The rise of so-called personalised medicine presents new challenges and opportunities for drugs companies, says Robert Andrews.
In the not-so-distant past, obtaining patent protection for a new therapeutic drug (or new use of a known drug) was simpler than it is today. The therapeutic landscape was comparatively unexplored, and our knowledge of disease pathology was uninformed by the battery of molecular techniques available today. This lack of detailed information meant the factors to consider when assessing a new therapeutic application were relatively few and, consequently, the required analysis was relatively straightforward.
Fast-forward to today, and the number and sophistication of the analytical techniques available mean that it is not uncommon for researchers to make discoveries beyond simply which disease(s) a compound has the potential to treat. For example, the research may characterise the subset of patients in which a drug works best (or not at all). Illustrations of this type of ‘personalised’ medicine abound in the scientific literature, and patients can be defined by, for example, genotype, single-nucleotide polymorphisms (SNPs), or protein markers.
This allows targeted treatment of the patients who respond best, and the avoidance of non-responders or those likely to suffer adverse effects. In some cases, defining the patient group means the difference between clinical trial success and failure, enabling rational design of smaller trials with high success rates in defined patient sub-groups.
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personalised medicine, EPC, T1020/03, Enlarged Board of Appeal