DCT
2:24-cv-09457
Esperion Therap Inc v. Aurobindo Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Esperion Therapeutics, Inc. (Delaware)
- Defendant: Aurobindo Pharma Limited (India); Apitoria Pharma Private Limited (India)
- Plaintiff’s Counsel: Walsh Pizzi O'Reilly Falanga LLP
- Case Identification: 2:24-cv-09457, D.N.J., 09/29/2025
- Venue Allegations: Plaintiff alleges venue is proper because Defendants are corporations organized under the laws of India, are not residents of the United States, and thus may be sued in any judicial district. The complaint also alleges Defendants have a regular and established place of business in New Jersey.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to manufacture and sell a generic version of the cholesterol-lowering drug NEXLIZET® constitutes an act of infringement of seven U.S. patents covering compositions of bempedoic acid and methods of its use.
- Technical Context: The dispute involves pharmaceutical compositions and methods for treating hyperlipidemia and reducing cardiovascular risk using bempedoic acid, an inhibitor of adenosine triphosphate citrate lyase (ACL), both alone and in combination with ezetimibe.
- Key Procedural History: This action is a Hatch-Waxman patent infringement suit triggered by Defendants' submission of ANDA No. 219653 with a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the proposed generic product. The complaint notes a related case involving the same parties and some of the same patents.
Case Timeline
| Date | Event |
|---|---|
| 2015-03-13 | Patent Priority Date (’751, ’816 Patents) |
| 2019-06-21 | Patent Priority Date (’714, ’511, ’584, ’087, ’227 Patents) |
| 2020-02-26 | FDA approves Plaintiff's NDA for NEXLIZET® |
| 2021-02-09 | U.S. Patent No. 10,912,751 issues |
| 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 |
| 2024-08-12 | Defendants send Paragraph IV Notice Letter regarding ANDA No. 219653 |
| 2025-08-26 | U.S. Patent No. 12,398,087 issues |
| 2025-09-02 | U.S. Patent No. 12,404,227 issues |
| 2025-09-29 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,760,714 - "Methods of Making Bmpedoic Acid and Compositions of the Same"
- Issued: September 19, 2023
The Invention Explained
- Problem Addressed: The patent background highlights 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. 1:16-21). It specifically identifies a need for a process to synthesize bempedoic acid with purity and impurity profiles suitable for a commercial drug product (’714 Patent, col. 1:22-29).
- The Patented Solution: The invention claims to provide an efficient process for producing high-purity bempedoic acid (’714 Patent, col. 2:31-35). It discloses pharmaceutical compositions containing a specific crystalline form of bempedoic acid (referred to as formula V) that is highly pure (e.g., greater than 98% by weight) and contains a strictly controlled, low level of a specific diol impurity (referred to as formula VI) (’714 Patent, col. 50:1-15).
- Technical Importance: For regulatory approval and commercial sale of a pharmaceutical, the active ingredient must be consistently produced with very high purity and a well-defined, minimal impurity profile to ensure safety and efficacy.
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶89).
- Essential elements of Claim 1:
- A pharmaceutical composition comprising:
- A pharmaceutical material comprising a crystalline form of the compound of formula (V) (bempedoic acid), or a pharmaceutically acceptable salt thereof;
- Wherein the pharmaceutical material comprises the compound of formula (V) in an amount greater than 98% by weight;
- And the pharmaceutical material comprises 0.0001% to less than or equal to 0.15% of a compound of formula (VI) (a specified diol impurity);
- And a pharmaceutically acceptable excipient.
U.S. Patent No. 11,613,511 - "Methods of Making Bmpedoic Acid and Compositions of the Same"
- Issued: March 28, 2023
The Invention Explained
- Problem Addressed: The patent addresses the same technical challenge as the ’714 Patent: the need for an efficient manufacturing process to produce high-purity bempedoic acid suitable for use as an active pharmaceutical ingredient (’511 Patent, col. 1:16-29).
- The Patented Solution: The invention claims a pharmaceutical material containing a highly pure crystalline form of bempedoic acid with a controlled impurity profile, similar to the ’714 Patent (’511 Patent, col. 50:1-15). This patent further characterizes the crystalline form by defining it through specific peaks observed in an X-ray powder diffraction (XRPD) pattern, thereby claiming a specific polymorph (’511 Patent, col. 10:35-43).
- Technical Importance: Defining a specific crystalline form, or polymorph, by its XRPD pattern is critical in pharmaceutical development, as different polymorphs can have different physical properties such as stability and dissolution rate, which can affect a drug's performance.
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶101).
- Essential elements of Claim 1:
- A pharmaceutical material comprising a crystalline form of the compound of formula (V) (bempedoic acid), or a pharmaceutically acceptable salt thereof;
- Wherein the pharmaceutical material comprises the compound of formula (V) in an amount greater than 99.0% by weight;
- The pharmaceutical material comprises 0.0001% to less than or equal to 0.15% of a compound of formula (VI);
- And the crystalline form exhibits an XRPD pattern comprising peaks at specified 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.
