Biocom California v Illumina and Commission (Appeal - Intervention – Competition - Concentrations - Pharmaceutical industry market - Order) [2023] EUECJ C-523/23P(I)

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(Appeal – Intervention – Competition – Concentrations – Pharmaceutical industry market – Decision declaring a concentration incompatible with the internal market and the functioning of the Agreement on the European Economic Area – Action for annulment – Association of undertakings active in the relevant sector with the purpose of defending the interests of its members – Interest in the result of the case)

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 11 August 2023,

Biocom California, established in San Diego (United States), represented by B. Armory, E. Barbier de La Serre, A.S. Perraut and L. Van Mullem, avocats,

Illumina Inc., established in San Diego, represented by C.J. Blanco, F. González Díaz, abogados, N. Latronico, G.C. Rizza, M. Siragusa, avvocati, O.A. Magraner and T. Verheyden, avocats,

European Commission, represented by P. Berghe, A. Boitos, G. Conte, B. Ernst and N. Khan, acting as Agents,

1 By its appeal, Biocom California seeks to have set aside the order of the General Court of the European Union of 19 July 2023, Illumina v Commission (T‑709/22, EU:T:2023:416; ‘the order under appeal’), by which the General Court dismissed Biocom California’s application to intervene in support of the form of order sought by Illumina Inc., the applicant at first instance in Case T‑709/22.

2 Article 22(1) and (2) of Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (OJ 2004 L 24, p. 1) provides:

‘1. One or more Member States may request the Commission to examine any concentration … that does not have a Community dimension … but affects trade between Member States and threatens to significantly affect competition within the territory of the Member State or States making the request.

2. The Commission shall inform the competent authorities of the Member States and the undertakings concerned of any request received pursuant to paragraph 1 without delay.

Any other Member State shall have the right to join the initial request within a period of 15 working days of being informed by the Commission of the initial request.

3 The background to the dispute is set out in paragraphs 2 to 9 of the order under appeal. For the purposes of the present proceedings, that background may be summarised as follows.

4 On 20 September 2020, Illumina, which supplies sequencing solutions for genetic and genomic analysis, entered into an agreement and a plan of merger to acquire sole control of Grail LLC, formerly Grail Inc., which develops blood tests for the early detection of cancers (‘the concentration at issue’).

5 On 9 March 2021, the French competition authority requested the European Commission, pursuant to Article 22(1) of Regulation No 139/2004, to examine the concentration at issue. By letters of 24, 26 and 31 March 2021, the Belgian, Greek, Netherlands, Icelandic and Norwegian competition authorities requested to join the referral request, pursuant to Article 22(2) of that regulation.

6 By Decisions C(2021) 2847 final, C(2021) 2848 final, C(2021) 2849 final, C(2021) 2851 final, C(2021) 2854 final and C(2021) 2855 final, of 19 April 2021, the Commission upheld that referral request and those requests to join.

7 By judgment of 13 July 2022, Illumina v Commission (T‑227/21, EU:T:2022:447), the General Court dismissed an action by which Illumina sought the annulment of those decisions. In that judgment, the General Court rejected, inter alia, a plea in law alleging that the Commission does not have competence to initiate, under Article 22 of Regulation No 139/2004, an investigation into a concentration which does not satisfy the conditions enabling the Member State which has requested that the concentration be referred to that institution to examine that concentration under its national rules on the control of concentrations.

8 By Decision C(2022) 6454 final of 6 September 2022 (‘the decision at issue’), the Commission declared the concentration at issue to be incompatible with the internal market and the functioning of the Agreement on the European Economic Area of 2 May 1992 (OJ 1994 L 1, p. 3).

9 On 22 September 2022, Illumina brought an appeal against the judgment of 13 July 2022, Illumina v Commission (T‑227/21, EU:T:2022:447), registered in the Registry of the Court of Justice under number C‑611/22 P. By order of the President of the Court of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205), Biocom California was granted leave to intervene in support of the form of order sought by Illumina in Case C‑611/22 P.

