DCT

1:23-cv-01268

AbbVie Inc v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01268, D. Del., 11/07/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva Pharmaceuticals, Inc. is a Delaware corporation, and Defendant Teva Pharmaceutical Industries Ltd. is a foreign corporation subject to jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic version of the drug ORIAHNN® constitutes an act of infringement of a patent related to methods of co-administering elagolix with other drugs.
  • Technical Context: The technology involves managing pharmacokinetic drug-drug interactions that occur when treating gynecological conditions like uterine fibroids with elagolix while a patient is also taking other common medications.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' Paragraph IV certification challenging the patent-in-suit. The complaint states this is the third lawsuit filed by Plaintiff against Defendants concerning ANDA No. 217650, with two prior suits filed in early 2023 asserting different patents. The current suit was filed within 45 days of Plaintiff's receipt of Defendants' notice letter regarding the patent-in-suit.

Case Timeline

Date Event
2020-03-05 '845 Patent Priority Date
2020-05-29 ORIAHNN® FDA Approval Date
2022-12-21 Teva's First Notice Letter (re: '659, '470 patents)
2023-02-03 First Suit Filed (re: '659, '470 patents)
2023-02-13 Teva's Second Notice Letter (re: '239 patent)
2023-03-30 Second Suit Filed (re: '239 patent)
2023-07-04 '845 Patent Issue Date
2023-10-19 Teva's Third Notice Letter (re: '845 patent)
2023-11-07 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,690,845 - Methods of Administering Elagolix

  • Patent Identification: U.S. Patent No. 11,690,845, Methods of Administering Elagolix, issued July 4, 2023.

The Invention Explained

  • Problem Addressed: The patent describes the potential for drug-drug interactions when elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is taken by a patient who is also using drugs metabolized by certain cytochrome P450 enzymes, such as omeprazole, which is metabolized by CYP2C19. (Compl. ¶6; ’845 Patent, col. 1:31-45).
  • The Patented Solution: The invention provides specific methods for treating gynecological disorders with elagolix while a patient is concomitantly receiving a CYP2C19 substrate like omeprazole. The patent quantifies the pharmacokinetic effects of this co-administration and claims specific dosing regimens based on these findings, such as administering a 40 mg daily dose of omeprazole without adjustment. (’845 Patent, col. 4:5-23). The specification's Table 6, which contains clinical recommendations derived from the branded drug's label, details how to manage co-administration with omeprazole. (’845 Patent, col. 23:36-54).
  • Technical Importance: This approach provides a clinically tested framework and defined safety profile for physicians to manage patients who require treatment with both elagolix and other commonly prescribed medications, thereby enabling safe and effective concomitant use. (’845 Patent, col. 23:51-54).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the '845 patent and does not specify which claims will be asserted. (Compl. ¶2). Independent claim 1 is representative of the subject matter.
  • Independent Claim 1 recites a method with the following essential elements:
    • A method for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or management of moderate to severe pain associated with endometriosis, the method comprising:
    • orally administering to a patient in need thereof elagolix sodium,
    • wherein the patient concomitantly receives omeprazole,
    • wherein the omeprazole is administered without an adjustment to a recommended omeprazole dosing schedule and the recommended omeprazole dosing schedule comprises a 40 mg dose administered once per day.
  • The complaint reserves the right to assert additional claims, which may include dependent claims. (Compl. ¶59).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Teva's Generic Product," a proposed generic version of Plaintiff's ORIAHNN® product, which is the subject of Defendants' ANDA No. 217650. (Compl. ¶¶1, 49).

Functionality and Market Context

  • The product is a combination therapy of elagolix sodium, estradiol, and norethindrone acetate, formulated as oral capsules. (Compl. ¶1). It is intended for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. (Compl. ¶5). The complaint alleges that Teva has represented to the FDA that its generic product is "pharmaceutically and therapeutically equivalent" to ORIAHNN® and that Teva intends to market the product throughout the United States upon receiving FDA approval. (Compl. ¶¶35, 57).

IV. Analysis of Infringement Allegations

The complaint alleges infringement based on the act of filing the ANDA, which seeks approval for a product whose proposed label will allegedly instruct users to perform the patented method. (Compl. ¶¶58, 62).
No probative visual evidence provided in complaint.

