Proposal for unitary SPCs


The European Commission has published proposals for reforms of the EU Supplementary Protection Certificate (SPC) system, which would introduce unitary SPCs for medicinal products and for plant protection products. A unitary SPC would be granted by the EUIPO on the basis of a unitary patent and also, in the case of a unitary SPC for a medicinal product, on the basis of a centralised marketing authorisation. A unitary SPC would cover the 17 member states currently participating in the unitary patent system. Also, whereas currently SPCs are applied for nationally at local IPOs, in the new system a single centralised SPC application must be made to the EUIPO for non-unitary European patents where the marketing authorisation relied on is a centralised one, resulting in national SPCs in the designated EU member states. A centralised SPC application and a unitary SPC application may be filed together in a “combined” application, resulting in a unitary SPC and national SPCs in the designated EU member states not covered by the unitary patent.

An application would be examined by a panel of three examiners (one being a member of the EUIPO and two being SPC examiners from different national IPOs) which issues an examination opinion on whether an SPC should be granted or refused. A negative opinion may be appealed to the EUIPO Boards of Appeal, and then to the EU General Court, and finally (if admissible) to the CJEU. A third party may file an opposition against a positive opinion within 2 months. Whereas the EUIPO will grant unitary SPCs, national IPOs will (as now) grant national SPCs applied for using the new proposed centralised application procedure. These national offices shall implement the EUIPO’s opinion unless, for example, the national patent underlying the SPC has been revoked. To challenge a granted unitary SPC an invalidity action must be filed at the EUIPO, whereas an invalidity action against a national SPC would not be filed at the EUIPO but at the national court or at the Unified Patent Court (UPC) (as already provided for in the UPC Agreement).

Katie Cambrook


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