DCT

1:25-cv-01207

Boehringer Ingelheim Pharma Inc v. Ipca Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01207, D. Del., 09/29/2025
  • Venue Allegations: Venue is asserted on the basis that the defendant is a foreign corporation not residing in any U.S. judicial district and may therefore be sued in any district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of JARDIANCE® (empagliflozin) tablets constitutes an act of infringement of two U.S. patents directed to methods of using empagliflozin to treat type 2 diabetes.
  • Technical Context: The patents-in-suit relate to methods for improving glycemic control in type 2 diabetes patients with moderate renal impairment, a patient population for whom certain treatment options can be limited.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendant's submission of ANDA No. 220640 seeking FDA approval to market generic empagliflozin tablets. The complaint states Defendant submitted a Paragraph IV Certification, alleging the patents-in-suit are invalid or will not be infringed. The patents-in-suit are listed in the FDA's "Orange Book" as covering Plaintiff's JARDIANCE® product.

Case Timeline

Date Event
2013-04-05 Priority Date for ’323 and ’166 Patents
2021-08-17 U.S. Patent No. 11,090,323 Issues
2023-12-05 U.S. Patent No. 11,833,166 Issues
2025-08-18 Plaintiff receives Defendant's Paragraph IV notice letter (approx.)
2025-09-29 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"

The Invention Explained

Problem Addressed: The patent addresses 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 several common anti-diabetic agents is restricted in such patients due to safety or efficacy concerns related to kidney function (’323 Patent, col. 1:36-45).

The Patented Solution: The invention provides a method of using empagliflozin, an SGLT-2 inhibitor, to improve glycemic control specifically in diabetic patients with moderate renal impairment. The patent describes that this treatment can be effective within a specific window of kidney function, offering a therapeutic option for this patient sub-population (’323 Patent, Abstract; col. 2:50-56).

Technical Importance: The claimed method provides a specific treatment protocol, including dosage and patient selection criteria, for using an SGLT-2 inhibitor in a patient group for whom other common antidiabetic agents may be contraindicated or require dose adjustments (’323 Patent, col. 1:36-45).

Key Claims at a Glance

The complaint asserts infringement of at least one claim, providing claim 1 as representative (Compl. ¶29, 34).

Independent Claim 1 recites a method with the following essential elements:

  • A method for improving glycemic control in a patient with type 2 diabetes mellitus.
  • Administering empagliflozin to the patient if the patient's estimated glomerular filtration rate (eGFR) is ≥45 ml/min/1.73 m² and <60 ml/min/1.73 m².
  • The empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg.
  • The glycemic control in the patient is improved.
  • Discontinuing empagliflozin if the patient's eGFR falls below 30 ml/min/1.73 m².

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

The Invention Explained

Problem Addressed: The ’166 Patent, related to the ’323 Patent, addresses the same technical problem: the need for effective diabetes treatments for patients with renal impairment, a population in which the utility of other medications is often limited (’166 Patent, col. 1:13-49).

The Patented Solution: The patented solution is a method for using empagliflozin to improve glycemic control in patients with type 2 diabetes and a specific range of moderate renal impairment. This patent explicitly includes the step of evaluating the patient's kidney function as part of the method (’166 Patent, Abstract; col. 2:51-57).

Technical Importance: The method formalizes the diagnostic step of assessing renal function as an integral part of the claimed therapeutic method, linking patient assessment directly to the decision to administer the drug (’166 Patent, col. 3:1-4).

Key Claims at a Glance

The complaint asserts infringement of at least one claim, providing claim 1 as representative (Compl. ¶30, 46).

Independent Claim 1 recites a method with the following essential elements:

  • A method for improving glycemic control in a patient with type 2 diabetes mellitus.
  • Assessing the renal function of the patient.
  • Administering empagliflozin to the patient if the patient's eGFR is ≥45 ml/min/1.73 m² and <60 ml/min/1.73 m².
  • The empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg.
  • The glycemic control in the patient is improved.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant's proposed 10 mg and 25 mg generic empagliflozin tablets, for which Defendant submitted Abbreviated New Drug Application (ANDA) No. 220640 to the FDA (Compl. ¶9).

