MELINTA THERAPEUTICS, LLC et al v. U.S. FOOD AND DRUG ADMINISTRATION et al
| MELINTA THERAPEUTICS, LLC and REMPEX PHARMACEUTICALS, INC. |
| U.S. FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, XAVIER BECERRA and ROBERT M. CALIFF |
| NEXUS PHARMACEUTICALS, INC |
| 1:2022cv02190 |
| July 25, 2022 |
| US District Court for the District of Columbia |
| Rudolph Contreras |
| Other Statutory Actions |
| 05 U.S.C. § 702 Administrative Procedure Act |
| None |
Docket Report
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This docket was last retrieved on October 7, 2022. A more recent docket listing may be available from PACER.
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Filing 32
NOTICE [Joint] in Response to Minute Order by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC. re Motion Hearing,, Set Deadlines, (Bucholtz, Jeffrey)
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Filing 31
TRANSCRIPT OF MOTION HEARING (via teleconference) before the Honorable Rudolph Contreras held on 08/05/2022. Page Numbers: 1-15. Date of Issuance: 09/07/2022. Stenographic Court Reporter: Nancy J. Meyer. Telephone Number: 202-354-3118. Transcripts may be ordered by going to www.dcd.uscourts.gov. For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter.NOTICE RE REDACTION OF TRANSCRIPTS: The parties have 21 days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 10/6/2022. Redacted Transcript Deadline set for 10/16/2022. Release of Transcript Restriction set for 12/14/2022.(Meyer, Nancy J.)
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Minute Entry for proceedings held before Judge Rudolph Contreras: Motion Hearing held via videoconference on 9/15/2022 re #5 Motion for Temporary Restraining Order and Motion for Preliminary Injunction. Held under advisement. The parties shall notify the Court by 9/22/2022, whether they want to collapse the merits and the preliminary injunction into a single opinion. (Court Reporter: Nancy Meyer.) (hmc)
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Filing 30
Unopposed MOTION for Extension of Time to File Answer by XAVIER BECERRA, ROBERT M. CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Stephens, Kimberly)
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Set/Reset Hearings: Motion Hearing set for 9/15/2022 at 10:00 AM in before Judge Rudolph Contreras via zoom video. (tj)
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MINUTE ORDER granting #30 Unopposed Motion for Extension of Time to Answer: It is hereby ORDERED that the motion is GRANTED, and the Federal Defendant's deadline to respond to the Complaint is extended until after the Court rules on the parties' forthcoming summary judgment motions. SO ORDERED. Signed by Judge Rudolph Contreras on 8/26/2022. (lcrc2)
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MINUTE ORDER: It is hereby ORDERED that the parties shall appear for a hearing on Plaintiff's #5 Motion for a Temporary Restraining Order and Preliminary Injunction on September 15, 2022 at 10:00 a.m. by videoconference. Instructions to connect by videoconference will be provided by email. SO ORDERED. Signed by Judge Rudolph Contreras on 8/25/2022. (lcrc2)
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Filing 29
ANSWER to Complaint by NEXUS PHARMACEUTICALS, INC.(Aly, Imron)
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Filing 28
ADMINISTRATIVE RECORD Certified Index by XAVIER BECERRA, ROBERT M. CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Stephens, Kimberly)
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Filing 27
SURREPLY to re #5 MOTION for Temporary Restraining Order and MOTION for Preliminary Injunction filed by XAVIER BECERRA, ROBERT M. CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Stephens, Kimberly)
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Filing 26
Joint STATUS REPORT by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC.. (Bucholtz, Jeffrey)
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Filing 25
SURREPLY to re #22 Reply to opposition to Motion, filed by NEXUS PHARMACEUTICALS, INC. (Attachments: #1 Declaration of Joel Wallace in Support of Nexus's Sur-Reply, #2 Exhibit 1, #3 Exhibit 2)(Aly, Imron)
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Filing 24
RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. MELINTA THERAPEUTICS, LLC served on 8/2/2022; REMPEX PHARMACEUTICALS, INC. served on 8/2/2022 (Bucholtz, Jeffrey)
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Minute Entry for proceedings held before Judge Rudolph Contreras: Status Conference held on 8/5/2022. Parties inform the court of the status of this action. Joint Status Report due by 8/12/2022. Surreply due 8/12/2022. Parties shall adhere to the limited issues addressed by the court during this hearing. Court Reporter: Nancy Meyer (tj)
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Filing 23
RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 08/01/2022. (Bucholtz, Jeffrey)
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Filing 22
REPLY to opposition to motion re #21 Response to motion, #18 Response to motion, in Support of Plaintiffs' #5 Application for a Temporary Restraining Order and Preliminary Injunction filed by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC.. (Attachments: #1 Declaration in Support of Plaintiffs' Reply, #2 Exhibit 1 to Paul Alessio Mezzina's Declaration)(Bucholtz, Jeffrey); Modified on 8/5/2022 to add docket entry relationship (ztth).
