Paediatric extension of SPCs: prompt completion of PIP studies is essential

Written on 13 Mar 2015

Otsuka Pharmaceuticals Company applied to the Intellectual Property Office for a six month extension to the Supplementary Protection Certificate for its Abilify® (aripiprazole) treatment for schizophrenia and bipolar disorder under Article 36 of the Paediatric Regulation (Regulation (EC) No. 1901/2006), on the grounds that it had completed studies in accordance with an agreed paediatric investigation plan (“PIP”). The SPC was due to expire on 24 October 2014, and the application was filed in good time on 12 October 2012 i.e. more than two years before SPC expiry, as the Paediatric Regulation requires.

Article 28 of the Paediatric Regulation requires an applicant for an extension to file as part of the application a statement by the responsible authority that the studies in the PIP have been completed in compliance with the plan. Otsuka was unable to provide this statement, but stated that “significant studies contained in the agreed paediatric investigation plan … have been completed. At this time however EMEA has not issued a varied marketing authorisation containing an Article 28(3) statement.” The natural suggestion here was that the applicant had done everything necessary, but bureaucratic slowness was holding up the actual issuance of the statement of compliance. However, in correspondence with the examiner the applicant later admitted that not all of the studies had yet been completed, and made a request for more time in which to do so. At that point in 2013, two studies were outstanding: investigations of the effectiveness of orally administered Abilify in 10-13 year olds with bipolar disorder, and in 13-14 year olds with schizophrenia. Otsuka relied upon the Court of Appeal’s decision in EI du Pont de Nemours & Co v UK Intellectual Property Office ([2009] EWCA Civ 966), in which time was permitted to cure an irregularity in the application. The irregularity in that case was the fact that although all studies had been completed and submitted to the competent authorities of the concerned Member States, not all of them had in fact issued the statement of compliance in time. The Court of Appeal had concluded that it could not be the intent of the legislation to penalise the applicant for some action of a Member State beyond its control, and granted the extra time.

Otsuka’s case, however, is different, in that at the point of filing the application, and even a year later, Otsuka had not completed all of the studies, let alone submitted them to the authorities for consideration. It was apparent (although the applicant never responded to a request to confirm precisely when the last study would be finished) that one study, on 13-14 year olds with schizophrenia, might well not even be completed by the time the SPC expired. It was therefore in practice impossible that the competent authorities, however promptly they considered the study results, could have issued a statement of compliance while the SPC still subsisted.

The IPO therefore refused the application. It held that there could be no possibility of granting an extension if the grant could only be made after the SPC had already expired and third parties were legitimately able to market products which might then in theory have to be removed again when the paediatric extension took effect.

It remains to be seen whether this decision will be appealed.