By Brigitte Carion Taravella, French and European patent attorney The EU Biotech Act, proposed by the European Commission in December 2025, introduces a targeted Supplementary Protection Certificate (SPC) extension mechanism for qualifying biotech medicines — 12 additional months of exclusivity, conditioned on demonstrable investment in European clinical development and manufacturing. The proposal sits within a broader five-pillar regulatory package designed to address structural competitiveness deficits in the EU life sciences sector. Competitive Position of the EU Life Sciences Sector The EU's share of global industry-sponsored clinical trials fell from 22% in 2013 to 12% in 2023, a contraction of nearly...