Antitrust Agency Insights: Developments at the U.S. Antitrust Enforcement Agencies — Third Quarter 2023

Successfully navigating antitrust agency investigations requires a familiarity with Department of Justice and Federal Trade Commission processes, as well as insight into those agencies and their leaderships’ current priorities for enforcement and competition policy. This newsletter will provide periodic updates on both, offering an analytical look at how the antitrust agencies are approaching important competition issues and what current investigations may mean for potential future enforcement. We hope our experience — both inside and outside these agencies — will provide insights that help you make more informed decisions for your business.

Letter From the Editors

FTC To Investigate Patents Improperly Listed in the FDA’s Orange Book as Anti-Competitive Practices

On September 14, the Federal Trade Commission (FTC) issued a policy statement¹ outlining the circumstances in which the act of listing patents in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” catalog, also known as the Orange Book, can violate Section 5 of the FTC Act as an unfair method of competition. The FTC announcement came with a statement of support from the FDA citing the agencies’ history of collaboration and their shared engagement under President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy.² 

Background

Under the Hatch-Waxman Act,³ pharmaceutical manufacturers that submit new drug applications (NDAs) to the FDA are also required to provide the FDA with details of certain patents covering their new drugs. Specifically, manufacturers are required to submit patents that either (1) claim to be a drug substance (active ingredient) or drug product (formulation or composition) patent for which the NDA is sought or (2) claim to be a method of using a drug for which approval is sought or has been granted. The NDA holder who submits the patent information is responsible for ensuring its submission is consistent with the Orange Book listing requirements.

As part of the abbreviated NDA filing process, a company seeking FDA approval for a generic version of a branded drug must certify for each unexpired patent listed in the Orange Book that the brand company’s patent is either invalid or will not be infringed by the generic version. These so-called Paragraph IV certifications are themselves considered an act of infringement and allow the branded drug manufacturer to sue the generic manufacturer for patent infringement and trigger a 30-month stay of the approval of the generic or follow-on drug to allow time for the infringement litigation to run its course.

The FTC’s Policy Statement

The FTC’s policy statement articulated a purported concern that, due to the regulatory framework surrounding the Orange Book, patents that are listed improperly by brand drug manufacturers may “disincentivize investments in developing a competing product and increase the risk of delayed generic and follow-on product entry…”⁴ The FTC asserts that the potential for a 30-month stay before approval of a generic or follow-on product can, if abused (through an improperly listed patent), artificially limit competition, potentially keep prices high, and limit patient access to important medicines. However, the FTC does not provide specific guidance as to what it would view as an improper listing beyond listings “that do not meet the statutory criteria.”⁵

According to the FTC, improper listings may constitute an unfair method of competition. Specifically, (1) the FTC “views the improper listing of patents in the Orange Book as a method of competition” undertaken by brand drug manufacturers, rather than an inherent market condition and (2) such improper listings “can be unfair because it is not competition on the merits of drug quality or price, and it tends to negatively affect competitive conditions by impeding opportunities for generic rivals to compete, thus limiting consumer choice.”⁶ Finally, such improper listings can be conduct that results “in direct evidence of harm, or likely harm to competition, that does not rely upon market definition,” which the FTC asserts is consistent with the historical exercise of its Section 5 authority.⁷

The FTC’s policy statement also notes that it may use other tools to address what it views as abuse of the Orange Book system. Specifically, the policy statement warns that improper listing of patents in the Orange Book may constitute illegal monopolization in violation of Section 2 of the Sherman Act and that it would also scrutinize a firm’s history of improperly listing patents during merger reviews. Finally, the FTC advised NDA holders with patents improperly listed in the Orange Book to immediately remove the patents or risk referral to the Department of Justice for potential criminal investigation based on a false certification filed in relation to the Orange Book listing.⁸

Key Takeaways 

This policy statement neither binds courts nor changes the law. It is, however, consistent with the statement the FTC issued on Nov. 10, 2022, on its enforcement of Section 5 of the FTC Act.⁹ As we have previously written,¹⁰ that policy statement will have to be tested in federal courts for the public to understand its true significance, and the same is true for this policy statement as well. 

