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This case was last updated from PACER on 04/19/2021 at 10:08:12 (UTC).

Novartis Pharmaceuticals Corporation v. Lupin Atlantis Holdings, S.A. et al

Case Summary

On February 18, 2021, Novartis Pharmaceuticals Corporation (“Novartis”), represented by Alexandra M. Joyce and Daniel M. Silver of McCarter & English, LLP, filed an intellectual property lawsuit against Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. (collectively, “Defendants”) seeking injunctive relief, declaratory judgment and damages for alleged infringement of one or more claims of patents owned by Novartis. This case was filed in U.S. District Court in the District of Delaware with Judge Leonard P. Stark presiding.

 

In their complaint, Novartis alleged that the Defendants have infringed more than one claim of their U.S. Patents Nos. 8,101,659 entitled “Methods of treatment and pharmaceutical composition.” (the “’659 patent”), 8,796,331 entitled “Methods of treatment and pharmaceutical composition.” (the “’331 patent”), 8,877,938 entitled “Compounds containing S-N- valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” (the “’938 patent”), and/or 9,388,134 entitled “Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” (the “’134 patent”) (all collectively “patents in suit”).

 

Novartis alleged that “this is a patent infringement action arising under Title 35 of the United States Code and concerning an Abbreviated New Drug Application (“ANDA”) submitted to the United States Food and Drug Administration (“FDA”)” and that “this is the third complaint Novartis has filed against Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. in connection with ANDA No. 213808.”

 

Novartis further alleged that “Lupin Atlantis Holdings, S.A. has committed an act of alleged infringement in this judicial district by filing merged ANDA No. 213808 (or by filing an amendment to merge ANDA No. 213809 with ANDA No. 213808) with the intent to make, use, sell, offer for sale, and/or import the original ANDA Products of ANDA No. 213808 in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of alleged infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.”

 

In their cause of action, Novartis laid down that by filing merged ANDA No. 213808 (or amending ANDA No. 213808) under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the original ANDA Products of ANDA No. 213808 in or into the United States prior to the expiration of the patents in suit, the Defendants have committed an act of alleged infringement under 35 U.S.C. § 271(e)(2) and that if their request is approved, it will allegedly directly infringe or induce infringement of one or more claims of the patents in suit. Novartis further claimed that the alleged action of Defendant act is not within the limited exclusions of 35 U.S.C. § 271(e)(1) and therefore Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4).

 

In its prayer for relief Novartis requested the court to pass an order for permanent injunction, declaratory relief and monetary damages in addition to the costs of litigation.

 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-00229

  • Filing Date:

    02/18/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

  • Court:

    U.S. District Courts

  • Courthouse:

    Delaware District

Judge Details

Presiding Judge

Leonard P. Stark

 

Party Details

Plaintiff

Novartis Pharmaceuticals Corporation

Defendants

Lupin Pharmaceuticals, Inc.

Lupin Limited

Lupin Atlantis Holdings, S.A.

Lupin Inc.

Attorney/Law Firm Details

Plaintiff 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

 

Court Documents

#9

(#9) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Pharmaceuticals, Inc. waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

#8

(#8) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Limited waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

#7

(#7) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Inc. waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

#6

(#6) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Atlantis Holdings, S.A. waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

#5

(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Novartis AG for Novartis Pharmaceuticals Corporation filed by Novartis Pharmaceuticals Corporation. (apk) (Entered: 02/19/2021)

#4

(#4) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: 1/5/2021. Date of Expiration of Patent: SEE ANDA FORM.Thirty Month Stay Deadline: 7/7/2023. (apk) (Entered: 02/19/2021)

#3

(#3) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,101,659 ;8,796,331 ;8,877,938 ;9,388,134. (apk) (Entered: 02/19/2021)

#2

(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (apk) (Entered: 02/19/2021)

1 #2

Civil Cover Sheet

1 #1

Exhibit A-D

#1

(#1) COMPLAINT filed against Lupin Atlantis Holdings, S.A., Lupin Inc., Lupin Limited, Lupin Pharmaceuticals, Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3530964.) - filed by Novartis Pharmaceuticals Corporation. (Attachments: #1 Exhibit A-D, #2 Civil Cover Sheet)(apk) (Entered: 02/19/2021)

 

Docket Entries

  • 03/01/2021
  • View Court Documents
  • Docket(#9) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Pharmaceuticals, Inc. waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

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  • 03/01/2021
  • View Court Documents
  • Docket(#8) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Limited waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

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  • 03/01/2021
  • View Court Documents
  • Docket(#7) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Inc. waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

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  • 03/01/2021
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  • Docket(#6) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation: For Lupin Atlantis Holdings, S.A. waiver sent on 2/25/2021, answer due 4/26/2021. (Joyce, Alexandra) (Entered: 03/01/2021)

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  • 02/24/2021
  • DocketCase Assigned to Judge Leonard P. Stark. Please include the initials of the Judge (LPS) after the case number on all documents filed. (rjb) (Entered: 02/24/2021)

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  • 02/18/2021
  • DocketNo Summons Issued. (apk) (Entered: 02/19/2021)

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  • 02/18/2021
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  • Docket(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Novartis AG for Novartis Pharmaceuticals Corporation filed by Novartis Pharmaceuticals Corporation. (apk) (Entered: 02/19/2021)

    Read MoreRead Less
  • 02/18/2021
  • View Court Documents
  • Docket(#4) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: 1/5/2021. Date of Expiration of Patent: SEE ANDA FORM.Thirty Month Stay Deadline: 7/7/2023. (apk) (Entered: 02/19/2021)

    Read MoreRead Less
  • 02/18/2021
  • View Court Documents
  • Docket(#3) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,101,659 ;8,796,331 ;8,877,938 ;9,388,134. (apk) (Entered: 02/19/2021)

    Read MoreRead Less
  • 02/18/2021
  • View Court Documents
  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (apk) (Entered: 02/19/2021)

    Read MoreRead Less
  • 02/18/2021
  • View Court Documents
  • Docket(#1) COMPLAINT filed against Lupin Atlantis Holdings, S.A., Lupin Inc., Lupin Limited, Lupin Pharmaceuticals, Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3530964.) - filed by Novartis Pharmaceuticals Corporation. (Attachments: #1 Exhibit A-D, #2 Civil Cover Sheet)(apk) (Entered: 02/19/2021)

    Read MoreRead Less
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