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Also, Illumina told investors that the transaction would benefit Illumina by allowing it to participate in the high value clinical market, not just the DNA sequencing market. Accordingly, please do not include any confidential information until we verify that the firm is in a position to represent you and our engagement is confirmed in a letter. Read19 hours ago | Gerard Baker, Article viewed iconAn icon to mark the viewed articles Particular caution should be paid to document creation and interactions with third party customers and competitors. Unlike those cases, here Grail is not a nascent competitor of Illumina, rather, the concern is that Illumina would use its market power in NGS platforms to keep Grails MCED rivals out of the market, raise their costs, or otherwise diminish their competitiveness. Illumina scored a big win over U.S. antitrust regulators last week in its . Second, the Complaint alleges that Illumina will have the incentive to take some or all of those steps to foreclose or damage Grails rivals. LUXEMBOURG (Reuters) - U.S. life sciences company Illumina on Thursday criticised EU antitrust regulators for scrutinising its $8 billion cash-and-stock takeover of Grail even . The EC has a wide leeway to challenge mergers based on innovation theories of harm, which are more qualitative in nature compared to traditional price effects cases, and, therefore, much harder to defend for merging parties. The Federal. In most merger analyses, however, the enforcers at least have the benefit of past sales figures to help them with the difficult but necessary task of predicting the future. In a significant judgment rendered on July 13, 2022 (Judgment), the EUs General Court validated the position taken by the European Commission (EC) in a March 2021 Guidance Paper encouraging national competition authorities (NCAs) to use Article 22 of the EU Merger Regulation (EUMR) to refer transactions to the EC that do not meet national merger control thresholds, but which they believe may threaten to significantly affect competition within the EU. The Federal Trade Commission (FTC) sought to block Illumina's proposed acquisition of Grail. Even if the EC is open to providing such guidance, it is unclear how much information a company will need to provide and how long it will take for the EC to give its indicative view. The interim order, which was due to expire at the end of the month, was issued by the competition enforcer last year after Illumina jumped the gun and acquired Grail before securing the EU green light. The EC can now assert jurisdiction over any transaction that could potentially affect competition in the European Economic Area. Second, this case is another example that the antitrust agencies talk to each other. These potential foreclosure effects would undermine the ongoing innovation race in the emerging market for blood-based cancer tests, which is expected to reach more than 40 billion by 2035. outside its competence, as the EC had misinterpreted the EUMR by accepting an Article22 referral request from NCAs that were not authorised under their respective national merger control regimes to examine the transaction, invalid, including because the French NCAs referral request was out of time, or in the alternative, delayed such that it undermined the principles of legal certainty and the right to good administration, and. Litigating the Fix. Companies that alerted . 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. Cravath tried the matter for Illumina, a leader in DNA sequencing technology, in August and September 2021. Meta Plans to Begin Large-Scale Layoffs This Week, Russia Presses Evacuation of Kherson as Ukrainian Offensive Looms, Elon Musk Says Twitter Will Permanently Ban Users Who Impersonate Others, Opinion: Donald Trump Fires at Ron DeSantisand Misses, Opinion: Democrats Develop Elon Musk Derangement Syndrome, Watch: Griner to Serve Nine-Year Sentence After Judge Denies Appeal, Watch: Climate Protesters Throw Mashed Potatoes on $110 Million Monet Painting, Mortgages, Cars and Credit Cards: How Interest-Rate Hikes Are Hitting Americans' Wallets, Putinisms: Vladimir Putins Top Six One Liners. To learn how these difficult tasks will be handled under the new VMGs, antitrust practitioners should follow the saga of Illumina-Grail. To date, EC guidance has been limited, although presumably in time an established practice may develop. Read19 hours ago | Dave Hoppe, Article viewed iconAn icon to mark the viewed articles Illumina's ( Case T-755/21) and GRAIL's ( Case T-23/22) appeals against the interim measures are pending before the General Court in separate proceedings. Notably, in Illumina/GRAIL, FTC alleges a vertical potential-competition theory of harm, and Illumina has promised its clinical oncology customers equal and fair access to Illumina sequencing, which it argued would mitigate any potential competitive harms from acquiring Grail. Notably, in Illumina/GRAIL, FTC alleges a vertical potential-competition theory of harm, and Illumina has promised its clinical oncology . On 23 September 2023, Illumina appealed the EU General Courts judgment before the Court of Justice of the European Union (Case C-611/22 P for Illumina v. Commission and Case C-625/22 P for Grail v. Commission and Illumina). Not one of these miracle products has been fully developed, approved, or sold. In this particular case, it is clear that the antitrust enforcement in the EC influenced