DCT

1:23-cv-01212

AbbVie Inc v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 1:23-cv-01212, D. Del., 10/25/2023

  • Venue Allegations: Venue is asserted based on Defendant Sandoz Inc. being a corporation organized and existing under the laws of the State of Delaware.

  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's ORILISSA® product infringes four patents related to elagolix sodium compositions and methods of use.

  • Technical Context: The technology relates to elagolix sodium, a gonadotropin-releasing hormone (GnRH) receptor antagonist used for managing moderate to severe pain associated with endometriosis, a common condition affecting women of reproductive age.

  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant's submission of ANDA No. 217551 and an accompanying Paragraph IV certification asserting that Plaintiff's patents are invalid, unenforceable, or will not be infringed. The complaint notes a prior lawsuit filed in October 2022 against Defendant concerning the same ANDA but asserting different patents. The filing of the current complaint within 45 days of a notice letter from Defendant triggers a statutory 30-month stay of FDA approval for the generic product.

Case Timeline

Date Event
2018-07-23 Patent Priority Date (U.S. Pat. No. 11,542,239)
2018-07-23 ORILISSA® (NDA No. 210450) approved by FDA
2020-05-11 Patent Priority Date (U.S. Pat. Nos. 11,690,845; 11,690,854; 11,707,464)
2022-09-29 Sandoz's First Notice Letter sent to AbbVie regarding other patents
2022-10-27 AbbVie files "First Suit" against Sandoz regarding other patents
2023-01-03 U.S. Patent No. 11,542,239 Issues
2023-07-04 U.S. Patent No. 11,690,845 Issues
2023-07-04 U.S. Patent No. 11,690,854 Issues
2023-07-25 U.S. Patent No. 11,707,464 Issues
2023-10-13 Sandoz's Second Notice Letter sent to AbbVie regarding patents-in-suit
2023-10-25 Complaint Filing Date

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

U.S. Patent No. 11,542,239 - Elagolix Sodium Compositions and Processes

(Issued Jan. 3, 2023)

The Invention Explained

  • Problem Addressed: The patent's background section describes the technical challenge of manufacturing the active pharmaceutical ingredient elagolix sodium. Because the substance is generally amorphous (lacking a crystalline structure), its purification to meet stringent FDA impurity standards is more complex and less efficient than for substances with well-defined polymorphic forms. (’239 Patent, col. 1:53-58).
  • The Patented Solution: The invention provides for compositions of elagolix sodium (referred to as "Compound (I)") that are substantially pure, containing at least 97% of the active ingredient and limiting specific, named impurities to no more than 3%. (’239 Patent, col. 2:16-23). The patent also describes processes to achieve this purity, notably by using a crystalline intermediate (a salicylate salt referred to as "Compound (II)") which allows for more effective purification before creating the final amorphous drug substance. (’239 Patent, col. 13:30-41).
  • Technical Importance: Developing a reproducible, large-scale manufacturing process that reliably produces a high-purity amorphous drug substance is critical for commercial viability and regulatory approval. (’239 Patent, col. 1:47-52).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims without specifying which ones (Compl. ¶61). Independent claim 1 is representative of the composition claims.
  • Essential elements of Claim 1:
    • A composition comprising Compound (I) (elagolix sodium).
    • The composition also comprises one or more impurities selected from a specific list of four chemical structures ((iii), (v), (vi), and (vii)).
    • Compound (I) comprises at least 97 weight percent of the composition.
    • The selected impurity (or impurities) is present in an amount greater than zero and equal to or less than 3 weight percent of the composition.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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

(Issued Jul. 4, 2023)

The Invention Explained

  • Problem Addressed: The patent background identifies the potential for drug-drug interactions between elagolix and other drugs. Specifically, it notes that bupropion is metabolized by the enzyme CYP2B6, and elagolix may be an inhibitor or inducer of this enzyme, creating a need to understand and manage the clinical implications of co-administration. (’845 Patent, col. 1:21-34).
  • The Patented Solution: The invention claims a method of treating a gynecological disorder by co-administering elagolix sodium and bupropion according to a specific dosing schedule. The core of the claimed solution is the resulting pharmacokinetic profile, which is defined by specific numerical ratios for the maximum concentration (Cmax) and total exposure (AUC) of bupropion and its metabolite when administered with elagolix, compared to when administered alone. (’845 Patent, col. 2:48-64, Abstract).
  • Technical Importance: Defining the precise pharmacokinetic interaction between two drugs allows for informed prescribing, helping clinicians manage patient safety and efficacy when the drugs must be used concurrently.

