Published on Jan 06, 2025
The pharmaceutical industry thrives on innovation and competition, with patents and Supplementary Protection Certificates (SPCs) forming critical tools to safeguard intellectual property. Understanding the relevant patent landscape and any risks arising is essential for bringing products to market.
The UK has simplified its Supplementary Protection Certificate (SPC) process by introducing a single UK-wide Marketing Authorisation (MA) with effect from 1st January 2025. This arises from The Windsor Framework which amended the Northern Ireland Protocol and aims to streamline the post-Brexit dual-regulatory system for medicines in the UK which has been complex post-Brexit; with Northern Ireland (NI) adhering to EU laws meaning that centralised EU MAs continued to be valid in NI, and in parallel, Great Britain (GB) (i.e. England, Scotland, and Wales) governed separately by specific legislation and the Medicines and Healthcare Regulatory Agency (MHRA) functioning as the sole regulator for GB MAs.
The complexities underscore the importance of a dynamic and informed IP strategy.
Since 1 January 2025, the MHRA has exclusive power to grant new MAs for human medicines across the entire of the UK including NI. This change ensures that medicines can be approved and licensed on a UK-wide basis to be sold solely within the UK. The MHRA has published a guidance document setting out the key measures introduced:
In this legal environment, a comprehensive IP strategy is indispensable. For Patent proprietors, understanding and maximising patent protection is vital. For manufacturers of generic medicines, identifying and managing blocking patents and SPCs is critical to ensuring timely market entry.
The latest case law on inventive step at the European Patent Office (EPO) and emerging jurisprudence on SPCs in the UK are invaluable for formulating effective strategies. For instance, inventive step and enabling disclosure requirements have proven to be a fertile ground for invalidating patents, enabling generics to overcome the barriers to entry that patents are aimed at erecting. Similarly, the evolving legal landscape around SPCs presents opportunities for patent proprietors to be agile and primed to act where additional protection can be sought.
A strong Freedom to Operate (FTO) analysis remains a cornerstone of a successful IP strategy. With the legal frameworks in flux, FTO analyses must incorporate jurisdiction-specific nuances to assess risks accurately.
As SPC laws evolve, proactive adaptation of traditional strategies will be essential. Generic manufacturers should invest in understanding these changes and their implications, working closely with IP professionals to navigate the new legal landscape. Identifying opportunities for challenges, crafting tailored strategies for the UK and EU markets, and leveraging the latest insights into SPC validity will be crucial for maintaining competitive advantage.
By staying ahead of these legal shifts, companies can gain that competitive edge on their competitors – and build resilience into the organisation to capitalise on opportunity and manage market risks.
To understand more about this complex area, join Marie Walsh and Lawrence Cullen, the expert speakers, on our new event Patent Strategies for Generic Medicines and Generic Medicine Companies running on various dates throughout 2025.
Published on Jan 06, 2025 by Marie Walsh