Biotech Patents

Equivalency and Exclusion Under European and Us Patent Law

By: Li Westerlund

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Hardcover | 29 August 2002

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364 Pages

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This book discusses patent legal issues regarding inventions in the field of biotechnology. The scope of a patent is of central concern, and since biotechnology is very different from other technologies, the requirements for disclosure and infringement are in focus. Eligibility issues are touched upon, although from more of an explanatory perspective, since the law is settled in this respect.

The material for the analyses includes the European practices under the EPC, those of the United Kingdom, Germany, and the US. The mandated exclusions from patentability under the European patent laws of categories of plant and animal subject matter and certain biological processes are also analysed.

Claim interpretation is the common theme. The challenge has been to present a comprehensive basis for grasping the substantive law for the field of biotechnology. The book examines thoroughly the differences between practices, and the consequences of those differences for the possibility of being granted a patent for an invention, and the infringement doctrines' effects for what might be called a patent's 'after-life', i.e. the scope of its protection.

The principal message emerging in this book is the importance of relying on the policy arguments of uniformity and predictability in order to preserve a fair balance between an inventor and third parties, since in reality much of the controversy in this field turns on proper protection.

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Introduction	p. 1
Patents to Life Forms	p. 1
International and Regional Legal Instruments	p. 4
Eligibility	p. 5
The Basic Patentability Criteria	p. 6
Genetic Engineering	p. 7
Incentive to Invent	p. 9
Economics	p. 10
Intangible Content	p. 11
Drawbacks	p. 12
Complex Legal Situation	p. 13
Invention	p. 15
Exclusions from Patentability	p. 16
Proper Balance	p. 16
The Complex Picture Behind the Patent Systems	p. 17
Classical Methods of Assessing Patent Law	p. 18
Changes in Patent Practice Affect the Protection	p. 19
Trade Secret and Copyright Protection	p. 20
Scope of Study	p. 21
Division	p. 21
Mode of Operation	p. 22
Invention or Discovery	p. 23
Invention	p. 24
Legal Definition	p. 25
Invention as Opposed to Discovery	p. 25
Broadened Concept	p. 26
Typology	p. 26
Natural-Technological Processes	p. 27
Living Organisms- Products of Nature	p. 27
No New Properties	p. 28
Creation By Man	p. 28
Technical Means- New Organisms	p. 29
Living Organisms and Their Parts Patentable	p. 30
Prepared in Non-Natural Forms	p. 32
CDNA's are not 'Natural Products'	p. 33
Remarks	p. 34
Analysis	p. 35
Challenge of Traditional Concepts	p. 35
A Technical Solution (I)	p. 36
The Utilisaton of Natural Forces (II)	p. 38
The Inventive Kernel	p. 40
Existing in Nature	p. 42
The Human Body and Parts of the Human Body	p. 45
Not Freely Occurring in Nature	p. 47
Modifications at the Molecular Level	p. 48
The Necessity of Human Intervention	p. 49
The Result of Human Intelligence	p. 50
Patentability Problems	p. 52
Patentable Subject Matter	p. 53
An Exclusive Right to Exploit	p. 53
Production or Business Purpose	p. 56
Concluding Remarks	p. 56
Disclosure	p. 59
Functions of Disclosure	p. 60
Disclosing Inventions	p. 62
Identity of Invention	p. 63
The EPC	p. 63
Art. 83 EPC-Art. 84 EPC	p. 64
Disclosure and Scope of Claims	p. 65
Indentity of Invention	p. 68
Complex Technology	p. 68
Disclosed Indentity	p. 71
Identity Determination	p. 72
One Way to Carry out the Invention	p. 73
Proper Balance	p. 75
Rule of Presumption	p. 75
Not a Fixed Rule	p. 77
Serious Doubts	p. 77
Reversal of Proof	p. 78
Undue Burden of Experimentation	p. 79
Identical Results	p. 80
Repeatability of Examples	p. 81
Breadth of Claims	p. 82
Reproductability	p. 84
Sufficiently Disclosed	p. 86
The British Approach	p. 87
Practical Use	p. 89
Quid Pro Quo	p. 91
Concluding Remarks	p. 92
U.S. Patent Law	p. 92
Utility	p. 93
The EST Issue	p. 96
Partial Remedy for Overly Broad Claims	p. 97
Change in View	p. 98
Factual Proof	p. 99
The Biotechnological Field	p. 101
The USPTO Guideline	p. 102
Enablement	p. 105
Undue Burden of Experimentation	p. 106
Step-by-Step Method	p. 108
Effect Achieved Later On	p. 110
Technological Complexity	p. 112
Potential Rejection	p. 114
