Patent decision

BL number
O/146/12
Concerning rights in
SPC/GB/09/059
Hearing Officer
Dr L Cullen
Decision date
2 April 2012
Person(s) or Company(s) involved
AstraZeneca AB
Provisions discussed
Council Regulation (EC) No. 469/2009; Articles 3 and 13
Keywords
Supplementary Protection Certificates
Related Decisions
None

Summary

Application SPC/GB/09/059 concerns Gefitinib, the active ingredient in the medicinal product, IRESSA®, used in the treatment of lung cancer. A European marketing authorisation (MA) was approved by the European Medicines Agency (EMA) and granted for IRESSA on 24 June 2009. This MA is valid for the UK. An earlier MA for IRESSA was granted on 2 March 2004 by SwissMedic, the relevant national competent authority for Switzerland, and such authorisations, through regional legal arrangements between both states, are valid in Liechtenstein. Liechtenstein is a member of the European Economic Area (EEA).

The applicant considers that the European MA is the first relevant MA to place the medicinal product IRESSA on the market in the Community for the purposes of Article 3(d) and for determining the duration of the SPC according to Article 13. They argued that the earlier MA valid in Liechtenstein should be disregarded because it was suspended by SwissMedic after 20 months and there was a significant further delay before a MA valid in the European Community was approved by the EMA. The data supporting the earlier Swiss authorisation was insufficient to gain approval from the EMA and additional data was required.

Following a consideration of the relevant case law, in particular, joined cases C-207/03 & C-252/03, Novartis and others, and a review of the marketing authorisation history of the medicinal product, the hearing officer found that the MA granted in Switzerland and valid in Liechtenstein was the first relevant MA for the purposes of Article 3(d) and Article 13 of the Regulation. Based on the earlier MA valid in Liechtenstein, and not the later MA approved by the EMA, the hearing officer concluded that the duration of SPC protection will expire on 1 March 2019.

Full decision O/146/12 PDF document145Kb