DCT

1:26-cv-10744

Boehringer Ingelheim Pharma Inc v. FDC Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-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 corporation incorporated in New Jersey. Venue is alleged to be proper as to Defendant FDC Limited, an Indian corporation, on the basis that a foreign defendant may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege 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, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, for improving glycemic control in specific patient populations, such as those with renal impairment or of adolescent age.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Plaintiffs' receipt of a notice letter regarding Defendants' ANDA No. 220862, which included a Paragraph IV certification against the asserted patents. The complaint notes that the patents-in-suit are listed in the FDA's "Orange Book" for JARDIANCE®. The complaint also references related, pending litigation in the District of Delaware against other generic drug manufacturers.

Case Timeline

Date Event
2009-02-13 Priority Date for '810 Patent
2013-04-05 Priority Date for '323, '166, and '906 Patents
2021-08-17 '323 Patent Issued
2023-12-05 '166 Patent Issued
2025-10-07 '906 Patent Issued
2026-01-20 '810 Patent Issued
2026-07-09 Plaintiffs received Paragraph IV certification letter from FDC (approx.)
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

  • Issued: August 17, 2021

The Invention Explained

  • Problem Addressed: The patent's background section describes the difficulty of treating type 2 diabetes mellitus, particularly in patients who also suffer from chronic kidney disease (CKD), as many common anti-diabetic agents are contraindicated or require dose adjustments in this population ʼ323 Patent, col. 1:21-52
  • The Patented Solution: The invention provides methods of using empagliflozin, an SGLT-2 inhibitor, to improve glycemic control in patients with specific levels of renal impairment, such as moderate renal impairment ʼ323 Patent, abstract ʼ323 Patent, col. 2:1-12 By targeting a patient sub-population with specific kidney function levels (measured by eGFR), the invention aims to provide an effective treatment where other options may be limited ʼ323 Patent, col. 1:53-67
  • Technical Importance: This technology provided a therapeutic pathway for a challenging-to-treat patient population-diabetics with renal impairment-for whom other treatment options were often restricted ʼ323 Patent, col. 1:40-52

Key Claims at a Glance

  • The complaint asserts independent method claim 25 Compl. ¶38
  • The essential elements of Claim 25 are:
    • A method for improving glycemic control in a patient with type 2 diabetes mellitus;
    • comprising administering empagliflozin to the patient if the estimated glomerular filtration rate (eGFR) 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.
  • The complaint reserves the right to assert additional claims Compl. ¶45

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 '323 Patent, the background addresses the need for effective diabetes treatments for patients with renal impairment, a population for whom many standard therapies are less suitable ʼ166 Patent, col. 1:21-52
  • The Patented Solution: The invention provides methods for improving glycemic control that involve first assessing a patient's renal function and then administering empagliflozin if the patient falls within a specified range of moderate renal impairment ʼ166 Patent, abstract ʼ166 Patent, col. 3:5-20 This method formalizes the diagnostic step of assessing kidney function as part of the treatment method itself.
  • Technical Importance: This patented method provides a structured approach to safely and effectively treating diabetic patients with moderate CKD by explicitly linking the administration of the drug to an assessment of the patient's renal function ʼ166 Patent, col. 1:53-67

Key Claims at a Glance

  • The complaint asserts independent method claim 13 Compl. ¶58
  • The essential elements of Claim 13 are:
    • 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.
  • The complaint reserves the right to assert additional claims Compl. ¶65

Multi-Patent Capsule: U.S. Patent No. 12,433,906

  • Patent Identification: U.S. Patent No. 12,433,906, Pharmaceutical composition, methods for treating and uses thereof, issued October 7, 2025 Compl. ¶22
  • Technology Synopsis: The patent describes methods for treating type 2 diabetes by first determining a patient's glomerular filtration rate (eGFR) and then administering empagliflozin if the patient's eGFR falls within a specific range of moderate renal impairment ʼ906 Patent, abstract ʼ906 Patent, col. 3:5-20 This provides a targeted therapeutic approach for patients with compromised kidney function.
  • Asserted Claims: The complaint gives as an example independent method claim 31 Compl. ¶78
  • Accused Features: The infringement allegation is based on Defendants' submission of an ANDA for a generic empagliflozin product whose proposed label is alleged to instruct healthcare providers to treat type 2 diabetes in a manner that meets the claim limitations, specifically by recommending its use in patients with an eGFR between ≥30 and <60 ml/min/1.73 m² Compl. ¶79 Compl. ¶82