10 By application lodged at the Registry of the General Court on 17 November 2022, Illumina brought an action seeking annulment of the decision at issue, which was registered in the Registry of the General Court under number T‑709/22.

11 By document lodged at the Registry of the General Court on 16 March 2023, Biocom California requested leave to intervene in Case T‑709/22.

12 By the order under appeal, the General Court refused that application to intervene.

13 In paragraph 28 of that order, the General Court found, first of all, that Biocom California represents a significant number of undertakings active in the sector concerned by the concentration at issue and that its bylaws allow it to bring legal actions to defend the interests of its members.

14 Next, the General Court took the view, first, in paragraphs 34 and 49 of that order, that Biocom California had failed to establish, however, that the interpretation of the principle of territoriality constitutes a question of principle specifically affecting the functioning of the life sciences sector, or that the interests of Biocom California’s members might be affected significantly by the ruling to be given in Case T‑709/22.

15 The General Court held, second, in paragraphs 52 and 57 of that order, that similar findings should be made concerning the question of the standard of proof that the Commission must meet in order to demonstrate that a concentration is likely significantly to impede effective competition.

16 Lastly, it found, in paragraph 58 of the order under appeal, that the other arguments put forward by Biocom California to demonstrate that the interests of its members are directly affected by the decision at issue and by the ruling to be given in Case T‑709/22 were based on general and insufficiently substantiated considerations.

17 Consequently, the General Court held, in paragraph 59 of that order, that Biocom California had not established to the requisite legal standard that it had a direct and existing interest in the ruling on Illumina’s form of order seeking annulment of the decision at issue and, therefore, an interest in the result of the case which was the subject of Case T‑709/22.

– grant Biocom leave to intervene in support of the form of order sought by Illumina in Case T‑709/22;

20 Illumina asks the Court to uphold the form of order sought by Biocom California.

21 In support of its appeal, Biocom California submits four grounds of appeal alleging various errors and infringements of EU law concerning, with regard to the first two grounds of appeal, the principle of territoriality and, with regard to the third and fourth grounds, the standard of proof of efficiencies.

22 By the second and third parts of its first ground of appeal, which should be examined first of all, Biocom California submits that the General Court erred in law in holding that the legal questions of principle raised in Case T‑709/22 did not affect specifically the pharmaceutical sector.

23 Biocom California argues that the reasoning of the General Court in relation to the principle of territoriality is based on an incorrect analysis of the relevant questions of principle.

24 These were, it claims, artificially reduced, in paragraph 33 of the order under appeal, to merely determining the Commission’s international competence to examine the concentration at issue in view of the ‘qualified effects’ test.

25 First, in its view, the examination of the first plea in law of the action for annulment in Case T‑709/22 is directly related to Article 22 of Regulation No 139/2004, in so far as the examination of that plea in law should have led to the General Court deciding whether the exercise of the Commission’s competence pursuant to that article is subject to the requirement that the criteria governing the international competence of the Commission are fulfilled. Second, that plea in law is directly related to the fact that the concentration at issue concerns the acquisition of an American start-up without any turnover in a Member State, which, in itself, did not require notification at either national or EU level.

26 In those circumstances, Biocom California argues, in the light of the link between the questions of principle raised in Case T‑709/22 and Article 22 of Regulation No 139/2004, the General Court should have maintained the same logic as that adopted in the order of the President of the Court of Justice of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205), and should have inferred therefrom that the decision to be reached in that case would have a particular impact on the manner in which certain concentrations in the pharmaceutical sector are likely to be regarded under that Article 22.

28 The Commission submits that the first ground of appeal is based on a misreading of paragraph 32 of the order under appeal. That paragraph, it argues, does not describe the first plea in law of the action for annulment in Case T‑709/22 but summarises the overall situation resulting from the actions introduced by Illumina.

29 According to the Commission, the General Court correctly held in that context that that plea in law was not related to Article 22 of Regulation No 139/2004 but concerned solely the principle of territoriality. That plea in law was thus based on the idea that the Commission should always comply with that principle, including in situations where that institution was able, correctly, to base its competence on that article. Accordingly, the findings in the order of the President of the Court of Justice of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205), are not relevant in the present case.

