The French courts have this week referred additional questions to the CJEU. In a break from the stream of questions regarding the interpretation of Article 3(a) of the SPC Regulation, these questions relate to the requirement under Article 3(c) of the SPC Regulation that the product has not already been the subject of an SPC.
The referred questions arose from a decision of the French Court not to grant an SPC for the active ingredient ciclosporin for the treatment of keratitis because a different formulation of ciclosporin had previously been authorised for the treatment of a different inflammatory eye condition. In referring questions to the CJEU the French Court distinguished the present case from Neurim (C-130/121) because the basic patent claimed a new formulation rather than a new specific use.
In answering the most recent questions it will be interesting to see how far the CJEU considers Neurim to be applicable since it is generally accepted by many practitioners that this decision is limited to previous veterinary uses.
1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.: - be limited to the case of a human application following a veterinary application, - or concern an indication in a new therapeutic field; - or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention; or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?