This case was last updated from PACER on 08/22/2021 at 09:23:18 (UTC).

Otsuka Pharmaceutical Co., Ltd. v. Lupin Limited et al

Case Summary

On June 23, 2021, Otsuka Pharmaceutical Co., Ltd. (“Otsuka” or “Plaintiff”), represented by Jack B. Blumenfeld and Jeremy A. Tigan of Morris, Nichols, Arsht & Tunnell LLP, filed an intellectual property lawsuit against Lupin Limited and Lupin Pharmaceuticals, Inc. (“Lupin” or “Defendants”), seeking a preliminary and permanent injunction along with damages among other reliefs for alleged unlawful infringement of United States patents owned by the Plaintiff. This case was filed in the United States District Court in the District of Delaware. 

 

The Plaintiff filed this complaint for the alleged infringement of the U.S. Patent No. 8,501,730 (“the ’730 Patent”) entitled Process for Preparing Benzazepine Compounds or Salts Thereof and U.S. Patent No. 10,905,694 (“the ’694 Patent”) entitled Pharmaceutical Solid Preparation Comprising Benzazepines and Production Method Thereof (collectively “Patents-in-Suit”) owned by the Plaintiff. 

 

In the complaint, the Plaintiff has alleged that, “This action arises out of Lupin’s submission of an Abbreviated New Drug Application (“ANDA”) No. 216063 under § 505(j) of the Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration (“FDA”) approval to commercially manufacture, use, offer for sell and sell in the United States, and/or import into the United States, tolvaptan tablets (15, 30, 45, 60, and 90 mg) (“Lupin’s ANDA products”) prior to the expiration of the Patents-in-Suit.”

 

Further, the Plaintiff alleged that, “Lupin submitted to the FDA ANDA No. 216063 seeking approval to commercially manufacture, use, offer to sell and/or sell Lupin’s ANDA products in the United States, or import them into the United States, before the expiration of the ’730 Patent” and “Lupin submitted to the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a certification alleging that the claims of the ’730 Patent are invalid, unenforceable and/or not infringed.”

 

The Plaintiff also alleged that, “Under 35 U.S.C. § 271(e)(2)(A), Lupin has infringed one or more claims of the ’730 Patent, including at least claim 1, by submitting, or causing to be submitted, to the FDA ANDA No. 216063, seeking approval to commercially manufacture, use, offer to sell or sell Lupin’s ANDA products, or import them into the United States, before the expiration date of the ’730 Patent” and “if ANDA No. 216063 is approved, Lupin will infringe one or more claims of the ’730 Patent, including at least claim 1, under § 271(a), either literally or under the doctrine of equivalents, by commercially making, using, offering to sell, selling and/or importing Lupin’s ANDA products.”

 

Similar allegations have been made by the Plaintiff with reference to the infringement of other Patents-in-suit. 

 

There are two claims for relief laid down by the Plaintiff, one for the alleged infringement of each of the Patents-in-suit.

 

In the prayer for relief, the Plaintiff has requested the Court for preliminary and permanent injunctive relief and declaratory relief that Lupin’s making, using, offering to sell, selling or importation of Lupin’s ANDA products before the expiration of the Patents-in-Suit will infringe the said patents along with an award for damages under 35 U.S.C. §§ 271(e)(4)(B) and 283. Further, the Plaintiff has requested the Court for an award of cost, expenses and disbursements including reasonable attorney fees pursuant to 35 U.S.C. §§ 285 and 271(e)(4).

 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-00900

  • Filing Date:

    06/23/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

  • Courthouse:

    Delaware District

Judge Details

Presiding Judge

Richard G. Andrews

 

Party Details

Plaintiff

Otsuka Pharmaceutical Co., Ltd.

Defendants

Lupin Pharmaceuticals, Inc.

