(1) Dr Reddy’s Laboratories (UK) Limited (2) Dr Reddy’s Laboratories Limited v. Warner-Lambert Company LLC, Patents Court, Chancery Division, High Court of Justice, London, UK, 28 June 2012,  EWHC 1791 (Pat)
The Patents Court rejected Dr Reddy’s application for the Court to make a reference to the European Court of Justice (CJEU) in advance of the trial for a preliminary ruling under Article 267 TFEU regarding Regulation (EC) 1901/2206 (“the Paediatric Regulation”).
Pfizer (of which Warner-Lambert is a part ) was the proprietor of a patent, EP (UK) 0 247 633 B1, for atorvastatin, a statin marketed under the trade name LIPITOR. Pfizer also had the benefit of a supplementary protection certification, SPC/GB97/011, and a six month paediatric extension under the Paediatric Regulation. Dr Reddy’s applied to revoke the paediatric extension and applied for the Court to make a reference to the CJEU in advance of the trial for a preliminary ruling under Article 267 TFEU regarding the Paediatric Regulation.
Dr Reddy’s argued that the paediatric investigate plan (PIP) that was approved for Pfizer’s paediatric extension was not a lawful PIP because one of studies included had not been completed and so the approval was invalid. Pfizer argued that it was not necessary for all studies to be completed for a PIP to be valid under the Paediatric Regulation. Pfizer also raised a number of further arguments as to why it was not appropriate to make a reference to the CJEU in advance of the trial.
Mr Justice Roth held that it would be inappropriate to make a reference before the trial as it was possible the case could be resolved without a reference being necesssary. Furthermore, given the trial could take place in about six months' time, it was not a case where either significant delay or very substantial costs would be avoided by making a reference at this stage of the proceedings.
Read the judgment (in English) here.
Head note: Robert Fitt