The Court of Justice of the European Union (CJEU) recently delivered its decision in the case C-471/14 (Seattle Genetics). This case concerns how the duration of a Supplementary Protection Certificate (SPC) should be calculated.

The Court ruled that:

  1. Article 13(1) 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 must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.
  2. Article 13(1) of Regulation No 469/2009 is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

The granting of a marketing authorisation is often two to five days prior to the notification of it that is given to the addressee. The C-471/14 CJEU´s decision rules that the date of notification of the decision granting the marketing authorisation to the addressee, and no the granting date, is the one to be taken into account when calculating the SPC term. Thus, a longer duration for SPCs may be obtained for applicants not entitled to the full five years SPC term. The additional term is of immense commercial value, particularly because the market of a medicinal product will often reach its peak towards the end of the patent term.

Although the SPC regime is harmonised throughout the EU by the Regulation No 469/2009, SPCs are granted by national patent offices. Following the C-471/14 CJEU´s ruling, divergence regarding the pertinent date for calculation of the SPC term should not longer exist between member states. However, this remains to be seen since different national patent offices may apply the CJEU´s ruling differently.

In this sense, the Spanish Patent and Trademark Office (SPTO) took note of the judgment and recently published in the Official Bulletin of Industrial Property a communication explaining how the CJEU´s decision in the case C-471/14 will be applied by the SPTO.

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