DCT

1:22-cv-01423

AbbVie Inc v. Alkem Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01423, D. Del., 08/29/2023
  • Venue Allegations: Venue is alleged based on the defendants' incorporation in Delaware or, for foreign corporations, their systematic and continuous contacts with the United States and amenability to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of the drug ORILISSA® (elagolix sodium) constitutes an act of infringement of seven U.S. patents.
  • Technical Context: The technology involves elagolix, a nonpeptidic, orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist used for managing moderate to severe pain associated with endometriosis.
  • Key Procedural History: The current action is an amended complaint that appears to consolidate allegations against multiple generic drug manufacturers who have filed ANDAs. Plaintiffs note that separate infringement actions have been filed against certain defendants concerning some of the patents-in-suit. Applications for Patent Term Extension have been filed for U.S. Patent Nos. 7,056,927 and 7,419,983, which, if granted, would extend their expiration dates to 2029.

Case Timeline

Date Event
2003-07-07 Priority Date for ’927, ’211, and ’983 Patents
2006-06-06 U.S. Patent No. 7,056,927 Issued
2007-02-13 U.S. Patent No. 7,176,211 Issued
2008-09-02 U.S. Patent No. 7,419,983 Issued
2013-03-15 Priority Date for ’551 Patent
2015-09-01 Priority Date for ’572 and ’351 Patents
2018-07-23 ORILISSA® (elagolix) NDA Approved by FDA
2018-07-23 Priority Date for ’239 Patent
2020-01-21 U.S. Patent No. 10,537,572 Issued
2020-06-16 U.S. Patent No. 10,682,351 Issued
2022-05-31 U.S. Patent No. 11,344,551 Issued
2022-09-12 Hetero and Teva ANDA Notice Letters Sent
2022-09-13 Prinston ANDA Notice Letter Sent
2022-09-16 Lupin and Sun ANDA Notice Letters Sent
2022-09-23 Alkem ANDA Notice Letter Sent
2022-09-27 MSN ANDA Notice Letter Sent
2022-09-28 Zenara ANDA Notice Letter Sent
2022-09-29 Sandoz ANDA Notice Letter Sent
2023-01-03 U.S. Patent No. 11,542,239 Issued
2023-06-26 Alkem Second ANDA Notice Letter Sent
2023-06-28 Zenara Second ANDA Notice Letter Sent
2023-08-29 Amended Complaint Filed

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

U.S. Patent No. 7,056,927 - “Gonadotropin-Releasing Hormone Receptor Antagonists and Methods Relating Thereto”

The Invention Explained

  • Problem Addressed: The patent describes a need for effective, small-molecule GnRH receptor antagonists. Prior art antagonists were often peptidic compounds with limitations such as low bioavailability, requiring delivery by injection or nasal spray, and potential side effects like histamine release. (Compl. ¶ 260; ’927 Patent, col. 2:1-7).
  • The Patented Solution: The invention discloses a class of nonpeptidic, uracil-based compounds that function as GnRH receptor antagonists. These small molecules are designed to be orally available and are suitable for treating sex-hormone-related conditions by suppressing gonadotropins and, consequently, steroidal hormones. (Compl. ¶ 260; ’927 Patent, Abstract, col. 3:44-50).
  • Technical Importance: The development of orally active small-molecule GnRH antagonists represented a significant therapeutic advance over injectable peptidic drugs, offering a more convenient treatment option for chronic conditions like endometriosis. (’927 Patent, col. 2:1-7).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims; independent claim 1 is representative of the core compound invention. (Compl. ¶ 3).
  • The essential elements of independent claim 1 are:
    • A compound having a specific chemical structure identified as structure (I)
    • or a stereoisomer, prodrug or pharmaceutically acceptable salt thereof
    • wherein various substituent groups (R1a, R1b, R1c, R2a, R2b, R3, R4, R5, R6, and X) are defined from specified chemical classes (’927 Patent, col. 45:60–46:20).
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation of infringement.

U.S. Patent No. 7,176,211 - “Gonadotropin-Releasing Hormone Receptor Antagonists and Methods Relating Thereto”

The Invention Explained

  • Problem Addressed: The technical problem is identical to that described in the parent ’927 Patent: the need for effective, orally bioavailable, small-molecule GnRH antagonists for treating sex-hormone-related disorders without the drawbacks of prior peptidic compounds. (Compl. ¶ 264; ’211 Patent, col. 1:12–2:40).
  • The Patented Solution: This patent claims methods of treating specific sex-hormone-related conditions by administering an effective amount of the class of nonpeptidic uracil-based compounds disclosed in the ’927 Patent. The invention thus shifts focus from the compound itself to its therapeutic application. (Compl. ¶ 264; ’211 Patent, Abstract, col. 45:44-47).
  • Technical Importance: By claiming specific methods of treatment, the patent provides a different scope of protection than a pure compound patent, covering the therapeutic use of the disclosed antagonists for conditions like endometriosis and uterine fibroids. (’211 Patent, col. 3:5-9).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims; independent claim 1 is representative of the core method invention. (Compl. ¶ 7).
  • The essential elements of independent claim 1 are:
    • A method for treating a condition selected from a specified list, including endometriosis and uterine fibroids
    • comprising administering to a subject a pharmaceutically effective amount of a compound of structure (I)
    • wherein structure (I) and its substituent groups are defined as in the ’927 Patent (’211 Patent, col. 45:44–46:44).
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,419,983 - “Gonadotropin-Releasing Hormone Receptor Antagonists and Methods Related Thereto”

