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

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

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 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 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 Department of Justice (DOJ) lost its third jury trial in its mission to secure criminal convictions against companies and executives accused of labor-side antitrust violations on March 22, 2023, when a jury in Maine acquitted four home healthcare staffing executives of violating Section 1 of the Sherman Act. In United States v. Manahe, the DOJ charged Faysal Kalayaf Manahe, Yaser Aali, Ammar Alkinani, and Quasim Saesah with entering into an approximately two-month conspiracy between April and May 2020 not to hire each other’s caretakers and to fix caretaker wages.[1] After the district court declined to dismiss the indictment, holding the DOJ had successfully alleged a per se conspiracy to fix wages and allocate employees, the case proceeded to a two-week trial. At trial, defendants—all immigrants from Iraq, many of whom served as translators for U.S. forces there—admitted that they discussed setting wage levels and refraining from hiring each other’s employees, and even drafted an agreement with signature lines that outlined the terms of defendants’ discussions.[2] Defendants argued that they never reached an agreement in violation of Section 1 because the draft agreement was never signed. Defense counsel emphasized in opening statements that in defendants’ culture, “when dealing with business matters . . . the only way to confirm a commitment is to put it into a formal written contract.” Given the verdict, it appears the jury agreed.Continue Reading DOJ Loses Third Consecutive Antitrust Labor Trial

What Happened?

On Friday, February 3, the Department of Justice, Antitrust Division (the “DOJ”) announced its withdrawal of three policy statements on health care antitrust enforcement: (1) The Department of Justice and Federal Trade Commission Antitrust Enforcement Policy Statements in the Healthcare Area (Sept. 15, 1993); (2) The Department of Justice and Federal Trade Commission Statements of Antitrust Enforcement Policy in Healthcare (Aug. 1, 1996); and (3) The Department of Justice and Federal Trade Commission Statement of Antirust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (Oct. 20, 2011) (together, the “Healthcare Statements”). It has been reported that the Federal Trade Commission (the “FTC”), which shares antitrust enforcement authority with the DOJ (together the “Agencies”), intends to withdraw the Healthcare Statements as well. Assuming the FTC follows the DOJ’s lead, the withdrawal of the Healthcare Statements may be the most significant antitrust enforcement development under the Biden Administration to date and is likely the most significant healthcare antitrust development in decades.Continue Reading Department of Justice Withdraws Key Healthcare Antitrust Policy Statements

It is widely reported that healthcare is a top antitrust enforcement priority in the U.S. The healthcare industry has undergone a transformation over the over the last twenty years and now comprises 17.7% of the U.S. gross domestic product and over $3.795 trillion of the U.S. government budget. Mega-deals among national payors and household names have grabbed headlines and been targets of enforcement by the U.S. Department of Justice, Antitrust Division (the “DOJ”) and Federal Trade Commission (“FTC”) (collectively, “the Agencies”). Continue Reading Private Equity & Healthcare: Antitrust Enforcement in 2023–PE Roll-Ups in the Cross Hairs

Representing a sizable portion of the American economy, few industries in the United States have received more attention from the press, legislators, and antitrust agencies than the healthcare industry—particularly in recent years. Recent developments at the Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) reaffirm that healthcare remains a top antitrust enforcement priorities in the United States.Continue Reading U.S. Healthcare Industry Remains Antitrust Enforcement Priority

The AHLA’s Annual Meeting held June 27-29 in Chicago reunited healthcare attorneys across the country. The diverse group of attendees were eager not only to reconnect in-person, but also to process the changes that the now-easing pandemic has brought to all corners of the healthcare industry. The conference presenters grappled in real-time with the transitory nature of the healthcare landscape today, including the significant role that technology has played in driving shifts in care delivery. The panel discussions assessed which changes to healthcare delivery and reimbursement would continue after the pandemic, and in what format.Continue Reading Recap of AHLA’s Annual Meeting