| Preface |
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v | |
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xv | |
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xii | |
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Table of Statutory Instruments |
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xiv | |
| Introduction |
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1 | (14) |
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1 | (4) |
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Common intellectual property issues in life sciences |
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5 | (8) |
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13 | (1) |
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14 | (1) |
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Part I Patents in the Life Sciences: Validity and Enforcement |
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15 | (208) |
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Chapter 1 Requirements for a Valid Patent I: Novelty |
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17 | (30) |
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17 | (1) |
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17 | (3) |
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Disclosure and enablement |
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20 | (4) |
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Plausibility of the prior art |
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24 | (1) |
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Prior art: made available to the public |
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25 | (1) |
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26 | (2) |
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KEY ISSUE: Confidentiality and clinical trials |
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28 | (2) |
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Prior art published on the internet |
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30 | (1) |
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Prior art: what has been made available? |
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30 | (1) |
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KEY ISSUE: Novelty and scope of claims |
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31 | (1) |
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Implicit disclosure, inevitability and inherency |
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32 | (1) |
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Selected compounds and parameters |
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33 | (1) |
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KEY ISSUE: Numerical ranges |
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34 | (1) |
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Increased purity and isolation |
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35 | (1) |
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36 | (1) |
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36 | (1) |
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KEY ISSUE: Claims to treating a sub-population |
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37 | (4) |
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41 | (6) |
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Chapter 2 Requirements for a Valid Patent 2: Inventive Step |
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47 | (24) |
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47 | (1) |
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47 | (2) |
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Factors when assessing inventive step |
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49 | (4) |
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53 | (2) |
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55 | (1) |
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56 | (1) |
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KEY CASE: 10 obviousness factors -- Actavis v ICOS |
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56 | (7) |
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KEY ISSUE: Plausibility obviousness |
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63 | (4) |
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67 | (1) |
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The plausibility threshold -- dasatanib T 488/16 |
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68 | (3) |
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Chapter 3 Requirements for a Valid Patent 3: Patentable Subject Matter and Exclusions |
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71 | (30) |
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71 | (1) |
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71 | (3) |
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KEY CASE: Sequence homology -- Human Genome Sciences v Eli Lilly |
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74 | (3) |
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77 | (1) |
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KEY ISSUE: Computer programs and computer-implemented inventions |
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78 | (3) |
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Discoveries and scientific theories |
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81 | (1) |
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Mathematical methods and mental acts |
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82 | (1) |
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83 | (2) |
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Presentations of information |
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85 | (2) |
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Non-patentable subject matter and the Biotechnology Directive |
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87 | (1) |
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Plant and animal varieties and essentially biological processes for their production |
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87 | (2) |
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Microbiological processes |
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89 | (1) |
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`Ordre public' and morality |
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90 | (2) |
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Stem cell-based inventions |
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92 | (2) |
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KEY ISSUE: Methods of treatment and diagnostics |
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94 | (2) |
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Treatment by surgery and therapeutic methods |
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96 | (2) |
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98 | (3) |
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Chapter 4 Requirements for a Valid Patent 4: Sufficiency |
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101 | (24) |
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101 | (1) |
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102 | (1) |
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KEY CASE: Classic insufficiency and principles of general application -- Regenewn v Kymab |
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103 | (5) |
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`Hybrid' claims to a recombinant DNA molecule -- Biogen v Medeva |
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108 | (1) |
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A `pure' product claim to escitalopram -- Generics (UK) v Lundbeck |
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109 | (1) |
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Consistency with principles in Regeneron v Kymab |
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109 | (1) |
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110 | (2) |
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112 | (1) |
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113 | (1) |
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114 | (1) |
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KEY CASE: Pregabalin for treating pain -- Warner-Lambert |
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114 | (5) |
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Plausibility under Articles 56 and 83 of the EPC compared |
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119 | (3) |
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Lack of clarity and uncertainty |
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122 | (1) |
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KEY CASE: Ceric oxide catalyst -- Anan Kasei v Neo Chemicals |
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122 | (3) |
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Chapter 5 Patent Infringement I: Scope of Protection of Claims |
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125 | (16) |
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125 | (1) |
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125 | (3) |
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KEY ISSUE: Doctrine of equivalents |
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128 | (1) |
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KEY CASE: Dipotassium and disodium equivalent -- Actavis v Eli Lilly |
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129 | (3) |
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Applying the doctrine of equivalents to a mechanical patent |
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132 | (4) |
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KEY ISSUE: Numerical ranges |
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136 | (2) |
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Taking account of novelty -- a Formstein objection? |
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138 | (3) |
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Chapter 6 Patent Infringement 2: Acts of Infringement |
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141 | (32) |
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141 | (1) |
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141 | (3) |
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KEY ISSUE: Offers to supply made before patent expiry |
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144 | (2) |
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146 | (1) |
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Products made by an infringing process |
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147 | (1) |
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KEY ISSUE: Second medical use claim infringement |
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148 | (1) |
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KEY CASE: Pregabalin -- Warner-Lambert |
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149 | (6) |
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Infringement of DNA sequences |
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155 | (1) |
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156 | (4) |
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KEY CASE: Disposable canister for use in wound dressing treatment apparatus -- KCI Licensing Inc v Smith & Nephew |
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160 | (4) |
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164 | (1) |
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Second medical use claims and indirect infringement |
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165 | (1) |
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166 | (1) |
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167 | (6) |
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Chapter 7 Patent Infringement 3: Defences |
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173 | (20) |
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173 | (1) |
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The Bolar and experimental use exemptions |
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173 | (2) |
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Original Experimental Use Exemption |
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175 | (2) |
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177 | (2) |
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KEY ISSUE: New Experimental Use Exemption |
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179 | (1) |
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180 | (2) |
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182 | (2) |
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KEY ISSUE: `Arrow declarations' |
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184 | (4) |
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188 | (2) |
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190 | (1) |
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190 | (3) |
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Chapter 8 Patent Infringement 4: Remedies |
