3:26-cv-10744
Boehringer Ingelheim Pharma Inc v. FDC Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boehringer Ingelheim Pharmaceuticals Inc. (Delaware); Boehringer Ingelheim International GmbH (Germany); Boehringer Ingelheim Pharma GmbH & Co. KG (Germany)
- Defendant: FDC Limited (India); FDC Inc. (New Jersey)
- Plaintiff's Counsel: Walsh Pizzi Oreilly Falanga LLP
- Case Identification: 3:26-cv-10744, D.N.J., 08/21/2026
- Venue Allegations: Venue is alleged to be proper as to Defendant FDC Inc. because it is a New Jersey corporation, and as to Defendant FDC Limited because it is an Indian corporation not residing in any U.S. district.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug JARDIANCE® (empagliflozin) constitutes an act of infringement of four U.S. patents covering methods of using the drug.
- Technical Context: The technology relates to methods of using empagliflozin, an SGLT2 inhibitor, to treat type 2 diabetes mellitus, particularly in specific patient subpopulations such as those with renal impairment or adolescent patients.
- Key Procedural History: The complaint notes that this action is related to two other pending patent infringement cases filed by the Plaintiff in the District of Delaware against Lupin Ltd. and Ridhisidhi PLLC. The current action was filed within 45 days of Plaintiff's receipt of a Paragraph IV certification letter from the Defendants, a procedural step under the Hatch-Waxman Act that may entitle the Plaintiff to a 30-month stay of FDA approval for the generic drug.
Case Timeline
| Date | Event |
|---|---|
| 2009-02-13 | '810 Patent Priority Date |
| 2013-04-05 | '323, '166, and '906 Patents Priority Date |
| 2021-08-17 | '323 Patent Issue Date |
| 2023-12-05 | '166 Patent Issue Date |
| 2025-10-07 | '906 Patent Issue Date |
| 2026-01-20 | '810 Patent Issue Date |
| 2026-07-09 | Plaintiff receives Paragraph IV certification letter from FDC |
| 2026-08-21 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,090,323 - "Pharmaceutical composition, methods for treating and uses thereof"
- Patent Identification: U.S. Patent No. 11,090,323, "Pharmaceutical composition, methods for treating and uses thereof," issued August 17, 2021.
The Invention Explained
- Problem Addressed: The patent's background describes the limitations of existing anti-diabetic agents, particularly for patients with type 2 diabetes mellitus (T2DM) who also suffer from renal impairment or chronic kidney disease (CKD), as many treatments are either contraindicated or require dose adjustments in this population ʼ323 Patent, col. 1:21-44
- The Patented Solution: The invention provides a method of using the SGLT-2 inhibitor empagliflozin to improve glycemic control specifically in patients with moderate renal impairment, a patient population for whom other treatments may be less suitable ʼ323 Patent, col. 2:47-54 ʼ323 Patent, abstract The patent presents clinical data showing the drug's efficacy in this specific patient group ʼ323 Patent, FIG. 1A
- Technical Importance: This approach provided a therapeutic option for a difficult-to-treat diabetic subpopulation, addressing a need for effective treatments in patients with compromised kidney function ʼ323 Patent, col. 1:40-44
Key Claims at a Glance
- The complaint asserts at least one claim, providing claim 25 as an example Compl. ¶38
- Independent claim 25 includes the following essential elements:
- A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising
- administering empagliflozin to the patient if the eGFR of the patient is ≥30 ml/min/1.73 m² and <60 ml/min/1.73 m²,
- wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg,
- wherein the glycemic control in said patient is improved, and
- discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m².
U.S. Patent No. 11,833,166 - "Pharmaceutical composition, methods for treating and uses thereof"
- Patent Identification: U.S. Patent No. 11,833,166, "Pharmaceutical composition, methods for treating and uses thereof," issued December 5, 2023.
The Invention Explained
- Problem Addressed: As with the ʼ323 Patent, the background describes the need for effective diabetes treatments for patients who also have renal impairment, a condition that limits the use of many existing therapies ʼ166 Patent, col. 1:21-44
- The Patented Solution: The invention claims a method of improving glycemic control that involves the step of "assessing the renal function of the patient" before administering empagliflozin to patients within a specified range of moderate renal impairment ʼ166 Patent, col. 3:5-13 ʼ166 Patent, abstract This frames the diagnostic assessment as an explicit step in the patented method.
- Technical Importance: This method explicitly links the diagnostic step of assessing kidney function to the therapeutic decision to administer the drug, providing a specific treatment protocol for patients with moderate CKD ʼ166 Patent, col. 1:40-44
Key Claims at a Glance
- The complaint asserts at least one claim, providing claim 13 as an example Compl. ¶58
- Independent claim 13 includes the following essential elements:
- A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising:
- a) assessing the renal function of the patient; and
- b) administering empagliflozin to the patient if the eGFR of the patient is ≥30 ml/min/1.73 m² and <60 ml/min/1.73 m²,
- wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and
- wherein the glycemic control in said patient is improved.
