intelle tual p operty - p opriété intelle tuelle p opriété intelle tuelle - intelle tual p operty Jacques de Werra (éd.) La propriété intellectuelle dans l industrie pharmaceutique Intellectual Property in the Pharmaceutical Industry Jean-Christophe Galloux, Peter Beyer, Ahmed Abdel Latif, Trevor Cook, Hans-Friedrich Czekay, Matthijs Marell/ Martin Senftleben/Manon Rieger-Jansen
Table des matières / Table of contents Avant-propos... V Sommaire / Contents................................................... IX Table des abréviations / Table of abbreviations... XV Le droit des brevets pharmaceutiques en Europe : Quo vadis? Jean-Christophe Galloux I. La Via Appia : l acquisition de la protection par brevet dans le domaine pharmaceutique................................................. 2 A. Une voie rectiligne : l acquisition d un brevet pharmaceutique........ 3 1. La brevetabilité de la seconde application thérapeutique......... 3 2. Les revendications de posologie.............................. 6 B. Une voie parfois mal pavée : l acquisition d un titre complémentaire au brevet..................................................... 8 1. L acquisition d un CCP... 8 2. L octroi d une extension pédiatrique.......................... 10 II. Ego romam iterum crucifigi : La portée et l exploitation des titres... 13 A. Le retour vers Rome : la portée d un titre complémentaire... 13 1. La portée d un CCP... 14 2. La portée d une extension pédiatrique... 18 B. Le chemin de croix? Les limites apportées par le droit de la concurrence... 20 1. Les enseignements tirés de l enquête sectorielle de la Commission européenne............................................... 20 2. Les nouveaux fronts du droit de la concurrence................. 22
XII Table des matières / Table of contents Developing Socially Responsible Intellectual Property Licensing Policies Non-Exclusive Licensing Initiatives in the Pharmaceutical Sector Peter Beyer I. Introduction... 27 II. Current non-exclusive 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 number of licensees... 38 C. Geographical 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 licensed territory for rilpivirine and combination products (112 countries)........................... 57 Annex 3: Gilead licensed territory fortdf, elvitegravir and cobicistat and Quad (112 countries)..................................... 58 Genetic Resources, Patents and Benefit Sharing : State of Play and Challenges Facing Multilateral Discussions Ahmed Abdel Latif I. Introduction.................................................... 59 II. The Convention on Biological Diversity and the Nagoya Protocol....... 60 III. The WTO TRIPS Council... 65 IV. WIPO... 72 V. Lessons learned : the need for complementary solutions and for going beyond entrenched positions...................................... 77 VI. Managing complexity and ensuring mutual supportiveness between different forums................................................. 86 VII. Conclusion... 87
Table des matières / Table of contents XIII Regulatory Exclusivities for Medicinal Products in the EU Trevor Cook I. Introduction and Overview... 89 II. Regulatory Data Protection (or Data Exclusivity )................... 90 III. Orphan Medicinal Product Exclusivity... 101 IV. Conclusions... 103 Annex 1: Extracts from Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, as amended................................................. 105 Annex 2: Extracts from Regulation (EC) 141/2000 of 16 December 1999 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 similar medicinal product and clinical superiority............ 111 Challenges of Pharmaceutical Brand Name Creation Hans-Friedrich Czekay I. Introduction.................................................... 115 II. Marketing challenges............................................. 116 A. Brand properties... 116 B. Time lines... 117 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... 122 1. General remarks........................................... 122 2. Requirements to be fulfilled in the European Union............. 124 3. Requirements to be fulfilled in the USA... 124 4. Requirements in other countries... 126
XIV Table des matières / Table of contents Trademark Enforcement Issues in the Pharmaceutical Industry Matthijs Marell / Martin Senftleben / Manon Rieger-Jansen I. Introduction to trademark rights... 128 A. The initial stage of sign reservation... 129 B. The further stage of brand image creation....................... 131 C. Need for Enforcement Measures................................ 132 II. The tool box for trademark owners in the fight against counterfeit....... 133 A. EU Customs Regulation as an important tool for combating counterfeit. 134 B. Transit of counterfeit pharmaceutical products... 137 C. Parallel trade of medicines... 139 III. Conclusion... 141