Grubb P.W. Patents for chemicals, pharmaceuticals and biotechnology: fundamentals of global law, practice and strategy / P.W.Grubb, P.L.Thomsen. - 5th ed. - Oxford: Oxford University Press, 2010. - xlv, 537 p.: ill. - Incl. bibl. ref. - Ind.: p.517-537. - ISBN 978-0-19-957523-7  Место хранения:   032 | Институт органической химии им. Н.Н.Ворожцова СО РАН | Новосибирск | Библиотека

Оглавление / Contents

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