DCT
1:24-cv-00153
AbbVie Inc v. Sun Pharmaceutical Industries Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: AbbVie Inc. (Delaware)
- Defendant: Sun Pharmaceutical Industries Limited (India)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:24-cv-00153, D. Del., 02/05/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation subject to personal jurisdiction in the district, based on its regular and systematic business contacts, sales of other generic products in Delaware, and the act of filing an Abbreviated New Drug Application (ANDA) with the intent to market the accused product nationwide, including in Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff's ORILISSA® product constitutes an act of infringement of two patents covering methods of administering the active ingredient, elagolix.
- Technical Context: The technology involves specific pharmaceutical methods for treating gynecological conditions like endometriosis and heavy menstrual bleeding, focusing on managing drug-drug interactions and balancing efficacy with side effects.
- Key Procedural History: This action follows two prior lawsuits filed by AbbVie against Sun concerning the same ANDA but asserting different patents. This third suit was initiated after Sun provided a Paragraph IV certification notice for the two patents-in-suit, which issued in July 2023.
Case Timeline
| Date | Event |
|---|---|
| 2018-04-19 | ’854 Patent Priority Date |
| 2018-07-23 | FDA approves AbbVie's ORILISSA® New Drug Application |
| 2020-03-05 | ’845 Patent Priority Date |
| 2022-10-27 | AbbVie files "First Suit" against Sun regarding ANDA No. 215804 |
| 2023-06-23 | AbbVie files "Second Suit" against Sun regarding ANDA No. 215804 |
| 2023-07-04 | U.S. Patent No. 11,690,845 Issues |
| 2023-07-04 | U.S. Patent No. 11,690,854 Issues |
| 2023-12-22 | AbbVie receives "Third Notice Letter" from Sun regarding the '845 and '854 patents |
| 2024-02-05 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,690,845 - Methods of Administering Elagolix, Issued July 4, 2023
The Invention Explained
- Problem Addressed: The patent addresses the potential for adverse drug interactions when elagolix, a treatment for gynecological disorders, is co-administered with other drugs. Specifically, it notes that bupropion, an antidepressant, is metabolized by the enzyme CYP2B6, and that interactions with drugs that inhibit or induce this enzyme are a concern (’845 Patent, col. 1:20-38).
- The Patented Solution: The invention provides a specific method for co-administering elagolix and bupropion. It claims that administering a 300 mg twice-daily dose of elagolix sodium with a 150 mg once-daily dose of bupropion results in a specific, defined pharmacokinetic profile (’845 Patent, col. 2:44-65). The patent discloses the surprising discovery that this co-administration increases the peak plasma concentration (Cmax) of bupropion and its primary metabolite, contrary to what might be expected from in vitro data suggesting elagolix induces the metabolizing enzyme (’845 Patent, col. 8:50-59).
- Technical Importance: By defining a predictable pharmacokinetic outcome, the invention provides a basis for managing the co-administration of these two drugs to maintain safety and efficacy, particularly given that some adverse events with bupropion have been linked to its peak plasma concentration (’845 Patent, col. 1:33-36).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" but does not identify any specific claims (Compl. ¶54). The patent contains one independent claim, Claim 1.
- Essential elements of Independent Claim 1 include:
- A method for treating a gynecological disorder in a patient.
- Orally administering elagolix sodium in an amount equivalent to 300 mg of elagolix free acid twice daily.
- The patient concurrently receives a once daily dose of 150 mg of bupropion.
- The co-administration results in a specific set of four pharmacokinetic parameter ratios for bupropion and its metabolite, hydroxybupropion, concerning their respective Cmax and AUCinf values (’845 Patent, col. 9:48 - col. 10:4).
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,690,854 - Methods of Treating Heavy Menstrual Bleeding, Issued July 4, 2023
The Invention Explained
- Problem Addressed: The patent describes heavy menstrual bleeding (HMB) as a significant symptom associated with conditions like uterine fibroids, which can lead to anemia and the need for surgical intervention (’854 Patent, col. 1:31-43). The invention seeks to provide an effective, orally administered treatment for HMB.
