Losartan Appeal Heard in UK High Court

The High Court has upheld the Intellectual Property Office's decision of not granting an extension to the term of an SPC for Losartan (for the IPO decision, here - for our previous report on the IPO's decision, here) in In the Matter of E I Du Pont Nemours & Co [2009] EWHC 1112 (Ch), not yet available on BAILII but on LexisNexis Butterworth's subscription service.

John Baldwin QC, sitting as deputy judge of the Chancery Division, held the IPO had correctly identified the requirements of the Paediatric Regulation (EC Regulation 1901/2006) with regards to the availability of rewards of an extension to an existing SPC: Article 36 of the Paediatric Regulation must be considered as a whole. The first paragraph of Art. 36(1) cannot be considered in isolation. The second paragraph of Art. 36(1) clearly requires a completed marketing authorisation before a reward is available. Additionally, the second substantive requirement indicated in Art. 36(2) calls for the statement of compliance referred to in Art. 28(3) be included in the marketing authorisation used for applying for the extension. The third substantive requirement (Art. 36(3)) is that if the mutual recognition procedure was used , the extension shall only be granted if the product is authorised in all Member States. Therefore, an application for an extension of an SPC which does not satisfy all the requirements of Art. 36 is a defective application.

At the time of Du Pont's application for an extension, the procedure for obtaining a marketing authorisation in the Netherlands (the reference Member State) was not complete and accordingly, there was no entitlement to the extension.

It may seem unfortunate that applicants will need to rely on the relevant authority to grant a marketing authorisation in order to apply for an extension to an existing SPC, and that the timing of the grant of the marketing approval is not within the applicant's control. Unless of course the applicant chooses to test the medicine simultaneously in the paediatric and adult populations...