Despite the FTC’s assertions that the policy statement’s positions are consistent with past FTC practice, the FTC’s support for that proposition seems misguided. Specifically, the policy statement relies on quick-look cases involving horizontal agreements that unreasonably restrained trade.¹¹ Submitting an Orange Book listing is, however, unilateral conduct, and a challenge to unilateral conduct without proof of dangerous probability of monopolizing a properly defined relevant market would represent an interpretation of Section 5 that marks a dramatic departure from Section 2 of the Sherman Act. ¹² 

While the courts sort out the legal analysis of the FTC’s position, brand pharmaceutical manufacturers must be cognizant of the potential risks when listing patents in the Orange Book. While NDA holders that submit patent information are already required to attest under penalty of perjury that their submission is proper, this policy statement provides an indication that the government is paying even closer attention to these listings going forward. NDA holders would be well advised to make sure that future Orange Book listings abide by the letter of the law¹³ and to review their current listings to ensure that they are also properly included in the Orange Book and may not be viewed as unfairly restricting competition.

FTC Action on Interlocking Directorates in Natural Gas Sector Includes Warning on Signaling

On August 16, the FTC approved a consent order resolving the first case it has brought in 40 years under Section 8 of the Clayton Act, which prohibits interlocking directorates between competitors in certain circumstances. According to the FTC, the consent order is, among other things, designed to prevent the exchange of competitively sensitive information between Quantum Energy Partners and EQT Corporation, which allegedly compete in the production and sale of natural gas in the Appalachian Basin.¹⁴ EQT had announced that it would purchase oil and gas assets from two entities backed by the same private equity firm, Quantum, for US$5.2 billion split between cash and stock. The FTC’s consent order is a partly structural remedy, requiring the winding down of a joint venture between Quantum and EQT, and focused on the potential anti-competitive effects of Quantum becoming one of EQT’s largest shareholders with a seat on its board.

We have already discussed the remedy regarding interlocking directorates¹⁵ but want to draw attention to one less apparent highlight in the FTC’s case.¹⁶ The FTC’s complaint characterizes the production and sale of natural gas as having “a high degree of observable behavior and interrelationships between producers,” resulting in “multiple touch-points between producers.”¹⁷ According to the FTC, this leads to competitors having “ample means and opportunity to access and share competitively sensitive information” about the current and future drilling activity between rivals.¹⁸ The complaint notes that the means and opportunity include public signals about the producers’ preferred level of production.

The FTC alleged that EQT specifically “has been a leading voice” in the public signaling about maintaining the current level of production and exercising “capital discipline” across the industry.¹⁹ According to the FTC, the risk from this public signaling is “exacerbated by a dense and tangled web of co-investments, joint operations, and other methods of collaboration, between and among natural gas producers and investors in the Appalachian Basin and across the country.”²⁰

Key Takeaways

The FTC was clearly focused on interlocking directorate concerns in assessing the transaction between EQT and Quantum. It does not appear from the public materials that the cited public statements about production levels and the interwoven nature of competition in the industry were the genesis of the FTC’s complaint. But the FTC’s inclusion of these facts in its complaint demonstrates once again that government focus on signaling, particularly in concentrated sectors, is ongoing. It is therefore important to be mindful of regarding potential signaling concerns in the context of public statements about output as well as price. Finally, when a company is in front of the agencies in the context of a proposed transaction, the FTC is likely to consider potential signaling to competitors as an issue to be addressed in merger reviews.

