High Court upholds six-month extension of patent protection for Pfizer’s drug Lipitor, granted as a reward for paediatric research

20/12/12

The High Court has dismissed a challenge brought by Dr Reddy's, a producer of generic medicines, to the six-month extension granted by the UK Intellectual Property Office to the Supplementary Protection Certificate for Pfizer's drug Lipitor (atorvastatin). The extension was granted pursuant to the European regulatory scheme designed to incentivise research into the paediatric use of medicines, set out in Regulation (EC) 1901/2006 (the "Paediatric Regulation").

Dr Reddy's argued that the grant of the extension had been contrary to the provisions of the Paediatric Regulation in a number of ways, and sought a reference to the European Court of Justice if necessary. Roth J rejected each of Dr Reddy's grounds of challenge, without referring any questions to the ECJ. (In an earlier judgment, Roth J had likewise refused Dr Reddy's application to refer a number of questions to the ECJ in advance of the trial.)

The judgment is here.