The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug and biosimilar competition. In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler device and dose counter, rather than the drug itself, were improperly listed and has asked the court for judgment on the pleadings and an order to delist the patents at issue.Continue Reading FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

On March 5, 2024, the Federal Trade Commission (“the FTC”) hosted a public workshop titled “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care”, which covered the impact of private equity investment on the health care system. The workshop included panelists from the FTC, the Department of Justice (“the DOJ”), the Department of Health and Human Services (“HHS”) (together, “the Agencies”), academic thought-leaders, and health care professionals. On the same day as the workshop the Agencies launched a “Cross-Government Inquiry on Impact of Corporate Greed in Health Care,” issuing a Request for Information (“RFI”) seeking public comment on health care deals involving private equity firms, including deals that would not be reportable under the Hart-Scott-Rodino Act. The Agencies will use the RFI to inform future enforcement and policy decisions related to health care consolidation. The public has 60 days to submit comments to the Agencies.Continue Reading The FTC Hosts Workshop on Private Equity in Health Care

On December 18, 2023, the Federal Trade Commission and Department of Justice (the “Agencies”) jointly issued Final Merger Guidelines, following a public comment period on the Proposed Merger Guidelines first issued in July. The Final Merger Guidelines update and replace the 2010 Horizontal Merger Guidelines and the rescinded 2020 Vertical Merger Guidelines. The Final Merger Guidelines kept important components from the Proposed Merger Guidelines (e.g., lower thresholds rendering certain transactions presumptively illegal, focus on cumulative effects of multiple acquisitions, etc.). Among the most significant developments from prior iterations of the merger guidelines are the adoption of a market share threshold in determining when a transaction is presumed to be illegal, expansion of the concept of vertical mergers to include mergers involving “related” products or services, and formal espousal of the current Administration’s focus on the impact of mergers on labor.Continue Reading The Wait is Over: DOJ and FTC Issue Final Merger Guidelines

Last week the Federal Trade Commission (FTC) issued a press release highlighting recent and forthcoming actions by the FTC, Department of Justice (DOJ), and the Department of Health and Human Services (HHS), which they say will further promote competition, thereby lowering costs and increasing the quality of care in the U.S. health care market. In addition to highlighting recent actions by each of the agencies (e.g., the FTC’s proposed non-compete rule), the release states that the three agencies are entering into new partnerships to increase interagency cooperation and advance a “whole-of-government” approach to protect health care competition, including:Continue Reading FTC, DOJ, and HHS Announce Interagency Initiatives to Promote Healthcare Competition

On November 21, 2023, the Federal Trade Commission (“the FTC”) announced its approval of an omnibus resolution authorizing the use of compulsory process for nonpublic investigations concerning products or services that use artificial intelligence (“AI”). Compulsory process refers to information or document requests, such as subpoenas or civil investigative demands, for which compliance is enforceable by courts. Recipients who fail to comply with compulsory process may face contempt charges.Continue Reading AI Enforcement Update: FTC Authorizes Compulsory Process for AI Investigations

On June 27, 2023, the FTC and DOJ (together the “Agencies”) announced a notice of proposed rulemaking (“NPRM”) proposing extensive revisions to both the rules that implement the Hart-Scott-Rodino Antitrust Improvements Act (the “Act” or “HSR Act”) and the Premerger Notification and Report Form (the “Form”) that merging parties must submit under the Act. Our previous analysis of the NPRM is covered here.Continue Reading Mergers & Acquisitions Update: A Closer Look at the Impact of the FTC and DOJ’s Proposed HSR Act Filing Reform on Private Equity Firms

On September 21, 2023, the Federal Trade Commission (FTC) sued Welsh, Carson, Anderson & Stowe (WCAS) and U.S. Anesthesia Partners, Inc. (USAP), in the Southern District of Texas, alleging the two companies “[e]xecuted a multi-year anticompetitive scheme to consolidate anesthesiology practices in Texas, drive up the price of anesthesia services provided to Texas patients, and boost their own profits.”Continue Reading FTC Sues Private Equity Firm and Anesthesiology Practice for Antitrust Violations

On August 16, 2023, the Federal Trade Commission (“the FTC”) marked its first enforcement action of the prohibitions on interlocking directorates under Section 8 of the Clayton Act in over 40 years. Section 8 prohibits an officer or director of one firm from simultaneously serving as an officer or director of a competing firm under most circumstances.[1] The FTC accepted for public comment a consent order conditioning the 5.2 billion dollar cash‑and-stock deal between two rival natural gas producers on preventing “entanglements between the two companies and the exchange of confidential, competitively sensitive information.” Under the consent order, Quantum Energy Partners (“Quantum”) representatives may not serve on EQT Corporation’s (“EQT”) Board of Directors and must divest its EQT shares. The consent order also unwinds a pre-existing joint venture between the two entities and imposes additional restraints to protect competition.Continue Reading Antitrust Enforcement Agencies Continue to Target Interlocking Directorate Arrangements

As generative AI becomes an increasingly integral part of the modern economy, antitrust and consumer protection agencies continue to raise concerns about the technology’s potential to promote unfair methods of competition. Federal Trade Commission (“the FTC”) Chair Lina Khan recently warned on national news that “AI could be used to turbocharge fraud and scams” and the FTC is watching to ensure large companies do not use AI to “squash competition.”[1] The FTC has recently written numerous blogs on the subject,[2] signaling its intent to “use [the FTC’s] full range of tools to identify and address unfair methods of competition” that generative AI may create.[3] Similarly, Jonathan Kanter, head of the Antitrust Division at Department of Justice (“the DOJ”), said that the current model of AI “is inherently dependent on scale” and may “present a greater risk of having deep moats and barriers to entry.”[4] Kanter recently added that “there are all sorts of different ways to deploy machine learning technologies, and how it’s deployed can be different in the healthcare space, the energy space, the consumer tech space, the enterprise tech space,” and antitrust enforcers shouldn’t be so intimidated by artificial intelligence and machine learning technology that they stop enforcing the laws.[5]Continue Reading AI Under the Antitrust Microscope: Competition Enforcers Focusing on Generative AI from All Angles

On July 19, 2023, the Federal Trade Commission and Department of Justice jointly published long-anticipated proposed merger guidelines (the “Proposed Merger Guidelines”), which had been expected since President Biden issued an Executive Order Promoting Competition in the American Economy in the summer of 2021. According to the agencies, the Proposed Merger Guidelines “build upon, expand, and clarify” the prior guidance,[1] to keep up with “modern” market realities.[2] In contrast to the previous versions, the Proposed Merger Guidelines cover both horizontal and vertical mergers. They also cite case law for the first time.[3] Reflecting the Biden Administration’s views on federal antitrust merger enforcement, the Proposed Merger Guidelines substantially expand the types of competitive harm the agencies consider grounds for challenging a transaction under Section 7 of the Clayton Act (which prohibits mergers where the effect is “substantially to lessen competition” or “to tend to create a monopoly”).[4]Continue Reading A Big Deal: FTC and DOJ Issue Long-Awaited New Draft Merger Guidelines

The FTC announced today a notice of proposed rulemaking (“NPRM”)[1] proposing extensive revisions to both the rules that implement the Hart-Scott-Rodino Antitrust Improvements Act (the “Act” or “HSR Act”), and the Premerger Notification and Report Form (the “Form”) that merging parties must submit under the Act. The NPRM would also implement the Merger Filing Fee Modernization Act of 2022. Continue Reading Notice of Proposed Rulemaking: FTC Proposes to Redesign and Dramatically Expand the Scope of the HSR Act Filing Process