United States: Technology and Pharmaceutical Mergers
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The technology and pharmaceutical industries continue to attract immense antitrust scrutiny under the Biden Administration. With daily reports in the media and pressure from politicians to address what some perceive to be anticompetitive mergers by digital platforms and pharma companies, innovation in both sectors continues at breakneck speed. In this article, we discuss recent developments in the high-tech and pharma sectors, with an eye towards the unique issues that are driving antitrust enforcement in these industries.
- Antitrust reform and enforcement under the Biden Administration
- Issuance of a new Merger Remedies Manual
- Formation of a Multinational Pharmaceutical Task Force
- Nascent competition
Referenced in this article
- The Department of Justice
- The Federal Trade Commission
- The Merger Remedies Manual
- Proctor & Gamble/Billie Inc
Less than a year into his presidency, President Biden’s personnel moves signal aggressive enforcement
Just a few months into his presidency, President Biden sent a warning sign to Big Tech upon his announcement that two progressive antitrust scholars and prominent tech critics would fill top positions in his administration and the US Federal Trade Commission (FTC).
In March 2021, President Biden announced that Columbia Law School professor Timothy Wu would serve as Special Assistant to the President for Technology and Competition Policy. The White House Press Secretary has said that Wu will help advance the President’s agenda, including ‘addressing the economic and social challenges posed by the growing power of tech platforms’ and ‘promoting competition and addressing monopoly and market power issues’. Wu, credited with popularising ‘net neutrality’, has been a critic of big tech. In his 2018 book The Curse of Bigness: Antitrust in the New Gilded Age, Wu cautioned that ‘[e]xtreme economic concentration yields gross inequality and material suffering, feeding the appetite for nationalistic and extremist leadership.’ While the former law clerk for Judge Richard Posner and Justice Stephen Breyer will likely have influence over competition policy broadly, it is unlikely that Wu, sitting in the White House, will have direct influence over antitrust enforcement decisions, as the Biden Administration has promised that the White House will not interfere with enforcement decisions, in contrast to the Trump Administration. That influence was reflected in Biden’s 9 July executive order aimed at promoting competition across the economy, from directing the Department of Health and Human Services to take steps to allow hearing aids to be sold over the counter and reduce drug prices to directing the Department of Transportation to issue rules requiring airlines to disclose fees and refund fees when a plane’s WiFi does not work.
A few weeks after Wu’s appointment, President Biden nominated Lina Khan, a Columbia Law associate professor known for her law review article ‘Amazon’s Antitrust Paradox’, to become an FTC Commissioner. Khan has emerged as a champion among progressives, arguing that Amazon ‘has positioned itself at the center of e-commerce and now serves as essential infrastructure for a host of other businesses that depend upon it’ and that ‘[e]lements of the firm’s structure and conduct pose anticompetitive concerns – yet it has escaped antitrust scrutiny.’
After Khan was confirmed by the Senate, President Biden made her chair. The move took antitrust observers by surprise, since Biden did not identify Khan as the chair during her congressional hearings, and reports indicate Khan herself was not aware she would be named chair. Khan is even more aggressive than Rebecca Slaughter who served as acting chair since Biden’s inauguration.
For example, in a party-line vote in July, the FTC rescinded a 1995 policy statement that the FTC would not require prior approval of future transactions in consent decrees. Khan explained that without ‘prior approval’ provisions, the FTC could be forced to use scarce resources ‘to re-do all [the investigative work done in the underlying deal] any time the companies attempted a similar acquisition – even though the agency had already previously determined that this type of deal was illegal.’ In dissent, Commissioner Wilson argued that the 1995 statement had been issued by a Democratic chair as ‘a guardrail to prevent  questionable exercise of enforcement discretion’ and that ‘given recent actions by this Commission to bulldoze through other guardrails, I have heightened concerns about removing this one.’
In early August, the FTC announced that it would begin sending ‘standard from letters’ notifying parties that even ‘[w]hen the FTC does not challenge a transaction prior to its consummation, this does not constitute “approval” or “clearance” of the deal, and the agency maintains the right to challenge a deal regardless of whether it was initially investigated.’ The FTC’s announcement further stated that where the FTC does not complete its investigation within the requisite timeline, ‘[c]ompanies that choose to proceed with transactions that have not been fully investigated are doing so at their own risk.’