Additional Agency Updates

FTC Staffing Updates

• FTC names new Director of the Bureau of Competition. On August 22, the FTC announced the appointment of its new Director of the Bureau of Competition, Henry Liu. Liu was most recently a partner at Covington & Burling LLP in its antitrust and litigation practice groups and previously clerked on the U.S. Court of Appeals for the Sixth Circuit.
  • Read the Press Release

• Senate holds hearing for FTC commissioner nominees. The U.S. Senate Commerce, Science, and Transportation Committee held a hearing on September 20 to consider the nominations of three FTC commissioner nominees. Current Commissioner Rebecca Slaughter, who was renominated by President Biden for a second term, joined Republican nominees Melissa Holyoak and Andrew Ferguson at the hearing. If the three are confirmed, the FTC will reach its full membership of five commissioners. The full committee vote has not yet been scheduled.
  • Read the Senate Hearing Notice

FTC Cases and Proceedings

• By a 3-0 vote, the FTC filed an amicus brief in Applied Medical Resources Corp. v. Medtronic Inc. supporting a practical-effect-on-competition analysis for exclusive dealing arrangements. On July 3, the FTC filed an amicus brief in the Central District of California, clarifying the legal standard applicable to antitrust cases involving exclusive-dealing and bundling arrangements. The FTC’s amicus brief does not take a position on the substance of Applied Medical’s claims. The agency attacks arguments in Medtronic’s motion to dismiss Applied Medical’s complaint, arguing that the motion relies on formalistic distinctions and “mere labels” in its arguments. Per the FTC, under Supreme Court precedent, the core issue when assessing an exclusive dealing arrangement is the practical effect on competition. While buyers may receive a discount for bundled goods, that label may be a supplier’s “self-serving description that enables no consumer to receive a lower price.”
  • Read the Press Release
  • Read the Brief

• FTC dismisses complaint against Altria and Juul, vacating its ALJ’s initial decision. On June 30, the FTC vacated its administrative law judge’s (ALJ) initial decision and dismissed its complaint against Altria Group Inc. over its purchase of 35% of Juul Labs Inc. in December 2018. While vacating that initial decision and removing it as precedent for future cases, the FTC purported to clarify several matters of law raised by the ALJ’s initial decision.
  • Read the Press Release
  • Read our Advisory

• FTC sues to stop healthcare data provider IQVIA from buying Propel Media. The FTC filed an administrative complaint and sought a temporary restraining order and preliminary injunction to stop IQVIA Holdings Inc. from buying Propel Media Inc. (PMI) on July 17. The FTC alleges that IQVIA’s Lasso Marketing and PMI’s DeepIntent are two of the three top providers of programmatic advertising (or demand-side platforms) that target healthcare professionals with advertising for pharmaceuticals and other healthcare products, and that their combination would eliminate head-to-head competition.
  • Read the Press Release
  • Read the Administrative Complaint

• Surescripts and FTC settle allegations of illegal monopolization. On July 27, the FTC voted 3-0 to accept a proposed settlement with Surescripts, the health technology company. The FTC sued Surescripts in 2019, alleging that the company used anti-competitive restraints such as exclusive agreements, loyalty payments, and threats to illegally monopolize e-prescription routing (transferring prescriptions from healthcare providers to pharmacies) and eligibility (checking patient insurance information) services. The settlement order will last 20 years and involves prohibiting Surescripts from imposing majority share requirements on its routing and eligibility services customers, prohibits Surescripts from preventing its customers from promoting competitors’ services or communicating with its competitors, and prohibits Surescripts from discriminating against or threatening customers who refuse to agree to a majority share requirement, along with other prohibitions. The stipulated order received court approval on August 9.
  • Read the Press Release
  • Read the Stipulated Order

• Medical device manufacturer CooperCompanies terminates its planned acquisition of Cook Medical’s reproductive health business following FTC investigation. On August 1, the FTC celebrated Cooper Companies Inc.’s termination of its plan to acquire Cook Medical Holdings LLC and called that decision a win for patients that protects competition. The planned transaction had been announced in February 2022. CooperCompanies had agreed to pay US$675 million for Cook Medical’s reproductive health business, which makes minimally invasive medical devices focused on fertility, obstetrics, and gynecology.
  • Read the Press Release 