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims without specification (Compl. ¶76). Independent claim 1 is representative of the method claims involving bupropion.
  • Essential elements of Claim 1:
    • A method for treating a gynecological disorder.
    • Orally administering elagolix sodium equivalent to 300 mg of elagolix free acid twice daily.
    • The patient receives a once daily dose of 150 mg of bupropion.
    • The co-administration results in a specific ratio of Cmax for bupropion (between about 1.104 and 1.407) compared to bupropion administered alone.
    • The co-administration results in specific ratios for AUCinf of bupropion and Cmax/AUCinf of its metabolite, hydroxybupropion.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 11,690,854 - Methods of Treating Heavy Menstrual Bleeding

(Issued Jul. 4, 2023)

  • Patent Identification: U.S. Patent No. 11,690,854, "Methods of Treating Heavy Menstrual Bleeding," issued July 4, 2023.
  • Technology Synopsis: The patent claims methods for managing moderate to severe pain associated with endometriosis by administering specific daily doses of elagolix (e.g., 150 mg once daily) for a defined treatment duration (e.g., 24 months), with limitations on resulting bone mineral density loss. (’854 Patent, Abstract, claim 1). A potential point of contention may be the discrepancy between the patent's title, which refers to "Heavy Menstrual Bleeding," and its independent claims, which are directed to "pain associated with endometriosis."
  • Asserted Claims: The complaint does not specify claims; independent claims are 1, 12, and 16.
  • Accused Features: The proposed package insert for Sandoz's generic product, which is a therapeutic equivalent to ORILISSA®, will allegedly instruct healthcare providers and patients to use the product in a manner that directly infringes the claimed methods for treating endometriosis pain (Compl. ¶¶90-93).

U.S. Patent No. 11,707,464 - Methods of Treating Heavy Menstrual Bleeding

(Issued Jul. 25, 2023)

  • Patent Identification: U.S. Patent No. 11,707,464, "Methods of Treating Heavy Menstrual Bleeding," issued July 25, 2023.
  • Technology Synopsis: The patent claims methods for treating heavy menstrual bleeding (HMB), particularly in patients with uterine fibroids, by administering elagolix. The claims specify outcomes such as a reduction in menstrual blood loss of at least 50% from baseline and a reduction in uterine volume. (’464 Patent, Abstract, claims 1, 10).
  • Asserted Claims: The complaint does not specify claims; independent claims are 1, 10, and 15.
  • Accused Features: The complaint alleges Sandoz's generic product will be used in an infringing manner (Compl. ¶¶105-108). This assertion raises the question of how a generic version of ORILISSA®, which is indicated for endometriosis-associated pain, would infringe claims directed to treating HMB associated with uterine fibroids.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Sandoz's Generic Product," defined as the generic elagolix sodium oral tablets (equivalent to 150 mg base and 200 mg base) for which Sandoz seeks FDA approval under ANDA No. 217551 (Compl. ¶1, ¶51).
  • Functionality and Market Context: The complaint alleges that Sandoz's product is a generic version of AbbVie's ORILISSA® tablets and that Sandoz has represented to the FDA that its product is "pharmaceutically and therapeutically equivalent" to ORILISSA® (Compl. ¶59). ORILISSA®'s function is to manage moderate to severe pain associated with endometriosis by acting as a GnRH receptor antagonist, which reduces estrogen production (Compl. ¶5, ¶7). The complaint alleges that upon approval, Sandoz will manufacture, market, and sell its generic product throughout the United States (Compl. ¶16, ¶55).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed element-by-element infringement allegations. The infringement analysis is based on the narrative allegations in the complaint.

  • ’239 Patent (Composition Claim) Infringement Theory: The complaint's theory of infringement is based on Sandoz's representation to the FDA that its generic product is pharmaceutically and therapeutically equivalent to ORILISSA® (Compl. ¶59). The core allegation is that by being an equivalent generic copy, Sandoz's product will necessarily have the chemical composition, including the specific purity and impurity profiles, recited in the ’239 Patent claims (Compl. ¶¶57, 61). Infringement under 35 U.S.C. § 271(e)(2)(A) is alleged based on the act of filing the ANDA to obtain approval for this allegedly infringing composition (Compl. ¶60).

