Gilead Sciences, Inc. v. ProAct, Inc.

USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 1 of 46 PUBLISHED UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT No. 25-1828 GILEAD SCIENCES, INC.; GILEAD SCIENCES IRELAND UC IDA, Plaintiffs – Appellees, v. MERITAIN HEALTH, INC., Defendant – Appellant, and PROACT, INC.; RX VALET, LLC; ADVANCED PHARMACY, LLC; AQUA ENTERPRISE INC., d/b/a Affordable RX Meds; GREGORY SANTULLI; FETIH ECZANESI, Defendants. ------------------------------ HEALTHHIV; THE ADAP ADVOCACY ASSOCIATION; THE AUTOIMMUNE ASSOCIATION; THE HIV AND HEPATITIS POLICY INSTITUTE; THE INTERNATIONAL FOUNDATION FOR AUTOIMMUNE & AUTOINFLAMMATORY ARTHRITIS, Amici Supporting Appellees. No. 25-1829 GILEAD SCIENCES, INC.; GILEAD SCIENCES IRELAND UC IDA, Plaintiffs – Appellees, USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 2 of 46 v. PROACT, INC., Defendant – Appellant, and MERITAIN HEALTH, INC.; RX VALET, LLC; ADVANCED PHARMACY, LLC; AQUA ENTERPRISE INC., d/b/a Affordable RX Meds; GREGORY SANTULLI; FETIH ECZANESI, Defendants. ------------------------------ HEALTHHIV; THE ADAP ADVOCACY ASSOCIATION; THE AUTOIMMUNE ASSOCIATION; THE HIV AND HEPATITIS POLICY INSTITUTE; THE INTERNATIONAL FOUNDATION FOR AUTOIMMUNE & AUTOINFLAMMATORY ARTHRITIS, Amici Supporting Appellees. No. 25-1849 GILEAD SCIENCES, INC.; GILEAD SCIENCES IRELAND UC IDA, Plaintiffs – Appellees, v. RX VALET, LLC; ADVANCED PHARMACY, LLC; AQUA ENTERPRISE INC., d/b/a Affordable RX Meds, Defendants – Appellants, and MERITAIN HEALTH, INC.; PROACT, INC.; GREGORY SANTULLI; FETIH ECZANESI, 2 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 3 of 46 Defendants. ------------------------------ HEALTHHIV; THE ADAP ADVOCACY ASSOCIATION; THE AUTOIMMUNE ASSOCIATION; THE HIV AND HEPATITIS POLICY INSTITUTE; THE INTERNATIONAL FOUNDATION FOR AUTOIMMUNE & AUTOINFLAMMATORY ARTHRITIS, Amici Supporting Appellees. No. 25-1850 GILEAD SCIENCES, INC.; GILEAD SCIENCES IRELAND UC IDA, Plaintiffs – Appellees, v. GREGORY SANTULLI, Defendant – Appellant, and MERITAIN HEALTH, INC.; PROACT, INC.; RX VALET, LLC; ADVANCED PHARMACY, LLC; AQUA ENTERPRISE INC., d/b/a Affordable RX Meds; FETIH ECZANESI, Defendants. ------------------------------ HEALTHHIV; THE ADAP ADVOCACY ASSOCIATION; THE AUTOIMMUNE ASSOCIATION; THE HIV AND HEPATITIS POLICY INSTITUTE; THE INTERNATIONAL FOUNDATION FOR AUTOIMMUNE & AUTOINFLAMMATORY ARTHRITIS, Amici Supporting Appellees. 3 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 4 of 46 Appeals from the United States District Court for the District of Maryland, at Baltimore. Julie R. Rubin, District Judge. (1:24-cv-03566-JRR) Argued: May 6, 2026 Decided: August 13, 2025 Before AGEE and HARRIS, Circuit Judges, and KEENAN, Senior Circuit Judge. Affirmed by published opinion. Judge Agee wrote the opinion, in which Judge Harris and Judge Keenan joined. ARGUED: Michael Paul Beltran, BELTRAN LITIGATION, P.A., Tampa, Florida; Todd William Hesel, SILVERMAN THOMPSON SLUTKIN WHITE, Baltimore, Maryland, for Appellants. Timothy Alan Waters, PATTERSON BELKNAP WEBB & TYLER LLP, New York, New York, for Appellees. ON BRIEF: Jonathan W. Garlough, Ellen Matheson, FOLEY & LARDNER LLP, Chicago, Illinois for Appellant Meritain Health, Inc. Christopher Mincher, Ilona Shparaga, SILVERMAN THOMPSON SLUTKIN WHITE, Baltimore, Maryland, for Appellant ProAct, Inc. Michael P. Beltran, BELTRAN LITIGATION, P.A., Tampa, Florida; Rachel Atkin Hedley, Columbia, South Carolina, Michael E. Blumenfeld, Baltimore, Maryland, Jennifer W. Winkler, NELSON MULLINS RILEY & SCARBOROUGH LLP, for Appellants Rx Valet, LLC; Advanced Pharmacy, LLC; Aqua Enterprise, Inc., and Gregory Santulli. Steven M. Klepper, KRAMON & GRAHAM, PA, Baltimore, Maryland; Geoffrey A. Potter, Tara J. Norris, PATTERSON BELKNAP WEBB & TYLER LLP, New York, New York, for Appellees. William A. Sarraille, Washington, D.C., for Amici Curiae. 4 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 5 of 46 AGEE, Circuit Judge: Gilead Sciences, Inc. develops and sells prescription drugs in the United States and abroad, including the HIV drug Biktarvy. The same prescription drug may cost more in the United States than overseas. To reduce these higher domestic costs, some self-funded health plans turn to alternative funding programs (“AFPs”), which import and sell certain brand-name medications that are intended only for foreign sale. The issue in this case is whether the arrangement here likely infringes Gilead’s trademarks under the Lanham Act. After a Maryland patient received a Turkish version of his Biktarvy in the mail, Gilead investigated and discovered a broader importation scheme. That discovery led Gilead to sue those allegedly