Paediatric extensions of SPCs in Norway

Paediatric extensions in Norway will be implemented and available from 1 September 2017. This means that an SPC with expiry date later than 1 March 2017 is entitled to extension provided that the application for the extension is submitted according to the requirement in the regulation or in the transitional regulations.


The background for the amendments in the Norwegian Medicines Act and the Patents Act is in the EEA committee decision of 5 May 2017 (92/2017) adapting the SPC regulation 1768/92 – 469/2009 to include the EEA states.

The implication is that any SPC in Norway with expiry date later than 1 March 2017 is entitled to paediatric extensions. The maximum duration of the protection will however be no longer than 6 months after the expiry of the SPC.

Requirements

The requirement in Norway will be the same as in EU member states and application forms in Norwegian and English will be provided by NIPO.

NIPO will allow receipt of applications for paediatric extensions from 1 August 2017. The extension will be in force when the application is made public and after implementation of the regulation.

Deadlines

The normal deadline to apply for a paediatric extension is 2 years prior to expiry of the SPC. However, in a transition period of 5 years after implementation, which is until 1 September 2022, the deadline is 6 months prior to expiry of the SPC.

Please note that an application for an extension will not prevent any third party who, between the expiry of the certificate and the publication of the application for an extension, in good faith has commercially used the invention or made serious preparation for such use, to continue such use.

Examples

The transition regulations for SPC’s with an expiry close to the implementation can be interpreted with the following examples and timeline:

SPC expiry 1 April 2017
entitled to a 1 month extension from 1 September 2017 (until 1 October 2017)
applicable from 1 August 2017

SPC expiry 1 June 2017
entitled to a 3 months extension from 1 September 2017 (until 1 December 2017)
applicable from 1 August 2017

SPC expiry 1 November 2017
entitled to a 6 months extension (until 1 May 2018)
apply by 1 October 2017

SPC expiry 1 June 2018
entitled to a 6 months extension (until 1 December 2018)
apply by 1 December 2017

SPC

For further information or questions – please contact us.

Written by Arne Lund Kvernheim CV/contact.