Multi-Patent Capsule: U.S. Patent No. 12,527,810

  • Patent Identification: U.S. Patent No. 12,527,810, Pharmaceutical composition, methods for treating and uses thereof, issued January 20, 2026 Compl. ¶23
  • Technology Synopsis: The patent describes a method for improving glycemic control specifically in adolescent patients (ages 10 to 17 years) with type 2 diabetes mellitus '810 Patent, abstract The method comprises orally administering a therapeutically effective amount of empagliflozin.
  • Asserted Claims: The complaint gives as an example independent method claim 1 Compl. ¶95
  • Accused Features: The infringement allegation centers on Defendants' ANDA submission for a generic empagliflozin product. The complaint alleges the proposed label for this product will instruct its use for improving glycemic control in adolescent patients aged 10 years and older, thereby inducing infringement of the patented method Compl. ¶96 Compl. ¶98

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' 10 mg and 25 mg empagliflozin tablets for which ANDA No. 220862 was submitted to the FDA for approval as a generic version of Plaintiffs' JARDIANCE® product (the "FDC ANDA Products") Compl. ¶12

Functionality and Market Context

The complaint alleges that the FDC ANDA Products contain the same active ingredient (empagliflozin), are in the same dosage form (oral tablets), and are for the same 10 mg and 25 mg strengths as JARDIANCE® Compl. ¶29 Compl. ¶43 The infringement action arises from the act of filing the ANDA itself, which seeks approval to market the generic product before the expiration of the patents-in-suit Compl. ¶1 The complaint alleges that the proposed labeling for the FDC ANDA Products will instruct healthcare providers to use the tablets in a manner that infringes the asserted method claims Compl. ¶51 A table in the complaint, taken from the JARDIANCE® label, describes recommended dosages for various indications, including glycemic control in adults Compl. ¶41

IV. Analysis of Infringement Allegations

11,090,323 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 The complaint alleges that FDC's proposed labeling includes the "Improved Glycemic Control Indication" from the JARDIANCE® label. ¶39; ¶44 col. 4:21-31
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 The complaint alleges FDC's proposed label includes clinical trial data and other information from the JARDIANCE® label relating to the use of empagliflozin in patients with moderate renal impairment (eGFR 30 to <60 ml/min/1.73 m²). ¶42; ¶44 col. 4:32-35
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 labeling allegedly includes dosage information from the JARDIANCE® label. A table from that label shows 10 mg and 25 mg dosages. ¶41; ¶43 col. 8:1-3
wherein the glycemic control in said patient is improved The result of performing the method, which the proposed label allegedly instructs by indicating its use is to "improve glycemic control." ¶39; ¶44 col. 8:4-11
and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m² The JARDIANCE® label, which FDC's proposed label allegedly mirrors, provides a limitation of use stating it is "Not recommended for use to improve glycemic control in patients...with an eGFR less than 30 mL/min/1.73 m²." ¶40; ¶44 col. 4:1-5

11,833,166 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: The complaint alleges FDC's proposed labeling includes the "Improved Glycemic Control Indication." ¶59; ¶64 col. 3:5-20
a) assessing the renal function of the patient; and The practice of this step is allegedly induced by the label's eGFR-based recommendations and clinical data, which necessitates a physician first determine a patient's renal function status. ¶60; ¶61; ¶62 col. 3:21-23
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 complaint alleges FDC's proposed label includes information from the JARDIANCE® label recommending use in patients with an eGFR in this range. A clinical trial data table for this patient population is included. ¶61; ¶62 col. 3:31-40
wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and The FDC ANDA Products are 10 mg and 25 mg oral tablets, and the proposed labeling allegedly includes dosage information from the JARDIANCE® label. A table from that label shows these dosages. ¶61; ¶63 col. 1:11-13
wherein the glycemic control in said patient is improved. This is the claimed result of the method, which the proposed label allegedly instructs by indicating its use is to "improve glycemic control." ¶59; ¶64 col. 2:1-12
  • Identified Points of Contention:
    • Scope Questions: A primary question for claim 25 of the '323 Patent will be whether the label's language "Not recommended for use" in patients with an eGFR below 30 ml/min/1.73 m² constitutes an affirmative instruction to "discontinue" the drug if a patient's eGFR falls to that level. The defense may argue this language is a warning against initiation, not an instruction for cessation of ongoing therapy. For claim 13 of the '166 Patent, a question is whether providing eGFR-contingent information on a label constitutes an instruction to perform the affirmative step of "assessing the renal function," or if it merely provides information for a physician who may have already assessed it for other reasons.
    • Technical Questions: The infringement allegations rely on the content of FDC's proposed product label, which Plaintiffs had not seen at the time of filing Compl. ¶34 A central evidentiary question will be whether the final proposed label submitted in the ANDA actually contains the indications, dosages, and limitations of use that would induce infringement of the specific method steps as alleged.

