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Monday, 16 July 2012
The dispute arose over a paediatric extension for atorvastatin, where the European Medicines Agency had approved the paediatric investigation plan (PIP) without one of the three studies having been concluded. Seeking a reference for a preliminary ruling, Dr Reddy's applied for revocation.
Mr Justice Roth refused the application for a preliminary ruling. In his view, while most applications to the CJEU for a preliminary ruling involved the agreement of the parties, in this case the defendants vigorously opposed the reference and even the final draft of the questions to be referred did not appropriately express some of the questions on which the court might want to seek a ruling. Moreover, arguments of the parties had not been sufficiently developed and clarified on both sides to the point that the court could confidently frame clear, precise questions that would pinpoint the issues on which a preliminary ruling was required. It was indeed true that the court might decide to refer questions to the CJEU at the end of the trial, but at this stage it was by no means certain that such a reference would be necessary. On the financial side, this was not a situation in which the court could avoid substantial costs by making a reference ahead of the trial.