JAZZ PHARMACEUTICALS, INC. v. BECERRA et al
| JAZZ PHARMACEUTICALS, INC. |
| XAVIER BECERRA, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ROBERT CALIFF and U.S. FOOD AND DRUG ADMINISTRATION |
| AVADEL CNS PHARMACEUTICALS, LLC |
| FOOD AND DRUG ADMINISTRATION |
| 1:2023cv01819 |
| June 22, 2023 |
| US District Court for the District of Columbia |
| Amit P Mehta |
| Administrative Procedure Act/Review or Appeal of Agency Decision |
| 05 U.S.C. § 702 Administrative Procedure Act |
| None |
Docket Report
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Filing 33
ORDER granting #31 Motion for Scheduling Order. The following dates and deadlines are ordered in this case. August 11, 2023: Federal Defendants shall file with the Court an index of the certified Administrative Record and transmit the record to all parties' counsel, under the terms of the #30 Stipulated Protective Order. August 25, 2023: Plaintiff shall file any amended complaint. September 15, 2023: Plaintiff shall file its motion for summary judgment. September 19, 2023: Any amicus curiae supporting Plaintiff shall move for leave to participate in this action, which motion shall include the proposed amicus brief. October 20, 2023: Federal Defendants and Intervenor-Defendant shall each file combined oppositions to Plaintiff's motion for summary judgment and cross-motions for summary judgment. October 24, 2023: Any amicus curiae supporting Defendants shall move for leave to participate in this action, which motion shall include the proposed amicus brief. November 15, 2023: Plaintiff shall file its combined reply in support of its motion for summary judgment and opposition to the cross-motions for summary judgment filed by the Federal Defendants and Intervenor-Defendant. December 15, 2023: Federal Defendants and Intervenor-Defendant shall each file replies in support of their cross-motions for summary judgment. December 22, 2023: The parties shall file a Joint Appendix containing the portions of the Administrative Record relied upon by any party. Plaintiff shall take lead on preparing the Joint Appendix. Please see attached Order for additional details. Signed by Judge Amit P. Mehta on 08/14/2023. (lcapm3)
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MINUTE ORDER. Having considered Plaintiff Jazz Pharmaceuticals, Inc.'s Responses to the court's Minute Orders to Show Cause, ECF Nos. #16 , #26 , the court agrees that, pursuant to Local Civil Rule 40.5(a)(4), this case is related to the earlier matter, Avadel CNS Pharmaceuticals, LLC v. Becerra, 22-cv-2159 (APM). Accordingly, this case shall remain on this court's docket. Signed by Judge Amit P. Mehta on 08/14/2023. (lcapm3)
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| Set/Reset Deadlines/Hearings: Administrative Record due by 8/11/2023. Amended Pleadings due by 8/25/2023. Appendix due by 12/22/2023. Cross Motions due by 10/20/2023. Response to Cross Motions due by 10/24/2023. Reply to Cross Motions due by 11/15/2023. Summary Judgment motions due by 9/15/2023. Response to Motion for Summary Judgment due by 10/20/2023. Reply to Motion for Summary Judgment due by 10/24/2023. (zjch, ) |
| Filing 32 ADMINISTRATIVE RECORD Certified Index by XAVIER BECERRA, ROBERT CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Katzen, Noah) |
| Filing 31 Joint MOTION for Scheduling Order by JAZZ PHARMACEUTICALS, INC.. (Attachments: #1 Text of Proposed Order)(Akowuah, Kwaku) |
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Filing 30
ORDER granting #29 Motion for Protective Order. Please see attached Order. Signed by Judge Amit P. Mehta on 08/06/2023. (lcapm3)
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| Filing 29 Joint MOTION for Protective Order by JAZZ PHARMACEUTICALS, INC.. (Attachments: #1 Exhibit A - Proposed Stipulated Protective Order)(Akowuah, Kwaku) |
