Supplementary Protection Certificate (SPC)
A Supplementary Protection Certificate may be obtained for pharmaceuticals and plant protection products in Norway. The duration of the SPC is limited to the time between the filing of the patent application and the first marketing authorisation for the product given within the EEA, minus 5 years (a maximum of 5 years extension).
An application for an SPC must be filed within 6 months from the date of the first marketing authorisation for the product in Norway, or alternatively from the day the patent was granted, whichever is later.
We can file an SPC on your behalf. The following is required:
- Applicant’s name and address, as well as our name and address
- Number, title, expiration date and date of grant for the patent
- Information regarding the first marketing authorisation in Norway, as well as a copy of the approval letter from the Norwegian Medicines Agency or the Norwegian Food Safety Authority
- Country, number and date for the first marketing authorisation within the EEA (if other than the Norwegian), as well as a copy of the notification or a document proving that the authorisation has been given
- All information required for the PTO to control that the product is protected by the patent
- Payment of the application fee