This case was last updated from U.S. District Courts on 10/03/2021 at 07:21:29 (UTC).

Jazz Pharmaceuticals, Inc. et al v. Avadel Pharmaceuticals plc et al

Case Summary

On August 4, 2021, Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, “Jazz Pharmaceuticals” or “Plaintiffs''), represented by  Jack B. Blumenfeld and Jeremy A. Tigan of Morris, Nichols, Arsht & Tunnel  LLP, filed an intellectual property lawsuit against Avadel Pharmaceuticals plc, Avadel US Holdings, Inc., Avadel Specialty Pharmaceuticals, LLC, Avadel Legacy Pharmaceuticals, and Ors (collectively “Avadel” or “Defendants''), seeking injunctive relief and damages caused by the Defendants for the alleged infringement of Patent owned by the Plaintiffs. This case was filed in the U.S. District Court in the District of Delaware.

 

The Plaintiffs filed this complaint for the alleged infringement of the United States Patent No. 11,077,079 entitled “GHB formulation and method for its manufacture” (the “’079 patent” or “the patent-in-suit”) owned by them.

 

In this complaint, the Plaintiffs alleged that, “Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under Section 505(a) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for sodium oxybate oral solution (NDA No. 21-196), which it sells under the trade name XYREM®. The claims of the ’079 patent cover, inter alia, methods of use and administration of pharmaceutical compositions containing sodium oxybate. Jazz Pharmaceuticals owns the patent-in-suit.”

 

The Plaintiffs further alleged that, “Pursuant to Section 505(b)(2) of the FFDCA, Avadel filed an NDA (“Avadel’s NDA”) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, or importation of a sodium oxybate product (“Avadel’s Proposed Product”), before the patent-in-suit expires. On December 16, 2020, Avadel announced the submission of its NDA to the FDA. On information and belief, on February 26, 2021, the FDA notified Avadel of formal acceptance of Avadel’s NDA with an assigned Prescription Drug User Fee Act (“PDUFA”) target action date of October 15, 2021. Avadel has identified its Proposed Product using the code name FT218.”

 

The Plaintiffs also alleged that, “Avadel has published data comparing the pharmacokinetic properties of Avadel’s Proposed Product with twice-nightly sodium oxybate (i.e., XYREM®). Avadel owns U.S. Patent No. 10,272,062 (“Avadel’s ’062 patent”) entitled “Modified Release Gamma-Hydroxybutyrate Formulations Having Improved Pharmacokinetics,” Avadel’s Proposed Product, FT218, will be made available in unit dose-sachets at 4.5 gram, 6 gram, 7.5 gram, and 9 gram doses. The sachets containing the formulations described in Avadel’s ’062 patent are meant to be opened and their contents mixed with water to provide the nightly dose of gamma-hydroxybutyrate. Avadel’s Proposed Product, FT218, is covered by Jazz Pharmaceuticals’ ’079 patent. Avadel has made, and continues to make, substantial preparation in the United States to manufacture, offer to sell, sell, and/or import Avadel’s Proposed Product prior to expiration of the patent-in-suit.”

 

There is one claim laid down by the Plaintiffs which deals with alleged infringement of the patent-in-suit.

 

In its prayer for relief, the Plaintiffs have requested the Court for preliminary and permanent injunctions in furtherance of Avadel and its officers, agents, attorneys and employees, and those acting in privity and/or concert with them, from making, using, selling, offering to sell, and/or importing Avadel’s Proposed Product until after the expiration of the patent-in-suit, and pursuant to 35 U.S.C. § 271(e)(4)(B) along with an award of damages to the Plaintiffs resulting from such infringement together with interest.

 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-01138

  • Filing Date:

    08/04/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

Judge Details

Presiding Judge

Maryellen Noreika

 

Party Details

Plaintiffs and Counter Defendants

Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals Ireland Limited

Counter Claimants and Defendants

Avadel Pharmaceuticals plc

Avadel US Holdings, Inc.

Avadel Specialty Pharmaceuticals, LLC

Avadel Legacy Pharmaceuticals, LLC

Avadel Management Corporation

Avadel CNS Pharmaceuticals LLC

Attorney/Law Firm Details

Plaintiff and Counter Defendant Attorneys

Jack B. Blumenfeld

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Jeremy A. Tigan

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Counter Claimant and Defendant Attorneys

Daniel M. Silver

Attorney at McCarter & English, LLP

405 N. King Street, 8Th Floor

Wilmington, DE 19801

Alexandra M. Joyce

Attorney at McCarter & English, LLP

405 N. King Street, 8Th Floor

Wilmington, DE 19801

Daralyn J. Durie

Herman H. Yue

Katherine E. McNutt

Kira A. Davis

Marc N. Zubick

 

Court Documents

#17

#16

#15

#14

#13

#12

5 #5

Summons Issued

5 #4

Summons Issued

5 #3

Summons Issued

5 #2

Summons Issued

5 #1

Summons Issued

#5

#4

#3

#2

1 #2

Civil Cover Sheet

1 #1

Exhibit A-F

#1

14 More Documents Available
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Docket Entries

  • 09/30/2021
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  • Docket(#17) ANSWER to #12 Answer to Complaint,, Counterclaim, by Jazz Pharmaceuticals Ireland Limited, Jazz Pharmaceuticals, Inc..(Tigan, Jeremy) (Entered: 09/30/2021)

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  • 09/28/2021
  • DocketPro Hac Vice Attorneys Herman H. Yue and Marc N. Zubick for Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, and Avadel US Holdings, Inc. added for electronic noticing. Pursuant to Local Rule 83.5 (d)., Delaware counsel shall be the registered users of CM/ECF and shall be required to file all papers. (srs) (Entered: 09/28/2021)

