No SPC for off-label-use
Upon an Austrian reference, the European Court of Justice gave another judgement on SPCs.
In the judgement C-631/13 of January 15, 2015, the ECJ clarified that an active ingredient whose therapeutic effects do not fall within the therapeutic indications for which a marketing authorisation was granted may not give rise to the grant of an SPC. An off-label-use consequently is not rewarded by the SPC-Regulation.
This is due to the fact, so the ECJ, that the marketing authorization procedure was not able to delay the commercial use of the basic patent.
That the active ingredient is covalently bound to other active ingredients, which are part of a medicinal product, does not per se exclude the grant of an SPC.
In any case, an SPC can be granted solely if it is established that the active ingredient produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.