Supplementary Protection Certificate, SPC

Normally, you need a licence to use inventions relating to medicinal products or plant protection products. The licence requires comprehensive and time-consuming investigations to find out whether the products are safe for users and the environment. The investigations take up a significant part of the patent term, and that is why it is possible to extend the patent term by applying for a Supplementary Protection Certificate (SPC) for patents relating to medicinal or plant protection products.

Duration

An SPC is granted for a period of up to five years, but it may be extended, at request, for a further six months if the medicinal product’s suitability for children has been tested as referred to in a specific paediatric investigation plan, PIP.

The SPC enters into force when your basic patent expires at the end of the 20-year patent term. Example: if a basic patent filed on 10 October 2010 expires on 10 October 2030, the SPC will enter into force on 11 October 2030.

How to apply

File your application with the PRH in Finnish or in Swedish to obtain an SPC in Finland. The application form provides instructions on how to fill in the application and more details about the documents you must include with it. Use a specific form in Finnish or in Swedish to apply for an extension of an SPC for medicinal products for paediatric use. Please note that the application is subject to a fee.

Go to forms in Finnish or in Swedish .

Go to SPC fees.

Notification of use of an exception for manufacturing

Under certain conditions, third parties may start manufacturing products protected by an SPC already during the SPC protection period. This exception for manufacturing may be used if the product is manufactured or stored for the purpose of exporting the products outside the EU. An exception for manufacturing also enables that the product can be manufactured and stored in order to be launched on the EU internal market as soon as the SPC expires. For this purpose, an exception for manufacturing can be used not earlier than six months before the SPC expires. The manufacturer must give a notification about starting the manufacturing to both the SPC holder and the patent authority that has granted the SPC, using a standard form for notification. The publication of the exception for manufacturing is subject to a fee.

More information on the conditions to use the exception for manufacturing can be found in the EU regulation No 2019/933 published on 11 June 2019 in the Official Journal of the European Union L 153. The regulation also includes a standard form for notification (Annex –Ia).

Go to the EUR-Lex website to read the Official Journal of the European Union L 153.

Legislation

Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products

Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products

Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use

Finnish Patents Act (chapter 9 a, unofficial translation)

Finnish Patents Decree (sections 52 d–52 p, unofficial translation)

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Latest update 08.01.2021