Parties involved in or considering health care transactions in California have been focused on navigating the new rules set by California’s Office of Health Care Affordability (OHCA),[1] and newly proposed legislation could present additional challenges in consummating certain health care transactions, particularly those involving private equity. Introduced in February 2024, California’s Assembly Bill 3129 seeks to curb consolidation in the health care industry allegedly driven by private equity firms and hedge funds. As summarized in greater detail below, the bill would require that these parties obtain prior written consent from California’s Attorney General (AG) before an acquisition or change of control of many types of health care businesses and assets.Continue Reading California’s AB 3129: A New Hurdle for Private Equity Health Care Transactions on the Horizon?

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 January 26, 2024, the State Council of China published the “Regulations of the Filing Threshold for Operators’ Concentration (2024 Revision)” (the “New Filing Threshold”), which took effect on the same day. This amendment to the filing thresholds for operators’ concentration will enhance the allocation of anti-monopoly enforcement resources, and represents another step China takes to improve its competition policy, and foster the development of a more transparent and efficient competition regulatory framework.Continue Reading China Raises Turnover Threshold for Anti-Monopoly Filing in M&A Deals

In 2019, the Department of Justice created the Procurement Collusion Strike Force (PCSF or Strike Force), a joint law enforcement effort to combat antitrust crimes and related fraudulent schemes that impact government procurement, grant, and program funding at all levels of government—federal, state and local. The PCSF is a constellation of partnerships among the Antitrust Division of the U.S. Department of Justice, multiple U.S. Attorneys’ Offices around the country, the Federal Bureau of Investigation (FBI), and the Inspectors General for multiple federal agencies working together to crack down on unlawful anticompetitive activities in the public procurement process. As we have previously discussed,[i] the PCSF has been steadily growing its footprint and focus since its inception in November 2019. Now four years in, the Strike Force continues to add new partners at the Federal, State and global level, boasting of more than 30,000 government officials trained in detection and prosecution of procurement offenses. The Strike Force touts its growing ranks of trained eyes and ears on the ground anywhere government funds are spent. The PCSF is sending an increasingly aggressive enforcement message that should put those engaged with government contracts, federal funds, and procurement officials on high alert.Continue Reading Aggressive Procurement Collusion Enforcement Risk Remains High for 2024

As part of its European Economic Security Package, the European Commission (‘Commission’) has recently proposed a number of legislative proposals and White Papers intended to better protect Europe’s strategic interests. We have covered the wider initiative here.Continue Reading The EU Commission Gets Serious About Foreign Direct Investment Screening

1. Higher Jurisdictional Thresholds For HSR Filings

On January 22, 2024, the Federal Trade Commission announced revised, higher thresholds for premerger filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). The jurisdictional thresholds are revised annually, based on the change in Gross National Product (GNP).Continue Reading Higher Jurisdictional and Filing Fees Thresholds for HSR Act Premerger Notifications and Interlocking Directorates Announced

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