Internal Market, Industry, Entrepreneurship and SMEs

Supplementary protection certificates for pharmaceutical and plant protection products

Supplementary protection certificates for pharmaceutical and plant protection products

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.

EU legislation on SPCs

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.

Supplementary protection for unitary patents

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.

Export manufacturing waiver for SPCs

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.

This initiative was first considered in the Single Market Strategy of 2015, in the context of a targeted recalibration of certain aspects of patent and SPC protection. It is supported by a series of studies (see below) and was the subject of a public consultation in October 2017.

Studies

Following the adoption of the Single Market Strategy, a number of studies related to the EU SPC framework have been conducted. The impact assessment (see above) contains further details of these and other studies.

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