Journal Article

Fostering paediatric research and the right to extend supplementary protection certificates

Montserrat López-Bellosta and Ana Benetó Santa Cruz

in Journal of Intellectual Property Law & Practice

Volume 5, issue 1, pages 45-54
Published in print January 2010 | ISSN: 1747-1532
Published online December 2009 | e-ISSN: 1747-1540 | DOI: http://dx.doi.org/10.1093/jiplp/jpp187
Fostering paediatric research and the right to extend supplementary protection certificates

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Legal context

This article analyses Article 36 of EC Regulation 1901/2006 on medicinal products for paediatric use. Among the incentives for promoting paediatric research set out by this Regulation is the possibility of obtaining a 6-month extension to the Supplementary Protection Certificates, given that the conditions set out in Article 36 are met. Granting SPC extensions is reserved to the competent authorities of the EC Member States, this has led to various interpretations of Article 36.

Key points

The article discusses the interpretations of the requirements established by Article 36 for obtaining an SPC extension, concluding that the means of proving compliance with an agreed paediatric investigation plan are not limited to the statement set forth in Article 28.3 of Regulation 1901/2006, and that the required authorizations in all Member States must not necessarily have been granted on the basis of studies carried out according to an agreed paediatric investigation plan. Finally, the article analyses the moment at which an applicant should meet the requirements of Article 36.

Practical significance

The authors argue in favour of an interpretation of Article 36 that avoids introducing factors beyond applicants' control when considering whether the requirements for an SPC extension are met, and which is in line with the underlying objectives of the incentives established by Regulation 1901/2006. The compensation (obtaining an SPC extension) is for performing studies carried out according to an agreed paediatric investigation plan, not for obtaining marketing authorizations.

Journal Article.  7207 words. 

Subjects: Arbitration ; Intellectual Property Law

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