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In April 2023, the European Commission adopted a comprehensive package of proposed reforms to the legislation governing the authorisation of medicines in the EU.

The revamped UPC Case Management System (‘CMS’) is now live. The objective of the new CMS is to simplify access for users. This will be a welcome update for IP practitioners who have in the past experienced various issues when using the old CMS.

The implementation of the Windsor Framework on 1 January 2025 marked a significant turning point in the UK’s regulatory landscape for human medicines. Among the most consequential changes are those affecting the legal basis and procedural requirements for Supplementary Protection Certificates (SPCs) and paediatric extensions.

The Enlarged Board of Appeal of the European Patent Office has issued a landmark decision significantly altering the interpretation of what constitutes prior art.

The launch of the Cali Fund at COP16 marked a new international framework for sharing benefits from Digital Sequence Information (DSI). But while the broad architecture of the Fund has been agreed much remains uncertain for businesses, especially SMEs navigating this evolving landscape.

The Court of Appeal (CoA) confirms the UPC’s jurisdiction over infringements committed before 1 June 2023 and during an opt-out period where the European patent is subsequently opted back into the jurisdiction of the UPC.