A Swiss MA is the ‘first authorisation’ for the purpose of an SPC

Further to a request for a preliminary ruling from the High Court of Justice (England and Wales), in the proceeding AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks, the Court of Justice of the European Union (CJEU) has ruled that an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of article 13(1) of Regulation (EC) No 469/2009 for the purposes of obtaining a supplementary protection certificate (SPC).

This applies in circumstances where the 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/EC on the Community code relating to medicinal products for human use, and the authorities of the Republic of Iceland and the Kingdom of Norway…

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