Paediatric rewards

Paediatric rewards are the benefits granted by Regulation (EC) No 1901/2006 in return for conducting studies in compliance with an agreed paediatric investigation plan. Depending on the situation of the medicinal product, they consist of an extension of the supplementary protection certificate, an extension of orphan market exclusivity or a specific protection for paediatric authorisations of older products. They are due in recognition of the research effort, whether or not the results of the studies are positive.

Extension of the supplementary protection certificate

For a medicinal product protected by a certificate, the reward is a six-month extension, the procedure for which is governed by Regulation (EC) No 469/2009. It requires that the marketing authorisation application include the results of studies conducted in compliance with the plan, that the authorisation contain a statement of compliance and, for national authorisations, that the medicinal product be authorised in all Member States. The application is filed with the national office, the INPI in France, together with the certificate application, while it is pending or no later than two years before the certificate expires. The Court of Justice of the European Union accepts that a certificate with a zero or negative term may be granted to allow this paediatric extension, which can be granted only once.

Orphan rewards and the paediatric use marketing authorisation

For an orphan medicinal product, extension of the certificate is excluded and the reward consists of extending market exclusivity from ten to twelve years. For a medicinal product no longer protected by a patent or certificate, the Regulation creates a paediatric use marketing authorisation, reserved for an exclusively paediatric indication and form, which benefits from eight years of data protection and ten years of market protection. These rewards cannot be combined for the same product.

Litigation over rewards

The six-month extension delays generic entry by the same period and is frequently challenged. Generic manufacturers examine the regularity of the statement of compliance, compliance with the filing deadline and the validity of the certificate itself, whose invalidity leaves the extension without a basis. In France, these disputes fall within the jurisdiction of the Paris Judicial Court and, depending on the case, of the Unified Patent Court (UPC) for certificates based on a European patent. The term of the certificate must therefore always be recalculated to include the extension.

Key points

Paediatric rewards depend on the situation of the product: a six-month extension of the certificate, orphan exclusivity extended to twelve years or the specific protection attached to the paediatric use authorisation. The actual expiry date should be calculated including the extension, and compliance with the filing deadline of two years before the certificate expires should be checked. For a generic manufacturer, the statement of compliance and the validity of the certificate are the two lines of attack to examine first.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation