Table Of ContentCOMMERCIALIZING
NANOMEDICINE
TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk
Pan Stanford Series on Renewable Energy — Volume 2
Pan Stanford Series on Renewable Energy — Volume 2
COMMERCIALIZING
NANOMEDICINE
Industrial Applications, Patents, and Ethics
editors
edited by
Preben Maegaard
Anna Krenz Luca Escoffier
Wolfgang Palz
Mario Ganau
Julielynn Wong
The Rise of Modern Wind Energy
Wind Power
for the World
CRC Press
Taylor & Francis Group
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Version Date: 20150811
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July24,2015 16:50 PSPBook-9inx6in 00-Luca-Escoffier-prelims
Contents
Preface xi
SECTION I
1 Nanomedicine:TheDawnofaNewEra 3
MarioGanau,MarcoParis,NicolaNicassio,
andGianfrancoK.Ligarotti
1.1 FactsandForecasts 3
1.2 AimsofNanomedicine 6
1.2.1 ImprovingDiagnosticTools 7
1.2.2 ImprovingDrugDelivery 9
1.2.3 ImprovingSurgicalStrategies 12
1.3 OrganizationsandOpenProjects 14
2 DiagnosticChallengesofNanomedicine 21
MarioGanau,AlessandroBosco,PietroParisse,
andLoredanaCasalis
2.1 BeyondConventionalDiagnostics 21
2.2 MiniaturizationandFunctionalizationTechniques 23
2.2.1 ConventionalPhotolithographyandBeyond 24
2.2.2 Micro-andNanocontactPrinting 27
2.2.3 Dip-PenNanolithography 29
2.2.4 AFMNanografting 30
2.3 EvolutionofBiosensorsforDiagnostics 33
2.3.1 OpticalReadout 34
2.3.2 RadiolabeledReadout 36
2.3.3 MassDetectionReadout 37
2.3.4 Mechanical-SensingReadout 39
2.3.5 DNA-DirectedImmobilization 40
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vi Contents
2.4 InvitroDiagnostics 41
2.4.1 TrendsinSingle-CellDNABarcodeAnalysis 42
2.4.2 TrendsinCarbonNanotubesandTheirUsein
MicrofluidicDevices 44
2.5 InvivoDiagnostics 46
2.5.1 ImplantableDevices 46
2.5.2 ImprovementsinConventionalRadiology 48
2.6 FutureTrends 49
3 SurgeryintheRealmofNanometers 59
MarioGanau,RobertoIsraelForoni,andRossanoAmbu
3.1 Introduction 59
3.2 PotentialImplicationsintheFieldofNanotechnology
andRegenerativeMedicine 60
3.2.1 Nanomaterials 60
3.2.2 NextGeneration’sProstheses 62
3.2.3 GeneTherapyandSurgicalProcedures 64
3.2.4 PreventingPostoperativeFibrosisand
ExcessiveCicatrization 65
3.3 CellularandSubcellularSurgicalProcedures 66
3.3.1 DesignImprovementsofNanosurgical
Instruments 68
3.4 Nanorobotics 69
3.4.1 MiniaturizedPropellingSystems 70
3.4.2 ArtificialCells 71
3.5 Brain–MachineInterfaces 73
3.6 Conclusions 75
4 Nanotherapeutics 81
JulielynnWong
4.1 Introduction 81
4.2 Biological,Physical,andChemicalPropertiesand
PharmacologicalEffectsofNanotherapeutics 82
4.3 Nanoformulations 85
4.3.1 Nanoemulsions 85
4.3.2 Liposomes 87
4.3.3 Micelles 88
4.3.4 Nanogels 88
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Contents vii
4.3.5 Dendrimers 89
4.3.6 PolymerConjugates 90
4.3.7 GoldNanoparticles 91
4.3.8 MagneticNanoparticles 93
4.3.9 ImprovedCancerTherapieswithNanobased
DrugCarriers 93
4.3.10EncapsulatingNanovaccines 94
4.3.11NanobeadVaccines 95
4.3.12MicronanoprojectionVaccines 95
4.3.13CombinedDesignApproachesfor
Nanovaccines 95
4.4 CommercialAdvantagesofNanoformulatedAgents 96
