EU Court Advisor Positive On Negative SPC Term Extension

Case Summary

Merck Sharp & Dohme (MSD) is the owner of a European patent for a medicinal product containing the compound sitagliptine. The application for this patent was filed on 5 July 2002. MSD applied for a supplementary protection certificate (SPC) on the basis of the first marketing authorisation ("MA") for this product, which was granted on 21 March 2007. According to article 13 of the Regulation (EC) 469/2009 (SPC-Regulation), the term of an SPC is calculated as the period between the application for the patent and the grant of the fist MA, minus five years. In the case of MSD's sitagliptine product, the SPC extension term would be negative. So why bother with a negative SPC?