DCT
2:24-cv-06224
Esperion Therap Inc v. Accord Healthcare Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Esperion Therapeutics, Inc. (Delaware)
- Defendant: Accord Healthcare Inc. (North Carolina); Intas Pharmaceuticals, Limited (India)
- Plaintiff’s Counsel: Walsh Pizzi O'Reilly Falanga LLP; Allen Overy Shearman Sterling USA LLP
- Case Identification: 2:24-cv-06224, D.N.J., 05/16/2024
- Venue Allegations: Plaintiff alleges venue is proper based on Defendant Accord Healthcare’s consent to venue, both defendants having a regular and established place of business in New Jersey, and Defendant Intas Pharmaceuticals being a foreign corporation subject to suit in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's NEXLETOL® product constitutes an act of infringement of three patents covering compositions of bempedoic acid and methods of their use.
- Technical Context: The dispute centers on pharmaceutical formulations of bempedoic acid, an inhibitor used to lower low-density lipoprotein cholesterol (LDL-C) and reduce cardiovascular risk.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of notice letters from Defendants dated April 2, 2024, and April 23, 2024. The letters contained Paragraph IV certifications asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by Defendants' proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2019-06-21 | Priority Date for ’714, ’511, and ’584 Patents |
| 2020-02-21 | FDA Approval of Plaintiff's NEXLETOL® Product |
| 2023-03-28 | U.S. Patent No. 11,613,511 Issued |
| 2023-09-19 | U.S. Patent No. 11,760,714 Issued |
| 2024-03-12 | U.S. Patent No. 11,926,584 Issued |
| 2024-04-03 | Plaintiff receives first notice letter regarding ANDA submission |
| 2024-04-23 | Plaintiff receives second notice letter regarding ANDA submission |
| 2024-05-16 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,760,714 - “Methods of Making Bempedoic Acid and Compositions of the Same”
- Patent Identification: U.S. Patent No. 11,760,714, entitled “Methods of Making Bempedoic Acid and Compositions of the Same,” issued September 19, 2023 (’714 Patent) (Compl. ¶29).
The Invention Explained
- Problem Addressed: The patent’s background section identifies the "significant challenge" of developing robust, cost-effective, and efficient manufacturing methods for pharmaceutical compounds that achieve the purity and impurity profiles required by regulatory agencies (’714 Patent, col. 1:17-29).
- The Patented Solution: The invention claims to provide an efficient process for producing high-purity bempedoic acid, resulting in a pharmaceutical material where the active ingredient is present in an amount greater than 98% by weight and a specific diol impurity (formula VI) is limited to no more than 0.15% (’714 Patent, col. 1:30-36; Claim 1). This control over purity and specific impurities is presented as a solution to the manufacturing challenge.
- Technical Importance: Achieving high purity and strictly controlling specific impurities are critical in pharmaceutical manufacturing to ensure drug product safety, stability, and consistent therapeutic effect (Compl. ¶41; ’714 Patent, col. 1:25-29).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 (Compl. ¶57).
- Claim 1 of the ’714 Patent recites the following essential elements:
- A pharmaceutical composition comprising a pharmaceutical material and a pharmaceutically acceptable excipient.
- The pharmaceutical material comprises a crystalline form of bempedoic acid (formula V) or a salt thereof.
- The bempedoic acid is present in an amount greater than 98% by weight of the pharmaceutical material.
- The pharmaceutical material comprises 0.0001% to less than or equal to 0.15% of a specific impurity, the compound of formula (VI).
- The complaint reserves the right to assert infringement of other claims (Compl. ¶58).
U.S. Patent No. 11,613,511 - “Methods of Making Bempedoic Acid and Compositions of the Same”
- Patent Identification: U.S. Patent No. 11,613,511, entitled “Methods of Making Bempedoic Acid and Compositions of the Same,” issued March 28, 2023 (’511 Patent) (Compl. ¶32).
The Invention Explained
- Problem Addressed: The patent addresses the same general problem as the ’714 Patent: the need for robust manufacturing processes to produce pharmaceutical compounds with high purity and controlled impurity profiles (’511 Patent, col. 1:17-29).
- The Patented Solution: This invention claims a specific crystalline form of bempedoic acid, defined by a characteristic X-ray powder diffraction (XRPD) pattern, in addition to high purity (>99.0%) and low impurity (<0.15%) levels (’511 Patent, col. 9:49-10:19; Fig. 4). By claiming a specific solid-state form, the invention provides a solution for ensuring consistent physical properties of the drug substance.
- Technical Importance: The specific crystalline form, or polymorph, of an active pharmaceutical ingredient can significantly affect its solubility, dissolution rate, stability, and bioavailability, making polymorphic control a critical aspect of drug development (’511 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 (Compl. ¶69).
