Ciclosporin - EU

On Jul. 09, 2020, The Court of Justice of the European Union (CJEU) issued its decision on interpretation of Article 3(d) of SPC regulation & held that SPC cannot be granted for new indication.

Background:

Santen holds European patent (FR) No 057959306, which relates to an ophthalmic emulsion containing ciclosporin. Santen obtained a marketing authorisation (MA) on 19 March 2015 by the European Medicines Agency (EMA) for a medicinal product marketed under the name ‘Ikervis’ (ciclosporin). This product is used to treat severe keratitis in adult patients with dry eye disease. On 3 June 2015 Santen filed an application for an SPC for a product called ‘Ciclosporin for use in the treatment of keratitis’. By decision of 6 October 2017, the Director-General of the INPI rejected the application for an SPC, taking the view that the MA at issue was not the first MA, for the purpose of Article 3(d) of Regulation No 469/2009. Because there was another product (Sandimmun) which also contains ciclosporin, approved on 23 December 1983. Santen then brought an action against the decision of the Director-General of the INPI before the referring court, the Cour d’appel de Paris (Court of Appeal, Paris, France). Before that court, Santen sought, as its primary claim, the annulment of that decision and, in the alternative, to refer a question to the Court of Justice for a preliminary ruling concerning the interpretation of Article 3 of SPC regulation.

Article 3 of SPC regulation reads:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive;

(c) the product has not already been the subject of [an SPC];

(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.’

CJEU analysis:

In the present case, the questions referred for a preliminary ruling concern the interpretation of Article 3(d) of SPC Regulation and, more specifically, the interpretation of the concept of ‘first [MA for the product] as a medicinal product’ read in the light of the judgment in Neurim. In Neurim it was held that the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different therapeutic application of the same product for which an MA has been granted in human. CJEU said that for this issue it is necessary to examine whether Article 3(d) of Regulation must be interpreted as meaning that an MA may be considered to be the first MA, where it covers a new therapeutic application of an active ingredient and that active ingredient has already been the subject of an MA for a different therapeutic application. In this respect, the MA to which Article 3(d) of Regulation refers must be granted for a specified “product”, as defined in Article 1(b) of that regulation. Under that provision, ‘product’ means the “active ingredient” which have, at least, a therapeutic effect of their own. In conclusion, the term ‘product’ is understood to mean an active ingredient in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new SPC. Therefore, the fact that an active ingredient is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product. Moreover, this new MA granted for new indication is not the first MA to place the product on the market.

Therefore, the answer to the questions referred is that Article 3(d) of Regulation No 469/2009 must be interpreted as meaning that an MA cannot be considered to be the first MA, where it covers a new therapeutic application of an active ingredient, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.

On those grounds, the Court (Grand Chamber) hereby rules:

Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.