DCT

1:25-cv-00663

Boehringer Ingelheim Pharma Inc v. Granules India Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00663, D. Del., 05/29/2025
  • Venue Allegations: Venue is alleged to be proper as to Granules India Ltd. because it is a foreign corporation not residing in any U.S. judicial district, and as to Granules Pharmaceuticals, Inc. because it is a corporation incorporated in the State of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application ("ANDA") submission to the FDA, seeking to market a generic version of Plaintiff’s JARDIANCE® (empagliflozin) tablets, infringes four patents related to methods of treating type 2 diabetes.
  • Technical Context: The technology concerns specific methods for administering empagliflozin, an SGLT-2 inhibitor drug, to type 2 diabetes patients who also have moderate renal impairment, a common comorbidity that often limits treatment options.
  • Key Procedural History: The action was triggered by Granules’ submission of an ANDA with a Paragraph IV certification, asserting that Boehringer's patents are either invalid or will not be infringed by Granules' proposed generic product. Boehringer received notice of this certification via a letter from Granules on or about April 17, 2025, initiating the 45-day window to file suit under the Hatch-Waxman Act.

Case Timeline

Date Event
2013-04-05 Priority Date for '998, '637, '323, and '166 Patents
2018-04-24 U.S. Patent No. 9,949,998 Issues
2019-04-16 U.S. Patent No. 10,258,637 Issues
2021-08-17 U.S. Patent No. 11,090,323 Issues
2023-12-05 U.S. Patent No. 11,833,166 Issues
2025-04-17 Plaintiff Receives Granules' Paragraph IV Notice Letter
2025-05-29 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,949,998 - "Pharmaceutical composition, methods for treating and uses thereof"

(Issued April 24, 2018; Compl. ¶20)

The Invention Explained

  • Problem Addressed: The patent’s background section describes the challenge of treating type 2 diabetes in patients who also suffer from renal impairment or chronic kidney disease (CKD). It notes that the use of many anti-diabetic agents is restricted in these patients, creating a need for effective treatment methods for this specific population (’637 Patent, col. 1:12-46).
  • 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. The method is tailored based on the patient's estimated glomerular filtration rate (eGFR), claiming a specific range in which the drug should be administered and a specific threshold at which it should be discontinued (’637 Patent, col. 3:5-14; col. 4:1-4).
  • Technical Importance: This method provides a defined therapeutic protocol for using empagliflozin in a vulnerable patient subgroup with limited treatment options, potentially offering a safer and more effective way to manage their diabetes (’637 Patent, col. 1:42-46).

Key Claims at a Glance

  • The complaint asserts at least one claim, providing Claim 1 as representative (Compl. ¶31, 36).
  • The essential elements of independent Claim 1 are:
    • A method for improving glycemic control in a patient with type 2 diabetes mellitus;
    • Comprising administering empagliflozin if the patient's eGFR is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2;
    • Wherein the empagliflozin is administered orally once daily as a 10 mg or 25 mg pharmaceutical composition;
    • Wherein glycemic control in the patient is improved; and
    • Discontinuing empagliflozin if the patient’s eGFR falls below 45 ml/min/1.73 m2.

U.S. Patent No. 10,258,637 - "Pharmaceutical composition, methods for treating and uses thereof"

(Issued April 16, 2019; Compl. ¶21)

The Invention Explained

  • Problem Addressed: As with the related ’998 Patent, the technology addresses the need for methods to treat type 2 diabetes in patients with renal impairment, for whom many standard therapies are contraindicated or require dose adjustments (’637 Patent, col. 1:12-46).
  • The Patented Solution: The invention provides a method of administering empagliflozin to improve glycemic control in patients within a specific range of moderate renal impairment (defined by eGFR). The method specifies a range of potential oral daily dosages and a clear eGFR-based criterion for discontinuing therapy, creating a precise treatment algorithm (’637 Patent, Abstract; col. 39:4-16).
  • Technical Importance: The claimed method offers clinicians a structured approach for using empagliflozin in a difficult-to-treat patient population, balancing efficacy with safety considerations related to renal function (’637 Patent, col. 1:42-46).