  • '845 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or management of moderate to severe pain associated with endometriosis... The proposed label for Teva's Generic Product will instruct its use for the management of heavy menstrual bleeding associated with uterine leiomyomas. ¶¶1, 5 col. 27:39-44
...the method comprising: orally administering to a patient in need thereof elagolix sodium, Teva's Generic Product contains elagolix sodium, and its proposed label will instruct for oral administration. ¶1 col. 27:41-42
wherein the patient concomitantly receives omeprazole, The proposed label for Teva's Generic Product will contemplate and provide instructions for its co-administration with omeprazole. ¶62 col. 23:51-54
wherein the omeprazole is administered without an adjustment to a recommended omeprazole dosing schedule and the recommended omeprazole dosing schedule comprises a 40 mg dose administered once per day. The proposed label is expected to instruct that "No dose adjustment needed for omeprazole 40 mg once daily" when co-administered with the elagolix product. ¶62 col. 23:51-52
  • Identified Points of Contention:
    • Factual Question: The infringement analysis will depend entirely on the specific language contained within the proposed product label that Teva submitted to the FDA as part of its ANDA. A primary factual question is whether Teva's proposed label instructs, suggests, or encourages physicians and patients to co-administer the generic product with a 40 mg daily dose of omeprazole without adjustment, as required by the claim.
    • Legal Question (Intent for Inducement): Even if the proposed label contains language similar to the branded drug's label, a legal dispute may arise over whether this language demonstrates the specific intent required to induce infringement. The court may need to decide whether providing information on how to safely manage a known drug-drug interaction constitutes actively encouraging infringement of the patented method or is merely the provision of necessary safety information.

V. Key Claim Terms for Construction

  • The Term: "concomitantly receives"
  • Context and Importance: This term defines the required temporal relationship between the administration of elagolix and omeprazole. Its construction is critical because it will determine the scope of infringing activity. Practitioners may focus on this term because a narrow construction (e.g., requiring simultaneous ingestion) could allow Defendants to design around the patent, whereas a broader construction (e.g., covering any overlap in treatment regimens) would favor the patent holder.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent defines the related term "co-administration" broadly, stating that active agents may be administered in a sequential manner, with the time between administrations ranging from "a few seconds... to several hours or days." (’845 Patent, col. 6:45-58). The clinical study designs described in the patent, such as in FIG. 1, also show elagolix being administered for ten days before the co-administered drug is introduced, which may support an interpretation that "concomitantly" refers to an overlapping period of therapeutic activity rather than simultaneous dosing. (’845 Patent, FIG. 1).
    • Evidence for a Narrower Interpretation: The patent does not provide an explicit definition for "concomitantly receives." A party could argue that this phrase should be given its plain and ordinary meaning, which implies a closer temporal relationship than the separately defined term "co-administration," potentially meaning on the same day or at the same time.

VI. Other Allegations

  • Indirect Infringement: The complaint explicitly pleads a claim for active inducement of infringement under 35 U.S.C. § 271(b). (Compl. ¶59). The alleged factual basis is that Teva's proposed package insert and promotional activities for its generic product will instruct and encourage healthcare professionals and patients to use the product in a way that directly infringes at least one claim of the ’845 patent. (Compl. ¶¶61, 62).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it alleges that Teva has knowledge of the ’845 patent, citing Teva's notice letter to AbbVie dated October 19, 2023. (Compl. ¶63). This allegation of pre-suit knowledge could form the basis for a subsequent claim of willful infringement if Teva proceeds with marketing its product after the complaint was filed.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central evidentiary question will be one of label correspondence: does the precise text of the product label submitted in Teva's ANDA instruct or encourage the specific method of co-administering elagolix and omeprazole that is recited in the asserted claims of the '845 patent? The outcome of the inducement analysis will likely depend on the answer.
  • The case may also turn on a question of legal intent: assuming Teva's label provides instructions on managing the drug interaction, does this act of informing prescribers about a known pharmacokinetic effect rise to the level of specific intent to induce infringement, or does it fall within the scope of necessary and non-infringing communication of safety information?