The Emergence of Human Dignity as a Barrier to Patenting Biotechnology in European Patent Law

This chapter traces the emergence of human dignity as a fundamental constraint on biotech patentability within European patent law, examining both the European Patent Organisation and EU jurisdictions. It provides a comprehensive overview of patent law’s evolution from the Venetian Patent Statute (1474) to contemporary biotechnology challenges, charting how morality provisions entered European patent legislation and evolved to encompass increasingly complex ethical considerations surrounding living matter. The analysis reveals how rapid biotechnological advances since the 1990s have transformed morality from a marginal patent law concept into a central concern, particularly regarding hESC-based inventions. Through detailed examination of landmark cases including Relaxin , WARF , Brüstle and ISCC , the chapter demonstrates the inconsistent judicial interpretation of undefined concepts like “ordre public’, ‘morality’, and ‘human dignity’ across European institutions. Readers will gain understanding of the fundamental tension between promoting beneficial biotech innovation and protecting human dignity, and the legislative fragmentation across European patent regimes. Also, they will grasp the urgent need for coherent adjudicative frameworks as emerging technologies, like CRISPR and synthetic human embryos, present new bioethical challenges to patent law’s traditional boundaries.