Supplementary protection certificate

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In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based. 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 to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market).^[1]

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 (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006^[2]).

The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years. However, the reward of a 6-month SPC extension for the submission of data from an agreed PIP can extend this combined duration to 15.5 years.

SPCs extend the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent. For many SPC applications, there is no controversy about the definition of the "product" or whether it is protected by the patent upon which the SPC application was based. However, there are other SPC applications (particularly for medicinal products containing multiple active ingredients) where there may not be clear answers to questions such as what is a permissible definition of a "product", and what test should be applied for determining whether a patent protects that "product".

Supplementary protection certificates in the European Union are based primarily upon two regulations. Although all countries in the EU are required to provide supplementary protection certificates, no unified cross-recognition exist. Applications must be filed and approved on a country-by-country basis.