Introduction
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to enhance the efficacy and accuracy of the drug approval process, ensuring that applications incorporating AI meet rigorous
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified Patent Court (UPC) first decision – invalidating EP Patent No. 3,666,797 B1 – and provided a summary of that case. This analysis will focus
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. Thus, we reviewed the UPC’s first decision and provide a summary of the first revocation of a European patent by the new Unified Patent Court (UPC).
Please note that