Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy

Abstract

PART I: INTRODUCTION AND BACKGROUND TO THE MODERN PATENT SYSTEM 1. THE NATURE AND ORIGINS OF PATENT RIGHTS What is a Patent? Early History in England Early History in Continental Europe Early History in America The Consideration for the Grant of a Patent 2. HISTORICAL DEVELOPMENTS UK 1800-2009 USA 1790-2009 Other Industrialized Countries Developing Countries International Developments Outlook 3. HARMONIZATION OF PATENT LAW Introduction The TRIPs Agreement TRIPs Implementation - Changes to Patent Laws Further Initiatives on Harmonization The Convention on Biological Diversity (CBD) Opposition to TRIPs Summary PART II: PATENT LAW AND PROCEDURE 4. WHAT CAN BE PATENTED The Requirements of the European Patent Convention and European National Laws The Requirements of United States Law Grace Periods Special Categories of Inventions 5. FILING A PATENT APPLICATION Should an Application be Filed? When to File Where to File The Foreign Filing Decision Non-Convention Filings European Patent Applications International Applications Registration and Patents of Importation Petty Patents 6. OBTAINING A GRANTED PATENT - PCT PROCEDURE PCT Procedure General Ch. I Filing an International Application Ch. II: The IPRP 7. OBTAINING A GRANTED PATENT - EPO PROCEDURE Procedure in the European Patent Office Appeals in the EPO 8. OBTAINING A GRANTED PATENT - NATIONAL PROCEDURES Types of Examination Deferred Examination Oppositions Procedure in the United Kingdom Procedure in the USA 9. MAINTAINING A PATENT IN FORCE AND EXTENDING THE PATENT TERM Patent Term Renewal Fees Extension of Term Extensions to Compensate for Regulatory Delays Working Requirements Licences of Right 10. ENFORCING PATENT RIGHTS What Constitutes Infringement Infringement in the UK Infringement in the USA Procedure in the UK Procedure in the USA Procedure in Continental Europe Procedure in Asia PART III: PATENTABILITY OF INVENTIONS IN SPECIFIC TECHNICAL FIELDS 11. INVALIDITY AND AMENDMENT OF GRANTED PATENTS Grounds of Invalidity in the UK Revocation Proceedings Amendment of British Patents Invalidity and amendment in the USA Invalidity and Amendment in the EPO 12. CHEMICAL INVENTIONS Novel Compounds Selection Inventions Disclaimers Compounds of Unknown Structure Polymeric Compounds New Salt Forms New Physical Forms New Synthetic Processes Analogy Processes New Compositions and Mixtures New Uses and new Application Processes 13. PHARMACEUTICAL INVENTIONS New Chemical Entities Pharmaceutical Compositions First Pharmaceutical Use Second Pharmaceutical Use Scope of SPC Protection Regulatory Data Exclusivity Orphan Drug Exclusivity 14. BIOTECHNOLOGICAL INVENTIONS What is Biotechnology? Patents and Biotechnology Microbiological Inventions Recombinant DNA Technology Monoclonal Antibody Technology More Recent Technologies 15. PATENTING OF GENES, PLANTS AND ANIMALS Patents and Life Human Genes Transgenic Animals Transgenic Plants Patenting of Animals, Plants and Human Cells Morality Issues Patents for Life - from Bacteria to Oncomice Why are Patents being Targeted? PART IV: PATENTING IN PRACTICE 16. SOFTWARE-RELATED AND BUSINESS METHOD INVENTIONS Relevance of Software and Business Method Inventions to Chemistry and Biotechnology Patenting of Software-Related Inventions in the EPO Patenting of Software-Related Inventions in the UK Patenting of Software-Related Inventions in the USA Business Method Patents 17. THE PATENT PRACTITIONER AND HIS FUNCTIONS The British Patent Profession The Patent Profession in the USA The Patent Profession in other Countries European Patent Attorneys Patent Attorneys in Private Practice Industrial Practice The Job of the Patent Practitioner 18. DRAFTING THE PATENT SPECIFICATION Drafting the Scope The Structure of the Patent Specification Priority and Foreign Filing Texts Background of the Invention and Prior Art US Sufficiency Requirements Sufficiency Requirements in the UK and the EPO Sufficiency Requirements in other Countries Special Requirements for Biotech Inventions Length of Text 19. DRAFTING THE CLAIMS The Purpose and Nature of Patent Claims Form of Claims The Scope of the Claims 20. PROSECUTION OF THE PATENT APPLICATION TO GRANT Lack of Unity Lack of Novelty Lack of Inventive Step Interviews with the Examiner PART V: COMMERCIAL EXPLOITATION OF PATENTS 21. INVENTORSHIP, OWNERSHIP AND COMPENSATION Inventorship in the UK Inventorship in the EPO Inventorship in the USA Ownership Compensation for Employee Inventors The Right to Apply for a Patent and to be Granted a Patent Co-ownership Disputes as to Ownership Recordal and Transfer of Ownership 22. COMMERCIAL EXPLOITATION OF PATENTS Patents to Exclude the Competition - the Pharmaceutical Industry Patents for Survival - the Biotechnology Industry Patents as a Source of Royalty Income - Universities Patents as Lottery Tickets - Individual Inventors Patents as Bargaining Chips - the Electronics Industry 23. HOW TO CATCH THE INFRINGER - AND HOW NOT TO BE CAUGHT From the Viewpoint of the Patentee From the Viewpoint of the Potential Infringer 24. PATENT ASPECTS OF LICENSING Patent Conflict Licences Technology Transfer Licences The In-licensing Process Out-Licensing - Patent Strategy for the Licensor Research Collaboration Agreements Contract Research Agreements Funding Agreements Compound Purchase Agreements Licence Contracts 25. PATENTS AND COMPETITION LAW Charges against the Patent System Competition Law - United Kingdom Competition Law - EU Patent Licence Agreements in the EU Competition law - USA Collaboration between JD & EC Commission

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