ORDER OF THE PRESIDENT OF THE FIFTH CHAMBER (EXTENDED COMPOSITION) OF THE GENERAL COURT
27 July 2023 (*)
(Competition – Concentrations – Pharmaceutical industry market – Acquisition by Illumina of sole control of GRAIL – Decision declaring the concentration to be incompatible with the internal market and the functioning of the EEA Agreement – Action for annulment – Intervention – No interest in the result of the case)
In Case T‑709/22,
Illumina, Inc., established in Wilmington, Delaware (United States), represented by F. González Díaz, M. Siragusa, G. Rizza, N. Latronico, A. Magraner-Oliver, J. Blanco Carol, lawyers, D. Beard and J. Holmes, Barristers,
applicant,
v
European Commission, represented by N. Khan, P. Berghe, A. Boitos, G. Conte and B. Ernst, acting as Agents,
defendant,
THE PRESIDENT OF THE FIFTH CHAMBER (EXTENDED COMPOSITION) OF THE GENERAL COURT
makes the following
Order
1 By its action based on Article 263 TFEU, the applicant, Illumina, Inc. (‘Illumina’), seeks the annulment of Commission Decision C(2022) 6454 final of 6 September 2022 (‘the contested decision’) declaring a concentration to be incompatible with the internal market and the functioning of the Agreement on the European Economic Area (EEA) of 2 May 1992 (OJ 1994 L 1, p. 3; ‘the EEA Agreement’) and relating to the acquisition of sole control of Grail LLC, formerly Grail, Inc. (‘Grail’), by Illumina.
Facts and procedure
2 On 20 September 2020, Illumina, which supplies sequencing-based solutions for genetic and genomic analysis, entered into an agreement and a plan of merger to acquire sole control of Grail, which develops blood tests for the early detection of cancers (‘the concentration at issue’).
3 On 9 March 2021, the Autorité de la concurrence française (French Competition Authority) requested the Commission, pursuant to Article 22(1) of Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (OJ 2004 L 24, p. 1), to examine the concentration at issue (‘the referral request’). By letters of 24, 26 and 31 March 2021, the Belgian, Greek, Icelandic, Netherlands and Norwegian competition authorities asked to join the referral request, pursuant to Article 22(2) of Regulation No 139/2004.
4 By decisions of 19 April 2021, the Commission accepted the referral request and the requests to join it referred to in paragraph 3 above.
5 On 18 August 2021, Illumina publicly announced that the acquisition of Grail had been completed.
6 On 6 September 2022, by the contested decision, the Commission declared the concentration at issue to be incompatible with the internal market and the functioning of the EEA Agreement by virtue of Article 8(3) of Regulation No 139/2004.
7 More specifically, the Commission considered that the entity resulting from the concentration at issue would have the ability and incentive to foreclose access to inputs to the detriment of Grail’s competitors, first, in the worldwide market for early cancer detection tests based on next-generation sequencing (‘NGS’) at the development stage and, secondly, in the market for NGS-based early cancer detection tests at the commercialisation stage. This would give rise to adverse effects on competition in the EEA and in the States that had requested that the concentration at issue be referred to the Commission. The Commission therefore concluded that the concentration at issue would significantly impede effective competition in those markets.
8 By application lodged at the Registry of the General Court on 17 November 2022, Illumina brought an action seeking the annulment of the contested decision.
9 By document lodged at the Court Registry on 16 March 2023, Asociaţia Sănătate pentru Comunitate, established in Bucharest (Romania), applied for leave to intervene in the present proceedings in support of the form of order sought by Illumina.
10 The application to intervene was served on the main parties in accordance with Article 144(1) of the Rules of Procedure of the General Court.
11 Illumina indicated that it had no objections to Asociaţia Sănătate pentru Comunitate’s application to intervene. The Commission, for its part, contended that that application should be refused.
12 The main parties have requested that, in accordance with Article 144(5) and (7) of the Rules of Procedure, certain confidential information in the file not be communicated to the applicant for leave to intervene.
