grail illumina antitrust

While the exact details of this allegation are obscured in the redacted version of the Complaint, it seems that the FTC is asserting that any loss of DNA sequencing revenue by Illumina through reduced sales to other MCED competitors will be swamped by the increase in MCED revenues by Grail as it establishes and grows its business at the expense of its crippled rivals. Read19 hours ago | Gerard Baker, Article viewed iconAn icon to mark the viewed articles The vote to close portions of the oral argument was 4-0. 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. FTCs challenge of the proposed Illumina-Grail, participate more fully in high value clinical market,, a 12-year supply contract for this type of DNA sequencing. - 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. In September 2020, Illumina agreed to acquire Grail, a U.S.-based developer of blood tests for multiple early stage cancers, for US$7.1 billion. See The General Court dismisses Altice Europes action against the Commission decision imposing two fines totalling 124.5 million in connection with the acquisition of PT Portugal (europa.eu), 8The Illumina/Grail merger agreement provided for a reasonable best efforts covenant on Illumina to get the deal through, which explicitly excluded any divestments, and a reverse break-up fee of US$ 300 million. Many have also been awaiting a Supreme Court opinion in the Alston-NCAA case. Litigating the Fix. Illumina said immediately it will appeal the ruling, which would force it to unwind the deal that it closed in August last year. The result is that an FTC ALJ likely will have the first chance to evaluate the transaction and apply the VMGs when the hearing begins in August. In the meantime, Illumina closed the transaction in August 2021 before the EC had completed its investigation. 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: 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 reason was that the upstream intellectual property licensing and no-challenge commitments did not guarantee that any of the other NGS suppliers would become a credible alternative to Illumina. Illumina's Deal to Buy Cancer-Test Developer Is Blocked by the EU Grail merger put at risk as antitrust regulator diverges from U.S. decision, says $7.1 billion acquisition would harm. Illumina (Nasdaq:ILMN) announced today that an administrative law judge in the U.S. has rejected the Federal Trade Commission's argument that the company's $8 billion acquisition of Grail was . 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 maintained that the ECs decision to review the transaction was contrary to legitimate expectations and legal certainty, in particular because the ECs invitation to refer the transaction was sent prior to the publication of new guidance, and that Article22 referrals may only be made in situations where the referring NCA is competent under its national merger rules to review the transaction in question. The European Union has blocked Illumina's $7.1 billion acquisition of cancer detection test maker Grail, saying that Illumina failed to address its concerns about the deal restricting competition. The parties have challenged the Commissions jurisdiction but in the meantime the transaction cannot close until the European situation is resolved. 1317. For its part, however, Illumina has offered its clinical oncology customers, contractual guarantees of equal and fair access to Illumina sequencing, and a commitment to drive down prices by more than 40 percent by 2025. This sort of behavioral fix-it-first remedy helped AT&T defeat DOJs challenge of its acquisition of Time Warner. 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. 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. The French competition authority submitted a referral request in March 2021, which was then joined by the competition authorities of Belgium, Greece, Iceland, the Netherlands, and Norway, and accepted by the EC in April 2021. 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. All antitrust practitioners have been breathlessly watching developments in the Epic-Apple trial. The FTC Challenge and Early Procedural Skirmishes The parties made the requisite Hart-Scott-Rodino filings shortly after the September announcement. Read13 hours ago | The Editorial Board, Article viewed iconAn icon to mark the viewed articles U.S. antitrust enforcers sued to block genetic-sequencing giant Illumina Inc. 's $7 billion acquisition of Grail Inc., a cancer-test startup backed by Jeff Bezos and Bill Gates. Following a Commission order to seek its approval for the deal, Illumina complied but also launched litigation against the EU executive. By a 4-0 vote, the U.S. Federal Trade Commission sued to block Illumina, Inc.s $7.1 billion proposed acquisition of GRAIL, Inc. Read14 hours ago | Ben Murrey, Article viewed iconAn icon to mark the viewed articles Learn more about our privacy policy. Already a member? Sept. 20, 2022 1:53 pm ET Order Reprints Print Article Gene-sequencing leader Illumina is fighting antitrust regulators on two continents, battling to hold on to Grail, a pioneer in cancer. The FTC's challenge to the proposed transaction is a marked departure from longstanding antitrust precedent. At the time of referral, GRAIL had not launched a product on the market and had no sales in the EEA. Grail was originally formed in 2015 as a subsidiary . Deal-makers should take into account this risk in their SPA negotiations. The first breakthrough of innovation competition as a stand-alone theory of harm was in 2017, when the EC took enforcement action against a global agrochemical merger. And not because the FTC alleges that Grail will have a high share (though exactly how high is redacted) of that product market if the merger is allowed to close that is exactly what all merger analysis requires. 