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Norway patent supplementary protection certificate?

What is a Patent Supplementary Protection Certificate (SPC) in Norway?

An SPC is a legal instrument that extends the market exclusivity of a patented pharmaceutical (or biotechnological) product.
It is not a new patent – it simply gives you extra time before a generic competitor can enter the market, compensating for the time spent obtaining regulatory approval.

Feature Norway EU (for comparison)
Legal basis Norwegian Patent Act (2004) + SPC Act (2005) – a national implementation of EU Directive 2004/48/EC EU Directive 2004/48/EC
Who can apply? Pharmaceutical or biotech companies that hold a valid patent and have obtained a marketing authorization in Norway Same as above
Maximum extension 5 years for most products; up to 6 years for certain biologics (e.g., vaccines, monoclonal antibodies) Same limits
Application window Must be filed within 1 year after the product receives marketing approval (or the date the approval is published) Same
Scope of protection The SPC covers the same product, strength, dosage form, and route of administration as the original patent. It does not cover the patent’s expiry date. Same
Exclusivity Grants you the exclusive right to market the product for the SPC term, effectively blocking generics. Same
Transferability The certificate may be transferred to a third party (e.g., a subsidiary) – just as with any patent. Same
Fees • Application fee: ~ NOK 30 000 (subject to change)
• Renewal fee: ~ NOK 10 000 (annual)		 Similar but varies by member state

Why do companies use SPCs?

  • Bridge the “approval gap.” A patent is usually granted at the time of filing the application, but regulatory approval can take 1–3 years (sometimes longer). SPCs add the lost time back into the exclusivity period.
  • Compensate for R&D costs. By extending exclusivity, the company can achieve a better return on investment.
  • Maintain market position. It delays the entry of generics until the SPC expires, protecting sales and revenue.

How to apply for an SPC in Norway

  1. Confirm eligibility

    • You own a valid patent covering the product.
    • The product has a marketing authorization (Medsin or a Norwegian competent authority).
    • The original patent is still active (not expired or revoked).

  2. Gather required documents

    • Copy of the granted patent (or a certified copy).
    • Proof of marketing approval: the approval letter, certificate, or other official documentation.
    • Certificate of translation (if the patent was granted in another language).
    • List of the product’s technical data (


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