Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities. The EU wishes to provide sufficient protection for these products in the interest of public health and to encourage innovation in these areas to generate smart growth and jobs.
Supplementary protection certificates aim to offset the loss of patent protection for pharmaceutical and plant protection products that occurs due to the compulsory lengthy testing and clinical trials these products require prior to obtaining regulatory marketing approval.
An SPC can extend a patent right for a maximum of five years. A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP). PIPs are required to support the authorisation of medicines for children. They ensure that enough data is collected on the effects of the medicine on children. The extension compensates for the additional clinical trials and testing that PIPs require.
The regulations below created SPCs at EU level for patented pharmaceutical and plant protection products. These regulations make it possible to rectify disparities in national systems in EU countries.
The 'patent package' that lays the ground for the creation of unitary patent protection in the EU does not explicitly provide for a 'unitary SPC'. To ensure that companies which choose unitary patent protection can benefit from the SPC extension, the European Commission is working on the articulation of unitary patent protection and SPC legislation.
On 28 May 2018, the Commission adopted a proposal for a regulation to amend Regulation (EC) No 469/2009 on supplementary protection certificates for medicinal products. This initiative proposes to introduce an exception to let EU firms manufacture certain pharmaceuticals for export to non-EU markets during the term of the SPC.