Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC, 20 December 2012, Patents Court, UK, Case No. HC 11C03027
This is a UK decision clarifying certain provisions of Regulation (EC) 1901/2006 (the “Paediatric Regulation”) which applies in relation to the grant of a six month extension to Supplementary Protection Certificates (SPCs), and of Regulation (EC) 469/2009 (the “SPC Regulation”). The Court held that deferrals under the Paediatric Regulation can be requested on the ground where the safety of the product was a concern, or the paediatric study would have caused the delay in the authorisation for adults. Further, Article 45(3) of the Paediatric Regulation is transitional in nature and has no application in cases where all the studies included in a paediatric investigation plan were initiated after the regulation came into force on 26 January 2007.
The Court also clarified that Article 16 of the SPC Regulation grants discretion to national bodies whether or not to revoke an extension if the conditions of Article 36 of the Paediatric Regulation are not met.