High Court Judgment Template s16

Neutral Citation Number: [2012] EWHC 1791 (Pat)

Case No: HC 11C03027 IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION PATENTS COURT

Royal Courts of Justice Strand, London, WC2A 2LL

Date: 28/06/2012

Before :

MR JUSTICE ROTH ------Between :

(1) DR REDDY’S LABORATORIES (UK) LIMITED (2) DR REDDY’S LABORATORIES LIMITED Claimants - and -

WARNER-LAMBERT COMPANY LLC Defendant

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Christopher Vajda QC, Gerry Facenna and Julianne Stevenson (instructed by Innovate Legal) for the Claimants Kelyn Bacon and Max Schaefer (instructed by Arnold & Porter (UK) LLP) for the Defendant

Hearing dates: 28-29 May, 13 June 2012 ------Approved Judgment I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

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MR JUSTICE ROTH MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC Mr Justice Roth :

Introduction

1. This is an application by the Claimants for the court to make a reference in this case in advance of trial to the European Court of Justice (“ECJ”) for a preliminary ruling under Article 267 TFEU.

2. The Defendant is a major pharmaceutical manufacturer and part of the Pfizer group. It was referred to throughout the argument as “Pfizer” and I shall adopt the same nomenclature. The Claimants are, respectively, a manufacturer and distributor of generic pharmaceutical products in the UK and its Indian parent. The subject matter of the claim is atorvastatin, which is distributed by Pfizer in the UK as “Lipitor” one of its best selling products.

3. Pfizer was the patentee of a patent for atorvastatin, EP (UK) 0,247,633B1, (“the Patent”) which had the benefit of a supplementary protection certificate (“SPC”) SPC/GB97/011, which extended certain rights conferred by the Patent to 6 November 2011. Furthermore, pursuant to Regulation (EC) 1901/2006 (“the Paediatric Regulation”), a six months paediatric extension to the SPC was granted by the UK Intellectual Property Office (“UKIPO”). By this action, the Claimants seek an order that this paediatric extension be revoked.

4. The power to revoke a paediatric extension is set out in Article 16 of Regulation (EC) 469/2009. The issues in this case concern that provision and the application and interpretation of various provisions of the Paediatric Regulation to the facts.

5. I informed the parties at the conclusion of the argument that I would not accede to the application to make a reference in advance of trial. This judgment sets out my principal reasons for reaching that conclusion. Since a trial will therefore take place, it would be inappropriate to comment in detail on the various arguments that were addressed since obviously the court cannot pre-judge the outcome of that trial. It is sufficient now to explain why I consider that a reference at this stage is inappropriate although I recognise that it is very possible that the court may consider that it is appropriate to make a reference at the conclusion of the trial.

Reference to the ECJ

6. The principles which apply to the making of a reference to the ECJ for a preliminary ruling were not seriously in dispute between the parties. They may be summarised as follows:

(1) A national court may only make a reference for a preliminary ruling if a decision on the question is necessary to enable it to give judgment in the case pending before it: Art 267 TFEU.

(2) In those circumstances, a court of first instance has a discretion whether or not to make a reference. In that regard, its position is to be contrasted with that of a court from whose judgment there is no appeal: ibid. MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC (3) However, the ECJ has exclusive jurisdiction to quash an act of an EU institution. Accordingly, if a national court considers that one or more of the arguments relating to invalidity are well-founded, it cannot itself hold the act invalid but must make a reference to the ECJ for a preliminary ruling on validity: Case C-344/04 R (IATA) v Dept of Transport [2006] ECR I-403.

(4) A reference may be made at any stage of the proceedings: CPR 68.2(1). Although it is often desirable for the court first to find the facts if they are not agreed, this is not necessarily the case: a reference may be made on assumed facts: e.g. Case C-453/99 Courage v Crehan [2001] ECR I-6297.

(5) In exercising its discretion as to when to make a reference, the national court can take into account considerations of procedural organisation and efficiency, including whether significant trial cost would be avoided: Case 36/80 Irish Creamery Milk Suppliers Association v Ireland [1981] ECR 735.

(6) A reference should include all questions on which a ruling of the ECJ is required. It causes substantial additional delay and expense if the national court should have to make a further reference in the same case.

(7) Accordingly, if a reference is to be made at a preliminary stage, the court must have confidence that the factual situation can be sufficiently defined and that all the relevant legal issues have crystallised such that the questions on which a ruling of the ECJ is necessary can be framed with precision.

7. I should add that the Information Note from the ECJ on references from national courts (OJ 2009 C297/1) states, as regards the form of reference for a preliminary ruling:

“20. …It is only the actual reference for a preliminary ruling which is notified to the interested persons entitled to submit observations to the Court, in particular the Member State and the institutions, and which is translated.

21. Owing to the need to translate the reference, it should be drafted simply, clearly and precisely, avoiding superfluous details.

