Paediatric extension: six-month SPC extension for a completed PIP
The paediatric extension adds six months to a supplementary protection certificate as a reward for completing an agreed paediatric investigation plan.
Article 36 of Regulation (EC) No 1901/2006, the Paediatric Regulation, grants a six-month extension of the supplementary protection certificate (SPC) when an application for a new authorisation, indication, form or route includes the results of all studies in an agreed paediatric investigation plan (PIP). The reward applies whether or not the paediatric indication is approved, provided the results are reflected in the product information. The product must be authorised in all Member States. Orphan medicines are excluded from the SPC extension and instead receive two more years of orphan market exclusivity under Article 37.
The extension is granted by each national patent office under Article 13(3) of Regulation (EC) No 469/2009, so one PIP reward becomes a set of national filings, each with its own fee and formalities. The application relies on the compliance statement that the competent authority or EMA issues after checking the PIP against the dossier. Because the extension is attached to the SPC rather than the marketing authorisation, it is only worth having where an SPC exists and has not yet expired, and its value scales with the product's sales in the last six months of protection.
What goes wrong: a PIP that is not completed or modified in time, so the compliance check fails; studies whose results are in the dossier but not in the summary of product characteristics; a Member State where the product was never authorised, which breaks the all-Member-State condition; and a national SPC office application that misses the deadline. Generic planners get caught out too, by assuming market entry at SPC expiry when the six months have been added.
Two further conditions shape planning. The reward is granted once for the PIP, however many strengths, forms or Member States are involved, and it is only available where an SPC exists, not where the product is protected by a basic patent alone. Where a PIP contains deferred studies, the extension cannot be claimed until every study is complete and the compliance check confirms it, so a deferral that slips past the SPC application deadline forfeits the reward. The marketing authorisation must also carry the statement of compliance with the PIP provided for in Article 28(3) of the Paediatric Regulation, which patent offices rely on.
Timing
Under Article 7(4) of Regulation (EC) No 469/2009, the application for the extension must be lodged no later than two years before the SPC expires, or together with the SPC application itself. The paediatric compliance check is requested from the authority that assessed the application and should be scheduled before the SPC filings, as patent offices will not accept an application without it. Each national office then examines the request on its own timetable.
Used in
Originator and generic teams map SPC expiry and paediatric extensions per market in the loss-of-exclusivity workflow.
Related terms
- SPC: supplementary protection certificateA supplementary protection certificate (SPC) extends patent protection for an authorised medicine by up to five years to offset regulatory review time.
- PIP: paediatric investigation planA paediatric investigation plan (PIP) is the agreed programme of studies in children a new medicine must complete, waive or defer before EU authorisation.
- Orphan market exclusivity: ten-year protection for orphan medicinesOrphan market exclusivity gives an authorised orphan medicine ten years in which no similar product may be authorised for the same therapeutic indication.
- LoE: loss of exclusivityLoss of exclusivity (LoE) is the date when the last regulatory or patent protection on a medicine ends and generics or biosimilars can be marketed.
Last updated