The Secretary of State for Health & Anor v Servier Laboratories Ltd [2016] EWHC 366 (Ch)

Case Nos: HC-2011-000064, HC-2012-000189 &

Case No HC-2012-000188

[2016] EWHC 366 (Ch)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

Venue Rolls Building, Royal Courts of Justice, Fetter Lane, London, EC4A 1NL

Date 26/02/2016

Before

MR JUSTICE HENDERSON

Between

THE SECRETARY OF STATE FOR HEALTH AND ANOTHERClaimants

(1) SERVIER LABORATORIES LIMITEDDefendants

Between

SERVIER RESEARCH AND DEVELOPMENT LIMITED

LES LABORATOIRES SERVIER SAS

SERVIER SAS

And between:

THE SCOTTISH MINISTERS AND OTHERS Claimants

Between

SERVIER LABORATORIES LIMITED Defendants

SERVIER RESEARCH AND DEVELOPMENT LIMITED

LES LABORATOIRES SERVIER SAS

SERVIER SAS

And between:

THE WELSH MINISTERS AND OTHERS Claimants

Between

(1) SERVIER LABORATORIES LIMITEDDefendants

Between

SERVIER RESEARCH AND DEVELOPMENT LIMITED

LES LABORATOIRES SERVIER SAS

SERVIER SAS

Mr Paul Lasok QC, Mr Michael Edenborough QC, Mr David Drake and Mr Philip Woolfe (instructed by Peters & Peters Solicitors LLP) for English Claimants

Mr Daniel Beard QC and Mr Julian Gregory (instructed by Reynolds Porter Chamberlain LLP) for Scottish & Northern Ireland Claimants

Ms Leigh-Ann Mulcahy QC and Ms Laura Elizabeth John (instructed by Geldards LLP) for Welsh Claimants

Ms Helen Davies QC and Ms Sarah Ford (instructed by Bristows LLP) for Defendants

Hearing Hearing dates: 26 and 27 November 2015

Judgment

Introduction

[1]On 26 and 27 November 2015 I conducted a case management conference (“CMC”) in three linked sets of proceedings in which the United Kingdom health authorities claim damages for alleged breaches of competition law against four pharmaceutical companies in the Servier group (“Servier”). I will refer to the three sets of proceedings as, respectively, the English proceedings, the Scottish/NI proceedings, and the Welsh proceedings, brought by the English claimants, the Scottish/NI claimants, and the Welsh claimants (collectively “the Claimants”).

[2]For a brief description of the nature of the proceedings, and their history down to July 2014, reference should be made to the judgment which I handed down on 31 July 2014 following the last CMC in the case which took place on 9 and 10 June 2014: see

[2014] EWHC 2720 (Ch)

at [1] to [10].

[3]Since then, various developments have taken place which I can summarise as follows:(i) Servier has appealed to the General Court of the European Union against the decision (“the Decision”) which the European Commission (“the Commission”) adopted on 9 July 2014. The appeal is comprehensive in its scope, and is unlikely to be heard before late 2017. If there were then a further appeal to the Court of Justice, it is likely that at least two further years would elapse before Servier’s challenge to the Decision in the European Courts were finally determined. Realistically, therefore, it may well be 2020 or later when the present proceedings come to trial; and the earliest feasible date for a trial, even if there is no appeal to the Court of Justice, would probably be some time in 2018 or 2019.

(ii) Much of the material contained in the Decision was (and remains) highly confidential, either to Servier or to the numerous third parties who supplied information to the Commission. Arrangements therefore needed to be made for disclosure of the Decision into a confidentiality ring, on terms acceptable to the Commission, for the purposes of the present proceedings. To that end, I requested, and obtained, an opinion from the Commission on the terms of a draft confidentiality order, and a number of changes to it were then made in the light of the Commission’s opinion dated 22 December 2014: see my judgment on the terms of the confidentiality order,

[2015] EWHC 647 (Ch)

. The confidentiality order was eventually made on 4 March 2015, and has subsequently been amended in minor respects.

(iii) The Commission has since published a provisional non-confidential version of the Decision, running to some 800 pages. A definitive non-confidential version will follow in due course.

(iv) In my judgment of 31 July 2014 I dealt with disclosure at [36] to [39]. For the reasons which I there gave, I directed that Servier’s disclosure should be limited in the first instance to a review of the documents held on the Commission’s file. My decision was influenced by the then very recent release of the Decision, after the CMC in May 2014 but before I handed down my judgment.

[4]It will help to place the matters I now have to deal with in context if I cite the main parts of my reasoning in those paragraphs of the July 2014 judgment:

“36. … It is also common ground that all the parties now need to take careful stock of their positions and pleaded cases in the light of the Decision, bearing in mind the determinative effect of matters which the Commission has now decided, at any rate as a matter of EU and domestic competition law. This process of review and reconsideration is likely to lead to both clarification and reduction of the issues in the three sets of proceedings, and this in turn will have a significant impact on disclosure. 37. In these circumstances, it seems to me that the balance now comes down firmly in favour of Servier’s proposal, which is that Servier’s disclosure should be limited in the first instance to a review of the documents held on the Commission’s file. As I have already explained, this is a substantial archive which Bristows [Servier’s solicitors] estimate to contain around 30,000 pages, reflecting the extensive searches and enquiries carried out by the Commission in the course of its investigation. Furthermore, the review and giving of disclosure from this archive will itself be a major exercise, which is likely to occupy Servier’s lawyers for several months … 38. There are three further points which encourage me to accept Servier’s proposal at this stage. First, as Ms Manley emphasised more than once in her written evidence, Servier is not saying that its disclosure should necessarily be confined to the documents on the Commission’s file, but only that in the interests of proportionality this exercise should be undertaken first. Secondly, the Scottish/NI claimants were content that matters should proceed in this way, even before the issue of the Decision. Thirdly, in at least one recent case of parallel EU and UK competition law proceedings, the English court has considered it appropriate to limit disclosure in the first instance to material already disclosed to the Commission: see Infederation Ltd v Google Ireland Ltd [2013] EWHC 2295 (Ch), [2014] 1 CMLR 13, at [37] to [38] per Roth J. 39. In the light of what I have said, I hope that the parties will now be able to agree a timetable for this first stage of the disclosure exercise, bearing in mind that it cannot start (so far as Servier is concerned) before 22 September 2014 at the earliest. Unless there are any other aspects of disclosure on which the parties consider it essential for me to give a ruling now, I think that further consideration of disclosure-related issues should be postponed until after the parties have fully digested the Decision and the issues have crystallised. Meanwhile, I emphasise the need for all parties, and Servier in particular, to take active steps to ensure that all potentially relevant documents are preserved.”

