23Jun2009
Almirall v. Mylan, Court of Appeal Brussels (Hof van Beroep te Brussel), 23 June 2009
The Brussels Court of Appeal ruled that, in calculating the period of validity of an SPC, the ‘first authorisation to place the product on the market in the Community’, within the meaning of Article 13 of the SPC Regulation, does not necessarily need to be an authorisation issued in accordance with Directive 65/55/EEC or Directive 81/851/EEC. It can also be a national marketing authorisation issued in a Member State which has not yet transposed these directives into national law.
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