DCT
1:25-cv-00625
AbbVie Inc v. Hetero Labs Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: AbbVie Inc. (Delaware), AbbVie Ltd (Bermuda), and Neurocrine Biosciences, Inc. (Delaware)
- Defendant: Hetero Labs Limited (India), Hetero Labs Limited Unit-V (India), and Hetero USA Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Finnegan, Henderson, Farabow, Garrett & Dunner LLP
- Case Identification: 1:25-cv-00625, D. Del., 05/19/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Hetero USA Inc. is a Delaware corporation, and the foreign-domiciled Hetero entities may be sued in any judicial district.
- Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the drug ORILISSA® constitutes an act of patent infringement.
- Technical Context: The technology relates to stable, solid oral pharmaceutical formulations of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist used to treat pain associated with endometriosis.
- Key Procedural History: This lawsuit follows three prior suits filed by Plaintiffs against the same Defendants concerning the same ANDA, but asserting different patents. The complaint notes that the First Suit (C.A. No. 22-1423), Second Suit (C.A. No. 23-448), and Third Suit (C.A. No. 24-151) have all been consolidated. This action, involving a newly issued patent, follows a pattern of litigation triggered by Defendants' efforts to market a generic version of ORILISSA®.
Case Timeline
| Date | Event |
|---|---|
| 2017-08-18 | ’637 Patent Priority Date |
| 2018-07-23 | FDA Approval of ORILISSA® (NDA No. 210450) |
| 2022-10-27 | Filing of "First Suit" against Hetero (C.A. No. 22-1423) |
| 2023-04-24 | Filing of "Second Suit" against Hetero (C.A. No. 23-448) |
| 2024-02-05 | Filing of "Third Suit" against Hetero (C.A. No. 24-151) |
| 2024-10-01 | ’637 Patent Issue Date |
| 2025-04-04 | Hetero's Fourth Notice Letter regarding '637 Patent received |
| 2025-05-19 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,102,637 - "Pharmaceutical Formulations for Treating Endometriosis, Uterine Fibroids, Polycystic Ovary Syndrome or Adenomyosis"
- Patent Identification: U.S. Patent No. 12,102,637, "Pharmaceutical Formulations for Treating Endometriosis, Uterine Fibroids, Polycystic Ovary Syndrome or Adenomyosis", issued October 1, 2024.
The Invention Explained
- Problem Addressed: The patent specification identifies two key technical challenges in developing an oral dosage form for the active pharmaceutical ingredient (API), elagolix (referred to as "Compound A"). First, the API has a tendency to form a gel when administered, which can limit its dissolution and lead to highly variable patient bioavailability (’637 Patent, col. 2:40-49). Second, the API can degrade into an undesirable lactam impurity ("Compound B"), raising safety and efficacy concerns over the product's shelf-life (’637 Patent, col. 2:49-59).
- The Patented Solution: The invention is a pharmaceutical composition that incorporates an "anti-gelling agent," such as sodium carbonate. This agent serves a dual purpose: it facilitates the release and dissolution of the API by preventing gelling, and it acts as a stabilizer by creating a pH microenvironment that reduces the degradation of the API into the lactam impurity (’637 Patent, col. 3:2-10).
- Technical Importance: This formulation strategy provides a means to create a stable, solid oral tablet of elagolix with consistent and predictable drug release, which is critical for a commercially viable therapeutic product.
Key Claims at a Glance
- The complaint asserts infringement of at least one claim of the ’637 patent, with the specific claims to be identified later in the litigation (Compl. ¶69). Independent claim 1 is representative of the core invention.
- The essential elements of independent claim 1 are:
- A pharmaceutical composition comprising:
- from about 20 to about 60% by weight of elagolix sodium;
- from about 10 to about 30% by weight of sodium carbonate; and
- a first filler (mannitol) in an amount from about 20% to about 50% by weight and a second filler (pregelatinized starch) in an amount from about 1% to about 20% by weight;
- wherein the composition is in the form of a stable immediate release tablet.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Hetero's Generic Product," an elagolix sodium oral tablet for which Defendants have filed Abbreviated New Drug Application (ANDA) No. 217690 with the U.S. Food and Drug Administration (Compl. ¶1, ¶59).
