This case was last updated from U.S. District Courts on 05/28/2021 at 10:36:15 (UTC).

Akebia Therapeutics, Inc. et al v. FibroGen, Inc. et al

Case Summary

On March 29, 2021, Akebia Therapeutics, Inc. (“Akebia”) and Otsuka America Pharmaceutical, Inc. (“Otsuka America”) (collectively, “Plaintiffs”) represented by Brian E. Farnan, Joseph J. Farnan, Jr., Michael J. Farnan and Rosemary Jean Piergiovanni of Farnan LLP filed an intellectual property lawsuit against FibroGen, Inc. (“FibroGen”) and AstraZeneca AB (“AstraZeneca”) (collectively, “Defendants”) seeking a declaratory judgement along with costs of action for establishing that Plaintiff has not infringed Patents-in-Suit owned by the Defendants. This case was filed in U.S. District Court in the District of Delaware with Judge Colm F. Connolly presiding. 

Plaintiffs alleged that they have not infringed any of the claims of U.S. Patent Nos. 8,318,703 (“’703 patent”), 8,466,172 (“’172 patent), 8,614,204 (“’204 patent”), 9,920,011 (“’011 patent”), 8,629,131 (“’131 patent”), 8,604,012 (“’012 patent”), 8,609,646 (“’646 patent”), 8,604,013 (“’013 patent”), 10,626,090 (“’090 patent”), 10,894,774 (“’774 patent”), 10,882,827 (“’827 patent”), and 10,927,081 (“’081 patent”) (collectively, the “patents-in-suit”).

Plaintiffs in their complaint alleged that “FibroGen’s patents do not describe or enable vadadustat, and FibroGen has no valid patent claim that covers vadadustat or its use. Moreover, during prosecution of certain of its patents, FibroGen has distinguished the use of HIF-PHIs to treat anemia associated with CKD in order to obtain allowance of its patent claims directed to the use of HIF-PHIs to treat anemia of chronic disease.”

Plaintiffs further alleged that “Although FibroGen did not discover or develop vadadustat—and roxadustat has a different chemical structure from vadadustat—FibroGen has sought to use its patents related to HIF-PHIs to stifle competition by vadadustat. FibroGen has focused its recent patent prosecution on obtaining patents that purport to be directed to the treatment of anemia associated with CKD, confirming FibroGen’s intent to use its patents to try to stifle competition in this area. Indeed, certain claims of FibroGen’s recently issued patents do not even cover roxadustat, which confirms FibroGen’s strategy to extend its patent rights far beyond anything that FibroGen can purport to have invented.” furthermore “Akebia has obtained patents in the United States claiming vadadustat and its use, including but not limited to the U.S. Patent Nos. 7,811,595, 8,323,671, 8,343,952, 8,598,210, 8,940,773, 9,701,636, RE47,437, 9,987,262, and 10,149,842.”.

The Plaintiffs have laid down twenty four causes of action. All the causes of action relate to invalidity and non-infringement of the (“’703 patent”), the (“’172 patent), the (“’204 patent”), the (“’011 patent”), the (“’131 patent”), the (“’012 patent”), the (“’646 patent”), the (“’013 patent”), the (“’090 patent”), the (“’774 patent”), the (“’827 patent”), and the (“’081 patent”). 

In its prayer for relief, Plaintiffs have requested the court to declare that all claims of the patents-in-suit are invalid for failure to satisfy one or more of the conditions for patentability specified in Title 35 of the United States Code and related judicial doctrines, Declaring that the making, using, selling, offering for sale, or importation of vadadustat by Plaintiffs has not infringed and will not infringe, either directly or indirectly, any valid claim of the patents-in-suit and award Plaintiffs costs of this action. 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-00464

  • Filing Date:

    03/29/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

Judge Details

Presiding Judge

Colm F. Connolly

 

Party Details

Plaintiffs

Otsuka America Pharmaceutical, Inc.

Akebia Therapeutics, Inc.

Defendants

FibroGen, Inc.

AstraZeneca AB

Attorney/Law Firm Details

Plaintiff Attorneys

Michael J. Farnan

Rosemary Jean Piergiovanni

Joseph J. Farnan, Jr.

Brian E. Farnan

Emily R. Whelan

Laura L. Fairneny

Peter J. Armenio

Andrew J. Danford

Ryan S. Goldstein

Allyson E. Parks

Lisa J. Pirozzolo

Defendant Attorneys

Alexandra M. Joyce

Daniel M. Silver

 

Court Documents

#16

#15

#14

#13

#12

#11

#10

1 #13

Civil Cover Sheet

1 #9

Exhibit I

1 #8

Exhibit H

1 #7

Exhibit G

1 #6

Exhibit F

1 #5

Exhibit E

1 #4

Exhibit D

1 #3

Exhibit C

1 #2

Exhibit B

1 #1

Exhibit A

#1

18 More Documents Available
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Docket Entries

  • 05/13/2021

  • DocketPro Hac Vice Attorneys Peter J. Armenio, Laura L. Fairneny, Ryan S. Goldstein, Allyson E. Parks for Akebia Therapeutics, Inc. and Otsuka America Pharmaceutical, 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. (kmd) (Entered: 05/13/2021)

