This case was last updated from PACER on 09/27/2021 at 07:18:37 (UTC).

Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al

Case Summary

On July 29, 2021, Novartis Pharmaceuticals Corporation (“Novartis”) and Astex Therapeutics Ltd. (“Astex”) (collectively, “Plaintiffs”), represented by Alexandra M. Joyce and Daniel M. Silver of McCarter & English, LLP, filed an intellectual property lawsuit against MSN Pharmaceuticals Inc. and MSN Laboratories Pvt. Ltd. (collectively, “MSN” or “Defendants”), seeking declaratory relief, injunctive relief and damages, among other reliefs, for the alleged infringement of various United States patents by filing of (“ANDA”) No. 215976 by the Defendants. This case was filed in U.S. District Court in the District of Delaware. 

 

In their complaint, Plaintiffs alleged that this case arises due to “Abbreviated New Drug Application (“ANDA”) No. 215976 (the “MSN ANDA”) filed by Defendants with the United States Food and Drug Administration (“FDA”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of 200 mg ribociclib tablets, generic versions of Plaintiffs’ KISQALI® drug tablets (the “ANDA Product”), prior to the expiration of U.S. Patent Nos. 8,324,225 (“the ’225 patent”), 8,415,355(“the ’355 patent”), 8,685,980 (“the ’980 patent”), 8,962,630 (“the ’630 patent”), and 9,416,136 (“the ’136 patent”) (collectively, “the Asserted Patents”).”

 

Plaintiffs also alleged that “a letter (the “MSN Notice Letter”), Defendants notified Plaintiffs (i) that MSN had submitted to the FDA ANDA No. 215976, seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of 200 mg ribociclib tablets in or into the United States, including Delaware, prior to the expiration of the ’225 patent, the ’355 patent, the ’980 patent, the ’630 patent, and the ’136 patent, and (ii) that ANDA No. 215976 includes a certification pursuant to 21 U.S.C. §355(j)(2)(A)(vii)(IV) against the ’225 patent, the ’355 patent, the ’980 patent, the ’630 patent, and the ’136 patent.”

 

Plaintiffs further alleged that “ Defendants’ generic ribociclib tablets, if approved and marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim, including claim 1, of the ’225 patent under 35 U.S.C. § 271(a).” and that “If Defendants’ marketing and sale of generic ribociclib tablets prior to expiration of the ’225 patent and all other relevant activities are not enjoined, the Plaintiffs will suffer substantial and irreparable harm for which there is no adequate remedy at law.”

 

Similar allegations have been made by the Plaintiffs with respect to other Asserted Patents. 

 

Plaintiffs have laid down ten claims for relief, the first and second claims for relief are for the alleged infringement and declaratory judgment of the ’225 patent”, the third and fourth claims for relief are for the alleged infringement and declaratory judgment of the ’355 patent”, the fifth and sixth claims for relief are for the alleged infringement and declaratory judgment of the ’980 patent”, the seventh and eighth claims for relief are for the alleged infringement and declaratory judgment of the ‘630 patent and the ninth and tenth claims are for the alleged infringement and declaratory judgment of the ‘136 Patent. 

 

In their prayer for relief, Plaintiffs have requested the Court to declare that Defendants have infringed one or more claims of the Asserted Patents by filing ANDA No. 215976, declare that production as per ANDA before expiration of asserted patents will infringe them and grant injunctive relief against Defendants for infringement of asserted patents. Plaintiffs further requested the Court to make an order that the effective date of any approval of ANDA No. 215976 shall be a date that is not earlier than the latest to expire of Asserted patents and grant damages together with costs and expenses in this action. 

 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-01102

  • Filing Date:

    07/29/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

Judge Details

Presiding Judge

Leonard P. Stark

 

Party Details

Plaintiffs and Counter Defendants

Novartis Pharmaceuticals Corporation

Astex Therapeutics Ltd.

Counter Claimants and Defendants

MSN Pharmaceuticals Inc.

MSN Laboratories Pvt. Ltd.

Attorney/Law Firm Details

Plaintiff and Counter 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

Counter Claimant and Defendant Attorney

Karen L. Pascale

Attorney at Young, Conaway, Stargatt & Taylor LLP

1000 North King Street

Wilmington, DE 19801

 

Court Documents

#12

(#12) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent MSN Laboratories Private Limited for MSN Pharmaceuticals Inc. filed by MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals Inc.. (Pascale, Karen) (Entered: 09/13/2021)

#11

(#11) ANSWER to #1 Complaint, , COUNTERCLAIM against All Plaintiffs by MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals Inc..(Pascale, Karen) (Entered: 09/13/2021)

#10

(#10) STIPULATION TO EXTEND TIME Defendants' Deadline to Answer, Move or Otherwise Respond to the Complaint to Septemebr 13, 2021 - filed by Astex Therapeutics Ltd., Novartis Pharmaceuticals Corporation. (Silver, Daniel) (Entered: 08/12/2021)

#9

(#9) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd.: For MSN Laboratories Pvt. Ltd. waiver sent on 8/11/2021, answer due 10/12/2021. (Silver, Daniel) (Entered: 08/12/2021)

