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England and Wales Court of Appeal (Civil Division) Decisions |
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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> The Secretary of State for Health & Anor v Servier Laboratories Ltd & Ors [2019] EWCA Civ 1096 (27 June 2019) URL: http://www.bailii.org/ew/cases/EWCA/Civ/2019/1096.html Cite as: [2020] 1 All ER (Comm) 402, [2019] ECC 27, [2019] 5 CMLR 16, [2020] 1 All ER 432, [2019] EWCA Civ 1096, [2020] 2 WLR 149, [2019] WLR(D) 366 |
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A3/2019/0986 A3/2019/0987 |
ON APPEAL FROM THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
MR JUSTICE ROTH
Strand, London, WC2A 2LL |
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B e f o r e :
LADY JUSTICE ROSE
and
SIR STEPHEN RICHARDS
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Between: |
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THE SECRETARY OF STATE FOR HEALTH & ANOTHER |
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and (1) SERVIER LABORATORIES LIMITED (2) SERVIER RESEARCH AND DEVELOPMENT LIMITED (3) LES LABORATOIRES SERVIER SAS (4) SERVIER SAS And Between THE SCOTTISH MINISTERS & NORTHERN IRISH MINISTERS and (1) SERVIER LABORATORIES LIMITED (2) SERVIER RESEARCH AND DEVELOPMENT LIMITED (3) LES LABORATOIRES SERVIER SAS (4) SERVIER SAS And Between: THE WELSH MINISTERS & OTHERS and (1) SERVIER LABORATORIES LIMITED (2) SERVIER RESEARCH AND DEVELOPMENT LIMITED (3) LES LABORATOIRES SERVIER SAS (4) SERVIER SAS |
Claimant/ Respondent Defendants/Appellants Claimants/ Respondents Defendants/ Appellants Claimants/ Respondents Defendants/ Appellants |
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Robert Palmer QC and Julian Gregory (instructed by Reynolds Porter Chamberlain LLP) for the Scottish Ministers
Robert Palmer QC and Laura Elizabeth John (instructed by Geldards LLP) for the Welsh Ministers
Robert Palmer QC and David Drake (instructed by Peters & Peters Solicitors LLP) for the Secretary of State for Health)
Hearing date : 18 June 2019
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Crown Copyright ©
Lady Justice Rose:
The background
i) there was no material clinical difference between perindopril and other ACE-inhibitors which had been available in generic form from late 1999;ii) the Claimants should therefore have taken all reasonable steps to encourage switching from the prescription of perindopril to the prescription of cheaper alternative ACE-inhibitors in generic form but failed to do so;
iii) accordingly the Claimants failed to mitigate their loss and/or those events broke the chain of causation and/or rendered any damage too remote.
"1374. In that regard, it must be borne in mind that, according to settled case-law, although the EU judicature undertakes a comprehensive review of the question as to whether or not the conditions for the application of the competition rules are met, the review of complex economic appraisals made by the Commission is necessarily limited to checking whether the relevant rules on procedure and on stating reasons have been complied with, whether the facts have been accurately stated and whether there has been any manifest error of assessment or a misuse of powers …
1375 The Court of Justice has held that whilst, in areas giving rise to complex economic assessments, the Commission has a margin of discretion with regard to economic matters, that does not mean that the Courts of the European Union must refrain from reviewing the Commission's interpretation of information of an economic nature. Those Courts must establish, among other things, not only whether the evidence relied on is factually accurate, reliable and consistent but also whether that evidence contains all the information which must be taken into account in order to assess a complex situation and whether it is capable of substantiating the conclusions drawn from it …
1376 Moreover, it should be pointed out that, according to settled case-law of the Court of Justice, in the field of competition law, where there is a dispute as to the existence of an infringement, it is for the Commission to prove the infringements found by it and to adduce evidence capable of demonstrating to the requisite legal standard the existence of the circumstances constituting an infringement. Where the Court still has a doubt, the benefit of that doubt must be given to the undertakings accused of the infringement …"
i) it followed from the presentation of the basic information in the Decision that "the mode of action, main indications, contraindications and side effects of the ACE-inhibitors are similar": paragraph 1425;ii) the ATC classification system does not distinguish in any way between perindopril and other ACE-inhibitors with respect to therapeutic use: paragraph 1429;
iii) at paragraph 1481:
"In the light of all the documents in the file, it must be concluded that there is no significant difference between perindopril and the other ACE inhibitors in therapeutic terms, including in terms of efficacy and side effects. There is in the file no objective scientific evidence of the therapeutic superiority of perindopril over other ACE inhibitors. ACE inhibitors are widely perceived as substitutable by prescribers and there are numerous medicinal products regarded by doctors as therapeutic equivalents to perindopril. Accordingly, the Commission erred in considering that the ACE inhibitor class was heterogeneous and that perindopril exhibited particular therapeutic characteristics within that class of medicinal products."iv) it was not apparent from the documents in the file that the other ACE-inhibitors raised particular concerns on the part of prescribers relating to their side-effects or reduced efficacy. Since doctors did not regard ACE-inhibitors as heterogeneous, the Commission's analysis as regards any risks associated with switching was "called into question": "In the absence of differences in efficacy and tolerance between ACE inhibitors, it has not been established that switching between ACE inhibitors raised particular concerns on the part of doctors": (paragraph 1519).
