DCT

2:24-cv-06017

Esperion Therap Inc v. Renata Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-06017, D.N.J., 09/29/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendants Somerset Therapeutics and Somerset Pharma are Delaware corporations with principal places of business in New Jersey. Venue over Renata Limited, a foreign corporation based in Bangladesh, is asserted on the basis that it may be sued in any judicial district and that it has engaged in regular business contacts within New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic version of Plaintiff's NEXLETOL® drug, constitutes an act of infringement of six U.S. patents covering compositions of bempedoic acid and methods of its use.
  • Technical Context: The dispute centers on bempedoic acid, an active pharmaceutical ingredient used as a cholesterol-lowering therapy to treat cardiovascular disease, a field dominated by statin therapies but with a significant market for alternative or adjunctive treatments.
  • Key Procedural History: This is a Hatch-Waxman Act litigation triggered by Defendants' filing of ANDA No. 219257 with a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint references "First" and "Second" notice letters sent by Defendant Renata to Plaintiff, which is a statutory prerequisite to this type of patent infringement action.

Case Timeline

Date Event
2015-03-13 U.S. Patent No. 11,744,816 Priority Date
2019-06-21 Priority Date for '714, '511, '584, '087, '227 Patents
2020-02-21 FDA approves Plaintiff's New Drug Application for NEXLETOL®
2023-03-28 U.S. Patent No. 11,613,511 Issues
2023-09-05 U.S. Patent No. 11,744,816 Issues
2023-09-19 U.S. Patent No. 11,760,714 Issues
2024-03-12 U.S. Patent No. 11,926,584 Issues
2024-03-22 FDA approves a new label for NEXLETOL®
2024-03-28 Plaintiff receives First Notice Letter from Renata regarding ANDA filing
2024-04-09 Plaintiff submits '584 Patent for Orange Book listing
2024-04-19 Plaintiff submits '816 Patent for Orange Book listing
2024-04-29 Plaintiff sends Renata a proposed revision to the Offer of Confidential Access
2024-05-10 Plaintiff files original complaint in this action
2024-06-05 Plaintiff receives Second Notice Letter from Renata
2024-07-17 Date counsel first represents that Renata and Somerset entered into a Master Services Agreement
2025-08-21 Plaintiff informs Defendants of impending issuance of '087 and '227 Patents
2025-08-26 U.S. Patent No. 12,398,087 Issues
2025-09-02 U.S. Patent No. 12,404,227 Issues
2025-09-09 Plaintiff submits '087 and '227 Patents for Orange Book listing
2025-09-10 '087 and '227 Patents are listed in the Orange Book
2025-09-29 Plaintiff files Third Amended Complaint

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. 11760714, "Methods of Making Bempedoic Acid and Compositions of the Same," issued September 19, 2023. (Compl. ¶42).

The Invention Explained

  • Problem Addressed: The patent's background section describes the "significant challenge" in developing "robust, cost-effective and efficient manufacturing methods for the production of pharmaceutically active compounds with desired yield and purity." ('714 Patent, col. 1:17-22). It specifically highlights the need for a process to synthesize bempedoic acid with purity profiles that meet regulatory requirements for a commercial drug product. ('714 Patent, col. 1:22-29).
  • The Patented Solution: The invention provides methods for preparing highly purified bempedoic acid and compositions containing it. The detailed description and FIG. 1 lay out a multi-step chemical synthesis process designed to produce bempedoic acid with high purity and control the formation of specific impurities. ('714 Patent, col. 2:30-34; FIG. 1). The claims are directed not to the process itself, but to the resulting highly purified pharmaceutical composition characterized by a low level of a specific "diol impurity."
  • Technical Importance: Achieving high purity and minimizing specific impurities in an active pharmaceutical ingredient (API) is critical for ensuring drug safety, efficacy, and stability, and is a principal focus of regulatory agencies like the FDA. ('714 Patent, col. 1:25-29).

Key Claims at a Glance

  • The complaint asserts infringement of Claim 1. (Compl. ¶99).
  • Essential elements of Independent Claim 1 include:
    • A pharmaceutical composition comprising a pharmaceutical material.
    • The pharmaceutical material comprises a crystalline form of bempedoic acid (formula V) or a salt thereof.
    • The amount of bempedoic acid is 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 diol impurity (formula VI).
    • The composition further comprises a pharmaceutically acceptable excipient.
  • The complaint states that Defendants' actions constituted infringement of "the claims" of the ’714 Patent, which may suggest an intent to assert dependent claims later. (Compl. ¶100).

U.S. Patent No. 11,613,511 - Methods of Making Bempedoic Acid and Compositions of the Same

  • Patent Identification: U.S. Patent No. 11613511, "Methods of Making Bempedoic Acid and Compositions of the Same," issued March 28, 2023. (Compl. ¶45).

The Invention Explained

  • Problem Addressed: The problem is consistent with that of the ’714 Patent: the need for efficient manufacturing processes to produce bempedoic acid with the high purity and specific impurity profiles required for a commercial drug product. ('511 Patent, col. 1:17-29).
  • The Patented Solution: This invention claims a specific crystalline form of bempedoic acid, distinguished from other potential solid-state forms (polymorphs) by a unique X-ray powder diffraction (XRPD) pattern. (’511 Patent, col. 9:21-44). The claimed solution is a highly pure pharmaceutical material that not only meets purity thresholds but also consists of this specific, characterized crystalline structure, which can provide consistent physical properties like stability and dissolution rate.
  • Technical Importance: Controlling the specific crystalline form of an API is critical in pharmaceutical development, as different polymorphs can have different physical properties that significantly affect a drug's manufacturing, shelf-life, and bioavailability. ('511 Patent, col. 5:1-9).

Key Claims at a Glance

  • The complaint asserts infringement of Claim 1. (Compl. ¶112).
  • Essential elements of Independent Claim 1 include:
    • A pharmaceutical material comprising a crystalline form of bempedoic acid (formula V) or a salt thereof.
    • The amount of bempedoic acid is 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 a diol impurity (formula VI).
    • The crystalline form exhibits an X-ray powder diffraction pattern with peaks at specific 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.
  • The complaint broadly alleges infringement of "the claims," which may suggest a later assertion of dependent claims. (Compl. ¶113).

Multi-Patent Capsules

  • Patent Identification: U.S. Patent No. 11926584, "Methods of Making Bempedoic Acid and Compositions of the Same," issued March 12, 2024. (Compl. ¶48).

  • Technology Synopsis: This patent addresses the treatment of high cholesterol. It claims a method of lowering low-density lipoprotein cholesterol (LDL-C) in a human by administering a therapeutically effective amount of a pharmaceutical material that contains a highly purified (>99.0% by weight) crystalline form of bempedoic acid with a specified low level of a diol impurity (<0.15%). (Compl. ¶124; '584 Patent, col. 20:12-22).

  • Asserted Claims: Independent Claim 1. (Compl. ¶124).

  • Accused Features: The complaint alleges that the proposed package insert for the Renata ANDA Product will instruct patients and medical practitioners to administer the product for lowering LDL-C, thereby inducing infringement of the claimed method. (Compl. ¶¶130-132).

  • Patent Identification: U.S. Patent No. 11744816, "Fixed Dose Combinations and Formulations Comprising ETC1002 and Ezetimibe and Methods of Treating or Reducing the Risk of Cardiovascular Disease," issued September 5, 2023. (Compl. ¶51).

  • Technology Synopsis: This patent is directed to a specific combination therapy for a particular patient population. It claims a method of lowering LDL-C in a subject having familial hypercholesterolemia by administering 180 mg of bempedoic acid and 10 mg of ezetimibe. (Compl. ¶141; '816 Patent, col. 26:7-11).

  • Asserted Claims: Independent Claim 1. (Compl. ¶141).

  • Accused Features: The complaint alleges the Renata ANDA Product will contain 180 mg of bempedoic acid and that its proposed package insert will instruct and encourage its administration along with 10 mg of ezetimibe to lower LDL-C in patients with familial hypercholesterolemia. (Compl. ¶¶142, 151-152).

  • Patent Identification: U.S. Patent No. 12398087, "Methods of Making Bempedoic Acid and Compositions of the Same," issued August 26, 2025. (Compl. ¶54).

  • Technology Synopsis: This patent, like the '714 Patent, claims a pharmaceutical composition of bempedoic acid defined by purity and impurity profiles. It requires the bempedoic acid to be present in an amount greater than 98% by weight and a diol impurity (formula VI) to be present in an amount from 0.001% to 0.15%. (Compl. ¶162; '087 Patent, col. 27:16-28).

  • Asserted Claims: Independent Claim 1. (Compl. ¶162).

  • Accused Features: The complaint alleges on information and belief that the Renata ANDA Product will meet the specific purity and impurity profile claimed in this patent. (Compl. ¶¶163, 166).

