A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday, 18 December 2009

Paediatric extensions: a major article

"Fostering paediatric research and the right to extend supplementary protection certificates" is the title of a ten-age article in the Journal of Intellectual Property Law & Practice (JIPLP). The authors are Montserrat López-Bellosta and Ana Benetó Santa Cruz (both of Clifford Chance). The online version of this article has been available to JIPLP subscribers since 10 December and the paper version will soon be available too.

According to the article's abstract,
"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".

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