Personalised medicine: patient stratification

Personalised medicine

While the general idea of customising treatment to patients is not new, the degree to which treatments may be tailored to patient subgroups defined by objectively testable characteristics, or even to the level of the individual, is the most significant breakthrough in medical science to emerge in our lifetimes.  As NHS England explains, "Personalised medicine is a move away from a ‘one size fits all’ approach to the treatment and care of patients with a particular condition, to one which uses new approaches to better manage patients’ health and targets therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease."

There are a number of reasons why this is happening now, driven by a range of different technologies and therapies coming of age. The biotech revolution has brought us treatments, such as HERCEPTIN® that is targeted to those specific cancers that overexpress HER2 receptor.  This has been coupled with dramatic improvements in our ability to test patients to determine which therapies they are likely to respond to, such as by sequencing their whole genome to identify particular genetic variations.  Along with advances in bioinformatics and processing the information from these tests, patients and patient groups can be matched up to the treatments that offer the best chance of controlling or curing their disease.  At the extreme end of the spectrum, the next wave of immuno-oncology will make it possible to produce personalised adoptive cell therapies to programme an individual's immune cells to kill tumour cells while leaving normal cells unharmed (Rammensee et al., "Genomic and Personalised Medicine, Chapter 50, Cancer Vaccines: Some Basic Considerations").

Patent protection 

As you might expect, those working in this space are keen to protect their innovations through the patent system.  In the normal course of events, law is made and adapted in response to developments in the real world, often struggling to keep up with the fast pace of technological developments.  Unusually, in the case of personalised medicine in Europe, creative attorneys and the Boards of Appeal at the EPO have already developed the legal tools needed to protect inventions in the personalised medicine space.

For example, the principle that a newly appreciated patient subgroup could give rise to a patentable invention has been in place since 1987.  In this early decision at the EPO (T 19/86), the Board of Appeal decided that a patient subgroup could be the novel and inventive feature in medical use claims distinguishing an invention from the prior art based on "the physiological or pathological status" of the subgroup. 

More recently, in 2007, we successfully argued (in T 1642/06) that a new technical effect arising from a treatment can lead to "a new clinical situation" that is protectable using medical use claims at the EPO. 

This was supported some years later in decision T 1859/08 in which the Board agreed with us, holding that all the technical features of the therapeutic indication specified in the claims, and not just the therapeutic entity and disease to be treated, must be taken into account when considering whether claimed subject-matter is novel, supporting the patentability of patient subgroups or personalised medical regimes.

This legal rationale provides a sound basis for claims directed to many personalised medicine inventions in Europe.  Mewburn Ellis Life Sciences attorneys are excited to be helping to create the law that enables the protection of personalised medicine inventions in Europe.