Get your paperwork in order, Merck told

The SPC Blog has just received news of Lawrence Cullen's decision last week in Merck & Co., Inc's application, Case O/035/09, 6 February 2009. 

In short, this was an application for an extension to the duration of granted a granted supplementary protection certificate, SPC/GB/02/002. The active ingredient for which the SPC was granted was Caspofungin, an antifungal agent for human use which Merck marketed as Cancidas. This application was made under Article 7 of Regulation 1768/92 to obtain the reward provided under Article 36(1) of Regulation 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 1768/92 since 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 1901/2006. This view was upheld by the Hearing Officer, who considered the relevance of Articles 8, 23, 28 and 36 of Regulation 1901/2006 in deciding if Merck's documents fulfilled the requirement of Article 8(1)(d)(i) of Regulation 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 statement of compliance with an agreed completed paediatric investigation plan: what is needed is a copy of an updated marketing authorisation granted by a competent authority under Regulation 1901/2006. 

At para 43 of his decision Mr Cullen says:

"In their written submission, the applicant argued that if it was necessary to wait until they could furnish evidence of a granted updated or varied marketing authoristion to apply for the 6 month SPC extension for products that are already covered by an SPC rather than doing so on the basis of the opinion on compliance of the Paediatric Committee, they are in danger of being denied the reward for doing the paediatric studies through no fault of the applicant but rather because of the time taken by the competent authority to process the application and grant the update marketing authorisation. However, in my view the reward is not only based on completing an agreed PIP, it is also based on making sure that information regarding the use of medicinal products in the paediatric population is made available and improved and this achieved by including this information in the marketing authorisation and in the SmPC and, where relevant, the product & labeling information. This is illustrated for example by recital (28) of EC Regulation 1901/2006. Thus there would seem to a valid reason why it is necessary to wait until the varied marketing authorisation is granted. However, I do have some sympathy with the concern expressed by the applicant in relation to the impact of delays beyond their control in obtaining updated granted marketing authorisations from a competent authority and the need make an application for an SPC extension prior to expiry of the original granted SPC. Article 7(4) and 7(5) of EC Regulation 1768/92 require that the application for an extension to the SPC must be lodged before expiry of the original SPC. For the period of 5 years after EC Regulation 1901/2006 enters into force, the application must be made 6 months before the SPC expires, thereafter, the application must be lodged 2 years before the SPC expires. I do not think that it can be one of the intended consequences of this Regulation that the time taken by the competent authority to process the application and grant the update marketing authorisation should prevent an applicant from being able to obtain a reward for carrying out an agreed completed PIP and making the information on its outcomes available".

Merck was allowed a period of time within which to rectify the irregularity in its application.