AstraZeneca AB v. Comptroller General of Patents, High Court of Justice, Chancery Division, Patents Court, London, UK, 19 October 2012, Case No.  EWHC 2840 (Pat)
AstraZeneca applied for a supplementary protection certificate (SPC) on 11 December 2009 for the product gefitinib. This is the active ingredient in a medicinal product marketed by AstraZeneca as Iressa. Iressa is used to treat non-small-cell lung cancer. The basis for the SPC is EP (UK) 0 832 900 (“the Patent”), which will expire on 22 April 2016. The SPC was granted with an expiry date of 1 March 2019, being calculated by reference to a marketing authorisation granted by the Swiss regulatory authority on 2 March 2004 (“the Swiss MA”). AstraZeneca appealed this, contending that the correct expiry date is 22 April 2021 because the duration of the SPC should be calculated by reference to a marketing authorisation granted by the European Medicines Agency (“EMA”) on 24 June 2009 (“the European MA”).
Stating that the resolution of the appeal depends on two issues of interpretation of Regulation 469/2009/EC of 6 May 2009 (“the SPC Regulation”) Arnold J has referred the following questions to the Court of Justice of the European Union:
1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC?
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 European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or
(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?
3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?
Read the decision (in English) here.
Head note: Paul England