DCT
1:23-cv-00750
AbbVie Inc v. Lupin Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: AbbVie Inc. (Delaware)
- Defendant: Lupin Limited (India) and Lupin Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:23-cv-00750, D. Del., 07/10/2023
- Venue Allegations: Venue is alleged to be proper as to Lupin Pharmaceuticals, Inc. because it is incorporated in Delaware. Venue is alleged to be proper as to Lupin Limited, an Indian corporation, on the basis that it is subject to personal jurisdiction in the district and may be sued in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the endometriosis drug ORILISSA® constitutes an act of infringement of a patent covering specific compositions and manufacturing processes for the active ingredient, elagolix sodium.
- Technical Context: The technology concerns high-purity compositions of elagolix sodium, a gonadotropin-releasing hormone (GnRH) receptor antagonist, and methods for producing it with minimal impurities for commercial-scale manufacturing.
- Key Procedural History: This action follows a prior lawsuit filed in October 2022 by Plaintiff against the same Defendants regarding the same ANDA, but asserting a different set of patents. The patent-in-suit in this case, U.S. Patent No. 11,542,239, issued in January 2023 and was listed in the FDA’s Orange Book in February 2023, subsequent to the filing of the first action. The complaint alleges Defendants became aware of this new patent in March 2023 during the course of the prior litigation.
Case Timeline
| Date | Event |
|---|---|
| 2018-07-23 | FDA approves ORILISSA® (NDA No. 210450) |
| 2018-07-23 | ’239 Patent Priority Date |
| 2022-09-16 | Lupin sends Notice Letter for its ANDA regarding other patents |
| 2022-10-27 | Plaintiff files first suit against Lupin (No. 22-1423-RGA) |
| 2023-01-03 | ’239 Patent Issues |
| 2023-02-06 | ’239 Patent is listed in the FDA Orange Book for ORILISSA® |
| 2023-03-21 | Lupin allegedly becomes aware of ’239 patent |
| 2023-07-10 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,542,239 - "Elagolix Sodium Compositions and Processes"
- Issued: January 3, 2023
The Invention Explained
- Problem Addressed: The patent describes the challenge of producing a "commercially available active substance" that not only meets FDA standards for a low impurity profile but can also be manufactured in a reproducible, efficient, and cost-effective manner ('239 Patent, col. 2:46-52). The patent notes that because the active substance elagolix sodium is "generally amorphous," its purification can be more complex than substances with stable polymorphic forms, making it difficult to achieve a "substantially pure active substance" suitable for commercial scale manufacturing ('239 Patent, col. 2:53-58).
- The Patented Solution: The invention provides compositions of elagolix sodium (referred to as Compound I) that are defined by a high degree of purity (e.g., at least 97% by weight) and the presence of not more than a specified percentage of certain impurities ('239 Patent, col. 2:15-23). The patent also discloses novel processes and crystalline intermediates that facilitate the removal of impurities, thereby improving manufacturability and achieving the desired high-purity final product ('239 Patent, col. 13:28-41).
- Technical Importance: The invention provides a method for achieving high-purity amorphous elagolix sodium, a technical hurdle for consistent, large-scale pharmaceutical production where precise control over impurities is critical for safety and regulatory approval ('239 Patent, col. 2:58-62).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" without specifying any particular claim (Compl. ¶56). Independent claim 1 is representative of the composition claims.
- Independent Claim 1 requires:
- A composition comprising Compound (I) (elagolix sodium).
- The composition also comprises one or more impurities selected from a specific group of four chemical structures (impurities iii, v, vi, and vii).
- Compound (I) comprises at least 97 weight percent of the composition.
- The one or more selected impurities are present in an amount greater than zero and equal to or less than 3 weight percent of the composition.
- The complaint reserves the right to assert infringement of other claims, including dependent claims (Compl. ¶56, ¶61).
III. The Accused Instrumentality
Product Identification
- The accused products are the generic elagolix sodium oral tablets (150 mg and 200 mg base dosage forms) for which Defendants seek FDA approval under ANDA No. 217712 (Compl. ¶1, ¶50).
