A brave new world for supplementary protection certificates

Advocate-General Verica Trstenjak has delivered an opinion in the case of Neurim Pharmaceuticals that, if followed by the Court of Justice of the EU, will profoundly liberalise the law governing SPCs in Europe.

Supplementary protection certificates (SPCs) are a unique form of intellectual property that came into existence in Europe in 1993. They provide an extended period of monopoly to patent holders who experience substantially reduced effective patent terms due to the need to obtain regulatory approval prior to selling their patented medicinal or plant protection products.

SPCs sit at the interface between the patent and regulatory systems. That is, entitlement to SPC protection depends upon obtaining both a patent and a marketing authorisation for a regulated product. However, in order to provide a balanced system, the legislators stated their intention that SPC protection should be available only for new regulated products, with minor changes to those products (such as the use of a different salt, ester or pharmaceutical form) being barred from giving rise to additional SPCs.

For many years, the SPC legislation has been interpreted strictly with regard to the availability of protection for a specific ‘product’ (active ingredient or combination of active ingredients). This has resulted in the term of combined patent and SPC protection being capped to a maximum of 15 years (or 15½ years in some cases) from the date of the first authorisation in the European Economic Area for a medicinal product comprising the active ingredient(s) in question.