More than 10 years after the Pediatric Regulation entered into force in the EU, the regulation will now also be part of Norwegian legislation allowing patent holders to apply for the 6-month extension of supplementary protection certificates.

Regulation 1901/2006/EC (the Pediatric Regulation) entered into force in the European Union on 26 January 2007. The objective of the Pediatric Regulation is to improve the health of children by facilitating the development and availability of medicinal products for children. However, the Regulation was at the time not implemented into the Agreement on the European Economic Area (the EEA Agreement) for several reasons, most notably due to disagreements concerning whether the member states’ agencies or EFTAs Surveillance Authority should have the authority to impose penalties on pharmaceutical companies for non-compliance.

The lack of implementation of the Pediatric Regulation has had a significant effect for the pharmaceutical industry.

Regulation 469/2009/EC (the SPC Regulation), which allowed for a 6 month extension of supplementary protection certificates (SPCs), was not implemented. Patent holders have therefore not been able to receive the incentive laid out as a reward for submitting a Pediatric Investigation Plan (PIP).

On 5 May 2017, the EU regulations were adopted into the EEA Agreement, and yesterday (Monday May 12 2017), the Norwegian Parliament (Stortinget) voted to implement the Pediatric Regulation and the SPC Regulation into Norwegian law. More than 10 years after the Pediatric Regulation came into force in Norway, patent holders will now be able to apply for an extension of the SPC within the foreseeable future.

The formalities regarding implementation of the legislation in Norway are expected to be finalized shortly. The new legislation is planned to enter into force in Norway on 1 September 2017.

When adopting the regulations, the EEA Joint Comittee included provisions that provide a transitional arrangement for SPCs that have already expired or will expire before Pediatric Regulation enters into force. The transitional arrangement opens for the opportunity to apply for an extension if the SPC expires less than 6 months prior to the entry into force of the Pediactric Regulation (EC) No 1901/2006 in the EFTA-member state.

For Norway, this means that SPCs that have expired later than 1 March 2017 will eligible for a pediatric extension. However, the duration of the extension will have a “cut off” in the 6-month period, since the extension will not take effect before both the Regulation has entered into force and the application has been made public. For instance, an SPC that expired 1 April 2017 will receive a one-month effective extension. However, the extension will not take effect before both the Regulation has entered into force and the application has been made public.  It will nevertheless be possible to apply for the extension from 1 August 2017.

The transitional arrangement also contains a provision that concerns third parties who between the expiry of the certificate and the publication of the application for an extension has in good faith commercially used the invention or made serious preparation for such use. The application for an extension shall not prevent such third party for continuing such use.

Pharmaceutical companies that hold SPCs for medicinal products in Norway should review the transitional arrangement closely to ensure prolongation of their rights. Likewise, companies that plan to launch generic medicinal products in Norway in the future should take into account the new rules and the transitional arrangement.