[5]By paragraph 6 of my consequential order dated 21 October 2014, Servier was directed to:

“give disclosure by list of such documents as are contained in the European Commission’s files in the parallel Commission proceedings and fall within standard disclosure in accordance with CPR 31.6, and … simultaneously provide inspection by provision of copies.”

[6]After Servier had given disclosure in compliance, or purported compliance, with that order, disputes arose about the scope and nature of any further disclosure to be given by Servier. The parties set out their views in correspondence, and Servier proposed that the next CMC (which by then had been fixed for November 2015) should be postponed. In a ruling given on 23 July 2015, I said that there were real differences of principle between the parties about the further disclosure to be given by Servier, and that those differences needed to be resolved by the court at an early stage. I therefore refused to adjourn the forthcoming CMC, and directed the parties to exchange their proposals for further disclosure by Servier in accordance with a timetable which was embodied in an order of the same date. I also directed the Claimants to produce a draft list of issues, which the parties should endeavour to agree by 13 November 2015.

[7]Servier set out its proposals for further disclosure in a letter dated 16 October 2015 to the English claimants’ solicitors, Peters & Peters Solicitors LLP. After drawing attention to the extensive information-gathering exercise already conducted by the Commission, Servier said that the only further disclosure which it would be proportionate and reasonable for Servier to give at this stage would be to provide to the Claimants:(a) those documents contained in the confidential schedule to the disclosure statement of Dr Alain Renaud dated 17 October 2006 in the Apotex proceedings; and

(b) further documents which Servier had disclosed in the Apotex proceedings in response to a Part 18 request and in correspondence between the parties. The Apotex proceedings, in the English High Court and Court of Appeal, concerned a successful challenge by a generic manufacturer of Perindopril (Apotex) to the validity of European Patent EP 1 296 947 (“the 947 patent”), in case HC06C03050: see Servier v Apotex

[2008] EWCA Civ 445

[8]The reasoning which led Servier to make this proposal was, briefly, as follows:(a) To the extent that the Claimants’ claims were premised on matters contained within the Decision, the Commission had “searched all relevant locations and identified all relevant documents for this purpose”. Servier said it did “not consider that there are any other repositories of documents which have not been searched that are likely to contain documents relevant to such matters”.

(b) To the extent that, as Servier acknowledged, the claims include certain allegations which go beyond the scope of the Decision, that is to say the alleged abuse of the patent system and the alleged tort of interference with the economic interests of the English claimants by unlawful means, in relation to which the state of mind of Servier was alleged to be relevant, Servier again considered it “to be likely that the Commission’s file also contains all the documents that are relevant to those allegations”. However, to the extent that any further relevant documents might exist which had not been disclosed to the Commission, any such documents “would have been searched for, located and disclosed” in the Apotex proceedings.

[9]This limited proposal was unacceptable to the Claimants, who set out their own much more extensive proposals in a document dated 16 October 2015. Accordingly, the main matter which I had to deal with at the CMC in November 2015 was the question of the further disclosure to be given by Servier. I heard argument on this question from Paul Lasok QC and Michael Edenborough QC on behalf of the English claimants, Daniel Beard QC on behalf of the Scottish/NI claimants, and Helen Davies QC on behalf of Servier. I also had the benefit of witness statements from the parties’ solicitors, with extensive exhibits. Counsel for the Claimants sensibly divided up the topics between them, so duplication of submissions was avoided.

[10]Apart from issues relating to disclosure, it was always recognised that the parties would need to make further amendments to their statements of case in the light of the Decision. To a large extent, these further amendments have been agreed and do not need a ruling from the court. There are, however, two categories of amendments which remain controversial. First, Servier has refused to agree substantial parts of the amendments proposed by the Scottish/NI and Welsh claimants, on the ground that they plead and rely upon the findings of the Commission in the Decision with a degree of detail which is both unnecessary and disproportionate. The same criticism is not levelled against the amendments of the English claimants, which are more concisely pleaded and Servier has accepted in full. Secondly, Servier itself, at a very late stage, applied for permission to plead a defence that the Claimants had in various ways failed to mitigate their loss.

[11]Servier’s application to amend gives rise to potentially difficult questions of fact and law, and it soon became clear at the hearing that there would be insufficient time to deal with it within the two days allotted for the CMC, quite apart from the fact that the Claimants had not had enough time to respond to it, and Servier itself had not decided whether it wished to broaden the scope of the amendments so as to plead contributory negligence and/or a breach in the chain of causation. For these reasons, I ruled on the morning of day 1 that the application should be adjourned to a separate hearing, which has now been fixed to take place in early May 2016. It was also common ground that, if Servier’s amendment application were adjourned, Servier’s related application for further disclosure against the Claimants should likewise be adjourned. It follows that the only matter upon which I now need to rule, apart from the question of further disclosure by Servier, is the disputed parts of the amendments proposed by the Scottish/NI and Welsh claimants.

[12]With this introduction, I will first consider the question of further disclosure by Servier, but before doing so I will give a brief résumé of the issues as they now stand. The issues (1). The English proceedings

[13]The following summary is intended to be uncontroversial. It is based on the helpful summary contained in the skeleton argument of counsel for the English claimants.

[14]

(a) Tort: it is alleged that Servier tortiously interfered with the English claimants’ economic interests by unlawful means, in that it procured, defended and enforced the 947 patent in the European Patents Office (“the EPO”) and the English courts in reliance on claims that it knew to be untrue or as to the truth of which it was reckless. The unlawful interference began in 2001 when the application for the 947 patent was filed, and effectively continued until 6 July 2007 when the 947 patent was found to be invalid in the Apotex proceedings. However, the allegation concerning Servier’s knowledge and/or recklessness encompasses the period before 6 July 2001, which was the date of filing of the application which resulted in the grant of the 947 patent. The factual allegations relating to Servier’s conduct are a subset of those relied on in support of the Article 102 claim below. The claim for unlawful tortious interference does not require the English claimants to prove dominance on the part of Servier in the relevant market. Moreover, this claim, being a claim under English domestic law, is not directly covered by the Decision.

