Turning ideas into assets

Calculation of a SPC's duration - Case C-471/14 Seattle Genetics

On Tuesday, October 6 2015, the EU Court of Justice (CJEU) decided which date to be taken into account in a marketing authorization when calculating the duration of a supplementary protection certificate (SPC). 

The question arose in case C-471/14 (Seattle Genetics) where the CJEU was asked to consider how ‘the date of the first authorisation to place the product on the market’ in the SPC Regulation No. 469/2009, article 13(1) should be interpreted. 

A marketing authorisation issued under the European Medicines Agency (EMA), the so-called centralized procedure, has two dates that can be interpreted as ‘date of the first authorisation to place the product on the market’. 

The two possible dates are:

  • The date of the decision granting of the marketing authorisation (decision date)
  • The date the applicant is notified with the approval of the marketing authorisation (notification date) 

 

The CJEU ruled that article 13(1) in the SPC Regulation is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market’ 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 Danish Patent and Trademark Office takes note of the judgment, and will henceforth calculate the duration of the SPC applications based on a marketing authorisation issued by EMA on the basis of the notification date. 

 

What does this mean in practice?
If you have a pending SPC application or apply for a new SPC application, the application will be examined in accordance with the CJEU decision case C-471/14. 

If you have a certificate that has already been issued, you have the possibility to request for an administrative re-examination of the duration of your certificate in accordance with the Danish Patent Order section 78 and 82. 

This means that the Danish Patent and Trademark Office will not re-examine already issued certificates automatically.