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

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.

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, 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.

Brexit