Functionality and Market Context
- The products are proposed generic versions of AbbVie's ORILISSA®, a prescription drug used for managing moderate to severe pain associated with endometriosis (Compl. ¶5). The complaint alleges that in their ANDA, Defendants have represented to the FDA that their generic product is "pharmaceutically and therapeutically equivalent" to ORILISSA® (Compl. ¶57). This assertion of equivalence is a central pillar of the infringement allegation in this Hatch-Waxman Act case. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’239 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition comprising: Compound (I),... | The complaint alleges that Defendants' ANDA seeks approval for a generic version of ORILISSA®, whose active ingredient is elagolix sodium, or Compound (I). | ¶1, ¶46, ¶50 | col. 91:5-18 |
| and one or more impurity selected from a group consisting of [specific chemical structures]... | The complaint alleges on "information and belief" that the product described in the ANDA would infringe. This is predicated on the allegation that Defendants' generic product is represented as therapeutically equivalent to ORILISSA®, implying it will possess a composition that includes one or more of the specified impurities. | ¶56, ¶57, ¶60 | col. 91:21-col. 92:49 |
| wherein Compound (I) comprises at least 97 weight percent of the composition | The complaint alleges that the generic product will infringe, which implies that to achieve therapeutic equivalence with ORILISSA®, its composition will necessarily meet the claimed purity limitation of at least 97% elagolix sodium. | ¶56, ¶57, ¶60 | col. 92:41-43 |
| and wherein the one or more impurity is present in an amount that is greater than zero and equal to or less than 3 weight percent of the composition. | The complaint's infringement allegation rests on the belief that the ANDA product, by being equivalent to ORILISSA®, will contain the specified impurities within the claimed range. | ¶56, ¶57, ¶60 | col. 92:43-47 |
Identified Points of Contention
- Technical and Evidentiary Questions: The complaint is filed on "information and belief" prior to discovery of the confidential ANDA. The central dispute will be factual: does the chemical composition of the drug substance specified in Lupin's ANDA actually meet every limitation of an asserted claim? Specifically, does Lupin's manufacturing process, as detailed in the ANDA, necessarily produce a composition containing at least one of the four specific impurities listed in Claim 1 at the claimed purity and impurity levels?
- Scope Questions: Claim 1 is directed to a "composition" comprising the active ingredient and certain impurities. A potential point of contention may be whether this claim covers only the bulk active pharmaceutical ingredient (API) or extends to the final formulated drug product, which includes excipients.
V. Key Claim Terms for Construction
- The Term: "composition"
- Context and Importance: This term is foundational to the claim, as infringement requires that the accused product is the claimed "composition." Practitioners may focus on this term because its scope—whether it is limited to the bulk active pharmaceutical ingredient (API) or also covers the final formulated drug tablet containing excipients—could be dispositive.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent repeatedly discusses the importance of creating a "commercially available active substance" with a desirable impurity profile, and the claims are structured around the purity of that substance (Compound I) relative to process-related impurities ('239 Patent, col. 2:46-52). This may suggest the "composition" is the API itself, which is then formulated into a final product.
- Evidence for a Narrower Interpretation: The term "composition" is used without modifiers like "pharmaceutical" or the inclusion of excipients, which are typically found in claims directed to final drug products. A defendant could argue that had the patentee intended to claim the final tablet, it would have done so explicitly, and therefore the claim is limited to the bulk substance.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement and contributory infringement, asserting that Defendants know and intend for healthcare providers and patients to use the generic product in an infringing manner (Compl. ¶61-62). This allegation is based on the proposed package insert for the generic drug, which will presumably instruct uses identical to those of the branded ORILISSA® product (Compl. ¶64).
- Willful Infringement: While the complaint does not use the word "willful," it alleges facts to support such a claim. It asserts that Defendants had pre-suit knowledge of the ’239 Patent as of March 21, 2023, through their participation in prior litigation (Compl. ¶53, ¶73). The prayer for relief also seeks a declaration that this is an "exceptional case" warranting an award of attorney fees (Compl., p. 17, ¶G).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be factual and evidentiary: does the generic product as described in Lupin's confidential ANDA filing meet every limitation of the asserted claims? The case will likely hinge on whether discovery confirms that Lupin's specified manufacturing process and quality controls result in a drug substance with the exact purity profile and presence of specific impurities required by the patent.
- A secondary legal question will be one of claim scope: can the term "composition," which is defined in the patent by the purity of the active ingredient and the presence of process-related impurities, be construed to read on Lupin's final formulated drug product, or is its scope limited to the bulk drug substance pre-formulation?