V. Key Claim Terms for Construction

  • The Term: "discontinuing empagliflozin" (from Claim 25 of the '323 Patent)

    • Context and Importance: The infringement allegation for this element rests on the JARDIANCE® label language stating the drug is "Not recommended for use" in patients with an eGFR below 30 ml/min/1.73 m² (Compl. ¶40). The court's construction of "discontinuing" will determine if this warning label constitutes an instruction to perform the claimed step, making it a critical issue for infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: Plaintiffs may argue that the specification, in describing the overall treatment paradigm, implicitly supports that a recommendation against use in a certain patient population is equivalent to an instruction to cease use if a patient's condition changes to meet that profile. For example, the specification states the invention provides for "treating prediabetes, type 1 or type 2 diabetes mellitus" and that treatment may be discontinued if eGFR falls below a certain level (ʼ323 Patent, col. 4:1-5).
      • Evidence for a Narrower Interpretation: Defendants may argue that the claim term "discontinuing" requires an explicit instruction to stop the medication, which is absent from the "Not recommended" language. They may point to the specification's use of more direct instructional language elsewhere, such as "administering," to argue that the patentees could have used stronger language if that was the intended meaning.

  • The Term: "assessing the renal function of the patient" (from Claim 13 of the '166 Patent)

    • Context and Importance: This is an active, diagnostic step that must be performed for direct infringement to occur. The accused label likely does not explicitly state "assess the patient's renal function." The core issue is whether the label's structure and content, which provides recommendations based on eGFR levels, implicitly but affirmatively instructs a physician to perform this assessment as part of the claimed method.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent describes methods that are contingent on a patient's eGFR, for example, "treating a patient having moderate renal impairment" ʼ166 Patent, col. 3:9-14 Plaintiffs may argue that to practice the invention as described, a physician must necessarily first "assess" the patient's renal function, making it an inherent and instructed part of the method.
      • Evidence for a Narrower Interpretation: Defendants may argue that "assessing" is a distinct mental and physical step that the label does not command. A physician may learn of a patient's eGFR from routine lab work not performed for the purpose of prescribing empagliflozin. The specification may not explicitly link the act of "assessing" with the act of "administering" in a required sequence, which could support an interpretation that these are separable activities.

VI. Other Allegations

  • Indirect Infringement: The complaint's theory is entirely one of induced infringement under 35 U.S.C. § 271(b). It alleges that Defendants, by submitting an ANDA with a proposed label that instructs infringing uses, have taken active steps to encourage infringement Compl. ¶51 Compl. ¶71 Compl. ¶89 Compl. ¶105 Knowledge and intent are alleged based on Defendants' submission of a Paragraph IV certification, which demonstrates knowledge of the patents-in-suit Compl. ¶49 Compl. ¶69 Compl. ¶87 Compl. ¶103
  • Willful Infringement: The complaint does not use the word "willful." However, it alleges that the case is "exceptional" and requests an award of attorneys' fees pursuant to 35 U.S.C. § 285 Compl. Prayer for Relief ¶f The factual basis for this appears to be Defendants' alleged pre-suit knowledge of the patents, evidenced by the Paragraph IV certification letter sent to Plaintiffs Compl. ¶30 Compl. ¶49

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

  • A core issue will be one of induced infringement and claim scope: does a product label stating a drug is "Not recommended for use" in a specific patient population constitute an affirmative instruction to "discontinue" the drug, as required by claim 25 of the '323 patent?
  • A second central question of induced infringement will be whether providing eGFR-based clinical data and dosage recommendations on a product label is sufficient to legally constitute an instruction to perform the affirmative step of "assessing the renal function of the patient" as recited in claim 13 of the '166 patent.
  • A foundational evidentiary question will be whether the actual text of Defendants' proposed ANDA label, once produced, contains the specific indications and limitations that mirror the innovator's label, upon which Plaintiffs' entire infringement theory is predicated.