The term ‘active ingredient’, for the purposes of applying Regulation No 469/2009, concerns substances producing a pharmacological, immunological or metabolic action of their own. Since Regulation No 469/2009 does not draw any distinction according to whether an active ingredient is covalently bound with other substances, it is not appropriate to exclude, on that ground, the grant of an SPC for such an active ingredient. On the other hand, a substance which has no therapeutic effect of its own and which is used to obtain a certain pharmaceutical form of the medicinal product is not covered by the term ‘active ingredient’ and, consequently, cannot give rise to the grant of an SPC. The answer to the question whether a substance which is part of a medicinal product is an active ingredient within the meaning of Article 1(b) of Regulation No 469/2009 depends, therefore, on whether that substance has a pharmacological, immunological or metabolic action of its own, independently of any covalent binding with other active ingredients.

Articles 1(b) and 3(a) of Regulation No 469/2009 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.

Article 3(b) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products 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.

The supplementary protection certificate is designed to re-establish a sufficient period of effective protection of the patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of the basic patent which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first marketing authorisation in the European Union was granted. It follows from the foregoing that, unless it has been granted a marketing authorisation as a medicinal product, a patented product may not give rise to the grant of a supplementary protection certificate. Furthermore, it follows from Article 4 of Regulation No 469/2009 that the use of a product which has not been authorised, as a medicinal product, by the marketing authorisation may not be covered by a supplementary protection certificate.

Consequently, since no trial or data concerning an active ingredient’s own therapeutic effects was integrated into the marketing authorisation procedure for the medicinal product of which it forms part, that procedure was not able to delay the commercial use of the basic patent. In such circumstances, the grant of a supplementary protection certificate is contrary to the aim pursued by Regulation No 469/2009, which is to offset, at least in part, the delay to the commercial use of a patented invention on account of the time needed for the first marketing authorisation in the European Union to be granted.

(see paras 33-35, 38, 39, operative part 2)