A great deal of recent debate in the patent-y parts of Europe has focused on the role of the Court of Justice of the European Union (CJEU or, in the quote below, ECJ) in furnishing preliminary rulings to the Central and Regional Divisions of the patent courts that will hear disputes relating to the unitary patent -- according to the proposals for a new patent regime that are most keenly supported by those who know least about patents in practice. In this context it's worth taking a look at the comments of a trial judge concerning the realities of referring questions to the CJEU for preliminary rulings.
The case is Dr Reddy's Laboratories (UK) Ltd and another company v Warner-Lambert Company LLC  EWHC 1719 (Ch), a Patents Court, England and Wales, decision of Mr Justice Roth of 28 June in relation to a dispute which arose over atorvastatin, a popular pharma product distributed in the UK by Pfizer (Warner Lambert being part of the Pfizer group of companies: the defendant was referred to as 'Pfizer' throughout the proceedings). The UK Intellectual Property Office had granted a six month paediatric extension to Pfizer's supplementary protection certificate, following approval of its paediatric investigation plan (PIP), which the European Medicines Agency had approved on the basis of studies supporting it. Dr Reddy's sought revocation of the paediatric extension and maintained that, on the proper construction of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products, the PIP was not a lawful PIP since one of the three studies that it encompassed had only been initiated and not completed; the PIP being invalid, there had been no lawful basis for the grant of the paediatric extension. Dr Reddy's asked the court to make a reference to the Court of Justice of the European Union for a preliminary ruling on the interpretations of Regulation 469/2009
Roth J dismissed the application. What he said at  and  is worth noting:
"There are a number of cases in which the English court has made a reference to the ECJ for preliminary ruling in advance of trial. However, in the great majority of those cases, both sides agreed to request an early reference on the basis that the case involved clearly defined issues of EU law which were likely to be conclusive at to its outcome. Here, by contrast, a reference at this stage was strongly opposed by Pfizer and the court heard two and a half days of argument simply on the question of whether it would be right at this stage to make a reference. The parties' respective submissions involved a series of sometimes elaborate arguments and counter-arguments. At times, the hearing came close to a mini-trial of the underlying issues in the case. Moreover, although the drafting of questions for a reference is often something of an iterative process, here the Claimants successively produced four versions of their proposed questions, each of which was strongly criticised by Pfizer. The final version came during the period while this application was part heard, and even that draft does not, in my view, express appropriately some of the questions on which this court may wish to seek a ruling by the ECJ. Those circumstances are not a propitious basis for the making of a reference in advance of trial.The IPKat marvels at all of this. Do all IP courts in EU Member States take the same approach on whether to refer a question to the CJEU for a preliminary ruling? They may be scope for forum-shopping if you want a reference to be made but your adversary doesn't, and you have a choice of litigating in a country where consensus on a reference is either mandatory or desired, or in another country in which the court just gets on with making the reference regardless of what the litigants prefer. Do readers have any insights?
In summary, at the conclusion of the hearing I was not satisfied that the respective arguments of the parties were sufficiently developed and clarified such that the court could with confidence frame clear and precise questions which identify all the issues on which a preliminary ruling by the ECJ may be required. Still less do I feel that it is possible, on the basis of the necessarily limited hearing, adequately to summarise all the relevant arguments of each side or to set out a sufficiently succinct statement of the material facts, so as to assist both the ECJ and any Member States considering whether to intervene in the proceedings before the ECJ. Further, although as I have stated it is very possible that the court will decide to make a reference at the conclusion of the trial, I am not convinced that such reference will be necessary, which is of course a pre-condition to the jurisdiction to make a reference at all".
|CJEU reference? A pipe-dream|
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