In January, Senator Tammy Baldwin (D-WI) sent letters to companies warning of improper Orange Book listings of patents for inhalers, following up on the FTC’s focus on potential anticompetitive harm of improper listings. According to Senator Baldwin’s letters, the recipients of the letters were warned by the FTC in November regarding the listing of inhaler patents, but have not removed the patents from the Orange Book. The letters follow an investigation launched earlier this month by the Senate Committee on Health, Education, Labor, and Pensions (of which Senator Baldwin is a member) into the prices of inhalers.
Increased Reporting Thresholds for Hart-Scott-Rodino Antitrust Improvements Act
On January 22, 2024, the Federal Trade Commission (FTC) announced increases to the jurisdictional thresholds for premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act (HSR Act). The FTC adjusts the thresholds annually, consistent with changes to gross national product. The announced changes will become effective for filings made or transactions closing 30 days after publication of the revised thresholds in the Federal Register.
FTC and DOJ Issue Highly Anticipated Merger Guidelines
On December 18, 2023, the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) jointly issued new Merger Guidelines. The new guidelines amend, update and replace the numerous versions of merger guidelines previously issued by both agencies, including the 2010 Horizontal Merger Guidelines and the Vertical Merger Guidelines that were issued in 2020 and later withdrawn by the FTC in 2021. Below are our key takeaways, followed by some discussion of how the agencies apply the guidelines and then a deeper-dive into some industry-specific considerations.
Sanofi Terminates Proposed Licensing Agreement with Maze after FTC Complaint
On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the deal.
FTC, DOJ and HHS Promoting Competition in Healthcare Industry
On December 7, 2023, the Federal Trade Commission announced that it, the Department of Justice and the Department of Health and Human Services are collaborating to promote competition, lower healthcare costs and improve the quality and availability of healthcare.
What’s Next for Antitrust Enforcement After DOJ’s No-Poach Prosecution Dismissed?
On November 15, 2023, the U.S. District Court for the Northern District of Texas granted a motion by the U.S. Department of Justice (DOJ) to dismiss indictments in its last remaining criminal no-poach antitrust case, United States of America v. Surgical Care Affiliates, LLC, et al., No. 3:21-cr-00011-L (N.D. Tex. Nov. 15, 2023). The government’s voluntary dismissal of the case—the first criminal no-poach indictment brought by the DOJ in early 2021—could signify the beginning and end of DOJ’s quest to enforce no-poach agreements as per se violations of the Sherman Act.
Companies Receive FTC Notices Alleging Improper Orange Book Listings
On November 7, 2023, the Federal Trade Commission (“FTC”) announced that it had issued notice letters to 10 life sciences companies regarding 100 patents that the FTC contends are improperly listed in the Orange Book, the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations.
Read the full post on the Duane Morris Life Sciences Law Blog.