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  • 04/21/2021
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  • DocketSO ORDERED, re #16 STIPULATION TO EXTEND TIME Defendants' Deadline to Answer, Move or Otherwise Respond to the Complaint to June 4, 2021 filed by AstraZeneca AB, FibroGen, Inc. Set/Reset Answer Deadlines: AstraZeneca AB answer due 6/4/2021; FibroGen, Inc. answer due 6/4/2021. Signed by Judge Colm F. Connolly on 4/21/2021. (fms) (Entered: 04/21/2021)

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  • 04/20/2021
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  • Docket(#16) STIPULATION TO EXTEND TIME Defendants' Deadline to Answer, Move or Otherwise Respond to the Complaint to June 4, 2021 - filed by AstraZeneca AB, FibroGen, Inc.. (Joyce, Alexandra) (Entered: 04/20/2021)

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  • 04/20/2021
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  • Docket(#15) NOTICE of Appearance by Daniel M. Silver on behalf of AstraZeneca AB, FibroGen, Inc. (Silver, Daniel) (Entered: 04/20/2021)

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  • 04/19/2021

  • DocketPro Hac Vice Attorney Andrew J. Danford, Emily R. Whelan, Lisa J. Pirozzolo for Akebia Therapeutics, Inc.,for Otsuka America Pharmaceutical, 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: 04/19/2021)

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  • 04/07/2021
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  • DocketSO ORDERED, re #13 MOTION for Pro Hac Vice Appearance of Attorney Lisa J. Pirozzolo, Emily R. Whelan, and Andrew J. Danford filed by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc., #12 MOTION for Pro Hac Vice Appearance of Attorney Peter J. Armenio, Laura L. Fairneny, Ryan S. Goldstein, and Allyson E. Parks filed by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc. Signed by Judge Colm F. Connolly on 4/7/2021. (fms) (Entered: 04/07/2021)

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  • 04/05/2021
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  • Docket(#14) AFFIDAVIT OF MAILING BY CLERK - Postal Receipt(s) for the mailing of process to AstraZeneca AB on 4/5/2021. (cna, ) (Entered: 04/06/2021)

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  • 04/05/2021
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  • Docket(#13) MOTION for Pro Hac Vice Appearance of Attorney Lisa J. Pirozzolo, Emily R. Whelan, and Andrew J. Danford - filed by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc.. (Farnan, Brian) (Entered: 04/05/2021)

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  • 04/05/2021
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  • Docket(#12) MOTION for Pro Hac Vice Appearance of Attorney Peter J. Armenio, Laura L. Fairneny, Ryan S. Goldstein, and Allyson E. Parks - filed by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc.. (Farnan, Brian) (Entered: 04/05/2021)

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  • 04/01/2021
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  • Docket(#11) Amended DECLARATION re #10 Praecipe of Rosemary J. Piergiovanni by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc.. (Piergiovanni, Rosemary) (Entered: 04/01/2021)

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1 More Docket Entries
  • 03/31/2021

  • DocketCase Assigned to Judge Colm F. Connolly. Please include the initials of the Judge (CFC) after the case number on all documents filed. (rjb) (Entered: 03/31/2021)

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  • 03/30/2021
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  • Docket(#9) SUMMONS Returned Executed by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc.. FibroGen, Inc. served on 3/30/2021, answer due 4/20/2021. (Farnan, Brian) (Entered: 03/30/2021)

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  • 03/30/2021
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  • Docket(#8) DECLARATION re #7 Praecipe of Rosemary J. Piergiovanni by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc.. (Piergiovanni, Rosemary) (Entered: 03/30/2021)

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  • 03/30/2021
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  • Docket(#7) PRAECIPE filed by Rosemary Jean Piergiovanni on behalf of Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc. requesting Clerk to issue Rule 4(f)(2)(C)(ii) service on AstraZeneca AB (Piergiovanni, Rosemary) (Entered: 03/30/2021)

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  • 03/30/2021
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  • Docket(#6) Summonses Issued (please complete the top portion of the form and print out for use/service). (myr) (Entered: 03/30/2021)

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  • 03/29/2021
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  • Docket(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Otsuka America, Inc. for Otsuka America Pharmaceutical, Inc. filed by Otsuka America Pharmaceutical, Inc. (myr) (Entered: 03/30/2021)

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  • 03/29/2021
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  • Docket(#4) Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by Akebia Therapeutics, Inc. (myr) (Entered: 03/30/2021)

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  • 03/29/2021
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  • Docket(#3) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) See Attached. (myr) (Entered: 03/30/2021)

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  • 03/29/2021
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  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (myr) (Entered: 03/30/2021)

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  • 03/29/2021
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  • Docket(#1) COMPLAINT FOR DECLARATORY JUDGMENT OF PATENT INVALIDITY AND NONINFRINGEMENT filed against AstraZeneca AB, FibroGen, Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3581687.) - filed by Akebia Therapeutics, Inc., Otsuka America Pharmaceutical, Inc.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Exhibit E, #6 Exhibit F, #7 Exhibit G, #8 Exhibit H, #9 Exhibit I, #10 Exhibit J, #11 Exhibit K, #12 Exhibit L, #13 Civil Cover Sheet)(myr) (Entered: 03/30/2021)

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