EI Du Pont Nemours & Co v United Kingdom Intellectual Property Office

An application for a six-month paediatric extension to a supplementary protection certificate may be rectified after filing where it fails to contain documents required by Article 8. “Irregularity” in Article 10(3) of Regulation (EEC) No 1768/92 bears its natural, wide meaning. It covers missing or incomplete documents, even where they could not have been produced by the filing deadline. The reward under Regulation (EC) No 1901/2006 must nevertheless be supported by a marketing authorisation recording compliance with the paediatric investigation plan and by authorisations in all Member States reflecting the resulting information. The authority must allow an appropriate rectification period, guided by the Regulation’s purpose and the applicant’s conduct.

The appellant held supplementary protection certificates for losartan, due to expire on 1 September 2009. It applied on 18 February 2009 for six-month paediatric extensions under Regulation (EEC) No 1768/92, as amended by Regulation (EC) No 1901/2006.

The Patent Office hearing officer considered the applications deficient because they lacked a marketing authorisation containing the Article 28(3) statement and proof that the product was authorised in all Member States with the relevant paediatric information. The Deputy Judge of the Chancery Division upheld that decision. The appeal concerned the meaning of “irregularity” in Article 10(3), and whether the deficiencies could be cured after filing.

The appeal was allowed. Lord Justice Jacob gave the leading judgment. Lord Justice Stanley Burnton agreed and added reasons based on the context and documentary character of the requirements. Lord Justice Ward agreed with both judgments.

1. Marketing authorisation. For guidance, and although it was unnecessary to the outcome, the court held that Article 8(1)(d)(i) required a copy of a marketing authorisation containing the Article 28(3) statement. Evidence from the Paediatric Committee alone was insufficient. The scheme was intended to be practical, transparent and capable of administration by national authorities without reassessing the underlying research. The marketing authorisation was also the basis for disseminating the paediatric information.
2. Authorisation in all Member States. Article 8(1)(d)(ii), read with Article 36(3), required authorisations for the product as presented with the information generated by the paediatric investigation plan. Authorisations for formulations containing only the active ingredient were insufficient. The definition of “product” in Article 1 of the SPC Regulation yielded to the wider purpose and clear intention of the Paediatric Regulation.
3. Rectification. Article 10(3) was mandatory. “Irregularity” meant any respect in which the application failed to meet the conditions in Article 8. The term included missing or incomplete documents, and the documents could be supplied after the application date. Article 10(4) provided for rejection only if the irregularity was not rectified within the stated period, while Article 10(6) applied that mechanism to extension applications. It was incoherent to give time for rectification while treating the defect as incurable.
4. Time for rectification. The Comptroller could and should consider the reasons for the omission, unreasonable conduct or delay, and how close to expiry full compliance was expected. The purpose of the Regulation was the guiding principle. Unless the applicant had behaved unreasonably, time should be extended so that the reward could be obtained. This guidance concerned a question not before the court.

The appeal was allowed so that the Patent Office could extend the SPC before expiry.

1. Court of Appeal (Civil Division) allowed the appeal: [2009] EWCA Civ 966.
2. Chancery Division, John Baldwin QC sitting as Deputy Judge, upheld the Patent Office hearing officer’s decision.
3. Patent Office hearing officer Dr Cullen decided on 9 April 2009 that the application did not comply with the SPC Regulation and allowed until 6 July for defects to be rectified.