Slaughter had already taken a number of pro-enforcement moves, including suing to block a vertical merger, a first for the FTC in over 40 years. She also suspended grants of early termination and announced the creation of a new rulemaking group ‘to strengthen existing rules and to undertake new rulemakings to prohibit . . . unfair methods of competition.’ Perhaps most important, Slaughter announced in May 2021 that the FTC would join forces with a multilateral working group to build a new approach to pharmaceutical mergers ‘to take an aggressive approach to tackling anticompetitive pharmaceutical mergers.’
Khan previously served as a legal fellow to FTC Commissioner Rohit Chopra and as counsel for the House Judiciary antitrust subcommittee. Khan appears poised to follow in Chopra’s shoes with a very progressive enforcement agenda and has already put several of Chopra’s advisers into leadership roles at the FTC. As Commissioner, Chopra advocated for enforcement and expanded theories of harm to challenge mergers. For example, Chopra called on the FTC to close what he called a ‘loophole’ that allows transactions involving non-controlling minority investments to fall ‘below the radar.’  Chopra argued that ‘[s]ometimes, buyers might start with a minority stake, with the goal – or even with a contractual option – of an outright takeover as they learn more about the company’s operations. Even though they might have a small stake, they can exert outsized control.’
The DOJ is similarly expected to be active under US Attorney General Merrick Garland, who has both litigated and heard antitrust cases. At his confirmation hearing, Garland said that ‘I take it [antitrust enforcement] very seriously and have throughout my entire career.’ In July 2021, President Biden also nominated Jonathan Kanter, who some have characterised as a critic of big tech, as Assistant Attorney General for the Antitrust Division at the DOJ. During his time in private practice, while representing some technology companies, Kanter urged enforcers to bring monopolisation actions against other technology companies.
Congress contemplating antitrust reform
Even while expanding enforcement efforts, the agencies are bounded by the antitrust laws that they are tasked with enforcing. While those laws are quite broad, prohibiting mergers the effect of which ‘may be substantially to lessen competition’, judicial interpretations have imposed restrictions that some believe impose too high a burden on the government. Congress is taking a hard look at whether those laws should be changed to address perceived shortcomings in the DOJ and FTC’s ability to reign in conduct that they believe is anticompetitive.
Lawmakers are promising sweeping reform. In a February 2021 House Judiciary antitrust subcommittee hearing, for example, chair David Cicilline (D-RI) stated ‘[m]ark my words: Change is coming. Laws are coming.’
Legislative proposals take a variety of approaches. Proposals take aim specifically at mergers and acquisitions and would create a presumption of illegality for certain transactions. For example, certain transactions would be presumptively unlawful, putting the burden on the merging parties to prove that the merger is not anticompetitive. These transactions may include those valued at greater than US$5 billion and acquisitions of competitors or nascent competitors by a company with a market share of 50 per cent or more.
Three ideas have also permeated discussions around proposals to address big tech: (1) interoperability and data portability, (2) nondiscrimination requirements and (3) structural separation. Application of these concepts could result in significant change. The first idea, interoperability and data portability, would require dominant platforms to make information and content portable and services interoperable with other networks. The second idea, imposing nondiscrimination requirements, would prohibit dominant platforms from self-dealing and require products and services to be offered on equal terms. The idea of structural separation would implement line of business restrictions limiting the market in which a dominant firm can operate, and prohibit dominant platforms from operating in markets in which competitors are dependent on the dominant firm for its infrastructure.
While Republicans question the wisdom of some of the further-reaching reforms, both sides agree that some changes need to be made. House Judiciary Ranking Member Jim Jordan, for example has supported funding state attorneys general, allowing them to pick the forum where they can bring cases and fast-track their cases. Jordan’s antitrust agenda also includes a proposal to consolidate antitrust enforcement within the DOJ, as well as direct appeal of antitrust cases to the Supreme Court.
