Innovation Effects Are Front and Center: What Recent FTC Enforcement Signals for Life Sciences Deals

Life sciences, and health care more broadly, continue to be an antitrust enforcement priority in Washington, D.C., regardless of the party in power. During President Trump's second term, the Federal Trade Commission ("FTC") has continued to signal a willingness to intervene where competition is viewed as central to affordability, access, and innovation, particularly in the life sciences space. Two recent FTC enforcement actions—Edwards Lifesciences/JenaValve Technology and Alcon/LENSAR—confirm that life sciences transactions face increased scrutiny when they may eliminate innovation rivalry, pipeline competition, or an important future competitive constraint.

Together, these matters highlight that the current FTC—notwithstanding departures from certain Biden-era antitrust priorities—remains focused on innovation effects and potential competition in the life sciences sector, regardless of whether the competition is between on-market products or potential ones.

The Backdrop: 2023 Merger Guidelines as an Analytical Framework

The focus on innovation effects and potential competition is not novel and has been addressed in prior antitrust merger guidelines for the last several decades. However, when the FTC and the Department of Justice ("DOJ") issued the 2023 Merger Guidelines ("2023 Guidelines"), they significantly expanded and built upon the innovation effects and potential competition frameworks and provided additional detail as to when an agency may find that a merger "may substantially lessen competition" under Section 7 of the Clayton Act ("Act"). Specifically, a potential transaction may be a violation of the Act:

• When a transaction may eliminate substantial competition between firms, including competition to research and develop products or services—even if such products are not yet commercially available.
• When a transaction may eliminate a potential entrant in a concentrated market, including by removing reasonably probable future entry or current competitive pressure from a perceived potential entrant. Harm can occur in markets that do not yet consist of commercial products.
• When a transaction may reduce incentives to continue or initiate product development, pursue valuable upgrades or disruptive innovation, or maintain product variety—including incentives to cease offering a product that would cannibalize the other merging party's sales.

Although the 2023 Guidelines are a byproduct of the Biden administration, the Edwards/JenaValve and Alcon/LENSAR transactions, discussed below, highlight the FTC's continued support of the 2023 Guidelines' pipeline, potential competition, and innovation principles. FTC Chairman Andrew N. Ferguson has stated that the 2023 Guidelines are not "perfect," but they are "a restatement of prior iterations of the guidelines, and a reflection of what can be found in case law";[1] and thus, they create consistency and credibility that are key for regulators and practitioners alike. Otherwise, in his opinion, "if merger guidelines change with every new administration, they will become largely worthless to businesses and the courts." Therefore, the Edwards/JenaValve and Alcon/LENSAR transactions are useful guideposts for the enforcement one should expect to see in the life sciences industry.

Edwards/JenaValve: Pipeline Competition as Present Competition

In January 2026, the FTC obtained its first litigated merger win of the second Trump administration by securing a preliminary injunction against Edwards Lifesciences Corp.'s ("Edwards") proposed acquisition of JenaValve Technology, Inc. ("JenaValve"). Edwards had agreed in July 2024 to acquire both JC Medical and JenaValve—two separate companies developing transcatheter aortic valve replacement devices for aortic regurgitation ("TAVR-AR"), a less invasive treatment alternative for patients with severe aortic regurgitation.

Edwards closed the JC Medical transaction first, as the parties had not, and never did, report it to the competition agencies under the Hart-Scott-Rodino Act ("HSR Act"). (The FTC later secured $12 million in penalties for failing to report it; see our July 2026 alert, FTC Secures $12 Million in Penalties for Alleged HSR Violation here.) Edwards and JenaValve, on the other hand, did report their proposed transaction under the HSR Act. Given the TAVR-AR overlap created by Edwards' acquisition of JC Medical, the JenaValve transaction was paused for regulatory review and, ultimately, for litigation brought by the FTC. See Fed. Trade Comm'n v. Edwards Lifesciences Corp., No. CV 25-2569 (RC), 2026 WL 228723, at *1 (D.D.C. Jan. 28, 2026). The parties subsequently abandoned the transaction.

The agency alleged that Edwards/JC Medical and JenaValve were the only two companies conducting U.S. clinical trials for minimally invasive TAVR-AR devices, and that the proposed acquisition would reduce innovation, diminish product quality, and potentially increase prices. The federal court agreed and granted a preliminary injunction. Edwards subsequently abandoned the JenaValve transaction.

