Twenty-one years of SPCs – a cause for celebration?

Gordon Wright reviews the key SPC cases as Europe’s SPC Regulation for medicinal products approaches its 21st birthday.

Supplementary Protection Certificates (SPCs) for medicinal products were created in Europe 21 years ago this year, with the enactment of Council Regulation No. 1768/92. The aim was to improve the protection of innovation in the pharmaceutical sector. Although patents represented the best tool for protecting innovation in general, it was recognised by the European Commission that additional measures were required to support the research and development of new medicines.

Long safety and toxicity studies meant that on average new drugs did not get to the market until 12 years following the filing of the application for the patent protecting the active ingredient of the drug. This meant that only eight years remained of the 20-year patent term for the innovator company to recover the investment put into developing the drug.

SPCs offer a solution to this problem by giving the holder of a basic patent protecting the active ingredient(s) of the new drug protection supplementary to that given by the patent. The protection was to be strictly limited to the active ingredient(s) of the drug which was authorised for sale, the maximum expiry date of the certificate was to be 5 years from the normal expiry date of the patent and the duration of the patent and certificate combined was to be fifteen years from the first marketing authorisation in the European Community.