Ergänzende Schutzzertifikate – Überblick und Ausblick zur EU-Initiative, Arzneimittel & Recht, 2022

SPCs are currently based on Regulation (EC) No. 469/2009 on the supplementary protection certificate for medicinal products. Under a current EU initiative, the Commission is proposing, among other things, a single granting procedure and a single SPC system. In order to be able to evaluate the advantages and disadvantages of the options and also the impact of the resulting legal requirements for the granting of SPCs, Dr Gisela Grabow and Dr Marco Stief first present the development of case law on the problems relevant to practice as well as current requests for preliminary rulings at the European Court of Justice. Afterwards they analyse the opportunities and risks of the proposals in the context of the Pharmaceutical Strategy and the Intellectual Property Action Plan.