Supplementary Protection Certificates (SPCs) And The Patents Regulations 2007
On 17th December 2007, the Patents Regulations 2007 introduced clarified provisions on SPCs*.
The new provisions make it clear how the UK Patents Act 1977 applies in relation to SPCs for medicinal and plant protection products. It also gives effect to changes made to the SPC regime by European Regulation (EC) No. 1901/2006 which concerns medicinal products for paediatric use.
Regulation 1901/2006 aims to provide incentives to manufacturers who conduct studies of drugs in children. The European Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population ie. children up to the age of 18. As of 26th July 2008, data on the paediatric use of a medicinal product in the form of a paediatric investigation plan (PIP) must be provided at the time of applying for a marketing authorisation. The requirement to include a PIP may, however, be waived for medicinal products unlikely to benefit children.
In return for providing this data, it will be possible to extend the term of an SPC by 6 months. It would appear that regardless of the outcome of the paediatric studies, provided that the data from the PIP is incorporated into the marketing authorisation documentation, the extension will be granted. Importantly, the SPC term of extension will apply to all authorised indications for the product and will not be limited to the paediatric indications.
*An SPC can extend the maximum life time of a patent by up to 5 years but is only available for medicinal and plant protection products.