For those of you who don't quite master Ruud van Nistelrooy's native language, here is a summary of the key points the NPO argued:
- First, the grounds for refusal included in the SPC regulation appear to be limited.
- Secondly from the proposal of the Paediatric Regulation it is clear that the term extension was meant not only as a reward for carrying out mandatory paediatric studies for new marketing authorizations but also as an incentive for companies with existing marketing authorizations to perform such studies. It is repeatedly stated in the proposal that companies will want to develop new formulations, dosage forms and indications for their existing products in order to access the six-month SPC extension (see the references in our decision). Not granting a zero-term SPC would mean that in this case no such incentive exists. That does not seem in line with the purpose of the Paediatric Regulation which is to increase our knowledge on the safety and efficacy of medicines in the paediatric population. Furthermore applicants could also be tempted to delay granting of the marketing authorization in order to qualify for an SPC with a positive duration. Delayed entry of pharmaceuticals onto the market (and available to patients) is obviously not desirable and this is also explicitly stated in the preamble of the Paediatric Regulation (4th recital).
Thanks to Martijn de Lange from the Netherlands Patent Office for informing us on this decision.