Article 13 of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products is to be construed, for the purposes of the application of the Agreement on the European Economic Area (EEA), as providing that such a certificate is to take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the territory of one of the States covered by the EEA Agreement, reduced by a period of five years. That first authorisation to place the product on the market in the EEA is not intended to take the place of the marketing authorisation provided for in Article 3(b) of Regulation No 469/2009; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the EEA. The first marketing authorisation in the European Union therefore serves a purely temporal purpose.

The EEA Agreement — Annex II of which, as amended by Annex 2 to Decision No 1/95 on the entry into force of the Agreement on the European Economic Area for the Principality of Liechtenstein, permits that principality to apply, in parallel with Community legislation, Swiss technical regulations and standards deriving from its regional union with the Swiss Confederation — recognises that two types of marketing authorisation may co-exist in the Principality of Liechtenstein, namely marketing authorisations issued by the Swiss authorities, which are automatically recognised in Liechtenstein, and marketing authorisations issued in Liechtenstein in accordance with Community legislation.

A marketing authorisation issued by the Swiss authorities and automatically recognised in Liechtenstein in the context of its regional union with the Swiss Confederation may be regarded as a first marketing authorisation for the purpose of Article 13 of Regulation No 469/2009 if it was issued before the marketing authorisation granted by the European Medicines Agency pursuant to Regulation No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency or before the marketing authorisations granted by the competent intellectual property authorities of an EU Member State in accordance with Directive 2001/83 on the Community code relating to medicinal products for human use, or by the competent authorities of the Republic of Iceland or the Kingdom of Norway.

In the context of the EEA, Article 13(1) of Regulation No 469/2009 must be interpreted as meaning that a Swiss administrative marketing authorisation, which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place the medicinal product in question on the market within the meaning of that provision in the EEA where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency, or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83 and the authorities of the Republic of Iceland and the Kingdom of Norway.

(see paras 38-41, 60, operative part)