Losartan paediatric extension refused in UK

The attention of The SPC Blog has just been drawn to a decision of the Intellectual Property Office in the UK, summarised here and downloadable in full here, in which hearing officer Dr Cullen refused an application for a paediatric extension in respect of an SPC granted on 13 October 1995 in force from 9 July 2007. The active ingredient for which the SPC was granted was Losartan, as a potassium salt, used in treating hypertension in humans through its action as an antagonist of the angiotensin II receptor. The product was marketed in the UK under thevbrand name COZAAR by Merck & Co., Inc., a licensee under the SPC.

According to the IPO's summary,

"An application for a paediatric extension of granted certificate SPC/GB/95/010 was filed. The preliminary view of the examiner was that this application did not meet the requirements of Article 8(1)(d)(i) of Regulation (EEC) No. 1768/92 as it did not include a copy of the statement of compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of EC Regulation (EC) No. 1901/2006. This view was upheld by the Hearing Officer who considered the relevance of Articles 8, 23, 24, 29 and 36 of Regulation (EC) No. 1901/2006 and IPO decision BL O/035/09 (Merck & Co. Inc) [see SPC Blog note here for comment and link to the decision]. He further found that the application did not fulfil the condition of Article 8(1)(d)(ii) of Regulation (EEC) No. 1768/92 to prove that the product was approved for use in all EU member states. This he found to be an explicit requirement under Article 36(3) when the Mutual Recognition Procedure (MRP), as set out in Articles 32-34 of Directive 2001/83/EC, is used to gain approval for variation of the marketing authorisation. The documents supplied, a commission decision under Article 29 of Regulation (EC) No. 1901/2006, a preliminary variation assessment report from the national competent authority of the reference member state and an opinion from the Paediatric Committee of the European Medicines Agency (EMeA) on compliance with an agreed completed paediatric investigation plan were not sufficient to meet the requirements under Article 36 of Regulation (EC) No. 1901/2006 regarding a statement of compliance with an agreed completed paediatric investigation plan and that the product was approved for use in all EU member states".

The full decision is 25 pages long and I've not yet had a chance to read it in full, so the blog will return to it soon for fuller discussion and analysis.