Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use amends the Regulation on medicinal products in order to provide for the possibility and conditions for a six-month extension of the SPC for medicinal products.
The extension is only applicable under certain conditions, the most important being the requirement to submit a new application for a marketing authorization, containing data from all tests performed in accordance with an agreed pediatric investigation plan.
The consequences of the 6-month extension of the SPC include:
Maximum possible term of SPC for a medicinal product - 5 years and 6 months; and
Maximum duration of a market exclusive right (patent + SPC) - at least 15 years and 6 months.
An extension of the SPC may be granted by the Patent Office only if an SPC has been issued.
An effective extension of SPC protection can be obtained as long as at least 4 years and 6 months have elapsed and one day from the date of filing of the patent until the date of the first market authorization in the EEA.