Broad Claims	p. 115
Factual Proof of Enablement	p. 117
Complex Biological Phenomena	p. 118
Remarks	p. 122
Strict Interpretation	p. 124
Concluding Remarks on Disclosure	p. 126
Early Filing	p. 127
Required Use	p. 129
Claim Drafting	p. 130
Comparative Aspects	p. 131
Scope of Claims	p. 132
Scope of Protection the Main Issue	p. 135
Protection	p. 137
Literal Infringement-British Law	p. 139
German Law	p. 141
The U.S. Practice	p. 142
Literal Protection	p. 145
Claim Limitations	p. 147
Literal Protection	p. 148
Remarks	p. 150
Equivalency	p. 151
British Practice	p. 152
Purposive Construction	p. 154
Claim Construction	p. 156
Threshold Test	p. 157
Material Effect	p. 159
After-Developed Technology	p. 159
The EPC-Requirements	p. 161
Claim Limitations	p. 163
Harmonisation	p. 165
The 'New' Approach	p. 167
Application of Equivalents	p. 170
German Practice	p. 171
Doctrine of Equivalents	p. 172
Indirect Equivalency	p. 174
Obviousness	p. 175
Chemical and Biochemical Patents	p. 176
Disclosure as Basis	p. 178
Claim Limitations	p. 179
Harmonisation	p. 182
The New Practice	p. 184
European Harmonisation	p. 187
Different Outcomes	p. 188
The EC Directive	p. 188
Translucent Approach	p. 190
Remarks	p. 192
U.S. Practice	p. 193
Equivalent Changes	p. 194
Biochemical Inventions	p. 196
Biotechnological Inventions	p. 199
Case Law	p. 202
Claim Litigation	p. 205
Standard of Difference	p. 206
Element-by-Element	p. 207
The FWR Test and Standard of Differences	p. 211
Functional Claim Language	p. 213
De Novo Claim Construction	p. 215
Restrictions of the Doctrine	p. 217
Freely Usable State of the Art	p. 219
Remarks	p. 221
Basis	p. 222
Summarising Remarks	p. 223
Different Policies	p. 225
Different Practicies	p. 228
Uncertainty	p. 229
Decisive Aspects for Infringement	p. 231
Element-By-Element Contra Invention-As-A-Whole	p. 232
Point in Time	p. 234
Comparative Conclusions	p. 236
Exclusions from Patentability	p. 239
The Purpose	p. 240
International Regulations	p. 240
Europe	p. 242
The Concept of 'Plant Variety'	p. 245
The Regulation	p. 246
The Criteria	p. 248
Remarks	p. 250
EPC Case Law	p. 251
The Interpretation	p. 254
Questions Answered	p. 255
Points of Interpretation Cleared	p. 257
Proper Interpretation	p. 258
A Substantive Approach	p. 262
Remarks	p. 263
Analysis	p. 264
Protectable Varieties	p. 266
Technical Feasibility	p. 267
Patent and Plant Breeder's Right Protection	p. 268
Protectable Plant Variety	p. 270
Accept the PBR Definition	p. 270
Relevant Criteria	p. 272
Clarification by the EC Directive	p. 274
Scope of Protection	p. 276
Well-Balanced System	p. 277
Weighting Pros and Cons	p. 278
The Concept of Animal Variety	p. 280
Legal Problems Specific to Animals	p. 283
Unclear Concept	p. 284
Proper Interpretation	p. 286
Methods of Interpretation	p. 287
Clarification	p. 288
The Purpose of Law	p. 290
Analogous Application of the DUS Criteria	p. 291
Concluding Remarks	p. 292
Other Ways to Protect Varieties (Excurs) US Law	p. 294
U.S. Plant Protection	p. 294
Patent Protection vs. Copyright Protection	p. 297
A Sui Generis System	p. 299
Process Plants	p. 303
Technical Character	p. 304
A Higher Level of Technicality	p. 305
Interpretation	p. 306
Analysis	p. 308
Technical Standard	p. 309
Effect of End Product	p. 310
Microbiological Processes and Their Products	p. 311
EPC Case Law	p. 311
Method of Interpretation	p. 313
The Concept	p. 314
Objective Technological Method	p. 316
Analysing Remarks	p. 317
Application	p. 318
Overall Analysis	p. 321
Analytical Framework	p. 322
Defined Right	p. 322
No Satisfactory Solution	p. 323
Plant Variety	p. 324
Standpoint of PBR Law	p. 325
Alternative Legal Understanding	p. 326
The Animal Variety Concept	p. 328
Shift in Perspective	p. 329
Alternate Understanding	p. 329
Essentially Biological Process	p. 331
Comprehensive View	p. 332
Microbiological Process	p. 332
Intrinsic Incoherence	p. 333
Historical Explanation	p. 334
Point of Departure	p. 336
Available Protection	p. 337
Double Protection	p. 338
Cross- and Compulsory Licensing (Excurs)	p. 339
Other Kinds of Protection (Excurs)	p. 341
Remarks	p. 341
Predictable Basis	p. 343
Rules of Interpretation	p. 344
Different Solutions	p. 345
Distinguishable Aspects	p. 346
Range of Equivalents	p. 348
Proper Basis	p. 349
Table of Contents provided by Syndetics. All Rights Reserved.

Biotech Patents

Equivalency and Exclusion Under European and Us Patent Law

At a Glance

Hardcover

Shipping

How to return your order

Defective items

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