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193 | (30) |
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193 | (1) |
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General provision of remedies |
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194 | (1) |
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KEY ISSUES: Preliminary injunctions |
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195 | (6) |
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201 | (1) |
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Preliminary injunction to appeal |
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202 | (1) |
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203 | (1) |
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Damages, account of profits, or reasonable royalty? |
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204 | (7) |
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211 | (1) |
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212 | (1) |
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KEY ISSUES: Stays and tailored relief in life sciences cases |
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213 | (3) |
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216 | (7) |
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Part II Patent Ownership, Dealings and Litigation |
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223 | (138) |
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Chapter 9 The European Patent System and Obtaining a Patent |
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225 | (24) |
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Introduction to the European Patent Organisation and European Patent Office |
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225 | (8) |
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Drafting strategies for European life sciences patents |
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233 | (6) |
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Prosecuting a patent application in the life sciences |
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239 | (6) |
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245 | (4) |
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Chapter 10 Rights in a Patent |
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249 | (12) |
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249 | (1) |
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249 | (10) |
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Effect on licensee of co-ownership and transfer |
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259 | (2) |
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Chapter 11 Patent Dealings |
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261 | (28) |
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261 | (1) |
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261 | (1) |
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262 | (6) |
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268 | (1) |
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269 | (1) |
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270 | (6) |
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276 | (1) |
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Compulsory licences and licences of right |
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277 | (2) |
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279 | (2) |
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281 | (3) |
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284 | (5) |
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Chapter 12 Patent Proceedings in the Courts of England and Wales |
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289 | (28) |
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289 | (1) |
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290 | (1) |
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291 | (1) |
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Commencement and statements of case |
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292 | (2) |
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Case management, security and admissions |
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294 | (2) |
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296 | (3) |
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299 | (1) |
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300 | (5) |
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305 | (3) |
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308 | (4) |
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312 | (5) |
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Chapter 13 Amendment and Parallel Proceedings in the EPO and the English Courts |
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317 | (24) |
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317 | (1) |
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317 | (7) |
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Parallel EPO and English proceedings |
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324 | (4) |
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328 | (13) |
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Chapter 14 Terminating Patent Agreements and Points of Dispute |
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341 | (20) |
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341 | (1) |
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Terminating a licence agreement for breach |
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341 | (4) |
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The absence of termination provisions: common law rights |
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345 | (4) |
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Getting termination right |
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349 | (6) |
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KEY ISSUE: Royalty disputes |
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355 | (6) |
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PART III Other Rights Protecting Life Sciences Subject Matter |
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361 | (196) |
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Chapter 15 Supplementary Protection Certificates |
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363 | (28) |
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363 | (1) |
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364 | (2) |
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366 | (4) |
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370 | (3) |
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`Protected by a basic patent' |
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373 | (1) |
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Resolving what `identified / specified' means |
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374 | (5) |
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379 | (7) |
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386 | (1) |
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KEY ISSUE: The manufacturing waiver |
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387 | (4) |
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Chapter 16 Data and Market Exclusivity Rights |
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391 | (22) |
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391 | (1) |
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392 | (5) |
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New active substances and global marketing authorisations |
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397 | (7) |
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404 | (9) |
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413 | (18) |
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413 | (1) |
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413 | (3) |
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The three elements of breach of confidence |
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416 | (11) |
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427 | (4) |
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Chapter 18 Plants and Genetic Resources |
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431 | (8) |
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431 | (1) |
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432 | (4) |
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436 | (3) |
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Chapter 19 Trade Marks, Passing Off, Designs and Copyright |
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439 | (54) |
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439 | (1) |
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Naming of medicinal products |
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440 | (2) |
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442 | (44) |
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486 | (1) |
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487 | (4) |
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491 | (2) |
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Chapter 20 Exhaustion of Rights, IP Offences and Customs Powers |
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493 | (28) |
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Application to life sciences |
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493 | (1) |
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494 | (15) |
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509 | (3) |
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Customs powers and procedures |
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512 | (9) |
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Chapter 21 Personal Data -- GDPR Rights and Obligations |
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521 | (36) |
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521 | (1) |
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GDPR: General principles and features |
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522 | (14) |
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KEY ISSUE: Clinical trials and health research -- selecting a lawful basis |
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536 | (4) |
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KEY ISSUE: Controller and processor roles in clinical research |
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540 | (3) |
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KEY ISSUE: Exemptions and derogations for scientific research |
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543 | (2) |
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545 | (2) |
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547 | (1) |
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The impact of Brexit on EU-derived UK law |
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547 | (1) |
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Does a deal make a difference? |
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548 | (1) |
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548 | (2) |
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Participation in the UPC and Unitary Patent |
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550 | (1) |
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Supplementary protection certificates |
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550 | (2) |
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Data and market exclusivity rights |
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552 | (1) |
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The authority of CJEU case law |
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553 | (4) |
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557 | (240) |
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Appendix A Patents Act 1977 |
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559 | (150) |
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Appendix B Trade Secrets (Enforcement, etc.) Regulations 2018 |
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709 | (12) |
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Appendix C Intellectual Property (Enforcement, etc.) Regulations 2006 |
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721 | (4) |
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Appendix D Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products |
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725 | (12) |
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Appendix E Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use |
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737 | (28) |
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Appendix F Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products |
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765 | (12) |
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Appendix G European Union (Withdrawal) Act 2018 |
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777 | (20) |
| Index |
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797 | |