(b) The Article 102 claim: Servier was, at all material times, dominant on a market for the supply of Perindopril or for the supply of ACE inhibitors in the United Kingdom, and (in the period between 2001 and 2007) abused that dominant position, in particular in that: (i) it supplied misleading information to the EPO and the English courts in respect of the 947 patent and/or it was not transparent in its provision of information and/or it failed to make prompt and/or comprehensive disclosure of information relevant to the grant of the 947 patent (“the Patent Abuse”); (ii) it entered into an agreement dated 9 November 2004 for the purchase from Azad Pharma AG of intellectual property which could have been used by other undertakings to enter the market for Perindopril (“the Azad Abuse”); and (iii) it concluded the agreements which form the subject matter of the Article 101 claim below (“the Agreements Abuse”). The Decision does not directly cover the Patent Abuse, but it does cover the Azad Abuse and the Agreements Abuse, as to which the Commission’s finding was that there had been a breach of Article 102.

(c) The Article 101 claim: in 2005 and 2006, Servier concluded agreements with several other pharmaceutical companies (“the Generic Suppliers”), which precluded those companies from challenging the 947 patent and/or from manufacturing, marketing, selling or supplying generic Perindopril in the United Kingdom. The Decision also covers the Article 101 claim, and the Commission again concluded that there had been a breach of Article 101.

[17]These allegations are all denied by Servier, whose defence, set out in full in the proposed re-amended defence dated 9 October 2015, is in outline as follows.

[18]

(a) Tort: Servier’s actions before the EPO and the English courts in respect of the 947 patent were both lawful and reasonable. In particular, Servier relies on the facts that the validity of the 947 patent was upheld before the Opposition Division of the EPO, a summary revocation application before the English Patents Court failed, and the Patents Court granted Servier interim injunctions against two companies.

(b) The Article 102 claim: Servier says that the relevant market is that for ACE inhibitors plus angiotensin receptor blockers, alternatively ACE inhibitors alone; and that Servier was not dominant on either of those markets in the United Kingdom, for reasons including but not limited to the fact that other ACE inhibitors, such as Ramipril and Lisinopril, had market shares larger than Perindopril. Further, to the extent that the Decision covers this claim, Servier points out that the Decision was addressed to the first, third and fourth defendants, but not the second defendant. As regards the Patent Abuse, Servier says that its actions before the EPO and the English courts in respect of the 947 patent were both lawful and reasonable. As regards the Azad Abuse and the Agreements Abuse, Servier denies that the agreements in question constituted an abuse.

(c) The Article 101 claim: Servier admits concluding agreements with the Generic Suppliers, but asserts that the object of the agreements was the settlement and avoidance of litigation in respect of the 947 patent. In any event, Servier says that there were other reasons why the Generic Suppliers could not have supplied generic Perindopril in the UK, including the absence of the necessary marketing authorisations and the existence of other relevant patents.

(d) Failure to mitigate: as I have indicated, Servier now wishes to contend that the English claimants failed to take reasonable steps to mitigate their loss, in two pleaded respects: (i) they failed to take reasonable steps to encourage switching to cheaper ACE inhibitors; and (ii) they failed to act expeditiously to move Perindopril into Category M of the Drug Tariff once generics were on the market in July 2007. The English claimants have consented to the amendment on the second of these grounds, but their position is that Servier should be refused permission to amend in respect of the first ground. They say that Servier has no prospect of success on the point, and if it went to trial it would require very burdensome and expensive disclosure by them. (2). The Scottish/NI and Welsh proceedings

[22]For present purposes, it is unnecessary for me to summarise the issues in the Scottish/NI and Welsh proceedings. It is enough to say that they are essentially the same as the issues in the English proceedings, with the exception of the tort claim which is pursued in the English proceedings alone. (3). The draft List of Issues

[23]The parties have reached a substantial measure of agreement on a consolidated list of issues, which is intended to be a neutral working document for use as a case management tool by the parties and the court at all stages of the case. A number of issues are shaded in red, to indicate that they have been determined by the Commission in the Decision, subject to Servier’s appeal to the EU Courts. It is common ground that the English court must determine those issues in accordance with the findings in the Decision, to the extent that they are upheld by the EU Courts. Other issues, under the heading “Misleading the patent authorities”, are shaded in blue, because the parties disagree whether they have been determined by the Decision.

[24]I have not heard detailed argument on the principles which determine the extent to which a decision of the Commission is binding on a national court, but I do not think there is any disagreement between the parties that, as a minimum, such findings are binding where they are either(i) findings in the operative part of the decision, or

(ii) findings in the preceding recitals which are necessary to support such findings: see, for example,

Case T-474/04

Pergan Hilfsstoffe v Commission,

[2007] ECR II-04225

, at paragraph 52 of the judgment of the Court, and the cases there cited. Moreover, even the binding parts of a decision are only binding in a national court on the parties to whom the decision was addressed: see the Pergan case at paragraphs 73 and 77.

[25]On any view, it is hard to see how the binding effect of the Decision in the present case could extend to issues of causation of loss and damage, and quantification of loss and damage, as a result of the breaches of Articles 101 and 102 which the Commission has found to be established. None of these issues is shaded in blue in the draft list of issues. As currently formulated, they read as follows:

“Causation of loss and damage 12. Did the Claimants suffer any loss and damage as a result of Servier’s conduct leading to them incurring increased reimbursement costs? In particular, in the absence of Servier’s conduct: Date of Generic Entry: (a) When would generic Perindopril have begun to be marketed, for dispensing pursuant to generic prescriptions? Effect on open prescribing rates: (b) Would NHS prescribers have issued generic prescriptions for Perindopril to a greater extent than they actually did? Reimbursement prices: (c) Would the aggregate reimbursement price payable have been lower than the reimbursement price that was in fact payable in connection with prescriptions for Perindopril, and, if so, to what extent? In particular: (i) What would the market entrants’ prices have been? (ii) Would Servier have reduced the price at which it supplied Perindopril (whether Coversyl branded or generic) to dispensing pharmacists in response to competition from generic alternatives? If so, how and to what extent? (iii) To what extent would market entrants have captured Perindopril sales? (iv) Would the reimbursement price of Perindopril have fallen? If so, to what level, and how quickly? 13. Did Servier’s conduct affect imports into the UK? 14. Have the Claimants incurred financing costs as a result of being overcharged on their Perindopril reimbursements? Quantification of loss and damage 15. What is the quantum of the Claimants’ loss? In particular: (a) What were the volumes of Perindopril purchases that were subject to the Claimants’ reimbursement obligations? (b) What would the cost of reimbursement for those volumes have been, in the absence of Servier’s conduct? (c) If the Claimants incurred financing costs (issue 14 above), what is an appropriate measure of this loss (i.e. at what rate should compound interest be determined)? 16. What is the appropriate rate of interest to be applied to those losses?”

