No paediatric extension when conditions are not met before SPC expires

In BL O/098/15 Otsuka Pharmaceuticals Company Limited's application, 4 March 2015, Dr Lawrence Cullen, for the United Kingdom's Intellectual Property Office (UKIPO), held that it was not possible to grant an application for a paediatric extension for patent protection when the conditions for establishing one's entitlement to a paediatric extension -- the completion of investigations relating to paediatric indications and the issue of an updated marketing authorisation  -- had not been fulfilled before the expiry of the SPC.

Otsuka, who had an SPC for ‘aripiprazole or a salt thereof’, used in the treatment of schziphrenia and bipolar affective disorder, was unsuccessful in securing a paediatric extension. In reaching his decision, Dr Cullen distinguished the earlier and authoritative decision of the Court of Appeal for England and Wales in EI du Pont de Nemours & Co v UKIPO [2009] EWCA Civ 966 [on which see The SPC Blog post here and note by Sebastian Moore and Jonathan Turnbull here], on the basis that, in that case, while the requirements for an extension had not been met at the date of application, they had still been met before the date of expiry of the related SPC and it was the case that matters in relation to the extension of an SPC had to be decided before that SPC expired. This was so even if the decision was taken on the last day of the SPC's existence because, once the SPC expired, others were entitled to enter the market and the interest of third parties (i.e. generic pharmaceutical companies) had to be taken into account.

In Dr Cullen's own words:

"55 I accept that the applicant has to carry out the studies in the paediatric population first and get approval from the EMEA. This involves a commitment of time and resources up front. I accept that if the applicant carries out the necessary steps, then they should be entitled to the reward without taking too restrictive a view of how and when the applicant meets the requirements to qualify for an extension to the SPC.

56 However, I do not take this to mean that this should extend beyond the expiry date of the SPC. I think that it is reasonable to expect that matters in relation to an extension to an SPC are decided before the SPC expires, even if this decision is taken on the last day of the SPCs existence! Once the SPC expires, others are entitled to enter the market. Because of this, I think that, after the expiry date of the SPC, one must take account of the interest of third parties. Knowing when the SPC will expire is important for the entry of third parties, such as generic medicine companies, into the market because once the SPC expires; they are free to bring their own versions of the medicines comprising this active ingredient to market. If an application for an extension to a granted SPC was still considered to be capable of rectification after the expiry date of the SPC and the grant of an extension could be back-dated, this would, in my view, introduce uncertainty and, even, the potential for abuse. It would not be clear in such a situation when the paediatric studies would have to be completed by and when the updated MA would be available. There needs to be some clarity as to when matters are complete and others can enter the market. This seems to me to represent an appropriate balance, as referred to in recital 10 of the SPC regulation, to take account of all the interests at stake “in a sector as sensitive and complex as pharmaceuticals” while also making sure that research into paediatric uses of medicines is given the necessary incentive".

An applicant for a paediatric extension has 28 days in which to appeal.