Calculating supplementary protection certificate term

In 1993, a system of effectively extending the patent term of protection for pharmaceutical products was introduced by the supplementary protection certificate (SPC), Council Regulation (EEC) No 1768/92.

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 authorisation. This could result in a proprietor having little or no patent term remaining by the time he or she is able to reach the market with the related product.

The SPC regulation is intended to address this problem by providing for up to five years’ further monopoly protection for specific patented ‘products’, as defined.

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