behind the scheme—the Appellants here—claiming that Rx Valet, LLC, Advanced Pharmacy, LLC, Affordable Rx, and Gregory Santulli (together, the “Quartet”) directly infringed its trademarks by importing and distributing foreign-market Gilead-branded drugs and that Meritain Health, Inc. and ProAct, Inc. contributed to the Quartet’s infringement by facilitating the scheme. The district court granted Gilead’s motion for a preliminary injunction, enjoining Appellants from advertising, selling, or facilitating the sale of imported Gilead-branded medications in the United States. Appellants appeal. We affirm. I. A. Gilead is a biopharmaceutical company that develops and markets prescription medications worldwide. It owns the registered trademarks that appear on the tablets, 5 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 6 of 46 packaging, and accompanying patient information for those medications, including Biktarvy. Although Gilead manufactures and sells many of the same medications for multiple markets, it packages and labels them for the countries in which they are intended to be sold. The events giving rise to this case began with a single nonparty Maryland patient, John Doe, but Gilead’s investigation of that lone report uncovered a broader international-sourcing arrangement. To better understand that arrangement, some place setting is needed. Under a self-funded health plan, an employer, rather than an insurance company, bears the financial risk of its employees’ healthcare expenses. By assuming that risk, the employer may reduce costs because it pays claims as they arise rather than prepaying fixed premiums to an insurer. Self-funding also gives employers greater control over how healthcare benefits are structured and administered. They choose not only deductibles, copays, and covered services, but also the vendors and potential cost-savings arrangements used to administer those benefits. Rather than administer self-funded plans themselves, many employers hire a third- party administrator (“TPA”), such as Meritain, to process claims, prepare plan documents, connect the plan to provider networks, and maintain eligibility information identifying plan members and their available benefits. Employers often entrust the pharmacy benefits part of their self-funded health plan to a pharmacy benefit manager (“PBM”), which designs the plan’s formulary and determines at the point of purchase whether a particular prescription claim will be approved. 6 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 7 of 46 Meritain, a subsidiary of Aetna and CVS Health, provides PBM services through its affiliate, Meritain Health Pharmacy Solutions (“MPS”), for roughly half of the self-funded plans it administers. See J.A. 249, 1159. For the remainder, employers contract with a separate PBM, known as a “carve-out” PBM. ProAct, one of the Appellants here, serves in that role for Doe’s employer. Although Meritain isn’t a party to the contract between the employer and ProAct, it provides two services relevant here. First, Meritain supplies ProAct with its “patient data stream,” so ProAct, as the PBM, can identify plan members and their prescription drug benefits. ProAct uses that information to verify coverage and bill the plan (through Meritain) for covered pharmacy claims. Second, Meritain processes invoices from ProAct, paying them from the plan’s account. An employer’s choices don’t end with the TPA and PBM. Because the employer ultimately pays its employees’ prescription-drug claims, it has a direct incentive to seek alternatives to higher domestic drug prices. Some self-funded employers therefore contract separately with an AFP. As relevant here, AFPs obtain designated medications from foreign pharmacies rather than through a PBM’s domestic pharmacy network. The employer—not the PBM—decides what medications to source internationally and contracts with the AFP to obtain them. That’s what happened here. In 2024, John Doe, a Maryland resident who had taken Biktarvy to treat HIV for years, enrolled in his new employer’s self-funded health plan. Meritain served as the plan’s TPA and ProAct served as its carve-out PBM. When Doe tried to refill his Biktarvy prescription, the pharmacy submitted a “test claim” to ProAct. Using the patient data stream from Meritain, ProAct identified Doe, verified his coverage 7 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 8 of 46 eligibility, and compared the prescription against his employer’s formulary. ProAct then returned an electronic response to the pharmacy—a “system edit”—directing Doe to contact Rx Valet. It also forwarded Doe’s rejected claim and patient information to Rx Valet so that