U.S. Patent No. 10,912,751 - "Fixed Dose Combinations and Formulations Comprising ETC1002 and Ezetimibe and Methods of Treating or Reducing the Risk of Cardiovascular Disease"
- Issued: February 9, 2021
- Technology Synopsis: This patent claims a method for treating familial hypercholesterolemia. The method comprises administering a fixed-dose combination of bempedoic acid (also known as 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid) and ezetimibe at specific dosages.
- Asserted Claims: Claim 1 (Compl. ¶112).
- Accused Features: The accused features are the administration of Aurobindo's proposed generic product, which is a fixed-dose combination of 180 mg of bempedoic acid and 10 mg of ezetimibe, for treating familial hypercholesterolemia as allegedly instructed by its proposed package insert (Compl. ¶¶112, 117-119).
U.S. Patent No. 11,744,816 - "Fixed Dose Combinations and Formulations Comprising ETC1002 and Ezetimibe and Methods of Treating or Reducing the Risk of Cardiovascular Disease"
- Issued: September 5, 2023
- Technology Synopsis: This patent claims a method for lowering LDL-C in a subject with familial hypercholesterolemia. The claimed method involves administering specific doses of bempedoic acid (180 mg) and ezetimibe (10 mg).
- Asserted Claims: Claim 1 (Compl. ¶128).
- Accused Features: The accused features are the administration of Aurobindo's proposed generic product according to the instructions in its proposed package insert, which allegedly directs the claimed method of lowering LDL-C in subjects with familial hypercholesterolemia (Compl. ¶¶128, 133-135).
U.S. Patent No. 11,926,584 - "Methods of Making Bmpedoic Acid and Compositions of the Same"
- Issued: March 12, 2024
- Technology Synopsis: This patent claims a method of lowering LDL-C in a human. The method requires administering a therapeutically effective amount of a pharmaceutical material that comprises a specific crystalline form of bempedoic acid with defined purity (>99.0%) and impurity (<0.15% of a specific diol impurity).
- Asserted Claims: Claim 1 (Compl. ¶144).
- Accused Features: The accused feature is the administration of Aurobindo's ANDA product, which is alleged to be the claimed pharmaceutical material, to lower LDL-C in accordance with instructions allegedly provided in its proposed package insert (Compl. ¶¶144, 149-151).
U.S. Patent No. 12,398,087 - "Methods of Making Bmpedoic Acid and Compositions of the Same"
- Issued: August 26, 2025
- Technology Synopsis: This patent claims a pharmaceutical material comprising bempedoic acid. The claims require the bempedoic acid to have a purity greater than 98% by weight and to contain a specific diol impurity (formula VI) within a narrow range of 0.001% to 0.15%.
- Asserted Claims: Claim 1 (Compl. ¶160).
- Accused Features: The Aurobindo ANDA Product itself is alleged to be a pharmaceutical material that meets the claimed purity and impurity limitations (Compl. ¶161).
U.S. Patent No. 12,404,227 - "Methods of Making Bmpedoic Acid and Compositions of the Same"
- Issued: September 2, 2025
- Technology Synopsis: This patent claims a pharmaceutical material comprising a crystalline form of bempedoic acid. The material is defined by a purity of greater than 99.0% by weight and a specific ketone impurity (formula VIII) concentration between 0.0001% and 0.15%.
- Asserted Claims: Claim 1 (Compl. ¶172).
- Accused Features: The Aurobindo ANDA Product is alleged to be a pharmaceutical material that will meet the specific purity and impurity profile claimed by this patent (Compl. ¶173).
III. The Accused Instrumentality
Product Identification
- Defendants' proposed generic version of NEXLIZET®, for which ANDA No. 219653 was submitted to the FDA (Compl. ¶¶1, 14).
Functionality and Market Context
- The accused product is a fixed-dose combination of bempedoic acid (an ACL inhibitor) and ezetimibe (a cholesterol absorption inhibitor) (Compl. ¶68). The complaint alleges that by submitting its ANDA, Aurobindo has represented to the FDA that its product has the same active ingredients, dosage form, and strength as Plaintiff's NEXLIZET® product and is bioequivalent to it (Compl. ¶75). The product is indicated for lowering low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Compl. ¶68).
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)... | Defendants' ANDA Product is alleged to be a pharmaceutical composition containing a crystalline form of bempedoic acid, which is depicted in the complaint as formula (V) (chemical structure provided at Compl. ¶89). | ¶¶75, 89, 92 | col. 50:1-3 |
| 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... | Defendants' ANDA Product, being bioequivalent to NEXLIZET®, is alleged to contain bempedoic acid at a purity level of greater than 98%. | ¶¶75, 89 | col. 50:4-7 |
| and the pharmaceutical material comprises 0.0001 % to less than or equal to 0.15% of a compound of formula (VI)... | The manufacturing process for Defendants' ANDA Product will allegedly result in a pharmaceutical material containing the specified diol impurity, depicted as formula (VI) (chemical structure provided at Compl. ¶89), within the claimed range. | ¶¶75, 89 | col. 50:8-13 |
| and a pharmaceutically acceptable excipient. | Defendants' ANDA Product is alleged to be a formulated drug product that necessarily includes one or more pharmaceutically acceptable excipients. | ¶¶75, 89 | col. 50:14 |
Identified Points of Contention
- Evidentiary Questions: The complaint alleges infringement based on Defendants' ANDA filing, which represents bioequivalence to NEXLIZET®. A primary question will be one of chemical identity and purity: what is the actual purity level of bempedoic acid and the concentration of the formula (VI) impurity in the product Defendants intend to market? The analysis will depend on discovery and analytical testing of Defendants' product samples.
