Calculating SPC term
In 1993, a system of effectively extending the patent term of protection for pharmaceutical products was introduced by the supplementary protection certificate (“SPC”), Regulation 469/2009/EC ("SPC Regulation")¹.
The purpose of the extensions made possible by this legislation was to remedy the problem that the term of patent monopoly for many medicinal products is largely eroded as the patentee or their licensee awaits the grant of a marketing authorization. This could result in a proprietor having little or no patent term remaining by the time they are able to reach the market with the related product.
The SPC Regulation seeks to address this problem by providing for up to 5 years further monopoly protection for specific patented "products", as defined. The precise period of extension is calculated, as follows:
The period between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community, less 5 years, and subject to a cap of 5 years.
The formula provides that a patentee does not obtain an extension of its patent monopoly if it has only been eroded by 5 years or less by the wait for the grant of marketing authorization.
For example:
A patent filed on 1 November 2005 and marketing authorization granted on 1 November 2010 = the patent expires on 31 October 2025 with no further SPC protection.- A patent filed on 1 November 2000 and marketing authorization granted on 1 November 2010 = 5 years SPC protection commencing on 1 November 2020².
- A patent filed on 1 November 1995 and marketing authorization granted on 1 November 2010 = 5 years SPC protection commencing on 1 November 2015.
If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.
¹ The SPC Regulation came into force on 2 January 1993. It was superseded by Regulation (EC) No 469/2009 of 6 May 2009, which came into force on 6 July 2009.
² Whether the period of SPC protection ends at 23:59 on 31 October or 23:59 on 1 November depends on the country whose patent office granted the SPC (for example, the UK, Switzerland and the Netherlands adhere to the former, and Germany, Spain, Poland, Austria and Sweden adhere to the latter expiry dates).
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Paul England
Paul is a senior associate and professional support lawyer in the Patents group based in our London office.