Personalised and repurposed medicines: patentability, enforcement, SPCs, diagnostics, and regulatory exclusivities in the UK and EU

Published by a LexisNexis Life Sciences expert

Practice notes

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What is meant by ‘personalised medicines’?

The expression ‘personalised medicine’, sometimes called ‘targeted medicine’, commonly refers to therapies aimed at rare conditions. As outlined in this Practice Note, these medicines often involve small‑molecule products repositioned for fresh indications or for subsets of existing patient cohorts that share a predictive biomarker of disease. They can also be biological medicines characterised by functional attributes. Such products present distinct challenges for securing patents and for patent enforcement, some of which are yet to be determined by the English courts. This Practice Note also sets out the limits of patent protection and supplementary protection certificates (SPCs) for these approaches, and signposts other rights relevant to research in this field, including the protection afforded by data and market exclusivity.

What are rare diseases?

Rare diseases are conditions that affect a small minority of the population. In the US, a rare disease is defined by the Orphan Drug Act as a disease or condition affecting fewer than 200,000 people in the US. In the UK and the EU, a disease is considered rare when it impacts fewer than one in 2,000 people (see: Marketing exclusivity and orphan drugs). Accordingly, estimates of the number of rare conditions...

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Dr Paul England

Taylor Wessing LLP

Dr Paul Alexander England is the senior knowledge lawyer in the UK Patents Group, specialising in advisory work for clients and the Patents Group on contentious patent matters. Paul is also Secretary of the Academy of Experts, a professional body for expert witnesses, founded in 1987, which establishes and promotes high objective standards.Paul has a particular interest in the life sciences sector, having begun his career as a scientist and taken a doctorate in biochemistry and molecular biology at the University of Oxford. Paul publishes and speaks on patent law widely, including for Pfizer, Abbott, Takeda, Roche, Viatris, and is an author of the critically acclaimed A Practitioner's Guide to European Patent Law and A User's Guide to Intellectual Property in the Life Sciences. Paul is a reviewer for the Journal of Intellectual Property Law and Practice (Oxford University Press) and a...

Web page updated on 21/05/2026

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