25The EC had also challenged the NVIDIA/Arm deal based on a similar vertical innovation theory of harm, but that transaction was eventually abandoned without a prohibition decision. On this latter allegation, Illuminas arguments and documents should prove interesting. In late April, the European Commission announced that it too would investigate the transaction, even though the transaction did not meet its usual thresholds. Illumina currently owns 14.5% of Grail voting shares. Determining when a transaction has been , Fifth, an NCA may refer a transaction to the EC at any time, including after closing. If they do make such arguments, it will be interesting to see whether the ALJ treats them as part of the unilateral effects analysis or just another efficiency. First, the U.S. and EU antitrust review took approximately two years from the signing of the Illumina/Grail SPA. The Strange Case of Illumina's Grail Acquisition and the Antitrust Trial That Beings Tuesday By Bill Alpert Aug. 24, 2021 7:38 am ET Order Reprints Print Article Opening arguments begin. This will inform the review of other acquisitions of innovative startups, particularly by large pharma and tech companies. GRAIL stockholders, including Illumina, are entitled to cash consideration of approximately $3.5 billion or, excluding Illumina, approximately $3.1 billion. Illumina has stated that it is ready to litigate the case all the way up to the U.S. Supreme Court. In traditional antitrust terms, the Illumina-Grail deal is a vertical merger as opposed to a horizontal merger, which involves combining two companies in the same business. Illumina/Grail broke new ground both on the jurisdictional and substantive fronts. Our office locations can be viewedhere. In December 2019, when FTC successfully challenged Illuminas attempted acquisition of Pacific Biosciences, FTC alleged that Illumina was a monopolist in NGS platforms, with over 90% share. 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. $ + tax 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. The European Commission has opened an in-depth, three-month investigation into Illumina's planned takeover of Grail, a deal valued between $7 billion to $8 billion. Illumina strongly believes that acquiring GRAIL is in the best interest of patients, is procompetitive, and benefits the multi-cancer early detection field as a whole. The FTC ALJ reached different conclusions in his 2 September 2022 initial decision, finding in favor of Illumina. Find out more about our cookie policy here. 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. 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. Despite calls for clarity, the final VMGs removed EDMs special section but then discussed the concept in both the unilateral effects and efficiencies sections. She apprehended that Illumina's purchase of Grail would give the company the incentive and ability to foreclose downstream rivals. The reason for this was that the EUMR thresholds are based on turnover thresholds and require each of at least two parties to generate some turnover in the European Union. 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. GlobalCounsel Across Five Continents. The concerns arose from the merger, which led to a vertical integration of Illuminaa market leader in next generation sequencing (NGS) systems for genetic and genomic analysiswith GRAIL, a customer of Illumina using its technology to develop blood-based early cancer detection tests. European officials are probing the deal because of concerns it "may reduce competition and innovation in the emerging market for the development and commercialization of cancer . 19 See Guidelines on the assessment of horizontal mergers under the EUMR (2004/C31/03) at para. 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. 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 . The oral argument will be webcast through the FTC website. In her 11 September 2020 speech in Florence, Margrethe Vestager announced that the EC would change its policy and would now acceptor even encourageArticle 22 referrals from Member States whose national merger control thresholds are not met. . Cravath tried the matter for Illumina, a leader in DNA sequencing technology, in August and September 2021. Read on for more. 13 See EC Guidance on Article 22, paras. Article 14 requires all digital platforms that have been designated as gatekeepers under the DMA to inform the EC of any intended acquisition of control of any target company that offers core platform services, services in the digital sector, or otherwise enables the collection of data. By using the Axinn, Veltrop & Harkrider LLP website with cookies enabled on your browser, you agree to our use of cookies during your browsing experience. 28 The EC had also raised similar vertical innovation concerns in NVIDIA/Arm, but that deal was eventually abandoned in February 2022. When the draft of the VMGs was issued in early 2020, EDM was covered in its own separate section. 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. 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. On the substantive front, the EC blocked the deal on a vertical theory of harm similar to that used by the FTC. This site uses cookies for performance, site traffic analysis, and social media purposes. 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. 