.1.7.3 European Case Law Overview|150
4|4.1.7.4 American Normative and Case Law Overview|155
3|4.1.8 Presentations of Information|158
2|4.2 The Patentability of Synthetic Biology Inventions|160
3|4.2.1 Introduction|160
3|4.2.2 General Assessment|160
4|4.2.2.1 Applicable Norms|160
5|Biological Material|161
5|Consequences of the Inapplicability of the Biotech Directive|166
4|4.2.2.2 Subject Matter Patentability|169
5|Discovery and Invention|171
5|Degree of Change|173
5|Occurrence in Nature|175
5|Artificiality|176
5|Other Criteria|177
5|Protectable Items|178
3|4.2.3 Specific Assessment|179
4|4.2.3.1 Minimal Genome|180
5|Applicable Norms|180
5|Subject Matter Patentability|180
4|4.2.3.2 Synthetic Life|186
5|Applicable Norms|186
5|Subject Matter Patentability|187
4|4.2.3.3 Xenobiology|193
5|Applicable Norms|193
5|Subject Matter Patentability|195
4|4.2.3.4 Protocells|198
5|Applicable Norms|199
5|Subject Matter Patentability|200
4|4.2.3.5 Microorganisms|201
5|Applicable Norms|201
5|Subject Matter Patentability|202
4|4.2.3.6 De-extinction|204
5|Applicable Norms|205
5|Subject Matter Patentability|205
4|4.2.3.7 Data Processing and Encoding|209
5|Applicable Norms|209
5|Subject Matter Patentability|210
4|4.2.3.8 Algorithms and Simulation Tools|213
5|Applicable Norms|213
5|Subject Matter Patentability|214
4|4.2.3.9 Completely ex Novo|217
5|Applicable Norms|217
5|Subject Matter Patentability|218
3|4.2.4 Conclusions|220
2|References|221
1|Chapter 5: The Morality of Synthetic Biology Inventions|237
2|5.1 Exceptions to Patentability for Inventions Contrary to Ordre Public or Morality|237
3|5.1.1 Introduction|238
3|5.1.2 Normative Overview|241
4|5.1.2.1 EPC|241
5|Article 53(a) EPC|241
5|Rule 28 EPC|244
5|Relationship Between Article 52 and 53 EPC|245
4|5.1.2.2 Biotech Directive|246
5|Norms|246
5|History|251
4|5.1.2.3 Relationship Between Different Norms and Systems: The EPC and the Biotech Directive|253
4|5.1.2.4 TRIPS|254
4|5.1.2.5 Ordre Public and Morality|256
5|Scope of Interpretation|258
5|Common European Concept|260
5|Standards of Morality|262
5|Proof|263
5|History of the Invention|264
3|5.1.3 European Case Law Overview|264
4|5.1.3.1 Oncomouse|265
4|5.1.3.2 Plant Genetic Systems|267
4|5.1.3.3 WARF|270
4|5.1.3.4 Myriad|272
4|5.1.3.5 Brüstle|273
4|5.1.3.6 Other Cases|276
5|Lubrizol|276
5|Relaxin|276
5|Hairless Mouse|277
5|Leland Stanford|277
5|Michigan State|278
2|5.2 The Morality Clause and Synthetic Biology Inventions|278
3|5.2.1 Introduction|278
3|5.2.2 General Assessment|279
4|5.2.2.1 Relevant Moral Concerns|279
4|5.2.2.2 Applicable Norms|281
5|EPC|281
5|Directive|282
4|5.2.2.3 Balancing Exercise and Rebuttable Presumption Approaches|282
4|5.2.2.4 Environment|283
4|5.2.2.5 Safety, Dual-Use and Risks|284
4|5.2.2.6 Commercialisation|286
4|5.2.2.7 Impact of the Benefits Promised by Synthetic Biology|287
4|5.2.2.8 Public Perception|287
4|5.2.2.9 Perception of Equivalence|289
4|5.2.2.10 Perspectives and Conclusions|290
3|5.2.3 Specific Assessment|291
4|5.2.3.1 Minimal Genome|291
4|5.2.3.2 Synthetic Life|293
4|5.2.3.3 Xenobiology|297
4|5.2.3.4 Protocells|298
4|5.2.3.5 Microorganisms|299
4|5.2.3.6 De-extinction|299
4|5.2.3.7 Data Processing and Encoding|305
4|5.2.3.8 Algorithms and Simulation Tools|306
4|5.2.3.9 Completely ex Novo|306
3|5.2.4 Conclusions|307
2|References|309
1|Chapter 6: Novelty and Inventive Step|317
2|6.1 Introduction|317
2|6.2 Novelty|318
