This case was last updated from U.S. District Courts on 04/27/2022 at 11:38:49 (UTC).

Astellas US LLC et al v. GE Healthcare Inc.

Case Summary

On April 25, 2022, Astellas US LLC and Astellas Pharma US, Inc. (collectively, “Astellas”) and Gilead Sciences, Inc. (“Gilead”) (collectively, “Plaintiffs”), represented by Kelly A. Del Dotto, Robert M. Oakes, and William Chad Shear of Fish & Richardson, P.C., filed an intellectual property lawsuit against GE Healthcare, Inc. (“GEHC” or “Defendant”), seeking declaratory and injunctive relief along with damages for the alleged infringement of United States patents owned by the plaintiffs. This case was filed in the U.S. District Court for the District of Delaware.



The plaintiffs filed this complaint for the alleged infringement of United States Patent Nos. 8,106,183 (the “’183 patent”), RE 47,301 (the “’301 patent”), and 8,524,883 (the “’883 patent”) (collectively, “patents-in-suit”) owned by the plaintiffs.

 

 

In the complaint, the plaintiffs alleged, “By a letter dated March 15, 2022, GEHC notified Plaintiffs that GEHC had submitted ANDA No. 215955 to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) (‘the Lexiscan Notice Letter’).  GEHC’s submission of ANDA No. 215955 to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of the GEHC ANDA product prior to the expiration of the ’183 patent constituted a technical act of infringement of at least one of the claims of the ’183 patent, either literally or under the doctrine of equivalents, including but not limited to claims 1-3 and 8-9, under 35 U.S.C. § 271(e)(2)(A).”

 

 

The plaintiffs further alleged, “GEHC’s commercial manufacture, use, offer to sell, sale, or importation of the GEHC ANDA product prior to the expiration of the ’183 patent, and its inducement of and/or contribution to such conduct, would further infringe at least one of the claims of the ’183 patent, either literally or under the doctrine of equivalents, including at least claims 1-3 and 8-9, under 35 U.S.C. §§ 271(a), (b), (c) and/or (g).”

 

 

The plaintiffs also alleged, “Upon FDA approval of GEHC’s ANDA No. 215955, GEHC will infringe one or more claims of the ’183 patent, either literally or under the doctrine of equivalents, including at least claims 1-3 and 8-9, by making, using, offering to sell, and selling the GEHC ANDA product in the United States and/or importing said product into the United States, and/or by actively inducing and contributing to the infringement of the ’183 patent by others, under 35 U.S.C. § 271(a), (b), (c) and/or (g).”

 

 

Similar allegations have been made by the plaintiffs with respect to the other patents-in-suit owned by the plaintiffs. There are three claims for relief presented by the plaintiffs that deal with the alleged infringement of the patents-in-suit owned by the plaintiffs.

 

 

In its prayer for relief, the plaintiffs have requested judgment that the claims of the ’183 and ’301 patents are not invalid and are infringed by GEHC’s submission of ANDA No. 215955, either literally or under the doctrine of equivalents, under 35 U.S.C. § 271(e)(2)(A), a judgment declaring that the claims of the ’883 patent are not invalid, an order permanently enjoining GEHC from making or selling in the United States, or importing into the United States the GEHC ANDA product until after the latest expiration date of the patents-in-suit and for damages or other monetary relief including costs, fees, pre- and post-judgement interest along with such further relief as the court deems proper and just, including any appropriate relief under 35 U.S.C. § 285.

 

 

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Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    1:22-CV-00523

  • Filing Date:

    04/25/2022

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Intellectual Property - Patent

 

Party Details

Plaintiffs

Astellas US LLC

Astellas Pharma US, Inc.

Gilead Sciences, Inc.

Defendant

GE Healthcare Inc.

Attorney/Law Firm Details

Plaintiff Attorneys

Robert M. Oakes

Attorney at Fish & Richardson, P.C.

222 Delaware Avenue, 17Th Floor, P.O. Box 1114

Wilmington, DE 19899-1114

Kelly A Del Dotto

Attorney at Fish & Richardson, P.C.

222 Delaware Avenue, 17Th Floor, P.O. Box 1114

Wilmington, DE 19899-1114

William Chad Shear

Attorney at Fish & Richardson, P.C.

12390 El Camino Real

San Diego, CA 92130

 

Court Documents

#4

(#4) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 8,106,183 ;US RE 47,301 E ;US 8,534,883. (mpb) (Entered: 04/25/2022)

#5

(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Astellas Pharma Inc., Corporate Parent Astellas US Holding, Inc. for Astellas Pharma US, Inc., Astellas US LLC filed by Astellas Pharma US, Inc., Astellas US LLC. (mpb) (Entered: 04/25/2022)

#6

(#6) Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by Gilead Sciences, Inc.. (mpb) (Entered: 04/25/2022)

1 #1

Main Document

1 #1

Exhibit A

1 #2

Exhibit B

1 #3

Exhibit C

1 #4

Exhibit D

1 #5

Civil Cover Sheet

#2

(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (mpb) (Entered: 04/25/2022)

#3

(#3) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: 03/16/2022. Date of Expiration of Patent: 02/02/2027.Thirty Month Stay Deadline: 9/16/2024. (mpb) (Entered: 04/25/2022)

 

Docket Entries

  • 04/25/2022
  • DocketNo Summons Issued. (mpb) (Entered: 04/25/2022)

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  • 04/25/2022
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  • Docket(#6) Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by Gilead Sciences, Inc.. (mpb) (Entered: 04/25/2022)

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  • 04/25/2022
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  • Docket(#5) Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Astellas Pharma Inc., Corporate Parent Astellas US Holding, Inc. for Astellas Pharma US, Inc., Astellas US LLC filed by Astellas Pharma US, Inc., Astellas US LLC. (mpb) (Entered: 04/25/2022)

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  • 04/25/2022
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  • Docket(#4) Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 8,106,183 ;US RE 47,301 E ;US 8,534,883. (mpb) (Entered: 04/25/2022)

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  • 04/25/2022
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  • Docket(#3) Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: 03/16/2022. Date of Expiration of Patent: 02/02/2027.Thirty Month Stay Deadline: 9/16/2024. (mpb) (Entered: 04/25/2022)

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  • 04/25/2022
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  • Docket(#2) Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (mpb) (Entered: 04/25/2022)

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  • 04/25/2022
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  • Docket(#1) COMPLAINT filed against GE Healthcare Inc. - Magistrate Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC-3858468.) - filed by Astellas US LLC, Gilead Sciences, Inc., Astellas Pharma US, Inc.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Civil Cover Sheet)(mpb) (Entered: 04/25/2022)

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