Rx Valet could contact him directly. Gilead’s ensuing investigation revealed the reason for rejecting Doe’s claim: Doe’s employer had separately retained Rx Valet as its AFP and designated certain medications, including Biktarvy, for international sourcing. ProAct’s system edit thus directed Doe away from the ordinary domestic pharmacy network to Rx Valet. ProAct’s system edit placed Doe into Rx Valet’s “international sourcing program,” which Rx Valet markets as a way to reduce prescription-drug costs. Its promotional materials identify numerous Gilead medications, including Biktarvy, as available through that program. But Rx Valet isn’t a licensed pharmacy and thus can’t receive prescriptions directly from healthcare providers. So it instructed Doe to have his doctor send the prescription to its affiliate, Advanced Pharmacy, a licensed pharmacy that provides mail- order services exclusively for Rx Valet. Gregory Santulli serves as Chief Executive Officer of Rx Valet and President of Advanced Pharmacy. Advanced Pharmacy, in turn, forwarded Doe’s prescription to Affordable Rx, a “prescription referral service” that works exclusively with Rx Valet. Affordable Rx connects patients with foreign dispensing pharmacies: it accepts prescription orders, locates a foreign pharmacy to fill them, and arranges for the pharmacy to ship the medications directly to patients in the United States. Its website identifies available 8 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 9 of 46 medications, dispensing pharmacies, manufacturers, and countries of manufacture and shipment. Following that process, Advanced Pharmacy sent Doe’s Biktarvy prescription to Affordable Rx, which arranged for a Turkish pharmacy to dispense the Biktarvy and ship it to Doe. A few weeks later, Doe received Biktarvy packaged for the Turkish market—a version that the Food and Drug Administration (“FDA”) had not approved for sale in the United States. As shown above, the carton and the bottle were labeled in Turkish not English. The accompanying patient information was likewise written in Turkish and omitted labeling and warnings required for Biktarvy that the FDA has approved for distribution in the United States. 1 1 The Turkish Biktarvy was authentic in the limited sense that it bore Gilead’s legitimate, non-counterfeited trademarks, was manufactured with Gilead’s authorization, and was chemically identical to Biktarvy authorized for sale in the United States. As we explain below, however, those characteristics don’t necessarily make it “genuine” for Lanham Act purposes. 9 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 10 of 46 Concerned about the medication’s authenticity, Doe contacted his doctor in February 2024, and his doctor notified Gilead. In turn, Gilead obtained samples for testing, which confirmed that the tablets were authentic Gilead Biktarvy produced in Turkey, packaged for the Turkish market, and intended for sale only in Turkey. Gilead’s investigation soon revealed that Doe’s experience wasn’t an isolated incident. Through the same international-sourcing arrangement, the Quartet arranged for hundreds of bottles of foreign-market Gilead medications to be shipped to patients in the United States. Gilead alerted the FDA, which declined to take enforcement action. B. In December 2024, Gilead sued the Quartet, Meritain, and ProAct in the District of Maryland, alleging, among other claims, trademark infringement and unfair competition under the Lanham Act. 2 See 15 U.S.C. §§ 1114(1), 1125(a). Gilead alleges that the Quartet directly infringe its trademarks by importing and distributing foreign-market Gilead- branded medications that are materially different from the domestic version. As to Meritain and ProAct, Gilead alleges that they are contributorily liable because they continued supplying services to the Quartet despite knowing, or having reason to know, that the Quartet were infringing Gilead’s trademarks. 2 Gilead brought four other claims: importation of goods bearing infringing marks (15 U.S.C. § 1124), state law unfair competition, unjust enrichment, and civil conspiracy. Those claims aren’t before us at this stage as they didn’t form the basis of Gilead’s preliminary injunction motion. Likewise, Gilead also sued Fetih Eczanesi, the Turkish pharmacy, which defaulted in the district court and isn’t a party to this appeal. 