Patent term extensions and regulatory protection are essential elements of protection for a new medicinal product. Establishing an optimal strategy can make a real difference to product revenues in a given country. This requires a good understanding of how PTE/SPC and Regulatory Protection can interplay.

We support a large number of clients with their extensions & exclusivity strategy, providing advice and hands-on support on a Global or European basis for a given medicinal product. We strongly encourage early consideration of extensions & exclusivity strategy on a global basis to ensure valuable opportunities are not needlessly lost, and to ensure that the overall protection is maximised for a given product.

Mewburn Ellis was found to be in the top three firms when measured by number of recent UK SPC filings, but our experience in this area is global: having supported PTE & SPC filings from Belgium to Brunei.

Regulatory protection comes in different forms around the world, and the European system in particular has some unusual features to navigate. We regularly provide advice relating to European regulatory protection. Our hands-on support in this area includes preparing written submissions and leading oral proceedings with the European Medicines Agency (EMA) in connection with EU Orphan Drug Exclusivity.

An increasing number of countries now have some form of Regulatory-Patent Linkage system (like the US Orange Book) which can also interplay with PTEs and where short deadlines apply.

Our Extensions and Exclusivity team includes experienced IP counsel who previously specialised in the area of SPCs, PTEs, Regulatory Protection and Patent-Regulatory Linkage systems while working in-house for a global pharmaceutical company. This brings an additional dimension of hands-on, real-world experience and insight to our specialist team, supporting a holistic and integrated offering that we can provide to our pharma and life sciences clients.

Read more on our Speciality Pharma spotlight page.