The Court of Justice of the European Union (Court) delivered a preliminary ruling in 2011 in the case of Oliver Brüstle v Greenpeace on the interpretation of Article 6(2) of the Biotech Directive and thereby established an autonomous concept of the term ‘human embryo’. The Brüstle decision raises a number of questions about the limits to the Court’s jurisdiction and whether was acting as a legislator rather than in a judicial capacity. As a consequence of the Court’s judicial activism, biotechnological inventions manoeuvre in a new, more restrictive legal environment than before. However, this autonomous interpretation of ‘human embryo’ and the flexibility allowed to the national courts needed further clarification. This clarification was recently given by the Court’s Grand Chamber in International Stem Cell Corporation v Comptroller General Patents where the Court concluded that a non-fertilised human ovum, not capable of developing into a human being, is not a ‘human embryo’. Hence, ‘where a non-fertilised human ovum does not fulfil that condition [inherent capacity of developing into a human being], the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a “human embryo”.’ This contribution discusses the two judgments both in relation to the role of the EU institutions and the potential effects of the judgments on biotech inventions, in particular on medical innovation