Paediatric extension applications: substance and timing

Authors: Sebastian Moore and Jonathan Turnbull (Herbert Smith)

EI Du Pont Nemours & Co. v United Kingdom Intellectual Property Office [2009] EWCA Civ 966, 17 September 2009

Citation: Journal of Intellectual Property Law & Practice 2010 5(3):134-136; doi:10.1093/jiplp/jpp211

The Court of Appeal for England and Wales provides the first clear guidance on the timing and substantive requirements for applying for and obtaining a paediatric extension to an existing Supplementary Protection Certificate (‘SPC’).

Facts

On 18 February 2009, DuPont applied for a 6-month paediatric extension to its existing SPC for the hypertension drug losartan, which is marketed as Cozaar by its licensee Merck. The United Kingdom's Intellectual Property Office (‘IPO’) Hearing Officer refused the application on 9 April 2009 and this refusal was upheld in May 2009 on appeal to the High Court (John Baldwin QC sitting as a Deputy Judge). Following the High Court's decision, DuPont requested an expedited appeal as it was unclear whether a paediatric extension could be granted if the underlying SPC had expired before the appeal was heard. Consequently, on 19 August 2009, Lord Justices Jacob, Ward and Stanley Burnton heard DuPont's appeal during the Court's vacation. In its written judgment of 17 September 2009, the Court of Appeal agreed with the IPO and the High Court that the conditions for granting the paediatric extension had not been met in DuPont's application but disagreed with the decision that the application could not be rectified.

Legal Context

DuPont was unable to obtain a varied marketing authorization (‘MA’) by the deadline for filing its paediatric extension application (currently 6 months prior to expiry of its SPC under the transitional provisions of Articles 7(4) and 7(5) of the SPC Regulations, Regulation 1768/1992, now replaced by a codified version 469/2009). This was because the administrative procedures for varying the MA had not been completed in time for reasons outside DuPont's control.

The Hearing Officer rejected DuPont's application as it was not made in accordance with the SPC Regulations and because it did not fulfil the substantive requirements of the Paediatric Regulations (Regulation 1901/2006). The Court of Appeal summarized the alleged deficiencies in DuPont's application as being that it did not include:

1. an MA containing a statement of compliance with the agreed paediatric investigation plan (‘PIP’) (in accordance with Article 28(3) of the Paediatric Regulations); and

2. proof that varied MAs containing a statement of compliance had been obtained in each Member State, as required by Article 36(3) of the Paediatric Regulations, following DuPont's use of the mutual recognition procedure to vary its MAs.

Further, both the Hearing Officer and the High Court held that the IPO was not required to provide DuPont with further time under Article 10(3) of the SPC Regulations to correct the application's deficiencies. This was because the Hearing Officer and the High Court interpreted narrowly the term ‘irregularity' in Article 10(3) of the SPC Regulations, which excluded deficiencies that were incapable of being rectified at the time the application was made.

Analysis

In order to obtain a paediatric extension, an applicant must comply with Articles 7 and 8 of the SPC Regulations, which set out the timing for filing a paediatric extension application and the requirements for the content of that application. Article 8 in turn cross-refers to Article 36 of the Paediatric Regulations which itself cross-refers not only to other provisions of the Paediatric Regulations but also to Directive 2001/83 (which deals with the MA system). This has led to confusion underlined by Jacob LJ's leading judgment, in which he stated: ‘All this cross-referring and sub- and sub-sub- cross-referencing begins to make the mind boggle'.

In untangling the myriad of cross-referencing and to determine the underlying requirements of Article 8 of the SPC Regulations, Jacob LJ considered the objective of the Paediatric Regulations in providing the reward of a paediatric extension to an SPC. In agreement with the submissions of the IPO, he held that the aims and objectives are:

• to facilitate the development and accessibility of medicinal products for use in the paediatric population;
• to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorized for use in the paediatric population; and
• to improve the information available on the use of medicinal products in the various paediatric populations.

Consequently, when considering the Paediatric Regulations as a whole, Article 36 should be interpreted as meaning that in order to obtain a paediatric extension:

• all the measures in the agreed PIP must have been compiled with;
• the authorized product information must include relevant information on the results of the paediatric studies (including the Summary of Product Characteristics); and
• the product must be authorized in all Member States.

Jacob LJ concluded that to fulfil the requirements of the Paediatric Regulations, a varied MA containing a statement of compliance with the agreed PIP (in accordance with Article 28(3) of the Paediatric Regulation) must be obtained. Jacob LJ suggested that this would promote a transparent system for granting paediatric extensions such that ‘all a Patent Office has to do is to look at the MA to see whether the PIP has been complied with'. Although DuPont argued that the results of the paediatric studies could be disseminated in other ways, such that a paediatric extension could be granted even if a varied MA had not been obtained, Jacob LJ was not convinced by these alternative methods. In summarizing his views, Jacob LJ stated ‘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'. Further, unless the centralized procedure was used to obtain and vary the MA, varied MAs must also be obtained in each Member State, so that the results of the paediatric studies are available throughout the European Community.

To this extent, the Court of Appeal is in agreement with the decisions of the Hearing Officer and the High Court that strict compliance with Article 36 of the Paediatric Regulations is required to obtain a paediatric extension. The Court of Appeal, however, held that strict compliance was required on grant of the reward and, importantly, that the requirements of Articles 7 and 8 of the SPC Regulations did not state that the requirements of Article 36 of the Paediatric Regulations must have been completed at the time of filing an application for a paediatric extension. Consequently, if applicants submit their applications for a paediatric extension within the time required by Article 7 of the SPC Regulations but are unable to provide a copy of the varied MA or evidence that varied MAs have been obtained in every Member State (as required by Article 8(1)(d) of the SPC Regulations), the IPO must, in accordance with Article 10(3) of the SPC Regulations, ask the applicant to rectify its application within a stated period of time. The Court of Appeal rejected the Hearing Officer's and High Court's narrow interpretation of Article 10(3) of the SPC Regulations stating that there was no support for such an interpretation in the SPC 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.

Although not in issue in the DuPont case, Jacob LJ indicated that the IPO should take into account all relevant factors when considering the amount of time the IPO should provide to an applicant to rectify its application under Article 10(3) of the SPC Regulations. The relevant factors include the reason for the failure to include the required documentation and the date on which compliance could be expected and, the delay by and the conduct of the applicant.

Practical Significance


Although Jacob LJ acknowledged the different approaches of various Member States to grant DuPont's paediatric extension for losartan, the Court of Appeal's decision brings the position in the UK closer to the approach of the Dutch Courts. This decision has clarified the requirements for obtaining a paediatric extension in the UK and these requirements are now reflected in the sections concerning paediatric extensions in the recently reissued SPC ‘Guide For Applicants’ of the IPO. Further, the broad interpretation of Article 10(3) of the SPC Regulations has mitigated what appeared to be a harsh result in which an applicant could be prevented from obtaining a paediatric extension to an existing SPC due to a delay on the part of a regulatory authority in completing the relevant administrative procedures and through no fault of its own. In such circumstances, unless it has behaved unreasonably, an applicant should now be granted sufficient time to rectify its application and obtain a paediatric extension.