10 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 11 of 46 Along with its complaint, Gilead moved for a temporary restraining order. After a hearing, the district court entered a TRO enjoining Appellants from continuing to advertise, sell, or facilitate the sale of imported Gilead-branded medications. J.A. 690–95. At Appellants’ request, the court extended the TRO and permitted expedited discovery. Santulli meanwhile moved to dismiss the claims against him for lack of personal jurisdiction under Rule 12(b)(2). The district court denied that motion before deciding Gilead’s then-pending preliminary injunction motion. Following a two-day evidentiary hearing, the district court issued an opinion and order granting Gilead’s motion and converting the TRO into a preliminary injunction. The court enjoined Appellants from, among other things, “[i]mporting, advertising the importation of, or otherwise facilitating the importation of product bearing a [defined] Gilead Mark . . . into the United States from outside the United States.” J.A. 3361. Meritain, ProAct, and the Quartet timely noted this interlocutory appeal, and we have jurisdiction under 28 U.S.C. § 1292(a)(1). 3 3 Santulli asks us to exercise pendent appellate jurisdiction and review the denial of his motion to dismiss for lack of personal jurisdiction. That ruling “is a non-final order that is not . . . immediately appealable,” which we can review only in two “narrow” circumstances: “(1) when an issue is inextricably intertwined with a question that is the proper subject of an immediate appeal; or (2) when review of a jurisdictionally insufficient issue is necessary to ensure meaningful review of an immediately appealable issue.” Rux v. Republic of Sudan, 461 F.3d 461, 475 (4th Cir. 2006) (internal quotation marks omitted). Neither circumstance is present here. Two rulings are “‘inextricably intertwined’ if ‘the same specific question will underlie both the appealable and the non-appealable order, such that resolution of the question will necessarily resolve the appeals from both orders at once.’” Indus. Servs. Grp., Inc. v. Dobson, 68 F.4th 155, 167 (4th Cir. 2023) (quoting Scott v. Fam. Dollar Stores, Inc., 733 F.3d 105, 111 (4th Cir. 2023)). That’s not so here. To overcome a 12(b)(2) motion, a plaintiff must make a prima facie showing of jurisdiction, (Continued) 11 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 12 of 46 II. To secure a preliminary injunction, a plaintiff must demonstrate that (1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities tips in its favor, and (4) an injunction is in the public interest. Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 22 (2008). We review the grant of a preliminary injunction for abuse of discretion. Leaders of a Beautiful Struggle v. Baltimore Police Dep’t, 2 F.4th 330, 339 (4th Cir. 2021) (en banc). Under this deferential standard, we don’t reweigh evidence that the district court considered, reviewing factual findings for clear error. See Mountain Valley Pipeline, LLC v. 6.56 Acres of Land, Owned by Sandra Townes Powell, 915 F.3d 197, 213 (4th Cir. 2019). “[S]o long as the district court’s account of the evidence is plausible in light of the record viewed in its entirety, we may not reverse, even if we are convinced that we would have weighed the evidence differently.” Id. (cleaned up). Legal conclusions, however, are reviewed de novo. Salomon & Ludwin, LLC v. Winters, 150 F.4th 268, 274 (4th Cir. 2025). A. We begin with the likelihood of success on the merits. Gilead “need not establish a certainty of success, but it must be clear that [it] is likely to succeed at trial.” Jensen v. Md. Cannabis Admin., 151 F.4th 169, 175 (4th Cir. 2025) (cleaned up). The district court while securing a preliminary injunction requires it to show a “reasonable probability of ultimate success” on that question. Visual Scis., Inc. v. Integrated Commc’ns Inc., 660 F.2d 56, 59 (4th Cir. 1981). Because the two motions require different standards, review of one is neither “inextricably intertwined” with nor “necessary to ensure meaningful review” of the other. Dobson, 68 F.4th at 167. We thus see no basis to exercise pendent appellate jurisdiction over the issue of personal jurisdiction. 12 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 13 of 46 concluded that Gilead is likely to succeed on the merits of its direct trademark infringement claims against the Quartet and its contributory trademark infringement claims against Meritain and ProAct. Before turning there, we address two threshold issues: whether the district court erred by not finding that Gilead satisfied its personal jurisdiction burden as to Santulli and whether the Federal Food, Drug, and Cosmetic Act (“FDCA”) precludes Gilead’s claims. 