SPCs & PTE Disputes: Key Developments and Emerging Challenges for the Life Sciences

20 Jan 2027
Pharma & Biotech Patent Litigation Europe

In the context of legislative change, landmark rulings and paradigm-shifting Court of Justice referrals, renewed focus has been placed on Supplementary Protection Certificates (SPCs) and Patent Term Extensions (PTEs) as crucial, complementary aspects of pharmaceutical IP strategy. Covering the SPC Manufacturing Waiver, recent CJEU references, exclusivity term changes under the EU Biotech Act and the evolving global PTE landscape, this session delivers practical insights to help you navigate dynamic SPC and PTE frameworks with confidence.

 

- Review recent national court decisions from Belgium, the Netherlands, Germany and the UK on the SPC Manufacturing Waiver.  

- Discuss the implications of the CJEU Advocate General’s Opinion on the Halozyme referral (C-456/24). - Explore how recent CJEU referrals C-15/26 (Boehringer Ingelheim v GPTO) and C-794/25 (Stada v Takeda) might shape the interpretation of SPC Regulation Articles 1(b), 3(b) and 3(d).  

- Learn the latest updates in the PTE litigation space across major jurisdictions.  

 

Speakers
Beatriz Díaz de Escauriaza
Beatriz Díaz de Escauriaza, Head of IP Legal - Insud Pharma