EU Biotech Act: The Coming EU IP Shake-Up? Part II

Joana Santos and Sara Nazaré are the authors of a new article published on the Kluwer Patent Blog, focusing on the analysis of the “Clear, Confirm & Control” (Triple C) system, one of the most widely debated proposals within the framework of the EU Biotech Act.

In this second contribution by NLP, the article examines the impact of the proposed model on the enforcement of pharmaceutical patents in Europe, as well as its effects on predictability and transparency for the entry of generic and biosimilar products, in light of the UPC system and ongoing regulatory reforms.

Set against the backdrop of the Unified Patent Court (UPC) and current European regulatory reforms, the article reflects on how coordination between patent enforcement and marketing authorisation procedures could be operationalised, and on the institutional design choices required to ensure legal certainty and fair competition.