Date of Generic Entry: Effect on open prescribing rates: Reimbursement prices:

Quantification of loss and damage

[26]Paragraph 17 of the draft list of issues then itemises a number of issues relating to limitation, including the question whether Servier deliberately concealed its entry into the agreements with the Generic Suppliers and/or its other allegedly abusive conduct.

Further disclosure by Servier

[27]Against this background, the Claimants’ basic submission is that the limited further disclosure now offered by Servier is clearly inadequate. In their skeleton argument, counsel for the English claimants identify four main outstanding areas of concern which underlie the detailed heads of relief sought in the draft order annexed to their application notice dated 19 November 2015.

[28]First, disclosure of relevant documents from the Commission file and the Apotex proceedings only is insufficient in respect of:(i) the factual allegations that found the English claimants’ economic tort claim;

(ii) the Article 102 Patent Abuse claim; and

(iii) all issues of causation and quantum of the Claimants’ loss. None of these points was in issue in the Apotex proceedings, nor were they decided by the Commission in the operative section of the Decision. The most that can be said is that the Commission did make some limited and indicative findings about the likely effect of the anti-competitive conduct that it had found.

[29]Secondly, the Claimants seek an order that Servier be required to give “train of enquiry” disclosure in respect of a limited class of documents which are relevant to Servier’s state of mind in relation to the application for the 947 patent, and thus to the allegations of deceit and/or reckless misrepresentation.

[30]Thirdly, the Claimants seek an order requiring Servier to give certain information which is said to be necessary in order to enable the Claimants and the court to ascertain whether Servier’s disclosure is adequate, and to understand the nature of the documents disclosed.

[31]Fourthly, even disclosure of documents from the Commission’s file remains to be completed. No disclosure has yet been given of documents from the Commission’s file which originated from third parties, and which fall within the scope of standard disclosure. Any concerns on the ground of confidentiality can easily be met, say the Claimants, because any such disclosure would be into the confidentiality ring established in connection with the Decision itself. Moreover, consistently with the Court’s earlier order requiring disclosure of documents from the Commission’s file in respect of Servier’s agreements with the Generic Suppliers, Servier should now also be ordered to give disclosure of documents relating to the Azad Abuse, which is the subject of express findings in the Decision and has now been pleaded by each of the Claimants.

[32]The Claimants seek an order that Servier give standard disclosure by list in respect of(a) liability for (i) the English claimants’ claim of interference with economic interests by unlawful means, and (ii) the Claimants’ claims for breach of Article 102 TFEU which consist in the alleged abuse of the patent system; and

(b) issues of causation and quantum.

[33]In my view it is clearly appropriate to make an order for standard disclosure in those terms, and to make the order now rather than wait and see whether it is still needed after the Claimants have received and digested the limited further disclosure offered by Servier. The main reasons which lead me to this conclusion are as follows.

[34]First and foremost, all these issues lie outside the main scope of the Commission’s investigation and the Decision. The issues of causation and quantum also lie outside the scope of the Apotex proceedings. I fully accept that a considerable number of documents on the Commission’s file are nevertheless likely to be relevant to one or more of these issues, but it seems to me all but self-evident that disclosure of such documents alone would at best be partial and incomplete when compared with the requirements of standard disclosure in CPR rule 31.6.

[35]Secondly, these issues lie at the heart of the present proceedings and the concerted campaign of unlawful activity which Servier is alleged to have undertaken. The proceedings have been brought in the public interest by the health authorities of the United Kingdom, and very substantial amounts of money are claimed as damages (of the order of £250 million in the English proceedings, £24 million in the Scottish/NI proceedings, and £12 million in the Welsh proceedings). This is therefore “big money” litigation, with a public as well as a private dimension. None of the Claimants is in any sense a commercial competitor of Servier. Fair resolution of the claims in my judgment demands full standard disclosure by Servier in at least these core areas.

[36]Thirdly, the issues in category (a), which will turn to a significant extent on Servier’s knowledge and intentions, relate to events which took place many years ago, and had their origin well before 2001. As I have pointed out on several previous occasions, it is desirable that disclosure on these issues should be completed as soon as reasonably possible, so that the Claimants can complete their enquiries and obtain full witness statements from the relevant people before memories fade still further or potential witnesses die or become incapable.

[37]Allied to this is a fourth point, which is that if Servier is guilty of the kind of conduct alleged, it is unlikely to have embarked on it openly, and may well have taken steps designed to cover its tracks or disguise its true motivation. In a case of that nature, it is imperative that Servier’s disclosure on issues relating to its knowledge and intentions should be comprehensive, and in particular should include all documents which adversely affect Servier’s own case.

[38]Fifthly, the issue in the Apotex proceedings was the validity of the 947 patent, and not, at least directly, the state of Servier’s knowledge in that respect. It is true, as Ms Davies submitted, that there is likely to be a considerable overlap between those issues, but the more important point for present purposes is that in patent actions disclosure is normally restricted to the period of two years on either side of the priority date (which for the 947 patent was 6 July 2000): see CPR Part 63 rule 9, and PD 63.6. Although some earlier documents were ultimately disclosed in the Apotex proceedings, including one relating to XRPD analysis that had been carried out in 1987, the court cannot possibly be confident that all the material falling within standard disclosure on these issues under CPR rule 31.6 in the present case would have been disclosed.

[39]Finally, it is now more than four years since the commencement of the English proceedings, and more than three years since the commencement of the Scottish/NI and Welsh proceedings. Issues relating to disclosure have been under intermittent discussion since 2012, but the approaches of Servier and the Claimants remain far apart. It was reasonable and proportionate to limit Servier’s initial disclosure to documents contained in the Commission’s file, but it is now more than 18 months since the Decision was issued, and in these key areas I am satisfied the time has now come for a clear statement of the disclosure that Servier must give. I am well aware that this will place a considerable burden upon Servier, but it is a large and well-resourced organisation, and, as I have commented before, Servier has only itself to blame for the litigation caused by its unlawful conduct: see the July 2014 judgment at [32].

