Precision medicine: getting patenting spot on

Precision medicine has come a long way since the completion of the Human Genome Project in 2003, but how have IP regimes developed in this area, asks Sheena Linehan of Potter Clarkson.

Precision medicine is an emerging approach to the diagnosis and treatment of disease which is tailored to the individual characteristics of each patient. It relies on the classification of individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology or prognosis of disease, or in their response to a specific treatment. The advent of cheap genome sequencing and ‘big data’ analysis brings unprecedented opportunity for the development of patient-targeted diagnostics and therapies based on genetic profiles.   

This year, the UK’s ambitious 100,000 Genomes Project is expected to be completed, focusing on patients with cancer or rare diseases. In addition, the US 21st Century Cures Act of 2016 includes provisions that will advance precision medicine, including the Precision Medicine Initiative, which will review the genetic data of no fewer than one million Americans. Allied to this, a Cancer Moonshot initiative aims to ‘eliminate cancer as we know it’.

While public funding for precision medicine seems to be in the ascendancy, a key question is whether IP or regulatory regimes create commercial incentives and what can be done now to capture IP value.