CJEU: Swiss authorisation automatically recognised in Liechtenstein may be regarded as the first authorisation when calculating SPC duration

06 February 2014

Ewan Grist

On 14 November 2013, the CJEU gave a reasoned order in AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks, following a reference from the High Court of England & Wales (C-617/12)

AstraZeneca is the proprietor of a European patent covering the active ingredient gefitinib, due to expire on 22 April 2016.

In July 2002, AstraZeneca submitted an application to the Swiss Institute for Medicinal Products (Swissmedic) for a marketing authorisation (MA) to place the medicinal product Iressa (gefitinib) on the market in Switzerland (the "Swiss MA"). The Swiss MA was granted on 2 March 2004, conditional upon the provision of further clinical data to demonstrate the effects of Iressa. By virtue of the customs union between the Swiss Confederation and the Principality of Liechtenstein, relating, inter alia, to patents, the Swiss Authorisation was automatically recognised in Liechtenstein. The Swiss MA was later suspended 24 October 2005.

In January 2003, AstraZeneca also submitted an application for an MA for Iressa to the EMA, however the Committee for Proprietary Medicinal Products (now the Committee for Medicinal Products for Human Use (CHMP) refused to grant the MA on the basis of the Phase II studies provided by AstraZeneca.  In May 2008, AstraZeneca resubmitted its application to the EMA with a refined therapeutic indication, supported by further studies undertaken to address the CHMP’s concerns with the original application. On the basis of this data, the EMA granted an MA for Iressa on 24 June 2009 (the "European MA") pursuant to Regulation No 726/2004.

On 11 December 2009, AstraZeneca submitted an SPC application to the UK Patent Office for the active ingredient gefitinib, on the basis of its European patent and the European MA. The Patent Office granted that application by decision of 2 April 2012, calculating the duration of the SPC on the basis that the Swiss MA was to be regarded as the first MA for the purposes of Article 13(1) of Regulation No 469/2009 (the "SPC Regulation")[1]. The SPC was accordingly granted for just under 3 years.

AstraZeneca challenged the Patent Office’s decision before the High Court of England & Wales, arguing that the duration of the SPC should have been calculated on the basis that the European MA, and not the Swiss MA, was the first MA in the Community. Accordingly, the SPC should have been granted for the maximum term of 5 years.

The High Court referred the following questions to the CJEU:

(1)        Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, but automatically recognised by the Principality of Liechtenstein, capable of constituting the “first authorisation to place the product on the market” for the purposes of Article 13(1) of Regulation No 469/2009?

(2)       Does it make a difference to the answer to the first question if:

(a)       the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the [EMA] as not satisfying the conditions for the grant of a [MA] pursuant to Regulation No 726/2004; and/or

(b)       the Swiss marketing authorisation was suspended after grant and was reinstated only following the submission of additional data?

(3)       If Article 13(1) of Regulation No 469/2009 refers solely to [MAs] granted pursuant to the administrative procedure laid down in Directive 2001/83, does the fact that a medicinal product was first placed on the market within [the European Economic Area (EEA)] pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein, which was not granted pursuant to Directive 2001/83, render that product ineligible for the grant of a supplementary protection certificate, pursuant to Article 2 of Regulation No 469/2009?

The CJEU took the view that the answers to these questions could be clearly deduced from previous case law, in particular Novartis ([2005] ECR I-3209). The CJEU therefore elected to give its decision by way of reasoned order.

In answering questions 1 and 2, the CJEU first noted that the EEA Agreement recognised that two types of MA may co-exist in the Principality of Liechtenstein, namely MAs issued by the Swiss authorities, which, because of the regional union between the Swiss Confederation and the Principality of Liechtenstein are automatically recognised in the latter; and MAs issued in Liechtenstein in accordance with Directive 2001/83. Thus, under Article 13 of the SPC Regulation, an MA issued by the Swiss authorities and automatically recognised in Liechtenstein in the context of its regional union with the Swiss Confederation may be regarded as a first MA in the Community for the purpose of Article 13.

Furthermore, such an interpretation is consistent with the purpose of SPC Regulation, set out in recital 8, according to which the holder of both a patent and an SPC should not be able to enjoy more than 15 years of exclusivity from the time the medicinal product concerned first obtains authorisation to be placed on the market in the EEA. Indeed, if a marketing authorisation issued by the Swiss authorities and automatically recognised by the Principality of Liechtenstein were precluded from constituting a first MA for the purposes of Article 13, the duration of SPCs would have to be calculated by reference to an MA issued subsequently in the EEA. There would therefore be a risk of the period of 15 years of exclusivity being exceeded in the EEA.

The CJEU found that the arguments put forward by AstraZeneca had already been extensively considered and rejected in Novartis and that the Court’s answer in that judgment was unequivocal. Furthermore, the Court's judgments in Hassle, Synthon and Generics (UK) were not inconsistent with Novartis.

The Court therefore answered questions 1 and 2 as follows:  in the context of the EEA, Article 13(1) of the SPC Regulation must be interpreted as meaning that an administrative authorisation issued for a medicinal product by SwissMedic, which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of that provision in the EEA where that authorisation predates MAs issued for the same medicinal product, either by the EMA, or by the competent authorities of EU Member States in accordance with the requirements laid down in Directive 2001/83 and with the requirements of the Republic of Iceland and the Kingdom of Norway. The fact that, on the basis of similar clinical data, the EMA, unlike the Swiss authority, refused to grant an MA for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss MA was suspended by SwissMedic and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant.

In view of the CJEU's answers to questions 1 and 2, there was no need for it to answer question 3.



[1] Article 13(1) sets out the duration of the SPC: "The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years."

This article is part of the International Life Sciences Update for February 2014

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