21.1.2019

Official Journal of the European Union

C 25/24

(Case C-673/18)

(2019/C 25/30)

Language of the case: French

Referring court

Parties to the main proceedings

Applicant: Santen SAS

Defendant: Directeur général de l’Institut national de la propriété industrielle

Questions referred

1.Must the concept of a ‘different application’ within the meaning of the judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted strictly, that is to say:

—as limited only to the situation where an application for human use follows a veterinary application;

—or as relating to an indication within a new therapeutic scope, in the sense of a new proprietary medical product, compared with the earlier marketing authorisation, or a medicinal product in which the active ingredient acts differently from how it acts in the medicinal product to which the first marketing authorisation related;

—or more generally, in the light of the objectives of Regulation (EC) No 469/2009 (1) of establishing a balanced system taking into account all the interests at stake, including those of public health, must the concept of a ‘new therapeutic use’ be assessed according to stricter criteria than those for assessing the patentability of the invention;

or must it on the other hand be interpreted broadly, that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration?

2.Does the expression ‘[application] within the limits of the protection conferred by the basic patent’ within the meaning of the judgment [of the Court of Justice] of 19 July 2012, Neurim (C-130/11, [EU:C:2012:489]), mean that the scope of the basic patent must be the same as that of the marketing authorisation relied upon and, therefore, be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation?

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).

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