- Scope Questions: What is the scope of the term "crystalline form"? The dispute may raise the question of whether Defendants' product uses the same polymorph of bempedoic acid as that covered by the patent, or a different, non-infringing one.
’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)... | Defendants' ANDA Product is alleged to be a pharmaceutical material containing a crystalline form of bempedoic acid, depicted as formula (V) (chemical structure provided at Compl. ¶101). | ¶¶75, 101, 104 | col. 50:1-3 |
| wherein the pharmaceutical material comprises the compound of formula (V)... in an amount greater than 99.0% by weight... | The ANDA Product, to be bioequivalent to NEXLIZET®, is alleged to contain bempedoic acid at a purity level exceeding 99.0%. | ¶¶75, 101 | col. 50:4-7 |
| the pharmaceutical material comprises 0.0001 % to less than or equal to 0.15% of a compound of formula (VI)... | The manufacturing process for the ANDA Product will allegedly result in the specified diol impurity, depicted as formula (VI) (chemical structure provided at Compl. ¶101), within the claimed range. | ¶¶75, 101 | col. 50:8-13 |
| and the crystalline form... 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. | The crystalline bempedoic acid in the ANDA Product is alleged to be a specific polymorph that produces the claimed set of XRPD peaks. | ¶¶71, 75, 101 | col. 10:35-43 |
Identified Points of Contention
- Technical Questions: A key technical question will be one of structural identity: does the crystalline form of bempedoic acid in Defendants' actual product exhibit an XRPD pattern with peaks at the diffraction angles required by the claim? Infringement will depend on precise analytical characterization (e.g., via XRPD) of Defendants' active pharmaceutical ingredient.
- Scope Questions: How will the court construe the term "comprising" in the context of a list of XRPD peaks? This raises the question of whether an accused product that has additional, unlisted peaks, or is missing one of the recited peaks, falls within the claim scope.
V. Key Claim Terms for Construction
The Term: "crystalline form"
- Source: ’714 Patent, Claim 1; ’511 Patent, Claim 1
Context and Importance
- This term is central to the composition patents. The patents claim not just the bempedoic acid molecule, but a specific solid-state form of it. Practitioners may focus on this term because infringement will depend on whether Defendants' ANDA product contains this specific form, as opposed to an amorphous version or a different, non-infringing crystalline polymorph.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification provides general descriptions of crystallization processes, which a party might argue supports a broader definition covering any solid material resulting from such a process (’714 Patent, col. 3:41-44).
- Evidence for a Narrower Interpretation: The specification provides highly specific characterization data for one crystalline form, including a complete X-ray powder diffraction pattern (FIG. 4, Table 1), unit cell parameters (Table 2), and a differential scanning calorimetry curve (FIG. 5) (’714 Patent, col. 10:44-col. 12:30). This detailed data may support a narrow construction limited to the specific polymorph disclosed. The ’511 Patent's claim 1 explicitly recites specific XRPD peaks, strongly suggesting a narrow definition tied to that specific crystal structure.
VI. Other Allegations
Indirect Infringement
- The complaint alleges induced and contributory infringement for the asserted method-of-use patents (’751, ’816, and ’584 Patents). The allegations are based on the contention that Defendants' proposed product label and package insert will instruct and encourage medical practitioners and patients to administer the ANDA product in a manner that directly infringes the claimed methods (Compl. ¶¶116-119, 132-135, 148-151). The complaint further alleges that the product is not suitable for substantial non-infringing uses (Compl. ¶¶123, 139, 155).
Willful Infringement
- The complaint does not contain an explicit count for willful infringement but includes allegations that may support such a claim. It alleges that Defendants had knowledge of the asserted patents at least by the time they submitted their ANDA, citing the patents' listing in the FDA's Orange Book and their identification in Defendants' Paragraph IV Notice Letter (Compl. ¶¶93, 105, 121, 137, 153). For the method patents, it alleges Defendants are "willfully blind" to the infringing acts that will be performed by end-users following the package insert's instructions (Compl. ¶¶122, 138, 154).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of physical and chemical identity: will discovery and analytical testing of Defendants’ proposed generic product reveal that it contains a crystalline form of bempedoic acid that meets the specific XRPD peak limitations and falls within the stringent purity and impurity profiles required by the asserted composition claims?
- A key legal question will be one of inducement: does the specific language in Defendants’ proposed package insert contain sufficient affirmative instruction to establish that Defendants possessed the specific intent to encourage medical professionals and patients to perform the patented methods of treatment?
- A central question of claim scope will be whether the term "crystalline form," particularly as defined by a set of "comprising" XRPD peaks, can be narrowly construed to cover only the single polymorph detailed in the specification, or if it allows for variations that may be present in the accused product.