List of Figures and Tables ................................... xiii
Table of Cases ................................................. xv
Table of Legislation ....................................... xxxiii
List of Abbreviations ......................................... xli
PART I: INTRODUCTION AND BACKGROUND TO THE MODERN PATENT
SYSTEM
1 The Nature and Origins of Patent Rights ...................... 3
What is a Patent? ............................................ 3
Early History in England ..................................... 8
Early History in Continental Europe ......................... 10
Early History in North America .............................. 12
Consideration for the Grant of a Patent ..................... 14
2 Historical Developments ..................................... 15
The UK 1800-2009 ............................................ 16
The USA 1790-2009 ........................................... 20
Other Industrialized Countries .............................. 24
Developing Countries ........................................ 26
International Developments .................................. 28
Outlook ..................................................... 36
3 Harmonization of Patent Law ................................. 38
Introduction ................................................ 39
The TRIPs Agreement ......................................... 39
TRIPs Implementation: Changes to Patent Laws ................ 42
Further Initiatives on Harmonization ........................ 50
The Convention on Biological Diversity ...................... 52
Opposition to TRIPs ......................................... 54
Summary ..................................................... 57
PART II: PATENT LAW AND PROCEDURE
4 What can be Patented ........................................ 61
Introduction ................................................ 61
The Requirements of the European Patent Convention and
European National Laws ...................................... 62
The Requirements of US Law .................................. 72
Grace Periods ............................................... 76
Special Categories of Invention ............................. 77
5 Filing a Patent Application ................................. 81
Should an Application be Filed? ............................. 81
When to File ................................................ 82
Where to File ............................................... 86
The Foreign Filing Decision ................................. 90
Non-Convention Filings ...................................... 94
European Patent Applications ................................ 94
International Applications .................................. 96
Registrations and Patents of Importation .................... 97
Petty Patents ............................................... 98
6 Obtaining a Granted Patent: Patent Cooperation Treaty
Procedure .................................................. 100
Patent Cooperation Treaty Procedure ........................ 100
Chapter I: Filing an International Application ............... 101
Chapter II: The International Preliminary Report on
Patentability ..................................... 108
7 Obtaining a Granted Patent: European Patent Office
Procedure .................................................. 115
Procedure in the European Patent Office .................... 115
Appeals in the European Patent Office ...................... 130
8 Obtaining a Granted Patent: National Procedures ............ 135
Types of Examination ....................................... 135
Deferred Examination ....................................... 138
Oppositions ................................................ 141
Procedure in the UK ........................................ 143
Procedure in the USA ....................................... 150
9 Maintaining a Patent in Force and Extending the Patent
Term ....................................................... 163
Patent Term ................................................ 163
Renewal Fees ............................................... 164
Extension of Term .......................................... 168
Extensions to Compensate for Regulatory Delays ............. 170
Working Requirements ....................................... 178
Licences of Right .......................................... 179
10 Enforcing Patent Rights .................................... 181
What Constitutes Infringement .............................. 181
Infringement in the UK ..................................... 182
Infringement in the USA .................................... 188
Procedure in the UK ........................................ 193
Procedure in the USA ....................................... 199
Procedure in Continental Europe ............................ 203
Procedure in Asia .......................................... 206
11 Invalidity and Amendment of Granted Patents ................ 208
Introduction ............................................... 208
Grounds of Invalidity in the UK ............................ 209
Revocation Proceedings ..................................... 210
Amendment of British Patents ............................... 213
Invalidity and Amendment in the USA ........................ 215
Invalidity and Amendment in the European Patent Office ..... 221
PART III: PATENTABILITY OF INVENTIONS IN SPECIFIC TECHNICAL FIELDS
12 Chemical Inventions ........................................ 229
Novel Compounds ............................................ 229
Selection Inventions ....................................... 232
Disclaimers ................................................ 238
Compounds of Unknown Structure ............................. 240
Polymeric Compounds ........................................ 241
New Salt Forms ............................................. 243
New Physical Forms ......................................... 243
New Synthetic Processes .................................... 244
Analogy Processes .......................................... 246
New Compositions and Mixtures .............................. 246
New Uses and New Application Processes ..................... 247
13 Pharmaceutical Inventions .................................. 250
New Chemical Entities ...................................... 250
Pharmaceutical Compositions ................................ 257
First Pharmaceutical Use ................................... 258
Second Pharmaceutical Use .................................. 259
