What is meant by ‘personalised medicines’?

The term ‘personalised medicine’, or sometimes ‘targeted medicine’, is generally used to describe treatments for rare diseases.

As this Practice Note explains, such medicines are typically small molecule drugs repurposed for new indications or sub-populations of existing patient groups that share a predictive biomarker for disease. They may also be biological drugs defined by functional features.

These types of medicine raise particular issues for patenting and patent enforcement, some of which remain to be resolved by the English courts.

This Practice Note also explains the limits of patent and supplementary protection certificates (SPCs) for these forms of treatment and other rights that may be relevant to research in the area, including the protection provided by data and market exclusivity.

What are rare diseases?

Rare diseases are those 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 that impacts fewer than 200,000 people in the US.

In the UK and