The court, citing the 2023 Guidelines' discussion of innovation and pre-commercial markets as persuasive authority, made several key findings:

• The relevant market did not need to be composed of currently commercialized products. The court accepted a relevant market for the research, development, and commercialization of TAVR-AR devices—even though no such device had yet been commercialized. The court relied on ordinary-course documents from the parties and testimony from physicians and economic experts that other procedures or devices were not substitutable.
• The FTC did not have to show high, combined market share, given that the market was composed of pre-commercial products. Instead, the FTC met its burden of showing potential anticompetitive effects by demonstrating through documents and testimony that the transaction would eliminate substantial head-to-head competition.
• The FTC established that pipeline competition constituted present competition via evidence. The court credited ordinary-course documents and testimony showing that Edwards/JC Medical and JenaValve competed on valve sizes, patient indications, speed to market, clinical testing strategies, clinical outcomes, and anticipated future price competition. According to the court, these factors signaled a degree of rivalry sufficient to establish that pipeline competition constituted present competition—not merely speculative future harm.

Alcon/LENSAR: Innovation Rivalry in an Established Technology Market

Similarly, the FTC focused on the impact Alcon's potential acquisition of LENSAR would have on innovation; however, the products at issue were already on the market. In March 2025, Alcon agreed to acquire LENSAR for $14.00 per share in cash, plus up to $2.75 per share in contingent value rights.[2] The deal would have given Alcon control of LENSAR's ALLY Robotic Cataract Laser Treatment System, Streamline software, and LENSAR's legacy laser system, expanding Alcon's femtosecond laser-assisted cataract surgery ("FLACS") platform.

The FTC alleged that the transaction would have combined the two leading players in FLACS laser systems and that evidence showed the companies had been locked in a price war, resulting in further innovation and lower costs.[3] The FTC threatened to challenge the deal,[4] and ultimately the parties decided to abandon the transaction before the agency filed suit.

The FTC's press release highlights that it will not limit its scrutiny to pre-commercial pipeline assets. Rather, the agency will continue to look closely at competition in established life sciences markets in which rivalry may drive innovation, quality improvements, and lower costs for physicians and patients.

Practical Implications for Life Sciences Transactions

Not every life sciences transaction with pipeline or innovation overlaps will be challenged. But Edwards Lifesciences/JenaValve Technology and Alcon/LENSAR confirm that such overlaps require early antitrust planning and careful document discipline. Companies contemplating deals in this space should consider the following:

• Assess innovation overlaps early. Due diligence should map R&D programs, pipeline assets, clinical timelines, product roadmaps, regulatory strategies, and the degree to which parties monitor or respond to each other's development decisions. Overlaps in pre-commercial or development-stage products can independently support a theory of harm.
• Recognize that ordinary-course documents are critical. In Edwards/JenaValve, the court relied heavily on internal business documents, employee testimony, and industry evidence to establish competitive dynamics. Companies should ensure that ordinary-course documents and deal-related communications accurately reflect competitive conditions and do not overstate the competitive significance of potential targets.
• Broaden the competitive analysis beyond price. A robust antitrust assessment should address competition factors such as speed to market, clinical trial strategy, product design, physician and customer adoption, quality, and innovation—not only current sales and pricing overlaps. Alcon/LENSAR illustrates that innovation rivalry in established markets will invite the same scrutiny as pipeline competition in emerging ones.
• Plan for the 2023 Merger Guidelines' continued relevance. Despite the change in administration, the current FTC and federal courts are treating the 2023 Guidelines' innovation and potential competition framework as persuasive analytical authority. Parties should continue to evaluate transactions against that framework.

[1] Memorandum from Andrew N. Ferguson, Chairman, Fed. Trade Comm'n, to FTC Staff, Merger Guidelines 2 (Feb. 18, 2025), https://www.ftc.gov/system/files/ftc_gov/pdf/ferguson-memo-re-merger-guidelines.pdf

[2] Press Release, Alcon Inc., Alcon Agrees to Acquire LENSAR, Inc. (Mar. 24, 2025), https://investor.alcon.com/news-and-events/press-releases/news-details/2025/Alcon-Agrees-to-Acquire-LENSAR-Inc-/default.aspx.

[3] Press Release, Fed. Trade Comm'n, FTC Stops Proposed Merger of Leading Cataract-Surgery Device Makers (Mar. 17, 2026), https://www.ftc.gov/news-events/news/press-releases/2026/03/ftc-stops-proposed-merger-leading-cataract-surgery-device-makers.

[4] Press Release, LENSAR, Inc., LENSAR® Announces Termination of Merger Agreement with Alcon Research, LLC (Mar. 16, 2026), https://ir.lensar.com/news-releases/news-release-details/lensarr-announces-termination-merger-agreement-alcon-research (stating that the FTC "intends to seek to enjoin the acquisition").