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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