| Filing 28 NOTICE OF WITHDRAWAL OF APPEARANCE as to JAZZ PHARMACEUTICALS, INC.. Attorney Christopher S. Ross terminated. (Ross, Christopher) |
| Filing 27 NOTICE of Appearance by Isaac Belfer on behalf of XAVIER BECERRA, ROBERT CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Belfer, Isaac) |
| Filing 26 RESPONSE TO ORDER TO SHOW CAUSE re Order,,,,, Response to Minute Order of July 18, 2023 filed by JAZZ PHARMACEUTICALS, INC.. (Attachments: #1 Exhibit A)(Akowuah, Kwaku) |
| Filing 25 NOTICE of Appearance by Noah T. Katzen on behalf of XAVIER BECERRA, ROBERT CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Katzen, Noah) |
| Filing 24 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES served on 7/5/2023 (Akowuah, Kwaku) |
| Filing 23 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. U.S. FOOD AND DRUG ADMINISTRATION served on 7/10/2023 (Akowuah, Kwaku) |
| Filing 22 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. XAVIER BECERRA served on 7/5/2023 (Akowuah, Kwaku) |
| Filing 21 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. ROBERT CALIFF served on 7/10/2023 (Akowuah, Kwaku) |
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MINUTE ORDER. In the court's Minute Order to Show Cause entered on June 27, 2023, it neglected to ask Plaintiff Jazz Pharmaceuticals, Inc. to address a second requirement of the Rule 40.5(a)(4) related-case designation: whether this case involves the "same subject matter" as the earlier Avadel matter. The Avadel matter involved a challenge to FDA's decision that Avadel's new drug application (NDA) for Lumryz was deficient because it lacked a patent certification as to one of the patents listed in the Orange Book for Xyrem. This case challenges a different FDA action: the agency's determination, in connection with its later approval of Lumryzs NDA, that Lumryz had "overcome" the orphan drug exclusivity recognized for Jazz's related product, Xywav. The question is whether two cases that challenge different agency decisions, albeit regarding the same product, relate to the "same subject matter." See Wilderness Soc'y v. Bernhardt, No. 20-cv-1176 (BAH), 2020 WL 2849635, at *3 (D.D.C. June 2, 2020) (holding that two cases did not involve the "same subject matter" when each challenged a different agency action, even though they related to the same mineral rights leases). Jazz shall answer that question by July 25, 2023. Defendant Avadel may file a response, too, if it wishes to do so. Signed by Judge Amit P. Mehta on 07/18/2023. (lcapm3)
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| Filing 20 NOTICE of Appearance by Tobias S. Loss-Eaton on behalf of JAZZ PHARMACEUTICALS, INC. (Loss-Eaton, Tobias) |
| Filing 19 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 6/27/23. (Akowuah, Kwaku) |
| Filing 18 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 6/27/2023. Answer due for ALL FEDERAL DEFENDANTS by 8/26/2023. (Akowuah, Kwaku) |
| Filing 17 SUMMONS (4) Issued Electronically as to XAVIER BECERRA, ROBERT CALIFF, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Attachment: #1 Notice and Consent)(zjm) |
| Filing 16 RESPONSE TO ORDER TO SHOW CAUSE re Order,,,,, DIRECTING JAZZ TO SHOW CAUSE THAT ITS RELATED CASE DESIGNATION IS PROPER filed by JAZZ PHARMACEUTICALS, INC.. (Akowuah, Kwaku) |
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Filing 15
ORDER granting #9 Motion to Intervene. Avadel may intervene as of right as a Defendant in this action. Intervenor-Defendant Avadel shall file its responsive pleading on the same day as the Federal Defendants. See the attached Order for additional details. Signed by Judge Amit P. Mehta on 06/28/2023. (lcapm1)