[40]The documents of which the Claimants seek disclosure under this heading are set out in paragraph 5 of the draft order. They fall into two categories.

(a) comprises technical documents described as follows:

“Documents containing data, analysis, descriptions of experiments or other information relating to the crystalline form, stability and/or other qualities of the tert-butylamine salt of Perindopril produced by different processes or production regimes (including different cooling rates), whether derived from X-Ray Diffraction Pattern analysis, infra-red spectrum analysis or any other analysis and whether on industrial batches for commercial supply or otherwise, including instructions to and correspondence with any third parties instructed to carry out such research on behalf of Servier, and documents evidencing the communication of and access to such information (whether in summary or detailed form) within Servier.”

Certain sub-categories of these documents are then set out by reference to five sets of experiments and analyses, together with “any similar experiments and analyses”.

[41]Category (b) consists of:

“Documents constituting or relating to submissions to regulatory authorities in relation to Perindopril (including combination products containing Perindopril), including the application documents (with any supporting expert reports, product dossiers, batch analysis data and/or experimental results), follow-up submissions and any other documents describing or setting out control procedures to verify the nature and/or form of Servier’s Perindopril product.”

[42]Paragraph 6 of the draft order then defines the “enhanced disclosure” of these two categories of documents which is sought in terms similar to CPR rule 31.5(7)(d), that is to say:

“… any documents which it is reasonable to suppose may contain information which may – (i) enable the party applying for disclosure either to advance his own case or to damage that of the party giving disclosure; or (ii) lead to a train of enquiry which has either of those consequences.”

The difference from standard disclosure lies in the inclusion of documents “which it is reasonable to suppose may contain information” which may enable the Claimants to advance their own cases, or damage that of Servier, as well as documents which may lead to “a train of enquiry” with either of those consequences. By virtue of the opening words of rule 31.5(7), before the court makes such an order it must have regard “to the overriding objective and the need to limit disclosure to that which is necessary to deal with the case justly”.

[43]In relation to this part of the case, I am not satisfied that it would be appropriate to make an order for enhanced disclosure at this stage, particularly in the very broad terms sought. The Claimants start with the great advantage of the findings of infringement already made in the Decision, and the finding in the Apotex proceedings that the 947 patent was invalid for obviousness. The disclosure now offered by Servier includes all relevant documents on the Commission’s file, as well as the disclosure given in the Apotex proceedings. That disclosure was extensive, and included (as I have said) a number of documents going back beyond the normal two year period before the priority date of the 947 patent. In addition to that, I have now said I will order standard disclosure, unlimited in point of time, in relation to the English claimants’ tort claim and the claims of all the Claimants for abuse of the patent system in breach of Article 102. In my view it would clearly be premature to order any enhanced disclosure before all of this material has been carefully analysed and considered by the Claimants. If there are still gaps in the disclosure by Servier which need to be filled, the first step should be to make appropriately focused requests to Servier’s solicitors, and only if satisfactory responses are not forthcoming would any question of enhanced disclosure arise. Considerations of cost and proportionality are always of paramount importance in the context of disclosure, and as matters now stand it is far from clear to me that it will really be necessary to go beyond the standard disclosure which I have ordered in these areas.

[44]Both sides referred me in this context to the judgment of Gloster J, as she then was, on an application for an order for enhanced disclosure in the well-known litigation between Boris Berezovsky and Roman Abramovich: see Berezovsky v Abramovich

[2010] EWHC 2010 (Comm)

. In that case, Gloster J considered that it would be “wholly inappropriate” to make an order for enhanced disclosure before standard disclosure had taken place. In particular, I respectfully agree with the following observations of Gloster J in paragraph [12] of her judgment:

“(iv) In my judgment, if any order for enhanced disclosure is to be applied for, the applications should be focused, directed at an identifiable category or class of document and linked to specific issues, not broadly aimed at the whole gamut of issues as presently is the case with the Claimant’s application. Moreover some explanation should be provided as to the nature of the enquiry envisaged. (v) The burden imposed on a party to conduct wide-ranging searches for documents which might reasonably be expected to lead to an enquiry does not simply have the consequence of imposing an increased costs burden on that party. The task is an onerous one not only because of the difficulty which may exist in identifying or defining the categories of document that may come within the ambit of such an order, and thus will have to be reviewed, but also because the decision-maker has to apply the relevant test to each document “Is it reasonable to suppose that this particular document might lead to or might advance a train of enquiry?” (vi) Moreover, if a document is not searched for or disclosed when it should have been, the consequences for a party may be serious, as he may be accused of deliberately withholding it. I take the view that if such an order is to be made in this case, then the relevant party who is being asked to conduct disclosure on such a basis, and the court before whom the application is being made, should have an appropriately clear idea as to: what documents are likely to fall within the scope of the order; to what specific issues the relevant documents to be searched on the enhanced basis relate; and what the relevant “trains of enquiry” might be. On the basis of the information presently before me, I have no way whatsoever of making an informed decision as to such matters. (vii) Moreover, I see no reason why the current timetable would not permit a further application to be made for enhanced disclosure at a later stage, once standard disclosure has taken place. By then, the parties will have a far better picture of what categories of document have been disclosed and what documents have not, and what remaining categories of documents (if any) they respectively contend should be searched and disclosed on the enhanced basis.”

[45]There are two further points which fortify me in reaching this conclusion. First, in addition to the material which I have already mentioned, there is a very large amount of material relating to the 947 patent publicly available on the EPO website. Ms Davies produced a chronological index of such documents, dating from 2001 to 2013, which apparently contain in total over 4,300 pages. Presumably a similar amount of material is also publicly available in respect of the other related patents which the Claimants wish to investigate. According to Mr Edenborough, the EPO takes a robust view on questions of confidentiality, so it is entirely possible that this archive will yield material of real assistance to the Claimants. Furthermore, since it is publicly available, there is nothing to prevent them from searching it themselves.