1. a. Santulli contends that the district court erred by concluding that Gilead was likely to succeed on the merits against him without first finding “that there is a reasonable probability that it has personal jurisdiction over [him].” Quartet Opening Br. 55. In other words, separate from his challenge to the district court’s denial of his Rule 12(b)(2) motion (which we lack jurisdiction to review, see supra note 3), Santulli contends the district court needed to, but did not, find that Gilead met the higher “reasonable probability of ultimate success” standard before granting preliminary relief. Cf. Visual Scis., Inc., 660 F.2d at 59. We decline to consider this argument because Santulli never made it below. See In re Under Seal, 749 F.3d 276, 285 (4th Cir. 2014). An overview of the timeline makes that clear. The record shows that Santulli put his personal-jurisdiction defense and Gilead’s request for a preliminary injunction on two separate tracks throughout the proceedings below. After Gilead moved for a preliminary injunction, Santulli filed a Rule 12(b)(2) motion arguing that Gilead had not made a prima facie showing of personal jurisdiction. J.A. 1112–22. Although the district court initially planned to address responsive motions 13 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 14 of 46 after the preliminary-injunction hearing, Santulli asked it to decide his “individual Rule 12 motion” first. J.A. 1130 (“We respectfully ask the Court to hear Mr. Santulli’s Motion to Dismiss before the Preliminary Injunction hearing[.]”). Gilead proposed addressing personal jurisdiction in its preliminary-injunction reply, but Santulli objected and again asked the court to resolve his Rule 12(b)(2) motion separately and before the hearing. J.A. 1442–45, 1467–68. The court agreed and established a separate briefing schedule for that motion. J.A. 1469–70. The briefing on the two motions overlapped, but Santulli did not make the same argument in both briefs. The Quartet’s preliminary-injunction opposition stated in a footnote that Santulli’s participation was “subject to and without waiver of his motion to dismiss for lack of personal jurisdiction.” J.A. 1383 n.1. The opposition itself made no personal-jurisdiction argument. It didn’t invoke the “reasonable probability” standard or ask the court to deny preliminary relief for failing to satisfy it. In support of his Rule 12(b)(2) motion, Santulli instead focused his jurisdictional argument on the prima facie standard that governs that motion (and rightfully so). His reply supporting his 12(b)(2) motion—filed after preliminary-injunction briefing had concluded—added only in a footnote that a prima facie showing “is not sufficient for a preliminary injunction against a party challenging personal jurisdiction.” J.A. 2114 n.4. But the footnote did not identify the “reasonable probability” standard or ask the court to apply it in deciding Gilead’s preliminary-injunction motion. The district court denied Santulli’s 12(b)(2) motion, concluding that Gilead had made a prima facie personal jurisdiction showing. J.A. 2196–2212. 14 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 15 of 46 Santulli points out that the district court had earlier recognized that it could not enjoin a defendant over whom it lacked personal jurisdiction. See J.A. 1132. But that observation only generally acknowledged that personal jurisdiction was required for a court to act as to a particular defendant. At no point did Santulli then identify to the court the “reasonable probability” standard or ask the court to apply it. In short, Santulli placed his 12(b)(2) motion and Gilead’s preliminary-injunction motion on separate tracks. On the first, he argued that Gilead had not made a prima facie showing of personal jurisdiction. On the second, he never argued that the court had to find a “reasonable probability” of personal jurisdiction before enjoining him. 4 To the extent Santulli maintains that the district court had an independent obligation to apply that standard whether he requested it or not, we disagree. To be sure, once a defendant contests personal jurisdiction, the plaintiff bears the burden of establishing it at each stage of the litigation. See Grayson v. Anderson, 816 F.3d 262, 268 (4th Cir. 2016). But that doesn’t relieve the defendant of the obligation to identify the legal standard he contends governs the court’s analysis. Personal jurisdiction is a waivable defense, not a jurisdictional limitation like subject-matter jurisdiction that courts must police sua sponte. See al-Suyid v. Hifter, 139 F.4th 368, 374 (4th Cir. 2025). Accepting Santulli’s position would require district courts to revisit personal jurisdiction sua sponte each time a case 4 The district court told Santulli, at the end of the evidentiary hearing on the preliminary injunction, that it would not reconsider the personal jurisdiction question it had resolved against him on the Rule 12(b)(2) motion. Even given this direct opportunity, Santulli did not articulate or argue for application of a different, “reasonable probability” standard. J.A. 3021–22. 