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| Filing 14 LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by AVADEL CNS PHARMACEUTICALS, LLC identifying Corporate Parent AVADEL US HOLDINGS, INC., Corporate Parent AVADEL PHARMACEUTICALS PLC. for AVADEL CNS PHARMACEUTICALS, LLC. (See Docket Entry #9 to view document). (zed) |
| Filing 13 NOTICE of Appearance by Nicholas L Schlossman on behalf of AVADEL CNS PHARMACEUTICALS, LLC (Schlossman, Nicholas) |
| Filing 12 NOTICE of Appearance by Andrew D. Prins on behalf of AVADEL CNS PHARMACEUTICALS, LLC (Prins, Andrew) |
| Filing 11 NOTICE of Appearance by John Richard Manthei on behalf of AVADEL CNS PHARMACEUTICALS, LLC (Manthei, John) |
| Filing 10 NOTICE of Appearance by Philip Jonathan Perry on behalf of AVADEL CNS PHARMACEUTICALS, LLC (Perry, Philip) |
| Filing 9 Unopposed MOTION to Intervene by AVADEL CNS PHARMACEUTICALS, LLC. (Attachments: #1 Corporate Disclosure Statement, #2 Text of Proposed Order)(Perry, Philip) |
| Filing 8 SUMMONS (2) Issued Electronically as to U.S. Attorney and U.S. Attorney General. (Attachment: #1 Notice and Consent)(zed) |
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MINUTE ORDER to Show Cause. Plaintiff Jazz Pharmaceuticals, Inc. has designated this matter as "related" to Avadel CNS Pharmaceuticals, LLC v. Becerra et al., 22-cv-2159 (APM), pursuant to Local Civil Rule 40.5(a)(4). ECF No. 3. Under that rule, civil cases are related where "a case is dismissed, with prejudice or without, and a second case is filed involving the same parties and relating to the same subject matter." LCvR 40.5(a)(4). In the Avadel matter, the court granted the Federal Defendants' and the Intervenor Defendant's motions for summary judgment and entered judgment in their favor. Thus, it would appear that the earlier Avadel matter was not "dismissed" as that term is used in Local Civil Rule 40.5(a)(4). See Wilderness Soc'y v. Bernhardt, No. 20-cv-1176 (BAH), 2020 WL 2849635, at *2 (D.D.C. June 2, 2020) (holding that the entry of summary judgment in favor of the defendants in an earlier case does not constitute a "dismissal" for purposes of Rule 40.5(a)(4)). Accordingly, Plaintiff shall show cause by no later than July 7, 2023, why this matter should not be forwarded to the Calendar Committee for random reassignment. Signed by Judge Amit P. Mehta on 06/27/2023. (lcapm1)
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| Case Assigned to Judge Amit P. Mehta. (zsl) |
| Filing 7 REQUEST FOR SUMMONS TO ISSUE by JAZZ PHARMACEUTICALS, INC. filed by JAZZ PHARMACEUTICALS, INC..(Akowuah, Kwaku) |
| Filing 6 NOTICE of Appearance by Peter A. Bruland on behalf of JAZZ PHARMACEUTICALS, INC. (Bruland, Peter) |
| Filing 5 NOTICE of Appearance by Christopher S. Ross on behalf of JAZZ PHARMACEUTICALS, INC. (Ross, Christopher) |
| Filing 4 NOTICE of Appearance by Sean Christopher Griffin on behalf of JAZZ PHARMACEUTICALS, INC. (Griffin, Sean) |
| Filing 3 NOTICE OF RELATED CASE by JAZZ PHARMACEUTICALS, INC.. Case related to Case No. 1:22-cv-2159. (Akowuah, Kwaku) |
| Filing 2 LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by JAZZ PHARMACEUTICALS, INC. (Akowuah, Kwaku) |
| Filing 1 COMPLAINT against XAVIER BECERRA, ROBERT CALIFF, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES ( Filing fee $ 402 receipt number ADCDC-10158104) filed by JAZZ PHARMACEUTICALS, INC.. (Attachments: #1 Civil Cover Sheet, #2 Exhibit A, #3 Exhibit B, #4 Exhibit C, #5 Exhibit D, #6 Exhibit E, #7 Exhibit F, #8 Exhibit G, #9 Summons XAVIER BECERRA, #10 Summons ROBERT CALIFF, #11 Summons FOOD AND DRUG ADMINISTRATION, #12 Summons U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES)(Akowuah, Kwaku) |
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