Medical uses in the EPO: The importance of a new effect

Medical uses in the EPO: The importance of a new effect

It can often be instructive to compare apparently conflicting European Patent Office (EPO) decisions in an attempt to understand certain subtleties of how patentability requirements are assessed.  This brief article compares two recent decisions, each relating to the second medical use of known ingredients.

The first decision, T 254/93, related to the use of a corticosteroid in a cream intended for the prevention of skin atrophy.  Compositions including retinoids and corticosteroids as active ingredients were already known for the same therapeutic use. In this case the Technical Board of Appeal (TBA) of the EPO concluded that the contribution made by the patent was merely the discovery that it was the corticosteroid which prevented the skin atrophy.  This explanation of the mode of action of the composition was not enough to make the claims novel. The patent was therefore held to be invalid.

T 286/09, by way of comparison, related to a pre-biotic and its use in a medicine intended for decreasing inflammatory processes in the elderly.  Compositions containing pre-biotics had previously been administered to people with certain immunological conditions associated with ageing, some of which conditions led to an increase in the inflammatory response. However, no direct link had been made in the prior art between the use of the pre-biotic and its potential activity in the reduction of the inflammatory process.  Accordingly, in this case the TBA felt that the claims were novel, since it was not directly known to use pre-biotics for decreasing inflammatory processes.

These two decisions are interesting as they highlight what may sometimes be a fine line between what is new and what is known for the purposes of assessing novelty in the EPO.  It is clear from these cases that, if the specific link between an ingredient within a composition and a therapeutic effect was not known before the filing of the application, novelty will be present; however, the simple explanation of why a substance, known to have a particular therapeutic effect, works in that therapeutic indication is not enough.

This difference may be useful in infringement situations - if the alleged infringer can show that the key component was known (or strongly suspected) to have the claimed therapeutic effect before the filing of the patent in question, the infringer’s activities may be argued simply to fall within the realm of what was already known.  For this reason if the patent is infringed, it may also be invalid for the reasons set out in T 254/93.

Joanna Westwood
Life Sciences & Chemistry Group