The German Federal Patent Court has decided to refer a question for preliminary ruling on negative term SPCs to the Court of Justice of the European Union in the Sitagliptin case (Case 15 W (pat) 36/08):"Can an SPC be granted for a medicament if the period between the filing of the application for the basic patent and the time point of first authorization for marketing in the Community is shorter than five years?"
A copy of the decision can be downloaded here (for the moment, in German only).
Thanks to Klemens Stratmann (Hoffmann Eitle, Munich) for providing a translation of the question.
1 comment:
As always, the comments are entirely mine,not of my employer and anyone else...
Just to brief, a SPC comes into force only after the corresponding general patent expires. It normally has a maximum life time of 5 years however the duration can be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006[2]).
Further to note, the total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years. However, the reward of a 6-month SPC extension for the submission of data from an agreed PIP can extend this combined duration to at least 15.5 years. It extends the life time of a patent.
Considering this, if we assume that time period between the basic patent filing and first authorization marketing approval is 4 years as in the present case(less than 5 years), than the total combined duration of market exclusivity of a basic patent and SPC would exceed 15 years (which is 16 years remaining of patent term plus 5 years of SPC), which is not allowed under the regulations.
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