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October 9, 2018 - Second medical indication and SPC - Referral to the CJEU

Second medical indication and SPC - Referral to the CJEU - Gérard Dossmann, French IP and European patent attorney comments the decision of the Paris Court of Appeal of 9 october 2018 referring questions to the CJEU for a preliminary ruling on the interpretation of Article 3d) of Regulation (EC) No 469/2009 in the light of the NEURIM judgment (CJEU C-130/11).


The subject of the SANTEN’s patent :

The use of a submicron oil-in-water ophthalmic emulsion comprising an immunosuppressive agent selected from the group consisting of ciclosporin, sirolimus and tacrolimus, according to claim 21 the active substance is ciclosporin A, for the preparation of an ophthalmic composition for the treatment of ocular diseases such as (...) keratitis (...). The patent also relates to compositions not limited to the disease to be treated and the treatment of other ocular diseases..

The SANTEN marketing authorization :

A central marketing authorization dated March 19, 2015 for the medicinal product Ikervis® which includes as active substance "ciclosporin". This medicament is in the form of an emulsion eye-drop containing, per 1 ml, 1 mg ciclosporin ; it is administered by dose of a drop in the eye and can treat severe keratitis which is an inflammation of the cornea, anterior part of the eyeball.

The previous marketing authorization :

On December 23, 1983, a marketing authorization was granted for Sandimmun®, which active substance was already ciclosporin ; this medicine was in the form of an oral solution containing, per 1 ml, 100 mg ciclosporin. It had several therapeutic indications, on the one hand in the prevention of the rejection of solid organ transplants or bone marrow, on the other hand non-transplant, including the treatment of endogenous uveitis, which is an inflammation of all or part of the uvea, the central part of the eyeball ;

The subject of the SANTEN’s SPC :

"Ciclosporin for its use in the treatment of keratitis".

The decision the SPC application by the French Patent office :

The marketing authorization of March 19, 2015 is not the first for the active ingredient "ciclosporin" within the meaning of Article 3 (d) of EC Regulation 469/2009, since December 23, 1983 has already been granted a marketing authorization for Sandimmun ®, the active substance of which was ciclosporin.

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