What is an SPC?
The background to the introduction of an extended protection period for medicines and plant protection products is that the "effective" patent period is often substantially shorter for these products than for other patented inventions. This is due to the fact that medicines and plant protection products have to undergo extensive testing before they can be sold or placed on the market. It is not unusual for half the patent period to have elapsed before marketing authorisation is granted for plant protection products and medicines.
The issuing of a certificate can extend the period of protection by up to five years. The period of validity of the certificate becomes the period that has elapsed from the time when the patent application was submitted until the decision on the first authorisation to market the product in the EEA was notified, less five years. The period of validity nevertheless cannot exceed five years.
When can you apply for an SPC?
You must send an application for a certificate to the Norwegian Industrial Property Office within six months from the date when the first marketing authorisation for the product existed in Norway, or if applicable, from the date on which the patent was granted, if this is later.
What must the application for an SPC contain?
The application must contain:
- Request for issue of certificate.
- The applicant's name and address.
- Name and address of any representative.
- A power-of-attorney document if the representative is not a qualified lawyer or trainee lawyer.
- Number, title, expiry date and date of granting of basic patent (the patent that covers the invention for which an extended period of protection is requested).
- Number and date of the first marketing authorisation in Norway. The application must also contain a copy of the letter of approval for the product as a plant protection product (issued by the Norwegian Food Safety Authority) or the first authorisation to place the product on the market as a medicinal product (issued by the Norwegian Medicines Agency) in Norway.
- Member state, number and date of the first marketing authorisation in the EEA. The application must also contain a copy of the notification of this authorisation or any document proving that authorisation has been granted and showing the date of the authorisation and identifying the product.
- All information necessary for the Norwegian Industrial Property Office to be able to check that the product protected by the base patent, for example indication of the claim in which the product is protected.
- Application fee.
If an application does not contain the information or documents required, you will be given an opportunity to rectify these deficiencies within a specified time limit.
An application for a certificate may be in Norwegian or English.
Application form for SPC
- Application form for SPC (PDF-fil) - in Norwegian
What is needed to obtain an SPC?
We will decide whether the following conditions are met:
- The production for which protection is sought is protected by a base patent which is in effect. The product must be specifically stated in one of the claims in the base patent.
- The marketing authorisation on which the application is based is confirmed as being the first marketing authorisation for the product in Norway.
- The application, and the marketing authorisation on which the application is based, must concern the same product.
- A certificate has not previously been issued for the same product in Norway.
What is protected by the SPC certificate?
The protection provided by the certificate applies only to the product covered by the marketing authorisation for the plant protection product or medicinal product concerned, and any use of the product as plant protection product or medicinal product for which authorisation has been granted before the certificate expires.
Right to appeal on SPC
If an application for a certificate is rejected or shelved, you, as applicant, may appeal against this decision within two months to the Norwegian Board of Appeal for Industrial Property Rights (KFIR).
Change of period of validity of SPC
Anyone can request that the period of validity of a granted certificate be changed if the specified date of first marketing authorisation in the EEA proves not to be correct.
You must submit the request in writing to the Norwegian Industrial Property Office, and it must be justified.
If your request for the period of validity of the certificate to be changed is rejected, you can appeal within two months to KFIR.
Application for extended period of validity of SPC
The Paediatric Regulation has been introduced into Norwegian law and makes it possible to apply for a further six months' extension to the period of validity of supplementary protection certificates.
The statutory amendments due to the Paediatric Regulation entered into force 1 September 2017.
The new rules are intended to ensure that medicines for children have better evidence of quality, safety and efficacy, and to contribute to improving the availability of medicines specially intended for children.
An application for an extended period of validity can be submitted at the same time as an application for a certificate, or apply to a previously submitted application for a certificate or a certificate already granted. In connection with the introduction of the new regulatory framework for applying for an extended period of validity, separate transitional rules have been introduced for certificates that expire in the first few years after the statutory amendments due to the Paediatric Regulation enter into force in Norway. An application for an extended period of validity may be in Norwegian or English.
Application form for extended period of validity
The Norwegian Industrial Property Office has drawn up a special application form with associated guidance in connection with implementation of the Paediatric Regulation in Norwegian law. Use the application form to submit applications for extended period of validity
For further information about times limits for application, application conditions and requirements for evidence when submitting an application for extended period of validity, see separate article concerning the new rules:
The application form is in English, but Notes are in Norwegian only.
- Application for an Extension of a Supplementary Protection Certificate (SPC) for Pharmaceutical Products (PDF-fil)
- Notes - in Norwegian only (PDF-fil).
When will the certificate lapse?
A certificate will lapse:
- On expiry of the period of validity
- If the holder waives the certificate or the base patent
- If the annual fees for the certificate or base patent are not paid before the time limit expires
- If the product covered by the certificate is no longer authorised for marketing in Norway.
Professional assistance in the application process
Patenting and SPC is a complex field in which it is easy to take a wrong step. If you have little experience of patenting and SPC or little time to work on the application process, you should consider using a professional patent agency (also known as a patent agent or patent attorney). A patent agency can assist you, for instance, in preparing and formulating your patent application or SPC application. There are some strict requirements and deadlines to meet during the processing of the case. The patent agency will be able to assist in keeping track of these, as well as various payments such as annual fees.
- For a list of the various patent agencies, check the professional adviser database on the website iprhjelp.no. (This website is in Norwegian).