ORDER OF THE PRESIDENT
OF THE FIFTH CHAMBER OF THE GENERAL COURT
12 June 2023 (*)
(Competition – Concentrations – Pharmaceutical industry market – Acquisition by Illumina of sole control of GRAIL – Decision declaring the concentration 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, B. Ernst, acting as Agents,
defendant,
THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT
makes the following
Order
1 By its action under 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), relating to the acquisition by Illumina of sole control of Grail LLC, formerly Grail, Inc. (‘Grail’).
Facts and procedure
2 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, which develops blood tests for the early detection of cancers (‘the concentration at issue’).
3 On 9 March 2021, the Autorité de la concurrence (French competition authority) requested the European Commission, pursuant to Article 22(1) of Council Regulation 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 requested 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 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 pursuant to Article 8(3) of Regulation No 139/2004.
7 More specifically, the Commission considered that the merged entity at issue would have the ability and incentive to foreclose access to inputs to the detriment of Grail’s rivals (i) in the worldwide market for early cancer detection tests based on next-generation sequencing (‘NGS’) at the development stage, and (ii) in the market for NGS-based early cancer detection tests at the commercialisation stage, giving 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 General Court Registry on 17 November 2022, Illumina brought an action for annulment of the contested decision.
9 By document lodged at the Court Registry on 16 March 2023, Fondazione per la Medicina Personalizzata (‘FMP’), established in Genoa (Italy), 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 stated that it had no objections to FMP’s application to intervene. The Commission, however, contended that that application should be dismissed.
12 The main parties requested that, in accordance with Article 144(5) and (7) of the Rules of Procedure, certain confidential information in the file be excluded from communication to the applicants for leave to intervene.
Law
13 In accordance with 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 thereof, any person establishing an interest in the result of a case submitted to the General Court, except in cases between Member States, between EU institutions, or between Member States and EU institutions, is entitled to intervene in that case.
14 It is settled case-law that the concept of ‘an 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, 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 (see order of the Vice-President of the Court of 24 June 2021, ratiopharm and Others v Commission, C‑220/21 P(I), not published, EU:C:2021:521, paragraph 18 and the case-law cited).
15 Thus, in proceedings concerning an application for annulment, a person must be regarded as having established an interest in the result of the case, and therefore as having the right to intervene in the case, if that person establishes a direct, existing interest in the grant of the form of order sought by the party in support of which it seeks to intervene and, accordingly, in the ruling on the contested measure (see order of 14 July 2022, EAA v Commission, T‑782/21, not published, EU:T:2022:470, paragraph 8 and the case-law cited).
16 It is necessary in particular to verify that the applicant for leave to intervene is directly affected by the contested act and that its interest in the result of the case is certain. In principle, an interest in the result of the case can be considered to be sufficiently direct only to the extent that that result is likely to alter the legal position of the applicant for leave to intervene (see order of the Vice-President of the Court of 24 June 2021, ratiopharm and Others v Commission, C‑220/21 P(I), not published, EU:C:2021:521, paragraph 19 and the case-law cited).
17 In addition, it is for the applicant for leave to intervene to adduce the necessary evidence to prove that it satisfies the conditions set out in paragraph 13 above (order of 7 May 2020, Canon v Commission, T‑609/19, not published, EU:T:2020:203, paragraph 14).
18 FMP’s application to intervene must be analysed in the light in particular of those considerations.
19 The applicant for leave to intervene, a non-profit foundation governed by Italian law, submits that it has an interest in the result of the case that stems, on the one hand, from its field of activities and, on the other, from its interactions with Illumina concerning the Galleri test. It further submits that, if admitted as an intervener, it could make its scientific expertise available to the General Court.
20 In the first place, with regard to its field of activities, it states that, according to its by-laws, its object is to conduct scientific research with a particular focus on pre-clinical and clinical studies in the field of personalised medicine with a view to promoting a comprehensive approach to disease prevention, diagnosis, treatment and monitoring based on a person’s specific characteristics. It has participated in or contributed to numerous events or research projects regarding personalised medicine, including in the field of oncology, and has promoted a number of scientific studies, events and initiatives that are relevant to the present case. In addition, its president is a leading expert in the field of oncology.
