SPC - Supplementary Protection Certificate
A Supplementary Protection Certificate (SPC) can be granted in Norway for pharmaceuticals for humans and animals and plant protection products. This may extend the total period for actual patent protection up to a maximum of 25 years; i.e. an additional 5 years of patent protection beyond the normal 20 years.
To be able to file an application for an SPC you must have: 1) a granted patent in Norway and 2) a Norwegian marketing Authorisation (from the Norwegian Medicines Agency) or a corresponding confirmation from the Norwegian Food Safety Authority for plant protection products. The latter document must be enclosed in the application.
The final deadline for filing an SPC application is no later than 6 months after grant of the patent application or 6 months after the first marketing authorisation in Norway based on the latest of these two dates. It is not possible to request restitution for missing these deadlines.
The application must be filed in Norwegian and with a Norwegian translation of the essential documents. A SPC application must also enclose a confirmation regarding the first marketing authorisation within the EEA and if possible a copy of the EEA Official Journal where the decision was mentioned. An application must also be followed by a proof of connection between the product indentified in the marketing authorisation and its structural formula as well as identification of the relevant claims and paragraphs of the basis application. It should also be indicated if the application shall apply for the compound per se or also for its pharmaceutically acceptable salts etc. A Power of Attorney must also be enclosed.
If a Supplementary Protection Certificate (SPC) is granted, the certificate shall take effect at the end of the lawful term of the basic patent 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 authorization to place the product on the market in the EEA, reduced by a period of five years.
Arne Lund Kvernheim, Bryn Aarflot
Published in Managing Intellectual Property, November Edition 2009
