Seven regimes, no coherent concept: human dignity in biotechnological patent law on the continent of Europe

The morality provisions of the European Patent Convention (EPC) and the European Union (EU) Biotechnology (Biotech) Directive govern the patentability of biotech inventions across 39 EPC (40 from 1 June 2026, when Moldova accedes) and 27 EU member states. Human dignity, invoked in the recitals of the Directive and transposed into the EPC’s Implementing Regulations, underpins these provisions. Yet the concept lacks any coherent articulation in patent law. Scholars have raised significant concerns about dignity adjudication in biotech patent law. This article identifies at least seven distinct legal regimes on the continent of Europe through which biotech patent cases raising dignity questions could arise, mapping the structural incoherence between them. These regimes result from overlapping memberships in the EPC, EU, Council of Europe and Unified Patent Court (UPC) systems, and include states that would adjudicate biotech patent cases entirely under their own national laws, without recourse to any supranational framework. The constitutional asymmetry is acute: the EU must ground dignity in a constitutional fundamental rights framework; the EPC framework has no equivalent. While the UPC, approaching its third anniversary, has not yet had a biotech case raising dignity concerns, it is bound by EU law, including the EU Charter and Court of Justice of the EU jurisprudence. This article argues for explanatory legal reasoning on the concept of dignity for patent law purposes—reasoning that articulates its grounds and requirements, enabling all stakeholders to understand which inventions do and do not violate dignity as biotechnology progresses. Emerging biotechnologies—including clustered regularly interspaced short palindromic repeats (CRISPR) germline editing and synthetic embryos—are already reaching patent offices, with potentially irreversible ramifications.