Intellectual Property in the Pharmaceutical Industry

Transcription

1 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

2 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 A. Une voie rectiligne : l acquisition d un brevet pharmaceutique La brevetabilité de la seconde application thérapeutique Les revendications de posologie B. Une voie parfois mal pavée : l acquisition d un titre complémentaire au brevet L acquisition d un CCP L octroi d une extension pédiatrique II. Ego romam iterum crucifigi : La portée et l exploitation des titres A. Le retour vers Rome : la portée d un titre complémentaire La portée d un CCP La portée d une extension pédiatrique B. Le chemin de croix? Les limites apportées par le droit de la concurrence Les enseignements tirés de l enquête sectorielle de la Commission européenne Les nouveaux fronts du droit de la concurrence

3 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 II. Current non-exclusive licensing initiatives in the pharmaceutical sector background III. Current trends in the development of voluntary licensing programmes in the pharmaceutical industry A. Products and disease areas B. The number of licensees C. Geographical scope of marketing rights territory D. Royalties E. Technology transfer F. Other aspects IV. Conclusion / prospective analysis Annex 1: List of voluntary license agreements and non-assert declarations Annex 2: Tibotec Pharmaceutical licensed territory for rilpivirine and combination products (112 countries) Annex 3: Gilead licensed territory fortdf, elvitegravir and cobicistat and Quad (112 countries) Genetic Resources, Patents and Benefit Sharing : State of Play and Challenges Facing Multilateral Discussions Ahmed Abdel Latif I. Introduction II. The Convention on Biological Diversity and the Nagoya Protocol III. The WTO TRIPS Council IV. WIPO V. Lessons learned : the need for complementary solutions and for going beyond entrenched positions VI. Managing complexity and ensuring mutual supportiveness between different forums VII. Conclusion... 87

4 Table des matières / Table of contents XIII Regulatory Exclusivities for Medicinal Products in the EU Trevor Cook I. Introduction and Overview II. Regulatory Data Protection (or Data Exclusivity ) III. Orphan Medicinal Product Exclusivity IV. Conclusions 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 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 Challenges of Pharmaceutical Brand Name Creation Hans-Friedrich Czekay I. Introduction II. Marketing challenges A. Brand properties B. Time lines C. Process III. Trademark law challenges A. Availability of protection B. Time lines IV. Regulatory challenges A. Approval needed B. Methodology General remarks Requirements to be fulfilled in the European Union Requirements to be fulfilled in the USA Requirements in other countries

5 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 A. The initial stage of sign reservation B. The further stage of brand image creation C. Need for Enforcement Measures II. The tool box for trademark owners in the fight against counterfeit A. EU Customs Regulation as an important tool for combating counterfeit. 134 B. Transit of counterfeit pharmaceutical products C. Parallel trade of medicines III. Conclusion