- The Patented Solution: The invention is a method for treating HMB by administering elagolix (a GnRH receptor antagonist) in combination with an estrogen and a progestogen (’854 Patent, Abstract). This "add-back" therapy is designed to reduce menstrual bleeding by suppressing estrogen via the GnRH pathway, while simultaneously providing exogenous hormones to mitigate the side effects of low estrogen, such as bone mineral density loss (’854 Patent, col. 2:41-50).
- Technical Importance: This combination therapy provides an oral treatment option that aims to balance the therapeutic benefit of reducing HMB with the management of side effects, potentially enabling longer-term treatment for patients.
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶67). The patent contains two independent claims, Claims 1 and 2.
- Essential elements of Independent Claim 1 include:
- A method of treating heavy menstrual bleeding in a subject with or without uterine fibroids.
- Administering an effective amount of elagolix or a pharmaceutically acceptable salt thereof.
- The administration is in combination with an estrogen and a progestogen (’854 Patent, col. 27:4-10).
- Independent Claim 2 is similar but is limited to subjects with uterine fibroids and specifies a dose of 300 to 600 mg per day of elagolix (’854 Patent, col. 27:11-15).
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- Sun Pharmaceutical Industries Limited’s proposed generic elagolix sodium oral tablets, described in ANDA No. 215804, in dosage forms equivalent to 150 mg and 200 mg base (Compl. ¶¶ 1, 44).
Functionality and Market Context
- The accused product is a generic version of AbbVie’s commercial product ORILISSA® and is alleged to be "pharmaceutically and therapeutically equivalent" to it (Compl. ¶¶ 1, 52, 65).
- ORILISSA® is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for managing moderate to severe pain associated with endometriosis (Compl. ¶6).
- The act of infringement alleged is the filing of ANDA No. 215804, which seeks FDA approval to market this generic product for a patented use prior to the expiration of the patents-in-suit (Compl. ¶2).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint. The complaint does not contain a claim chart or detailed factual allegations mapping elements of the proposed generic product's use to the specific limitations of the asserted claims. The infringement theory is based on the allegation that Sun's ANDA filing under 35 U.S.C. § 271(e)(2) seeks approval for a product that is therapeutically equivalent to ORILISSA® and that its use, as will be directed by its proposed label, will infringe the patents-in-suit (Compl. ¶¶ 52, 65).
'845 Patent Infringement Allegations
The complaint does not provide sufficient detail for a full analysis of infringement. The following table summarizes the general theory.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating a gynecological disorder... | The use of Sun's Generic Product for its FDA-approved indication, which the complaint alleges is for a gynecological disorder (endometriosis) (Compl. ¶6). | ¶55 | col. 9:48-54 |
| ...orally administering... elagolix sodium... in an amount equivalent to 300 mg of elagolix free acid twice daily... | The complaint does not allege that Sun's ANDA seeks approval for this specific dosage regimen. It only references 150 mg and 200 mg dosage forms (Compl. ¶1). | ¶55 | col. 9:55-58 |
| ...wherein the patient receives a once daily dose of 150 mg of bupropion... | The complaint does not allege that Sun's proposed label will instruct for co-administration with bupropion at this specific dose. | ¶55 | col. 9:59-60 |
| ...wherein [a specific set of four pharmacokinetic ratios are achieved]... | The complaint does not allege that the use of Sun's product will result in the claimed pharmacokinetic outcomes. | ¶55 | col. 9:61- col. 10:4 |
'854 Patent Infringement Allegations
The complaint does not provide sufficient detail for a full analysis of infringement. The following table summarizes the general theory.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating heavy menstrual bleeding... | The use of Sun's Generic Product for an indication covered by the ORILISSA® Orange Book listing, which Plaintiff alleges will constitute treating HMB. | ¶68 | col. 27:4-5 |
| ...administering an effective amount of [elagolix]... | The use of Sun's Generic Product (150 mg and 200 mg tablets) as directed by its proposed label (Compl. ¶1, ¶70). | ¶68 | col. 27:6-9 |
| ...in combination with an estrogen and a progestogen. | The complaint does not allege that Sun's proposed label will instruct for co-administration with an estrogen and a progestogen. | ¶68 | col. 27:9-10 |
Identified Points of Contention
- Scope Questions: A primary issue for the '845 patent is whether Sun’s ANDA seeks approval for a use that falls within the narrow scope of Claim 1, which requires a specific 300 mg twice-daily elagolix dosage co-administered with a 150 mg once-daily bupropion dosage. The complaint does not allege facts to support this. For the ’854 patent, a central question is whether the approved indication for ORILISSA® ("management of moderate to severe pain associated with endometriosis") constitutes a "method of treating heavy menstrual bleeding."
