62018CJ0673_RES
Case C‑673/18
Santen SAS
v
Directeur général de l’Institut national de la propriété industrielle
(Request for a preliminary ruling from the Cour d’appel de Paris)
Judgment of the Court (Grand Chamber), 9 July 2020
(Reference for a preliminary ruling — Medicinal product for human use — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Article 3(d) — Conditions for the grant of a certificate — Obtaining the first authorisation to place the product on the market as a medicinal product — Authorisation to place on the market a new therapeutic application of a known active ingredient)
Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Concept of the active ingredient of a medicinal product — Substance having to produce a pharmacological, immunological or metabolic action of its own — Concept of ‘product’ — New therapeutic application of an active ingredient or of a combination of active ingredients — Active ingredient or combination of active ingredients used for the purposes of a different, already known, therapeutic application — Not included
(European Parliament and Council Regulation No 469/2009, Arts 1(b), and 4)
(see paragraphs 41-47)
Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for obtaining — First marketing authorisation for the product as a medicinal product — Concept — Marketing authorisation for a new therapeutic application of a known active ingredient which is already covered by a marketing authorisation — Not included
(European Parliament and Council Regulation No 469/2009, Art. 3(d))
(see paragraphs 49-53, 55, 61, operative part)
Résumé
Santen, a pharmaceutical laboratory specialising in ophthalmology, holds a European patent, filed on 10 October 2005 (‘the basic patent at issue’), which protects an ophthalmic emulsion in which the active ingredient is ciclosporin, an immunosuppressive agent. On 19 March 2015, that laboratory also obtained a marketing authorisation (MA) granted by the European Medicines Agency (EMA) for the medicinal product marketed under the name ‘Ikervis’, the active ingredient of which is likewise ciclosporin.
On the basis of the basic patent at issue and that MA, on 3 June 2015 Santen filed an application for a supplementary protection certificate (SPC) covering a product called ‘Ciclosporin’ for the purposes of its use in the treatment of keratitis. By decision of 6 October 2017, the Director-General of the Institut national de la propriété industrielle (the National Institute for Industrial Property, France) (INPI) rejected that application for an SPC, taking the view that the MA at issue was not the first MA for ciclosporin.
Seised of an action for annulment brought by Santen against that decision, the Cour d’appel de Paris referred a question to the Court of Justice on the interpretation of the concept of ‘first MA as a medicinal product’ for the purpose of Article 3(d) of the Regulation concerning the SPC for medicinal products. (
1
) That court thereby requested the Court of Justice, inter alia, to make clear the scope of the concepts of ‘different therapeutic application’ and ‘therapeutic application within the limits of the protection conferred by the basic patent’ in the judgment in Neurim. (
2
) In that judgment, the Court had 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, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC. (
3
)
In its Grand Chamber judgment of 9 July 2020, the Court ruled on the issue whether, in terms of Article 3(d) of the Regulation concerning the SPC for medicinal products, an MA may be regarded as the first MA for the product as a medicinal product 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 an MA for a different therapeutic application.
In the first place, the Court considered the issue whether the concept of a ‘product’ (
4
) is dependent on the therapeutic application of the active ingredient. The Court observed in that regard that, for the purposes of the application of the Regulation concerning the SPC for medicinal products, that concept refers to the active ingredient or combination of active ingredients of a medicinal product. In addition, it stated that the scope of that concept need not be limited, in the absence of any definition of the concept of ‘active ingredient’ in that regulation, only to one of the therapeutic applications to which such an active ingredient or combination of active ingredients may give rise. The Court pointed out that although the protection conferred on a product by an SPC extends only to the product covered an MA, it covers any use of that product as a medicinal product which was authorised before the expiry of the SPC. (
5
) In those circumstances, the Court concluded that the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application.
In the second place, the Court explained the concept of ‘first MA for the product, as a medicinal product’ in Article 3(d) of the Regulation concerning the SPC for medicinal products. It thus noted that, in order to define that concept, there is no need to take into account the limits of the protection of the basic patent. The European Union legislature intended, in establishing the SPC regime, to promote the protection of pharmaceutical research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product, and not to promote the protection of all research giving rise to the grant of a patent and the marketing of a new medicinal product. Thus the Court concluded that, for the purpose of Article 3(d) of that regulation, an MA cannot be considered to be the first MA 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 an MA for a different therapeutic application.
(
1
)	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 (OJ 2009 L 152, p. 1). Article 3(d) of that regulation provides that an SPC is granted if, in the Member State in which the application for the SPC is submitted and at the date of that application the MA obtained by a product, as a medicinal product, is the first MA for that product, as a medicinal product.
(
2
)	Judgment of the Court of 19 July 2012, Neurim Pharmaceuticals (1991) (C‑130/11, EU:C:2012:489; ‘the judgment in Neurim’).
(
3
)	Judgment in Neurim, point 1 of the operative part.
(
4
)	As provided for in Article 1(b) of Regulation No 469/2009.
(
5
)	Article 4 of Regulation No 469/2009.