Paediatric Extensions in Norway

The SPC Blog is grateful to Arne Lund Kverneheim at Bryn Aaflot for the following news on paediatric extensions in Norway:

"Paediatric extensions in Norway will be implemented and available from 1 September 2017. This means that SPCs with expiry dates later than 1 March 2017 will be entitled to extensions 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 Patent Law 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. 

RequirementsThe requirement in Norway will be the same as in EU member states.  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. 

DeadlinesThe 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. 

ExamplesThe transition regulations for SPC 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"

Many thanks to Arne again!

Max Planck Institute SPC Survey - deadline for participating - 23 June 2017

As many readers of this Blog will be aware, the Max Planck Institute for Innovation and Competition is currently conducting a study on supplementary protection certificates in the European Union on behalf of the European Commission.  The study aims to include the views and opinions of a wide range of stakeholders including pharmaceutical companies, professional and industry associations as well lawyers, patent attorneys and other interest groups.

As part of the study, a survey is being conducted which includes questions on the past experience with the system, general policy considerations, assessment of the present legal rules, as well as some proposals on the potential amendment of the current SPC Regulations. The answers will be collected on an anonymous basis.  The deadline for participating in the survey is this Friday, 23 June 2017

If you are interested in participating in the survey, please contact Victoria Rivas at the Max Planck Institute at victoria.rivas@ip.mpg.de