Supplementary Protection Certificate (SPC)

Supplementary protection certificate (SPC) is an extension of the exclusive right that you can get in certain cases for medicinal products and plant pharmaceutical products.

Why have medicines and plant pharmaceutical products extended the protection period?

The "effective" patent term is often significantly shorter for these products than for other patented inventions.

This is because pharmaceuticals and plant-pharmaceutical products must go through extensive testing before they can be marketed or placed on the market. It is not unusual for half of the patent period to have passed before a marketing authorization is granted for plant pharmaceutical products and medicinal products.

How long can the protection period be extended with SPC?

The issuance of a certificate can extend the protection period by up to five years.

The period of validity for the certificate is the time that has elapsed from the time the patent application was submitted until the decision on whether the first permission to market the product within the EEA was granted, reduced by five years. However, the period of validity cannot exceed five years.

What does it take to get SPC?

We will determine whether the following conditions are met:

  1. The product for which protection is sought is protected by a basic patent that is in force.
  2. The marketing authorization that forms the basis of the application is confirmed to be the first marketing authorization for the product in this country.
  3. The application, and the permission for marketing on which the application is based, must relate to the same product.
  4. No certificate has previously been issued for the same product in Norway.

What is protected by the SPC certificate?

The protection provided by the certificate only covers the product covered by the marketing authorization for the corresponding plant protection product or medicinal product, and any use of the product as a plant protection product or medicinal product for which permission has been granted before the certificate expires.

When can you apply for SPC?

You must send an application for a certificate to the Norwegian Industrial Property Office (NIPO) within six months from the day the first marketing authorization for the product was granted in this country. Or from the day the patent was granted, if this is later.

What must the application for SPC contain?

  1. Requirements for issuing a certificate.
  2. Applicant's name and address.
  3. Name and address of any representative.
  4. A copy of any power of attorney document if the power of attorney is not a lawyer or legal assistant. It is sufficient that there is authorization in the basic patent, if this authorization includes applications for SPC.
  5. Number, title, expiry date and notification date of the basic patent (the patent covering the invention for which an extension of the protection period is sought).
  6. Number and date of the first marketing authorization in Norway. The application must also contain a copy of the approval letter for the product as a phytopharmaceutical product (issued by the Norwegian Food Safety Authority) or the first permission to place the product on the market as a medicinal product (issued by the National Medicines Agency) in Norway.
  7. State, number and date of the first marketing authorization within the EEA area. The application must also contain a copy of the announcement of this permit or any document proving that the permit has been granted, indicating the date of the permit and identifying the product.
  8. All information that is necessary for the NIPO to be able to check that the product is protected by the basic patent, for example an indication of the claim in which the product is protected.
  9. Application fee.

If an application does not contain the information or documents required, you will be given the opportunity to correct these deficiencies within a specified deadline.

Application for a certificate can be in Norwegian or English.

Appeal possibility SPC

If an application for a certificate is refused or dismissed, you as the applicant can appeal this decision to the Board of Appeal (KFIR) within two months.

Change of validity period SPC

Anyone can submit a claim to have the validity period of a notified certificate changed if the specified date for the first permission to market within the EEA area turns out to be incorrect.

You must submit the claim in writing to the NIPO, and it must be justified.

If your request to change the validity period of a certificate is rejected, you can appeal to KFIR within two months.

When will the certificate expire?

A certificate will lapse:

  1. at the end of the validity period
  2. if the holder renounces the certificate or basic patent
  3. if the annual fees for the certificate or basic patent are not paid within the deadline
  4. if the product covered by the certificate is no longer allowed to be marketed in Norway

Application for extended validity period SPC - paediatrics

The Paediatrics Ordinance entered into force on 1 September 2017, and makes it possible to apply for a further six-month extension of the validity period of supplementary protection certificates.

The regulations shall ensure that medicinal products for children have better documentation for quality, safety and efficacy, and shall contribute to increasing the availability of medicinal products specially intended for children.

When do you have to submit the application?

You must apply for an extended period of validity no later than two years before the certificate expires. You can submit the application at the same time as an application for a protection certificate, or you can apply for an extended validity period for a previously submitted application for a certificate or an already issued certificate. An application for an extended period of validity can be in Norwegian or English.

Necessary documentation

You must provide documentation showing that there is a valid marketing authorization for all EEA states (except Liechtenstein). This must contain a statement that pediatric studies have been carried out in accordance with an approved, completed pediatric trial plan.

If the marketing authorization has been issued centrally by The European Medicines Agency (EMA), attach a copy of the European Commission's decision and a copy of the declaration of performed pediatric studies issued by the EMA. If marketing authorizations and declarations of performed pediatric studies have been issued by the competent authorities in the individual EEA states nationally, you must include copies of all these with the application.

How much does it cost?

You must pay a fee for extending the supplementary protection certificate (SPC) of NOK 2,000.

Application form for extended validity period

We recommend that you apply for an extended validity period via Altinn.

If you can't use Altinn, we have an application form and a guide in PDF. The guid is only available in Norwegian.


Marketing authorization checklist

You can use this checklist to find out whether you have marketing authorization for all EEA countries, or from the European Commission:

Read more about the pediatric regulation at regjeringen.no

Do you need help from an advisor?

Patenting and SPC is a complex field where it is easy to make mistakes. If you have little experience with patenting and SPC, or have little time to work with the application process, you should consider using a professional patent agency (also called a patent attorney or just an attorney).

A patent office can, among other things, help you prepare your patent application or SPC application. They can also ensure that important deadlines and payments are followed up in the case management process.