INNsight articles by Duncan Curley

26 January 2012 marks the passing of the fifth year since the coming into force of Regulation (EC) No. 1901/2006 on medicinal products for paediatric use (“the Paediatric Regulation”). The Paediatric Regulation is probably best known amongst generic industry players for the ability that it confers on innovator companies to extend by an extra six months the term of a supplementary protection certificate (“SPC”): a “paediatric extension”.

Monitoring and predicting when paediatric extensions are likely to be granted has now become important in the planning of a generic product launch in Europe. The present temporary (in legal terms, transitional) system prescribed by the Paediatric Regulation allows applications for paediatric extensions on SPCs that protect existing, authorised products to be filed by the innovator companies no later than six months before the expiry of a SPC. Many such applications for paediatric extensions have been made close to the relevant six month deadline, since 2007. It means effectively that generic companies planning to launch on SPC expiry in a particular EU country have had less than six months’ notice of whether an SPC will actually expire at the end of its original term, or whether a paediatric extension will be granted, thereby forcing the postponement of any launch plans by six months.

However, this lead time is about to change. From 26 January 2012, the deadline for innovators to file an application for a paediatric extension to a SPC will change from six months to two years before SPC expiry. According to the European Commission - at a meeting of SPC experts from the various national patent offices that took place at the European Medicines Agency on 28 September 2008 - this is a cut-off date, in the sense that if a paediatric extension is applied for by an innovator after 26 January 2012, the SPC in question must have at least two years of its term remaining. The two year rule therefore applies to all SPCs expiring after 26 January 2012. In particular, for SPCs expiring between 26 July 2012 and 25 January 2014, an application for a paediatric extension will need to have been filed by 26 January 2012, otherwise the two year pre-SPC expiry deadline will have been missed.

The European Commission’s opinion on this matter is not definitive (because the last word on the interpretation of the Paediatric Regulation rests with the Court of Justice of the European Union), but the wording in the regulation is quite clear: “The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate” – see Article 52(2) of the Paediatric Regulation. So: if there is a scramble by some of the innovator companies to meet the 26 January 2012 deadline that results in some applications for paediatric extensions being filed in only partially complete form, how might the national patent offices with responsibility for processing these applications respond?

Relevant lessons were learned in the losartan case in the English courts. This concerned an application by Merck for a paediatric extension to the UK SPC for losartan (Cozaar®). The UK Intellectual Property Office (“UK IPO”) decided that Merck’s application was incomplete, because certain prescribed formalities had not been complied with. The UK IPO gave Merck an extra period of time in which to remedy these deficiencies. This extra time was granted pursuant to Article 10(3) of the Regulation No 469/2009, which governs the eligibility and grant of SPCs and paediatric extensions and which provides: “Where the application for a certificate does not meet the conditions laid down in Article 8, [the relevant national patent office] shall ask the applicant to rectify the irregularity...within a stated time”. Merck subsequently rectified its application with the requisite information. Just days before the losartan SPC was due to expire, the Court of Appeal allowed the paediatric extension, deciding that the essential paperwork that was missing from Merck’s initial application was an “irregularity” within the meaning of Article 10(3) of Regulation No 469/2009.

This may have been a generous interpretation of the term “irregularity” by the English Court of Appeal. What seemed to play a large part in the decision was the fact that Merck had done everything in its power to obtain the documentation that it needed for its paediatric extension, prior to the deadline. The Court of Appeal was asked to clarify – for the future – just how late an applicant could be in supplementing an application for a paediatric extension with missing material. The Court of Appeal declined to lay down strict parameters, saying only that it would depend on matters such as the reasons for the failure to make the initial application complete and the extent to which the applicant had itself delayed. It will be interesting to see whether and to what extent such leeway is given to the innovator companies in other countries, once the key date of 26 January 2012 has passed.