30 As a preliminary point, it should be borne in mind that, as the General Court pointed out in paragraph 20 of the order under appeal, an association may be granted leave to intervene in a case if, first, it represents a significant number of undertakings active in the sector concerned, if, second, its objects include protecting the interests of its members, if, third, the case may raise questions of principle affecting the functioning of the sector concerned and if, fourth, the interests of its members may therefore be affected significantly by the forthcoming judgment (orders of the President of the Court of Justice of 10 March 2023, Illumina v Commission, C‑611/22 P, EU:C:2023:205, paragraph 10, and of 21 July 2023, WhatsApp Ireland v European Data Protection Board, C‑97/23 P, EU:C:2023:608, paragraph 15).

31 The second and third parts of the first ground of the present appeal relate to the third of those conditions, in the light of the legal considerations at issue in the first plea in law of the action for annulment in Case T‑709/22.

32 In paragraph 32 of the order under appeal, the General Court held that the latter plea in law raises the question of whether the Commission’s competence to adopt the decision at issue is subject to a twofold condition requiring, first, that Article 22 of Regulation No 139/2004 allows that institution to conduct an investigation and, secondly, compliance with the principle of territoriality, which presupposes a demonstration of the existence of qualified effects within the territory of the European Union.

33 The General Court thus held that the examination of that plea in law required it to establish whether or not the extent of the Commission’s competence, in the case where it adopts a decision under that Article 22, is limited by the principle of territoriality.

34 In that regard, it must be pointed out that, while the Commission claims that paragraph 32 of the order under appeal is not intended to analyse the first plea in law of the action for annulment in Case T‑709/22, it is apparent from the very terms of that paragraph that such an interpretation thereof cannot be accepted. In addition, even if it is necessary to understand the Commission’s argument as disputing the understanding of that plea in law accepted by the General Court, it should be observed that such an argument cannot succeed, as it is not for the Court of Justice to question the assessments of the General Court that are not referred to by a ground of an appeal or of cross-appeal.

35 The question referred to in paragraph 32 of the order under appeal relates, not to the general conditions of application of the principle of territoriality, in respect of which the absence of a specific link to the pharmaceutical sector was stated by the General Court in paragraph 33 of that order, but to the very applicability of that principle to merger control carried out by the Commission pursuant to Article 22 of Regulation No 139/2004.

36 That question thus arises only in cases in which that article is applicable and is liable to have a decisive influence on the treatment of such cases by the Commission.

37 In that context, it should be recalled that, as is made clear by Biocom California, it is apparent from paragraph 16 of the order of the President of the Court of Justice of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205), that it follows from the Commission’s Guidance on the application of the referral mechanism set out in Article 22 of the regulation on concentrations to certain categories of cases (OJ 2021 C 113, p. 1) that the pharmaceutical sector is one of the specific economic sectors in respect of which the Commission intends to encourage and accept more referrals from the competition authorities of the Member States under Article 22 of that regulation.

38 In the light of the connection established, in paragraph 32 of the order under appeal, between the first plea in law of the action for annulment in Case T‑709/22 and the concentrations examined under Article 22, that specificity of the pharmaceutical sector for the purposes of the application of that article cannot, contrary to what the General Court held in paragraph 40 of that order, be viewed as being irrelevant in the present case.

39 Likewise, by reason of that connection, the fact, noted in paragraph 36 of that order, that Cases C‑611/22 and C‑709/22 do not have the same subject matter is not such as to establish that that specificity of the pharmaceutical sector must not be taken into consideration in Case T‑709/22.

40 It follows from the foregoing considerations that the General Court should have inferred from its assessment of the first plea in law of the action for annulment in Case T‑709/22 that that case would have a particular impact on the way in which certain concentrations in the pharmaceutical sector are likely to be handled under Article 22 of Regulation No 139/2004 in the future and that that finding was sufficient to hold that that case raises questions of principle affecting the functioning of the specific sector in which some of Biocom California’s members are active (see, by analogy, order of the President of the Court of Justice of 10 March 2023, Illumina v Commission, C‑611/22 P, EU:C:2023:205, paragraph 17).

