1. Introduction 1
A General 1
B The arguments 2
C The EPO jurisprudence 5
D The question of patentability 6
E The future of medical patents 7
2. Arguments for patent protection 9
A Introduction 9
B Incentive to disclose 11
C Incentive to invent/innovate 14
D The prospect theory 23
E Rent dissipation theory 27
F Reward/desert 31
G Liberty/autonomy 34
H Conclusion 39
3. Arguments against patent protection 41
A Introduction 41
B Methods and products 43
C Public health implications 45
D Physician liberty and autonomy 58
E Physician/patient relationship 60
F The Hippocratic Oath/sharing norm 61
G Other incentive structures 66
H Breach of patient’s privacy 68
I Conclusion 69
4. Therapeutic methods 71
A Introduction 71
B Legislative history 73
C Defining therapeutic methods 75
D Medical treatment and implantable devices 78
E Involvement of medical practitioners 88
F Cosmetic methods 89
G Contraceptive methods 97
H Animals 101
I New medical technology 112
J Conclusion 116
5. Surgical methods 117
A Introduction 117
B Legislative history 119
C The referral to the EBA 123
D Defining surgical methods 124
E MEDI-PHYSICS/treatment by surgery 138
F Cosmetic methods 148
G Other considerations 153
H An excluded surgical step 158
I Disclaimers 168
J Conclusion 183
6. Diagnostic methods 184
A Introduction 184
B Legislative history 187
C The narrow approach 189
D The broad approach 196
E Reconciling the two approaches 201
F Application of principles 208
G New medical technology 218
H Conclusion 228
7. Second and further medical uses 229
A Introduction 229
B Legislative history 230
C The origin of second medical uses 234
D Requirements of Swiss-type claims 237
E Extending the reach of the EISAI principle 244
F Second medical uses of devices and instruments 246
G Reform of the EPC 254
H Dosage or treatment regimes 255
I New medical technology 285
J Conclusion 286
8. Manner of new manufacture 287
A Introduction 287
B Nature of the exclusion 288
C The rationale for the exclusion 295
D Contraceptive methods 315
E The Commonwealth 321
F Conclusion 330
9. United Kingdom Patents Act 2004 332
A Introduction 332
B Comparison with pre- 1977law 333
C Application of the exclusion 338
D Second and further medical uses 345
E Dosage regimes 356
F Conclusion 372
10. United States of America 374
A Introduction 374
B Initial judicial determination 375
C Legislative intervention 382
D The constitutional power 392
E Conclusion 431
11. Conclusion 433
A Judicial determination of the exclusion 433
B European patent office jurisprudence 436
C The arguments for and against patent protection 443
Bibliography 448
Index 457