Experts in Pharma extensions (SPCs & PTEs) and Regulatory Exclusivity

Mewburn Ellis has unparalelled experience with SPC’s and other Patent Term Extensions. We handled the UK’s first SPC application for leuprorelin back in 1993 and we’ve been in the top three firms for SPC filings in recent years, supporting some of the biggest multinational pharma firms worldwide.

Our Extensions & Exclusivity Team regularly supports large and small clients with their extensions strategies and filings. Before filing SPC applications for a medicinal product there should generally be a phase of careful strategic analysis to inform the final key decisions about which patent to extend in each country. To conduct this assessment properly, there often needs to be a detailed appreciation of the regulatory picture surrounding a given drug product to be sure of reaching the right decisions. Specialist understanding is important at this stage to avoid missing critical details and going down the wrong path on such a commercially important decision.

Our pharma Extensions and Exclusivity team includes experienced IP counsel who previously specialised in this area while working in-house for a global pharmaceutical company and our team regularly supports clients with such analysis, often before progressing to the SPC and PTE filings themselves.

In other situations, the Extensions and Exclusivity Team have assisted with evaluations and due diligences, to understand the likely timelines of exclusivity around a medicinal product in key countries towards a commercial assessment of the asset.

We encourage pharma companies to work with us from an early stage in order that significant opportunities are not missed in maximising extensions and the overall value of your asset.

Mewburn Ellis have been involved with key aspects of over 1000 SPCs/PTEs for our clients and we’re well-placed to support you in this specialist area of great commercial importance.

Read our Supplementary Protection Certificates (SPCs) & Patent Term Extensions (PTEs) law and practice guide.