Norway To Grant Pediatric Extensions Of SPCs From Sept. 1
Executive Summary
Norway has acted swiftly to amend its national legislation to allow six-month pediatric extensions to supplementary protection certificates as of Sept. 1, when the EU Paediatric and SPC Regulations will take effect in the country. Also, transitional arrangements have been put in place that will allow certificates expiring between March 1 and Aug. 31 to become valid again.
Norway has made changes to its legislation to allow companies to request six-month pediatric extensions to their supplementary protection certificates (SPCs) as of Sept 1, 2017, when the EU Paediatric and SPC Regulations take effect in the country following changes to the European Economic Area (EEA) Agreement .
Under transitional arrangements that are being put in place, it will be possible for companies that have an SPC with an expiry date later than March 1, 2017 to apply for a pediatric extension, explains Arne Lund Kvernheim of Bryn Aarflot, a Norwegian intellectual property firm. Drug companies with SPCs in Norway are being advised to review the transitional arrangements carefully in order to safeguard their rights.
This is because an extension is possible for any part of the six-month period that remains on Sept. 1, said Per Thomas Thomassen, associate and special adviser at Norwegian law firm Grette. For example, he explained, a certificate expiring on April 1 would qualify for a one-month extension as of Sept. 1 (until Oct. 1), while a certificate expiring on June 1 would qualify for a three-month extension (until Dec. 1).
Simply put, the transitional arrangements mean that certificates expiring between March 1 and Aug. 31 this year may become valid again as of Sept. 1, said Thomassen.
The Norwegian Industrial Property Office (NIPO) will receive and publish applications for pediatric extensions as of Aug. 1. The extension will come into effect from the date of the publication of the application and after implementation of the regulations.
Changes To EEA Agreement
Six-month pediatric SPC extensions are already possible in EU countries under the EU Paediatric Regulation (1901/2006), which came into effect in 2007 and was later reflected in the codified EU SPC Regulation (469/2009). (Also see "Companies Get 19 EU Paediatric Extensions in 2016, But Many Firms Miss Trial Completion Deadlines" - Pink Sheet, 4 Jul, 2017.)
However, such extensions were not available in Norway, Iceland and Liechtenstein (the non-EU members of the European Economic Area) because the incorporation of the EU Paediatric and SPC Regulations was significantly delayed in these countries. But this will change after the EEA Joint Committee incorporated the two regulations into the EEA Agreement on May 5.
“It has been a kind of a record that things have moved so quickly through the parliament” – Per Thomas Thomassen of Norwegian law firm Grette
Both Kvernheim and Thomassen said they did not know whether Iceland and Liechtenstein have also made necessary amendments to their respective legislation following the EEA Agreement changes.
“I would be surprised if they have [done this],” said Thomassen. In Norway, he explained to the Pink Sheet, things have moved quite swiftly. In fact, he said, it has been a “kind of a record that things have moved so quickly through the parliament.” On June 12, the necessary amendments to the Norwegian law were adopted by the Storting (parliament), and on June 16 the Cabinet of Ministers decided that the new legislation would enter into force on Sept. 1, Thomassen writes in his blog.
The other EEA nations, he explained, have six months to give feedback on whether they have fulfilled their obligation to implement the necessary changes.
Getting An Extension And Transitional Arrangements
The requirements for getting a six-month SPC extension in Norway are the same as in other EU countries. The marketing authorization should include the results of all studies conducted in compliance with an agreed pediatric investigation plan (PIP), the medicinal product must be authorized in all EEA member states (except Liechtenstein), and the product should be protected by an SPC or by a patent which qualifies for the granting of an SPC, explains Thomassen.
The deadline to apply for a pediatric extension is two years prior to expiry of the SPC, said Kvernheim. During the transition period – which will last for five years until Sept. 1, 2022 – the deadline for applying is six months prior to expiry of the SPC. This deadline is applicable to SPCs that expire after April 1, 2018, Thomassen added.
He clarified, however, that an extension to the SPC will not prevent a third party who has, between the expiry of the certificate and the publication of the application for an extension, used the invention commercially in good faith or made serious preparation for such use, from continuing such use. “To avoid commercialisation in good faith, it is recommended to submit applications for extensions as early as possible and preferably on 1 August 2017,” he added.
From the editors of Scrip Regulatory Affairs.