Avant-propos. Table des abreviations / Table. Jean-Christophe l'universite Pantheon-Assas (Paris II), President de de

Transcription

1 / Contents Avant-propos Contents Table des abreviations / Table V IX XV Jean-Christophe l'universite Pantheon-Assas (Paris II), President de de Recherche en Propriete Henri-Desbois, Paris Le droit des brevets pharmaceutiques Europe: Quo vadis? 1 Peter Beyer Senior Advisor at the World Health Organization Department of Public Health, Innovation and Intellectual Property, Geneva Developing Socially Responsible Intellectual Property Licensing Policies - Licensing Initiatives in the Pharmaceutical Sector 27 Ahmed Abdel Latif Innovation, Technology and Intellectual Property Senior Programme Manager, International Trade and Sustainable Development, Geneva Genetic Resources, Patents and Sharing: State of and Challenges Facing Multilateral Discussions 59 Trevor Cook London Regulatory Exclusivities for Medicinal Products in the EU 89 Hans-Friedrich Czekay Head of Trademark Department, F. Hoffmann-La Roche AG, Basel Challenges of Pharmaceutical Brand Name Creation 115 Matthijs Marell Lawyer, The Hague Martin Senftleben Professor of Intellectual Property, VU University Amsterdam; Senior Consultant, The Hague Manon Rieger-Jansen Lawyer, The Hague Trademark Issues in the Pharmaceutical Industry 127 La propri 2012 digitalisiert durch: IDS Luzern

2 Table des Table of Contents Avant-propos Contents Table des abreviations / Table of abbreviations V IX XV Le droit des brevets pharmaceutiques en Quo vadis? Jean-Christophe Galloux I. La Via Appia: l'acquisition de protection par brevet dans le 2 A. voie rectiligne: l'acquisition d'un brevet pharmaceutique 3 1. La brevetabilite de la seconde application therapeutique 3 2. Les revendications de posologie 6 B. Une voie parfois mal l'acquisition d'un titre complementaire au brevet 8 1. L'acquisition d'un CCP 8 2. L'octroi d'une extension 10 II. Ego crucifigi: La portee et l'exploitation des titres 13 A. Le retour vers la portee d'un titre complementaire La portee d'un CCP La portee d'une extension pediatrique 18 B. Le de croix? Les limites apportees par le droit de la concurrence Les enseignements tires de sectorielle de la Commission europeenne Les nouveaux fronts du droit de la concurrence 22

3 XII Table des / Table of Developing Responsible Intellectual Property Licensing Policies - Licensing Initiatives in the Pharmaceutical Sector Peter Beyer I. Introduction 27 IL Current licensing initiatives in the pharmaceutical sector - background 32 III. Current trends in the development of voluntary licensing programmes in the pharmaceutical industry 36 A. Products and disease areas 36 B. The of licensees 38 C. scope of marketing rights - territory 38 D. Royalties 40 E. Technology transfer 41 F. Other aspects 42 IV. Conclusion/prospective analysis 43 Annex 1: List of voluntary license agreements and non-assert declarations 47 Annex 2: Tibotec Pharmaceutical territory for rilpivirine and combination products countries) 57 Annex 3: Gilead licensed territory fortdf, elvitegravir and cobicistat and Quad countries) 58 Genetic Resources, Patents and Benefit Sharing: State of Play and Challenges Facing Multilateral Discussions Ahmed Abdel I. Introduction 59 IL The Convention on Biological Diversity and the Nagoya Protocol 60 III. The TRIPS Council 65 IV. WIPO 72 V. Lessons the need for complementary Solutions and for going beyond entrenched positions 77 VI. Managing complexity and ensuring supportiveness different 86 VII. Conclusion 87

4 Table des / Table of XIII Regulatory Exclusivities for Medicinal Products in the EU Trevor Cook I. Introduction and Overview 89 IL Regulatory Data Protection (or "Data Exclusivity") 90 III. Orphan Medicinal Product Exclusivity 101 IV. Conclusions 103 Annex 1: Extracts Directive of 6 November 2001 on the Community code relating to medicinal products human as amended 105 Annex 2: Extracts from Regulation (EC) 141/2000 of on orphan medicinal products and Commission Regulation (EC) 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts medicinal product" and "clinical superiority" 111 Challenges of Pharmaceutical Brand Name Creation Czekay I. Introduction 115 II. Marketing challenges 116 A. Brand properties 116 B. Time C. Process 118 III. Trademark law challenges 119 A. Availability of protection 119 B. Time lines 121 IV. Regulatory challenges 121 A. Approval needed 121 B. Methodology General remarks Requirements to be fulfilled in the European Union Requirements to be fulfilled in the USA Requirements in other countries 126

5 XIV Table des Table of Trademark Enforcement Issues in the Pharmaceutical Industry Matthijs Rieger-Jansen I. Introduction to trademark rights 128 A. The initial stage of "sign reservation" 129 B. The further stage of "brand creation" 131 C. Need for Enforcement Measures 132 II. The box for trademark owners in the fight against counterfeit 133 A. EU Customs Regulation as an tool for combating counterfeit 134 B. Transit of counterfeit pharmaceutical products 137 C. Parallel trade of medicines 139 III. Conclusion 141