Dr Reddy's Laboratories (UK) Ltd & Anor v Warner -Lambert Company LLC

A first-instance court may refer a question to the European Court of Justice only where a ruling is necessary to enable judgment in the pending case. The court retains discretion as to the timing of a reference. It may defer the reference until after fact-finding where the factual position, legal arguments or precise questions have not sufficiently crystallised. Procedural efficiency and the avoidance of duplicated references are relevant considerations. A reference should be sufficiently complete and precise to identify the material facts, issues and arguments. Where a short trial can clarify the issues without substantial delay or cost, an advance reference is inappropriate.

The claimants, manufacturers and distributors of generic pharmaceutical products, applied before trial for a reference under Article 267 TFEU. They challenged the validity of a six-month paediatric extension to a supplementary protection certificate relating to atorvastatin. The proposed reference concerned the construction and application of the Paediatric Regulation, including the requirements for an agreed paediatric investigation plan, completed and significant studies, and the possible revocation of the extension under Article 16 of Regulation (EC) 469/2009.

The defendant opposed an early reference. The court had to decide whether the issues were sufficiently developed and whether a preliminary ruling was necessary before factual evidence and the parties’ full arguments had been tested.

1. Application refused. The court declined to make a reference to the European Court of Justice before trial. A reference might be appropriate after the factual and legal issues had been fully explored.
2. Under Article 267 TFEU, a reference is permissible only where a ruling is necessary to enable the national court to give judgment. A first-instance court has discretion whether and when to refer. The court may refer at any stage, including on assumed facts, but must be able to frame the questions with sufficient precision.
3. Relevant considerations include procedural organisation, trial efficiency and whether a reference would avoid significant cost or delay. The court should seek to include all questions requiring a ruling, since a further reference in the same proceedings may cause substantial additional expense and delay.
4. An early reference was inappropriate because the parties’ arguments remained incomplete and insufficiently clarified. The proposed questions had undergone repeated revision, and the hearing had approached a mini-trial of issues which would benefit from factual findings. Questions concerning severance, the significance of completed studies, and the role of the Commission Decision required fuller investigation.
5. The court also identified a possible issue concerning whether a national court could revoke a nationally granted paediatric extension and whether EU principles of legitimate expectation and legal certainty might affect that remedy. Those matters required full argument and were not conclusively determined on the application.
6. The anticipated trial was short and could take place within about six months. Since the trial would clarify the evidence and issues without substantial additional delay or cost, the balance favoured postponing any reference.