• Intercontinental Exchange and Black Knight settle FTC concerns over mortgage technology deal. On August 31 the FTC announced that it approved a proposed consent order that will resolve its concerns related to Intercontinental Exchange Inc.’s (ICE) acquisition of Black Knight Inc., a mortgage technology firm that offers loan origination systems. The FTC alleged that the deal would combine the two top mortgage technology providers, reducing competition in the mortgage origination process. As a part of the consent order, Black Knight will divest its Optimal Blue and Empower businesses to third party Constellation Web Solutions Inc., another provider of mortgage-related tools and software. Black Knight and ICE are required to maintain the businesses’ viability until the divestiture and provide Constellation with transition assistance. The companies are further required to seek prior approval from the FTC before either reacquiring divested assets or acquiring an interest in another loan origination system business, as well as other requirements. 
  • Read the Press Release
  • Read the Consent Order

• Federal court rules that state approval of Louisiana hospital merger prevents FTC scrutiny. On September 27, Eastern District of Louisiana Judge Lance Africk granted summary judgment to the State of Louisiana and two hospital systems, agreeing with them that the issuance of a certificate of public advantage (COPA) by the Louisiana Department of Justice permitted one hospital system, Louisiana Children’s Medical Center, to purchase three facilities from the other system, HCA Healthcare Inc., without notifying federal authorities under the Hart-Scott-Rodino Act. The court reasoned that under Supreme Court precedent, the state action doctrine allowed Louisiana’s COPA to exempt the transaction from federal antitrust laws, and that there was “no reason to subject a merger exempt from Section 7 to a waiting period and filing requirements designed to allow the FTC to determine whether that merger may violate Section 7.”
  • Read the Order

DOJ Cases and Proceedings

• Two Pinterest directors resign from Nextdoor’s board of directors following DOJ enforcement against interlocking directorates. On March 15, 2022, Nextdoor, the hyperlocal, neighborhood-based social media network, identified Pinterest, the image-sharing social media site, as a competitor in its 10-K filing. At the time, two individuals served on both companies’ boards of directors. After the DOJ raised concerns about this arrangement, the two directors resigned from the Nextdoor board without admitting any fault. The DOJ issued a press release on these resignations, citing its ongoing enforcement efforts related to Section 8 of the Clayton Act (which prohibits interlocking directorates among competitors) on August 16, the same day the FTC announced its first Section 8 enforcement action in 40 years.
  • Read the Press Release
  • Read our Advisory

• Generic pharmaceutical companies settle DOJ price-fixing charges. On August 21, the DOJ announced that it had reached deferred prosecution agreements with generic drug manufacturers Teva Pharmaceuticals USA Inc. and Glenmark Pharmaceuticals Inc. These agreements resolved the DOJ’s criminal charges, with the companies admitting to participating in price-fixing conspiracies for certain medicines. As part of the agreements, Teva will pay a US$225 million criminal penalty and make a US$50 million drug donation to humanitarian organizations that provide drugs to Americans in need; Glenmark will pay a US$30 million criminal penalty. The companies will also need to abide by other remedial measures, including the divestiture of their drug lines for pravastatin (a cholesterol medicine), for which both Glenmark and Teva admitted to conspiring to fix prices. Teva also admitted to participating in price-fixing conspiracies for other essential medicines as well, including clotrimazole and tobramycin. The DOJ noted that Teva’s criminal penalty of US$225 million is the largest to date for a domestic antitrust cartel.
  • Read the Press Release

• Two military contractors sentenced for bid-rigging for maintenance and repair of tactical vehicles. On August 23, two owners of military contractor companies were sentenced in Texas for their roles in rigging bids for government contracts for the repair and maintenance of heavy military equipment. One individual was sentenced to 18 months in prison and a fine of $50,000, while the other was sentenced to six months in prison and a fine of $300,000. They each were charged with participating in the conspiracy between 2013 and 2018.
  • Read the Press Release