Law
13 Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, applicable to the procedure before the General Court by virtue of the first paragraph of Article 53 of that statute, any person establishing an interest in the result of a case submitted to the General Court, with the exception of cases between Member States, between institutions of the Union, or between Member States, on the one hand, and institutions of the Union, on the other, is entitled to intervene in that case.
14 Asociaţia Sănătate pentru Comunitate is a registered association governed by Romanian law. According to its by-laws, it is a body which defends the rights of patients suffering from cancer or chronic illness and whose object is to protect the interests of such patients.
15 It argues that it has a direct and existing interest in the result of the case.
16 In the first place, it argues that the aim of protecting the interests of patients suffering from cancer or chronic illness includes ensuring access, for patients in Romania and within the European Union more generally, to new cancer screening and treatment methods. Its remit therefore has a direct link with the subject matter of the case.
17 In the second place, Asociaţia Sănătate pentru Comunitate claims that the present case raises questions of principle liable to affect the interests which it defends.
18 In that regard, it submits that the Court will be called upon to rule on the burden of proof incumbent on the Commission, in a case involving assumptions about developments in science and clinical practice and about the products developed by the parties to the concentration at issue and by third parties.
19 This will require the Court to address the question of principle of how the relevant market is to be defined in relation to (i) the various early detection tests available and (ii) the substitutability of those tests. According to Asociaţia Sănătate pentru Comunitate, it has an interest in ensuring that the Court has a proper understanding of the relevant markets for early detection tests since those tests are a crucial element in fighting cancer, improving patient comfort and saving lives.
20 The present case also raises questions of principle regarding the functioning of the relevant markets and the commercial drivers of buyers and sellers active on those markets. The applicant for leave to intervene has an interest in ensuring that those commercial drivers are properly understood by the Court, in particular regarding contracts such as the Open Offer made by Illumina in March 2021, and the incentives created by that Open Offer to ensure standardised, non-discriminatory, long-lasting access to Illumina’s NGS technology.
21 In addition, the present case raises questions of principle as to the standard the Commission should apply in weighing the evidence required to demonstrate the benefits and efficiencies of a newly developed cancer detection test. Asociaţia Sănătate pentru Comunitate considers that it has an interest in preserving the possibility of arguing the benefits and efficiencies of potential transactions, in order to ensure that innovation in the medical sector can lead to better results for patients and enable those results to be obtained significantly faster. It also maintains that its intervention will help to avoid a risk of erroneous market definitions and erroneous scientific and commercial assumptions.
22 Lastly, the applicant for leave to intervene submits that, due to its extensive experience in the area of cancer screening programmes, it is well placed to provide the Court with the necessary information to assess whether the contested decision complies with the standards applicable to the analysis of economic and scientific evidence.
23 Illumina submits that Asociaţia Sănătate pentru Comunitate satisfies the conditions for being granted leave to intervene in the present case. For its part, the Commission contends, in essence, that the applicant for leave to intervene has failed to demonstrate its interest in the result of the case.
24 The Court has held, with regard to actions brought by environmental protection organisations, that the condition that there must be an ‘interest in the result of the case’ within the meaning of Article 40 of the Statute of the Court of Justice assumes, first, that the remit of those organisations, as derived from their objective laid down, as the case may be, in their articles of association, has a sufficiently direct link with the subject matter of that case and, secondly, that that case raises questions of principle which are liable to affect the interests defended by the organisations in question (see order of 15 June 2020, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2020:276, paragraph 14 and the case-law cited).
25 The Court has also stated that the requirement for a direct, existing interest in the result of the case means either that the remit of those organisations must coincide with that of the region and sector concerned by the proceedings before the Court or, where their remit is wider, that they must be actively involved in protection programmes or studies relating to the region and sector concerned, the viability of which could be jeopardised by the adoption or, conversely, the annulment of the contested measure (see, to that effect, order of 18 May 2018, PlasticsEurope v ECHA, T‑636/17, not published, EU:T:2018:301, paragraph 13 and the case-law cited, and order of 15 June 2020, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2020:276, paragraph 15 and the case-law cited).
