Plaintiffs Notch First Pay-for-Delay Jury Verdict 13 Years After FTC v. Actavis
On May 18, 2026, after a five-week trial, a federal jury in Boston awarded over $884 million in single damages against Takeda Pharmaceuticals for entering into an anticompetitive “pay-for-delay” settlement of patent litigation that delayed generic competition. With automatic trebling, the verdict is expected to balloon to over $2.6 billion. Not only is the exposure significant, but this is the first time that a jury has found a patent holder liable for delaying generic pharmaceuticals in the 13 years since the Supreme Court decided FTC v. Actavis. This bulletin discusses the relevant allegations, the jury’s findings, and the implications, including the potential for the Supreme Court to revisit such challenges.
The Pay-for-Delay Allegations
In the Supreme Court’s June 2013 decision in FTC v. Actavis, the Court resolved a circuit split and held that “large” and “unjustified” reverse payments from the patent holder to the alleged infringer that settle patent litigation may be subject to antitrust scrutiny. That decision has since opened the doors to more than 35 separate reverse-payment lawsuits based on a variety of reverse “payment” theories, many of which have not involved explicit monetary terms.
Courts initially held that no-authorized generic (no-AG) settlement terms—where the patent holder agrees not to launch its own generic product in competition with generic manufacturers—did not plausibly state an antitrust claim under Actavis. Since then, however, several courts have held that an explicit no-AG agreement can plausibly state an antitrust claim under Actavis.
In 2021, class action and individual retailer plaintiffs filed antitrust suits seeking to recover alleged overcharges for Takeda’s brand drug Amitiza (lubiprostone), which is used to treat constipation in adults. The antitrust claims arose from a 2014 settlement agreement between patent holder Takeda and generic manufacturer Par Pharmaceutical that allegedly delayed generic entry of Amitiza. Under that settlement, Par agreed to drop its patent challenge and wait roughly 7 years before selling any generic version of Amitiza, which it could then do under a Takeda license. In return, Takeda allegedly agreed to help keep other generic competitors off the market.
Specifically, Par “agreed to delay launching a generic version of Takeda’s Amitiza until January 1, 2021, at which point it could sell either its own generic product or Sucampo-supplied AG product.”[1] Takeda and its partner Sucampo, in turn, agreed to “keep other generics out of the market for as long as they possibly could,” and to “structure the royalty for sales of the Par generic in such a way that, according to plaintiffs, would effectively ensure that there would only be a single generic available in the market.”[2] Sucampo and Takeda “nominally retained the right to launch a competing AG product,” but the settlement also “provided for the royalty on sales of the Par generic to decrease so significantly (from 50% to 15%),” such that Sucampo allegedly had no incentive to sell an AG through Takeda.[3] The U.S. District Court for the District of Massachusetts held that, under this scheme, plaintiffs plausibly alleged that the generic manufacturer received “unjustified profits” from its alleged monopoly in the generic Amitiza market.[4]
Court filings show Amitiza’s wholesale brand price was $5.74 per capsule just before Par’s generic launched in January 2021. Par’s generic entered at $3.83 per capsule. After additional generics arrived in January 2023, the price fell to $1.26, and by March 2024 it had dropped to $0.63 per capsule.[5]
The Trial Verdict
At trial, Takeda defended the settlement as a “good settlement” promoting competition, noting it allowed Par to sell an AG without needing its own FDA approval for its generic version or waiting for Amitiza’s patents to expire in 2025 and 2027—enabling earlier generic entry.[6]
The purchasers countered that Par would have launched even sooner absent the agreement, arguing Par could have invalidated the patents and obtained FDA approval years before 2021. Takeda dismissed this as speculation, citing the “many obstacles in their way,” including strong patents, manufacturing challenges with Amitiza’s active ingredient lubiprostone—“a difficult molecule”—and the need to secure FDA approval through an abbreviated new drug application.[7]
But following the five-week trial, a Boston-area jury disagreed by finding:
“substantial market power within the relevant market”;
“a large and unjustified reverse payment” with “anticompetitive effects”;
“an implicit agreement with Par not to launch its own authorized generic”;
the settlement had procompetitive benefits, but they were “not necessary to achieve those procompetitive benefits, and that there were alternative ways to achieve the same result with less harm to competition”;
the settlement resulted in overcharges to the direct-purchaser class, individual retailers (Albertsons, CVS, H-E-B, Kroger, Walgreen), and members of the end-payor class;
finding generic Amitiza would have come to market prior to patent expiry in April 2018 but for the anticompetitive settlement.[8]
As a result, the jury awarded $884,943,990 in single damages.[9] Under U.S. antitrust law, the damages awarded to the wholesaler class ($74,897,965 in single damages) and individual retailers (collectively $346,837,646 in single damages) will be automatically trebled upon entry of judgment.[10] For damages under the end payors’ various state-law claims, the jury did not find the settlement “flagrant” or that it warranted double or triple damages.