Scope of Supplementary Protection Certificates ............. 265
Other Exclusivity Periods .................................. 267
Integrated View on Exclusivity ............................. 273
14 Biotechnological Inventions ................................ 274
What is Biotechnology? ..................................... 274
Patents and Biotechnology .................................. 275
Microbiological Inventions ................................. 276
Recombinant DNA Technology ................................. 279
Monoclonal Antibody Technology ............................. 291
More Recent Technologies ................................... 294
Biosimilars and Follow-on Biologics ........................ 298
15 Patenting of Genes, Plants, and Animals .................... 301
Patents and Life ........................................... 301
Human Genes ................................................ 302
Transgenic Animals ......................................... 304
Transgenic Plants .......................................... 306
Patenting of Animals, Plants, and Human Cells .............. 307
Morality Issues ............................................ 315
Patents for Life: From Bacteria to the OncoMouse® .......... 317
Why are Patents Being Targeted? ............................ 319
16 Software-Related and Business Method Inventions ............ 321
Relevance of Software and Business Method Inventions
to Chemistry and Biotechnology ............................. 321
Patenting of Software-Related Inventions in the European
Patent Office .............................................. 322
Patenting of Software-Related Inventions in the UK ......... 327
Patenting of Software-Related Inventions in the USA ........ 329
Business Method Patents .................................... 330
PART IV: PATENTING IN PRACTICE
17 The Patent Practitioner and his Functions .................. 339
Introduction ............................................... 339
The British Patent Profession .............................. 340
The Patent Profession in the USA ........................... 343
The Patent Profession in Other Countries ................... 345
European Patent Attorneys .................................. 346
Patent Attorneys in Private Practice ....................... 349
Industrial Practice ........................................ 350
The Job of the Patent Practitioner ......................... 352
18 Drafting the Patent Specification .......................... 356
Drafting the Scope ......................................... 356
The Structure of the Patent Specification .................. 358
Priority and Foreign Filing Texts .......................... 360
Background of the Invention and Prior Art .................. 360
US Sufficiency Requirements ................................ 362
Sufficiency Requirements in the UK and the European
Patent Office .............................................. 366
Sufficiency Requirements in Other Countries ................ 368
Special Requirements for Biotech Inventions ................ 368
Length of Text ............................................. 370
19 Drafting the Claims ........................................ 372
The Purpose and Nature of Patent Claims .................... 372
Form of Claims ............................................. 376
The Scope of the Claims .................................... 381
20 Prosecution of the Patent Application to Grant ............. 385
Introduction ............................................... 385
Lack of Unity .............................................. 385
Lack of Novelty ............................................ 389
Lack of Inventive Step ..................................... 394
Interviews with the Examiner ............................... 399
PART V: COMMERCIAL EXPLOITATION OF PATENTS
21 Inventorship, Ownership, and Compensation .................. 403
Inventorship in the UK ..................................... 403
Inventorship in the European Patent Office ................. 406
Inventorship in the USA .................................... 407
Ownership .................................................. 409
Compensation for Employee-Inventors ........................ 414
The Right to Apply for a Patent and to be Granted a
Patent ..................................................... 418
Co-Ownership ............................................... 419
Disputes as to Ownership ................................... 419
Recordal and Transfer of Ownership ......................... 422
22 Commercial Exploitation of Patents ......................... 423
Patents to Exclude the Competition: The Pharmaceutical
Industry ................................................... 423
Patents for Survival: The Biotechnology Industry ........... 431
Patents as a Source of Royalty Income: Universities ........ 434
Patents as Lottery Tickets: Individual Inventors ........... 437
Patents as Bargaining Chips: The Electronics Industry ...... 438
Patents as Tools of Extortion: Patent Trolls ............... 439
23 How to Catch the Infringer—and How not to be Caught ........ 441
From the Viewpoint of the Patentee ......................... 441
From the Viewpoint of the Potential Infringer .............. 458
24 Patent Aspects of Licensing ................................ 463
Patent Conflict Licences ................................... 463
Technology Transfer Licences ............................... 464
The In-licensing Process ................................... 466
Out-licensing: Patent Strategy for the Licensor ............ 470
Research Collaboration Agreements .......................... 472
Contract Research Agreements ............................... 475
Funding Agreements ......................................... 475
Compound Purchase Agreements ............................... 475
Licence Contracts .......................................... 476
25 Patents and Competition Law ................................ 480
Charges Against the Patent System .......................... 481
Competition Law: The UK .................................... 481
Competition Law: The European Union ........................ 482
Patent Licence Agreements in the European Union ............ 488
Competition Law: The USA ................................... 497
Glossary ...................................................... 505
Index ......................................................... 517
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