26 In view of the arguments put forward by the applicant for leave to intervene, it is in the light of those principles that Asociaţia Sănătate pentru Comunitate’s application to intervene must be analysed.
27 First, as regards the criterion that the association’s remit must have a sufficiently direct link with the subject matter of the case, the contested decision which is the subject of the present case, by which the Commission declared the concentration at issue to be incompatible with the internal market and the functioning of the EEA Agreement by virtue of Article 8(3) of Regulation No 139/2004, forms part of the Commission’s control of concentrations. During its control, the Commission examined the effects of the concentration at issue, first, in the worldwide market for NGS-based early cancer detection tests at the development stage and, secondly, in the market for NGS-based early cancer detection tests at the commercialisation stage. Thus, in the present case, the operative part of the forthcoming judgment can do no more than confirm or invalidate the finding that Illumina’s acquisition of Grail is incompatible with the internal market of the European Union.
28 It follows that Asociaţia Sănătate pentru Comunitate, which by its own account is largely concerned with the promotion of cancer screening, cannot validly claim that its remit has a sufficiently direct link with the subject matter of the present case, which concerns the annulment of the contested decision by which the Commission declared the acquisition by Illumina (an undertaking which markets NGS systems) of sole control of Grail (an undertaking which develops NGS-based early cancer detection blood tests) to be incompatible with the internal market.
29 Moreover, because it is so broad, the objective of Asociaţia Sănătate pentru Comunitate, as set out in its by-laws and referred to in paragraph 14 above, also does not make it possible to establish a sufficiently direct link between the remit of that association and the subject matter of the present case.
30 The argument of the applicant for leave to intervene that its remit has a direct link with the subject matter of the case in so far as the contested decision would delay the introduction of the test developed by Grail, known as the Galleri test, on the EU market, to the detriment of the patients whose interests it defends, also cannot succeed in the present case.
31 The actual availability of the Galleri test to patients within the European Union depends on a number of factors, some of which are entirely independent of the concentration at issue.
32 In those circumstances, in the absence of evidence of any specific activity relating to the concentration at issue or of any particular expertise relating to the subject matter of the present case, it cannot be concluded that Asociaţia Sănătate pentru Comunitate has an interest in the result of the present case from the perspective of the first of the two cumulative criteria laid down in the case-law cited in paragraph 24 above.
33 In any event, the questions of principle allegedly identified by the applicant for leave to intervene, that is to say, the question of the standard of proof incumbent on the Commission, in particular in assessing the benefits and efficiencies of the concentration at issue, the question of the definition of the relevant markets and the question of the functioning of those markets, however important they may be, necessarily remain linked to the subject matter of the case, namely the annulment of the contested decision, which concerns the incompatibility of the concentration at issue with the internal market and the functioning of the EEA Agreement under the provisions of Regulation No 139/2004. They are therefore, in any event, distinct from the public health concerns defended by the applicant for leave to intervene.
34 As regards, in particular, assessing the efficiencies, the applicant for leave to intervene does not show how or to what extent the interests it defends are affected by the question of the assessment of the criteria used to evaluate the alleged efficiencies of a concentration.
35 Secondly, Asociaţia Sănătate pentru Comunitate also fails to demonstrate its interest in the result of the case in the light of the case-law cited in paragraph 25 above, pursuant to which it is appropriate to examine whether its remit coincides with the region and sector concerned by the proceedings before the Court or, in the event that it has a wider remit, whether it is actively involved in protection programmes or studies relating to the region and sector concerned.
36 It should be recalled that the contested decision declares that a concentration relating to the acquisition by Illumina (an undertaking which markets NGS systems) of sole control of Grail (an undertaking which develops NGS-based early cancer detection blood tests) is incompatible with the internal market.
