. WHAT ARE THE FACTS OF THE ILLUMINA/GRAIL CASE? Illumina's hold on Grail depends now on separate appeals in U.S Then, in what was apparently a co-ordinated move, the Autorit de la concurrence (French Competition Authority) sent a referral request under Article 22 EUMR, joined by several other national authorities. All eyes are on the Court as a decision is expected in the next few months. Court says EU can probe M&As where one party has no EU ops General Court upholds the Commissions new approach to reviewing below-threshold deals, The General Court dismissed the idea that, as put forward by the claimants, the main objective of the EUMR was to improve the efficiency and effectiveness of the EU merger control system by establishing a one-stop-shop principle. With Illumina action court to test EU Commissions new merger referral Create an account and set your email alert preferences to receive the content relevant to you and your business, at your chosen frequency. Article 22 has been regularly used by Member States with merger jurisdiction to refer a deal to the Commission where the latter is better placed. In the 13 July 2022, judgment reported in this note, the General Court rejected all pleas and dismissed the action in its entirety. The application of the Article 22 procedure to the Illumina-GRAIL deal was recently tested before the EU's General Court. Illumina to appeal EU court ruling on Grail deal | Reuters General Court Upholds European Commission's Power to Review Illumina-Grail The judgement from the European Union's General Court found that it had the right to look into and rule on the planned merger between US biotech firms Illumina and Grail. Illumina/Grail is the first case in which the Commission applied a controversial new policy regarding Article 22 of the EU Merger Regulation (EUMR), which allows member states to refer mergers to Brussels for review. Antitrust Review of Illumina-Grail Deal Can Proceed, European Court As the Invitation Letter was sent on February 19, 2021 and Frances referral request was submitted on March 9, 2021, the period of 15 working days was complied with. Further, dealmakers will need to carefully consider the likelihood of potential complainants. But few have been paying attention to the FTC's challenge of the proposed Illumina-Grail merger and that is a mistake. Illumina (ILMN), Grail Merger Sees Futher Regulatory Challenges Third parties such as competitors, interlopers, customers, and associations could potentially encourage the Commission to request referral requests, including to further their own interests. The Court considered that the 47 working days period between the complaint and the invitation letter did breach that requirement. This is undoubtedly a big expansion of EU jurisdictional reach. Illumina/Grail: An unholy war continues - The Thicket In short, the Commissions main objective was to catch deals that have neither a European dimension under the EUMR nor meet the national thresholds but which it considers nonetheless would have an effect on competition in the EU (due, in Illumina/Grail, to vertical foreclosure issues - but not limited to these). The General Court stressed that the Commission is required to comply with a reasonable time limit in administrative procedures, particularly in the context of merger control, and found that the period of 47 days between the complaint being received and the invitation letter being sent was unreasonable. It is also the latest step in the notoriously fraught Illumina/Grail saga that has already seen a challenge to the Commission's jurisdiction rejected on appeal to the General Court (see VBB on Competition Law, Volume 2022, No. It was only fulfilled following the reception of the Commissions invitation letter. The EC subsequently on February 19, 2021 sent a letter to the Member States (the Invitation Letter) to inform them of the Transaction and to invite them to submit a referral request under Article 22. If the Commission concludes that there was a breach, it could impose a fine of up to 10% of each companies' annual worldwide turnover. Illumina And Grail Run Into First-Ever Interim Measure For Gun-Jumping Grail was originally formed in 2015 as a. This whole thing becomes a moot point if the FTC decides to disband the Illumina-GRAIL merger. The USD 7.1 billion transaction did not meet the review thresholds the EUMR or any national merger control rules, since Grail had no sales in the EU at all. PDF Illumina/GRAIL: EU General Court gives green light to below-threshold The Court considered that the 47 working days which elapsed between the complaint and the Commissions letter inviting Member States to trigger Article 22. Illumina announced that it would hold GRAIL as a separate company during the EC's ongoing regulatory review. Litigating the Fix. [2] Communication from the Commission: Commission Guidance on the application of the referral mechanism set out in Article 22 of the Merger Regulation to certain categories of cases. Illumina responded by filing an action in the General Court of the EU challenging the EC's jurisdiction to investigate the deal.The EC has now decided to open an in-depth investigation into the proposed takeover, f ollowing its preliminary investigation. On 19 February 2021, the Commission sent an invitation letter to Member States informing them of the Illumina/Grail transaction and inviting referral requests. The EUs General Court has ruled that national competition authorities can rely on Article 22 of the EU Merger Regulation (EUMR) to refer a transaction to the Commission for merger control review where the transaction does not meet the EU or Member State thresholds. In the 13 July 2022, judgment reported in this note, the General Court rejected all pleas and dismissed the action in its entirety. This prompted