The Court does not have jurisdiction to rule on the validity of Article 21(2) of SPC Regulation for Medicinal Products.
"The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) 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, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community."
Article 21(2) of SPC Regulation for Medicinal Products applies to a supplementary protection certificate granted by a Member State prior to its accession to the European Union.
"Article 21(2) of Regulation No 469/2009, as amended, must be interpreted as meaning that it applies to a supplementary protection certificate, relating to a given medicinal product, granted by a Member State prior to its accession to the European Union."
If a market authorisation is granted in the EEA before it is granted in a Member State and before its accession to the EU, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate.
"To the extent that that medicinal product was the subject, within the European Economic Area, of a marketing authorisation before that granted in that Member State, and, as the case may be, before its accession to the European Union, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate."
IPPT20161005, CJEU, F. Hoffman-La Roche v Accord Healthcare
C‑572/15 - ECLI:EU:C:2016:739