Key Claims at a Glance

  • The complaint asserts at least one claim, providing Claim 1 as representative (Compl. ¶32, 47).
  • The essential elements of independent Claim 1 are:
    • A method for improving glycemic control in a patient with type 2 diabetes mellitus;
    • Comprising administering empagliflozin if the patient's eGFR is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2;
    • Wherein the empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg, or 25 mg;
    • Wherein glycemic control in the patient is improved; and
    • Discontinuing empagliflozin if the patient’s eGFR falls below 45 ml/min/1.73 m2.

U.S. Patent No. 11,090,323 - "Pharmaceutical composition, methods for treating and uses thereof"

(Issued August 17, 2021; Compl. ¶22)

  • Technology Synopsis: This patent claims a method for improving glycemic control in type 2 diabetes patients with moderate renal impairment by administering empagliflozin. A distinguishing feature of its representative claim is the requirement to discontinue the drug if the patient's eGFR falls below a lower threshold (30 ml/min/1.73 m2) than that specified in the ’998 and ’637 Patents (’323 Patent, Abstract; Compl. ¶33).
  • Asserted Claims: At least one claim, with Claim 1 cited as representative (Compl. ¶33, 58).
  • Accused Features: The proposed use of Granules' generic product, as allegedly directed by its package insert, is accused of infringing by instructing administration and discontinuation according to the claimed eGFR parameters (Compl. ¶61, 65).

U.S. Patent No. 11,833,166 - "Pharmaceutical composition, methods for treating and uses thereof"

(Issued December 5, 2023; Compl. ¶23)

  • Technology Synopsis: This patent claims a method for improving glycemic control that explicitly includes the step of "assessing the renal function of the patient" before administering empagliflozin. The administration step is conditioned on the patient's eGFR falling within the specified range for moderate renal impairment (’166 Patent, Abstract; Compl. ¶34).
  • Asserted Claims: At least one claim, with Claim 1 cited as representative (Compl. ¶34, 69).
  • Accused Features: The proposed use of Granules' generic product is accused of infringing by instructing medical professionals to perform the claimed diagnostic step (assessing renal function) and then follow the claimed conditional administration protocol (Compl. ¶72, 76).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Granules' 10 mg and 25 mg empagliflozin tablets, for which Granules submitted Abbreviated New Drug Application No. 220408 to the FDA (Compl. ¶11).

Functionality and Market Context

The "Granules ANDA Products" are generic versions of Boehringer's brand-name drug, JARDIANCE® (Compl. ¶1). The complaint alleges that the ANDA refers to and relies upon the JARDIANCE® New Drug Application and contains data demonstrating bioequivalence (Compl. ¶28). The products are intended for commercial manufacture, marketing, and sale throughout the United States upon receiving FDA approval (Compl. ¶12).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not include a claim chart exhibit. The infringement theory is one of induced infringement, alleging that the package insert for Granules' proposed generic product will instruct medical professionals and patients to perform the steps of the patented methods.

U.S. Patent No. 9,949,998 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for improving glycemic control in a patient with type 2 diabetes mellitus... The proposed label for the Granules ANDA Product will allegedly instruct its use for improving glycemic control in patients with type 2 diabetes. ¶39 col. 3:5-9
...comprising administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2... The proposed label will allegedly instruct physicians to prescribe, and patients to take, the product if their renal function falls within this specified eGFR range. ¶39, 43 col. 3:9-14
...wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg or 25 mg of empagliflozin... Granules' product is an oral tablet formulated in 10 mg and 25 mg strengths, and its label will allegedly instruct once-daily administration. ¶11, 39 col. 8:15-18
...wherein the glycemic control in said patient is improved... The proposed label will allegedly describe the product's efficacy in improving glycemic control, thereby encouraging its use for that purpose. ¶39, 43 col. 3:5-9
...and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m2. The proposed label will allegedly instruct physicians to monitor patient eGFR and cease administration if it falls below the claimed threshold. ¶39, 43 col. 4:1-4