  • ’845 Patent (Method Claim) Infringement Theory: The complaint alleges that Sandoz will indirectly infringe the method claims. The theory is that Sandoz's proposed product labeling and package insert will instruct and encourage healthcare professionals and patients to administer the generic product according to the claimed methods (Compl. ¶78, ¶79). For patients who are also taking bupropion, following these instructions would allegedly result in direct infringement, for which Sandoz would be liable as an inducer (Compl. ¶78, ¶80).

  • Identified Points of Contention:

    • Technical Questions: A primary factual dispute for the ’239 Patent will concern the actual composition of Sandoz's product. What does chemical analysis of Sandoz's proposed generic product reveal about its purity and the identity and quantity of its impurities, and does this profile meet the limitations of the asserted claims?
    • Scope Questions: For the method claims of the ’845 Patent, a central question will be whether the language in Sandoz's proposed product label constitutes specific intent to induce infringement. Does the label merely provide standard safety and drug-interaction information, or does it actively instruct a method of co-administration that results in the specific pharmacokinetic outcomes required by the claims?

V. Key Claim Terms for Construction

  • The Term: "a composition comprising" (from ’239 Patent, claim 1)

    • Context and Importance: This transitional phrase is standard but critical in composition claims. Its construction determines whether the presence of additional, unrecited ingredients (such as other impurities not listed in the claim) would allow the accused product to avoid infringement. Practitioners may focus on this term because the dispute will center on the precise impurity profile of the accused product.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term "comprising" is well-established in patent law as being open-ended, meaning it does not exclude additional, unrecited elements.
      • Evidence for a Narrower Interpretation: A party might argue that the claim's detailed recitation of specific weight percentages for the active ingredient ("at least about 97 weight percent") and the listed impurities ("not more than about 3 weight percent") creates a compositional total that implicitly closes the claim to other material components.

  • The Term: "a ratio ... is between about 1.104 and about 1.407" (from ’845 Patent, claim 1)

    • Context and Importance: This term defines a required outcome of the claimed method using a pharmacokinetic (PK) parameter. The scope of the word "about" will be critical to determining infringement, as it addresses the degree of permissible deviation from the recited numerical range.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification's use of "about" suggests the inventors did not intend to be limited to the exact numerical values, acknowledging the inherent variability in biological measurements.
      • Evidence for a Narrower Interpretation: The patent claims this PK ratio to three decimal places. A party could argue that such precision implies the inventors intended a very narrow range of equivalents, thus limiting the scope of "about" to minimal measurement error.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for the method patents (’845, ’854, and ’464). The basis for inducement is the allegation that Sandoz, through its promotional activities and proposed package insert, will instruct healthcare professionals and patients to use the generic product in a way that directly infringes the claims (Compl. ¶63, ¶78, ¶91, ¶106). The complaint also pleads contributory infringement for the ’239 patent, alleging the generic product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶67-68).
  • Willful Infringement: The complaint does not include a specific count for willful infringement. However, it alleges that Sandoz has had knowledge of the patents-in-suit since at least the date of its October 13, 2023 notice letter, which could form the basis for a future claim of post-suit willfulness (Compl. ¶65, ¶80, ¶93, ¶108). The prayer for relief requests a declaration that this is an "exceptional case," which is related to claims for enhanced damages and attorney fees (Compl. p. 21).

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

  • A primary factual question will be one of compositional identity: What evidence will discovery yield regarding the precise impurity profile of Sandoz's proposed generic product, and does that profile fall within the specific purity and impurity limitations of the ’239 patent claims?
  • A central legal issue for the method claims will be one of induced infringement: Does the language in Sandoz's proposed product label contain sufficient instruction or encouragement to meet the legal standard for inducing infringement, particularly for the specific pharmacokinetic outcomes claimed in the ’845 patent?
  • A key legal question may arise regarding the scope of infringement for method claims: Can patents claiming methods for treating heavy menstrual bleeding associated with uterine fibroids (’464 patent) be infringed by a generic product whose branded equivalent, ORILISSA®, is indicated by the FDA only for endometriosis-associated pain?