Judge Burke unsealed an interesting opinion last week on the applicability of Lanham act claims to pharmaceuticals.
In Vanda Pharms., Inc. v. MSN Pharms., Inc., C.A. No. 24-505-JLH (D. Del. July 31, 2025), the Plaintiff accused various generic drug manufacturers of violating the Lanham by allegedly making false statements in their label and advertisements. In particular, Plaintiff alleged that the Defendants described Plaintiff's product "Hetlioz" as the brand reference for their generic products when "the reference product used in Defendants’ Bioequivalence Study was not actually Hetlioz, or because that study was so flawed that it undermines any assertion that Defendants’ product is bioequivalent to Hetlioz." Id. at 14 (quoting complaint).
The issue was that the FDA had reviewed the bioequivalence data, and the corresponding label in granting the Defendants' ANDA. The Defendants thus argued that the FDCA -- which grants the FDA authority to review and "pass on the safety and efficacy of new drugs" (Id. at 11 (quoting Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 230 (3d Cir. 1990)) -- precluded a private Lanham Act action here.
In what appears to be the first opinion on the issue in Delaware, Judge Burke held that the Lanham Act claims were precluded and recommended granting the motion to dismiss:
here, as the Complaint notes, the FDA went through the process of analyzing the evidence regarding bioequivalence that was in MSN’s ANDA—and thereafter, it approved the ANDA and MSN’s label, providing Defendants’ generic product an AB-rating for the treatment of Non-24 . . . And there is no question that as part of its process of reviewing and approving the ANDA, the FDA also considered and approved MSN’s label for use in marketing the generic product at issue.
Thus, there can also be no doubt that adjudication of Plaintiff’s Lanham Act claim would require the Court to assess—and potentially second-guess—the FDA’s decision-making and its enforcement of the FDCA’s provisions
Id. at 16 (internal citations omitted)
The Court then went on to dismiss the various state law claims, finding no reason to exercise supplemental jurisdiction now that the lone federal cause of action had been dismissed.
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