Prerequisites for the Protective Ability of Further Medical Uses Due to SPCs

Decision of the Court of Justice of 9 July 2020, C-673/18 Santen

Abstract

The CJEU judgment in case C-673/18 Santen resolved the problem of granting Supplementary Protection Certificates (SPCs) for further medical uses of known active substances. The earlier case-law of the Court was not uniform in this regard and did not specify enough under which conditions patented substances and substances authorized for further medical use could be subject to SPCs. In the discussed judgment, the Court found that only new active substances, not previously used as medicinal products, could be protected by SPCs. According to the Court’s opinion, SPCs were introduced into the EU legal order to stimulate research and development of new medicines, which are first-class breakthrough innovations. The author approves the Court’s decision in her commentary.