41 The General Court therefore erred in law in finding, in paragraph 34 of the order under appeal, that Biocom California had failed to prove that the third condition referred to in paragraph 30 of the present order was satisfied in the present case in respect of the questions of principle raised by the first plea in law of the action for annulment in Case T‑709/22.

42 Consequently, the second and third parts of the first ground of appeal are well founded. That said, the error of law made by the General Court is not sufficient to justify setting aside the order under appeal, since the conditions referred to in paragraph 30 of the present order are cumulative and the General Court found, in paragraph 49 of the order under appeal, that the fourth of those conditions was not satisfied in relation to those questions of principle.

43 It is necessary, in those circumstances, to examine the second ground of appeal, which seeks to question the findings made by the General Court in that regard in that order.

44 By the first two parts of its second ground of appeal, Biocom California submits that the considerations relating to the fourth condition to which the granting of leave to intervene is subject, contained in paragraphs 41 to 44 of the order under appeal, are too vague to satisfy the obligation to state reasons.

45 In particular, it argues, in paragraph 41 of that order, the General Court merely stated that Biocom California had failed to demonstrate, on the basis of concrete and specific evidence, that that condition was satisfied, without explaining why it rejected the evidence put forward in the application to intervene which was found to be relevant in the order of the President of the Court of Justice of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205).

46 Illumina does not take a position on the question of whether the order under appeal is sufficiently reasoned but submits that the reasoning adopted by the General Court in that order is incompatible with the reasons adopted by the President of the Court of Justice in the order of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205).

47 The Commission considers that the first two parts of the second ground of appeal of Biocom California should be rejected as being based on the premiss that the procedure in Case T‑709/22 is related to Article 22 of Regulation No 139/2004. In addition, it submits, Biocom California fails to set out the evidence that was, in its view, wrongly overlooked by the General Court.

48 It should be borne in mind, first, that, in the context of an appeal, the purpose of the Court of Justice’s review is, inter alia, to ascertain whether the General Court addressed, to the requisite legal standard, all the arguments raised by the appellant and, secondly, that the ground of appeal alleging that the General Court failed to respond to arguments relied on at first instance amounts, essentially, to pleading a breach of the obligation to state reasons which derives from Article 36 of the Statute of the Court of Justice of the European Union, applicable to the General Court by virtue of the first paragraph of Article 53 of that statute, and from Article 117 of the Rules of Procedure of the General Court (order of the Vice-President of the Court of Justice of 12 July 2022, Cipla Europe v EUIPO and Glaxo Group, C‑245/22 P(I), EU:C:2022:549, paragraph 28 and the case-law cited).

49 That obligation to state reasons does not require the General Court to provide an account which follows exhaustively and one by one all of the arguments put forward by the parties to the case and the reasoning may therefore be implicit, on condition that it enables the persons concerned to know why the General Court has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (order of the Vice-President of the Court of Justice of 12 July 2022, Cipla Europe v EUIPO and Glaxo Group, C‑245/22 P(I), EU:C:2022:549, paragraph 29 and the case-law cited).

50 In the present case, it is apparent from paragraph 26 of the order under appeal that Biocom California claimed in particular, before the General Court, that the interests of its members would be specifically and significantly affected by the forthcoming judgment in Case T‑709/22 on account of the fact that the members of Biocom California include start-up companies active in the life sciences sector, operating therefore without significant turnover, but in respect of which market transactions and strategies for finding investors would be affected if recognition were to be given to the Commission’s competence to assess the concentrations of undertakings in that sector involving parties without turnover in the European Union.

51 With a view to addressing those arguments, the General Court merely stated, in paragraph 41 of the order under appeal, that Biocom California had failed to demonstrate, on the basis of concrete and specific evidence, that the forthcoming judgment in Case T‑709/22 would affect the conditions under which its members operate in the market concerned by the concentration at issue and their strategies for finding investors.