  • Patent Identification: U.S. Patent No. 12404227, "Methods of Making Bempedoic Acid and Compositions of the Same," issued September 2, 2025. (Compl. ¶57).

  • Technology Synopsis: This patent claims a pharmaceutical material containing a crystalline form of bempedoic acid defined by a different impurity profile. It requires bempedoic acid purity of greater than 99.0% and limits a different, ketone-related impurity (formula VIII) to a range of 0.0001% to 0.15%. (Compl. ¶175; '227 Patent, col. 30:8-21).

  • Asserted Claims: Independent Claim 1. (Compl. ¶175).

  • Accused Features: The complaint alleges on information and belief that the Renata ANDA Product will meet the purity level and specific ketone impurity profile claimed in this patent. (Compl. ¶¶176, 179).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the "Renata ANDA Product," a generic version of NEXLETOL® (bempedoic acid) for which Defendants have sought FDA approval via Abbreviated New Drug Application No. 219257. (Compl. ¶¶1, 15).

Functionality and Market Context

  • The Renata ANDA Product contains bempedoic acid as its active pharmaceutical ingredient and is intended to be bioequivalent to NEXLETOL®, with the same dosage form and strength. (Compl. ¶69). The product is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated for lowering LDL-C and reducing the risk of myocardial infarction and coronary revascularization. (Compl. ¶63). The complaint alleges the product contains 180 mg of bempedoic acid. (Compl. ¶142). By filing an ANDA, Defendants seek to enter the U.S. market and compete with Plaintiff's branded product prior to the expiration of the patents-in-suit. (Compl. ¶1). Somerset Therapeutics and Somerset Pharma are alleged to hold the exclusive right to market and sell the product in the United States. (Compl. ¶88). The complaint includes a chemical structure diagram of bempedoic acid, identified as formula (V). (Compl. ¶99).

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,760,714 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 Renata ANDA Product is alleged to comprise a pharmaceutical material containing a crystalline form of bempedoic acid. ¶99 col. 2:42-44
wherein the pharmaceutical material comprises the compound of formula (V)...in an amount greater than 98% by weight based on the total weight of the pharmaceutical material The pharmaceutical material in the Renata ANDA Product is alleged to comprise bempedoic acid at a purity level of greater than 98% by weight. ¶99 col. 2:48-52
and the pharmaceutical material comprises 0.0001% to less than or equal to 0.15% of a compound of formula (VI) The pharmaceutical material in the Renata ANDA Product is alleged to contain a diol impurity (formula VI) within the claimed percentage range. ¶99 col. 2:53-56
and a pharmaceutically acceptable excipient The Renata ANDA Product is a pharmaceutical composition that is alleged to contain a pharmaceutically acceptable excipient. ¶99 col. 4:5-14
  • Identified Points of Contention:
    • Factual/Evidentiary Questions: The complaint alleges infringement based on "information and belief" without providing empirical data for the accused product. The central dispute will be factual: does the Renata ANDA Product, as disclosed in the ANDA and as will be produced, actually possess a pharmaceutical material meeting the specific purity (>98%) and diol impurity (<0.15%) limitations of Claim 1?
    • Scope Questions: The definition of "pharmaceutical material" will be critical for determining the basis upon which the weight percentages for purity and impurity are calculated. A dispute may arise over whether this term refers solely to the API and related impurities or includes other substances present before final formulation.

U.S. Patent No. 11,613,511 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) The Renata ANDA Product is alleged to contain a specific crystalline form of bempedoic acid. ¶112 col. 4:50-52
wherein the pharmaceutical material comprises the compound of formula (V)... in an amount greater than 99.0% by weight The pharmaceutical material in the Renata ANDA Product is alleged to have a bempedoic acid purity of greater than 99.0% by weight. ¶112 col. 4:52-56
the pharmaceutical material comprises 0.0001 % to less than or equal to 0.15% of a compound of formula (VI) The pharmaceutical material in the Renata ANDA Product is alleged to contain a diol impurity within the claimed percentage range. ¶112 col. 4:56-60
and the crystalline form... exhibits an X-ray powder diffraction pattern comprising peaks at... [specific] diffraction angles (2θ) The crystalline form of bempedoic acid in the Renata ANDA Product is alleged to have the specific X-ray powder diffraction pattern required by the claim. ¶112 col. 9:36-44
  • Identified Points of Contention:
    • Technical Questions: A primary technical question is whether the specific crystalline form of bempedoic acid in the Renata ANDA Product exhibits the XRPD pattern recited in Claim 1. The infringement analysis will depend entirely on a comparison of the accused product's XRPD data with the claimed diffraction angles. Any deviation may support a non-infringement argument.
    • Scope Questions: Does the term "crystalline form" as used in the patent, when combined with the specific XRPD peaks, read on the actual solid-state form used by Renata? This raises the question of whether Renata employs a different, non-infringing polymorph of bempedoic acid.

