Judgment of the court of justice
of the European Union of 9 july 2020
Case C‑673/18 – Santen v INPI
The ruling of the CJEU in the Santen Case C‑673/18 has been published.
In this case, Santen held a European patent No 057959306, which protects, inter alia, an ophthalmic emulsion in which the active ingredient is ciclosporin, an immunosuppressive agent.
Santen obtained a marketing authorisation (‘MA’) for the medicinal product ‘Ikervis’ which active ingredient is ciclosporin indicated in the treatment of severe keratitis in adult patients with dry eye disease that has not improved despite treatment with tear substitutes, causing inflammation of the cornea.
A SPC application was filed at the French patent office for a product defined as ‘Ciclosporin for use in the treatment of keratitis’.
The SPC application was refused as an earlier MA had been granted for ‘Sandimmun’, an oral solution that had ciclosporin as active ingredient, and was indicated for preventing the rejection of solid organ and bone marrow grafts and for other therapeutic indications, including the treatment of endogenous uveitis, an inflammation of all or part of the uvea, the middle part of the eyeball.
Santen filed an appeal againt the decision of refusal based on the earlier judgment of the CJUE of 19 July 2012, Neurim Pharmaceuticals (1991) (C‑130/11, EU:C:2012:489), and the Court of Appeal of Paris referred a question to the Court of Justice for a preliminary ruling concerning the interpretation of Article 3 of Regulation No 469/2009.
In Neurim, the CJUE had held that the mere existence of an earlier marketing authorisation [obtained for a veterinary medicinal product] does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation 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 supplementary protection certificate.
The concept of a “different application” within the meaning of the Neurim decision created uncertainty for being conflicting with the literal wording of the provisions of the SPC Regulation. The French patent office, for instance, restricted application of this concept to situations where the first MA is for a veterinary product, and the subsequent MA, forming basis of the SPC application, is for a medicinal product for human use.
In Santen, the question therefore related to the interpretation of a « different application ».
The Court has now ruled that « 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. »
The Court thereby departs from Neurim and holds that the MA obtained for the product which is the subject of the SPC application must, at the date of that application, be the first MA for that product as a medicinal product in the Member State in which that application is submitted, irrespective of the limits of the protection of the basic patent.
The Court made clear that this principle is not called into question in the event that the most recent MA is the first MA to fall within the limits of the protection of the basic patent relied on in support of the SPC application.
Hence, an SPC should not be obtained for a new therapeutic application of an active ingredient which has already been the subject of an MA prior to the MA on which the application for that SPC is based.