- Claim 1 of the ’511 Patent recites the following essential elements:
- A pharmaceutical material comprising a crystalline form of bempedoic acid (formula V) or a salt thereof.
- The bempedoic acid is present in an amount greater than 99.0% by weight of the pharmaceutical material.
- The pharmaceutical material comprises 0.0001% to less than or equal to 0.15% of the compound of formula (VI).
- The crystalline form exhibits an XRPD pattern with peaks at specific diffraction angles (2θ), including 10.3±0.2, 10.4±0.2, and 17.9±0.2.
- The complaint reserves the right to assert infringement of other claims (Compl. ¶70).
U.S. Patent No. 11,926,584 - “Methods of Making Bempedoic Acid and Compositions of the Same”
- Patent Identification: U.S. Patent No. 11,926,584, entitled “Methods of Making Bempedoic Acid and Compositions of the Same,” issued March 12, 2024 (’584 Patent) (Compl. ¶35).
- Technology Synopsis: This patent claims a method of medical treatment. The technical problem addressed is the need to lower LDL-C in humans, and the patented solution is a method comprising administering a therapeutically effective amount of the high-purity pharmaceutical material containing bempedoic acid, as defined by the same purity (>99.0%) and impurity (<0.15%) limits found in the ’511 Patent (Compl. ¶80).
- Asserted Claims: The complaint asserts infringement of at least Claim 1 (Compl. ¶80).
- Accused Features: The complaint alleges that Defendants will infringe by marketing their ANDA product with a proposed package insert that instructs patients and medical practitioners to administer the product for the patented method of lowering LDL-C (Compl. ¶¶85-87).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the "Accord ANDA Product," a generic version of NEXLETOL® (bempedoic acid) for which Defendants submitted Abbreviated New Drug Application No. 219430 to the FDA for approval (Compl. ¶1, ¶14).
Functionality and Market Context
- The Accord ANDA Product is alleged to contain the same active ingredient, bempedoic acid, at the same dosage and in the same dosage form as NEXLETOL® (Compl. ¶50). It is intended for the same therapeutic use: lowering LDL-C as an adjunct to diet and statin therapy to reduce cardiovascular risk (Compl. ¶41). The complaint alleges that Defendants intend to commercially manufacture and sell the product in the United States immediately upon receiving FDA approval, prior to the expiration of the Asserted Patents (Compl. ¶49). The complaint includes a chemical structure diagram of bempedoic acid, the active ingredient in both NEXLETOL® and the accused product (Compl. ¶42).
IV. Analysis of Infringement Allegations
’714 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pharmaceutical composition, comprising: a pharmaceutical material comprising a crystalline form of the compound of formula (V) ... or a pharmaceutically acceptable salt thereof; | The Accord ANDA Product is alleged to be a pharmaceutical composition containing a crystalline form of bempedoic acid (formula V). | ¶57 | col. 1:37-44 |
| wherein the pharmaceutical material comprises the compound of formula (V), or a pharmaceutically acceptable salt thereof, in an amount greater than 98% by weight based on the total weight of the pharmaceutical material, | Upon information and belief, the pharmaceutical material in the Accord ANDA Product contains bempedoic acid at a purity greater than 98% by weight. | ¶57 | col. 50:41-48 |
| and the pharmaceutical material comprises 0.0001 % to less than or equal to 0.15% of a compound of formula (VI) | Upon information and belief, the pharmaceutical material in the Accord ANDA Product contains the specified diol impurity (formula VI) within the claimed range. | ¶57 | col. 51:5-12 |
| and a pharmaceutically acceptable excipient. | The Accord ANDA Product is alleged to contain at least one pharmaceutically acceptable excipient. | ¶57 | col. 4:5-8 |
’511 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pharmaceutical material comprising a crystalline form of the compound of formula (V) ... or a pharmaceutically acceptable salt thereof; | The Accord ANDA Product is alleged to contain a crystalline form of bempedoic acid (formula V). | ¶69 | col. 9:18-24 |
| wherein the pharmaceutical material comprises the compound of formula (V) ... in an amount greater than 99.0% by weight based on the total weight of the pharmaceutical material, | Upon information and belief, the pharmaceutical material in the Accord ANDA Product contains bempedoic acid at a purity greater than 99.0% by weight. | ¶69 | col. 3:50-55 |
| the pharmaceutical material comprises 0.0001 % to less than or equal to 0.15% of a compound of formula (VI) | Upon information and belief, the pharmaceutical material in the Accord ANDA Product contains the specified diol impurity (formula VI) within the claimed range. The complaint provides the chemical structure for this impurity (Compl. ¶69). | ¶69 | col. 51:5-12 |
| and the crystalline form of the compound of formula (V) exhibits an X-ray powder diffraction pattern comprising peaks at the following diffraction angles (2θ): 10.3±0.2, 10.4±0.2, 17.9±0.2, 18.8±0.2, 19.5±0.2, and 20.7±0.2. | Upon information and belief, the crystalline form of bempedoic acid in the Accord ANDA Product exhibits the claimed characteristic XRPD pattern. | ¶69 | col. 9:51-60 |
- Identified Points of Contention:
- Technical Questions: A primary factual dispute will concern the composition of the Accord ANDA Product itself. The complaint's allegations are based on "information and belief," likely derived from Defendants' confidential ANDA submission (Compl. ¶54). The central technical questions will be: (1) Does the drug substance in the Accord ANDA Product meet the specific purity thresholds (>98% for the ’714 Patent; >99% for the ’511 and ’584 Patents) on a consistent basis? (2) Is the level of the specific diol impurity (formula VI) consistently within the claimed range of 0.0001% to 0.15%?