• Amazon Marketplace DVD and Blu-Ray sellers and companies sentenced for price-fixing. The DOJ announced on August 23 that four companies and five individuals were sentenced after pleading guilty for their roles in fixing prices in the market for DVD and Blu-Rays sold through Amazon Marketplace storefronts. The sentences ranged from one to 18 months in prison and fines of up to $38,000 for the individuals and $234,000 for the companies.
  • Read the Press Release

• Oncologist pleads guilty to suppressing competition for cancer treatments in Southwest Florida. On August 24, Dr. William Harwin pled guilty to participating in a conspiracy between 1999 and 2016 to allocate the market for oncology treatments for cancer patients in Southwest Florida. According to court documents, Harwin participated in a conspiracy in three counties where the oncology practice at which he was formerly president and managing partner, Florida Cancer Specialists & Research Institute LLC (FCS), would offer chemotherapy treatments while another practice would offer radiation treatments. FCS was charged for its role in the criminal conspiracy in April 2020, resulting in a deferred prosecution agreement and the payment of a US$100 million criminal penalty.
  • Read the Press Release

• Multiple guilty pleas in asphalt paving bid-rigging case. On August 29, the DOJ announced that a Michigan company, F. Allied Construction Company Inc. (Allied), and its president, Andrew Foster, pled guilty to conspiring with two other unnamed companies and their employees to rig bids for asphalt paving services. This came 12 days after the DOJ had announced that Allied’s vice president of estimating, Kevin Shell, had pled guilty to the same conspiracy. According to the DOJ, Allied and its officers had engaged in these conspiracies between June 2013 and June 2019 and between July 2017 and May 2021, respectively. The two individuals pled guilty to two counts of violating Section 1 of the Sherman Act, the maximum penalty for which is 10 years in prison and a US$1 million criminal fine. The company’s guilty plea could lead to a maximum US$100 million criminal fine. These fines can be increased to twice the gain derived from the crime or twice the loss suffered by the victims if a higher amount. The guilty pleas are a result of an investigation into anti-competitive conduct in the asphalt paving services industry by the DOJ’s Chicago office as well as the Offices of the Inspectors General for the Department of Transportation and the U.S. Postal Service.
  • Read the Press Release

• Guilty plea and sentencing for bid-rigging and fraud at U.S. military bases in South Korea. The DOJ announced on September 12, that J&J Korea, a company in the Republic of Korea, or South Korea, was sentenced to pay US$8.6 million in fines and restitution over its role in a scheme involving rigged bids for repair-and-maintenance subcontract work at U.S. military hospitals in South Korea. The company pleaded guilty in U.S. federal court on May 10 and two of its officers are also under indictment in connection with the scheme.
  • Read the Press Release

• DOJ sues Agri Stats for alleged anti-competitive information exchange among animal protein processors. On September 28, the DOJ filed a lawsuit against Agri Stats Inc., alleging that the company violated Section 1 of the Sherman Act by producing and distributing comprehensive weekly and monthly reports, filled with recent data on sales prices, labor and farmer costs, and output, that often include details by facility or company, and that over 90% of broiler chicken and turkey producers and 80% of pork producers (by sales output) participated in the information exchange. The DOJ further alleges that Agri Stats both knew and encouraged the anti-competitive use of the information it distributed, encouraging processors to both raise prices and reduce supply, and restricted access to its data solely to the participating processors, resulting in a greater information asymmetry. The lawsuit was filed in the District of Minnesota.
  • Read the Press Release
  • Read the Complaint

FTC Policy

• FTC withdraws policy statements on healthcare enforcement. On July 14, the FTC announced its withdrawal of two policy statements it had made on antitrust enforcement in healthcare markets. The first, Statements of Antitrust Enforcement Policy in Health Care, was made in August 1996. The second, Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program, was made in October 2011. In so doing, the FTC described the statements as being largely outdated and “no longer reflect[ing] market realities in this important sector of the economy.” The vote to rescind the statements was 3-0. The FTC pointed to its more recent record of enforcement actions, policy statements, and competition advocacy in healthcare to provide more updated public guidance. The FTC’s announcement follows the DOJ’s announcement in February 2023 on its withdrawal of the same two policy statements. The DOJ’s withdrawal announcement also included a third policy statement made in 1993, which was itself revised by the subsequent 1996 statement, now withdrawn.
  • Read the FTC Press Release
  • Read the DOJ Press Release