22. … The order for reference must be succinct but sufficiently complete and must contain all the relevant information to give the Court and the interested persons entitled to submit observations a clear understanding of the factual and legal context of the main proceedings. In particular, the order for reference must:

- …

- explain the reasons which prompted the national court to raise the question of the interpretation or validity of the European Union law provisions, and the relationship between those provisions and the national provisions applicable to the main proceedings; MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC - include, if need be, a summary of the main relevant arguments of the parties to the main proceedings.”

Summary

8. 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.

9. 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.

Discussion

10. Fundamental to the scheme of the Paediatric Regulation is a paediatric investigation plan or “PIP”. An appropriate PIP has to be approved by the European Medicines Agency (“EMA”), following the advice of its Paediatric Committee (“PDCO”). Here, the PIP was approved by the EMA in a decision of 20 July 2008, which was published pursuant to Article 25.1

11. In broad outline, under the regime of the Regulation, a paediatric extension is generally applied for following an application for market authorisation, including an authorisation for a paediatric indication or a new pharmaceutical form of a product covered by an existing SPC. The applicant is entitled to a paediatric extension if the application “includes the results of all studies conducted in compliance with an agreed paediatric investigation plan”: Article 36(1). Further, Article 45(3) provides:

1 All references, save as otherwise indicated, are to the Paediatric Regulation. MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC “…The rewards and incentives of Articles 36, …shall only be granted provided that significant studies contained in an agreed Paediatric Investigation Plan are completed after the entry into force of this Regulation.”

12. The Claimants essentially contend that on the proper construction of the Regulation, the PIP that was approved in the present case was not a lawful PIP since one of the three studies which it encompassed had only to be initiated and not completed; and that the decision of the EMA approving the PIP was therefore invalid. Accordingly, since Pfizer complied with only an invalid PIP, there was no lawful basis for the grant of the paediatric extension. Further, as regards the two studies which were completed at the time of the application, there was no substantive determination by any competent body that either of them was significant and thus the requirement of Article 45(3) was not complied with.

13. The Defendant contends, inter alia, that there is no such requirement that all the studies must be completed for a PIP to be valid; and further that Article 45(3) is irrelevant in this case as it is only a transitional provision which has no application here since the paediatric studies were all initiated after the entry into force of the Regulation.

14. If those were the only issues between the parties, I can see that there might be considerable advantage in making a reference to the ECJ in advance of trial, although I would still wish to hear argument on the issue of the application of Article 45(3), especially as in its Guideline published pursuant to Article 45(4), the Commission clearly takes the view that this is indeed only a transitional provision, as Pfizer contends.

15. However, those issues of interpretation of the Regulation are by far not the only arguments advanced by Pfizer and rebutted by the Claimants. Pfizer raised a large number of grounds of opposition to this claim, to which the response by the Claimants was only clarified by submissions in the course of the hearing (no Reply had been served), to which in turn Pfizer wished to reply. Thus I did not feel satisfied that all the legal arguments as between the parties had been fully raised or identified and that a trial would serve no useful purpose when considering a reference. In this judgment, I give only three examples:

(a) Pfizer contends that if, contrary to its primary submission, it was not lawful to include within a PIP a study that was only to be initiated and not completed by the time of the application for a paediatric extension, then in circumstances where the third study was included in the PIP only as a form of post- authorisation requirement that could have been imposed under Article 34, that element of the PIP can be severed. I can see considerable force in Mr Vajda’s response that if there is any possibility of severance of the act of an EU institution, such severance can be determined only by the ECJ and not by a national court. But although he submitted strongly that this was a question to be determined by the ECJ on the basis of the documents, I consider that the ECJ may be assisted by findings by the national court as to the manner in which the third study came to be included in the PIP. That is a question of fact, and despite Mr Vajda’s argument that it would be difficult or unsatisfactory for this court to make any findings in the absence of evidence from the EMA, I was not MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC persuaded that no useful findings can be made in that regard. If that is so, the procedures before this court are clearly more suited to the exploration of detailed factual evidence than those of the ECJ on a reference under Article 267 TFEU.

(b) As to Article 45(3), if it does apply in this case, Pfizer contends that one of the two completed studies was found to be significant as recorded in the marketing authorisation granted by the Medicines and Healthcare Products Regulatory Agency (“MHRA”), in its statement made for the purpose of Article 28(3), which is determinative for the purpose of Article 36. The Claimants responded that the MHRA relied on the opinion of the Committee for Medicinal Products for Human Use of the EMA, as reflected in the decision of the Commission of 1 July 2010 (“the Commission Decision”). However the EMA made no substantive determination that either study was significant, nor did it give any reasons for that view. This raised the question of what was meant by the statement in the PDCO Opinion of 13 November 2009 that the second study in the PIP “could be considered significant”, and what assessment had been carried out to reach that conclusion.

