This case was last updated from U.S. District Courts on 11/21/2021 at 09:19:44 (UTC).

Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP et al

Case Summary

On September 22, 2021, Puma Biotechnology, Inc. (“Puma”) and Wyeth LLC (collectively, “Plaintiffs”), represented by Jack B. Blumenfeld, Megan Elizabeth Dellinger and Rodger Dallery Smith, II of Morris, Nichols, Arsht & Tunnell LLP, filed an intellectual property lawsuit against AstraZeneca Pharmaceuticals LP, AstraZeneca AB, and AstraZeneca PLC (collectively, “AstraZeneca” or “Defendants”), seeking declaratory reliefs and injunctive reliefs along with prejudgement interest among other reliefs for the alleged infringement of the United States Patents owned by the Plaintiffs. This case was filed in the United States District Court in the District of Delaware.

 

The Plaintiffs filed this complaint for the alleged infringement of the United States Patent Nos. 10,603,314 (“the ’314 patent”) and 10,596,162 (“the ’162 patent”) (collectively, “the Patents-in-suit”) owned by the Plaintiffs. 

 

In the complaint, the Plaintiffs alleged that, “AstraZeneca’s commercial manufacture, use, importation, marketing, sale, and/or offer for sale of the Tagrisso® Products, including tablets of 40 mg and 80 mg dosage strength, in or into the United States directly infringes, contributes to the infringement of, and/or actively induces the infringement by others of one or more claims of the ’314 patent under 35 U.S.C. § 271(a)–(c).”

 

The Plaintiffs further alleged that, “On information and belief, AstraZeneca, through their own actions or through the actions of their agents, affiliates, and subsidiaries, market and/or distribute Tagrisso® Products to resellers, pharmacies, hospitals, clinics, healthcare professionals, and other end users. On information and belief, AstraZeneca knowingly and intentionally accompany the Tagrisso® Products with a product label or product insert that includes instructions for using or administering the Tagrisso® Products to treat NSCLC patients which infringes the ’314 patent.”

 

The Plaintiffs also alleged that, “On information and belief, AstraZeneca is actively inducing infringement of the ’314 patent. AstraZeneca’s activities are done with knowledge of the ’314 patent and specific intent to infringe that patent” and “AstraZeneca’s infringement is deliberate and willful, entitling Plaintiffs to seek enhanced damages under 35 U.S.C. § 284 and to seek attorneys’ fees and costs incurred in prosecuting this action under 35 U.S.C. § 285. AstraZeneca’s infringement of the ’314 patent is with full and complete knowledge of the ’314 patent and its applicability to the use of Tagrisso® Products without a good faith belief that the ’314 patent is invalid or not infringed.”

 

Similar claims have been made by the Plaintiffs with reference to the alleged infringement of other Patents-in-suit. 

 

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

 

In the prayer for relief, the Plaintiffs have requested the Court for declaratory reliefs and permanent injunctive reliefs along with actual damages, together with prejudgment interest, an accounting of all damages sustained by the Plaintiffs, increased or enhanced damages, an award of attorneys’ fees and costs, and any other relief the Court deems just and proper.

 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:21-CV-01338

  • Filing Date:

    09/22/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

Judge Details

Presiding Judge

Colm F. Connolly

 

Party Details

Plaintiffs and Counter Defendants

Puma Biotechnology, Inc.

Wyeth LLC

Pfizer Inc.

Defendants and Counter Claimants

AstraZeneca Pharmaceuticals LP

AstraZeneca AB

AstraZeneca PLC

Attorney/Law Firm Details

Plaintiff and Counter Defendant Attorneys

Jack B. Blumenfeld

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Megan Elizabeth Dellinger

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Rodger Dallery Smith, II

Attorney at Morris, Nichols, Arsht & Tunnell LLP

1201 North Market Street, P.O. Box 1347

Wilmington, DE 19899

Defendant and Counter Claimant Attorneys

Ashley Winkler

Christopher N. Sipes

Einar Stole

Jason Reinecke

Megan P. Keane

Melissa Keech

Karen Elizabeth Keller

Attorney at Shaw Keller LLP

1105 North Market Street, 12Th Floor

Wilmington, DE 19801

 

