New CJEU decision on SPCs


A recent decision from CJEU specified what is a first marketing authorisation

In case <link http: juris document external-link-new-window internal link in current>C-673/18, CJEU had to judge a dispute between Santen SAS and the Director-General of the Institut National de la Propriété Industrielle.

Santen is a pharmaceutical laboratory specialising in ophthalmology. It holds a European patent which protects, inter alia, an ophthalmic emulsion in which the active ingredient is ciclosporin, an immunosuppressive agent.

Santen obtained a marketing authorisation (MA) for a medicinal product marketed under the name ‘Ikervis’, the active ingredient of which is ciclosporin. That medicinal product is used to treat severe keratitis in adult patients with dry eye disease that has not improved despite treatment with tear substitutes, causing inflammation of the cornea.

On the basis of the same patent, Santen filed an application for an Supplementary Protection Certificate (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 that 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, for ciclosporin.

CJEU therefore had decide what a first MA is and ruled 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.