V. Key Claim Terms for Construction

  • The Term: "crystalline form"

  • Context and Importance: This term appears in the preambles of the independent claims of multiple asserted patents, including the ’714 and ’511 Patents. Its construction is critical because infringement hinges on whether the Defendants' generic product contains bempedoic acid in a solid state that meets this definition. If the Defendants use an amorphous form or a different, unclaimed crystalline polymorph, they may avoid infringement. Practitioners may focus on this term because the existence of different polymorphs with distinct properties is a common issue in pharmaceutical patent litigation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a general definition, stating the invention provides a "high purity crystalline form of bempedoic acid" and later refers to its characterization by XRPD, suggesting crystallinity is a general property to be further defined. ('714 Patent, col. 6:9-11).
    • Evidence for a Narrower Interpretation: The specification of the ’511 Patent heavily details a specific crystalline form, providing its XRPD pattern in FIG. 4 and Table 1, its unit cell parameters, and describing it as a monoclinic crystal system. ('511 Patent, col. 9:45-56, Table 2). The independent claim of the ’511 Patent explicitly recites specific XRPD peaks, which may support an argument that "crystalline form" in that patent is necessarily limited to a form exhibiting those peaks.

  • The Term: "pharmaceutical material"

  • Context and Importance: This term provides the basis for the weight percentage calculations that define the purity (>98% or >99%) and impurity (<0.15%) limitations in the asserted claims of the '714, '511, '584, '087, and '227 patents. The definition of this term is central to determining whether the accused product infringes, as the denominator in the percentage calculation could include or exclude different substances (e.g., residual solvents, processing aids), potentially moving the calculated percentage inside or outside the claimed range.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term could be interpreted broadly to mean the entire bulk drug substance produced by the synthesis process before it is mixed with excipients to form the final drug product.
    • Evidence for a Narrower Interpretation: Claim 1 of the ’714 Patent states "a pharmaceutical material comprising a crystalline form of the compound of formula (V)... wherein the pharmaceutical material comprises the compound of formula (V)... in an amount greater than 98% by weight based on the total weight of the pharmaceutical material." ('714 Patent, col. 83:13-22). This circular language suggests the "pharmaceutical material" may be defined by its primary components (the API and its direct impurities), which could support a narrower construction excluding other substances like residual solvents from the calculation basis.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. For the method-of-use patents ('584 and '816), inducement is based on the allegation that Defendants' proposed package insert for the Renata ANDA Product will instruct and encourage medical practitioners and patients to administer the drug for the claimed methods of lowering LDL-C. (Compl. ¶¶130, 149). Knowledge is alleged based on Defendants' Paragraph IV notice letters and the listing of the patents in the FDA's Orange Book. (Compl. ¶¶104, 134).
  • Willful Infringement: While the complaint does not explicitly use the word "willful," it lays the factual groundwork for such a claim by alleging that Defendants had knowledge of the patents-in-suit at least as of their ANDA submission and receipt of notice letters. (Compl. ¶¶71, 84-85, 94, 104). The prayer for relief seeks a declaration that this is an "exceptional case" and an award of attorneys' fees, which is consistent with an allegation of willful infringement. (Compl. ¶193).

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

  • A central issue will be one of factual proof: Does the proposed Renata ANDA Product, as it will be manufactured and sold, actually fall within the scope of the asserted claims? This will require extensive discovery into the precise chemical and physical properties of the generic drug, focusing on whether it meets the specific limitations regarding crystalline form (including XRPD peaks), purity thresholds, and maximum levels of specific, named impurities.
  • A key legal and technical question will be one of claim construction and validity: Can claims directed to specific purity levels and a particular crystalline form of a known compound withstand challenges of obviousness? The case may turn on whether achieving these specific characteristics required overcoming a technical hurdle or produced an unexpected result, versus being the routine outcome of standard purification techniques.
  • For the asserted method claims, a core issue will be induced infringement: Will the final, FDA-approved label for the generic product contain language that actively instructs or encourages physicians and patients to use the drug in the exact manner recited in the method claims, particularly regarding the specified patient population of familial hypercholesterolemia for the '816 patent?