In EI Du Pont Nemours & Co v United Kingdom Intellectual Property Office  EWCA Civ 966, the Court of Appeal provided the first clear guidance on the timing and substantive requirements for applying for and obtaining a paediatric extension to an existing SPC.
The decision clarifies that:
- in order for an application for a paediatric extension to an existing SPC to be granted it must contain a copy of a varied marketing authorisation ("MA") containing a statement of compliance with an agreed paediatric investigation plan ("PIP") and, unless the varied MA was obtained under the centralised procedure, proof that similar varied MAs have been obtained EU wide;
- if the applicant is unable to provide this material at the time it makes its application, the United Kingdom Intellectual Property Office ("UK-IPO") must provide the applicant with a period of time to rectify this, even if the required material was not available to the applicant at the time of filing its application; and
- unless the applicant has behaved unreasonably, the period of time provided by the UK-IPO should be sufficient to allow the applicant to provide the missing material so that it can obtain the requested paediatric extension, its reward for completing the agreed PIP and obtaining the varied MAs.
A six month paediatric extension to an SPC can be granted if the substantive requirements of the Paediatric Regulations (Regulation 1901/2006) are met and the application is made in accordance with the provisions of the SPC Regulations (originally Regulation 1768/92 but now replaced by a codified version, Regulation 469/2009). The relevant Articles of the SPC Regulation are Article 7 which sets out the timing of filing the application and Article 8 which sets out the requirements for the content of the application. Unfortunately, these relevant provisions are unclear, particularly as Article 8(1)(d) of the SPC Regulations cross-refers to Article 36 of the Paediatric Regulations which in turn cross-refers not only to other provisions of the Paediatric Regulations but also to another Directive (Directive 2001/83, which deals with the MA system). This has led to confusion and to Jacob LJ observing in the Court of Appeal's leading judgment that 'All this cross-referring and sub- and sub-sub- cross-referencing begins to make the mind boggle'.
In this case, the issue was that DuPont had been unable to obtain a varied MA in time for its application for a paediatric extension. The MA was only varied after the deadline for filing the application through no fault of DuPont.
The Court of Appeal judgment
Despite Jacob LJ recognising that, ultimately, questions regarding the SPC system are for the ECJ, the Court of Appeal went as far as it felt it could legitimately go in providing guidance as, in reality, there will often be insufficient time for a reference to be determined.
Jacob LJ analysed the Articles and Recitals of the Paediatric Regulations and agreed with the submissions of the UK-IPO that the aims and objectives of the Paediatric Regulations are:
- to facilitate the development and accessibility of medicinal products for use in the paediatric population;
- to ensure that medicinal products that are used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population; and
- to improve the information available on the use of medicinal products in the various paediatric populations.
These objectives are reflected in the substantive requirements of Article 36 of the Paediatric Regulations, considered in light of the entire Paediatric Regulations, which provide that:
- all the measures in the agreed PIP must have been compiled with;
- the authorised product information must include relevant information on the results of the paediatric studies (including the Summary of Product Characteristics); and
- the product must be authorised in all Member States.
As agreeing an updated Summary of Product Characteristics is the final step in the process for obtaining a varied MA, a varied MA must be granted to fulfil the second of these requirements. Jacob LJ was not convinced by DuPont's arguments that there were alternative methods to disseminate the information on the results of the paediatric studies, concluding that 'in the end it is what is on and in the packet which counts. And that is not determined finally until the MA is settled.'
Consequently, in order for an application for a paediatric extension to be granted:
- the application must contain a copy of the varied MA which contains a statement of compliance with the agreed PIP (in accordance with Article 28(3) of the Paediatric Regulations) – Article 8(1)(d)(i) of the SPC Regulations. This results in a practical, open and transparent system such that 'All a Patent Office has to do is to look at the MA to see whether the PIP has been complied with'; and
- unless the varied MA was obtained under the centralised procedure, the application must contain proof that varied MAs which contain the results of the paediatric studies have been obtained EU wide – Article 8(1)(d)(ii) of the SPC Regulations.
Currently and until 9 January 2012, under transitional provisions of Articles 7(4) and 7(5) of the SPC Regulations an application for a paediatric extension to an existing SPC must be filed at least 6 months prior to expiry of the SPC; thereafter the application must be filed 2 years before SPC expiry. If an application is filed in the last 6 months of the duration of an SPC, it will be rejected. However, if filed with at least 6 months remaining but the application fails to provide the requested documents (under Article 8 of the SPC Regulations), Article 10(3) of the SPC Regulations specifies that the UK-IPO shall ask the applicant to rectify the 'irregularity' within a stated period of time.
Jacob LJ and Stanley Burnton LJ saw no reason why 'irregularity' should be given a restrictive meaning such that it only encompasses something missing from the application that could have been contained within it at that time. Jacob LJ highlighted that there is no support for a narrow interpretation in the Paediatric Regulations: the reward of a paediatric extension is for complying with the agreed PIP and obtaining the necessary varied MAs, it is not for doing all that before the application is made. Jacob LJ and Stanley Burnton LJ concurred that the meaning of 'irregularity' should be such that an applicant could supplement its application with material even if this material was not available at the time of filing its application. Therefore, save for an 'improbably extreme case', this interpretation removes the risk that for applications for paediatric extensions based on national marketing authorisations obtained under the mutual recognition (or decentralised) procedure, that an applicant could be denied its reward through no fault of its own but by virtue of the failure of a national authority to comply with its obligations to vary an MA within the time required by community law.
Despite the issue not being before the court, Jacob LJ provided further guidance on the period of time that the UK-IPO should provide to applicants under Article 10(3) of the SPC Regulations. The UK-IPO should take into account all relevant factors, including the reason for the failure to include the required documentation and, the delay by and the conduct of the applicant. Therefore, in light of the purpose of the Paediatric Regulations, unless the applicant has behaved unreasonably it should be given the time to obtain its reward.