Paedriatric extensions: note on Merck

Writing in the Oxford University Press monthly Journal of Intellectual Property Law & Practice 2009 4: 457-459, Professor Dr Ulrich M. Gassner has produced a helpful note, "Paediatric extensions: the requirement of a compliance statement", on the decision in Merck and Co., Inc. [2008] BL O/035/08, UK IPO, 6 February 2009 (see also the posting on The SPC Blog here). According to the abstract,

"Taking a narrow interpretation of what is meant by a statement indicating compliance with an agreed completed paediatric investigation plan (PIP), the UK Intellectual Property Office has held that a valid application for a paediatric extension must include an authorization containing such a statement and that therefore a positive opinion of the Paediatric Committee of the EMEA, as such, is not suitable as a means to meet this requirement".

The SPC Blog is taking steps to get permission from the publishers to make this note available to its readers.