The possibility of obtaining a six months paediatric extension of a Supplementary Protection Certificate ("SPC") was introduced in the European Union in 2007 through Regulation 1901/2006 and has later been reflected in the codified SPC-regulation of 2009 (Regulation 469/2009).
For many reasons the incorporation of Regulation 1901/2006 and Regulation 469/2009 into the EEA Agreement has been significantly delayed. Thus, it is today still not possible to obtain paediatric extensions of SPCs in Norway and the other EEA EFTA states (Iceland and Liechtenstein).
However, as the EEA Joint Committee on Friday 5 May 2017 decided to incorporate, inter alia, Regulations 1901/2006, 1902/2006 and 469/2009 into the EEA Agreement, this is now about to be changed. On 5 May 2017 the Norwegian Government submitted a draft bill to the Parliament containing the amendments to the Patents Act that are necessary to introduce the paediatric extension in Norway. Depending on whether the Parliament is able to adopt the proposed amendments before or after its summer break, it is expected that the amended legislation and the possibility of obtaining paediatric extensions in Norway will enter into force either on 1 September 2017 or on 1 January 2018.
Since the possibility of obtaining paediatric extensions will enter into force at a much later stage in Norway and the other EEA EFTA states than in the European Union, the EEA Joint Committee has adopted a transitional arrangement for SPCs that have expired or is about to expire close in time to the entry into force of the paediatric extension.
In order for the proprietors of SPCs to safeguard their rights, it is crucial that they are aware of the content of the transitional arrangement.
The transitional arrangement makes it possible to apply for a paediatric extension even if the regular deadline according to Regulation 469/2009 for applying for such an extension has expired. Further, the transitional arrangement makes it possible to apply for extensions of SPCs that have expired less than six months prior to the entry into force of the paediatric extension. In order for the proprietors of SPCs to safeguard their rights, it is crucial that they are aware of the content of the transitional arrangement.
When the amended legislation enters into force it will also be possible to obtain SPCs with negative duration in Norway, provided that the SPC, taking into account the six months extension under a paediatric extension, will provide for protection beyond the duration of the underlying basic patent, cf. CJEUs Judgement in case C-125/10 Merck.
Please feel free to contact us if you have any questions or need our assistance in relation to the introduction of the paediatric extension in Norway