7.2.3 Pharmaceutical compositions

In T 1616/09 the board pointed out that, for the purposes of Art. 83 EPC, the level of disclosure in the application which is required for claims directed to pharmaceutical compositions or kits is not the same as that which is required for medical-use claims. For claims directed to pharmaceutical compositions or kits it is in principle sufficient that the application provides information which allows the skilled person to produce the composition or kit, and that there are no substantiated doubts that it could indeed be used in therapy. For second-medical-use claims, on the other hand, it is required not only that the composition itself is disclosed in an enabling way but also that its suitability for the claimed treatment is plausibly disclosed in the application. In the case of a claim directed to a pharmaceutical composition comprising two classes of compounds which had both already been used in therapy in the prior art, there was a priori no reason to doubt that such a pharmaceutical composition could be produced; no specific functional effect had to be demonstrated. In the case of second-medical-use claims, if the claimed therapeutic effect was already known to the skilled person at the priority date, it was not necessary to demonstrate it in the application. According to T 1616/09, T 609/02 does not apply to compositions but only to second-medical-use-claims (see also T 1592/12, which also states that it is not sufficient to show that the skilled person can apply the claimed dosage regime, points 16-17 of the Reasons).