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SPCs - when can they be granted?


SPC News



Medicinal Product SPCs in Europe from 1991 to 2005

SPCs
 

Strategic use of Supplementary Protection Certificates - Part II

Strategic use of Supplementary Protection Certificates - Part I

The practicalities of paediatric extensions to the Supplementary Protection Certificate



In European Union member countries, a supplementary protection certificate (SPC) is a sui generis, extension of a patent under a specific, different, set of right. This type of right is available for medicinal products, such as drugs, and plant protection products, such as insecticides, and herbicides. 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).[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 at least 15.5 years (it is yet to be judicially clarified whether more than 15.5 years can be obtained in some circumstances).

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.



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