Skip to main content
European Commission logo
enen
Business, Economy, Euro
Internal Market, Industry, Entrepreneurship and SMEs

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 provide the legal EU framework for the creation of SPCs for patented pharmaceutical and plant protection products.

On 27 April 2023, the Commission proposed a comprehensive reform of the SPC regime, including an impact assessment and it’s executive summary, along with 4 regulation proposals.

This reform will replace the existing SPC regulation by new ones, for medicinal products and plant protection products respectively. Each will include the current national procedure as well as a new centralised procedure for the granting of national SPCs, available where the basic patent is a European patent, and the products has a market authorisation.

Two additional proposals relate to the creation of unitary SPCs for medicinal products and plant protection products respectively. This is available where the basic patent has unitary effect, and is granted on the basis of the same centralised procedure. Furthermore, it will be possible to file a single ‘combined application’, resulting in the granting of a unitary SPC and of national SPCs for additional Member States.

Under the proposal, the European Union Intellectual Property Office (EUIPO) will implement the new centralised procedure, with the close involvement of national examiners experienced in SPC matters.

This essentially procedural reform aims at reducing costs and administrative burden, and improving legal certainty and transparency.

Supplementary protection for unitary patents

The 'patent package' of 2012 that laid the ground for the creation of unitary patent protection in the EU did not provide for a 'unitary SPC'. The proposals of April 2023 mentioned above confirm that national SPCs can be granted on the basis of a unitary patent. In addition, once these proposals are adopted, it will be possible to extend a unitary patent by a unitary SPC.

SPC manufacturing waiver

Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the SPC for medicinal products entitles EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done either for the purpose of exporting to a non-EU market, or for stockpiling during the final 6 months of an SPC ahead of entry into the EU market.

The aim of this regulation is to remove a major competitive disadvantage of EU-based manufacturers compared to manufacturers based in non-EU countries (where SPC-type protection is not available or not enforceable) and ensure a better deal for patients. The revision is a well-calibrated adjustment to the current regime striking a balance between ensuring the attractiveness of Europe for innovative pharmaceutical companies and allowing EU-based generics and biosimilars to compete on the global market.

On 28 May 2018 the Commission proposed the regulation in the context of the Single Market Strategy of 2015. The draft was supported by an impact assessment based on a number of studies, a public consultation and other evidence.

Studies

Following the adoption of the single market strategy in 2015, a number of studies related to the EU SPC framework were conducted.

Brexit