Patents for Chemicals, Pharmaceuticals and Biotechnology

Philip W. Grubb is an Intellectual Property Consultant; formerly Intellectual Property Counsel, Novartis International AG; Adjunct Professor, Franklin Pierce Law Center, Concord, NH (2007-8). Peter L. Thomsen is a qualified European Patent Attorney and CEIPI (Centre d'Etudes Internationales de la Propriete Industrielle, Robert Schuman University, Strasbourg) tutor, currently working as the manager of Global IP-Litigation and Transaction, Planning & Coordination at Novartis Corporate IP.

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