Case: 23-10362 Document: 543-1 Page: 38 Date Filed: 08/16/2023
ular degree of likelihood of success that is required in every case, the party seeking a preliminary injunction must establish at least some likelihood of success on the merits before the court may proceed to assess the remaining requirements.”). A plaintiff need not prove “its entitlement to summary judgment in order to establish a substantial likelihood of success on the merits.” Byrum v. Landreth, 566 F.3d 442, 446 (5th Cir. 2009) (internal quotation marks omitted). But at a minimum, it must “present a substantial case on the merits.” Bryne, 847 F.2d at 1133 (quoting Celestine, 823 F.2d at 77).
A. 2000 Approval
As explained above, the Medical Organizations and Doctors have standing to challenge the 2000 Approval, the 2016 Amendments, and the 2021 Non-Enforcement Decision. Before addressing the merits of the challenge as to the 2000 Approval, we must consider a threshold issue: whether that claim was timely asserted.
The Medical Organizations and Doctors admit that they did not raise a claim as to FDA’s denial of their 2002 citizen petition within six years, as required for civil actions filed against the United States. 28 U.S.C. § 2401. They present two independent arguments for why their claim as to the 2000 Approval is nonetheless timely. The motions panel rejected both arguments. All. for Hippocratic Med., 2023 WL 2913725, at *13–15. We do the same.
1. Reopening Doctrine
First, the Medical Organizations and Doctors point to a judge-made exception to the statute of limitations called the “reopening doctrine.” Essentially, this doctrine allows a plaintiff to challenge an agency action past the ordinary timeline if the agency substantively reconsiders the original action in a subsequent decision. See Nat’l Biodiesel Bd. v. EPA, 843 F.3d 1010, 1017 (D.C. Cir. 2016); Sierra Club v. EPA, 551 F.3d 1019, 1024 (D.C. Cir. 2008). The Medical Organizations and Doctors maintain that the 2016 Amend-
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