Re Council Regulation (EEC) No.1768/92 & Ors

An application for a paediatric six-month extension of a supplementary protection certificate must satisfy the substantive conditions in Article 36 of the Council Regulation (EC) No 1901/2006 by the applicable deadline. The requirements include completion of the agreed paediatric investigation plan, inclusion of the relevant results in authorised product information and, where the mutual recognition procedure is used, authorisation of the medicinal product in all Member States. An Article 28(3) statement is informative, but only reliable equivalent evidence can replace it. A failure to satisfy substantive eligibility conditions is not an irregularity capable of later correction under Article 10(3) of the Council Regulation (EEC) No 1768/92.

E I du Pont de Nemours & Co appealed from the Comptroller General of Patents’ decision dated 9 April 2009, reported as BL/O/096/09. The Comptroller had found irregularities in Dupont’s application for a six-month extension of the supplementary protection certificate for Cozaar.

At the application deadline, the relevant marketing authorisation procedure had not been completed in the reference Member State, and authorisations had not been obtained in all Member States. The central questions were whether the statutory requirements could be satisfied by evidence other than the prescribed statement, and whether the outstanding deficiencies were correctable irregularities after the deadline.

1. The appeal was dismissed. Dupont’s application, lodged on 18 February 2009, did not satisfy the conditions for an extension by the 1 March 2009 deadline.

2. Article 36 of the Council Regulation (EC) No 1901/2006 had to be read as a whole. The substantive requirements were: completion and compliance with the agreed paediatric investigation plan; inclusion of relevant study results in authorised product information; and, where the mutual recognition procedure was used, authorisation of the medicinal product in all Member States.

3. The Article 28(3) statement was an informative means of demonstrating compliance. The judge accepted that reliable equivalent information might suffice, but gave no general guidance on what evidence would qualify. The Paediatric Committee’s opinion did not address whether all study results were included in the application and therefore could not replace the statement.

4. The reference in Article 36(3) to authorisation in all Member States concerned the medicinal product subject to the paediatric investigation plan, not merely its active ingredient. The recitals and legislative materials supported that construction because the scheme was intended to secure Community-wide paediatric benefit.

5. The deficiencies were substantive, not formal. Article 10(3) of the Council Regulation (EEC) No 1768/92 allowed correction of an irregularity in an application, but did not permit an applicant to acquire essential eligibility conditions after the Article 7(5) deadline. Allowing that would undermine certainty for patentees, competitors and consumers.

6. The construction adopted did not infringe proportionality. The conditions served the Regulation’s purpose and were not disproportionate.

• High Court (Chancery Division): appeal from the Comptroller General of Patents’ decision dated 9 April 2009, BL/O/096/09; appeal dismissed.