[46]Secondly, in relation to submissions to regulatory authorities, the English claimants have already obtained access to, and reviewed, documents submitted by Servier to the Medicines and Healthcare Regulatory Agency (“the MHRA”). These documents have revealed significant material which appears to support the English claimants’ case, as summarised in paragraph 25 of their counsel’s skeleton argument. It is true that this material also prompts some further questions, which Mr Edenborough relied upon in his submissions, but again I consider that the proportionate approach will be for the Claimants first to review the extensive disclosure already ordered by the court or proffered by Servier, and then to consider whether it is really necessary to go any further.

[47]It is convenient to deal at this stage with paragraph 7 of the Claimants’ draft order, which asks that Servier give disclosure by list of documents falling within seven specified categories. This is, in effect, an application for specific disclosure under CPR rule 31.12(2). For the reasons which I have already given in relation to the application for enhanced disclosure, I consider that this application too is premature, and subject to a few specific points which arose during the course of the hearing any such application should await completion of the standard disclosure which will now be given and the disclosure offered by Servier.

[48]As matters stand, it seems to me that the categories of documents listed in paragraph 7 of the draft order can usefully be taken as giving an indication of particular areas which the Claimants will expect Servier to cover in its standard disclosure, but it would be potentially oppressive and disproportionate to make specific orders in the terms sought before standard disclosure has been given and reviewed by the Claimants.

[49]I have mentioned that certain specific points arose in the course of the hearing, in respect of which Ms Davies said that Servier would investigate the position and give disclosure of relevant documents. Without revealing any confidential information, I think I can say safely that these areas included:(a) the manufacture of Perindopril by a company in the Servier group based in Ireland, as well as at the two sites in France of which the Claimants were previously aware;

(b) any internal documents of Servier which underlay its submissions to the MHRA or other regulatory authorities;

(c) any XRPD tests or data relating to the crystalline form of Perindopril, other than those disclosed in the Apotex proceedings; and

(d) relevant communications and/or documents passing between Servier, Solvay and Abbott Products Inc in connection with the projected manufacture, sale and distribution of Perindopril in the United States, including the application that was made to the United States Patent and Trademark Office and subsequently withdrawn by Servier. I confirm that in my opinion Servier’s standard disclosure ought to deal with each of these matters.

The fourth issue: further information requested by the Claimants

[50]Paragraph 2 of the Claimants’ draft order asks that Servier be ordered to serve a witness statement setting out, to the best of its knowledge, the following matters:

“(a) An explanation of the relevant parts of the corporate structure of the Servier group at all material times. (b) An explanation of the companies or other organisations (whether part of the Servier group or otherwise) instrumental in the research and analysis that led to the applications for, and in the applications for, [eight numbered patents, including the 947 patent]. (c) An explanation of the relevant companies or other organisations (whether part of the Servier group or otherwise) instrumental at all material times in the manufacture and quality control of Perindopril for Servier. (d) An explanation of the in-house monograph used to control the production of Perindopril, including when it was introduced, when and how (if at all) it was amended over time and at which manufacturing sites it was used. (e) An explanation of the relevant individuals, teams, companies or other organisations (whether part of the Servier group or otherwise) instrumental at all material times in the research and analysis that led to, and/or were referred to in, the applications for medicines regulatory approvals such as marketing authorisations for Perindopril. (f) An explanation of all technical or scientific analysis (including X-Ray Diffraction Pattern analysis and infra-red spectrum analysis) and experiments carried out on Perindopril by or on behalf of Servier, including analysis carried out by third parties on the instructions of Servier. (g) In respect of each company or organisation identified in response to paragraphs (b)-(d) above, whether or not, for the purposes of CPR 31.8, the Defendants will give disclosure of documents in the control of that company or organisation.”

[51]This request is really one for information, rather than disclosure, but I see no reason why the court should not consider it in the context of the CMC, and Ms Davies did not suggest otherwise. Her objection was, rather, that it was a very odd application, which appeared to seek to pre-empt a disclosure statement that Servier would be required to provide in due course, and/or explanations that would normally be provided in witness statements or expert evidence. Ms Davies also submitted that some of the information requested had already been provided, as explained by Ms Manley in paragraphs 81 to 85 of her fifth witness statement. So, for example, Servier had already disclosed a detailed and confidential company “organigram” which specified the roles of the individual entities in the group as at 30 September 1999. Ms Manley said Servier would check whether those details remained correct until 2009, and inform the Claimants accordingly. After the hearing, a further organigram as at 30 September 2009 was provided under cover of a letter dated 16 December 2015.

[52]Apart from that, Ms Manley said in respect of the requests in paragraphs 2(d) to (e) that they had been raised for the first time on 19 November 2015, only a week before the CMC. She said she would seek instructions on those points, and attempt to resolve them by way of inter-solicitor correspondence in the first instance. With regard to paragraph 2(f), she said that a certain amount of technical information had already been provided by Servier in its amended defence and in a response to a request for further information dated 23 November 2012; and that Servier would be prepared to consider what further explanation, if any, may be needed once the Claimants had reviewed the documents to be disclosed from the Apotex proceedings.

[53]In my view the information contained in the two organigrams is extremely compressed, and the Claimants are in principle justified in seeking considerably more detailed information about the relevant organisation and personnel of the Servier group than they have so far obtained. I am conscious, however, that by the time when this judgment is handed down, some three months will have elapsed since the date of the hearing in late November 2015. Unless the Claimants’ requests in paragraphs 2(a), (b), (c), and (e) have by then been answered in correspondence to the reasonable satisfaction of the Claimants, I would propose to order the production of a witness statement by Servier dealing with those matters in sufficient detail to make its disclosure intelligible, and to satisfy both the Claimants and the court that enough is known about Servier’s internal organisation and procedures to enable the Claimants to complete their reasonable investigations and prepare for trial. I am not, however, minded at this stage to order the provision of an explanation of Servier’s in-house monograph, or of the technical matters included in paragraph 2(f). These matters should in my view await the completion of standard disclosure, to the extent that they cannot be resolved in the meantime through correspondence.

The fifth issue: disclosure of further documents from the Commission’s file

[54]Paragraph 3(b) of the Claimants’ draft order sets out three further categories of documents of which the Claimants seek disclosure by Servier from the Commission’s file:(a) documents originating from parties other than Servier;

(b) any submissions made by Servier to the Commission, including its response to the Statement of Objections; and

[55]I can deal with the third of these categories swiftly. Ms Davies informed me, on instructions, that although the allegations relating to the Azad Technology Acquisition had not yet been pleaded by the Claimants when Servier gave its disclosure from the Commission’s file, documents relating to that acquisition were nevertheless provided as part of Servier’s disclosure. I therefore do not think that any further order is needed, although Servier should check that, in the light of the Claimants’ pleaded case on the Azad issue, there are no further relevant documents on the Commission’s file of which disclosure should be given.

