July 2026

Why Europe Needs the Biotech Act’s SPC Extension?

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...

SPC Manufacturing Waiver CJEU Referral on the Export Exemption: Case C-371/26

By European Federation of Pharmaceutical Industries and Association Supplementary Protection Certificates and the Manufacturing Waiver Intellectual property (IP) rights, and their effective enforcement, are fundamental to ensure continued investment in pharmaceutical innovation and the development of innovative medicines. Supplementary protection certificates (SPCs) are a key component of this incentive structure by providing a limited period of additional patent term to innovative medicinal products in order to compensate for the time lost during the long development and regulatory approval processes required for innovative medicines. As such, SPCs are a critical form of IP protection for pharmaceutical investment in Europe, supporting continued...