Functionality and Market Context

The complaint alleges that the Ipca ANDA Products are generic versions of Plaintiffs' JARDIANCE® tablets and that the ANDA contains data intended to demonstrate bioequivalence (Compl. ¶¶1, 23). The act of infringement alleged is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2), which constitutes a statutory act of infringement if the product, once approved and marketed, would infringe the patents-in-suit (Compl. ¶34, 46). The complaint alleges that Defendant intends to commercially manufacture and sell the products in the United States prior to the expiration of the patents-in-suit (Compl. ¶10, 24).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain or reference a claim chart. The infringement theory is statutory, based on Defendant's submission of an ANDA with a Paragraph IV certification seeking to market a generic drug prior to patent expiry (Compl. ¶¶24, 34, 46). Plaintiffs' central allegation is that the proposed labeling for Defendant’s ANDA Products will instruct or encourage medical professionals and patients to use the generic tablets in a manner that directly infringes the asserted method claims (Compl. ¶37, 40, 51, 54). The complaint further alleges that in its notice letter, Defendant did not dispute that its proposed products would infringe the claims of the ’323 and ’166 patents (Compl. ¶33, 47).

Identified Points of Contention

  • Label Scope: A primary question for the court may be whether the final, FDA-approved label for Defendant's generic product will instruct, recommend, or encourage administration to the specific patient population defined by the claims (i.e., type 2 diabetes patients with an eGFR between ≥45 and <60 ml/min/1.73 m²).
  • Performance of Claimed Steps: The infringement analysis may raise questions of whether the proposed product label will induce physicians to perform all recited steps. For the ’166 Patent, this includes the active step of "assessing the renal function of the patient." For the ’323 Patent, this includes the step of "discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m²."

V. Key Claim Terms for Construction

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

(from Claim 1 of both patents)

Context and Importance

This term is critical as it defines the specific sub-population of patients to which the patented methods apply. The infringement analysis will turn on whether Defendant's proposed drug label induces use in patients falling within this precise range of renal function.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of evidence supporting a broader interpretation.
  • Evidence for a Narrower Interpretation: The specification provides clinical trial data organized by specific eGFR ranges, including data for patients with "moderate renal impairment (eGFR ≥30 to <60 ml/min/1.73 m²)" (’323 Patent, FIG. 1A). The patent further defines "Moderate A renal impairment (CKD 3A)" as "eGFR ≥45 to <60 ml/min/1.73 m²" (’323 Patent, col. 22:1-5). This explicit definition and supporting data may support a narrow construction limited to the precise numerical boundaries recited in the claim.

"assessing the renal function of the patient"

(from Claim 1 of the ’166 Patent)

Context and Importance

This is a required active step in the method claimed by the ’166 Patent. To prove induced infringement, Plaintiffs will need to show that Defendant's proposed label encourages or instructs physicians to perform this assessment as part of the treatment method.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification notes that eGFR can be derived from serum creatinine values using various known formulas, such as the MDRD or Cockcroft-Gault formulas (’166 Patent, col. 17:46-54). A party could argue that any standard blood test from which eGFR is calculated would satisfy this limitation.
  • Evidence for a Narrower Interpretation: The claim language recites "assessing" as a distinct step "a)" before the "administering" step "b)." A party may argue this structure requires a deliberate evaluation of renal function for the purpose of making the treatment decision, rather than a passive or routine blood screening.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for both patents. The factual basis for inducement is the allegation that Defendant's "promotional activities and package inserts" for its ANDA products will instruct users on how to infringe the method claims, and that Defendant has knowledge of the patents (Compl. ¶¶40-41, 54-55).

Willful Infringement

The complaint does not explicitly allege willful infringement. However, for both patents it alleges that the case is "exceptional" under 35 U.S.C. § 285, which warrants an award of attorneys' fees (Compl. ¶43, 57). The factual basis for this allegation is not detailed beyond the underlying infringement claims.

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

  • A central issue will be one of label-induced infringement: will the final, FDA-approved label for Defendant’s generic product instruct or encourage physicians to prescribe empagliflozin for the specific patient population with an eGFR between 45 and 60 ml/min/1.73 m², thereby inducing infringement of the asserted method claims?
  • A key legal question may concern divided infringement: can Plaintiffs demonstrate that Defendant's proposed product label will induce medical professionals to perform all steps of the claimed methods, particularly the explicit "assessing" step of the ’166 Patent, which is an action taken by a physician?
  • While not the focus of the complaint, the outcome of the case may ultimately depend on patent validity. The core of the defense, as indicated by the Paragraph IV certification, will likely be whether the claimed methods of treating a specific patient sub-population defined by a narrow eGFR range were obvious or anticipated by prior art at the time of invention.