Court Documents

#13

(#13) SO ORDERED, re #11 STIPULATION TO EXTEND TIME for Plaintiffs to respond to (1) the Counterclaims filed by AstraZeneca Pharmaceuticals LP and AstraZeneca AB (D.I. 8), and (2) the Motion to Dismiss filed by Defendant AstraZeneca PLC (D.I. 6) to December 3, 2021, filed by Wyeth LLC, Puma Biotechnology, Inc. Set Briefing Schedule: re #6 MOTION to Dismiss for Lack of Jurisdiction Over the Person and FRCP 4(k)(1). Answering Brief due 12/3/2021. Signed by Judge Colm F. Connolly on 11/18/2021. (kmd) (Entered: 11/18/2021)

#12

(#12) SUMMONS Returned Executed by AstraZeneca Pharmaceuticals LP, AstraZeneca AB. Pfizer Inc. served on 11/10/2021, answer due 12/1/2021. (Keller, Karen) (Entered: 11/18/2021)

#11

(#11) STIPULATION TO EXTEND TIME for Plaintiffs to respond to (1) the Counterclaims filed by AstraZeneca Pharmaceuticals LP and AstraZeneca AB (D.I. 8), and (2) the Motion to Dismiss filed by Defendant AstraZeneca PLC (D.I. 6) to December 3, 2021 - filed by Puma Biotechnology, Inc., Wyeth LLC. (Smith, Rodger) (Entered: 11/18/2021)

#10

(#10) MOTION for Pro Hac Vice Appearance of Attorney Christopher N. Sipes, Einar Stole, Megan P. Keane, Ashley Winkler, Jason Reinecke and Melissa Keech - filed by AstraZeneca Pharmaceuticals LP. (Keller, Karen) (Entered: 11/16/2021)

#9

(#9) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent AstraZeneca PLC for AstraZeneca AB, AstraZeneca Pharmaceuticals LP filed by AstraZeneca AB, AstraZeneca Pharmaceuticals LP. (Keller, Karen) (Entered: 11/05/2021)

#8

(#8) ANSWER to #1 Complaint, with Jury Demand , COUNTERCLAIM and Affirmative Defenses against Puma Biotechnology, Inc., Wyeth LLC, Pfizer Inc. by AstraZeneca AB, AstraZeneca Pharmaceuticals LP.(Keller, Karen) (Entered: 11/05/2021)

7 #2

Exhibit B

7 #1

Exhibit A

#7

(#7) OPENING BRIEF in Support re #6 MOTION to Dismiss for Lack of Jurisdiction Over the Person and FRCP 4(k)(1) filed by AstraZeneca PLC.Answering Brief/Response due date per Local Rules is 11/19/2021. (Attachments: #1 Exhibit A, #2 Exhibit B)(Keller, Karen) (Entered: 11/05/2021)

6 #1

Text of Proposed Order

#6

(#6) MOTION to Dismiss for Lack of Jurisdiction Over the Person and FRCP 4(k)(1) - filed by AstraZeneca PLC. (Attachments: #1 Text of Proposed Order)(Keller, Karen) (Entered: 11/05/2021)

#5

#4

#3

#2

1 #2

Civil Cover Sheet

9 More Documents Available
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Docket Entries

  • 11/18/2021
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  • Docket(#13) SO ORDERED, re #11 STIPULATION TO EXTEND TIME for Plaintiffs to respond to (1) the Counterclaims filed by AstraZeneca Pharmaceuticals LP and AstraZeneca AB (D.I. 8), and (2) the Motion to Dismiss filed by Defendant AstraZeneca PLC (D.I. 6) to December 3, 2021, filed by Wyeth LLC, Puma Biotechnology, Inc. Set Briefing Schedule: re #6 MOTION to Dismiss for Lack of Jurisdiction Over the Person and FRCP 4(k)(1). Answering Brief due 12/3/2021. Signed by Judge Colm F. Connolly on 11/18/2021. (kmd) (Entered: 11/18/2021)

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  • 11/18/2021
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  • Docket(#12) SUMMONS Returned Executed by AstraZeneca Pharmaceuticals LP, AstraZeneca AB. Pfizer Inc. served on 11/10/2021, answer due 12/1/2021. (Keller, Karen) (Entered: 11/18/2021)