"1540. It follows from the foregoing that the Commission underestimated the propensity of patients treated with perindopril to switch treatment, relying, moreover, on the erroneous assumption of the heterogeneity of medicinal products in the ACE-inhibitors class. It is apparent from the documents in the file that treatment switching of patients commencing treatment with perindopril is significant over a period of five years, which calls into question the average length of treatment as assessed by the Commission and the significance of the lock-in effects of perindopril's patient base."
" … the prescribing behaviour of doctors was not characterised by a high degree of 'inertia' and treatment switching by continued-use patients was significant. It is therefore on the basis of erroneous assumptions liable to vitiate its analysis that the Commission considered that the potential impact which the promotional activities of producers of other medicinal products had on sales of perindopril should be regarded as particularly limited."
"1589. In the present case, at the end of the overall assessment of the elements on which the Commission based its assessment and of the examination of the applicants' complaints, it must be concluded that the Commission made a series of errors in the analysis of the definition of the relevant market. The Commission:
- wrongly considered, with regard to therapeutic use, that ACE inhibitors were a class of heterogeneous medicinal products and that perindopril had particular characteristics within this class of medicinal products;
- wrongly concluded that a mechanism of doctors' 'inertia' had significantly restricted the competitive pressure exerted on perindopril by the other ACE inhibitors with respect to new patients;
- underestimated the propensity of patients treated with perindopril to switch treatment;
- failed to give due consideration to the companies' promotional activities and their significance in the analysis of competitive relationships;
- disregarded the particular characteristics of competition in the pharmaceutical sector, erroneously inferring from an analysis of natural events based primarily on price changes that perindopril was not subject to significant competitive pressures from other ACE inhibitors.
1590 By relying on an analysis vitiated by the errors referred to above, the Commission restricted the relevant market to the perindopril compound alone, while the documents in the file show that perindopril may have been exposed to significant non-price competitive pressures from the other ACE inhibitors. In those circumstances, it must be held that the Commission's errors are such as to vitiate the result of its analysis.
1591 It must therefore be concluded, following an assessment made by the Court in accordance with the limits on judicial review … that it has not been established that the relevant product market is limited solely to originator and generic perindopril."
" … as regards Article 102 TFEU, the Court considers that it has not been established that the relevant finished product market was limited to perindopril. Since it has not been established that Servier had a dominant position … on that market…, the existence of an abuse of such a position is called into question …"
i) Would it have been reasonable or appropriate in the period between 2003 and 2009 for a clinician to prescribe another ACE inhibitor instead of perindopril in all circumstances, except where the patient was allergic to or intolerant of all alternative ACE inhibitors?ii) If not, in what circumstances would that have been unreasonable or inappropriate?
iii) Was it unreasonable for [the Claimants] to fail to take any (and if so, which) of the steps set out in paragraph 83C of the Defendants' Re-Re-Amended Defence to the English Claimants' claim or identified in the Defendants' Further Information dated 29 September 2017?
(a) the finding that there was no significant difference between perindopril and other ACE-inhibitors in therapeutic terms, including in terms of efficacy and side effects, mode of action, main indications and contraindications: see paragraphs 1425, 1429, 1481, 1519 and 1589 of the Servier Judgment.(b) the finding that ACE-inhibitors were widely perceived as substitutable by prescribers and there were many medications considered by physicians as therapeutic equivalents to perindopril: see paragraphs 1481 and 1489 of the Servier Judgment.
(c) the finding that there was no element that limited the discretion available to physicians to prescribe ACE-inhibitors other than perindopril for new patients: see paragraph 1489 of the Servier Judgment; and
(e) the findings: (i) that the Commission had not established that the prescribing behaviour of physicians was characterised by a high degree of "inertia"; and (ii) treatment changes in patients undergoing continuous treatment were significant: see paragraphs 1540 and 1544 of the Servier Judgment.
"77. … It is that finding which is inseparable from, and necessary to explain, the operative part of the judgment annulling article 6 of the Decision which found that Servier had abused its dominant position. At most, the res judicata could extend to the immediately preceding para 1590 and the conclusion that perindopril was exposed to significant non-tariff competitive pressures from other ACE inhibitors. In my judgment, there is no basis in EU law for applying res judicata erga omnes to all the myriad factual findings based on careful scrutiny of the evidence in the over 200 preceding paragraphs of section 12, or to the subsidiary conclusions in the four sub-sections of analysis of the second of the three complaints assessed by the Court in section 12, or indeed to the findings under the various heads within those sub-sections."
The main case law of the EU Courts
"insofar as the findings in question are upheld by the General Court (and by the Court of Justice in the event of further appeal) and to the extent that such findings form part of or are necessary for the operative part of the Decision".
"41. Contrary to the view taken by the Court of First Instance, the BAI v Commission judgment did not only have relative authority preventing merely new actions from being brought with the same subject-matter, between the same parties and based on the same grounds. That judgment was invested with the force of res judicata with absolute effect and prevented legal questions which it had already settled from being referred to the Court of First Instance for re-examination.