[56]As for Servier’s response to the Statement of Objections served by the Commission, I agree with Mr Beard (who presented this part of the case for the Claimants) that it is plainly relevant and should be disclosed. Similarly, the Statement of Objections itself should be disclosed, if only so that the Claimants and the court can see what it was to which Servier was responding. These documents were in my view analogous to pleadings, and although extensive reference is made in the Decision to the contentions advanced by Servier on the matters covered in the Decision, it remains relevant to see precisely how Servier stated its case, both in relation to matters covered in the Decision and in relation to matters which, for whatever reason, the Commission decided not to pursue.

[57]A related question is how far Servier should give disclosure of the numerous requests for further information made by the Commission, and of Servier’s responses to those requests. To a large extent this is no longer controversial, because Servier has now stated its willingness to disclose relevant material provided in response to such requests, subject to appropriate protection for confidential information. Ms Davies confirmed that Servier’s lawyers were planning to review the requests for further information, and disclosure would be given of the relevant material. She did not accept, however, that the requests were inherently relevant documents, so that they should all automatically be disclosed regardless of their connection to the issues in the present proceedings. On this point, I agree with Ms Davies that it is not self-evident that every request for further information made by the Commission will be relevant to the issues in the present case. Some of the requests, for example, may have related to purely procedural matters. I think, therefore, that Servier should be left to complete the task on which it has now embarked, of providing such disclosure as it considers relevant from the requests and Servier’s responses to them. If the Claimants are dissatisfied with this, they should seek to resolve their concerns in correspondence in the usual way, and in due course it may be necessary to make an application for specific disclosure. What I am not prepared to do at this stage is to assume, in the Claimants’ favour, that every single request, and the whole of Servier’s response to each request, are relevant to the issues in the present case.

[58]I now turn to the third category of documents, namely those originating from parties other than Servier. There are two issues here, the first of which is whether Servier was obliged to give disclosure of third party documents pursuant to the order which I made on 21 October 2014: see paragraph [5] above. The answer to this question must be affirmative, because the order contained no exclusion of documents emanating from third parties, and even if those documents were supplied to the Commission in confidence, or contained confidential material, confidentiality is not in itself a sufficient reason to refuse disclosure in domestic English proceedings: see generally Science Research Council v Nassé

[1980] AC 1028

(HL), especially per Lord Wilberforce at 1065 to 1067. On the other hand, Ms Davies fairly pointed out that the only disclosure from the Commission’s file which Servier had offered to give was of material which Servier itself had provided to the Commission, and that disclosure of documents provided by third parties would have involved precisely the same considerations of confidentiality as disclosure of the Decision itself, which led in due course to my request for an opinion from the Commission and the establishment of the confidentiality ring. There was no discussion of any of those questions before the order of 21 October 2014 was made, and I suspect it did not occur to anybody that the disclosure in fact ordered was in this important respect different from the disclosure which Servier had said it was willing to give. It is only with the benefit of hindsight that the difference is obvious. For these reasons, I do not think it is helpful for the Claimants to criticise Servier for failing to comply with the order as actually made, and the real question is what protection should now be put in place so as to enable disclosure by Servier of relevant third party documents from the Commission’s file. That is the second issue which I need to consider.

[59]Fortunately, the answer to it is in my judgment straightforward. Full account was taken of the interests of third parties in my correspondence with the Commission regarding disclosure of the Decision, and in formulating the detailed terms of the confidentiality ring. I do not consider that any further, or different, protection is needed in relation to the underlying third party documents which were provided to the Commission, and the concerns which the Commission has raised will in my view be fully met if those documents, like the Decision itself, are disclosed into the confidentiality ring. Ms Davies confirmed Servier’s willingness to give disclosure of such documents, provided that the question of confidentiality was adequately addressed. She also confirmed that, if I took the view that the existing confidentiality ring was adequate for that purpose, Servier would not argue that any further protection was needed. That is accordingly the order which I will make.

The disputed amendments to the Particulars of Claim of the Scottish/NI and Welsh Claimants

[60]In order to understand the nature of this dispute, it is helpful to make a comparison between the way in which the Decision is pleaded and relied upon(a) in the re-re-re-amended Particulars of Claim of the English claimants, which are not challenged by Servier, and

(b) in the proposed amended Particulars of Claim of the Scottish/NI and Welsh claimants, which are challenged by Servier.

[61]The English claimants provide a concise summary of the Decision in paragraphs 45A to 45F, dealing with: the relevant markets and Servier’s dominance on them; Servier’s abuse of its dominant position by devising and implementing an exclusionary strategy, in particular through the acquisition of the Azad Technology and the entry into agreements with the Generic Suppliers, none of which were objectively justified; and the infringement of Article 101 by Servier’s entry into the settlement agreements, none of which met the conditions for exemption pursuant to Article 101(3). Paragraph 45G then says:

“The foregoing summary is without prejudice to the precise terms of the Decision, on which the Claimants will rely pursuant to Article 16 of Regulation 1/2003/EC, further or alternatively on which the Claimants will rely as evidence properly admissible before an English court. Pursuant to Article 16 of Regulation 1/2003/EC, when national courts rule on agreements, decisions or practices under Article 101 TFEU or Article 102 TFEU which are already the subject of a Commission decision, they cannot take decisions running counter to the decision adopted by the Commission.”

[62]These topics are then dealt with in more detail in the remainder of the English claimants’ particulars, and in each case the pleading states which findings in the Decision will be relied upon, by reference to the relevant paragraph and article numbers of the Decision. The English claimants do not, however, directly plead the underlying facts and matters which led the Commission to make the relevant findings. The reason for this, no doubt, is that the relevant findings will be binding upon the English court as against the first, third and fourth defendants, to the extent that they are contained in the operative articles or in the recitals which underpin them, subject only to any success which Servier may achieve on its appeal to the EU courts. Assuming that Servier’s appeal is unsuccessful, it will be enough for the English claimants to rely on the relevant findings in the Decision, and it will be unnecessary for them to plead and prove the underlying facts and matters relied upon by the Commission in making those findings. Indeed, it would be positively wrong for the English claimants to do so, because of the primacy which national courts must afford to decisions adopted by the Commission.

