European Court of Justice, Case C-443/17, Decision of 21 March 2019

28. März 2019 – On 21 March 2019, the European Court of Justice passed a preliminary ruling holding that the marketing authorization referred to in Art. 3(b) SPC-Regulation (No. 469/2009), relied on in support of an application for a Supplementary Protection Certificate (SPC) concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorization for the product concerned as a medicinal product according to Art. 3(d) SPC-Regulation in the case where that active ingredient has already been the subject of a marketing authorization as an active ingredient. This means that an SPC is not available for new formulations of old active ingredients of medicinal products.