15 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 16 of 46 advances to a new procedural stage, even without any argument that a different standard applies. There is no basis to impose such a requirement. Because Santulli never argued that the district court had to find a “reasonable probability” of personal jurisdiction before enjoining him, he cannot now fault the court for failing to do so.5 b. Next, Appellants maintain that the FDCA’s exclusive enforcement provision bars Gilead’s Lanham Act infringement claims. We disagree. The FDCA and the Lanham Act “complement each other.” POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 115 (2014). While the Lanham Act is mainly concerned with “protect[ing] commercial interests against unfair competition, [] the FDCA protects public health and safety.” Id. A cause of action for trademark infringement lies under the Lanham Act when “[a]ny person . . . without the consent of the registrant . . . use[s] in commerce any . . . registered mark in connection with the sale . . . of any goods . . . [and] such use is likely to cause confusion.” 15 U.S.C. § 1114(1)(a). The FDCA regulates the approval, labeling, and distribution of prescription drugs, and entrusts enforcement to the FDA rather than private litigants. See 21 U.S.C. §§ 352, 384; see id. § 337 (providing that “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States”). 5 To be clear, we don’t address whether Santulli waived his personal-jurisdiction defense for the case as a whole—an issue the district court expressly declined to reach and that we lack jurisdiction to decide. See J.A. 2211 (“[T]he court declines to reach the question of waiver.”). We hold only that Santulli waived the separate argument that the district court couldn’t enter a preliminary injunction against him without first finding a reasonable probability of personal jurisdiction. 16 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 17 of 46 Appellants first argue that the FDCA forbids Gilead’s claims because those claims necessarily require judicial interpretation or enforcement of the FDCA and its implementing regulations. See, e.g., Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990). Specifically, Appellants contend that resolving the claims requires determining whether the labeling of imported Gilead-branded medications complies with FDA regulations. They do not. As explained below, Gilead’s theory of infringement depends on the material differences between domestic and foreign Gilead- branded medications—and not on whether those differences violate the FDCA. Under the facts of this case, comparing two products to determine whether they materially differ for Lanham Act purposes doesn’t require interpreting FDA regulations. Indeed, the district court concluded that Gilead was likely to succeed on the merits without first finding an FDCA violation, showing that one doesn’t depend on the other. That distinguishes this case from the authorities on which Appellants rely. In Sandoz, for example, the plaintiff brought a Lanham Act false advertising claim, alleging that a drug label was “literally false” because it described an ingredient as “inactive.” 902 F.2d at 230–31. But FDA regulations directly govern whether an ingredient is “inactive,” and the FDA had yet to speak on the issue. In other words, whether the challenged statement could give rise to liability for false advertising under the Lanham Act turned on interpreting the FDCA and its regulations. For that reason, the Third Circuit concluded that the FDCA precluded the plaintiff’s claim. Id. at 231. That’s not the case here. Appellants alternatively argue that our decision in Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993), precludes Gilead’s claims as they rest on an implicit 17 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 18 of 46 representation that imported Gilead-branded medications are FDA-approved. Appellants’ reliance is misplaced. In Mylan, the plaintiff asserted a Lanham Act false advertising claim alleging that the defendant falsely implied FDA approval merely by marketing its drugs with package inserts commonly associated with FDA-approved drugs. Id. at 1139. We rejected that theory as “too great a stretch under the Lanham Act” absent any statement that the drug had “proper FDA approval.” Id. Gilead advances no such FDA-contingent theory here. For example, it doesn’t claim that Appellants falsely imply FDA approval by selling imported