PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY

Transcription

1 PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY FUNDAMENTALS OF GLOBAL LAW, PRACTICE AND STRATEGY by PHILIP W. GRUBB European Patent Attorney CLARENDON PRESS OXFORD 1999

2 CONTENTS Preface to the Third Edition ~ v List of Figures and Tables xiii Table of Cases xv List of Abbreviations xxv 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 America 12 The consideration for the grant of a patent 14 2 The development of patent law 15 UK USA Continental Europe 23 International developments 24 GATT-TRIPs a major step forward 30 3 Patents in developing countries 34 Level of patent protection 34 Transfer of technology 36 International developments in the 1970s 37 New developments in the 1980s 38 TRIPs implementation changes to patent laws 39 The Convention on Biological Diversity (CBD) 44 Opposition to TRIPs 46 Summary 49 PART II: PATENT LAW AND PROCEDURE 4 What can be patented 53 The requirements of the European Patent Convention 53 The requirements of United States law 63 Grace periods 65 ' Special categories of inventions 66 5 Filing a patent application 70 Should an application be filed? 70 When to file 71, Where to file 75 The foreign filing decision 78

3 viii CONTENTS Non-convention filings 82 European patent applications 82 International applications 85 Registration and patents of importation 86 6 Obtaining a granted patent national procedures 88 Types of examination 88 Deferred examination 91 Oppositions 94 Procedure in the United Kingdom 95 Procedure in the USA Obtaining a granted patent EPO and PCT procedures 112 Procedure in the European Patent Office 112 Appeals in the EPO 126 PCT Procedure * Maintaining a patent in force and extending the patent term 140 Patent term 140 Renewal fees 141 Extension of term 144 Extensions to compensate for regulatory delays 145 Working requirements 150 Licences of right Enforcing patent rights 154 What constitutes infringement 154 Infringement in the United Kingdom 155 Infringement in the USA 160 Procedure in the United Kingdom 163 Procedure in the USA 169 Procedure in continental Europe 172 Procedure in Japan Invalidity and amendment of granted patents 175 Grounds of invalidity in the United Kingdom 176 New grounds of invalidity 179 Revocation by the Patent Office 179 Partial validity 180 Amendment of British patents 180 Invalidity and amendment in the USA 182 Invalidity and amendment in the European Patent Office 185 PART III: PATENTABILITY OF INVENTIONS IN SPECIFIC TECHNICAL FIELDS 11 Chemical inventions 193 Novel compounds 193

4 CONTENTS Selection inventions Disclaimers Compounds of unknown structure Polymeric compounds New physical forms New synthetic processes Analogy processes New compositions and mixtures New uses and new application processes 12 Pharmaceutical inventions New chemical entities Pharmaceutical compositions First pharmaceutical use Second pharmaceutical use Scope of SPC protection 13 Biotechnological inventions What is biotechnology? Patents and biotechnology Microbiological inventions Recombinant DNA technology Monoclonal antibody technology More recent technologies 14 Patenting of genes, plants, and animals Patents and life Human genes Transgenic animals Transgenic plants Patenting of animals and plants Morality issues Patents for life from bacteria to oncomice Why are patents being targeted? 15 Software-related inventions Relevance of software inventions to chemistry Patenting of software-related inventions in the Patenting of software-related inventions in the Patenting of software-related inventions in the PART IV: PATENTING IN PRACTICE 16 The patent practitioner and his functions The British patent profession The patent profession in the USA The patent profession in other countries and biotechnology EPO United Kingdom USA

5 x CONTENTS European patent attorneys 279 Patent attorneys in private practice 281 Industrial practice 282 The job of the patent practitioner Drafting the patent specification 288 Drafting the scope 288 The structure of the patent specification 289 Priority and foreign filing texts 291 Background of the invention and prior art 292 US sufficiency requirements 29^4 Sufficiency requirements in the United Kingdom and the EPO 297 Sufficiency requirements in other countries 299 Special requirements for biotechnology inventions 300 Length of text Drafting the claims 303 The purpose and nature of patent claims 303 Form of claims 306 The scope of the claims Prosecution of the patent application to grant. 313 Lack of unity 313 Lack of novelty 317 Lack of inventive step 321 Interviews with the examiner Patents and information 328 The increasing volume of patent literature 328 Patents as a source of technical information Availability of patents 331 Other patent information on the Internet 334 Legal information relevant to patents 334 Patent searching 335 PART V: COMMERCIAL EXPLOITATION OF PATENTS 21 Inventorship, ownership, and compensation 345 Inventorship in the United Kingdom 345 Inventorship in the EPO 348 Inventorship in the USA 349 Ownership 351 Compensation for employee inventors 356 The right to apply for a patent and to be granted a patent 359 Co-ownership 360 Disputes as to ownership 361

6 CONTENTS xi Registration and transfer of ownership Commercial exploitation of patents 364 Patents to exclude the competition the pharmaceutical industry 364 Patents for survival the biotechnology industry 370 Patents as a source of royalty income universities 373 Patents as lottery tickets individual inventors 376 Patents as bargaining chips the electronics industry How to catch the infringer and how not to be caught 378 From the viewpoint of the patentee 378 From the viewpoint of the potential infringer Patent aspects of licensing 395 Patent conflict licences 395 Technology transfer licences 396 The In-licensing process 398 Out-licensing patent strategy for the licensor 402 Research collaboration agreements 405 Licence contracts Patents and competition law 412 Charges against the patent system 412 Competition law United Kingdom 413 Competition law EU 414 Patent licence agreements in the EU 420 Competition law USA 426 EU/US collaboration 431 Glossary of Patent Terms and Jargon 432 Index AA3