[63]The proposed amended particulars of claim of the Scottish/NI and Welsh claimants also contain high-level summaries of the Decision, in terms comparable to paragraphs 45A to 45G of the English claim. No objection is made by Servier to these parts of the proposed amendments. When, however, the Scottish/NI and Welsh claimants go on to deal with the issues in more detail, not only do they state the relevant parts of the Decision upon which reliance is placed, but they also plead specific facts and matters which underpin the Commission’s findings. Those facts and matters are all under appeal by Servier to the General Court. These are the parts of the proposed amendments to which Servier takes exception, not because the pleaded material is irrelevant, but rather because it has already been conclusively determined against Servier by the Decision, subject only to the outcome of Servier’s appeal. It would be entirely wasteful of time and effort, says Servier, if it had to plead in response to these allegations, when the present position is that the English court is bound by the relevant findings in the Decision. It is true that the position may change, if and to the extent that Servier’s appeal succeeds; but unless and until that happens, it would be wrong in principle to permit the relevant claimants to plead a positive case on the underlying facts and matters which support the relevant parts of the Decision. It can be seen, therefore, that Servier’s objection is essentially advanced on case management grounds, with the object, so it is said, of avoiding duplication of matters already covered in the Decision.

[64]On behalf of the Welsh claimants, who took the lead on this part of the case, Ms John made a number of points. She argued that it was paradoxical for her clients to be criticised for providing detailed particulars in support of their case, when a party is normally criticised if particulars are not provided. She pointed to the length of the Decision, and said (correctly) that the passages in dispute represented a very concise distillation of matters which the Commission had treated at far greater length. She argued that it was relevant to the proper pleading of the case to understand which parts of the Decision were accepted by Servier as binding, and which of the specified recitals provided necessary support for them.

[65]Ms John’s next point was that it is unsafe to assume that, if Servier’s appeal were successful, it would necessarily provide a conclusive answer to the relevant underlying issues. It is clear from the summary of Servier’s appeal to the General Court in the Official Journal that some of Servier’s challenges to the Decision are procedural in nature. If Servier were to succeed on those grounds alone, the Decision would be annulled, but the underlying substantive issues would remain unresolved. Furthermore, it would not place any undue burden on Servier to require it to plead its case on the underlying issues in the Welsh proceedings. Servier must know what its case is, because all of the amendments to which exception is taken are subject to the appeal to the General Court. If there are any concerns on the ground of third party confidentiality, they could if necessary be met by directing the relevant parts of Servier’s defence to be put into the confidentiality ring.

[66]Finally, submits Ms John, this is not the kind of case where the courts have criticised pleadings for being too prolix or lacking in focus. Admittedly, the English claimants have contented themselves with a more concise approach, but there is room for legitimate differences of opinion about how the Claimants’ respective cases should be formulated, and the court has at an earlier stage rejected an application that the Claimants should be jointly represented.

[67]Ms John’s submissions were adopted by Mr Beard on behalf of the Scottish/NI claimants. He emphasised the importance of identifying the recitals in the Decision upon which reliance was placed. He also submitted that the purpose of all the disputed amendments was to narrow down and clarify the issues. He accepted that, in due course, there may be room for argument about the extent to which those issues are effectively settled by the Commission’s findings, but said that in the meantime his clients wished to know what was in dispute between them and Servier. The formulation of the disputed issues was a separate question from that of the extent to which those issues may have been definitively resolved by the Decision.

[68]In her submissions in answer, Ms Davies made it clear that Servier had no objection to any of the Claimants identifying in their pleading the particular recitals in the Decision upon which they rely. She accepted that some of the apparently disputed amendments (marked for convenience in green on versions of the proposed amendments prepared by Servier) did no more than this, and were in fact unobjectionable. She identified Servier’s core objection, however, in the terms which I have already indicated. She emphasised that, where the relevant Claimants pleaded primary facts derived from the Decision, this court would ultimately be bound either by the view already taken of those facts by the Commission, which is binding unless and until displaced on appeal, or by any future decision in the European proceedings. In the event that Servier’s appeal succeeded on procedural grounds alone, the whole of the pleadings in the case would anyway have to be revisited, and the question would be more appropriately addressed at that stage. Ms Davies also submitted that it would not be a simple matter for Servier to transpose its case on the appeal into the pleadings in the present case, because different law firms and advocates are engaged in each set of proceedings, with only Ms Manley of Bristows being instructed in both. Furthermore, the appeal has been lodged in French, and there is no English translation of it.

[69]I have not found this an easy question to decide, but on balance I would accept the submissions of Servier. As a matter of case management, it seems to me that the approach of the English claimants is more conducive to the efficient conduct of the present case, and avoids the large element of duplication which is inherent in the pleading of primary facts which the Commission has already taken into account in reaching its determination. I think that the approach of the Welsh and Scottish/NI claimants makes insufficient allowance for the binding effect of the Decision, and rather than narrowing down the real issues between the parties, it would run the risk of much expensive and unnecessary duplication. With the limited information available to me, I also think it improbable that Servier’s appeal to the General Court would succeed on purely procedural grounds; and, even if that were to happen, I agree with Ms Davies that the consequential impact on the present claims would be far better dealt with after, rather than in anticipation of, the event. Nor has anybody suggested that it would be sensible or proportionate to require the Claimants to plead out in full matters covered by the Decision merely because the Decision is not addressed to the second defendant.

[70]In principle, therefore, I would uphold Servier’s main objection to the proposed amendments, and would disallow them to the extent that they go beyond identifying the parts of the Decision upon which reliance is placed, and seek to plead primary facts which support the Commission’s conclusions. With the benefit of this ruling in principle, I hope the parties will now be able to agree the extent to which the disputed amendments should be permitted.

Other matters

[71]A number of other matters were canvassed at the CMC, but I think I have now dealt with all those which required a ruling. It is common ground that the three sets of proceedings should henceforth be subject to joint directions and a joint timetable to trial, and that the Claimants must co-operate with a view to avoiding duplication in respect of all common issues at all stages of the proceedings. The parties have agreed appropriate wording to this end for inclusion in the order which I will make after this judgment has been handed down.