the FTC and vice-versa, both on the procedural and substantive fronts. The EU's General Court has upheld the European Commission's (the "Commission") jurisdiction to review the acquisition of GRAIL by Illumina. And perhaps most importantly, the challenge is one of the first applications of the new Vertical Merger Guidelines (VMGs), giving us all an opportunity to see how the FTC will treat Elimination of Double Marginalization (EDM) and other vertical merger concepts under that new guidance. Finally, the Complaints treatment of Grails expected position in the MCED market is remarkable, at least to some of us. However, the EFTA member states have the right to join an Article 22 referral request made under the EUMR. September 6, 2022. GlobalCounsel Across Five Continents. We discuss below the key takeaways for dealmakers, and then we dive deeper into the background and timeline of the case, the ECs unlimited jurisdiction under the EUMR, and the ECs novel innovation theory of harm. Illumina acquired Grail for US$ 8 billion while struggling to get regulatory clearance in the U.S. and EU; Illumina may be required to undo the acquisition if it loses the case. The EC now has unlimited jurisdiction to review any transaction that can potentially have anticompetitive effects in the European Economic Area. The latest example is the European Commissions order Tuesday to derail gene-sequencing giant Illumina s acquisition of cancer blood-test startup Grail. Screenings dont exist for most cancers, so many arent caught until theyve spread and are harder to treat. BRUSSELS, Sept 20 (Reuters) - U.S. life sciences company Illumina ILMN.O faces interim measures for closing its $8 billion cash-and-stock takeover of cancer detection test maker Grail GRAL.O. GRAIL is a start-up developing blood tests for the early detection of cancer - a nascent field. Everyone should celebrate the lives that will be potentially saved when the tests make it to market and remember the costs of delaying approval for ideological posturing." More from CEI: Following a Commission order to seek its approval for the deal, Illumina complied but also launched litigation against the EU executive. In the most recent potential-competition case litigated through trial, the FTC lost its bid to block Steriss acquisition of Synergy in 2015. Many have also been awaiting a Supreme Court opinion in the Alston-NCAA case. 12 Commission Guidance on the application of the referral mechanism set out in Article 22 of the Merger Regulation to certain categories of cases, C(2021)1959 final, (Article 22 Guidance) at para. REUTERS/Mike Blake BRUSSELS, Oct 28 (Reuters) - EU antitrust regulators on Friday renewed interim measures ordering U.S. life sciences company Illumina (ILMN.O) to keep Grail (GRAL.O) as a. PROCEDURAL BACKGROUND On September 21, 2020, Illumina, an American company specializing in genomic sequencing, announced its intention to acquire sole control of Grail, an American biotechnology company which relies on genomic sequencing to develop cancer screening tests, to " Launch New Era of Cancer Detection " (the Transaction). 26See FTC Complaint, Administrative Part 3 Complaint (ftc.gov). When Europe's antitrust regulators barred Illumina $8 billion acquisition of cancer-test developer Grail this past Tuesday, Illumina stock rose. Illuminas (Case T-755/21) and GRAILs (Case T-23/22) appeals against the interim measures are pending before the General Court in separate proceedings. That unsurprising move was designed to ensure that the parties did not close the transaction before the FTCs administrative proceeding had run its course. 3255. Currently, the antitrust lawyers are closely following the. The Illumina/GRAIL transaction was referred even though GRAIL generated no EU revenues, suggesting that the bar for determining whether a transaction may . Innovation was already identified as a key parameter for the ECs competitive assessment in the 2004 Horizontal Merger Guidelines and the 2008 Non-Horizontal Merger Guidelines.19Innovation also is one of the criteria in the Horizontal Merger Guidelines to assess whether the merger would eliminate an important competitive force.20 Despite these references, the ECs merger enforcement until recently focused primarily on price and output. The matter has several elements that should generate plenty of antitrust excitement. The conditions precedent included the HSR Act, but they did not include any specific condition precedent for EUMR clearance (Section 7.07). Learn more about our privacy policy. See guidance_article_22_referrals.pdf (europa.eu). It is also difficult for antitrust enforcers and ALJs to predict when a particular level of vertical integration will be anti-competitive. Illumina Inc.'s move to buy the cancer-detection startup Grail Inc. has wiped out $11.5 billion in market value since Bloomberg News first reported its intentions on Wednesday. That's $3.5 . We analyzed Grail's patent portfolio and found that the company's most widely deployed patent families are valuable in the patent market. The parties have challenged the Commissions jurisdiction but in the meantime the transaction cannot close until the European situation is resolved. At the time of referral, GRAIL had not launched a product on the market and had no sales in the EEA. The test, designed to detect more than 50 types of cancer before symptoms appear, looks at the DNA in a patient's blood to . EDM can occur when an upstream and downstream company merge and one of the