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NOTICE OF ERROR re #19 Declaration; emailed to ialy@schiffhardin.com, cc'd 10 associated attorneys -- The PDF file you docketed contained errors: 1. In future, the Declaration should be filed as an attachment to the main document. (ztth, )
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Filing 21
RESPONSE re #5 MOTION for Temporary Restraining Order and MOTION for Preliminary Injunction filed by XAVIER BECERRA, ROBERT M. CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Attachments: #1 Declaration)(Stephens, Kimberly)
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Filing 20
NOTICE of Appearance by Kevin M. Nelson on behalf of NEXUS PHARMACEUTICALS, INC (Nelson, Kevin)
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Filing 19
DECLARATION of Joel M. Wallace by NEXUS PHARMACEUTICALS, INC re #18 Response to motion, filed by NEXUS PHARMACEUTICALS, INC. (Attachments: #1 Exhibit 1, #2 Exhibit 2, #3 Exhibit 3, #4 Exhibit 4)(Aly, Imron)
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Filing 18
RESPONSE re #6 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC. (This document is SEALED and only available to authorized persons.), #5 MOTION for Temporary Restraining Order and MOTION for Preliminary Injunction filed by NEXUS PHARMACEUTICALS, INC. (Aly, Imron)
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Filing 17
NOTICE of Appearance by Imron T. Aly on behalf of NEXUS PHARMACEUTICALS, INC (Aly, Imron)
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Filing 16
RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 7/28/2022. Answer due for ALL FEDERAL DEFENDANTS by 9/26/2022. (Bucholtz, Jeffrey)
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MINUTE ORDER granting #9 Motion to Intervene: Nexus Pharmaceuticals, Inc. has moved to intervene as a defendant in this action. The Court determines that Nexus meets the standard for intervention as of right under Federal Rule of Civil Procedure 24(a). The motion is timely because Nexus moved to intervene just one day after the pending TRO motion was filed, and its participation will not delay resolution of the motion. Nexus has a protectable interest in the FDA approval at issue in this action, and the action may have the result of impeding Nexus's ability to market and sell its generic product. See, e.g., Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 107879 (D.C. Cir. 2001) (noting the intervention of companies holding ANDAs for a generic drug). Nor do the current federal defendants adequately represent Nexus's private interests. See Crossroads Grassroots Pol'y Strategies v. FEC, 788 F.3d 312, 321 (D.D.C. 2015) ("We look skeptically on government entities serving as adequate advocates for private parties."). Accordingly, upon consideration of the motion and the lack of opposition thereto, it is hereby ORDERED that Nexus Pharmaceutical, Inc.'s Motion to Intervene is GRANTED, and FURTHER ORDERED that the caption in this case is amended to reflect the same. It is FURTHER ORDERED that Nexus is permitted to submit briefing on the TRO motion on or before August 3, 2022. SO ORDERED. Signed by Judge Rudolph Contreras on 8/2/2022.(lcrc2)
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Filing 15
MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Imron T. Aly, Filing fee $ 100, receipt number ADCDC-9410700. Fee Status: Fee Paid. by NEXUS PHARMACEUTICALS, INC. (Attachments: #1 Declaration, #2 Supplement Certificate of Admission, #3 Text of Proposed Order)(Carlan, Janine)
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Filing 14
MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Kevin M. Nelson, Filing fee $ 100, receipt number ADCDC-9410687. Fee Status: Fee Paid. by NEXUS PHARMACEUTICALS, INC. (Attachments: #1 Declaration, #2 Supplement Certificate of Admission, #3 Text of Proposed Order)(Carlan, Janine)
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MINUTE ORDER granting #14 Motion for Admission Pro Hac Vice: It is hereby ORDERED that the motion is GRANTED, and that Kevin M. Nelson is admitted pro hac vice to represent Movant Nexus Pharmaceuticals, Inc. in this matter. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. SO ORDERED. Signed by Judge Rudolph Contreras on 8/1/2022. (lcrc2)