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  • 11/18/2021
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  • Docket(#11) STIPULATION TO EXTEND TIME for Plaintiffs to respond to (1) the Counterclaims filed by AstraZeneca Pharmaceuticals LP and AstraZeneca AB (D.I. 8), and (2) the Motion to Dismiss filed by Defendant AstraZeneca PLC (D.I. 6) to December 3, 2021 - filed by Puma Biotechnology, Inc., Wyeth LLC. (Smith, Rodger) (Entered: 11/18/2021)

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  • 11/17/2021
  • DocketPro Hac Vice Attorneys Jason Reinecke, Christopher N. Sipes, Megan P. Keane, Melissa Keech, Ashley Winkler, and Einar Stole for AstraZeneca AB, AstraZeneca PLC, and AstraZeneca Pharmaceuticals LP 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: 11/17/2021)

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  • 11/16/2021
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  • DocketSO ORDERED, re #10 MOTION for Pro Hac Vice Appearance of Attorney Christopher N. Sipes, Einar Stole, Megan P. Keane, Ashley Winkler, Jason Reinecke and Melissa Keech, filed by AstraZeneca Pharmaceuticals LP. Ordered by Judge Colm F. Connolly on 11/16/2021. (kmd) (Entered: 11/16/2021)

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  • 11/16/2021
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  • Docket(#10) MOTION for Pro Hac Vice Appearance of Attorney Christopher N. Sipes, Einar Stole, Megan P. Keane, Ashley Winkler, Jason Reinecke and Melissa Keech - filed by AstraZeneca Pharmaceuticals LP. (Keller, Karen) (Entered: 11/16/2021)

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  • 11/05/2021
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  • Docket(#9) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent AstraZeneca PLC for AstraZeneca AB, AstraZeneca Pharmaceuticals LP filed by AstraZeneca AB, AstraZeneca Pharmaceuticals LP. (Keller, Karen) (Entered: 11/05/2021)

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  • 11/05/2021
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  • Docket(#8) ANSWER to #1 Complaint, with Jury Demand , COUNTERCLAIM and Affirmative Defenses against Puma Biotechnology, Inc., Wyeth LLC, Pfizer Inc. by AstraZeneca AB, AstraZeneca Pharmaceuticals LP.(Keller, Karen) (Entered: 11/05/2021)

    Read MoreRead Less
  • 11/05/2021
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  • Docket(#7) OPENING BRIEF in Support re #6 MOTION to Dismiss for Lack of Jurisdiction Over the Person and FRCP 4(k)(1) filed by AstraZeneca PLC.Answering Brief/Response due date per Local Rules is 11/19/2021. (Attachments: #1 Exhibit A, #2 Exhibit B)(Keller, Karen) (Entered: 11/05/2021)

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  • 11/05/2021
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  • Docket(#6) MOTION to Dismiss for Lack of Jurisdiction Over the Person and FRCP 4(k)(1) - filed by AstraZeneca PLC. (Attachments: #1 Text of Proposed Order)(Keller, Karen) (Entered: 11/05/2021)

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  • 09/29/2021
  • 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: 09/29/2021)

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  • 09/22/2021
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  • Docket(#5) Summons Issued with Magistrate Consent Notice attached as to AstraZeneca AB on 9/22/2021; AstraZeneca PLC on 9/22/2021; AstraZeneca Pharmaceuticals LP on 9/22/2021. (srs) (Entered: 09/22/2021)

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  • 09/22/2021
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  • Docket(#4) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Pfizer Inc. for Wyeth LLC. No Parents or Affiliates Listed for Puma Biotechnology, Inc. filed by Puma Biotechnology, Inc. and Wyeth LLC. (srs) (Entered: 09/22/2021)

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  • 09/22/2021
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  • Docket(#3) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,603,314 B2 ;10,596,162 B2. (srs) (Entered: 09/22/2021)

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  • 09/22/2021
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  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (srs) (Entered: 09/22/2021)

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  • 09/22/2021
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  • Docket(#1) COMPLAINT for PATENT INFRINGEMENT filed with Jury Demand against AstraZeneca AB, AstraZeneca PLC, and AstraZeneca Pharmaceuticals LP - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3704835.) - filed by Puma Biotechnology, Inc. and Wyeth LLC. (Attachments: #1 Exhibit A-C, #2 Civil Cover Sheet)(srs) (Entered: 09/22/2021)

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