This case was last updated from U.S. District Courts on 07/11/2021 at 09:23:58 (UTC).

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

Case Summary

On May 12, 2021, Jazz Pharmaceuticals, Inc. (“Jazz Pharmaceuticals” or “Plaintiff”), represented by Jack B. Blumenfeld and Jeremy A. Tigan of Morris, Nichols, Arsht & Tunnell LLP, filed an intellectual property lawsuit against Avadel Pharmaceuticals plc, Avadel US Holdings, Inc., Avadel Specialty Pharmaceuticals, LLC, Avadel Legacy Pharmaceuticals, LLC, and others (collectively, “Avadel” or “Defendants”), seeking declaratory relief, injunctive relief, and damages, among other reliefs, for alleged unlawful infringement of United States patents owned by Plaintiff. This case was filed in U.S. District Court in the Eastern District of New York with Judge Maryellen Noreika presiding.

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®. 

In its complaint, Plaintiff alleged that  “Avadel has made, and will continue to make, substantial preparation in the United States to manufacture, offer to sell, sell and/or import Avadel’s Proposed Product prior to the expiration of the ’488 patent.”

Plaintiff further alleged that  “Unless enjoined by this Court, upon FDA approval of Avadel’s NDA, Avadel will induce infringement of one or more claims of the ’963 patent under 35 U.S.C. § 271(b), including at least claim 1, by making, using, offering to sell, selling, and/or importing Avadel’s Proposed Product in the United States. On information and belief, upon FDA approval of Avadel’s NDA, Avadel will encourage acts of direct infringement with knowledge of the ’963 patent and knowledge that its acts are encouraging infringement, with specific intent to induce infringement of the ’963 patent.”

There are five claims for relief laid down by the Plaintiff, the alleged infringement of the Patents-in-suit in violation of 35 U.S.C. § 271 (b) and (c), wherein it has been alleged that future commercial manufacture, use, offer for sale, sale, and/or importation of Avadel’s Proposed Product prior to expiration of the Patents-in-suit by Avadel will constitute direct infringement, induced infringement, and/or contributory infringement of the Patents-in-suit.

In the prayer for relief the Plaintiff has requested the Court to enter a judgment that Avadel has infringed the patents-in-suit; an order that the effective date of FDA approval of Avadel’s NDA for its sodium oxybate drug product be a date which is not earlier than the later of the expiration of the patents-in-suit; grant preliminary and permanent injunctions enjoining Avadel and its representative from further infringement; and a permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and enjoining Avadel from practicing any methods as claimed in the patents-in- suit. Plaintiff further requested the Court to make an award of damages, in case Avadel engages in the commercial manufacture, use, sale, or offer for sale, or importation into the United States of Avadel’s Proposed Product prior to the expiration of the Patents-in-suit and award costs of litigation. 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-00691

  • Filing Date:

    05/12/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

Judge Details

Presiding Judge

Maryellen Noreika

 

Party Details

Plaintiff and Counter Defendant

Jazz Pharmaceuticals, Inc.

Defendants and Counter Claimants

Avadel Legacy Pharmaceuticals, LLC

Avadel CNS Pharmaceuticals, LLC

Avadel Specialty Pharmaceuticals, LLC

Avadel Pharmaceuticals PLC

Avadel Management Corporation

Avadel US Holdings, Inc.

Attorney/Law Firm Details

Plaintiff and Counter Defendant Attorneys

Jeremy A. Tigan

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Jack B. Blumenfeld

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Frank C. Calvosa

Gabriel P. Brier

F. Dominic Cerrito

Eric C. Stops

Evangeline Shih

Defendant and Counter Claimant Attorneys

Alexandra M. Joyce

Attorney at McCarter & English, LLP

405 N. King Street, 8Th Floor

Wilmington, DE 19801

Daniel M. Silver

Attorney at McCarter & English, LLP

405 N. King Street, 8Th Floor

Wilmington, DE 19801

Alex M. Grabowski

Marc N. Zubick

Sarah W. Wang

 

Court Documents

#18

#16

#15

#14

#13

#12

#11

#10

#9

#8

#7

#6

#5

#4

#3

#2

1 #2

Civil Cover Sheet

1 #1

Exhibit A-I

8 More Documents Available
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Docket Entries

  • 07/09/2021
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  • DocketSO ORDERED re #18 MOTION for Pro Hac Vice Appearance of Attorney Bornali Rashmi Borah and Herman Yue filed by Avadel CNS Pharmaceuticals, LLC, Avadel Specialty Pharmaceuticals, LLC, Avadel US Holdings, Inc., Avadel Pharmaceuticals PLC, Avadel Management Corporation, Avadel Legacy Pharmaceuticals, LLC. ORDERED by Judge Maryellen Noreika on 7/9/2021. (dlw) (Entered: 07/09/2021)

