Paris Court of Appeal - SAS SANTEN v/ INPI
Paris Court of Appeal
SAS Santen v/ INPI
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.
The basic patent relied upon not only protects a new application of ciclosporin (claims 23-24), but also and principally a submicron oil-in-water ophthalmic emulsion comprising an active substance, including ciclosporin (claims 1-21), 25-26).
It has not been demonstrated that the medical use of the marketing authorization for the Ikervis® proprietary medicinal product constitutes a new therapeutic application, within the meaning of the NEURIM case-law, in relation to the Sandimmun® proprietary medicinal product, both of which relate to the treatment of inflammations in the ophthalmological field.
The NEURIM case-law of 19 July 2012 CJEU, C-130/11:
The Court had ruled
"Articles 3 and 4 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 in such a case as in in the main proceedings, the mere existence of a prior marketing authorization obtained for the 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 authorization has been granted, provided that such application falls within the scope of the protection conferred by the basic patent claimed in support of the application for a supplementary protection certificate."
The legal situation in Europe:
Since the CJEU has not given any indication about what is covered by the concept of “new therapeutic use”, it has been apprehended in different ways by the offices of the various EU Member States;
- - The Dutch Office strictly limited it to the case in point of the NEURIM case (human marketing authorization against veterinary marketing authorization),
- - The UK judge went so far as to question the need to include new formulations of known products and put a preliminary question to the CJEU.
- - France concerning the Patent Office applies the case law in a measured way,
- by requiring that the basic patent be limited as in the case of NEURIM to the subject of the marketing authorization invoked, and
- that the marketing authorization, an indication falling within a new therapeutic field, in the sense of a new medical specialty, compared to the previous marketing authorization, or a medicinal product in which the active ingredient exerts an action different from that which it exercises
- in the medicine that was the subject of the first marketing authorization
The problem raised at the Court of Appeal:
It appears that the two drugs:
- - relate both:
- to the treatment of inflammations of parts of the eye in humans,
- by the same mechanism of anti-inflammatory action of ciclosporin
- - they differ:
- by their therapeutic indications:
- keratitis (inflammation of the anterior part of the eyeball)
- uveitis (inflammation of the central part of the eyeball);
- by their formulation:
- submicron oil in water emulsion
- oral solution;
- their dosage:
- 1mg of ciclosporin in 1 ml of emulsion
- 100mg in 1 ml of solution;
- their dose regimen.
- by their therapeutic indications:
The questions referred for a preliminary ruling by the Paris Court of Appeal:
1- the notion of different application within the meaning of the NEURIM judgment of 19 July 2012 CJUE, C-130/11, must it be understood strictly, ie:
- - be limited to the only case of a human use following a veterinary use,
- - or relate to an indication falling within a new therapeutic field, in the sense of a new medical specialty, in relation to the previous marketing authorization,
- - or a medicine in which the active ingredient has an action different from that which it exercises in the drug which was the subject of the first marketing authorization;
- - or more generally, in view of the objectives of Regulation (EC) No 469/2009 to establish a balanced system taking into account all the interests at stake, including those of public health, to be assessed according to more stringent criteria than those presiding over the assessment of the patentability of the invention;
- - or should it, on the contrary, be understood in an extensive manner, ie including not only different therapeutic indications and diseases, but also different formulations, dosages and / or modes of administration?
2– Does the concept of application falling within the scope of protection conferred by the patent according to the NEURIM judgment of July13, 2012 CJUE, C-130/11 imply that the scope of the basic patent should be consistent with that of the marketing authorization invoked and, by therefore, be limited to the new medical use corresponding to the indication therapeutic of said marketing authorization.
The questions referred to the CJEU are therefore different in scope.
1- The first aims to define what is meant by “new therapeutic use” protected within the SPC framework:
- - human versus animal
- - a new therapeutic field, implicitly in the human domain,
- - at the level of the action of the active ingredient in the drug,
- - should more stringent criteria be applied than those relating to the assessment of patentability by the EPO?
- - Is it enough that
- the formulation,
- the dosage or
- the mode of application
As a reminder, the EPO Boards of Appeal admit that the second therapeutic use may result from a new group of patients, from a different technical effect, from a new mode of administration, from a new dosage.
2- The second question concerns the scope of the basic patent.
Should the basic patent be limited to the new therapeutic use of the MA invoked in the SPC?
The question of the date of the assessment of such a criterion may arise.
Is it at the time of filing the application, the grant of the patent or following a post-grant limitation that has a retroactive effect, requested at the time of the issuance of the MA or the filing of the application for SPC.