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  • 09/27/2021
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  • DocketSO ORDERED re #16 MOTION for Pro Hac Vice Appearance of Attorney Kenneth G. Schuler, Marc N. Zubick, Alex Grabowski, Sarah W. Wang, Bornali Rashmi Borah, and Herman Yue filed by Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc., Avadel CNS Pharmaceuticals LLC, Avadel Pharmaceuticals plc, Avadel Management Corporation, Avadel Legacy Pharmaceuticals, LLC. ORDERED by Judge Maryellen Noreika on 9/27/2021. (dlw) (Entered: 09/27/2021)

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  • 09/27/2021
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  • Docket(#16) MOTION for Pro Hac Vice Appearance of Attorney Kenneth G. Schuler, Marc N. Zubick, Alex Grabowski, Sarah W. Wang, Bornali Rashmi Borah, and Herman Yue - filed by Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc.. (Silver, Daniel) (Entered: 09/27/2021)

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  • 09/15/2021
  • DocketPro Hac Vice Attorneys Daralyn J. Durie,Katherine E. McNutt, and Kira A. Davis for Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, and Avadel US Holdings, Inc. added for electronic noticing. Pursuant to Local Rule 83.5 (d)., Delaware counsel shall be the registered users of CM/ECF and shall be required to file all papers. (srs) (Entered: 09/15/2021)

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  • 09/14/2021
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  • DocketSO ORDERED re #15 MOTION for Pro Hac Vice Appearance of Attorney Daralyn Durie, Kira Davis and Katherine E. McNutt filed by Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc., Avadel CNS Pharmaceuticals LLC, Avadel Pharmaceuticals plc, Avadel Management Corporation, Avadel Legacy Pharmaceuticals, LLC. ORDERED by Judge Maryellen Noreika on 9/14/2021. (dlw) (Entered: 09/14/2021)

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  • 09/14/2021
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  • Docket(#15) MOTION for Pro Hac Vice Appearance of Attorney Daralyn Durie, Kira Davis and Katherine E. McNutt - filed by Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc.. (Silver, Daniel) (Entered: 09/14/2021)

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  • 09/13/2021
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  • Docket(#14) NOTICE of Appearance by Alexandra M. Joyce on behalf of Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc. (Joyce, Alexandra) (Entered: 09/13/2021)

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  • 09/09/2021
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  • Docket(#13) Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc.. (Silver, Daniel) (Entered: 09/09/2021)

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  • 09/09/2021
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  • Docket(#12) ANSWER to #1 Complaint, , COUNTERCLAIM against Jazz Pharmaceuticals Ireland Limited, Jazz Pharmaceuticals, Inc. by Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, Avadel CNS Pharmaceuticals LLC, Avadel US Holdings, Inc., Avadel Legacy Pharmaceuticals, LLC.(Silver, Daniel) (Entered: 09/09/2021)

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2 More Docket Entries
  • 08/20/2021
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  • Docket(#9) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals Ireland Limited. Avadel Pharmaceuticals plc served on 8/19/2021, answer due 9/9/2021. (Tigan, Jeremy) (Entered: 08/20/2021)

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  • 08/20/2021
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  • Docket(#8) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals Ireland Limited. Avadel Management Corporation served on 8/19/2021, answer due 9/9/2021. (Tigan, Jeremy) (Entered: 08/20/2021)

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  • 08/20/2021
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  • Docket(#7) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals Ireland Limited. Avadel Legacy Pharmaceuticals, LLC served on 8/19/2021, answer due 9/9/2021. (Tigan, Jeremy) (Entered: 08/20/2021)

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  • 08/20/2021
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  • Docket(#6) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals Ireland Limited. Avadel CNS Pharmaceuticals LLC served on 8/19/2021, answer due 9/9/2021. (Tigan, Jeremy) (Entered: 08/20/2021)

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  • 08/11/2021
  • DocketCase Assigned to Judge Maryellen Noreika. Please include the initials of the Judge (MN) after the case number on all documents filed. (rjb) (Entered: 08/11/2021)

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  • 08/05/2021
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  • Docket(#5) Summons Issued with Magistrate Consent Notice attached as to Avadel CNS Pharmaceuticals LLC on 8/5/2021; Avadel Legacy Pharmaceuticals, LLC on 8/5/2021; Avadel Management Corporation on 8/5/2021; Avadel Pharmaceuticals plc on 8/5/2021; Avadel Specialty Pharmaceuticals, LLC on 8/5/2021; Avadel US Holdings, Inc. on 8/5/2021. (Attachments: #1 Summons Issued, #2 Summons Issued, #3 Summons Issued, #4 Summons Issued, #5 Summons Issued)(mal) (Entered: 08/05/2021)

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  • 08/04/2021
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  • Docket(#4) Disclosure Statement pursuant to Rule 7.1: identifying Other Affiliate Jazz Pharmaceuticals plc for Jazz Pharmaceuticals Ireland Limited, Jazz Pharmaceuticals, Inc. filed by Jazz Pharmaceuticals Ireland Limited, Jazz Pharmaceuticals, Inc.. (mal) (Entered: 08/05/2021)

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  • 08/04/2021
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  • Docket(#3) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 11,077,079,B1. (mal) (Entered: 08/05/2021)

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  • 08/04/2021
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  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (mal) (Entered: 08/05/2021)

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  • 08/04/2021
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  • Docket(#1) COMPLAINT FOR PATENT INFRINGEMENT - filed against Avadel CNS Pharmaceuticals LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation, Avadel Pharmaceuticals plc, Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3672835.) - filed by Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals Ireland Limited. (Attachments: #1 Exhibit A-F, #2 Civil Cover Sheet)(mal) (Entered: 08/05/2021)

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