Functionality and Market Context
- The complaint alleges that Hetero's ANDA seeks approval to market generic versions of Plaintiffs' ORILISSA® product in 150 mg and 200 mg dosage forms (Compl. ¶59). It further alleges that Hetero has represented to the FDA that its product is "pharmaceutically and therapeutically equivalent" to ORILISSA® (Compl. ¶67). The infringement alleged is a statutory act under 35 U.S.C. § 271(e)(2)(A), triggered by the submission of the ANDA itself, which seeks approval to market the generic product before the expiration of the ’637 Patent (Compl. ¶68). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’637 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pharmaceutical composition comprising: from about 20 to about 60% by weight of elagolix sodium | Hetero’s ANDA product is alleged to be a generic version of ORILISSA® and is therefore alleged to contain elagolix sodium within the claimed percentage range. | ¶59, ¶67 | col. 13:58-62 |
| from about 10 to about 30% by weight of sodium carbonate | As a generic equivalent, Hetero's ANDA product is alleged to contain sodium carbonate, which functions as an anti-gelling agent and stabilizer, within the claimed range. | ¶59, ¶67 | col. 16:15-18 |
| a first filler in an amount from about 20% to about 50% by weight... wherein the first filler is mannitol | Hetero’s ANDA product is alleged to contain mannitol as a filler within the claimed percentage range. | ¶59, ¶67 | col. 31, Table 1 |
| and a second filler in an amount from about 1% to about 20% by weight... wherein the second filler is pregelatinized starch | Hetero’s ANDA product is alleged to contain pregelatinized starch as a second filler within the claimed percentage range. | ¶59, ¶67 | col. 31, Table 1 |
| wherein said composition is in the form of a stable immediate release tablet | The complaint alleges Hetero's product is therapeutically equivalent to ORILISSA®, implying it is also a stable, immediate-release tablet as required by the claim. | ¶67 | col. 22:30-34 |
- Identified Points of Contention:
- Scope Questions: A central dispute may concern the scope of the term "about" as used in the claimed weight percentage ranges. The resolution of this issue will determine whether Hetero's formulation, if it lies near the boundaries of the claimed ranges, literally infringes.
- Technical Questions: As the specific composition of Hetero's product is not detailed in the complaint, a primary factual question is whether its formulation contains the claimed components in the claimed amounts. A second question is whether Hetero's product meets the qualitative requirements of a "stable immediate release tablet," which raises further questions about its dissolution profile and impurity levels compared to the standards described in the patent.
V. Key Claim Terms for Construction
The Term: "stable immediate release tablet"
- Context and Importance: This term defines the fundamental character of the claimed invention. The definition of "stable" is critical, as a primary objective of the invention is to limit the formation of a specific degradation product ("Compound B") (’637 Patent, col. 2:49-59). The definition of "immediate release" is also key to defining the therapeutic profile. Practitioners may focus on this term because demonstrating that Hetero's product is not "stable" or not "immediate release" under the patent's definition could be a path to a non-infringement finding.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue the term should be given its ordinary meaning in the pharmaceutical arts, where "immediate release" is often defined by standard dissolution tests (e.g., USP standards) and "stable" is defined by meeting regulatory impurity limits over a specified shelf life.
- Evidence for a Narrower Interpretation: A party could argue the term is implicitly defined by the patent's examples. For instance, "stable" could be argued to require the very low levels of Compound B detailed in the patent's stability studies (e.g., less than 0.5% after 24 months) (’637 Patent, col. 24:15-35; Table 16). "Immediate release" could be tied to the specific dissolution profiles shown, for example, in FIG. 4, where over 80% of the drug is released by 45 minutes.
The Term: "about"
- Context and Importance: The term "about" modifies all the quantitative ranges in the independent claims. Its construction is therefore dispositive for the question of literal infringement, as it determines the precise boundaries of the claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party advocating for a broader scope may argue that "about" should be interpreted to encompass normal manufacturing variances and measurement tolerances, consistent with its general use in the field.
- Evidence for a Narrower Interpretation: A party advocating for a narrower scope may point to the specific weight percentages listed in the patent's exemplary formulations, such as in Table 1, arguing that these precise values limit the breath of "about" and suggest the inventors had specific, less-flexible targets in mind (’637 Patent, col. 31-32, Table 1).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will actively induce infringement by, among other things, providing a package insert with their generic product that will instruct healthcare professionals and patients to use the product in a manner that directly infringes the ’637 Patent (Compl. ¶71-73).
- Willful Infringement: While the complaint does not use the term "willful," it establishes a basis for such a claim by alleging that Defendants had knowledge of the ’637 Patent at least as of their April 4, 2025 notice letter, which was sent to Plaintiffs prior to the filing of the lawsuit (Compl. ¶61, ¶73).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of quantitative scope: does the specific formulation of Hetero’s proposed generic product, once revealed in discovery, fall within the numerical ranges for each component as recited in the asserted claims, particularly in view of how the term "about" is construed?
- A second central issue will be one of qualitative performance: does Hetero's product meet the claim requirement of a "stable immediate release tablet" as that term is defined by the patent's specification and examples, or is there a material difference in its degradation profile or dissolution characteristics that could support a finding of non-infringement?