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MINUTE ORDER granting #15 Motion for Admission Pro Hac Vice: It is hereby ORDERED that the motion is GRANTED, and Imron T. Aly is admitted pro hac vice to represent Movant Nexus Pharmaceuticals, Inc. in this matter. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) #Click for instructions. SO ORDERED. Signed by Judge Rudolph Contreras on 8/1/2022. (lcrc2)
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MINUTE ORDER: It is hereby ORDERED that the Defendants shall respond to #5 Plaintiffs' Motion for a Temporary Restraining Order/Preliminary Injunction on or before August 3, 2022. It is FURTHER ORDERED that the parties shall appear for a hearing on the motion on August 5, 2022 at 3:30 p.m. by videoconference. Instructions to connect by videoconference will be provided by email. SO ORDERED. Signed by Judge Rudolph Contreras on 7/28/2022. (lcrc2)
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Filing 13
NOTICE of Appearance by Amy R Upshaw on behalf of MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC. (Upshaw, Amy)
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Filing 12
NOTICE of Appearance by Paul Alessio Mezzina on behalf of MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC. (Mezzina, Paul)
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Filing 11
SUMMONS (6) Issued Electronically as to All Defendants, U.S. Attorney and U.S. Attorney General (Attachment: #1 Notice and Consent)(zmrl)
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Filing 9
MOTION to Intervene by Nexus Pharmaceuticals, Inc.. (Attachments: #1 Memorandum in Support, #2 Text of Proposed Order)(Carlan, Janine)
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Filing 8
NOTICE of Appearance by Scott Patrick Kennedy on behalf of XAVIER BECERRA, ROBERT M. CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Kennedy, Scott)
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Filing 7
NOTICE of Appearance by Kimberly Ruthsatz Stephens on behalf of All Defendants (Stephens, Kimberly)
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Case Assigned to Judge Rudolph Contreras. (zmrl)
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Filing 6
SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC. (This document is SEALED and only available to authorized persons.) (Attachments: #1 Memorandum in Support, #2 Exhibit A - SEALED Declaration of John Harlow, #3 Text of Proposed Order)(Bucholtz, Jeffrey)
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Filing 5
MOTION for Temporary Restraining Order and, MOTION for Preliminary Injunction by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC.. (Attachments: #1 Exhibit A - Redacted Declaration of John Harlow, #2 Memorandum in Support, #3 Text of Proposed Order)(Bucholtz, Jeffrey)
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Filing 4
REQUEST FOR SUMMONS TO ISSUE (Amended) re #1 Complaint, filed by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC.. Related document: #1 Complaint, filed by REMPEX PHARMACEUTICALS, INC., MELINTA THERAPEUTICS, LLC.(Bucholtz, Jeffrey)
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Filing 3
ENTERED IN ERROR.....REQUEST FOR SUMMONS TO ISSUE re #1 Complaint, filed by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC.. Related document: #1 Complaint, filed by REMPEX PHARMACEUTICALS, INC., MELINTA THERAPEUTICS, LLC.(Bucholtz, Jeffrey) Modified on 7/28/2022.....document refiled as docket entry #4 (zmrl).
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Filing 10
NOTICE OF RELATED CASE by All Plaintiffs. (zmrl)
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Filing 2
LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC. (Bucholtz, Jeffrey)
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Filing 1
COMPLAINT against XAVIER BECERRA, ROBERT M. CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-9394400) filed by MELINTA THERAPEUTICS, LLC, REMPEX PHARMACEUTICALS, INC.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Civil Cover Sheet, #4 Notice of Related Case, #5 Summons, #6 Summons, #7 Summons, #8 Summons)(Bucholtz, Jeffrey)
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