UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA MELINTA THERAPEUTICS, LLC, et. al, : : Plaintiffs, : Civil Action No.: 22-2190 (RC) : v. : Re Document No.: 5, 6 : U.S. FOOD & DRUG ADMINISTRATION, : et. al, : Defendants, : : : NEXUS PHARMACEUTICALS, INC., : : Intervenor-Defendant. : MEMORANDUM OPINION GRANTING PLAINTIFFS’ MOTION FOR A TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION, AS CONSOLIDATED WITH THE MERITS; GRANTING PLAINTIFFS’ MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL I. INTRODUCTION Plaintiffs Melinta Therapeutics, LLC and its wholly owned subsidiary Rempex Pharmaceuticals, Inc. (collectively, “Melinta”) have moved for a temporary restraining order and preliminary injunction, asking the Court to set aside or suspend the Food and Drug Administration’s (“FDA”) approval of an Abbreviated New Drug Application (“ANDA”) for a generic version of the drug Minocin, which treats certain bacterial infections. Compl. ¶¶ 1–2, 12–14, ECF No. 1. Nexus Pharmaceuticals, Inc. (“Nexus”), the generic drug manufacturer, moved to intervene on July 27, 2022. Federal Defendants 1 and Nexus each filed an opposition 1 Federal Defendants are FDA, the Department of Health and Human Services (“HHS”), Robert M. Califf in his official capacity as Commission of FDA, and Xavier Becerra in his official capacity as Secretary of HHS. on August 3, 2022. Melinta filed a reply on August 4, 2022. Federal Defendants and Nexus each filed surreplies at the Court’s invitation on August 12, 2022, and the Court held a hearing on September 15, 2022. In response to the Court’s request, Melinta and Federal Defendants have agreed to collapse the motion for a temporary restraining order and preliminary injunction into consideration on the merits under Fed. R. Civ. P. 56. 2 See Joint Notification at 1. Accordingly, the Court treats this as a motion for summary judgment, which it grants for Melinta. II. BACKGROUND A. Statutory and Regulatory Framework Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), drug manufacturers must obtain approval from FDA before marketing a new drug by demonstrating the safety and effectiveness of their products for their intended use. 21 U.S.C. § 355(a). An innovator drug manufacturer seeking FDA approval submits a “New Drug Application,” or “NDA,” which 2 Pursuant to Fed. R. Civ. P. 65(a)(2), the Court notified the parties of its intent to advance to the merits and requested objections during a hearing and in a subsequent minute order on September 15, 2022. On September 22, 2022, the parties jointly filed notification that Federal Defendants and Melinta agreed to advance to the merits, but that Nexus did not agree due to “potential additional genuine disputes of fact.” Joint Notification at 1–2, ECF No. 32. Nexus cited two such potential disputed facts: (1) when actual notice was received, under the statutory framework outlined in Section II.A. of this opinion; and (2) whether the doctrine of unclean hands precludes relief. The former is a factual determination to be made by FDA on remand and the latter is a legal question that was fully briefed for purposes of …
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