Journal Article

Paediatric extensions: the requirement of a compliance statement

Ulrich M. Gassner

in Journal of Intellectual Property Law & Practice

Volume 4, issue 7, pages 457-459
Published in print July 2009 | ISSN: 1747-1532
Published online May 2009 | e-ISSN: 1747-1540 | DOI:
Paediatric extensions: the requirement of a compliance statement

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  • Arbitration
  • Intellectual Property Law


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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.

Journal Article.  1384 words. 

Subjects: Arbitration ; Intellectual Property Law

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