#8

(#8) SUMMONS Returned Executed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd.. MSN Pharmaceuticals Inc. served on 7/30/2021, answer due 8/20/2021. (Joyce, Alexandra) (Entered: 07/30/2021)

7 #1

Summons Issued

#7

(#7) Summons Issued with Magistrate Consent Notice attached as to MSN Laboratories Pvt. Ltd. on 7/29/2021; MSN Pharmaceuticals Inc. on 7/29/2021. (Attachments: #1 Summons Issued)(myr) (Entered: 07/29/2021)

#6

(#6) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Otsuka America, Inc., Corporate Parent Otsuka Pharmaceutical Co., Ltd., Corporate Parent Otsuka Holdings Co., Ltd. for Astex Therapeutics Ltd. filed by Astex Therapeutics Ltd.. (myr) (Entered: 07/29/2021)

#5

(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Novartis AG for Novartis Pharmaceuticals Corporation filed by Novartis Pharmaceuticals Corporation. (myr) (Entered: 07/29/2021)

#4

(#4) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,324,225 ;8,415,355 ;8,685,980 ;8,962,630 ;9,416,136. (myr) (Entered: 07/29/2021)

#3

(#3) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: No Earlier than May 18, 2021. Date of Expiration of Patent: See Attached. (myr) (Entered: 07/29/2021)

#2

(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (myr) (Entered: 07/29/2021)

1 #2

Civil Cover Sheet

1 #1

Exhibit A-E

#1

(#1) COMPLAINT filed against MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3668076.) - filed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd. (Attachments: #1 Exhibit A-E, #2 Civil Cover Sheet)(myr) (Entered: 07/29/2021)

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Docket Entries

  • 09/13/2021
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  • Docket(#12) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent MSN Laboratories Private Limited for MSN Pharmaceuticals Inc. filed by MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals Inc.. (Pascale, Karen) (Entered: 09/13/2021)

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  • 09/13/2021
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  • Docket(#11) ANSWER to #1 Complaint, , COUNTERCLAIM against All Plaintiffs by MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals Inc..(Pascale, Karen) (Entered: 09/13/2021)

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  • 08/12/2021
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  • DocketSO ORDERED, re #10 STIPULATION TO EXTEND TIME Defendants' Deadline to Answer, Move or Otherwise Respond to the Complaint to Septemebr 13, 2021 filed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd. Signed by Judge Leonard P. Stark on 8/12/21. (ntl) (Entered: 08/12/2021)

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  • 08/12/2021
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  • Docket(#10) STIPULATION TO EXTEND TIME Defendants' Deadline to Answer, Move or Otherwise Respond to the Complaint to Septemebr 13, 2021 - filed by Astex Therapeutics Ltd., Novartis Pharmaceuticals Corporation. (Silver, Daniel) (Entered: 08/12/2021)

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  • 08/12/2021
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  • Docket(#9) WAIVER OF SERVICE returned executed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd.: For MSN Laboratories Pvt. Ltd. waiver sent on 8/11/2021, answer due 10/12/2021. (Silver, Daniel) (Entered: 08/12/2021)

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  • 08/04/2021
  • 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: 08/04/2021)

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  • 07/30/2021
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  • Docket(#8) SUMMONS Returned Executed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd.. MSN Pharmaceuticals Inc. served on 7/30/2021, answer due 8/20/2021. (Joyce, Alexandra) (Entered: 07/30/2021)

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  • 07/29/2021
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  • Docket(#7) Summons Issued with Magistrate Consent Notice attached as to MSN Laboratories Pvt. Ltd. on 7/29/2021; MSN Pharmaceuticals Inc. on 7/29/2021. (Attachments: #1 Summons Issued)(myr) (Entered: 07/29/2021)

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  • 07/29/2021
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  • Docket(#6) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Otsuka America, Inc., Corporate Parent Otsuka Pharmaceutical Co., Ltd., Corporate Parent Otsuka Holdings Co., Ltd. for Astex Therapeutics Ltd. filed by Astex Therapeutics Ltd.. (myr) (Entered: 07/29/2021)

    Read MoreRead Less
  • 07/29/2021
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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. (myr) (Entered: 07/29/2021)

    Read MoreRead Less
  • 07/29/2021
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  • Docket(#4) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,324,225 ;8,415,355 ;8,685,980 ;8,962,630 ;9,416,136. (myr) (Entered: 07/29/2021)

    Read MoreRead Less
  • 07/29/2021
  • View Court Documents
  • Docket(#3) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: No Earlier than May 18, 2021. Date of Expiration of Patent: See Attached. (myr) (Entered: 07/29/2021)

    Read MoreRead Less
  • 07/29/2021
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  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (myr) (Entered: 07/29/2021)

    Read MoreRead Less
  • 07/29/2021
  • View Court Documents
  • Docket(#1) COMPLAINT filed against MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3668076.) - filed by Novartis Pharmaceuticals Corporation, Astex Therapeutics Ltd. (Attachments: #1 Exhibit A-E, #2 Civil Cover Sheet)(myr) (Entered: 07/29/2021)

    Read MoreRead Less
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