Illumina, supported by Grail, to file suit before the General Court (against the Contested Decisions and the Information Letter). Given that Grail had no turnover in the EU, neither the Commission nor any Member State was competent to review the transaction, at least under the Commissions previous stance on Article 22. The Federal Trade Commission filed an administrative complaint and authorized a federal court lawsuit to block Illumina's $7.1 billion proposed acquisition of Graila maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. Now that the General Court has endorsed the Commissions approach to moving the goalposts on jurisdiction, the Commission and indeed Member States will be on the hunt for candidate referral cases that would have previously escaped merger control scrutiny. NEW YORK - The European Union's General Court ruled on Wednesday that the European Commission's investigation into Illumina's purchase of Grail can continue. In its action for annulment, Illumina claimed that the Commission lacked competence under Article 22 EUMR, that the referral had been made out of time, and that the Commissions change of policy as regards referrals from Member States under Article 22 violated its legitimate expectations and legal certainty. At the same time, Illumina has challenged the jurisdiction of the EC in the General Court of the European Union and expects a decision by early 2022. Both are U.S. biotechnology companies, with Illumina manufacturing systems for genetic analysis, while Grail develops cancer screening tests. Some hard limits (especially with respect to closed deals) are likely to emerge for legal certainty reasons, but it will take years for case experience and litigation to flesh these out. According to the General Court, made known requires an active transmission of the appropriate information to the EU Member State concerned. Beware of Gun Jumping: EU Court Upholds EUR 20 Million Fine Imposed On Norwegian Seafood Company, DOJ Prosecutes Attempted Collusion among Business Competitors for First Time in Decades, Why Courts Are Rejecting Agencies Merger Challenges, Seven Corporate Directors Resign: DOJ Ramps Enforcement Against Board Members Serving on Competitors Boards, International News Spotlight on Competition Law. It was the (re)acquisition of Grail by Illumina, a global genomics company which was spun out of Illumina four years earlier, and is also based in the US (but with operations in Europe as well), that piqued the Commissions interest. On 29 April 2021, Illumina announced that it had filed an action in the General Court of the EU asking for annulment of this . Also relevant was that the termination fee of US$300 million owed to Grail in the event the deal didnt close on time was more than the maximum possible fine. . At the same time, the Commissions view has been that value-based thresholds risked being disproportionate (where the threshold is set too low) or ineffective (if set too high). Commissioner Vestager has already indicated that the Commission has potential killer acquisitions on its radar following the court ruling. For the time being, however, the General Court's endorsement of the Commission's approach is likely to encourage use of the referral The company's stock has lost more than half of its value since it closed the deal, falling from to about $201 a share today from $517 in August 2021. And it certainly is individually and directly concerned by the decision taken today. Finally, the General Court rejected Illuminas final plea that the Commission infringed the principles of legal certainty and legitimate expectation by stating in September 2020 that its existing policy would not change until it was amended by the publication of new guidance towards the middle of 2021. Depending on the assessment of the points above, the parties will need to consider their strategy regarding engagement with the Commission (or lack thereof). The Commission has issued guidance, but this gives itself a wide discretion to assert jurisdiction and spongy time limits. The EC became aware of the existence of the transaction in question on December 7, 2020 after a complaint was lodged. Illumina/GRAIL: EC Blocks Transaction Below EU and Referring Member A press release is not sufficient. You can browse, search or filter our publications, seminars and webinars, multimedia and collections of curated content from across our global network. Many EU competition commentators have reacted strongly saying, the decision undermines the legal certainty that came from jurisdiction being strictly confined to notifiable transactions. The General Court agreed, holding that: However, the General Court recalled that the infringement of the reasonable time principle, justifies the annulment of a decision taken at the end of an administrative procedure concerning competition only in so far as it also constitutes an infringement of the rights of defence of the undertaking concerned. In an assertive move, the Commission revived an old mechanism provided for in Article 22 of the European Union Merger Regulation (EUMR). The General Court rejected this argument on any interpretationon plain reading as well as after a historical, contextual and theological interpretation. It is apparent from the EUMR that its objective is . The Commission has now sent a Statement of Objections to Illumina alleging that it breached the suspension obligation under the EUMR by completing the transaction while the Commissions investigation was ongoing. Illumina, joined by Grail, challenged the Commissions acceptance of the referral before the General Court in December 2021. In a landmark ruling, the EU General Court (GC) has confirmed the European Commission (EC)'s decision to accept a referral request from several Member States for the assessment of gene . The