Status quo

Supplementary Protection Certificates (SPC) in the EU extend the market exclusivity provided by patents by up to five years. Similar protection also exists in the USA and Japan for up to five years, depending on the relevant legal criteria. Supplementary Protection Certificates are designed to compensate for the time lapse between the patent application and the granting of the marketing authorisation, when the originator company has to complete the development of its product and obtain regulatory approval. The relevant piece of EU regulation is Regulation (EC) No. 469/2009.

At present, EU-based manufacturers of generic and biosimilar medicines are not permitted to make these products for export to non-European markets for as long as the reference medicinal product is protected by an SPC, even if protection for the product has already expired in the export markets. In addition, EU-based manufacturers cannot even start manufacturing during the SPC period for launch in EU markets immediately after the expiry of the SPC.

Indeed, during both the patent and the SPC protection period, the makers of the protected medicinal product have the manufacturing and marketing monopoly for it, i.e. production of the generic medicine for commercial use is prohibited.

Milestones

  • The European Commission published its report 'The Single Market Strategy for Europe' on 28 October 2015 (see download section), in which the Commission proposed to lift the production ban during the intra-European protection period by means of an “SPC manufacturing waiver”.
  • In February 2017, the Commission published its Inception Impact Assessment Optimising the Internal Market’s industrial property legal framework relating to supplementary protection certificates (SPC) and patent protection research exemptions for sectors whose products are subject to regulated market authorisations.
  • This was followed by a public consultation between 12 October 2017 and 04 January 2018.

  • In this context, the Commission published the study 'Assessing the economic impacts of changing exemption provision during patent and SPC protection in Europe' (see download section). This study was conducted by Charles River Associates on behalf of the Commission (CRA study). It shows that such a waiver provision would generate

    • additional net sales for the EU pharmaceutical industry amounting to €9.5 billion;

    • 25,000 additional jobs;

    • €254.3 million additional net sales of EU Active Pharmaceutical Ingredients (API);

    • 2,000 new direct jobs for the EU API industry and

    • savings in the European healthcare system of €3.1 billion.