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

Wednesday 30 July 2008

70 positives for PDCO in first year of operation

Writing in Pharma Times Peter Mansell reports that, in its first year of operation, the European Medicines Agency’s Paediatric Committee (PDCO) received 233 applications (covering 420 indications), adopting 70 positive opinions on paediatric investigation plans (PIPs) and waivers from these requirements, but only one negative one. 61% of these decisions were for as-yet unlicensed products.

Under Regulation 1901/2006 companies seeking approval for a new medicinal product, a new indication, route of administration or pharmaceutical form of an existing patent-protected drug must submit a PIP which spells out how they they propose to develop the drug for the various subsets of the paediatric population. If the proposal is approved, the drug's supplementary protection certificate will secure a six-month extension.

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