margins in transactions between the two entities is eliminated. This new policy was formalized on 26 March 2021 in the ECs Article 22 Guidance.12The only two conditions are that the transaction affects trade between Member States, and that it threatens to affect competition within the territory of the Member State making the request.13, Less than a month after the Article 22 Guidance was adopted, on 19 April 2021, the EC accepted an Article 22 referral request by France, which was joined by several other Member States (including Belgium, Greece, Iceland, the Netherlands, and Norway).14, Illumina challenged the ECs decision to assert jurisdiction on several grounds, notably: (i) the EUMR did not allow for the referral of below-threshold transactions by Member States; (ii) the change in policy constituted a breach of the principle of legal certainty; and (iii) the change constituted a breach of legitimate expectations. Customer Service. The parties announced Illuminas proposed acquisition of Grail in September 2020 and claimed that it would speed global adoption of Grails MCED and enhance patient access to the tool. Interestingly, Illumina founded Grail in 2015, but in 2017 it reduced its ownership below a 20% voting interest. An MCED promises to be able to detect biomarkers associated with up to fifty types of cancer by extracting the DNA from a simple blood sample. EC Commissioner for Competition Margrethe Vestager stressed that this case creates important synergies with the reporting obligation under Article 14 of the Digital Markets Act,2pursuant to which digital gatekeepers will need to inform the EC of all their acquisitions in the digital sector.3 But, beyond startups, the case is also highly relevant for acquisitions of established companies in oligopolistic markets where innovation plays a key role, as it affirms the ECs policy priority to challenge and even prohibit mergers if they may reduce innovation competition. - Up to 70% off, The 2022 Midterm Election Endangers Democrats, Not Democracy, Donald Trump Fires at Ron DeSantisand Misses, A GOP Game Plan: Get Federal Spending Under Control, Israels Right-Wing Coalition Gets the Cold Shoulder From Biden, You Gotta Have Heart to Play for Dusty Baker, Tyson Foods CFO Arrested After Authorities Say He Fell Asleep in Wrong House. The clear takeaway is that for this type of transaction, it is essential to build-in sufficient flexibility to extend drop-dead dates due to merger review, without triggering the payment of reverse break-up fees.8. FTC Objected to the Illumina-Grail Merger The FTC rejected Illumina's plan to reunite with Grail. This publication/newsletter is for informational purposes and does not contain or convey legal advice. Find out more about our cookie policy here. Dealmakers should be particularly careful when they negotiate a sale and purchase agreement (SPA) involving an innovative start-up or an established company that is active in an oligopolistic market where innovation is a key driver. Whistleblowers dodged $10 bln in EU cartel fines in past 16 years. This lawsuit features several unique and interesting facets and could mark an important opening gambit for merger enforcement in the Biden Administration. The parties made the requisite Hart-Scott-Rodino filings shortly after the September announcement. This is the FTC's second high-profile loss in an in-house administrative trial this year, following a similar setback in the Altria/JUUL matter.1 The FTC has appealed the ALJ's ruling to the full Commission.2 . Grail is one of several companies developing a multi-cancer early detection (MCED) test. Sign In. Illumina Inc. won a US Federal Trade Commission lawsuit seeking to unwind its $7 billion acquisition of cancer-startup Grail Inc. after an administrative judge ruled the tie-up didn't violate. See The General Court dismisses Altice Europes action against the Commission decision imposing two fines totalling 124.5 million in connection with the acquisition of PT Portugal (europa.eu), 8The Illumina/Grail merger agreement provided for a reasonable best efforts covenant on Illumina to get the deal through, which explicitly excluded any divestments, and a reverse break-up fee of US$ 300 million. 1The EC has already sent a statement of objections against Illumina for the unprecedented step of closing the acquisition pending a Phase II review by the EC. Without other official preliminaries of any kind, on February 19, 2021, the European Commission invited Member State antitrust agencies to request a referral to the EC of the Illumina/Grail transaction under the Dutch Clause. A federal judge recently dismissed the Federal Trade Commission's challenge of Illumina Inc.'s acquisition of Grail Inc., a cancer-screening firm started and spun off years . Following unsuccessful preliminary challenges in France and the Netherlands, Illumina appealed the ECs decision to take jurisdiction, arguing that the EUMR was not intended to allow for the referral of transactions that do not meet national merger control thresholds. 