FTC Win Clarifies Antitrust Enforcement in Development Pipeline Deals

On January 9, 2026, Judge Rudolph Contreras in the United States District Court for the District of Columbia granted the Federal Trade Commission’s (FTC) request for a preliminary injunction in the agency’s challenge to the proposed acquisition of medical device startup JenaValve Technology, Inc. (JenaValve) by Edwards Lifesciences Corporation (Edwards). Despite arguments from Edwards and JenaValve that the merger would benefit high-risk patients, the court agreed with the FTC that the proposed merger would harm competition in a specialized cardiac device market where no product has yet received clearance from the U.S. Food and Drug Administration (FDA). The court’s opinion, filed in redacted form on January 28, 2026, provides helpful guidance for parties considering transactions involving products in development.

The FTC’s Challenge

On July 23, 2024, Edwards, a global cardiac device manufacturer, agreed to acquire JenaValve for $945 million. JenaValve is developing Trilogy, a transcatheter aortic valve replacement (TAVR) device to treat aortic regurgitation (AR), which affects over 100,000 Americans.

Just one day before Edwards’ agreement to purchase JenaValve, Edwards agreed to acquire JC Medical for $115 million, plus a $25 million investment in JC Medical’s parent company. The transaction did not trigger a filing and waiting period under the Hart-Scott-Rodino Act, and later in July 2024, Edwards closed the acquisition of JC Medical, including SOJOURN, its TAVR-AR device in development. As the FTC challenge ultimately made clear, JenaValve was not aware of Edwards’ acquisition of JC Medical.

After a lengthy investigation, the FTC voted unanimously on August 6, 2025 to initiate an administrative proceeding to determine whether the proposed merger would substantially lessen competition or tend to create a monopoly in violation of Section 7 of the Clayton Act. On the same day, the FTC sought a preliminary injunction in the United States District Court for the District of Columbia to prevent the merger from closing before the FTC could complete its administrative proceeding.

In its challenge, the FTC asserted that there are limited current treatments for AR, with open-heart surgery as the only FDA-approved treatment. TAVR-AR devices, such as Trilogy and SOJOURN, would allow AR to be treated through a device implanted through a catheter, without the need for open-heart surgery. The FTC alleged that JenaValve and JC Medical represented the only two companies conducting U.S. clinical trials for minimally invasive TAVR-AR devices.

On November 18, 2025, the court held a six-day evidentiary hearing with testimony from the merging parties, third parties, and several economic and industry experts, and ultimately granted the FTC’s request for a preliminary injunction on January 9, 2026 in a sealed order. The parties abandoned the transaction shortly thereafter.

The Court’s Opinion

In a 107-page opinion, the court outlined its reasons for enjoining the Edwards/JenaValve transaction, holding that the deal “would eliminate the vigorous competition in which Edwards and JenaValve currently engage,”¹ and reduce innovation by eliminating competition for TAVR-AR devices that are still being developed. Importantly, Judge Contreras’s opinion lays out considerations for how courts will assess market definition as well as the competitive effects of mergers involving products in development.

Court Finds Pre-Commercial Products Can Constitute a Relevant Product Market

Section 7 of the Clayton Act prohibits acquisitions “where in any line of commerce or in any activity affecting commerce in any section of the country, the effect of such acquisition may be substantially to lessen competition, or to tend to create a monopoly.”² A first step, therefore, is defining the line of commerce or relevant product market in which to analyze the transaction. Here, the court concluded that the relevant product market encompassed the research, development, and commercialization of transfemoral TAVR-AR devices, despite the fact that there are no such devices yet approved for use in the U.S.

Under the practical indicia factors laid out in Brown Shoe Co. v. United States, 370 U.S. 294, 323 (1962), which are used (among other tools) to define relevant product markets, the court found that transfemoral TAVR-AR devices differ from other AR treatment options in their peculiar characteristics and uses, customers, and prices, and that the medical device industry distinguishes transfemoral TAVR-AR devices from all other AR treatments. To reach its conclusion, the court relied on expert testimony from interventional cardiologists about the interchangeability of TAVR-AR devices with other treatments and ordinary course documents on the merging parties’ pricing strategies and industry recognition. For example, JenaValve documents suggested an intent to sell Trilogy at a premium price after receiving FDA commercial approval on the assumption that Trilogy would be the only device for the treatment of AR in the U.S. In corporate presentations, JenaValve referred to AR as an “untapped market,” and Edwards stated that “a dedicated AR product is needed for a unique patient population.”³ A qualitative hypothetical monopolist test also supported the court’s relevant product market definition, albeit without limiting the market to only transfemoral devices. The court agreed with the FTC’s economic expert that, based on testimony from physicians and defendants’ ordinary course documents, patients and physicians would not substitute another procedure or device in response to a small but significant and non-transitory increase in price, even without actual pricing data, on TAVR-AR devices, and that these treatment options should therefore be excluded from the relevant product market.

Although the defendants argued that defining a market of pre‑commercial products was too speculative, the court disagreed. It held that including TAVR‑AR devices in the relevant product market was prudent, even though no device has yet received commercial approval, because the proposed merger would reduce Edwards’ incentives to innovate. “In any event, courts, economists, and the Merger Guidelines do recognize that a relevant antitrust market can include products still in clinical development.”⁴

The court pointed to evidence suggesting that Edwards’ and JenaValve’s TAVR-AR devices will be close substitutes and will compete among similar patient indications. The court also relied on the recent Illumina, Inc. v. FTC decision, where the Fifth Circuit found a viable antitrust market that included products in clinical trials because there was “ongoing competition to bring additional products to market.”⁵ Here, the court found that “there is indisputably ongoing competition” between Edwards and JenaValve, that defendants’ TAVR-AR devices have been clinically validated, and that both devices are expected to go to market in the next few years.⁶

Court Finds FTC Demonstrates Substantial Lessening of Competition Without a Presumption

The court found that the FTC met its prima facie burden of showing a “reasonable probability” that an effect of the proposed merger “may be substantially to lessen competition.”⁷ The court relied on the facts and economic analyses presented by the FTC, showing the proposed merger would eliminate substantial head-to-head competition between Edwards and JenaValve.