Lupin Limited

Attorney/Law Firm Details

Plaintiff 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

 

Court Documents

#8

(#8) WAIVER OF SERVICE returned executed by Otsuka Pharmaceutical Co., Ltd.: For Lupin Limited waiver sent on 7/7/2021, answer due 9/7/2021. (Blumenfeld, Jack) (Entered: 07/08/2021)

#7

(#7) WAIVER OF SERVICE returned executed by Otsuka Pharmaceutical Co., Ltd.: For Lupin Pharmaceuticals, Inc. waiver sent on 7/7/2021, answer due 9/7/2021. (Blumenfeld, Jack) (Entered: 07/08/2021)

6 #1

Summons- Lupin Pharma

#6

(#6) Summonses Issued (please complete the top portion of the form and print out for use/service). (Attachments: #1 Summons- Lupin Pharma)(smg) (Entered: 06/24/2021)

#5

(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Otsuka Holdings Co., Ltd. for Otsuka Pharmaceutical Co., Ltd. filed by Otsuka Pharmaceutical Co., Ltd. (smg) (Entered: 06/24/2021)

#4

(#4) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,501,730 ; 10,905,694. (smg) (Entered: 06/24/2021)

#3

(#3) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: May 11, 2021. Date of Expiration of the '730 Patent: September 1, 2026 Date of Expiration of the '694 Patent: April 7, 2030.Thirty Month Stay Deadline: 11/11/2023. (smg) Modified on 6/24/2021 (smg). (Entered: 06/24/2021)

#2

(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (smg) (Entered: 06/24/2021)

1 #3

Civil Cover Sheet

1 #2

Exhibit B

1 #1

Exhibit A

#1

(#1) COMPLAINT for PATENT INFRINGEMENT- filed against Lupin Limited, Lupin Pharmaceuticals, Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3642051.) - filed by Otsuka Pharmaceutical Co., Ltd.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Civil Cover Sheet)(smg) Modified on 6/24/2021 (smg). (Entered: 06/24/2021)

 

Docket Entries

  • 07/08/2021
  • View Court Documents
  • Docket(#8) WAIVER OF SERVICE returned executed by Otsuka Pharmaceutical Co., Ltd.: For Lupin Limited waiver sent on 7/7/2021, answer due 9/7/2021. (Blumenfeld, Jack) (Entered: 07/08/2021)

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  • 07/08/2021
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  • Docket(#7) WAIVER OF SERVICE returned executed by Otsuka Pharmaceutical Co., Ltd.: For Lupin Pharmaceuticals, Inc. waiver sent on 7/7/2021, answer due 9/7/2021. (Blumenfeld, Jack) (Entered: 07/08/2021)

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  • 06/30/2021
  • DocketCase Assigned to Judge Richard G. Andrews. Please include the initials of the Judge (RGA) after the case number on all documents filed. (rjb) (Entered: 06/30/2021)

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  • 06/24/2021
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  • Docket(#6) Summonses Issued (please complete the top portion of the form and print out for use/service). (Attachments: #1 Summons- Lupin Pharma)(smg) (Entered: 06/24/2021)

    Read MoreRead Less
  • 06/23/2021
  • View Court Documents
  • Docket(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Otsuka Holdings Co., Ltd. for Otsuka Pharmaceutical Co., Ltd. filed by Otsuka Pharmaceutical Co., Ltd. (smg) (Entered: 06/24/2021)

    Read MoreRead Less
  • 06/23/2021
  • View Court Documents
  • Docket(#4) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,501,730 ; 10,905,694. (smg) (Entered: 06/24/2021)

    Read MoreRead Less
  • 06/23/2021
  • View Court Documents
  • Docket(#3) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: May 11, 2021. Date of Expiration of the '730 Patent: September 1, 2026 Date of Expiration of the '694 Patent: April 7, 2030.Thirty Month Stay Deadline: 11/11/2023. (smg) Modified on 6/24/2021 (smg). (Entered: 06/24/2021)

    Read MoreRead Less
  • 06/23/2021
  • View Court Documents
  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (smg) (Entered: 06/24/2021)

    Read MoreRead Less
  • 06/23/2021
  • View Court Documents
  • Docket(#1) COMPLAINT for PATENT INFRINGEMENT- filed against Lupin Limited, Lupin Pharmaceuticals, Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3642051.) - filed by Otsuka Pharmaceutical Co., Ltd.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Civil Cover Sheet)(smg) Modified on 6/24/2021 (smg). (Entered: 06/24/2021)

    Read MoreRead Less
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