• FTC withdraws its prior pharmacy benefit manager advocacy statements and studies. Citing changes to market realities, the FTC voted 3-0 on July 20 to issue a statement cautioning against the public’s reliance on its prior statements and studies relating to pharmacy benefit managers (PBMs). The FTC is currently studying the PBM industry. Until that study is complete, the FTC has distanced itself from nine of its prior statements that had advocated against proposals to increase regulatory oversight and transparency of PBMs as well as a joint report with the DOJ in 2004 and a study in 2005.
  • Read the Press Release

• Department of Labor and FTC to collaborate on anti-competitive practices affecting workers. The FTC and the Department of Labor (DOL) announced on September 21 that they had signed a memorandum of understanding (MOU) that outlines how the agencies will work together to protect workers from unfair, deceptive, and unlawful practices and methods of competition. The MOU highlights labor market concentration, one-sided contract terms, and developments in the gig economy as key issues for collaboration. FTC Chair Lina Khan explained that the FTC and DOL aim to “work collectively to tackle illegal conduct that suppresses wages, reduces access to good benefits and working conditions, and stifles economic liberty for workers across the economy.”
  • Read the Press Release

DOJ Policy

• DOJ to work with Mexico and Canada to detect collusive schemes related to 2026 FIFA World Cup. On September 22, the DOJ announced that it will launch a joint initiative with Mexico’s Federal Economic Competition Commission and Canada’s Competition Bureau to “deter, detect and prosecute collusive schemes related to the provision of goods and services” connected to the 2026 FIFA World Cup. The three countries are jointly hosting the 2026 World Cup.
  • Read the Press Release

Inter-Agency Initiatives

• FTC and DOJ release Draft Merger Guidelines, seek public comment. On July 19, the FTC and DOJ released their long-awaited proposed Draft Merger Guidelines (Draft Guidelines). If finalized, these guidelines will replace the agencies’ joint 2010 Horizontal Merger Guidelines and 2020 Vertical Merger Guidelines. The FTC has already repealed the two prior sets of guidelines, while the DOJ has left them in place. The Draft Guidelines set new presumptions of harm to competition based on market shares, both combined and by a single party, and expand upon prior theories of actual and perceived potential competition. In line with the agencies’ recent actions and statements, the Draft Guidelines pay special attention to the impact mergers may have on labor markets. Arnold & Porter published an Advisory analyzing the Draft Guidelines.
  • Read the FTC Press Release
  • Read the DOJ Press Release
  • Read our Advisory

• DOJ and FTC extend public comment period for proposed changes to Hart-Scott-Rodino form. As we previously discussed, the FTC and the DOJ are proposing changes to the premerger notification form and associated instructions, as well as certain premerger notification rules, that implement the Hart-Scott-Rodino Act. The agencies extended the deadline for public comments on the proposed changes from August 28 to September 27.
  • Read the Press Release
  • Read our Advisory on the Proposed Changes

FTC Speeches

• FTC Chair Khan testifies before U.S. House Judiciary Committee. On July 13, FTC Chair Lina Khan appeared before the U.S. House Judiciary Committee. Her opening statement gave an overview of the agency’s recent actions and policy initiatives, such as proposing a rule against noncompete restrictions and launching an inquiry into the pharmacy benefits management industry.
  • Read the Opening Statement

• FTC Chair Khan speaks to Economic Club of New York. On July 25, FTC Chair Lina Khan spoke to the Economic Club of New York. Khan began by discussing one of the early speakers at the club from 1912, Louis Brandeis, who spoke on promoting competition and stopping monopolization. Khan drew a line between the principles at play in Brandeis’ lecture and those guiding the FTC now, referencing recent actions by the agency.
  • Read the Remarks

© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.