EC's Decision Such a sandwich seems unlikely to reflect the legislatures intention. We expect the Commission and EU Member States will more regularly cooperate on referring deals that fall below their respective thresholds but which could raise competition concerns. The General Court of the European Union will hear Illumina's jurisdictional challenge later this year. FTC's Drop Of Illumina-Grail Federal Court Case Raises Uncertainty The General Court's Illumina/GRAIL judgment confirms that the European Commission (EC) has the power under Article 22 of the EU Merger Regulation (EUMR) to accept referral requests from a Member State National Competition Authority (NCA) to review transactions over which the NCA does not have jurisdiction under national law. Conventional wisdom suggests that such transactions are more likely to take place in technology, pharmaceutical and life sciences markets, in which highly innovative new entrants can quickly disrupt and dislodge the incumbent given technology cycles and limitations on the duration of patent protection. Illumina has announced that it will appeal. If the Commission is to radically change policy, businesses need to know this in advance so they can modify their behaviour. The wording of Article 22 EUMR, specifically, the use of the expression any transaction, makes it clear that a Member State is entitled to refer any transaction which satisfies the Article 22 Conditions to the Commission, irrespective of the existence or scope of national merger control rules. Illumina said it would appeal the General Court ruling to the Court of Justice of the European Union, Europe's highest. Hannelore Wiame focuses her practice on European and Belgian competition law. However, in April 2021 - and some 7 months after the deal was publicly announced- the French competition authority, following an invitation from the Commission, took advantage of the new guidance on Article 22 (issued in March 2021) to make a referral request. the court gave a literal, contextual, purposive and historical interpretation of article 22(1) of the eu merger regulation which allows (1) one or more member states to request the commission to review any concentration which (2) does not meet eu notification thresholds, but which (3) affects trade between member states and (4) threatens to Illumina loses challenge against EU antitrust probe into Grail deal In particular, the General Court held that the objective of the EUMR was to permit effective control of all concentrations with significant effects on competition in the EU. Last December the General Court heard Illuminas appeal requesting annulment of the European Commissions decision to accept jurisdiction in Illumina/GRAIL. the court carried out a literal, contextual, teleological and historical interpretation of article 22 (1) of the eu merger regulation that permits (1) one or more member states to request the commission to examine any concentration that (2) does not meet the eu notification thresholds, but that (3) affects trade between member states, and (4) Illumina Files Action for Annulment of European Commission's Decision The transaction at issue concerns an acquisition announced in September 2021 by Illumina, a U.S. company specialising in genomic sequencing, of GRAIL, a U.S.-based start-up developing blood tests for the early detection of cancer, which is a nascent field. Illumina may disagree. Illumina has announced that it will appeal the General Courts judgment. By holding GRAIL separate while proceedings are ongoing, Illumina is positioned to follow whatever final . General Court decision in Illumina/Grail to lead to greater EU merger In short. Five other authorities (the Greek, Belgian, Norwegian, Icelandic and Dutch competition authorities) joined the request for referral, which was accepted by the Commission. The Transaction was therefore not notified to the EC nor any of the EU or EFTA Member States. The referral mechanism under Article 22 EUMR is therefore a corrective mechanism whichin the view of the General Courtprovides the needed flexibility in a system based principally on turnover thresholds which is therefore rigid in nature. While the Commission had in particular the digital and pharmaceutical sectors in mind, in principle this new policynow endorsed by the General Courtenables the Commission to review any transaction that meets the necessary conditions at the request of even a single EU Member State. Karolien Van der Putten focuses her practice on European law and competition law. On 13 July 2022, the General Court of the European Union (the General Court) handed down its judgment in Case T-227/21 concerning an action brought by Illumina, Inc. (Illumina) and Grail LLC (Grail) to challenge the decision of the European Commission (the Commission) to review the acquisition of Grail by Illumina (the Transaction). We will be in touch with details on how to reset your password via this email address. The proposed transaction was not notified to the Commission or the national competition authority (NCA) of any EU Member State because GRAIL did not generate any revenue in the EU or, indeed, anywhere else in the world and therefore did not meet the relevant jurisdictional thresholds for review. And within this new approach to deals that do not meet the thresholds, fits the case of Grail; a US-based company with no presence in Europe that develops blood tests for cancer detection using an innovative technology based on genomic sequencing and data science. 