21 In the second place, as regards the interactions it claims to have had with Illumina, FMP submits that from May 2022 onwards, its president and Illumina representatives started to discuss a possible agreement concerning a clinical study of the Galleri test that would be carried out by FMP. On 10 September 2022, FMP specifically proposed including the Galleri test in a scientific study and the Illumina representatives showed great interest. However, according to FMP, the agreement could not be concluded because of the adoption of the contested decision.
22 The applicant for leave to intervene thus maintains that the contested decision caused it harm in so far as, but for that decision, it would have entered into an agreement with Illumina for the purposes of conducting clinical studies on the Galleri test. It also argues that those studies would have contributed to a better use of the Galleri test.
23 Lastly, in the third place, as regards the expertise from which the Court might benefit if FMP were admitted as an intervener, that expertise would relate in particular to the different NGS-based tests, the degree of competition on the market and the benefits which the Galleri test would bring to patients in the European Union.
24 Illumina submits that FMP 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.
25 Under Article 143(2)(f) of the Rules of Procedure, the application to intervene must contain a statement of the circumstances establishing the right to intervene, where the application is submitted pursuant to the second or third paragraph of Article 40 of the Statute.
26 In addition, according to settled case-law, it is in principle for the person alleging facts in support of a claim to adduce proof of such facts (see order of 23 September 2020, Deutsche Telekom v Commission, T‑64/20, not published, EU:T:2020:481, paragraph 23 and the case-law cited).
27 In the present case, it should be noted that the operative part of the forthcoming judgment in the present case will only be able to confirm or invalidate the prohibition of the concentration at issue and will, therefore, concern only the parties to that concentration. In those circumstances, as is apparent from the case-law cited in paragraph 26 above, it is for the applicant for leave to intervene to demonstrate that the result of the case is still likely to alter its legal position.
28 In that regard, it is apparent from the file that the applicant for leave to intervene has not adduced any evidence to establish that an agreement was envisaged between FMP and Illumina for clinical studies to be conducted on the Galleri test. In fact the information submitted merely shows that the president of FMP was invited to participate as a speaker at an event organised by Illumina on 5 October 2022 entitled ‘Oncology and genomics: new frontiers for cancer research’ and at an event organised with Illumina’s management on 10 September 2022 concerning precision medicine and, specifically, full genomic profiling. However, none of the evidence submitted serves to establish that any collaboration was contemplated at those events.
29 It follows that it cannot be established from the evidence adduced by the applicant for leave to intervene that an agreement on carrying out clinical studies on the Galleri test was on the point of being concluded prior to the adoption of the contested decision. Thus, the ruling on the contested decision is not likely to alter FMP’s contractual situation and, therefore, its legal position.
30 Furthermore and in any event, FMP’s claimed interest in entering into an agreement with Illumina would appear, at this stage, to be purely commercial. However, to recognise that each natural or legal person demonstrating a commercial interest in the result of a case has a direct and existing interest in the result of the case would lead to the category of potential interveners being so wide that there would be a risk of seriously undermining the effectiveness of the procedure before the Courts of the European Union (see, by analogy, order of 27 November 2013, Pilkington Group v Commission, T‑462/12, not published, EU:T:2013:670, paragraph 22 and the case-law cited).
31 Lastly, as regards the argument that FMP could make its expertise available to the Court if it were admitted as an intervener, it follows from the case-law referred to in paragraphs 14 to 16 above that that argument must be rejected in so far as such expertise is not capable of proving the existence of an interest in the result of the case in accordance with the criteria laid down by that case-law.
32 It follows from all of the above 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 dismissed.
33 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
34 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.
35 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.
36 In the present case, since the applicant for leave to intervene has been unsuccessful, it must bear its own costs relating to the present application to intervene and 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 OF THE GENERAL COURT
hereby orders:
1. The application to intervene of Fondazione per la Medicina Personalizzata is dismissed.
2. Fondazione per la Medicina Personalizzata shall bear its own costs relating to its application to intervene and pay those incurred by the European Commission.
Luxembourg, 12 June 2023.
V. Di Bucci | | J. Svenningsen |