Gilead-branded medications in the United States. Instead, as explained below, Gilead alleges that the imported products are materially different from the domestic version and thus infringe its trademarks. On that basis, Mylan is simply inapposite. The FDCA doesn’t preclude Gilead’s Lanham Act claims, 6 so we turn to whether Gilead is otherwise likely to succeed on the merits of them. 6 The Supreme Court recently held that the FDCA didn’t bar a Lanham Act claim relating to food labeling. See POM Wonderful LLC, 573 U.S. at 120–21. In doing so, the Court observed that neither the text of the Lanham Act nor that of the FDCA “in express terms, forbids or limits Lanham Act claims challenging [food] labels that are regulated by the FDCA.” Id. at 113. Moreover, “[a] holding that the FDCA precludes Lanham Act claims challenging food and beverage labels[,]” the Supreme Court explained, “would not only ignore the distinct functional aspects of the FDCA and the Lanham Act but also would lead to a result that Congress likely did not intend.” Id. at 116. The district court understandably applied POM Wonderful’s directives to the drug label Lanham Act claims here in concluding that they aren’t precluded by the FDCA. We need not decide the full scope of POM Wonderful here as it’s clear that the FDCA doesn’t preclude Gilead’s claims under the facts of this case. 18 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 19 of 46 2. To prevail on the merits of its direct trademark infringement claims against the Quartet, Gilead must establish, among other things, that the Quartet’s use of its marks “is likely to confuse consumers.” 7 Rosetta Stone Ltd. v. Google, Inc., 676 F.3d 144, 152 (4th Cir. 2012); see also Lamparello v. Falwell, 420 F.3d 309, 13 (4th Cir. 2005) (applying the same elements to 15 U.S.C. §§ 1114 and 1125 claims). This appeal turns on whether the Quartet’s importation of authentic Gilead-branded medications intended only for sale and distribution abroad is likely to do just that. Those foreign-sourced medications are classic gray market goods. See K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 285 (1988) (defining a gray market good as a “foreign-manufactured good, bearing a valid United States trademark, that is imported without the consent of the United States trademark holder”). Trademark law permits the resale of genuine goods bearing a trademark owner’s mark, even without the owner’s consent in some circumstances. See Shell Oil Co. v. Com. Petroleum, Inc., 928 F.2d 104, 107 (4th Cir. 1991). The reason is straightforward: when the imported product is identical to the domestic version, consumers receive “exactly the bundle of characteristics that they associate with the mark.” Societe Des Produits Nestle, S.A. v. Casa Helvetia, Inc., 982 F.2d 633, 641 (1st Cir. 1992). Because consumers get what they expect, there is little risk of confusion. 7 The other elements—that Gilead owns a legally protectable trademark, that the Quartet used that trademark in commerce without Gilead’s consent, and that the use was “in connection with the sale, offering for sale, distribution, or advertising” of goods or services, Rosetta Stone, 676 F.3d at 152—are not in dispute on appeal. 19 USCA4 Appeal: 25-1829 Doc: 123 Filed: 08/13/2026 Pg: 20 of 46 Relatedly, “[u]nder what has sometimes been called the ‘first sale’ or ‘exhaustion’ doctrine, the trademark protections of the Lanham Act are exhausted after the trademark owner’s first authorized sale of that product.” Davidoff & Cie, S.A. v. PLD Int’l Corp., 263 F.3d 1297, 1301 (11th Cir. 2001). So our initial task is to determine whether the internationally sourced Gilead- branded medications at issue are genuine for Lanham Act purposes. Relevant here, there are two ways in which goods bearing an authentic mark are still not genuine: they (1) materially differ from the goods the trademark owner has authorized for sale, see Nestle, 982 F.2d at 638, or (2) are manufactured or distributed outside the trademark owner’s legitimate quality-control system, see Shell Oil, 928 F.2d at 107. 8 Under the material-differences doctrine, goods aren’t genuine if (1) the trademark owner hasn’t authorized them for domestic sale, and (2) they materially differ from the goods authorized for sale domestically. 9 See Nestle, 982 F.2d at 638. The doctrine reflects a common-sense proposition: consumers who encounter products bearing identical marks 8 The Quartet argue that the foreign-sourced medications aren’t gray market goods because they’re genuine. See Quartet Opening Br. 22–23. This argument is misplaced. Whether a good is a gray market good doesn’t turn on its genuineness but whether the trademark owner a