- Technical Questions: A key factual question for the '845 patent is whether the use of Sun's product as described in its ANDA would actually result in the specific pharmacokinetic profile required by Claim 1. For the '854 patent, a question may arise as to whether its claims require combination with "add-back" therapy, and whether Sun’s proposed label instructs or suggests such a combination.
V. Key Claim Terms for Construction
For the '845 Patent
- The Term: The pharmacokinetic limitations recited in the "wherein" clause of Claim 1 (e.g., "a ratio of Cmax for bupropion... is between about 1.104 and about 1.407").
- Context and Importance: These limitations are the core of the claimed invention and distinguish it from the prior art. Infringement will require proof that the administration of Sun’s proposed product will necessarily result in these PK outcomes. The construction of "about" will be critical to determining the breadth of these ranges.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's use of the term "about" explicitly signals that the claimed ranges are not intended to be strictly limited to the recited numerical values ('845 Patent, col. 11:41-43).
- Evidence for a Narrower Interpretation: The recited numerical ranges are derived directly from the results of a specific clinical study depicted in the patent's figures and tables (e.g., FIG. 3). A party may argue that the claims should be construed as being tied to the conditions and outcomes of that particular study.
For the '854 Patent
- The Term: "method of treating heavy menstrual bleeding"
- Context and Importance: The infringement case for the '854 patent depends on whether the use for which Sun seeks approval (a generic of ORILISSA® for endometriosis-associated pain) falls under this definition. Practitioners may focus on this term because the approved indication for the branded drug does not explicitly mention HMB.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent’s background section states that HMB is a common symptom of uterine fibroids and that endometriosis can also cause heavy periods (’854 Patent, col. 1:31-35, 1:56-59). A party could argue that treating the underlying condition (endometriosis) inherently treats its common symptoms like HMB.
- Evidence for a Narrower Interpretation: A party could argue that the claim requires HMB to be the condition being treated, not merely a possible symptom of another condition. The specification defines HMB as a blood loss greater than 80 mL per cycle, suggesting a specific diagnostic threshold may be required rather than just a general treatment for endometriosis pain (’854 Patent, col. 1:38-40).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Sun will induce infringement under 35 U.S.C. § 271(b). The factual basis alleged is that Sun knows of the patents and that its promotional activities and proposed package insert for the generic product will instruct healthcare providers and patients on how to engage in infringing uses (Compl. ¶¶ 56-57, 69-70).
- Willful Infringement: The complaint does not use the term "willful," but it alleges that Sun has knowledge of the patents-in-suit as evidenced by its "Third Notice Letter" dated December 22, 2023 (Compl. ¶¶ 58, 71). It also requests a finding that the case is "exceptional" and an award of attorney fees under 35 U.S.C. § 285, which is often predicated on a finding of willful infringement (Compl., Prayer for Relief ¶G).
VII. Analyst’s Conclusion: Key Questions for the Case
A central evidentiary question for the ’845 patent will be one of factual correspondence: Does Sun’s ANDA, including its proposed product label, actually describe or inevitably lead to the highly specific dosing regimen (300 mg elagolix twice daily with 150 mg bupropion once daily) and the precise pharmacokinetic outcomes required by the patent's only independent claim? The complaint currently lacks direct allegations on this point.
A key legal question will be one of definitional scope: Can the approved use for ORILISSA®, "management of moderate to severe pain associated with endometriosis," be properly construed as a "method of treating heavy menstrual bleeding" under the claims of the '854 patent, especially when the branded product's primary indication is pain, not bleeding?
A determinative issue for inducement will be the content of Sun's proposed product label. The court will need to assess whether the instructions and indications on the label would actively encourage or instruct medical professionals to prescribe, and patients to use, the generic product in a manner that directly infringes one or more claims of the patents-in-suit.