On January 9, 2026, the U.S. District Court for the District of Columbia granted the Federal Trade Commission’s request for a preliminary injunction blocking Edwards Lifesciences’ proposed acquisition of JenaValve. The court found a “reasonable probability” that the deal may substantially lessen competition in violation of Section 7 of the Clayton Act.
The key takeaway is not just that the court treated this as a “merger to monopoly,” but how it did so: the court accepted a relevant market focused on the research, development, and commercialization of a product that is not yet sold commercially in the United States. The court concluded that eliminating the two most advanced, U.S. trial competitors would likely reduce incentives to innovate and slow progress to market.
This innovation-centered reasoning tracks the agencies’ growing focus on “potential competition” and pipeline harms — and it closely echoes the rationale courts and enforcers have relied on in disputes like FTC v. Illumina/Grail.
Background
Over 100,000 Americans suffer from severe aortic regurgitation (AR), and open-heart surgery is currently the only FDA approved treatment in the United States. Two companies have been pursuing a less invasive alternative — transcatheter aortic valve replacement for AR (TAVR AR) — through U.S. clinical trials: JenaValve (Trilogy) and JC Medical (J Valve, later rebranded by Edwards as SOJOURN).
In July 2024, Edwards agreed to acquire JC Medical and separately agreed to acquire JenaValve — the only two companies with TAVR AR devices in U.S. clinical trials. The JC Medical deal closed; the JenaValve deal was paused for regulatory review. The FTC filed an administrative challenge and sought a preliminary injunction to prevent closing while the administrative case proceeds (with the administrative trial scheduled to begin April 8, 2026).
What the Court Emphasized
A pre-commercial “R&D market” can be an antitrust market.
The court defined the relevant market as the research, development, and commercialization of TAVR AR devices in the United States, despite the absence of an FDA approved, commercially sold TAVR AR device today. The court reasoned that antitrust law can recognize markets that include products still in clinical development, particularly where the alleged harm is decreased incentives to innovate.
The harm theory was innovation and “potential competition.”
The court credited evidence that competition between the two programs has pushed faster development, expanded efforts to cover broader patient needs (including valve sizing and indications), and helped drive decisions that could benefit patients and physicians. The court concluded that combining the two programs would likely reduce incentives to develop both products in parallel and could weaken innovation pressure in the run-up to commercialization.
The court leaned on Illumina-style reasoning.
In supporting the idea that an R&D market can be cognizable, the court cited Illumina Inc. v. FTC and emphasized that the antitrust laws must reach products in development because to hold otherwise could prevent R&D markets from being recognized for antitrust purposes, which would run counter to Section 7’s goal of stopping competitive harm “in its incipiency” (relying on the Fifth Circuit opinion in Illumina v. FTC).
“Global pipeline” entry into the U.S. arguments were unpersuasive.
Defendants argued that other TAVR AR developers worldwide could enter the U.S. market. The court found the FDA process to be a major barrier and concluded that foreign development and conference presence did not amount to timely, likely, sufficient entry that would constrain the U.S. programs at issue — even if those foreign firms are conducting R&D on similar products. In particular, the court found that the FDA’s lengthy premarket approval process posed a significant barrier to entry for competitors seeking to commercialize a foreign TAVR AR device in the United States, making any foreign firm meaningfully different from the two firms already competing head to head within the U.S. approval pipeline. In addition, the court noted that the parties’ business documents distinguished between TAVR AR devices on the path toward commercialization in the United States and all other TAVR AR devices.
Practical Takeaways
The court adopted many of the policy positions from the merger guidelines the FTC adopted in 2023, including their recognition that antitrust markets can include products still in clinical development. Here are additional takeaways:
Expect scrutiny when a deal combines leading pipelines.
If your transaction would consolidate advanced U.S. programs in a therapeutic area — even before commercialization — assume the agencies may frame the case around lost innovation rivalry and potential competition.
Prepare for market definition fights that don’t depend on price data.
Where products are pre commercial, traditional tools like pricing comparisons may be less central. Courts may rely more heavily on documents, industry testimony, and how companies describe their competitive “universe.”
Don’t over rely on “someone else will enter.”
The ability of firms to enter a market may significantly diminish concerns of market concentration arising from a merger, if that entry is timely, likely, and sufficient. If your defense depends on new entrants, you will likely need credible evidence of timely U.S. entry — not just global development activity — especially where FDA approval is a long, uncertain path.
Be ready to prove efficiencies with specifics.
Verifiable evidence of cognizable efficiencies arising from a proposed merger may ameliorate concerns about the overall effects of a merger. But the court treated broad statements about scale, capabilities, and improved execution as insufficient without concrete, verifiable support, particularly where the transaction would eliminate the closest rival program.
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