U.S. Patent No. 12,433,906 - "Pharmaceutical composition, methods for treating and uses thereof"
- Patent Identification: U.S. Patent No. 12,433,906, "Pharmaceutical composition, methods for treating and uses thereof," issued October 7, 2025.
Technology Synopsis
The patent addresses the need for effective T2DM treatments in patients with renal impairment ʼ906 Patent, col. 1:21-44 The claimed solution is a method of treating T2DM that involves first "determining the glomerular filtration rate (eGFR)" and then administering empagliflozin if the patient falls within a specified eGFR range corresponding to moderate renal impairment ʼ906 Patent, abstract ʼ906 Patent, col. 3:45-52
Asserted Claims
The complaint asserts at least one claim, providing claim 31 as an example Compl. ¶78
Accused Features
The accused features are the instructions on the Defendants' proposed product label, which are alleged to direct healthcare providers to determine a patient's eGFR and administer the drug to patients with moderate renal impairment, thereby infringing the patented method Compl. ¶¶79-82
U.S. Patent No. 12,527,810 - "Pharmaceutical composition, methods for treating and uses thereof"
- Patent Identification: U.S. Patent No. 12,527,810, "Pharmaceutical composition, methods for treating and uses thereof," issued January 20, 2026.
Technology Synopsis
The patent addresses the need for diabetes treatments in adolescent populations ʼ810 Patent, col. 2:1-4 The invention provides a method for improving glycemic control specifically in adolescent patients aged 10 to 17 years by administering a therapeutically effective amount of empagliflozin ʼ810 Patent, col. 32:46-54
Asserted Claims
The complaint asserts at least one claim, providing claim 1 as an example Compl. ¶95
Accused Features
The infringement allegation is based on the Defendants' proposed product label, which is alleged to include an indication for use in pediatric patients aged 10 years and older, thereby instructing the infringing use Compl. ¶¶96-98
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants' 10 mg and 25 mg empagliflozin tablets for which FDC submitted ANDA No. 220862 to the FDA, referred to as the "FDC ANDA Products" Compl. ¶12
Functionality and Market Context
The FDC ANDA Products are alleged to be a generic version of Plaintiff's JARDIANCE® tablets Compl. ¶1 By filing the ANDA, FDC has represented to the FDA that its products have the same active ingredient, method of administration, dosage form, and dosage amount as JARDIANCE® and will be bioequivalent Compl. ¶29 The complaint alleges that FDC's proposed product labeling will include the "Improved Glycemic Control Indication" and other information from the JARDIANCE® label, which forms the basis of the infringement allegations Compl. ¶44 Compl. ¶64 Compl. ¶82 Compl. ¶98 The complaint includes a table from the JARDIANCE® label detailing recommended dosages for various patient populations, which is alleged to be part of the infringing instructions Compl. ¶41
IV. Analysis of Infringement Allegations
'323 Patent Infringement Allegations
| Claim Element (from Independent Claim 25) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering empagliflozin to the patient if the eGFR of the patient is ≥30 ml/min/1.73 m² and <60 ml/min/1.73 m² | FDC's proposed product label is alleged to instruct healthcare providers to use the drug to improve glycemic control in T2DM patients, including those with an eGFR in the moderate renal impairment range of 30 to <60 ml/min/1.73 m². | ¶38; ¶39; ¶42; ¶44 | '323 Patent, col. 3:40-46 |
| wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg | The FDC ANDA Products are 10 mg and 25 mg oral tablets, and the proposed label allegedly instructs for their administration. | ¶43 | '323 Patent, col. 9:10-15 |
| wherein the glycemic control in said patient is improved | The proposed label allegedly includes the "Improved Glycemic Control Indication" from the JARDIANCE® label and clinical trial data demonstrating this effect. | ¶39; ¶44 | '323 Patent, col. 2:1-4 |
| and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m² | The JARDIANCE® label, which FDC's label allegedly mirrors, contains a limitation of use stating the drug is "Not recommended for use" in patients with an eGFR less than 30 mL/min/1.73 m², thereby instructing discontinuation. | ¶38; ¶40 | '323 Patent, col. 4:5-8 |
'166 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising: a) assessing the renal function of the patient; and | The proposed label allegedly instructs providers to determine a patient's eGFR before and during treatment, which constitutes "assessing the renal function." | ¶58; ¶60 | '166 Patent, col. 3:59-62 |
| b) administering empagliflozin to the patient if the eGFR of the patient is ≥30 ml/min/1.73 m² and <60 ml/min/1.73 m² | The proposed label allegedly contains clinical data and indications for use in patients with moderate renal impairment, thereby instructing administration to this group. The complaint provides a table excerpted from the JARDIANCE® label detailing clinical trial results in patients with an eGFR of 30 to less than 60 mL/min/1.73 m² Compl. ¶62 | ¶58; ¶62; ¶64 | '166 Patent, col. 3:45-51 |
| wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg | FDC's ANDA products are formulated as 10 mg and 25 mg oral tablets. | ¶63 | '166 Patent, col. 9:6-11 |
| and wherein the glycemic control in said patient is improved. | The proposed label allegedly includes the "Improved Glycemic Control Indication." | ¶59 | '166 Patent, col. 2:1-4 |
Identified Points of Contention
- Scope Questions: The infringement theory relies on the doctrine of inducement, where the product label is alleged to encourage infringement by physicians. A central question for the court will be whether the language on the proposed FDC label, which is expected to mirror the JARDIANCE® label, constitutes active "instruction" or "encouragement" to perform every step of the claimed methods.