The proposal most likely to be adopted in the near term is increasing the budgets of the antitrust enforcement agencies. The 2021 budget included an increase of US$38.8 million for the FTC and US$16 million for the DOJ, an 11 per cent and 8.6 per cent increase, respectively. Some legislative proposals would go further, increasing the civil penalties that can be collected by the DOJ and FTC. Other proposals would increase merger filing fees – fees that have remained the same since 2000. Senator Amy Klobuchar, the leading Democrat on the Senate Judiciary Committee Antitrust Subcommittee, has argued, ‘[y]ou cannot take on trillion-dollar companies, the biggest companies the world has ever seen, with just Band-Aids and duct tape.’
Although this is not the first time antitrust reform has been on the table, current proposals could have big implications for technology companies. Klobuchar argues, ‘[w]hile the United States once had some of the most effective antitrust laws in the world, our economy today faces a massive competition problem. We can no longer sweep this issue under the rug and hope our existing laws are adequate.’
A renewed focus on efficacy of remedies
The DOJ and FTC are both focused on the efficacy of merger remedies, that is, relief imposed on merging companies to prevent alleged anticompetitive effects of transactions allowed to proceed. The DOJ issued a new Merger Remedies Manual that emphasises both the rigour with which it expects to review potential divestiture buyers and the emphasis on divestiture packages. FTC Commissioners have also expressed concern about the effectiveness of remedies in public statements. We are seeing increased scrutiny of proposed divestitures, and companies can expect longer merger review timelines for approval of proposed remedies.
In September 2020, the Trump Administration DOJ released a new Merger Remedies Manual, clarifying the analytical framework used to evaluate remedies that may address competitive harms stemming from proposed mergers and acquisitions as well as consummated mergers. Former Assistant Attorney General Makan Delrahim said that the Manual reflected the DOJ’s ‘renewed focus on enforcing obligations in consent decrees and reaffirms the division’s commitment to effective structural relief’. Whether the Biden Administration will be more amenable to behavioural relief remains to be seen.
The DOJ Manual spells out six key principles:
- the purpose of a remedy is to preserve competition at pre-merger levels;
- remedies should not create ongoing government regulation;
- temporary relief should not be used to remedy persistent competitive harm;
- the remedy should preserve competition, not protect competitors;
- the risk of a failed remedy should fall on the merging parties, not on consumers; and
- the remedy must be enforceable.
While the Biden Administration accepted non-discrimination behavioural remedies to address vertical mergers, while allowing such mergers to achieve efficiencies, the Manual articulates a strong preference for divestitures in lieu of conduct remedies, stating that ‘structural relief is the appropriate remedy for both horizonal and vertical mergers’.
Also outlined are ‘red flags’ suggesting that a remedy may not be acceptable:
- divestiture of less than a stand-alone business;
- mixing and matching of assets from merging parties;
- allowing the parties to retain critical intangible assets that may make it more difficult for the divestiture buyer to differentiate its product or reduce its incentive to compete;
- ongoing entanglements between the merging parties and the divestiture buyer that may leave the divestiture buyer dependent on the merged firm; and
- substantial regulatory or logistical hurdles.
With increased scrutiny of potential remedies comes lengthier merger reviews. Under the Biden Administration, parties to transactions that may require a divestiture should expect a longer and more rigourous review.
Multilateral task force formed to review pharmaceutical merger enforcement
In spring 2021, the FTC announced a Multilateral Pharmaceutical Merger Task Force (the Task Force) to modernise the agencies’ approach to analysing the effects of pharmaceutical mergers.
The Task Force, comprised of antitrust enforcement authorities around the globe, includes the FTC, Canada’s Competition Bureau, the European Commission Directorate General for Competition, the UK’s Competition and Markets Authority, the DOJ’s Antitrust Division, and offices of State Attorneys General. According to then-Acting Chair Slaughter:
[i]n the face of skyrocketing drug prices and ongoing concerns about anticompetitive conduct by pharmaceutical companies, we need to ensure that our investigations fully capture the potential impact on prices, quality, access, drug supply chain resilience, capital market investment, and innovation for new drugs. 
The Task Force has announced three goals: (1) explore ‘new or refreshed theories of harm to address all anticompetitive effects’ from pharmaceutical mergers, acquisitions, joint ventures and consolidation; (2) explore what evidence may be relevant to determine whether a merger gives rise to competition concerns and, where applicable, sustain a challenge should the agencies seek to block these mergers; and (3) consider potential remedies to resolve competition concerns, such as the feasibility and effectiveness of divestitures under new or refreshed theories of harm.
