Following the adoption of the Single Market Strategy in 2015, the European Commission has been reviewing the EU Supplementary Protection Certificate (SPC) framework, to help decide both whether to revise the existing SPC legislation (which introduced national SPC rights to be granted by member states) and whether to introduce a new SPC title at EU level: a ‘unitary SPC’. The current legislation creating the new unitary patent system does not create a ‘unitary SPC’, although it is general understood (but not yet confirmed by the Commission) that a unitary patent may be used as the basic patent for a national SPC application . The Commission has recently published: a Summary of the replies to the public consultation on patent research exemptions and SPCs (the ‘consultation’), a Study and annexes on the legal aspects of Supplementary Protection Certificates in the EU by the Max Planck Institute for Innovation and Competition (the ‘legal study’) and a Study of the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe by Copenhagen Economics (the ‘economic study’). The creation of a unitary SPC was favoured by a large majority of respondents in the consultation and by those interviewed as part of the legal study, and that view was endorsed by both legal and economic analysis. Respondents included originators, manufacturers of generics, SMEs and national patent offices (NPOs). However, there was less consensus on the preferred operation of certain aspects of a unitary SPC system – for example, which body would grant a unitary SPC, its territorial scope, and the language regime.
The granting authority could be, for example, the EPO, NPOs, the EUIPO, an EU institution (such as the EMA), or a stand-alone institution. Views among respondents in the consultation varied considerably, but in the legal study the majority of stakeholders favoured a team of experts from NPOs in a ‘virtual’ office examining and granting. Regarding appeals of decisions of the granting body, the majority of stakeholders in the legal study preferred these to be to the Unified Patent Court (UPC) rather than to an EU court. Such a system (with that virtual office granting, and appeals to the UPC) had already been proposed by industry associations in July 2015 (here) and the legal study concluded there was no reason for this not to be explored. (The legal study’s view was that if the EPO were the granting authority, the UPC could be granted jurisdiction to hear appeals, which would enable the CJEU to exercise supervisory jurisdiction over EPO decisions relating to SPCs as required by Union law.)
There was a general view that national SPCs (as well as MAs granted by the EMA’s centralised authorisation procedure) could support the application for a unitary SPC. The territorial scope of the unitary SPC would be restricted according to the national MAs, but that scope could be ‘static’ (corresponding to the national MAs used in the application) or ‘dynamic’ (extending to any other member states where an MA is granted before the patent expires).
For more on SPCs and the UPC system, see here.