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.

 

See our practice in pharmaceutical patents and medicines regulation.

Extension pédiatrique : l’essentiel

The paediatric extension rewards the completion of an agreed paediatric investigation plan. The holder thus obtains six additional months of protection on the supplementary protection certificate, even where the results of the studies do not lead to a paediatric indication. However, the application for a paediatric extension is subject to strict time limits, and its grant is frequently challenged by generic manufacturers. The actual expiry date of a medicinal product must therefore always be checked taking this extension into account. See our page on pharmaceutical patents and SPCs and the regulation on the website of the European Medicines Agency.

---

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

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. Where the question arises in a real case, the useful moment is almost always before proceedings are issued.

Patent litigation · Unified Patent Court · Pharma case law · Tell us about your situation