In European Union member countries, a supplementary protection certificate (SPC) is a unique right that provides an additional monopoly that comes into force after expiry of a patent upon which it is based.

Pills in blister packs

An SPC effectively increases the term of the patent rights. A separate certificate needs to be applied for in each individual EU state.

This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products (e.g. insecticides, and herbicides). Supplementary protection certificates were introduced in order to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market), which runs in parallel with the normal 20 year patent term.

SPCs extend the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent.

A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum lifetime of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan have been submitted.

Supplementary protection certificates can have the effect of making new drugs less expensive than otherwise, since manufacturers can recoup their manufacturing costs over a longer period than the normal 20 year patent term, and therefore price new drugs lower than would be needed if they only had the normal 20 year exclusivity.

Otherwise, patentees would only have a relatively short patent term left to recoup their investment, once their product has completed the long, expensive and arduous development and approval cycle.

Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exists between states, and applications must be filed and approved on a country-by-country basis.

More information is available in our download below.