Patent decision

BL number

O/035/09

Concerning rights in

SPC/GB/02/002

Hearing Officer

Dr L Cullen

Decision date

6 February 2009

Person(s) or Company(s) involved

Merck & Co., Inc

Provisions discussed

Council Regulation (EC) No. 1901/2006; Articles 7, 8, 23, 28, 36 Council Regulation (EC) No. 1768/92; Article 8

Keywords

Extension for Paediatric Testing, Supplementary Protection Certificates

Related Decisions

None

Summary

An application for an extension to the duration of granted SPC/GB/02/002 was made under Article 7 of Regulation (EC) 1768/92 to obtain the reward provided under Article 36(1) of Regulation (EC) 1901/2006 for completing studies on medicinal products in the paediatric population. The preliminary view of the examiner was that this application did not meet the requirements of Article 8(1)(d)(i) of Regulation (EC) 1768/92 as it did not include a copy of the statement of compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of EC Regulation (EC) 1901/2006. This view was upheld by the Hearing Officer who considered the relevance of Articles 8, 23, 28 and 36 of Regulation (EC) 1901/2006 in deciding if the documents provided by the applicant fulfilled the requirement of Article 8(1)(d)(i) of Regulation (EC) 1768/92. An opinion of the Paediatric Committee of the European Medicines Agency (EMeA) on compliance with an agreed completed paediatric investigation plan was considered not to be sufficient as a the statement of compliance with an agreed completed paediatric investigation plan. A copy of an updated marketing authorisation granted by a competent authority under Regulation (EC) 1901/2006 is required. The applicant was allowed a period of time within which to rectify the irregularity with his application.