2 December 2016

Supplementary Protection Certificates & Brexit

A supplementary protection certificate (SPC) is the intellectual property right that extends the protection for patented active ingredients in pharmaceutical or plant protection products requiring marketing authorisation. The aim of an SPC is to compensate patent owners whose effective patent term has been eroded by the length of time taken to obtain marketing authorisation for the product in question. It is in truth a political comprise as the countries of the European Patent Convention could not agree on a simple patent term extension. For this reason Brexit may allow for an improvement in the approach to patent term extension as there is no long term reason to maintain the SPC system.

The duration of an SPC is equal to the period which has elapsed between the filing of the patent application and grant of the first EU marketing authorisation, less five years, up to a maximum of five years. A further extension of SPC term by six months is available for a product where its use is extended to children. To qualify for SPC protection, an active ingredient of a medicinal product must be protected by a patent in force in the country of interest, and there must be a valid marketing authorisation in that country.

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