Paediatric exclusivities: a new article

Pediatric Exclusivities in Europe -- a Quest for the Grail?' is the title of an article by Geneviève Michaux (of Counsel. Covington & Burling LLC, Brussels, Belgium), which has recently been published in 64 Food and Drug Law Journal, 631-662 (2009). According to the abstract,

"This article examines the rules applicable to pediatric rewards and their interpretation by the competent European authorities, i.e. the European Commission and the EMEA, and national authorities, i.e. the national Medicines Agencies and patent offices, in particular in relation to medicinal products that are approved at the national level. Depending on the patent protection of the active substance or status of the medicinal product, the reward for pediatric development is an extension of the term of the supplementary protection certificate (“SPC,” the EU equivalent of the patent term extension) or, where the medicinal product has been designated as an orphan, an extension of the term of the market exclusivity (the EU equivalent of the orphan exclusivity). Where the active substance is not or no longer protected by a patent or an SPC, the pediatric obligation is optional and the pediatric research is rewarded by data exclusivity (the EU equivalent of market exclusivity) for the new pediatric data through the grant of a pediatric use marketing authorization (PUMA). Except for the PUMA, the pediatric rewards are subject to stringent substantive requirements, in particular the approval of the medicinal product in all the EU Member States and the so-called “PIP compliance,” i.e., the implementation of the agreed PIP".

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