Commissioners Slaughter and Chopra have been vocal critics of FTC pharmaceutical merger decisions over the last several years. In a 2019 dissent in response to the Bristol-Myers Squibb/Celgene merger, for instance, Slaughter expressed concern about branded drug prices rising, pharmaceutical merger activity continuing, and anticompetitive conduct such as ‘pay-for-delay settlements’ of patent litigation and product hopping. She argued, ‘the Commission should more broadly consider whether any pharmaceutical merger is likely to exacerbate anticompetitive conduct by the merged firm or to hinder innovation.’
Chopra expressed concern about the FTC’s approval of AbbVie’s 2020 acquisition of Allergan, with divestitures, stating that ‘the agency’s default strategy of requiring merging parties to divest overlapping drugs is narrow, flawed, and ineffective’ and ‘misses the big picture, allowing pharmaceutical companies to further exploit their dominance, block new entrants, and harm patients in need of life-saving drugs’. He argued that looking for product overlaps and then accepting risky or questionable buyers to eliminate them is not sound competition policy. He complained specifically that the divestiture buyer, Nestlé, was not a pharmaceutical manufacturer but a ‘maker of KitKats and Tidy Cats’. He offered that:
[t]he Commission should improve its approach to analyzing mergers where new market entrants drive innovation, enhance our divestiture buyer evaluation process by including staff with financial and technical expertise, strengthen our coordination and cooperation with state attorneys general in merger investigations, and provide greater transparency to the public about the scope of merger reviews and remedies. 
More recently, Chopra said that he found it ‘deeply troubling’ that ‘[i]nstead of allocating resources to conduct robust investigations covering the full range of anticompetitive effects of mergers, Commissioners have generally been comfortable with superficial analyses of product overlaps resolved by settlements with a narrow set of divestitures.’ 
The current chair Lina Khan is likely to take up the torch of her former boss and continue the drumbeat of concerns about the FTC’s methodology for both analysing pharmaceutical mergers and divestitures. Pharmaceutical industry mergers will no doubt be closely scrutinised over the next few years and new theories of anticompetitive harm may be trotted out, but those theories will have to stand up to scrutiny, if companies make the FTC prove its case in court.
The FTC targets life sciences in vertical merger challenge
The FTC brought suit in March 2021 seeking to block Illumina’s proposed US$7.1 billion acquisition of Grail, the first FTC litigation challenge to a vertical merger in over 40 years.
Illumina, a producer of next-generation DNA sequencing (NGS) platforms, proposes to acquire Grail, a company developing a multi-cancer early detection (MCED) test founded by Illumina and spun off in 2017.
The FTC alleges that the acquisition would substantially lessen competition by ‘diminishing innovation and potentially increasing prices and reducing the choice and quality of MCED tests’. According to the FTC, ‘Illumina’s NGS platforms are an essential input for the development and commercialization of MCED tests’ and that ‘[a]s the only supplier of a critical input, Illumina already possesses the ability to foreclose or disadvantage Grail’s MCED rivals.’  The FTC alleges that:
[i]f Illumina determined it would maximize its profits by limiting the competitiveness of an MCED test that posed a threat to Grail . . . it could (1) raise the test developer’s prices for NGS instruments and consumables, (2) impede the rival’s research and development efforts by denying important technical assistance and other proprietary information needed to obtain FDA approval or design a commercially successful MCED test, or (3) refuse or delay the execution of a license agreement required to sell distributed in vitro diagnostic (“IVD”) versions of the test (or offer the license on terms that would restrict the competitiveness of the rival’s IVD test).
In response, Illumina and Grail argue that the transaction will ‘accelerate the development, approval and adoption of a revolutionary blood test that can simultaneously detect more than 50 cancers, over 45 of which have no approved screening test today’. The companies also emphasise that the ‘merger will not lead to any form of foreclosure or higher prices of any potential rival to GRAIL who is, or may become, an Illumina customer’ because ‘a foreclosure strategy would cause significant losses from reduced sales of Illumina’s upstream sequencing products, and there is no basis to predict that those losses would be offset by diversion of sales of unknown future rivals.’
