Supplementary protection of medicinal products and plant protection products

It is possible to apply for supplementary protection for medicinal products and plant protection products manufactured on the basis of a patent after obtaining a marketing authorization.

It is possible to apply for supplementary protection for medicinal products and plant protection products, which prolongs the period of validity of the patent. The maximum term of validity of a patent is generally 20 years.

The development of medical protection and plant protection products includes long-term expensive research that takes a long period of time due to which the actual use of medicinal products and plant production products may be delayed and efficient patent protection may expire before the expenditure will pay off. Therefore it is possible to apply for supplementary protection of medicinal products and plant production products for maximum 5 years (Patents Act Chapter VIII1). In case of medicinal products for pediatric use it is possible to extend the term of supplementary protection for 6 months.

In order to get a supplementary protection certificate a prescribed application should be filed with the Estonian Patent Office and the following conditions must be fulfilled:

  • a  valid basic patent protects the medicinal product or plant production product;
  • the product has a valid sales permit;
  • the product has not been granted supplementary protection before;
  • the application for getting the certificate has been filed within 6 months from the grant of the sales permit or within 6 months from the date of grant of the patent, if the sales permit had been received before the basic patent.

An application for this action may be sent as an e-mail with a digitally signed attachment to [email protected], by post, or delivered to the address itself. 

In case of medicinal products for pediatric use it is possible to extend the term of supplementary protection for 6 months.

Supplementary protection certificates for medicinal products and plant protection products (SPC-s) valid in Estonia

The Database contains essential data of supplementary protection certificates for medicinal products and plant protection products (SPC-s) registered and valid in the Republic of Estonia.

The database is updated every Thursday from 16.30 to 17.00.

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SPC Waiver Notification in accordance with Article 5(2) (b) or (c) of Regulation EC No. 469/2009

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  • Jaga

Last updated: 03.06.2022