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?
The reason to nevertheless apply for an SPC is the Paediatrics Regulation (Regulation (EC) 1901/2006), which provides for an additional extension of the SPC term with six months, if extra safety and efficacy research is performed with regard to the use of the product by children.
The German Patent Office decided to reject the SPC application because there is no explicit basis for such negative term in the SPC Regulation or the Paediatrics Regulation. MSD appealed this decision and the German Federal Patent Court referred the decision to the European Court of Justice. MSD argues that its SPC for sitagliptine should be granted because it is necessary to have a SPC in order to get a six months extension on the basis of the Paediatrics Regulation in a later stage. According to MSD a positive term is not one of the conditions for the grant of a SPC.
The Advocate General is of the opinion that the SPC and the Paediatrics Regulation are aimed at providing a compensation for the time loss and investments made as a result of the obligatory safety and efficacy research. The legislator created a balance between the compensation and the interests of consumers in affordable medicinal products in setting the maximum term of exclusivity at 15 years and 6 months.
On the basis of these considerations the Advocate General concludes that a negative term SPC may indeed be granted. This extension should take effect at the end of this negative term and not after patent expiry.
Click here for the full opinion of the Advocate General.
The final judgment of the ECJ, in which it usually follows the opinion of the A-G, is expected by October/November of this year.
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