Die Marktexklusivität als absolutes Recht (Teil I), GRUR 11/2024

Investment and innovation protection are closely linked in the pharmaceutical sector for the development and marketing of new medicinal products. In addition to patent protection, market exclusivity under pharmaceutical law, which creates a legally defined protection period for the marketing of a medicinal product that has been approved for the first time, is of particular importance. The exclusivity periods under pharmaceutical law must be reconciled with the entrepreneurial freedom of competitors and the interest of the general public in access to and price efficiency of available medicinal products. On the occasion of the decision of the Regional Court Munich I of August 4, 2023 in the “Eculizumab” case (21 O 6235/23), this two-part article deals with the question of which legal protection options are available to the holder of a first marketing authorization for a reference medicinal product with regard to document protection and market exclusivity. Part I of the article first describes the basic principles and the mode of action of the various legal institutions, presents their dogmatic basis and summarizes the case law that has been handed down to date.