Abstract

With a view to crucial importance of innovation in the pharmaceutical sector, the pharmaceutical law has introduced a system of non-patent protection. It covers, in general, reference medicinal products, which are products authorized basing on proprietary data. The system provides for data and market exclusivity period. Before the end of the data exclusivity period a generic medicinal product cannot be authorised. Furthermore, it can be marketed only after the market exclusivity period has elapsed. The EU legislation also introduced an additional market exclusivity periods for orphan medicinal products. Data and market exclusivity are topics generating many legal issues concerning access to market for generic medicinal products. These issues are resolved by the Court of Justice of the European Union. In its rulings the CJEU elaborated and bolstered the application of data and market exclusivity