- Scope Questions: For the ’511 Patent, a key point of contention may be whether the crystalline form of bempedoic acid used by Accord is the specific polymorph claimed. This will involve comparing the XRPD data for Accord's product with the peak locations recited in Claim 1, raising the question of whether any observed differences fall within the claim's scope, including the "±0.2" margin for the peak locations.
V. Key Claim Terms for Construction
The Term: "pharmaceutical material"
Context and Importance: This term appears in the independent claims of all three Asserted Patents and defines the substance to which the purity (>98% or >99%) and impurity (<0.15%) limitations apply. Practitioners may focus on this term because its definition is critical for determining the exact point in the manufacturing process at which infringement is assessed—whether it applies only to the final, highly purified active pharmaceutical ingredient (API) or could also read on earlier-stage intermediates that might not meet the purity thresholds.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patents do not provide an explicit definition. A party could argue for a plain and ordinary meaning that might encompass the API mixed with minor processing aids or stabilizers before formulation with bulk excipients.
- Evidence for a Narrower Interpretation: The claims distinguish between the "pharmaceutical material" and the "pharmaceutically acceptable excipient," suggesting they are distinct components. The use of percentage-by-weight limitations based on "the total weight of the pharmaceutical material" strongly suggests it is a discrete, analyzable substance, i.e., the API itself (’714 Patent, Claim 1; ’511 Patent, Claim 1).
The Term: "crystalline form"
Context and Importance: This term is foundational to the composition claims (’714 and ’511 Patents) and the composition used in the method claim (’584 Patent). Its construction will determine which solid-state forms of bempedoic acid are covered by the patents.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The ’714 Patent uses the term without further limitation by physical parameters, which may support a construction covering any form of bempedoic acid exhibiting long-range molecular order, regardless of the specific crystal lattice structure.
- Evidence for a Narrower Interpretation: The ’511 Patent explicitly defines the "crystalline form" by its characteristic XRPD pattern (Compl. ¶69; ’511 Patent, Claim 1). A party may argue that this specific definition in a related patent narrows the term's meaning across the family, or at a minimum, limits the scope of the ’511 Patent to a single, specific polymorph.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will induce and contribute to infringement. For the method claims of the ’584 Patent, inducement is alleged based on the proposed product labeling, which will instruct medical professionals and patients to administer the Accord ANDA Product for the patented use of lowering LDL-C (Compl. ¶¶84-87). For the composition claims, inducement is alleged based on marketing the product for infringing uses, and contributory infringement is alleged on the basis that the product is not suitable for substantial non-infringing use (Compl. ¶¶62-63, 74-75).
- Willful Infringement: The complaint does not explicitly use the term "willful infringement," but it alleges that Defendants have had knowledge of the Asserted Patents at least by virtue of their listing in the FDA's Orange Book and through the notice letters sent to Esperion (Compl. ¶¶61, 73, 89). Plaintiff requests a declaration of an exceptional case and an award of attorneys' fees, which is often predicated on findings of willful infringement or litigation misconduct (Compl. ¶101).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of analytical evidence: can Plaintiff prove, by a preponderance of the evidence, that the "Accord ANDA Product," as described in its confidential regulatory filing, will necessarily meet the specific quantitative limitations of the asserted claims, particularly the purity thresholds (>98% or >99%) and the narrow range for a key impurity (<0.15%)?
- A key technical question will be one of polymorphic identity: for the ’511 Patent, does the crystalline form of bempedoic acid manufactured by Accord exhibit the specific X-ray powder diffraction pattern recited in Claim 1, or does it represent a distinct, non-infringing polymorph that falls outside the claim scope?
- A crucial legal question, prompted by Defendants' Paragraph IV certification, will be one of patent validity: are the claims, which are distinguished from the prior art primarily by specific purity levels and/or a particular crystalline form, non-obvious to a person of ordinary skill in the art of pharmaceutical chemistry and manufacturing?