1See, e.g., FTCs December 2020 challenge of Procter & Gambles acquisition of Billie; DOJs November 2020 challenge of Visas acquisition of Plaid; and FTCs December 2019 challenge of Illuminas acquisition of PacBio. Anthony Kwan/Bloomberg As an antitrust trial began this past week on Illumina $8 billion acquisition of cancer-screening pioneer Grail, federal regulators claimed that the deal would stifle. Illumina acquired GRAIL, a cancer screening company originally founded by Illumina that has developed a test that can detect over 50 cancers with a simple blood draw. Instead, the EC decided in 2020 to address the killer acquisition issue through the referral mechanism already included in Article 22 of the EUMR. According to the FTC, Grail is one of several companies developing a new kind of diagnostic test, multi-cancer early detection (MCED), that would revolutionize how cancer is detected and screened, allowing much earlier diagnosis by detecting cancer in asymptomatic patients. In September 2020, Illumina agreed to acquire Grail, a U.S.-based developer of blood tests for multiple early stage cancers, for US$7.1 billion. 14Iceland and Norway are members of the European Free Trade Association (EFTA), and not the European Union. The FTC expressed very similar concerns that Illumina, through its NGS platform, would control the fate of every potential rival to Grail for the foreseeable future and would have the ability and incentive to slow the development of any products that could compete with Grail.26, The EC rejected Illuminas proposed commitments to address these concerns in the upstream NGS and the downstream blood-testing markets. The tests could save tens of thousands of lives a year if widely adopted. In the meantime, Illumina closed the transaction in August 2021 before the EC had completed its investigation. That hearing will begin August 24. This case involved many firsts: It is the first time that the EC prohibited the acquisition of a U.S. startup with no revenues in the European Union; it is the first time that the EC used the vertical innovation theory of harm to prohibit a merger; and it appears likely it will result in the highest gun-jumping fine ever imposed by the EC under the European Union Merger Regulation (EUMR).1. This is almost twice as long as the one-year drop-dead date in the Illumina/Grail SPA. BRUSSELS--The European Union is blocking U.S. life-sciences company Illumina Inc.'s $7.1 billion acquisition of Grail Inc. just days after the company won its case in the U.S . On the substantive front, the EC blocked the deal on a vertical theory of harm similar to that used by the FTC. Should the commissioners find against Illumina, Illumina can appeal that decision to a panel of federal U.S. judges. Illumina, Inc. (ILMN) said Tuesday that the company is reviewing the European Commission's ((EC)) decision prohibiting the acquisition of cancer test developer GRAIL, and it plans to. The EU General Court, in its 13 July 2022 judgment, fully upheld the ECs decision to assert jurisdiction based on Article 22 of the EUMR.15The EU General Court carried out a comprehensive literal, historical, contextual, and teleological interpretation of Article 22 of the EUMR and related provisions, and it concluded that the EC was fully entitled to use the referral mechanism even when the national merger control thresholds are not met.16The EU General Court noted in particular that: (i) the question of whether the conditions for the exercise of Article 22 are met is a matter of EU and not national law;17 (ii) even if the initial objective of Article 22 was to cover referrals from Member States that did not have their own merger control regime, Article 22 did not exclude the ability of Member States that have adopted merger control laws to refer below-threshold concentrations; and (iii) ultimately, the objective of Article 22 was to be an effective corrective mechanism to capture transactions that were likely to significantly impede competition in the internal market.18. According to the FTCs complaint, it is the dominant provider of this DNA sequencing, with one other smaller US provider plus a Chinese provider currently blocked from selling in the US due to patent disputes. 28 The EC had also raised similar vertical innovation concerns in NVIDIA/Arm, but that deal was eventually abandoned in February 2022. Third, companies will need to decide whether to seek guidance as to whether a referral is likely. First, the U.S. and EU antitrust review took approximately two years from the signing of the Illumina/Grail SPA. On this latter allegation, Illuminas arguments and documents should prove interesting. Grail was initially formed by Illumina in 2015, but two years later Illumina reduced its ownership interest to a minority share; today, Illumina owns 14.5% of Grail. 2012. All Rights Reserved. You can adjust your preferences in cookie settings. That reaction showed that many Illumina. Vertical cases involving even established products can be difficult to prove. This expansive jurisdictional approach is still subject to judicial scrutiny. 20 See Horizontal Merger Guidelines at para. You will be notified in advance of any changes in rate or terms. First, the Complaint alleges that Illumina will have the ability to foreclose or raise the costs of Grails MCED rivals in several ways. Illumina is continuing to evaluate "strategic options" for Grail as it faces antitrust pushback for its $7.1 billion acquisition of the maker of blood tests used to detect cancer, according to analysts at J.P. Morgan. Ftc & # x27 ; s happy outcome to reflect on the VMGs was issued in early 2020, was! Grail has developed a lab test that can potentially have anticompetitive effects in the Illumina/Grail SPA See also on: //www.nytimes.com/2022/09/07/business/illumina-grail-antitrust.html '' > Daniel F. Spulber: & quot ; How Do vertical mergers and can result a! 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