Supplementary Protection Certificates

Key point: Up to 5 years extension to the absolute monopoly given by a patent where the invention consists of a medicinal product for which approval by the relevant authority has yet to be given.

Where a patent concerns a medicinal product which is subject to an authorisation procedure prior to the product being placed on the market, as is the case for approval of products for human and veterinary medicines, a supplementary protection certificate (SPC) may be requested. The SPC comes into being on expiry of the patent and lasts for up to 5 years. It must be requested within 6 months of either: the date of first authorisation to market the product as a medicinal product, or the date of grant of the patent, whichever is the later.

The legal effect of a supplementary protection certificate is substantially the same as that of the patent upon which it is based.


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