# C_2023024EN.01005801.xml

| 23.1.2023 | EN | Official Journal of the European Union | C 24/58 |
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23.1.2023

EN

Official Journal of the European Union

C 24/58

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Action brought on 17 November 2022 — Illumina v Commission

(Case T-709/22)

(2023/C 24/81)

Language of the case: English

Parties

Applicant: Illumina, Inc. (Wilmington, Delaware, United States) (represented by: D. Beard, B. Cullen and J. Holmes, Barristers and F. González Díaz, M. Siragusa, G. Rizza, N. Latronico and L. Bitsakou, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | annul Commission Decision C(2022) 6454 final of 6 September 2022 declaring a concentration to be incompatible with the internal market and the functioning of the EEA agreement (Case M.10188 — ILLUMINA / GRAIL); |
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annul Commission Decision C(2022) 6454 final of 6 September 2022 declaring a concentration to be incompatible with the internal market and the functioning of the EEA agreement (Case M.10188 — ILLUMINA / GRAIL);

| — | order the Commission to bear its costs and pay the applicant’s costs for the present proceeding. |
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order the Commission to bear its costs and pay the applicant’s costs for the present proceeding.

Pleas in law and main arguments

In support of the action, the applicant relies on ten pleas in law.

| 1. | First plea in law, alleging that the Commission erred in law in failing to consider whether the transaction falls within the territorial scope of the EU Merger Regulation and in asserting jurisdiction to review and prohibit the transaction without analysing whether the latter had the necessary nexus to, and would foreseeably produce immediate and substantial effects in, the EEA. |
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1.

First plea in law, alleging that the Commission erred in law in failing to consider whether the transaction falls within the territorial scope of the EU Merger Regulation and in asserting jurisdiction to review and prohibit the transaction without analysing whether the latter had the necessary nexus to, and would foreseeably produce immediate and substantial effects in, the EEA.

| 2. | Second plea in law, alleging that the Commission infringed the applicant’s rights of defence by failing to issue a supplementary Statement of Objections. The Commission substantially supplemented the objection that the applicant would have the ability and the incentive to foreclose GRAIL’s putative rivals by introducing, in particular, a quantitative analysis in the first Letter of Fact. |
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2.

Second plea in law, alleging that the Commission infringed the applicant’s rights of defence by failing to issue a supplementary Statement of Objections. The Commission substantially supplemented the objection that the applicant would have the ability and the incentive to foreclose GRAIL’s putative rivals by introducing, in particular, a quantitative analysis in the first Letter of Fact.

| 3. | Third plea in law, alleging that the Commission failed to discharge its burden of proof under either the strong probability or the balance of probabilities standard. |
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3.

Third plea in law, alleging that the Commission failed to discharge its burden of proof under either the strong probability or the balance of probabilities standard.

| 4. | Fourth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in adopting a definition of the relevant markets that (a) creates an artificial distinction between the development and commercialization stages for NGS-based early cancer detection (ECD) tests, (b) finds substitutability among different NGS-based ECD, DAC, and MRD tests at the putative development stage, and (c) finds innovation substitutability between NGS-based multi-cancer (GRAIL’s Galleri test) and single-cancer early detection tests. |
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4.

Fourth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in adopting a definition of the relevant markets that (a) creates an artificial distinction between the development and commercialization stages for NGS-based early cancer detection (ECD) tests, (b) finds substitutability among different NGS-based ECD, DAC, and MRD tests at the putative development stage, and (c) finds innovation substitutability between NGS-based multi-cancer (GRAIL’s Galleri test) and single-cancer early detection tests.

| 5. | Fifth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in failing to treat the Open Offer as part of the factual situation arising from the transaction in assessing the applicant’s alleged ability or incentive to engage in input foreclosure strategies, as well as the transaction’s efficiencies and effects on effective competition. |
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5.

Fifth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in failing to treat the Open Offer as part of the factual situation arising from the transaction in assessing the applicant’s alleged ability or incentive to engage in input foreclosure strategies, as well as the transaction’s efficiencies and effects on effective competition.

| 6. | Sixth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in claiming that the transaction would result in Illumina’s ability to foreclose. |
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6.

Sixth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in claiming that the transaction would result in Illumina’s ability to foreclose.

| 7. | Seventh plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in claiming that Illumina would have an incentive to foreclose. |
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7.

Seventh plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in claiming that Illumina would have an incentive to foreclose.

| 8. | Eighth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in claiming that the transaction would have a direct and adverse effect on effective competition in the six referring countries or the EEA. |
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8.

Eighth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in claiming that the transaction would have a direct and adverse effect on effective competition in the six referring countries or the EEA.

| 9. | Ninth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in dismissing the parties’ claims that the transaction would accelerate Galleri’s launch in the EEA by at least five years and save thousands of lives, and that internalizing Illumina’s margins when selling NGS systems to GRAIL would eliminate double marginalization and lead to substantial savings for the Member States’ national health systems and taxpayers by reducing cancer treatment costs. Contrary to the Commission’s allegations, the transaction’s efficiencies would all be merger-specific, verifiable, and would have benefitted consumers. |
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9.

Ninth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in dismissing the parties’ claims that the transaction would accelerate Galleri’s launch in the EEA by at least five years and save thousands of lives, and that internalizing Illumina’s margins when selling NGS systems to GRAIL would eliminate double marginalization and lead to substantial savings for the Member States’ national health systems and taxpayers by reducing cancer treatment costs. Contrary to the Commission’s allegations, the transaction’s efficiencies would all be merger-specific, verifiable, and would have benefitted consumers.

| 10. | Tenth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in rejecting Illumina’s comprehensive remedy package, which not only included the Open Offer, but also licensing, waiver, and no-enforcement commitments that would have facilitated upstream entry and expansion by Illumina’s rivals. |
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10.

Tenth plea in law, alleging that the Commission erred in law, and committed errors of fact and assessment, in rejecting Illumina’s comprehensive remedy package, which not only included the Open Offer, but also licensing, waiver, and no-enforcement commitments that would have facilitated upstream entry and expansion by Illumina’s rivals.

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