Patent decision

BL number
Concerning rights in
Hearing Officer
Dr L Cullen
Decision date
4 March 2015
Person(s) or Company(s) involved
Otsuka Pharmaceuticals Company Limited
Provisions discussed
Regulation (EC) No. 469/2009, Articles 7, 8 and 10; Regulation (EC) 1901/2006, Articles 28, 36
Extension for Paediatric Testing, Supplementary Protection Certificates
Related Decisions


This is an application for a six-month extension to SPC number SPC/GB04/039, filed on 12 October 2012, just before the deadline for doing so, i.e. 2 years before the expiry date of the SPC which (if not extended) is 26 October 2014. The SPC concerns aripiprazole, the active ingredient in medicinal product, Abilify®, marketed by Otsuka for the treatment of schizophrenia and bipolar disorder.

The applicant was carrying out clinical studies concerning the use of Abilify to treat these two conditions in children. At the date of application, all of the studies in the agreed Paediatric implementation Plan (PIP) had not been completed. As a consequence, the application, as acknowledged by the applicant, did not contain a marketing authorisation with an updated summary of product characteristics (SmPC) including the results of the studies in all the paediatric population nor did it contain a statement of compliance according to Article 28(3) of the paediatric regulation. These are necessary requirements for obtaining the six-month extension to the SPC under article 8 of the SPC regulation and Article 36 of the paediatric regulation. The applicant argued that they should be entitled to the extension based on all the studies in the paediatric population that they had completed so far and because the delay in completing these studies arose from the time taken to agree the PIP with the EMEA, i.e. not their fault.

The hearing officer took note of IPO decision BL O/035/09, Merck, and referred to the UK Court of Appeal decision, EI du Pont de Nemours & Co v UK Intellectual Property Office [2009] EWCA Civ 966, in his finding that the application for the extension did not meet the requirements of Article 8(1)(d) of the SPC regulation because it did not include an updated MA with the results of the paediatric studies and an Article 28(3) compliance statement. Although the applicant was set a period of time under Article 10(3) to address the irregularity identified with their application, they were unable to do so within this time limit. The hearing officer also considered that, on the balance of probability, this irregularity would not be addressed before the expiry date of the SPC. He rejected the application for an extension to granted SPC/GB04/039 under Article 10(4) of the SPC Regulation.

Full decision O/098/15 PDF document550Kb