A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 5 June 2009

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...


Anonymous said...

Many thanks for this information

Does anyone knows how the losartan PIP extension is procceding in other countries?

Unknown said...

The Dutch IPO has just (02/06)granted the the request for extension.

Tim Felgate said...

I note that the SPC has not been revoked yet.

I seems that an appeal was lodged on 24 June 2009 and I am unable to see an outcome yet.