2|6.3 Inventive Step|322
2|References|324
1|Chapter 7: Conclusions|326
1|Index|328
1|Contents|7
1|About the Author|9
1|Abbreviations|10
1|Chapter 1: Introduction|12
2|References|15
1|Chapter 2: Synthetic Biology|17
2|2.1 Synthetic Biology|17
3|2.1.1 Definition of Synthetic Biology|17
4|2.1.1.1 Origin of the Term|17
4|2.1.1.2 Range of Definitions|19
4|2.1.1.3 Radically New Technology or Extension of Earlier Practices|23
4|2.1.1.4 Negative Connotation|24
4|2.1.1.5 Engineering Principles|25
3|2.1.2 Difference from Other Technologies|26
4|2.1.2.1 Genetic Engineering|27
4|2.1.2.2 Metabolic Engineering|28
4|2.1.2.3 Synthetic Chemistry|28
4|2.1.2.4 Systems Biology|29
4|2.1.2.5 Other Related Disciplines|30
2|2.2 Techniques, Research Areas and Applications|30
3|2.2.1 Techniques Used in Synthetic Biology|30
4|2.2.1.1 Designing Techniques|31
4|2.2.1.2 Production Techniques|32
4|2.2.1.3 Standardisation|33
3|2.2.2 Current Research Areas|34
4|2.2.2.1 Minimal Genome|35
4|2.2.2.2 Synthetic Life|37
4|2.2.2.3 Xenobiology|41
3|2.2.3 Futuristic Research Areas|43
4|2.2.3.1 De-extinction|44
4|2.2.3.2 Protocells|46
3|2.2.4 Applications|47
4|2.2.4.1 Health|47
4|2.2.4.2 Food and Agriculture|49
4|2.2.4.3 Energy and Fuel|50
4|2.2.4.4 Environment|52
4|2.2.4.5 Data Processing and Storing|52
4|2.2.4.6 Others|54
3|2.2.5 Technical Background: The Chemical and Informational Content of DNA|55
2|2.3 Market and Players|59
3|2.3.1 Market|59
3|2.3.2 Players|60
4|2.3.2.1 Governments|60
4|2.3.2.2 Universities and Research Institutions|61
4|2.3.2.3 Companies|63
4|2.3.2.4 Public|64
4|2.3.2.5 DIY Movement|66
2|2.4 Risks, Concerns and Regulations|67
3|2.4.1 Risks and Concerns Connected to Synthetic Biology|67
4|2.4.1.1 Ethics|67
4|2.4.1.2 Safety|69
3|2.4.2 Synthetic Biology in the Normative and Regulatory Framework|73
2|References|75
1|Chapter 3: Norms and Patents in the Field of Synthetic Biology|89
2|3.1 Patent Norms Applicable to Synthetic Biology Inventions|89
2|3.2 The Patenting Landscape in the Field of Synthetic Biology|95
2|References|97
1|Chapter 4: The Patent Eligibility of Synthetic Biology Inventions|101
2|4.1 Patentable Subject Matter|101
3|4.1.1 Introduction|102
3|4.1.2 Inventions|103
4|4.1.2.1 Overview|103
4|4.1.2.2 Technical Requirement|106
5|European Normative Overview|106
5|European Case Law Overview|107
3|4.1.3 Discoveries|110
4|4.1.3.1 European Normative Overview|110
5|European Patent Convention|110
5|Biotech Directive|113
4|4.1.3.2 European Case Law Overview|116
5|European Patent Convention and the Pre-Directive Framework|116
5|Biotech Directive|119
3|4.1.4 Microorganisms|119
4|4.1.4.1 European Normative Overview|119
4|4.1.4.2 European Case Law Overview|121
3|4.1.5 Technical and Essentially Biological Processes|122
4|4.1.5.1 European Normative Overview|122
4|4.1.5.2 European Case Law Overview|123
3|4.1.6 The Laws and Product of Nature Doctrines|125
4|4.1.6.1 US Patent Norms|125
4|4.1.6.2 The Development of the Doctrines|126
4|4.1.6.3 The Laws of Nature Doctrine|127
4|4.1.6.4 The Product of Nature Doctrine Pre-Myriad|129
4|4.1.6.5 The Product of Nature Doctrine Post-Myriad|135
5|The Myriad Saga in the US|135
5|The Myriad Saga Around the World|142
5|Impact of the Myriad Decisions in Europe|144
3|4.1.7 Mathematical Methods|146
4|4.1.7.1 Overview|146
4|4.1.7.2 European Normative Overview|148
4|4.1.7.3 European Case Law Overview|150
4|4.1.7.4 American Normative and Case Law Overview|155
