While Article 3(d) of the SPC Regulation (No. 469/2009) was thought to prevent the grant of an SPC covering a new therapeutic application of a product which had already received a MA for a medicinal product, the CJEU ruled in its Neurim decision (C-130/11) of 19 June 2012 that “the mere existence of an earlier MA does not preclude the grant of a SPC for a different application of the same product”.
The meaning of the terms “a different application of the same product” has since been subject to different interpretations by the national offices granting SPCs.
In a case between Santen and the French patent office, the latter refused to grant an SPC on the basis of Article 3(d) of the Regulation on the ground that, since ciclosporin had already received a MA for the treatment of a particular type of ophthalmological inflammation (uveitis), the basic patent relied upon by Santen did not only protect a new application of ciclosporin (to treat another type of ophthalmic inflammation, i.e. keratitis) but also and mainly a new formulation of ciclosporin (in the form of an ophthalmic oil-in-water emulsion of submicron type). The French Patent Office therefore refused to accept that the basic patent relied upon by Santen effectively protects a “different application” of ciclosporin within the meaning of the Neurim decision.
The Paris Court of Appeal, seized of this dispute, has chosen to refer the following questions to the CJEU:
- – Does the concept of different application according to the CJEU Neurim decision of 19 July 2012, C-130/11, have to be strictly understood, that is: – be limited to the case of a human application following an earlier veterinary application only, – or concern an indication in relation to a new therapeutic field, within the meaning of a new medical specialty, compared to the earlier MA, or a medicinal product in which the active substance exerts a different action from the one it exerts in the medicinal product for which the first MA was granted; – or more generally, in light of the objectives of Regulation (EC) No. 469/2009 which aims at establishing a balanced system that takes into account all the interests at stake, including those of public health, is it to be assessed under more stringent criteria than those governing the assessment of 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.
- Does the concept of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, consequently, be limited to the new medical use corresponding to the therapeutic indication of said MA.
Answering these questions (as well as the one referred to by the UK High Court of Justice in Abraxis Bioscience (C-443-17)) should enable the CJEU to clarify the criteria laid down in the Neurim decision and to determine to what extent new therapeutic indications, formulations, dosages and/or modes of administration (relating to an active substance already used as a medicinal product) can be protected by an SPC. The impact of such decisions could thus be of major importance for the pharmaceutical industry.