The Implications
According to Takeda, it will vigorously pursue post-trial motions and an appeal.[11] So this dispute may be far from over. And whether this specific case is likely to warrant review by the U.S. Supreme Court, the bigger-picture issue that remains is how the Supreme Court’s 5-3 decision in Actavis has been applied in the 13 years since it was decided. Indeed, Actavis resolved a circuit split and since then courts have continued to grapple with, and sometimes have diverged on, how to interpret that decision.
The majority in Actavis—when adopting the rule-of-reason test over the scope-of-the-patent and quick-look tests that had been proposed—said it would “leave to the lower courts the structuring of the present rule-of-reason antitrust litigation.”[12] But as Chief Justice Roberts expressed in his Actavis dissent: “Good luck to the district courts that must, when faced with a patent settlement, weigh the ‘likely anticompetitive effects, redeeming virtues, market power, and potentially offsetting legal considerations present in the circumstances.’”[13]
Chief Justice Roberts’ dissent emphasized that such antitrust challenges “weaken the protections afforded to innovators by patents, frustrates the public policy in favor of settling, and likely undermines the very policy it seeks to promote by forcing generics who step into the litigation ring to do so without the prospect of cash settlements.”[14] As a result, the dissent concluded that the Court should have kept “things as they were and not subject basic questions of patent law to an unbounded inquiry under antitrust law, with its treble damages and famously burdensome discovery.”[15]
The evolution of reverse payment theories—from the cash payments to contemporaneous business agreements to explicit no-AG agreementsto implicit no-AG agreements and all sorts of other “payment” theories—raises the prospect that the Supreme Court, at some point, may rein in how Actavis has been applied.
Notably, since Actavis was decided in 2013, four other reverse-payment cases have been tried to verdict. With the exception of an FTC administrative trial involving brand drug Opana, all of the other jury trials (including one also involving the same Opana settlement) resulted in complete defense verdicts (Nexium, Opana, HIV), arguably validating some of Chief Justice Roberts’ concerns.
If anything is certain in this area, it is that pharmaceutical companies should continue to carefully navigate antitrust risks when settling patent litigation.
If you have questions about this Client Alert or are interested in additional details or guidance, please reach out to Adam M. Acosta (adam.acosta@pierferd.com) or your regular PierFerd contact for assistance.
Copyright 2026, American Health Law Association, Washington, DC. Reprint permission granted.
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[1] In re Amitiza Antitrust Litig., 2022 U.S. Dist. LEXIS 231668, at *6-7 (D. Mass. Dec. 27, 2022) (internal quotes omitted).
[2] Id. (internal quotes omitted).
[3] Id.
[4] Id. at *10-11.
[5] Carolyn Muyskens, Takeda Liable In IBS Drug Pay-For-Delay Trial, Law360 (May 18, 2026), https://www.law360.com/classaction/articles/2478517?nl_pk=4a80adac-607f-4c0b-a4fe-d63485874a65&utm_source=newsletter&utm_medium=email&utm_campaign=classaction&utm_content=2478517&read_more=1&nlsidx=0&nlaidx=0.
[6] Id.
[7] Id.
[8] Jury Verdict Form, In re Amitiza Antitrust Litigation, No. 21-cv-11057 (D. Mass. May 18, 2026), ECF 903.
[9] Takeda Provides an Update regarding Jury Verdict in AMITIZA® (lubiprostone) Antitrust Litigation in the U.S. and Related Revision to FY2025 Financial Results, Press Release (May 19, 2026), https://www.takeda.com/newsroom/newsreleases/2026/takeda-provides-update-regarding-jury-verdict-in-amitiza-antitrust-litigation-in-the-us-and-related-revision-to-fy2025-financial-results/.
[10] Id.
[11] Takeda Provides an Update regarding Jury Verdict in AMITIZA® (lubiprostone) Antitrust Litigation in the U.S. and Related Revision to FY2025 Financial Results, Press Release (May 19, 2026), https://www.takeda.com/newsroom/newsreleases/2026/takeda-provides-update-regarding-jury-verdict-in-amitiza-antitrust-litigation-in-the-us-and-related-revision-to-fy2025-financial-results/.
[12] FTC v. Actavis, Inc., 570 U.S. 136, 160 (2013).
[13] Actavis, 570 U.S. at 173 (Roberts, C.J., dissenting).
[14] Id.
[15] Id.
