“Article 16(1) of Parliament and Council Regulation (EC) No 469/2009 gave a discretion to the national body (in the United Kingdom, the court) to revoke an extension to a supplementary protection certificate on the basis set out therein, but not an obligation to do so. The fact that the results of a particular study would not be available by the completion date of a paediatric investigation plan made pursuant to Parliament and Council Regulation (EC) No 1901/2006 did not render the plan unlawful and did not deprive the applicant of its right to the ‘reward’ of a paediatric extension under article 36 of that Regulation. article 45(3) of Regulation (EC) 1901/2006 was not of general application and did not apply when all the studies included in a paediatric investigation plan were initiated after that Regulation came into force.”
WLR Daily, 20th December 2012
Source: www.iclr.co.uk