3|4.1.8 Presentations of Information|158
2|4.2 The Patentability of Synthetic Biology Inventions|160
3|4.2.1 Introduction|160
3|4.2.2 General Assessment|160
4|4.2.2.1 Applicable Norms|160
5|Biological Material|161
5|Consequences of the Inapplicability of the Biotech Directive|166
4|4.2.2.2 Subject Matter Patentability|169
5|Discovery and Invention|171
5|Degree of Change|173
5|Occurrence in Nature|175
5|Artificiality|176
5|Other Criteria|177
5|Protectable Items|178
3|4.2.3 Specific Assessment|179
4|4.2.3.1 Minimal Genome|180
5|Applicable Norms|180
5|Subject Matter Patentability|180
4|4.2.3.2 Synthetic Life|186
5|Applicable Norms|186
5|Subject Matter Patentability|187
4|4.2.3.3 Xenobiology|193
5|Applicable Norms|193
5|Subject Matter Patentability|195
4|4.2.3.4 Protocells|198
5|Applicable Norms|199
5|Subject Matter Patentability|200
4|4.2.3.5 Microorganisms|201
5|Applicable Norms|201
5|Subject Matter Patentability|202
4|4.2.3.6 De-extinction|204
5|Applicable Norms|205
5|Subject Matter Patentability|205
4|4.2.3.7 Data Processing and Encoding|209
5|Applicable Norms|209
5|Subject Matter Patentability|210
4|4.2.3.8 Algorithms and Simulation Tools|213
5|Applicable Norms|213
5|Subject Matter Patentability|214
4|4.2.3.9 Completely ex Novo|217
5|Applicable Norms|217
5|Subject Matter Patentability|218
3|4.2.4 Conclusions|220
2|References|221
1|Chapter 5: The Morality of Synthetic Biology Inventions|237
2|5.1 Exceptions to Patentability for Inventions Contrary to Ordre Public or Morality|237
3|5.1.1 Introduction|238
3|5.1.2 Normative Overview|241
4|5.1.2.1 EPC|241
5|Article 53(a) EPC|241
5|Rule 28 EPC|244
5|Relationship Between Article 52 and 53 EPC|245
4|5.1.2.2 Biotech Directive|246
5|Norms|246
5|History|251
4|5.1.2.3 Relationship Between Different Norms and Systems: The EPC and the Biotech Directive|253
4|5.1.2.4 TRIPS|254
4|5.1.2.5 Ordre Public and Morality|256
5|Scope of Interpretation|258
5|Common European Concept|260
5|Standards of Morality|262
5|Proof|263
5|History of the Invention|264
3|5.1.3 European Case Law Overview|264
4|5.1.3.1 Oncomouse|265
4|5.1.3.2 Plant Genetic Systems|267
4|5.1.3.3 WARF|270
4|5.1.3.4 Myriad|272
4|5.1.3.5 Brüstle|273
4|5.1.3.6 Other Cases|276
5|Lubrizol|276
5|Relaxin|276
5|Hairless Mouse|277
5|Leland Stanford|277
5|Michigan State|278
2|5.2 The Morality Clause and Synthetic Biology Inventions|278
3|5.2.1 Introduction|278
3|5.2.2 General Assessment|279
4|5.2.2.1 Relevant Moral Concerns|279
4|5.2.2.2 Applicable Norms|281
5|EPC|281
5|Directive|282
4|5.2.2.3 Balancing Exercise and Rebuttable Presumption Approaches|282
4|5.2.2.4 Environment|283
4|5.2.2.5 Safety, Dual-Use and Risks|284
4|5.2.2.6 Commercialisation|286
4|5.2.2.7 Impact of the Benefits Promised by Synthetic Biology|287
4|5.2.2.8 Public Perception|287
4|5.2.2.9 Perception of Equivalence|289
4|5.2.2.10 Perspectives and Conclusions|290
3|5.2.3 Specific Assessment|291
4|5.2.3.1 Minimal Genome|291
4|5.2.3.2 Synthetic Life|293
4|5.2.3.3 Xenobiology|297
4|5.2.3.4 Protocells|298
4|5.2.3.5 Microorganisms|299
4|5.2.3.6 De-extinction|299
4|5.2.3.7 Data Processing and Encoding|305
4|5.2.3.8 Algorithms and Simulation Tools|306
4|5.2.3.9 Completely ex Novo|306
3|5.2.4 Conclusions|307
2|References|309
1|Chapter 6: Novelty and Inventive Step|317
2|6.1 Introduction|317
2|6.2 Novelty|318
2|6.3 Inventive Step|322
2|References|324
1|Chapter 7: Conclusions|326
1|Index|328