The question whether the EMA made any substantive determination of significance should, if possible, be subject to determination in advance of any reference being made to the ECJ. It is a question of fact and could have a significant influence on the shape of the argument, and hence on the form of any question that might be posed in that regard to the ECJ. It is undesirable simply to wait for the EMA to put in its observations to the ECJ, of which the parties would have no knowledge at the time when they had to submit their observations, for this information to emerge only then.

I note that in response to an enquiry from the Claimants’ solicitors, the MHRA stated on 2 December 2011 that it did not carry out an assessment of compliance with the PIP but relied on the assessment performed by the EMA. Despite the express suggestion by the MHRA in that response, no approach was then made to the EMA to ask them to clarify the position. That now can (and should) be done, and I would hope that the EMA will be able to provide a substantive response clarifying the facts in advance of trial.

(c) I consider that the role of the Commission Decision, which was given under the centralised referral procedure of Article 29, and in effect fed into the MHRA authorisation decision which included the statement of significance under Article 28(3), needs to be explored more fully than in the rather abbreviated submissions on this application. It became evident that this was a matter of serious dispute between the parties.

16. Aside from those aspects, it is important to recognise that the substantive relief sought in these proceedings is an order revoking the decision of the UKIPO to grant the paediatric extension to the SPC. As I stated above, the jurisdiction to make such an order lies under Article 16 of Regulation (EC) 469/2009 which provides:

“1. The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of [the Paediatric Regulation]. MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC 2. Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.”

17. Ms Bacon asserted that this gives a discretion to the national court and, in the present case, even if the other grounds of the Claimants’ case are made out revocation should be refused on the basis of the principles of legitimate expectation and legal certainty. Ms Bacon sought to argue that Pfizer could rely on these principles as a matter of domestic law, in addition or in alternative to those principles under EU law. I am not sure that there is in fact a significant difference between them, and in any event my provisional view is that for the application of a provision of an EU regulation it is the EU principles that would apply. Mr Vajda accepted that the EU principles of legitimate expectation and legal certainty could form a ground to refuse revocation. But he argued that the application of those principles to the facts of the case was for the ECJ and not for the national court. He did not shrink from the implication of this argument that this effectively meant that the decision on revocation would be taken by the court in Luxemburg rather than the court in London. He argued that this was necessary so as to achieve uniformity as regards the validity of the paediatric extension across the EU.

18. This issue essentially arose in the course of Mr Vajda's reply, to which Ms Bacon therefore had no opportunity to respond, but I consider that the Claimants’ position is far from self-evident. It should be remembered that the paediatric extension at issue is to the SPC for the UK designation of a European patent. But as Jacob LJ has pointed out, the notion of a “European patent” under the current regime is a misnomer since in reality the grant by the European Patent Office leads to a series of national parallel patents any of which can be independently challenged on the basis of validity in the respective national court: see Unilin Beheer BV v Berry Floor NV [2007] EWCA Civ 364, [2007] Bus LR at [9]-[18]. Just as the national court can make a determination that the national patent reflecting a European patent is to be revoked as invalid, without thereby abrogating the underlying European patent, so also may the national court have jurisdiction to revoke a nationally granted paediatric extension, albeit that this grant is founded on decisions taken by the EU institutions. On that basis, it may be that there is no requirement for a ‘centralised’ decision by the ECJ.

19. I should emphasise that I am not expressing the view that this is the correct interpretation, only that this is a possible construction having regard to the underlying patent regime, and that the matter requires full argument. It is possible that this may itself give rise to a question for reference to the ECJ concerning the interpretation of Article 16 of Regulation (EC) 469/2009, although it did not feature expressly in the Claimants’ fourth draft since the point only crystallised, as I have mentioned, in the course of Mr Vajda’s submissions. On the other hand, this court may consider after full argument that it can resolve this issue to its satisfaction without a reference and that Pfizer’s view is correct. If so, then as the principles of legitimate expectation and legal certainty are well established, this court might conclude that irrespective of the potential invalidity of the EMA decision as regards the content of the PIP or the Commission Decision, it would be inappropriate on the facts to revoke the paediatric extension here. In those circumstances, no reference to the ECJ would be necessary to decide this case. MR JUSTICE ROTH Approved Judgment Dr Reddy’s Laboratories (UK) Ltd & anr v Warner-Lambert Co LLC 20. Finally, I appreciate that the making of a reference in this case before rather than after trial might save costs and time. For example, if the ECJ ruled that Article 45(3) was a transitional provision, as Pfizer contends, then several other significant issues would fall away. However, the trial in this case can be held in about six months’ time, as anticipated in an order agreed, but inadvertently not drawn up, last January. Further, since I will exclude from the scope of that trial Pfizer’s additional argument that the two studies completed under the PIP in fact satisfied the criteria for significance that apply under Article 45(3), since that is a discrete issue, would require substantial and detailed factual evidence, and can sensibly be postponed, such a trial should last no more than three to four days. Accordingly, this is not a situation where either significant delay or, by the standards of IP litigation, very substantial additional costs would be avoided by making a reference at this stage.