Belgium SPC Calculation

In view of the CJEU Seattle Genetics (C - 471/14) and Incyte (C - 492/16) the Belgian Office for Intellectual Property recently issued a circular letter on addressing details on the calculation of the duration of Supplementary Protection Certificates (SPCs).

The date for calculating duration of SPC is the date of Notification of the decision granting Marketing Authorization rather than the decision itself is decided based on determination by the Court of Justice of the European Union (The CJEU, Seattle Genetics: C - 471/14) in 2015.

Recently, the CJEU provided more details about the correction of SPC durations that were granted based on the decision date based on Incyte case (C - 492/16).

Recent Amendment:
Recently, the Belgian Office for Intellectual Property has issued a circular letter providing details about the practice in Belgium in relation to the date of the Marketing Authorization.

• Marketing Authorization Granted by European Commission: Notification Date considered for calculation of SPC duration. (The Notification Dates published in official journal)
• Marketing Authorization Granted by National Authority: The date of the decision to be the date of the Marketing Authorization if there is no official publication of the Notification Date. The applicant has the option to provide proof that it was only notified at a later date in order to use that notification date as the date of the MA.

Compliance of Article 7 and article 13 of SPC Regulations: Circular also covers practice for the date of the Marketing Authorization thus the Belgian Office will use the Notification Date not only for the calculation of the SPC duration but also for the Calculation of deadline of filing the SPC.

It is good to submit proof of Date of Notification when Date of Notification is after the Date of Decision to enjoy the longer SPC duration in Belgium!

Click here to view circular.