The Neurim CJEU decision of July 2012 has arguably caused an equal amount of excitement and controversy. On the one hand, it seemed to open the door to supplementary protection certificates (SPCs) for second or further medical uses. On the other, it seemed to go against a number of previous decisions. On a strict literal interpretation of Article 3(d) of the SPC Regulation, it should not be possible to obtain an SPC for new applications of old active ingredients that had already been the subject of a marketing authorisation. In Neurim, based on a teleological interpretation to the SPC Regulation, the CJEU held that such an SPC could be validly granted.
A recent Opinion from Advocate General M. Giovanni Pitruzzella in the Santen SPC preliminary reference urges the CJEU to expressly reject the Neurim decision, considering that the mere limitation of its application or marginalisation would not be a satisfactory option.
The facts in Santen
On 3 June 2015, Santen filed an SPC application relying on European Patent No. 057959306 as the basic patent in force (the “basic patent”) and on an EMA marketing authorisation granted on 19 March 2015 for the drug Ikervis (an eye drop emulsion containing the active ingredient ciclosporin used to treat severe keratisis). The French National Institute of Industrial Property (“INPI”) rejected the application on the ground that a marketing authorisation had been previously issued for the same active ingredient for a medication called Sandimmun (an oral solution with several therapeutic indications including the eye disease uveitis, an inflammation of some or all of the uvea (the middle part of the eye)).
INPI held that the conditions in Neurim had not been satisfied for two reasons:
- the basic patent was not limited to the severe keratisis indication – the claims included product only claims and claims to numerous other eye diseases; and
- Santen had not demonstrated that the marketing authorisation constituted a ‘new therapeutic indication’ within the meaning of Neurim (for example, where the mode of action of the active ingredient differs or where the medical field differs).
Santen appealed the decision to the Paris Court of Appeal and it, in turn, decided to stay proceedings referring two preliminary questions to the CJEU. The first question has asked the CJEU to consider how the concept of “different application” of an old active substance as understood in Neurim should be interpreted and the question provides a range of possible options from strict to broad interpretations. The second question asks whether, in the context of determining whether the “[SPC application is] within the limits of the protection conferred by the basic patent” as understood in Neurim, the scope of the basic patent should be the same as the marking authorisation relied upon (i.e. it should be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation).
Less than six months after the preliminary reference was made by the Paris Court of Appeal, the CJEU had the opportunity to consider the scope and relevance of the Neurim decision in the Abraxis SPC case. In that case the CJEU did not openly criticise the Neurim decision and, instead, limited its ramifications by referring to it as an “exception to the narrow interpretation of Article 3(d)” which “does not, in any event, refer to cases of new formulations of the product at issue”.