  • Technology Synopsis: This patent is from the same family as the ’927 and ’211 Patents and further narrows the claims to specific compounds within the previously disclosed genus. It specifically claims the compound elagolix, which is the active ingredient in ORILISSA®. (Compl. ¶ 267).
  • Asserted Claims: One or more unspecified claims. (Compl. ¶ 3).
  • Accused Features: The active pharmaceutical ingredient, elagolix sodium, in Defendants' proposed generic products. (Compl. ¶ 1, ¶ 291).

U.S. Patent No. 10,537,572 - “Methods of Administering Elagolix”

  • Technology Synopsis: This patent claims methods of treating endometriosis by administering elagolix, with specific claim limitations directed to co-administration with drugs like rifampin that induce metabolic enzymes. The invention addresses the resulting pharmacokinetic interactions by claiming specific dosing adjustments to maintain therapeutic effect. (’572 Patent, Abstract; col. 4:1-5).
  • Asserted Claims: One or more unspecified claims. (Compl. ¶ 2).
  • Accused Features: The proposed use of Defendants' generic elagolix products for the treatment of endometriosis, as would be instructed by the product labeling. (Compl. ¶¶ 338, 340).

U.S. Patent No. 10,682,351 - “Methods of Administering Elagolix”

  • Technology Synopsis: Similar to the ’572 Patent, this patent covers methods of administering elagolix for endometriosis. It focuses on dosing regimens and pharmacokinetic profiles, particularly in the context of co-administration with other drugs that can alter elagolix metabolism, such as ketoconazole. (’351 Patent, Abstract; col. 4:46-50).
  • Asserted Claims: One or more unspecified claims. (Compl. ¶ 2).
  • Accused Features: The proposed methods of use for Defendants' generic products, which are expected to mirror the approved uses and instructions for ORILISSA®. (Compl. ¶¶ 351, 353).

U.S. Patent No. 11,344,551 - “Methods of Treating Heavy Menstrual Bleeding”

  • Technology Synopsis: This patent claims methods for treating heavy menstrual bleeding (HMB), another condition associated with uterine fibroids and endometriosis. The claims specify administration of elagolix in combination with estrogen and progestogen "add-back" therapy to manage side effects. (’551 Patent, Abstract).
  • Asserted Claims: One or more unspecified claims. (Compl. ¶ 2).
  • Accused Features: The proposed labeled use of Defendants' generic elagolix products, which would include indications for which ORILISSA® is approved. (Compl. ¶¶ 364, 366).

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

  • Technology Synopsis: This patent is directed to compositions of elagolix sodium. It claims compositions with a high degree of purity, defining them by the maximum allowable weight percent of specified impurities, and also covers processes for preparing these substantially pure compositions. (’239 Patent, Abstract).
  • Asserted Claims: One or more unspecified claims. (Compl. ¶ 2).
  • Accused Features: The final drug substance formulation of Defendants' generic elagolix sodium tablets, which must be bioequivalent to ORILISSA®. (Compl. ¶¶ 284, 875).

III. The Accused Instrumentality

Product Identification

  • Defendants’ proposed generic elagolix sodium oral tablets in dosage forms equivalent to 150 mg and 200 mg base. (Compl. ¶ 1).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs’ commercial drug, ORILISSA®. (Compl. ¶ 1). The complaint alleges that the products are intended for the management of moderate to severe pain associated with endometriosis, a condition where tissue that normally lines the uterus grows outside it. (Compl. ¶¶ 12-13). The products function by having elagolix, a GnRH receptor antagonist, inhibit GnRH signaling, which in turn reduces estrogen levels and helps manage endometriosis pain. (Compl. ¶ 14). The defendants have filed ANDAs under the Hatch-Waxman Act, which is a statutory act of infringement that allows patent holders to litigate before the generic product enters the market. (Compl. ¶ 1).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. Patent No. 7,056,927 Infringement Allegations

The complaint makes general infringement allegations. The claim chart below is based on the inferred theory that Defendants' ANDA products, containing elagolix sodium, will infringe the patent’s compound claims.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound having the structure (I) ... or a ... pharmaceutically acceptable salt thereof Defendants' ANDA products contain elagolix sodium as the active ingredient, which is a pharmaceutically acceptable salt of a compound falling within the genus of structure (I). ¶1; ¶291 col. 20:15-22:45

Identified Points of Contention:

  • Scope Questions: A potential dispute may arise over whether the specific crystalline form or purity profile of the defendants’ elagolix sodium falls outside the literal scope or doctrine of equivalents of the asserted claims.
  • Technical Questions: The primary technical question will be one of identity: does the active ingredient in the ANDA products meet all structural limitations of the asserted compound claim?