4.5 NanomedicinePublications,Patents,Product
Development,andCompanies 96
4.6 CurrentChallengesandPriorities 97
4.7 Nanotoxicity 98
4.8 FutureTrends 99
SECTION II
5 EthicsandNanoethics 111
MarioGanau,LaraPrisco,andLauraGanau
5.1 Introduction 111
5.2 LearningfromOurPast 112
5.3 UtopianPromises,DystopianFears 113
5.4 DevelopmentRegulations 114
5.5 EvolvingOurNature 115
5.6 Conclusions 116
6 NanomedicinePolicyandRegulationSchemes 119
SarahRouseJanosik
6.1 Overview 119
6.2 StandardizationofNanotechnologyTerminologyand
CharacterizationMethodologies 120
6.2.1 StandardizationofNanomedicineTerminology 121
6.2.2 StandardizationOrganizations 122
6.2.2.1 ASTMInternationalCommitteeE56 122
6.2.2.2 ISO/TR12802:2010 123
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viii Contents
6.2.3 StandardizationthroughPatentSystems 123
6.2.4 PhysicochemicalCharacterizationof
NanomedicalCompoundsandDevices 124
6.3 RegulationofNanomedicine 124
6.3.1 USFoodandDrugAdministration 124
6.3.2 USEnvironmentalProtectionAgencyandUS
ConsumerProductSafetyCommission 125
6.3.3 EuropeanMedicinesAgency 126
6.3.4 HealthCanada 127
6.4 Conclusion 128
SECTION III
7 OverviewofIntellectualPropertyRights 135
WimHelwegenandLucaEscoffier
7.1 Patents 136
7.1.1 Requirements 136
7.1.1.1 Patentablesubjectmatter 137
7.1.1.2 Novelty 138
7.1.1.3 Industrialapplication/utility 139
7.1.1.4 Inventivestep/nonobviousness 140
7.1.1.5 Disclosure 140
7.1.2 Postgrant 142
7.1.3 ExemptedUses 143
7.2 OtherformsofIntellectualProperty 144
7.2.1 UtilityModels 144
7.2.2 Copyright 145
7.2.2.1 Economicrights,moralrights,and
otherfeatures 146
7.2.3 Trademarks 146
7.2.3.1 Requirementsandcharacteristics 147
7.2.4 IndustrialDesigns 148
7.3 TradeSecrets 148
8 IPValuation:PrinciplesandApplicationsinthe
NanotechnologyIndustry 151
EfratKasznik
8.1 OverviewofIPValuation 151
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Contents ix
8.1.1 WhatIsIntellectualPropertyValuation? 151
8.1.1.1 BriefhistoryofIPvaluationinthe
UnitedStates 151
8.1.1.2 IPvaluationmethodologies 152
8.1.1.3 Typesofintangibleassets 153
8.1.2 IPValuationStandardsintheUnitedStates 154
8.1.2.1 IPvaluationlandscapeintheUnited
States 154
8.1.2.2 IPvaluationforlitigationdamages 155
8.1.2.3 IPvaluationforfinancialreporting 157
8.1.2.4 IPvaluationfortaxreporting 159
8.1.3 IPValuationCircumstancesinEurope 160
8.1.3.1 Litigationdamages 160
8.1.3.2 Financialreporting 161
8.1.3.3 Taxreporting 161
8.2 TheApplicationofIPValuationintheNanotechnology
Industry 162
8.2.1 IPValuationvs.Evaluation 162
8.2.2 ValuinganIPportfoliointheNanotechnology
Industry 163
8.2.2.1 Patentingalongthevaluechain 163
8.2.2.2 Technologytransferfromuniversityto
industry 164
8.2.2.3 Mitigatinglitigationrisk 165
9 Commercialization,Valuation,andEvaluationofNanotech
Innovations 169
LucaEscoffier
9.1 TheCommercializationofNanotechnology
Innovations 169
9.2 Cost,Price,andValue:PatentValuationvs.Patent
Evaluation 176
9.2.1 PatentValuation 178
9.2.1.1 Costapproach 180
9.2.1.2 Marketapproach 181
9.2.1.3 Incomeapproach 182
9.2.2 PatentEvaluation 184
9.2.2.1 Market 184
