For medical use claims as per the wording under EPC2000 “Compound X for use in the treatment of disease Y” or under EPC1973 “Use of X for the manufacture of a medicament for use in the treatment of disease Y” it is required that compound X is suitable for the claimed medical use Y over the whole scope of the claim. If plausible disclosure in support for said suitability is missing, then said claim does not comply with the enabling disclosure requirement of Article 83 EPC (see News of February 10, 2014).
Recent EPO’s Board of Appeal decision T 1616/09 of August 27, 2014 for the first time appears to answer the question, what level of disclosure under Article 83 EPC is required for claims directed to pharmaceutical compositions or kits usually having the wording “Pharmaceutical composition or kit comprising compound X” vs. second medical use claims.
According to the Board for claims directed to pharmaceutical compositions or kits – which are product claims, not restricted to any specific therapeutic effect – it is sufficient a) that information is provided which allows the skilled person to produce the composition or kit, and b) that there are no substantiated doubts that it could indeed be used in (any) therapy.
Furthermore, unlike medical use claims, for claims directed to a pharmaceutical composition or kit no specific functional effect or effectiveness has to be demonstrated in order to be in line with the enablement requirement of Article 83 EPC.