7)), as well as the opening of a gun-jumping investigation against the parties (see VBB on Competition Law, Volume The EC referred in particular to the digital and pharmaceutical sectors (see our On the Subject on the Article 22 Guidance here). The EUs jurisdiction to review mergers is no longer linked to notification. The General Court also addressed Illuminas argument that the delay between learning about the transaction and sending the invitation letter was contrary to the fundamental principle of legal certainty and the right to good administration. CURIA - List of results - European Court of Justice According to the General Court, this, however, had not affected Illuminas capacity to defend itself effectively and therefore did not justify an annulment. Grail is a customer of Illumina and develops blood tests for the early detection of cancer (using the NGS systems). The new approach would also give it the ability to review so-called killer acquisitions, i.e. The original EC investigation is expected to be completed no later than 29 November 2021. Speaking on the enforcement gap in March 2021, EU Commissioner Margrethe Vestager noted that [a] number of transactions involving companies with low turnover, but high competitive potential in the internal market are not reviewed by either the Commission or the Member States. As discussed in this briefing, on 19 April 2021 the European Commission took the unprecedented step of accepting a referral request from a national competition authority (NCA) which did not have jurisdiction to review the deal in question despite having a sophisticated merger control regime. The General Court rejected such claims; it considered that for the clock to start, a Member State authority must be in a position to carry out a preliminary assessment of the situation to assess whether the requirements for the referral are satisfied. Contrary to what Illumina tried to argue, in the absence of evidence of the active transmission of relevant information, either by the undertakings concerned or by other sources or means, to the French competition authority or to those of the Member States that made the requests to join the referral, the question of whether the Invitation Letter, the referral request and/or the Information Letter were based on information which was already known to the public on September 21, 2020 is irrelevant. The Federal Trade Commission filed an administrative complaint and authorized a federal court lawsuit to block Illumina's $7.1 billion proposed acquisition of Graila maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. The Illumina/Grail transaction (acquisition of Grail, a US biotechnology company working on cancer screening tests, by Illumina, another US biotechnology company and global leader in genomics) was the first case in which the Commission applied its new Article 22 EUMR policy. In parallel, the Commissions review of the merger entered into Phase II (in-depth review) and the Commission launched an investigation into a possible breach of the standstill obligation by Illumina, and this now seems likely to lead to a fine. General Court upholds EU's landmark Illumina/Grail Article 22 review The district court case is FTC v. Illumina Inc. et al., case number 3:21-cv-00800, in the U.S. District Court for the Southern District of California. On July 13, 2022, the General Court of the European Union endorsed the ability of the European Commission to exercise its jurisdiction over transactions that do not trigger merger control thresholds, neither European nor national, by virtue of the referral mechanism known as of article 22 (Case T-227/21).By this judgment, the General Court effectively validated a hybrid ex ante/ex . *** All antitrust practitioners have been breathlessly watching developments in the Epic-Apple trial. Illuminas third ground of appeal challenged the Commissions actions in acting contrary to Illuminas legitimate expectation that the Commission would not change policy without letting Illumina and the rest of the business world know what the Commission was going to do under the new policy by promulgating guidance. This period of 47 working days did not appear to be justified as . The right to rely on the principle of the protection of legitimate expectation presupposes that precise, unconditional and consistent assurances originating from authorised, reliable sources have been given to the person concerned by the competent authorities of the European Union which was not the case here. The companies publicly anticipated a gun-jumping fine but justified the decision on moral groundsbringing Grails life-saving test to as many patients as possible as quickly as possible. Grail is a customer of Illumina and develops blood tests for the early detection of cancer (using the NGS systems). As mentioned above, while the Commissions Guidance is not limited to any specific sectors, the pharmaceutical, life science and tech sectors are squarely within its sights as are any sectors where innovation is an important parameter of competition. SAN DIEGO-- (BUSINESS WIRE)-- Illumina, Inc. (NASDAQ: ILMN) announced today that it has filed an action in the General Court of the European Union asking for annulment of the European Commission's decision asserting jurisdiction to review Illumina's acquisition of GRAIL. Many have also been awaiting a Supreme Court opinion in the Alston-NCAA case. Illumina Loses Bid to Halt European Review of Grail Deal In a speech a few weeks before the Illumina/Grail deal was announced in September 2020, Commissioner Vestager signalled that the Commission was considering abandoning this practice so as to catch global below-threshold mergers.[1]. Such an interpretation of Article 22, Illumina said, creates a jurisdiction sandwich whereby the Commission reviews deals above the EUMR thresholds, NCAs review those below which are caught by their own rules, and the Commission sweeps up anything left behind. Been breathlessly watching developments in the Epic-Apple trial the existence of the transaction in question on 7! 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