In E I du Pont Nemours & Co.’s SPC Application ([2009] EWHC 1112 (Ch)) the High Court considered an appeal from a decision of the UK Intellectual Property Office to refuse a six month extension of a Supplementary Protection Certificate covering Cozaar (Losartan, an antihypertensive) under the Paediatric Regulation 1901/2006. Article 36 of the Paediatric Regulation (cross referred by Article 8 of the SPC Regulation 1768/92) requires the following at the time of the application for a six month extension:

  • the inclusion in a marketing authorisation of a statement by the Competent Authority indicating compliance with the agreed Paediatric Investigation Plan (PIP) (Art 36(2)); and
  • where the application for authorisation has been under Directive 2001/83, the product must be authorised in all Member States (Art 36(3))

The Paediatric Regulation amended the SPC Regulation so as to require (during a five year transitional period) applications for an extension to be filed at least six months before the expiry of the SPC (i.e. in this case by 1 March 2009). du Pont filed their application on 18 February 2009 but at that time, and indeed still at 1 March 2009, they could not comply with the conditions in Article 36. du Pont argued that it had substantively complied with the first requirement as a PIP had been complied with (only the inclusion of the statement in the marketing authorisation was missing). du Pont also argued that the second requirement had been complied with as a central authorisation for a paediatric syrup had been granted. The High Court, in upholding the UK Intellectual Property Office’s decision to refuse the the six month extension, found that an Opinion from the Paediatric Committee as to compliance with the PIP was not a satisfactory substitute for a statement from the Competent Authority; and that Article 36(3) of the Paediatric Regulation (i.e. the second condition) was to be interpreted having regard to Article 36 as a whole so that "product" meant the product defined in the updated marketing authorisation. The judgment was appealed to the Court of Appeal ([2009] EWCA Civ 966). Jacob LJ, giving the leading judgment, held that:

  • only a statement in the updated MA that the PIP has been complied with will suffice for the purposes of the first condition. The language used in the Article 36(2) was mandatory and made it clear that nothing short of this compliance statement will suffice. A mere indication from the Paediatric Committee that the PIP had been complied with was in itself insufficient even though this was their final decision; and
  • the authorisations to place the product on the market in all Member States as required by the second condition in fact refers to the need for modified MAs, updated to include the PIP compliance statement, to be in place.

As such, du Pont’s application had not satisfied the requirements of Article 36.

However, where the application for a six month extension does not meet conditions set out in Article 8 of the SPC Regulation (which cross refers to the Article 36 conditions), under Article 10(3), the Comptroller shall ask the applicant to cure the “irregularity” within a stated time.

The question therefore was whether the lack of a PIP compliance statement and lack of updated MAs in all Member States amounted to an irregularity which du Pont should have been given the opportunity to cure. Jacob LJ declined to limit the scope of what might constitute an “irregularity” to only those matters which were missing from the application but which could have been produced at the time of the application or at least by the last moment on which the application could have been made. Instead Jacob gave “irregularity” a wide meaning to encompass also matters which only became capable of cure after the date of application. Taking a pragmatic view, he argued that the six month extension is a reward offered for complying with the PIP and getting the necessary updated MAs, and not for doing all of that before the application is made. Furthermore, to interpret “irregularity” more narrowly would be to put applicants at the mercy of Member States who may in fact fail to grant the updated MAs in a timely fashion.

Commenting on how late an applicant can be in supplementing its application with missing material, Jacob LJ said that in setting the Article 10(3) period, the Comptroller should take into account, inter alia, the failure to include all the materials in the application and the extent to which the applicant is guilty of unreasonable conduct or delay.

This decision now largely accords with the decision of the Dutch Patent Office to allow the extension. The Dutch Patent Office accepted (i) a PIP compliance statement dated 16 April 2009 and (ii) an end-of-procedure marketing authorisation notification dated 6 April 2009 (i.e. both dated after the 1 March 2009 deadline) from the Dutch Medicinal Evaluation Board (Competent Authority), having initially allowed du Pont to submit these documents out of time under Article 10.3 of the SPC Regulation (which requires Patent Offices to ask applicants to rectify irregularities within a stated time).