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!

Norwegian valsartan ruling: now in English too

Earlier this month The SPC Blog posted this information concerning the ruling of the Oslo District Court on 10 February that Actavis’ valsartan/HCTZ product infringed Novartis’ Norwegian process patent NO 304 023 for a route of synthesis for valsartan as well as SPC/NO 1998 024. The judgment, which is now under appeal, was handed down on 10 February 2011; it deals inter alia with the question of the scope of Novartis’ Norwegian SPC in relation to valsartan (SPC/NO 1998 024).

Gunnar Sørlie (Partner, Bugge, Arentz-Hansen & Rasmussen) has now kindly sent this weblog a transcript of the original decision (in Norwegian) together with an unofficial translation into English. The SPC Blog thanks him very much for his kindness.

Norwegian valsartan case goes on appeal

The SPC Blog has just learned this morning from Kaja Veel Midtbø (Wikborg Rein, Oslo) that the litigation in Norway in Novartis v Actavis concerning valsartan (noted here by The SPC Blog on 8 March) is to go on appeal.  The original judgment, from the Oslo District Court (10 February 2011) will be appealed by Actavis to the Borgarting Court of Appeal. There are two grounds of appeal -- the patent infringement issue in general and the issue specifically concerning the scope of the SPC.

Wikborg Rein (Ingvild Hanssen-Bauer) represents Actavis in this litigation.

Novartis v Actavis in Norway

"Novartis v Actavis: ruling on the merits confirms scope of SPC" is the title of this blog's first note from Norway -- and also one of the first full hearings on the merits of any litigation relating to Novartis’ compound valsartan. In this ruling the Oslo District Court held that Actavis’ valsartan/HCTZ product infringes Novartis’ Norwegian process patent NO 304 023 which protects a route of synthesis for valsartan. The judgment, handed down on 10 February 2011, deals inter alia with the question of the scope of Novartis’ Norwegian SPC in relation to valsartan (SPC/NO 1998 024).

The SPC Blog is grateful to Gunnar Sørlie (Partner, Bugge, Arentz-Hansen & Rasmussen, Oslo) for kindly providing this information. As Gunnar explains:

"On the question of whether the scope of the valsartan SPC covers Actavis’ valsartan-plus-HCTZ combination products, the court found as follows:

“The wording of SPC/NO 1998 024 is not restricted to mono products. The target molecule is drawn under the product designation “Valsartan”. This is an argument in favour of concluding that SPC/NO 1998 024 protects against infringement through the marketing of any form of valsartan.

The Court is of the view that valsartan is a “product” for the purposes of Article 1(b). Reference is also made to Stenvik (2006), p. 359, where it is assumed that a certificate will also protect against use of the active ingredient in combination products.

The Court therefore concludes that SPC/NO 1998 024 also protects against valsartan in combination products.”

The effect of the decision is that following the expiry of patent NO 304 023 on 18 February 2011, SPC/NO 1998 024 will continue to provide protection until 13 May 2011 for any valsartan-containing medicine in Norway if the route of valsartan synthesis infringes Novartis’ synthetic process claims. As a result of the decision, Actavis had to withdraw both its monotherapy and combination therapy valsartan-containing medicines from the Norwegian market with immediate effect".