U.S. Patent No. 7,176,211 Infringement Allegations

The complaint makes general infringement allegations. The claim chart below is based on the inferred theory that the proposed labeling for Defendants' ANDA products will induce infringement of the patent’s method of treatment claims.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating ... endometriosis ... comprising administering to a subject a pharmaceutically effective amount of a compound of structure (I) The proposed package inserts for Defendants' generic products will instruct physicians and patients to administer the elagolix sodium tablets for the management of pain associated with endometriosis. ¶1; ¶12; ¶381 col. 3:5-9

Identified Points of Contention:

  • Scope Questions: A central question for inducement will be whether the language in the defendants' proposed product labels directs users to perform all steps of the claimed method. A defense could involve an attempt to "carve out" the patented use from the label, though this is often difficult if it is the only approved use.
  • Technical Questions: Does the administration of the generic product for its labeled indication necessarily result in the direct infringement of the claimed method by a patient or physician?

V. Key Claim Terms for Construction

The Term: "pharmaceutically acceptable salt" (from ’927 Patent, Claim 1)

Context and Importance:

This term is critical because the accused products contain elagolix sodium, a salt form of the underlying compound. The definition of this term will determine whether the specific salt form used by the defendants is covered by the claim. Practitioners may focus on this term to dispute whether a specific crystalline form or solvate of the salt is encompassed.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification provides a broad, conventional definition, stating that salts may be formed from "organic and inorganic cations such as those chosen from the alkali and alkaline earth metals (for example, lithium, sodium, potassium...)." (’927 Patent, col. 11:15-19). This language supports a broad reading that would include the sodium salt.
  • Evidence for a Narrower Interpretation: A defendant could argue that the specific examples in the patent, which may detail the synthesis of a particular form, implicitly limit the scope of "pharmaceutically acceptable salt" to those forms explicitly disclosed or produced by the disclosed methods.

The Term: "treating" (from ’211 Patent, Claim 1)

Context and Importance:

As a method of treatment claim, the scope of "treating" is fundamental to the infringement analysis. Its construction determines the nature of the infringing act that a defendant is accused of inducing.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent specification explicitly states that the context of "treat' includes prophylactic administration." (’211 Patent, col. 18:11-12). This suggests an expansive definition that is not limited to simply alleviating existing symptoms.
  • Evidence for a Narrower Interpretation: A defendant could argue that the clinical context described in the patent, which focuses on managing existing pain associated with endometriosis, suggests the term should be limited to symptomatic relief rather than prevention or cure of the underlying disease.

VI. Other Allegations

Indirect Infringement

  • The complaint repeatedly alleges induced infringement under 35 U.S.C. § 271(b). The basis for these allegations is the assertion that the defendants, through their proposed product labeling and package inserts, will knowingly and intentionally instruct healthcare professionals and patients to administer the generic products in a manner that directly infringes the asserted method-of-use patents. (Compl. ¶¶ 341-342, 382-383). The complaint also alleges contributory infringement for some patents, asserting the products are especially adapted for an infringing use and have no substantial non-infringing use. (Compl. ¶¶ 380, 386-387).

Willful Infringement

  • The complaint does not contain an explicit count for willful infringement. However, it establishes a basis for potential future claims of willfulness by alleging that each defendant had knowledge of the asserted patents as evidenced by the dates of their Paragraph IV notice letters sent to the plaintiffs. (Compl. ¶¶ 343, 384).

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

This complex Hatch-Waxman litigation against numerous generic manufacturers will likely center on the validity of a large and diverse patent portfolio covering a single drug product. The key questions for the court will be:

  • A central issue will be one of validity: can the defendants prove by clear and convincing evidence that any of the asserted claims—spanning from the basic compound, to specific methods of use, to dosage forms and purity profiles—are invalid as anticipated or obvious over the prior art? The staggered issuance dates and differing claim scopes across the seven patents will likely require distinct invalidity analyses for each patent family.
  • A key evidentiary question will be one of infringement scope, particularly for the later-issued patents. While infringement of the basic compound patent (’983) by a bioequivalent product may be straightforward, disputes concerning the method (’572, ’351, ’551) and composition (’239) patents may turn on nuanced technical distinctions between the defendants’ proposed products and manufacturing processes and the precise limitations recited in those claims.
  • A tertiary issue will be one of claim construction: how should key terms like "pharmaceutically acceptable salt" and "treating" be defined? The construction of these terms will directly impact the scope of the asserted claims and could be determinative for infringement, especially concerning the different salt forms, formulations, and labeled indications of the accused generic products.