Importantly, the court was not convinced that the FTC was entitled to a “short cut” presumption of illegality simply based on market share and concentration statistics under United States v. Philadelphia National Bank, 34 U.S. 321, 363 (1963). The 2023 Merger Guidelines articulated the agencies’ focus on structural presumptions in merger analysis, relying heavily on Philadelphia National Bank. Defendants argued that if the relevant product market comprises only pre-commercial products, there are no reliable market shares on which to calculate market concentration. The court agreed, and held that the FTC did not establish that the presumption typically holds in what it called “innovation markets,” citing to statements by the FTC under prior administrations that belied its current argument.

• In particular, the court noted that the FTC had previously explained that competition analysis in these situations may require a different calculus: A 1996 FTC report on “Competition Policy in the New High-Tech, Global Marketplace” stated that “a general causal relationship between innovation and competition” had not been established.⁸
• Further, former FTC Chairman Tim Muris’ closing statement in the FTC’s investigation of the Genzyme Corporation/Novazyme Pharmaceuticals, Inc. combination had noted that “[f]ar from serving to protect consumer interests,” applying the presumption in cases such as that one would “routinely block[] mergers likely to accelerate innovation.”⁹

Ultimately, the court found that the FTC had not done enough to prove that the presumption, based on market shares and concentration statistics, should be applied to the relevant product market here, which comprised only pre-commercial products.

Despite not benefitting from the presumption, the court found that the FTC had still met its burden to show that it was likely to be successful in showing that the proposed merger is likely to have extensive anticompetitive effects.

First, the court found that Edwards and JenaValve are currently the only two competitors in the TAVR-AR market in the U.S. Ordinary course documents and testimony from executives supported the conclusion that, prior to Edwards’ acquisition of JC Medical, JenaValve and JC Medical viewed each other as their closest competitors in the relevant market. Internal presentations from JC Medical referred to JenaValve as “[o]ur closest competitor” in the U.S. TAVR-AR market, and JenaValve similarly viewed JC Medical as its “main competitor.”¹⁰

Second, the court found that substantial evidence demonstrated that Edwards and JenaValve vigorously compete in the TAVR-AR market in the U.S. Defendants’ ordinary course documents and testimony showed that Edwards and JenaValve spur each other to increase the pace of innovation and bring a superior TAVR-AR device to patients. The court concluded that defendants compete in several areas related to their TAVR-AR products, including valve sizes, patient indications, speed to market, clinical testing, and clinical outcomes. Additionally, the court found that Edwards and JenaValve would engage in price competition once their TAVR-AR devices are commercialized.

Third, the court found that the proposed merger is likely to lessen the competition between Edwards and JenaValve substantially. Even at the clinical trial stage, Edwards and JenaValve were responding to competitive pressure from the other by accelerating development and enrollment in clinical trials, but that competitive pressure would not exist after the proposed merger. The court found “the central question here is not whether Edwards would have strong incentives to develop SOJOURN if JenaValve were out of the picture, but rather, whether Edwards would be meaningfully incentivized to develop both SOJOURN and Trilogy if it owns the two devices.”¹¹ Further, the court cited internal evidence indicating that Edwards anticipated setting a premium price if it owned both TAVR-AR devices.¹²

Defendants advanced several arguments to overcome the FTC’s claims of likely anticompetitive effects from the transaction, but the court rejected each in turn. For example, the court found that entry would not offset the proposed merger’s anticompetitive effects because there was little evidence suggesting an imminent threat of new entrants to the TAVR-AR market. Defendants also argued JenaValve was a weakened competitor and that the transaction would result in meaningful efficiencies. Despite JenaValve’s manufacturing limitations and financial constraints, the court was not convinced that these weaknesses were so severe that JenaValve would be unable to compete effectively without combining with Edwards. The court also found that defendants did not demonstrate how Edwards’ resources and capabilities would produce merger-specific and independently verifiable cost savings that would be passed on to consumers. Finally, the court found that JenaValve had feasible alternatives to an acquisition by Edwards. Indeed, JenaValve was in discussions with other strategic buyers, including one who appeared to express substantial interest in JenaValve.

Takeaways

The FTC’s challenge to the Edwards/JenaValve transaction and the court’s decision provides helpful guidance for parties considering potential transactions involving pre-commercial products. First, the decision recognizes the proposition from the 2023 Merger Guidelines that merging parties’ pipeline products can not only constitute a competitive overlap but also may constitute a relevant product market, even if the only products at issue are not yet sold in commerce. The factors for assessing the relevant market are likely to be similar to those for commercial products, and courts will evaluate whether overlapping products are close substitutes. Ordinary course documents and industry experts will often be key to this assessment.

The court’s opinion makes clear that the FTC may not benefit from a presumption of illegality for mergers combing overlapping pipeline products. This would create an additional challenge for the FTC to establish a substantial lessening of competition from the transaction. But Edwards/JenaValve shows this is not an impossible task. By relying on the merging parties’ ordinary course documents, testimony from executives, and testimony from other industry participants about ways in which they are already competing, the FTC may be able to satisfy its burden.

This decision marks a victory for the FTC and signals its intention to enforce the antitrust laws with respect to products in development where it can develop a factual record showing that products under development compete in the form of product design and/or speed to market and will compete in the future once commercialized. 

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.