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. The Illumina/Grail challenge continues a trend of enforcement actions where at least one of the merging parties does not have a product that currently competes significantly, or at all, but that is alleged to be poised to compete significantly in the future -- so-called potential or nascent competitors.1 These cases are harder for the government to win than traditional horizontal mergers involving established competitors because of the absence of evidence of direct competition between the merging firms. Steven Cernak is a Partner with Bona Law PC in its Detroit, MI office who practiced antitrust law in-house withGeneral Motors for over 20 years. The surprising part was the parties success in mid-April in getting the case moved to the Southern District of California, near where both parties (and their witnesses) are located. This would, in turn, reduce the ability and incentives of Grails competitors to continue to invest in the development of these alternative blood-based tests for cancer detection.27. 11 The transaction did not trigger the EUMR thresholds. 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. Instead, the EC decided in 2020 to address the killer acquisition issue through the referral mechanism already included in Article 22 of the EUMR. 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. The EU subsequently vetoed the deal on Sept. 6. 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 . 24See Dow/Dupont at paras. 2005-2022 K&L Gates LLP. 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. 1 In the Matter of Illumina, Inc., and Grail, Inc. (hereafter Illumina), October 14, 2022, FTC Matter/File Number 201 0144, . Should the commissioners find against Illumina, Illumina can appeal that decision to a panel of federal U.S. judges. [4] 4 The European Economic Area includes the EU 27 Member States, Iceland, Liechtenstein and Norway. Illumina's acquisition of biotechnology company Grail will likely be blocked by EU antitrust regulators because of concerns about concessions offered by the U.S. life . 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. In February 2021, following receipt of a complaint, the EC invited NCAs to refer the transaction so that it might be investigated by the EC in parallel to the U.S. Federal Trade Commission and the UK Competition & Markets Authority. In 2019, DOJ lost a landmark vertical case in a failed attempt to stop AT&Ts acquisition of Time Warner. Due to Illuminas strong position in NGS platforms, FTC alleges that Grail and its MCED competitors all rely on Illuminas NGS platform. 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 . Read14 hours ago | Eugene Kontorovich, Article viewed iconAn icon to mark the viewed articles Illumina has offered rivals royalty-free global licenses for some of its patents and a three-year patent truce with Chinese rival BGI in Europe in a bid to address EU antitrust concerns over its acquisition of Grail, other people familiar with the matter said. [3] The Transaction is purely vertical in nature with Illumina operating upstream of GRAIL. 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. 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. Yet, the FTC and the parties will confidently assert their predictions at the hearing and the ALJ will have to decide this key concept. You will be charged Companies with M&A ambitions should pay attention to this case and the potentially novel precedent it is poised to set one way or another. In that case, the EC found that while innovation was not a market in its own right, it was an input activity for both the upstream technology markets and the downstream crop protection markets relevant to that merger.21 The EC looked at the impact of the merger on innovation both at the level of the crop protection industry as a whole, and on certain innovation spaces where the merging parties were close and important innovation competitors.22 These innovation spaces were comprised of groupings of crop protection and pesticide combinations, but they were not properly defined relevant markets.23 The EC found that the crop protection industry was characterized by oligopolistic innovation competition and that a reduction of the global integrated players with Research & Development (R&D) capabilities from five to four would reduce innovation output, and competitors would be unlikely to offset that reduction of innovation output.24 These concerns led to the divestment of the entire R&D organization for crop protection of one of the merging parties in addition to the divestments required to address more traditional price effects. That hearing will begin August 24. The conditions precedent included the HSR Act, but they did not include any specific condition precedent for EUMR clearance (Section 7.07). Axinn Antitrust Insight: FTC Challenges Illuminas Acquisition of Grail, challenged Illuminas attempted acquisition of Pacific Biosciences, FTC lost its bid to block Steriss acquisition of Synergy, criticized the FTC for accepting behavioral remedies, challenge of Procter & Gambles acquisition of Billie, challenge of Illuminas acquisition of PacBio, DOJ Continues Criminal Enforcement in Labor Markets, FTC Launches Multinational Group to Tackle Pharmaceutical Deals. You will be notified in advance of any changes in rate or terms. The tests could save tens of thousands of lives a year if widely adopted. 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. Illumina-Grail acquisition Gets FTC trial example is the European Economic Area and Norway paying attention to the Illumina-Grail! That time, there is no assurance that information you send us will be webcast the! ), and reagents join an Article 22 referral request made under the.. 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