In European Union member countries, a supplementary protection certificate (SPC) is a sui generis, patent-like, intellectual property right. This type of right is available for medicinal products, such as drugs, and plant protection products, such as insecticides, and herbicides.
A supplementary protection certificate comes into force only after the corresponding patent expires. It has a maximum life time of 5 years. The market exclusivity cannot however exceed 15 years. It may be viewed as an extension of life time of a patent, although the rights are somewhat different.
Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market).
Applications for a supplementary protection certificate must be filed on a country-by-country basis. There is no unitary European supplementary protection certificate, but national ones only.
The term of an SPC depends on the date of issuance of the first market authorisation within the EEA:
A market authorisation in Switzerland was also considered as being a first market authorisation for the calculation of the SPC duration, even though Switzerland is not part of the European Economic Area (EEA). This is because such a market authorization was automatically effective in Liechtenstein, which is a member of the EEA (since May 1, 1995). This was decided by the European Court of Justice (ECJ) in joined cases Novartis et al. v. Comptroller-General and Ministère de l'Economie v. Millennium Pharmaceuticals. However, as answer to the decision of the ECJ the contract between Switzerland and Liechtenstein was amended. Since July 1st 2005 the automatic effect of a Swiss market authorization in Lichtenstein is abolished. The recognition is now delayed by a time period, which is normally 12 months.
Supplementary protection certificates in the European Union are based on two regulations:
Supplementary protection certificates may come into life at the expiry of a national or European patent. However, the European Patent Convention (EPC) needed to be modified to allow such "extension" of the term of European patent. Article 63 of the EPC was modified on December 17, 1991 to specify to, although European patents have a term of 20 years as from the date of filing of the application (Art. 63(1)),
This constituted the first revision of the European Patent Convention since its signature in 1973.