U.S. Patent No. 10,258,637 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for improving glycemic control in a patient with type 2 diabetes mellitus... The proposed label for the Granules ANDA Product will allegedly instruct its use for improving glycemic control in patients with type 2 diabetes. ¶50 col. 3:5-9
...comprising administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2... The proposed label will allegedly instruct physicians to prescribe, and patients to take, the product if their renal function falls within this specified eGFR range. ¶50, 54 col. 3:9-14
...wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg... Granules' product is formulated in 10 mg and 25 mg strengths, and its label will allegedly instruct administration consistent with the claimed dosage range. ¶11, 50 col. 39:4-16
...wherein the glycemic control in said patient is improved... The proposed label will allegedly describe the product's efficacy in improving glycemic control, thereby encouraging its use for that purpose. ¶50, 54 col. 3:5-9
...and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m2. The proposed label will allegedly instruct physicians to monitor patient eGFR and cease administration if it falls below the claimed threshold. ¶50, 54 col. 4:1-4

Identified Points of Contention

  • Scope Questions: A central issue may be whether the instructions in Granules’ proposed label will be specific enough to map to every limitation of the asserted method claims. For example, does the label require administration only within the eGFR range of "≥45 and <60," or does it provide more general guidance for patients with "moderate renal impairment" that does not perfectly align with the claim scope?
  • Evidentiary Questions: The complaint alleges infringement based on the anticipated contents of the proposed drug label. A key evidentiary question will be what the specific language of that label says and whether it is sufficient to prove that Granules possessed the requisite intent to induce infringement by third parties (doctors and patients).

V. Key Claim Terms for Construction

Claim Term: "if the eGFR of the patient is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2"

  • Context and Importance: This conditional limitation is the core of the asserted method claims. Its interpretation will be dispositive for infringement, which hinges on whether Granules' proposed label instructs administration specifically under these eGFR conditions. Practitioners may focus on this term because it carves out a specific subset of patients with moderate renal impairment, and any ambiguity could broaden or narrow the scope of induced infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses the invention in the broader context of treating patients with "moderate renal impairment," which it defines elsewhere as an eGFR of 30-59 ml/min/1.73 m2 (’637 Patent, col. 22:1-2). A defendant may argue the claimed range is an exemplary, not exclusive, embodiment of this broader category.
    • Evidence for a Narrower Interpretation: The claim language uses precise numerical endpoints ("≥45" and "<60"), suggesting the inventors intended to claim this specific sub-population. The specification provides detailed clinical trial data broken down by different stages of CKD, including stage 3A (eGFR 45-59), which reinforces the significance of these specific numerical boundaries (’637 Patent, Fig. 7A).

Claim Term: "discontinuing empagliflozin"

  • Context and Importance: This active step of cessation is a required limitation of the method claims. Infringement requires proof that the proposed label will instruct users not only to start but also to stop the therapy based on a specific clinical finding (e.g., eGFR falling below 45 ml/min/1.73 m2). The dispute may turn on whether a label's precautionary warnings or general guidance to physicians constitutes an instruction to perform this claimed step.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses the general principle of tailoring treatment based on renal function, which may support interpreting "discontinuing" as part of a physician's ordinary, flexible standard of care rather than a rigid, mandatory step (’637 Patent, col. 3:5-9).
    • Evidence for a Narrower Interpretation: The claims phrase this as a required step of the method ("...and discontinuing..."). The patent also presents clinical data from studies where patients' renal function was monitored, supporting the idea that active monitoring and discontinuation are integral parts of the invented method (’637 Patent, col. 31:47-53).

VI. Other Allegations

Indirect Infringement

The complaint alleges that Granules will actively induce infringement of the patents-in-suit (Compl. ¶43, 54, 65, 76). The basis for this allegation is that Granules' proposed package insert for its ANDA Product will instruct medical professionals and patients to use the generic drug in a manner that directly practices the steps of the claimed methods (Compl. ¶42, 53, 64, 75). The complaint further alleges contributory infringement, stating that the Granules ANDA Product is not a staple article of commerce suitable for substantial noninfringing use and is especially made for use in an infringing manner (Compl. ¶40, 51, 62, 73).

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

  • A core issue will be one of inducement and label interpretation: Will the specific text of Granules' proposed (and ultimately FDA-approved) drug label be found to contain instructions that are specific enough to encourage, recommend, or promote the performance of each and every limitation of the asserted method claims, thereby demonstrating the requisite intent for induced infringement?
  • A key question for the defense will be one of validity: As indicated by the Paragraph IV certification, Granules will likely challenge the patents' validity. This raises the question of whether methods of treatment that claim the administration of a known compound to a specific patient sub-population, defined by a biomarker range (eGFR), are non-obvious and represent patent-eligible subject matter.