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.
"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".