What are “Paediatric Extensions”, and are they included in the EPO INPADOC legal status database?
A supplementary protection certificate (SPC) has a life span of five years after the expiry of a 20 year patent for medicinal products and plant protection products.(See our FAQ on SPCs) SPCs may be extended for a further six months as paediatric extensions if they relate to products that undergo clinical testing in accordance with the regulations laid down by the European Parliament: Regulation 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC, and Regulation (EC) No 726/2004 . A unified application across Europe cannot be filed because applications for paediatric extensions must be filed and approved on a country-by-country basis. Currently data is available for the United Kingdom (GB), Ireland (IE) and France (FR) and are extracted from their Gazettes.
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