Paediatric extension of an SPC

The pediatric extension is a legal mechanism that allows the protection conferred by a Supplementary Protection Certificate (SPC), which itself extends a pharmaceutical patent, to be extended by six months. Its purpose is to encourage laboratories to conduct specific clinical studies on the pediatric population (infants, children, adolescents), in order to guarantee the safety and efficacy of medicines for these vulnerable groups.

Conditions for obtaining a Paediatric Extension

1. Paediatric Investigation Plan (PIP):
   The laboratory must have carried out the paediatric studies in accordance with the PIP approved by the European Medicines Agency (EMA).
2. Marketing Authorization (MA):
   The medicinal product must have a MA that includes paediatric data in its Summary of Product Characteristics (SPC).
3. Valid Supplementary Protection Certificate (SPC):
   The pediatric extension only applies to a medicine that already has an SPC.

Benefits of the Pediatric Extension

• Extension of profitability: It offers an additional 6 months of exclusive commercial protection, thus delaying the arrival of generics.
• R&D incentive: Encourages investment in pediatric studies, which are often costly and complex.
• Public health impact: Ensures that medicines are adapted to the specific needs of children.

Limitations

• The 6-month period is fixed and non-extendable
• The laboratory must demonstrate that all regulatory conditions have been strictly adhered to.

 

Voir notre pratique en matière de brevet pharmaceutique et réglementation du médicament.

Extension pédiatrique : ce qu’il faut retenir

L’extension pédiatrique récompense la réalisation d’un plan d’investigation pédiatrique approuvé. Ainsi, le titulaire obtient six mois de protection supplémentaire sur le supplementary protection certificate, même si les résultats des études ne conduisent pas à une indication pédiatrique. Toutefois, la demande d’extension pédiatrique obéit à des délais stricts, et son octroi est fréquemment contesté par les génériqueurs. Par conséquent, la date d’expiration effective d’un médicament doit toujours être vérifiée en tenant compte de cette extension. Voir notre page brevet pharmaceutique et CCP et le règlement sur le site de l’European Medicines Agency.