42. In the BAI v Commission judgment the Court of First Instance annulled the decision of 7 June 1995 in which the Commission held that the new agreement did not constitute State aid and consequently decided to terminate the review procedure which had been initiated in respect of the aid granted to Ferries Golfo de Vizcaya.
43. That annulment led retroactively to the disappearance of the decision of 7 June 1995 with regard to all persons. An annulling judgment of that nature thus has authority erga omnes, which gives it the force of res judicata with absolute effect (see, in particular, Case 1/54 France v High Authority [1954] ECR 1, or p. 17, 34; Case 2/54 Italy v High Authority [1954] ECR 37, at p. 55; Case 3/54 Assider v High Authority [1955] ECR 63; and Case C-310/97P Commission v AssiDomän Kraft Products and Others [1999] ECR I-5363, paragraph 54).
44 That authority is not attached only to the operative part of the BAI v Commission judgment. It is also attached to the ratio decidendi of that judgment which is inseparable from it (see, to that effect, Joined Cases 97/86, 193/86, 99/86 and 215/86 Asteris and Others v Commission [1988] ECR 2181, paragraph 27, and Commission v AssiDomän Kraft Products and Others, paragraph 54).
45 In addition, the question of the force of res judicata with absolute effect is a matter of public policy, which must, consequently, be raised by the Court of its own motion."
"the Commission should have classified the aid at issue as State aid … and that, following the annulment, it would have to reopen the review procedure in respect of that aid."
"50. In those circumstances, when the Diputación brought its application against the contested decision before the Court of First Instance that court could not re-examine the pleas alleging that the aid at issue did not amount to State aid without disregarding the scope of the BAI v Commission judgment. Consequently, in finding as it did, the Court of First Instance failed to have regard to the force of res judicata with absolute effect of its previous judgment."
"The institution whose act has been declared void or whose failure to act has been declared contrary to the Treaties shall be required to take the necessary measures to comply with the judgment of the Court of Justice of the European Union."
"26. In order to adjudicate upon the application for annulment of the Commission's refusal to act, in pursuance of the procedure initiated against it for failure to act, it is necessary first to determine what measures an institution is obliged to take under Article [266] in order to comply with a judgment of the Court of Justice annulling a measure adopted by it.
27. In order to comply with the judgment and to implement it fully, the institution is required to have regard not only to the operative part of the judgment but also to the grounds which led to the judgment and constitute its essential basis, in so far as they are necessary to determine the exact meaning of what is stated in the operative part. It is those grounds which, on the one hand, identify the precise provision held to be illegal and, on the other, indicate the specific reasons which underlie the finding of illegality contained in the operative part and which the institution concerned must take into account when replacing the annulled measure."
"54. … although the authority erga omnes exerted by an annulling judgment of a court of the Community judicature (…) attaches to both the operative part and the ratio decidendi of the judgment, it cannot entail annulment of an act not challenged before the Community judicature but alleged to be vitiated by the same illegality.
55. The only purpose of considering the grounds of the judgment which set out the precise reasons for the illegality found by the Community Court (…) is to determine the exact meaning of the ruling made in the operative part of the judgment. The authority of a ground of a judgment annulling a measure cannot apply to the situation of persons who were not parties to the proceedings and with regard to whom the judgment cannot therefore have decided anything whatever."
"87 In that regard, the Court has held, firstly, that res judicata extends only to the matters of fact and law actually or necessarily settled by the judicial decision in question (…) and, secondly, that the force of res judicata attaches not only to the operative part of that decision, but also to the ratio decidendi of that decision which is inseparable from it (…)."
"101 … That authority attaches to both the operative part and the ratio decidendi of the judgment, which provides the necessary underpinning for the operative part and is inseparable from it (see [P&O Ferries CJEU] paragraph 44 and the case-law cited).
102 Moreover, … EUIPO is required to take the measures necessary to comply with judgments of the Courts of the European Union. In that regard, it is apparent from settled case law that, in order to comply with a judgment annulling a measure and to implement it fully, the institution responsible for adopting that measure is required to have regard not only to the operative part of the judgment but also to the grounds constituting its essential basis. It is those grounds which, on the one hand, identify the precise provision held to be illegal and, on the other, indicate the specific reasons which underlie the finding of illegality contained in the operative part and which the institution concerned must take into account when replacing the annulled measure. …
103 In the present case, it must be stated that the grounds of the annulling judgment … relating to the degree of attention of the relevant public, constitute the necessary support for the operative part of that judgment. Therefore, those grounds themselves have the authority of res judicata with absolute effect and the Board of Appeal was required to comply with them."
Discussion
"In paragraphs 76 and 79 of [BAI v Commission], the Court, in assessing whether a normal commercial transaction was involved, adopted as the decisive criterion whether the agreement for the purchase of travel vouchers concluded between the Diputación and P&O Ferries reflected actual needs felt by the authorities. It found that that had not been satisfactorily established."
Sir Stephen Richards:
Lord Justice Longmore: