Official Journal of the European Union

C 73/7

(Case C-631/13) (<span class="super note-tag">1</span>)

(Reference for a preliminary ruling - Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - ‘Active ingredient’ - Pneumococcal conjugate vaccine - Paediatric use - Carrier protein - Covalent binding)

(2015/C 073/09)

Language of the case: German

Referring court

Parties to the main proceedings

Applicant: Arne Forsgren

Defendant: Österreichisches Patentamt

Operative part of the judgment

1)Articles 1(b) and 3(a) 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 not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.

2)Article 3(b) of Regulation No 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

3)Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings.

(<span class="note">1</span>) OJ C 61, 1.3.2014.