52 Such reasoning, however, is not such as to enable Biocom California to become aware of the reasons for which the General Court found that the alleged relationship between the questions of principle identified by Biocom California and the specific economic situation of some of its members did not suffice to determine that the fourth condition referred to in paragraph 30 of the present order was satisfied. Likewise, that statement of reasons does not provide the Court of Justice with sufficient evidence for it to exercise its power of review regarding the assessment made by the General Court in relation to the arguments put forward by Biocom California.

53 In addition, while the General Court adopted, in paragraphs 42 to 44 of the order under appeal, other reasoning relating to the repercussions of the decision at issue on the situation of the members of Biocom California, that reasoning is intended to respond not to the arguments referred to in paragraph 50 of the present order but to a claim that setting that decision aside would be likely to have direct effects on the situation of those members other than Illumina and Grail.

54 It follows that the second ground of appeal must be upheld and, consequently, the order under appeal set aside in its entirety, without it being necessary to examine the third and fourth grounds of appeal.

55 In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, where the Court of Justice sets aside a decision of the General Court, it may itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the General Court for judgment.

56 In the present case, the Court has the necessary elements to give a final ruling on Biocom California’s application to intervene.

57 Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, any person establishing an interest in the result of a case submitted to the Court, other than a case between Member States, between institutions of the European Union or between those States, on the one hand, and such institutions, on the other, may intervene in that case.

58 According to settled case-law, the concept of an ‘interest in the result of the case’, within the meaning of that provision, must be defined in the light of the precise subject matter of the case and be understood as meaning a direct and existing interest in the ruling on the forms of order sought and not as an interest in relation to the pleas in law or arguments put forward. The term ‘the result of the case’ refers to the final decision sought, as set out in the operative part of the future judgment (order of the Vice-President of the Court of Justice of 24 June 2021, ratiopharm and Others v Commission, C‑220/21 P(I), EU:C:2021:521, paragraph 18).

59 However, it is also settled case-law of the Court of Justice that a representative professional association, whose objective is to protect the interests of its members, may be granted leave to intervene where the case raises questions of principle which are liable to affect those interests. Therefore, the requirement that such an association should have a direct, existing interest in the result of a case must be found to be met where that association establishes that it is in such a situation, irrespective of whether the result of the case is likely to alter the legal position of the association as such (order of the President of the Court of Justice of 10 March 2023, Illumina v Commission, C‑611/22 P, EU:C:2023:205, paragraph 8).

60 Indeed, such a broad interpretation of the right to intervene in favour of representative professional associations is intended to facilitate assessment of the context of such cases submitted to the EU Courts while avoiding multiple individual interventions which would compromise the efficiency and the proper course of the procedure. However, unlike natural and legal persons acting on their own behalf, representative professional associations are likely to apply for leave to intervene in a case before the Court not in order to defend individual interests but rather to defend the collective interests of their members. Intervention by such an association offers an overall perspective of those collective interests, which are affected by a question of principle on which the result of the case depends, and is, accordingly, of such a nature as to enable the Court better to assess the context in which a case is submitted to it (order of the President of the Court of Justice of 10 March 2023, Illumina v Commission, C‑611/22 P, EU:C:2023:205, paragraph 9).

61 Such an association may be granted leave to intervene in a case if the four conditions referred to in paragraph 30 of the present order are satisfied.

62 In that regard, in the first place, it is apparent from the explanations provided by Biocom California that it represents a significant number of undertakings that are active in the pharmaceutical and medical devices sector. The concentration at issue concerns the sector of blood tests for the early detection of cancers using next-generation genomic sequencing and, more broadly, the pharmaceutical and/or medical devices sector. Biocom California therefore represents a significant number of undertakings active in the economic sector concerned by the concentration at issue, and can, therefore, be regarded as a representative professional association.

63 In the second place, it is apparent from Biocom California’s application to intervene and from the material annexed to the application that Biocom California has legal personality and that it may bring legal actions to defend the interests of its members.

