April 14, 2025, 9:12 AM
The Spring Meeting is the largest gathering of competition, consumer protection, and data privacy professionals globally, with lawyers, academics, economists, enforcers, journalists, and students from around the world. During the Spring Meeting, Axinn associates attended thought leadership panels to capture key insights.
Axinn partner Lisl Dunlop moderated a panel entitled “Pharma Under the Antitrust Microscope,” which outlined the legal and economic aspects of several new and emerging antitrust theories in the pharmaceutical industry. Key takeaways from the panel are below.
To read all the articles in the series, click here.
- Bundled Rebates. The panel highlighted a recent focus of the Federal Trade Commission (FTC) on the potential for large drug manufacturers to foreclose rivals and increase pricing through the practice of bundling rebates with Pharmacy Benefit Managers (PBMs), i.e., intermediaries who manage benefits and negotiate rebates with manufacturers. In 2023, the FTC challenged the Amgen/Horizon merger despite there being no direct product overlaps. Though it settled out of court, the challenge highlighted the FTC’s concern that pharmaceutical companies like Amgen could be able to bundle their portfolios of blockbuster drugs in order to foreclose actual or potential competitors to certain of those drugs.
- PBMs. Panelists explored increased FTC scrutiny of PBMs themselves. Specifically, the panel highlighted a years-long investigation into PBMs, which has so far resulted in two FTC interim reports released in July 2024 and January 2025. In September 2024, the FTC also issued an administrative complaint against the three largest PBMs for allegedly engaging in anticompetitive rebate practices that inflated the list prices of insulin drugs. The focus on PBMs is expected to continue under the Trump Administration, with President Trump promising in January to “knock out” PBMs.
- Harm to Innovation. Panelists discussed innovation theories of harm in FTC reviews of pharmaceutical mergers. In 2023, the FTC challenged the Sanofi/Maze merger, which specifically defined an alleged R&D market for pharmaceuticals. There has not yet, however, been a case brought in the U.S. in the pharma sector based on a pure innovation theory of harm. That said, the Pfizer/Seagen merger involved an in-depth review of potential harm to innovation by both the FTC and European Commission, and the EC decision in that case offers a roadmap for how the FTC could pursue such a theory of harm in the future.
- Harm to Potential Competition. Another recent trend involves the pursuit by the FTC of potential competition theories of harm. According to the panelists, this theory was most prominently illustrated in the FTC’s challenge to Sanofi's proposed acquisition of an exclusive license for Maze Therapeutics' Phase 1 clinical trial drug for Pompe disease. The FTC's concern with competition from a product in such an early stage of development, years away from the market, illustrated a change in approach from reviews of earlier transactions. The Commission argued that Sanofi's acquisition was about eliminating a future threat. The scrutiny of mergers involving early-stage pipeline products began to emerge during Trump’s first administration and is expected to continue under Trump’s second administration.
- Delisting Improper Patents from the Orange Book. The panel highlighted that the FTC is signaling a more assertive enforcement stance on improper Orange Book patent listings. Increasingly, the FTC has expressed its intention to scrutinize whether branded manufacturers are improperly listing patents as an unfair method of competition under Section 5 of the FTC Act. For example, in November 2023, the FTC issued warning letters to branded companies challenging the accuracy or relevance of hundreds of patent listings. In 2024, the FTC challenged the accuracy or relevance of over 300 additional Orange Book listings for drugs treating diabetes, weight loss, asthma, and COPD, emphasizing in a press release that such improper listings can “block competition and inflate the cost of prescription drugs.” The Orange Book is likely to remain a focal point for enforcement in the Trump administration.

To subscribe to our publications, click here.
Tags
News & Insights
News & Insights
SABA North America Annual Conference 2025
Speaking Engagement
Antitrust
NJSBA Annual Meeting and Convention 2025
Speaking Engagement
Intellectual Property
Hartford HealthCare Black and Red Gala 2025
Sponsorship
Antitrust
Informa CompLaw Antitrust West Coast Conference 2025
Speaking Engagement
Antitrust
AHLA Health Care Transactions Program 2025
Sponsorship
Antitrust
IAM Live: Auto IP USA 2025
Speaking Engagement
Intellectual Property
ACI 21st Annual Paragraph IV Conference
Speaking Engagement
Intellectual Property
A Labor of Love: Trump DOJ Obtains First Guilty Verdict in a Criminal Labor Case
Axinn Viewpoints
Antitrust
Managing Partner Jeny Maier Appears on Capitol Forum's ABA Spring 2025 Interview Series
Video
Antitrust
Federal Circuit Holds Generic’s Hatch-Waxman Litigation Expenses Deductible
Axinn Viewpoints
Intellectual Property