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.
- Council Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified text of the original Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products)
- Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
- Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products
A recently conducted evaluation paves the way for future initiatives regarding SPC legislation.
- Evaluation of Regulations 469/2009 and 1610/96 concerning supplementary protection certificates (report and executive summary)
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 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.
- Commission proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
- Impact assessment of the proposal
- Summary of the public consultation
- Press release: Commission refines pharmaceutical intellectual property rules
- FAQs: Supplementary protection certificates for medicinal products
Following the adoption of the single market strategy in 2015, a number of studies related to the EU SPC framework were conducted. The impact assessment (see above) contains further details of these and other studies.
- Study and annexes on the legal aspects of Supplementary Protection Certificates in the EU, Max Planck Institute (2018)
- Study of the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe, Copenhagen Economics (2018). This study analyses the combined effect of pharmaceutical incentives in the EU
- Assessing the economic impacts of changing exemption provisions during patent and SPC protection in Europe, Charles Rivers Associates (2017)
- 25 years of SPC protection for medicinal products in Europe: Insights and challenges, M. Mejer, (2017)
- Economic Analysis of Supplementary Protection Certiﬁcates in Europe, M. Kyle (2017) PDF, 313 KB