After the FTC filed suit, the European Commission exercised jurisdiction under an interpretation of its laws that allows it to review transactions that are referred by a member state even when the member state does not have jurisdiction to review the transaction. In response to the EC’s announcement, Illumina stated ‘[w]e do not believe that the European authorities have jurisdiction to review the GRAIL acquisition and look forward to resolving this matter expeditiously.’ Following the EC’s announcement, the FTC filed a motion to dismiss its request for preliminary relief, asserting that the deal could not close imminently given the EU investigation and so a preliminary injunction was no longer necessary.
Acquisitions of ‘nascent’ competitors on the FTC and DOJ’s radar
One of the most significant trends in US merger enforcement is the focus on acquisitions by incumbent firms of emerging or nascent competitors, especially in high-tech and life sciences. Both the DOJ and FTC are laser focused on markets allegedly dominated by established players that are being disrupted by new technologies and business models.
In November 2020, the DOJ sued to block Visa’s proposed US$5.3 billion acquisition of Plaid, an emerging fintech player that DOJ alleged ‘does not compete directly with Visa today’, but that the DOJ asserted is ‘a nascent competitor developing a disruptive, lower cost option for online debit payments’ and is ‘uniquely positioned’ to challenge Visa’s online debit business in the future. In December 2020, the FTC sued to block Procter & Gamble’s acquisition of start-up Billie, a direct-to-consumer seller of women’s razors and body care. The FTC alleged that Billie had grown rapidly, that in response P&G had introduced its own DTC razor brand, and asserted the acquisition would ‘eliminate [an] innovative nascent competitor’. Both transactions were abandoned in the face of the government’s challenges.
The FTC and 46 state attorneys general brought suit against Facebook in December 2020 alleging that the social media company ‘has maintained its monopoly position by buying up companies that present competitive threats and by imposing restrictive policies that unjustifiably hinder actual or potential rivals that Facebook does not or cannot acquire’. Challenging Facebook’s 2012 acquisition of Instagram and its 2014 acquisition of WhatsApp, the lawsuit alleged that ‘Facebook moved to squelch those threats by buying the companies.’ Facebook moved to dismiss the complaint, arguing that: the section 2 claim fails to establish a plausible relevant antitrust market; the complaint failed to allege facts establishing monopoly power; the complaint did not allege actionable exclusionary conduct; and the plaintiffs lack authority to maintain the lawsuit.
Facebook subsequently pointed to the Supreme Court’s April 22 ruling in AMG Capital v FTC, which found that the FTC lacks authority to maintain a suit in federal court for restitution or disgorgement before prosecuting a case through its administrative proceedings. Because the FTC is challenging consummated acquisitions, Facebook argued that the FTC lacks authority to bring the case in federal district court. In response, the FTC argued that it ‘seeks prospective injunctive relief to remedy an ongoing violation of the law’ and that the AMG court affirmed that the FTC is authorised to ‘seek such relief in federal court’.
In June 2021, the district court dismissed the FTC and states’ challenge. The court found that ‘[t]he FTC has failed to plead enough facts to plausibly establish a necessary element of all of its Section 2 claims – namely, that Facebook has monopoly power in the market for Personal Social Networking (PSN) Services.’ While the court gave the FTC 30 days to file an amended complaint, the court cautioned that as it relates to the challenge to Facebook’s policy of refusing interoperability permissions with competing apps that occurred in 2013, ‘the FTC lacks statutory authority to seek an injunction “based on [such] long-past conduct”.’ Quoting the AMG court, the district court stated that ‘given that [section 13(b)’s] requirement that the defendant “is violating” or “is about to violate” (not “has violated”) the antitrust laws, it contemplates “relief that is prospective, not retrospective.”’ However, the court found that ‘the agency is on firmer ground in scrutinizing the acquisitions of Instagram and WhatsApp, as the Court rejects Facebook’s argument that the FTC lacks authority to seek injunctive relief against those purchases.’
At the same time, the district court dismissed the states’ challenge in its entirety. The court concluded, among other things, that the states’ ‘attacks on Facebook’s acquisitions are barred by the doctrine of laches, which precludes relief for those who sleep on their rights’.
As concern continues to grow about dominant firms engaging in ‘killer acquisitions’ of nascent competitors, we can expect to see challenges to future acquisitions of nascent competitors.
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 id. at 3.
 id. at 42.
 id. at 3.
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