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Journal of Intellectual Property Law & Practice Advance Access published online on May 12, 2009
Journal of Intellectual Property Law & Practice, doi:10.1093/jiplp/jpp074
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© The Authors (2009). Published by Oxford University Press. All rights reserved.

Current Intelligence

Paediatric extensions: the requirement of a compliance statement

Ulrich M. Gassner
University of Augsburg, Germany

Merck and Co., Inc. [2008] BL O/035/08, UK IPO, 6 February 2009

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.

Correspondence: Email: ulrich.gassner{at}jura.uni-augsburg.de


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