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  • 07/09/2021
  • DocketPro Hac Vice Attorney Sarah W. Wang for Avadel CNS Pharmaceuticals, LLC, Avadel Legacy Pharmaceuticals, LLC, Avadel Management Corporation,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: 07/09/2021)

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  • 07/09/2021
  • DocketPro Hac Vice Attorney 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: 07/09/2021)

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  • 07/09/2021
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  • Docket(#18) MOTION for Pro Hac Vice Appearance of Attorney 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: 07/09/2021)

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  • 07/01/2021
  • DocketPro Hac Vice Attorney Evangeline Shih for Jazz Pharmaceuticals, 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. (twk) (Entered: 07/01/2021)

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  • 06/21/2021
  • Docket(#17) ORAL ORDER - IT IS HEREBY ORDERED that the parties shall confer regarding proposed dates in the scheduling order and shall submit a proposed order, including a proposal for the length and timing of trial, to the Court no later than thirty (30) days from the date of this Order. The parties are to use the Court's form scheduling order, which is posted at http://www.ded.uscourts.gov (see Chambers, Judge Noreika, Forms). If there are disputes or issues that the Court needs to address in the proposed scheduling order, the parties shall direct the Court to the paragraph numbers in which those appear in a cover letter to the Court. ORDERED by Judge Maryellen Noreika on 6/21/2021. (dlw) (Entered: 06/21/2021)

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  • 06/18/2021
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  • Docket(#16) ANSWER to #11 Answer to Complaint,, Counterclaim, by Jazz Pharmaceuticals, Inc..(Blumenfeld, Jack) (Entered: 06/18/2021)

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  • 06/10/2021
  • DocketPro Hac Vice Attorney Frank C. Calvosa for Jazz Pharmaceuticals, 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. (apk) (Entered: 06/10/2021)

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  • 06/08/2021
  • DocketPro Hac Vice Attorney Gabriel P. Brier,Eric C. Stops,F. Dominic Cerrito for Jazz Pharmaceuticals, 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. (myr) (Entered: 06/08/2021)

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  • 06/07/2021
  • DocketPro Hac Vice Attorney Alex M. Grabowski 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. (mal) (Entered: 06/07/2021)

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8 More Docket Entries
  • 05/13/2021
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  • Docket(#10) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc.. Avadel Management Corporation served on 5/13/2021, answer due 6/3/2021. (Blumenfeld, Jack) (Entered: 05/13/2021)

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  • 05/13/2021
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  • Docket(#9) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc.. Avadel US Holdings, Inc. served on 5/13/2021, answer due 6/3/2021. (Blumenfeld, Jack) (Entered: 05/13/2021)

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  • 05/13/2021
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  • Docket(#8) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc.. Avadel Specialty Pharmaceuticals, LLC served on 5/13/2021, answer due 6/3/2021. (Blumenfeld, Jack) (Entered: 05/13/2021)

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  • 05/13/2021
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  • Docket(#7) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc.. Avadel Legacy Pharmaceuticals, LLC served on 5/13/2021, answer due 6/3/2021. (Blumenfeld, Jack) (Entered: 05/13/2021)

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  • 05/13/2021
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  • Docket(#6) SUMMONS Returned Executed by Jazz Pharmaceuticals, Inc.. Avadel CNS Pharmaceuticals, LLC served on 5/13/2021, answer due 6/3/2021. (Blumenfeld, Jack) (Entered: 05/13/2021)

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  • 05/12/2021
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  • Docket(#5) Summonses Issued (please complete the top portion of the form and print out for use/service). (apk) (Entered: 05/13/2021)

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  • 05/12/2021
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  • Docket(#4) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Jazz Pharmaceuticals, plc for Jazz Pharmaceuticals, Inc. filed by Jazz Pharmaceuticals, Inc. (apk) (Entered: 05/13/2021)

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  • 05/12/2021
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  • Docket(#3) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,731,963 B1 ;10,758,488 B2 ;10,813,885 B1 ;10,959,956 B2 ;10,966,931 B2. (apk) (Entered: 05/13/2021)

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  • 05/12/2021
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  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (apk) (Entered: 05/13/2021)

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  • 05/12/2021
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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-3614091.) - filed by Jazz Pharmaceuticals, Inc.. (Attachments: #1 Exhibit A-I, #2 Civil Cover Sheet)(apk) (Entered: 05/13/2021)

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