Case: 23-10362 Document: 543-1 Page: 11 Date Filed: 08/16/2023
Approval, and 2021 Non-Enforcement Decision—violates the Administrative Procedure Act. Danco intervened to represent its interest as the manufacturer and distributor of Mifeprex in the United States. GenBioPro filed an amicus brief before this court but did not intervene or otherwise participate in the litigation, either in the district court or on appeal.
The Medical Organizations and Doctors filed a motion for a preliminary injunction. The district court held a hearing on the matter and granted the motion in part. All. for Hippocratic Med. v. FDA, __ F. Supp. 3d __, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023). For relief, the court “stayed” the “effective date” of FDA’s actions under 5 U.S.C. § 705.
FDA and Danco appealed and moved to stay the district court’s order pending appeal. A motions panel of this court stayed the district court’s order in part. All. for Hippocratic Med. v. FDA, No. 23-10362, 2023 WL 2913725 (5th Cir. Apr. 12, 2023). The panel stayed the portion of the district court’s order relating to the 2000 Approval but did not disturb the other components of the order—regarding the 2016 Amendments, 2019 Generic Approval, and 2021 Non-Enforcement Decision. FDA and Danco then applied to the Supreme Court for a full stay of the district court’s order, which was granted. Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.). The Court further provided that its stay of the district court’s order would extend through the request for a petition for certiorari, if any:
The April 7, 2023 order of the United States District Court for the Northern District of Texas, case No. 2:22–cv–223, is stayed pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall terminate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this Court.
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