In brief, Pfizer applied for and was granted a paediatric extension for Atorvastatin (Lipitor). Dr Reddy's challenged the grant of the paediatric extension on three grounds:
(1) The European Medicines Agency (EMA) acted ultra vires it powers under the Paediatric Regulation by approving a paediatric investigation plan (PIP) that let Pfizer to defer completion of the third of its three required studies. The circumstances in which studies in a PIP may be started but not finished are expressly defined by the Regulation and must be covered by a deferral under Article 20. No such deferral was applied for by Pfizer or granted in this case. Accordingly, the PIP was not lawfully approved under the Paediatric Regulation and Pfizer was therefore not entitled to the extension.
(2) Under Article 45(3), a paediatric extension should be granted only when significant studies contained in the PIP have been completed. Here, none of the relevant bodies made an assessment as to whether either of the two studies which had been completed was significant; and, on the facts, they were clearly not significant.
(3) Even if, contrary to ground (1), it was legitimate for the EMA to approve a PIP that required the initiation but not the completion of the third study, under Article 36 Pfizer was not entitled to a paediatric extension unless it included, within its application for a marketing authorisation, the results of the completed third study.The learned judge dismissed all three challenges, describing the third as "misconceived", and declined to follow what seems almost standard practice these days when he decided that there was no need to make a reference to the Court of Justice of the European Union relating to the second ground.
The decision is quite long -- some 76 paragraphs -- and would have benefited from being just a little bit longer, if Roth J had added a short paragraph at the end which summarised what he actually decided.