37 The remit of the applicant for leave to intervene is to defend all the interests of patients suffering from cancer and is therefore broader than the specific sector concerned by the present proceedings, namely the sector of NGS-based early cancer detection blood tests and, more broadly, the pharmaceutical and/or the medical devices sector. It is therefore necessary to ascertain whether the applicant for leave to intervene nevertheless demonstrates that it is actively involved in protection programmes or studies relating to that sector, the viability of which could be jeopardised by the adoption or, conversely, the annulment of the contested decision.
38 In that regard, the applicant for leave to intervene submits, inter alia, that it advocates ‘for early cancer detection and equal access to treatment and medical services’ and that its field of activity ‘includes the promotion and support of innovation in relation to cancer treatment and diagnostics’.
39 However, the evidence submitted by the applicant for leave to intervene is capable of establishing only that it (i) participated in a campaign offering free cancer prevention consultations and raising awareness among the Romanian population about risk factors and the importance of regular check-ups, (ii) participated in a roundtable on head and neck cancer, during which its chairperson addressed the issue of the treatment of that cancer in Romania and presented two ‘survivorship guides’, and (iii) participated in a non-invasive screening programme for colorectal cancer, which tested 1 500 at-risk individuals and also aimed to raise awareness of healthy lifestyles and risk factors.
40 Therefore, it has not been established that the applicant for leave to intervene is actively involved in programmes or studies relating to the sector concerned by the present proceedings, the viability of which could be jeopardised, or that it consequently has a direct and existing interest in the result of the case.
41 Furthermore, although it is true that the adoption of a broad interpretation of the right of associations to intervene can facilitate assessment of the context of such cases while avoiding multiple individual interventions which would compromise the effectiveness and proper course of the procedure (see, to that effect, judgment of 9 September 2009, Diputación Foral de Álava and Others v Commission, T‑30/01 to T‑32/01 and T‑86/02 to T‑88/02, EU:T:2009:314, paragraph 98 and the case-law cited), that objective cannot, in any event, justify Asociaţia Sănătate pentru Comunitate’s intervention in the present case. It is clear from the case file that the applicant for leave to intervene is not a representative association and therefore does not represent, through its application to intervene, any individual interests that its members might have in the result of the case.
42 Moreover, the purpose of a broad interpretation of the right of associations to intervene is not to increase the number of interventions from non-representative associations which have only an indirect and hypothetical interest in the result of the case (see orders of 20 May 2014, Lundbeck v Commission, T‑472/13, not published, EU:T:2014:354, paragraph 29, and of 6 October 2021, Illumina v Commission, T‑227/21, not published, EU:T:2021:672, paragraph 41 and the case-law cited).
43 It follows from all of the foregoing that the applicant for leave to intervene has not established its interest in the result of the case within the meaning of the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union. Accordingly, its application to intervene must be refused.
44 In those circumstances, there is no need to rule on the applications for confidential treatment of certain information in the file as regards the applicant for leave to intervene (see paragraph 12 above).
Costs
45 Under Article 133 of the Rules of Procedure, a decision as to costs is to be given in the judgment or order which closes the proceedings. Since the present order closes the proceedings as far as the applicant for leave to intervene is concerned, a decision should be made on the costs relating to its application to intervene.
46 Under Article 134(1) of the Rules of Procedure, read in conjunction with Article 144(6) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
47 In the present case, since the applicant for leave to intervene has been unsuccessful, it must be ordered to bear its own costs in relation to the present application to intervene and to pay those incurred by the Commission, in accordance with the form of order sought by the Commission.
On those grounds,
THE PRESIDENT OF THE FIFTH CHAMBER (EXTENDED COMPOSITION) OF THE GENERAL COURT
hereby orders:
1. Asociaţia Sănătate pentru Comunitate’s application to intervene is refused.
2. Asociaţia Sănătate pentru Comunitate shall bear its own costs relating to its application to intervene and shall pay those incurred by the European Commission.
Luxembourg, 27 July 2023.
V. Di Bucci | | J. Svenningsen |