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How DKPTO handles SPC applications

How DKPTO handles SPC applications as a consequence of CJEU case C-471/14 (Seattle Genetics) regarding calculation of duration of SPC 

 

An Austrian court has referred two questions to the CJEU regarding interpretation of article 13 of Regulation (EC) No. 469/2009 concerning supplementary protection certificates (SPC) for medicinal products. 

According to article 13(1) of the Regulation the SPC shall take effect 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 Community, reduced by a period of five years. 

The CJEU has been asked to consider how “the date of the first authorisation” in article 13(1) should be interpreted. Is it the date of the grant of the first marketing authorization (grant date) or the date where the applicant is notified of the grant of the first marketing authorization (notification date) which should be applied when calculating the duration of the SPC? 

The DKPTO will continue the processing of SPC applications and calculate the duration of the SPC on the basis of our current practice according to which the duration is based on the grant date of the marketing authorization. 

If you would like to have the processing of your SPC application put on hold while the decision of the CJEU is pending, you can request the DKPTO to do so. We will then asses the request and decide whether the proceedings can be put on hold. 

If your SPC has already been issued or it will be prior to the CJEU decision, you can request an administrative re-examination of the calculation of the duration of your SPC and at the same time apply to have the request for administrative re-examination put on hold while the CJEU decision is pending. 

If you have any questions you are most welcome to contact Susanne Schjang Bladt via e-mail  (link ssb@dkpto.dk ) or telephone +45 43 50 83 91.