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
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
The final judgment of the ECJ, in which it usually follows the
opinion of the A-G, is expected by October/November of this
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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