64 In the third place, it follows from paragraphs 32 to 40 of the present order that the third condition referred to in paragraph 30 of the present order is satisfied in this case in the light of the questions of principle raised by the first plea in law of the action for annulment in Case T‑709/22.

65 In that regard, it should be noted that, while the Commission submits that that first ground of appeal is inadmissible, it does not set out in a detailed manner the reasons forming the basis for that inadmissibility. Its claim in that regard cannot, therefore, in any event, question the finding in the preceding paragraph.

66 In the fourth place, it must be pointed out that, in paragraph 18 of the order of 10 March 2023, Illumina v Commission (C‑611/22 P, EU:C:2023:205), the President of the Court of Justice held that the Commission’s interpretation of Article 22 of Regulation No 139/2004 is more likely to apply to mergers of non-European undertakings, and in particular to mergers of undertakings active in sectors such as life sciences, which are characterised by the presence on the market of a large number of undertakings in the start-up phase. The President of the Court of Justice also noted that the undertakings involved in those operations are generally more likely, both in view of their place of establishment and because they have limited turnover in the European Union, to find themselves below the turnover thresholds for the notification of such operations, both at European and national level.

67 Therefore, in the light of the connection between the first plea in law of the action for annulment in Case T‑709/22 and the concentrations examined under Article 22 of Regulation No 139/2004, the response which might be given to the questions of principle raised in that case are of interest to the members of Biocom California, in so far as Biocom California principally represents life sciences undertakings established in the United States, and more specifically in California, including start-ups in search of financing and large undertakings in search of commercial opportunities to invest in such undertakings in the start-up phase (see, by analogy, order of the President of the Court of Justice of 10 March 2023, Illumina v Commission, C‑611/22 P, EU:C:2023:205, paragraph 19).

68 It follows from all of those considerations that, in view of the broad interpretation of the right of intervention of professional associations representing undertakings in the sector concerned by a case, Biocom California must be regarded as having established to the requisite legal standard, in the present case, that it has a direct, existing interest in the outcome of Illumina’s form of order seeking annulment of the decision at issue and, consequently, an interest in the result of the case submitted to the General Court in Case T‑709/22, as provided for in the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union.

69 Therefore, the application to intervene submitted by Biocom California in Case T‑709/22 must be allowed. It is accordingly for the General Court to adopt the procedural measures which flow from that decision.

70 Under Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is well founded and the Court itself gives final judgment in the case, the Court is to make a decision as to the costs.

71 Under Article 138(1) of those rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

72 As regards the costs of the appeal, first, since Biocom California applied for the Commission to be ordered to pay the costs and the latter has been unsuccessful, the Commission must be ordered to bear its own costs and to pay those incurred by Biocom California. Secondly, since Illumina did not request that the Commission be ordered to pay the costs, Illumina shall bear its own costs.

73 As regards the costs of the proceedings at first instance, under Article 137 of the Rules of Procedure of the Court of Justice, applicable to appeal proceedings by virtue of Article 184(1) thereof, a decision as to costs is to be given in the judgment or order which closes the proceedings.

74 In the present case, since Biocom California’s application to intervene has been granted, the costs relating to its intervention must be reserved.

1. The order of the General Court of the European Union of 19 July 2023, Illumina v Commission (T‑709/22, EU:T:2023:416), is set aside.

2. Biocom California is granted leave to intervene in Case T‑709/22 in support of the form of order sought by Illumina Inc.

3. The European Commission shall bear its own costs and pay those incurred by Biocom California relating to the present appeal.

5. The costs relating to Biocom California’s application to intervene are reserved.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Biocom California v Illumina and Commission (Appeal - Intervention – Competition - Concentrations - Pharmaceutical industry market - Order) [2023] EUECJ C-523/23P(I)_CO (07 December 2023) URL: http://www.bailii.org/eu/cases/EUECJ/2023/C52323P(I)_CO.html Cite as: EU:C:2023:974, [2023] EUECJ C-523/23P(I)_CO, ECLI:EU:C:2023:974

Court of Justice of the European Communities (including Court of First Instance Decisions)