- Technical Questions: The complaint's infringement theory is based on the content of the product label rather than the physical composition of the drug itself. A key evidentiary question will be whether FDC's final, FDA-approved label contains the specific indications, clinical data, and limitations of use that Plaintiff alleges will induce infringement of the patented methods of use for specific patient populations (e.g., those with moderate renal impairment, or adolescents). The complaint includes a table from the JARDIANCE® label showing clinical trial results in pediatric patients, which is foundational to the infringement allegation for the '810 patent Compl. ¶97
V. Key Claim Terms for Construction
The Term: "assessing the renal function of the patient" (from '166 Patent, claim 13)
Context and Importance: This term is a critical active step performed by a healthcare provider in the claimed method. The construction of this term will be central to determining whether the instructions on a product label-which may recommend monitoring kidney function as part of standard care-are sufficient to induce infringement of this specific claim limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests this can be a routine action, stating that the GFR can be "derived at screening from serum creatinine values" using well-known formulas like the MDRD equation ʼ166 Patent, col. 17:45-52 This may support an argument that standard patient monitoring fulfills this step.
- Evidence for a Narrower Interpretation: The claim structure links the "assessing" step (part a) to the "administering" step (part b), which may support an interpretation that the assessment must be performed for the specific purpose of determining eligibility for the drug, rather than as part of general patient monitoring.
The Term: "improving glycemic control" (from '323 Patent, claim 25; '166 Patent, claim 13)
Context and Importance: This term defines the ultimate purpose and outcome of the claimed method. Practitioners may focus on this term because its definition dictates the standard for proving the method is successfully practiced.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines "improving glycemic control" broadly to include reducing fasting plasma glucose, postprandial plasma glucose, and/or glycosylated hemoglobin HbA1c (ʼ323 Patent, col. 2:1-4). This could encompass any statistically significant positive change in these metrics.
- Evidence for a Narrower Interpretation: The patent's detailed description and figures present specific clinical trial data showing particular magnitudes of HbA1c reduction (e.g., -0.42 difference vs. placebo in FIG. 1A) ʼ323 Patent, FIG. 1A A party could argue that "improving" should be interpreted in light of these disclosed, clinically significant results, requiring more than a de minimis improvement.
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement for all four patents-in-suit. The allegations are based on the assertion that FDC's proposed prescribing label for its generic products will affirmatively instruct and encourage healthcare providers to use the products in a manner that directly infringes the patented methods of use Compl. ¶¶51-52 Compl. ¶¶71-72 Compl. ¶¶89-90 Compl. ¶¶105-106
Willful Infringement
The complaint does not explicitly use the term "willful infringement" but lays a foundation for such a claim. It alleges that FDC had pre-suit knowledge of the asserted patents, as demonstrated by its submission of a Paragraph IV Certification to the Plaintiff Compl. ¶49 Compl. ¶69 Compl. ¶87 Compl. ¶103 The prayer for relief requests a finding that the case is "exceptional" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 Compl. ¶(f) at p. 23
VII. Analyst's Conclusion: Key Questions for the Case
- Inducement via Labeling: A primary issue will be whether the content of FDC's proposed product label, by including specific clinical data and indications for use in patients with moderate renal impairment and in adolescents, constitutes sufficient encouragement or instruction for healthcare providers to perform the patented methods, thereby satisfying the legal standard for induced infringement under 35 U.S.C. § 271(e)(2).
- Method Claim Scope: The case may turn on the construction of the active steps in the method claims. A key question for the court will be one of definitional scope: does the claim term "assessing the renal function" require a specific diagnostic action taken for the purpose of prescribing empagliflozin, or can it be satisfied by a physician's routine review of a patient's lab results as part of the general standard of care?
- Patent Validity: While the complaint focuses on infringement, the core of most ANDA litigation is the subsequent challenge to patent validity. Therefore, an overarching question for the case will be whether the asserted method claims-which are directed to specific patient subpopulations-are valid over prior art that may have taught the use of empagliflozin for treating diabetes more broadly.