Boehringer Ingelheim Pharmaceuticals Inc v. Ridhisidhi PLLC

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: Ridhisidhi PLLC (Arizona)
  • Plaintiff's Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:26-cv-00372, D. Del., 04/03/2026
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant has consented to venue in the district for the purpose of this action.
• Core Dispute: Plaintiff alleges that Defendant's submission of a New Drug Application (NDA) for a generic version of Plaintiff's JARDIANCE® (empagliflozin) tablets constitutes an act of patent infringement under the Hatch-Waxman Act.
• Technical Context: The patents relate to pharmaceutical compositions and methods of using empagliflozin, an SGLT-2 inhibitor, for treating type 2 diabetes, particularly in patient populations with some degree of renal impairment.
• Key Procedural History: The action was triggered by a letter from Defendant, dated February 23, 2026, which included a Paragraph IV certification alleging that the asserted patents are either invalid or will not be infringed by Defendant's proposed generic product.

Case Timeline

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

U.S. Patent No. 9,949,998 - "Pharmaceutical Composition, Methods for Treating and Uses Thereof"

• Patent Identification: U.S. Patent No. 9,949,998, "Pharmaceutical Composition, Methods for Treating and Uses Thereof," issued April 24, 2018 Compl. ¶14

The Invention Explained

• Problem Addressed: The patent background describes the difficulty in treating type 2 diabetes mellitus (T2DM) in patients who also have renal impairment or chronic kidney disease (CKD) ʼ637 Patent, col. 1:24-30 Many existing anti-diabetic agents, such as metformin, are restricted or require dose reductions in these patients, creating a need for effective treatment options for this specific patient population ʼ637 Patent, col. 1:33-47
• The Patented Solution: The invention provides methods for treating T2DM using SGLT-2 inhibitors, specifically empagliflozin, in patients with renal impairment ʼ637 Patent, col. 1:48-54 The patent describes methods for improving glycemic control in patients with pre-diabetes or diabetes who have moderate renal impairment, defined by specific glomerular filtration rates (e.g., GFR 30-59) ʼ637 Patent, col. 2:30-32 ʼ637 Patent, col. 2:49-55
• Technical Importance: This approach provides a therapeutic option for a significant sub-population of diabetic patients for whom other common treatments were either contraindicated or less effective due to renal dysfunction ʼ637 Patent, col. 1:33-42

Key Claims at a Glance

• The complaint alleges infringement of "at least one claim of the '998 patent" but does not identify any specific asserted claims Compl. ¶30

U.S. Patent No. 10,258,637 - "Pharmaceutical Composition, Method for Treating and Uses Thereof"

• Patent Identification: U.S. Patent No. 10,258,637, "Pharmaceutical Composition, Method for Treating and Uses Thereof," issued April 16, 2019 Compl. ¶15

The Invention Explained

• Problem Addressed: As with the '998 patent, the '637 Patent addresses the clinical challenge of managing T2DM in patients with co-existing renal impairment, where many standard treatments are limited ʼ637 Patent, col. 1:24-30 ʼ637 Patent, col. 1:33-42
• The Patented Solution: The invention is directed to methods of using the SGLT-2 inhibitor empagliflozin to treat diabetes and related metabolic disorders in patients with renal impairment or CKD ʼ637 Patent, abstract ʼ637 Patent, col. 1:48-54 The specification details methods for improving glycemic control in patients with specific stages of renal impairment, such as moderate A (CKD stage 3A) or moderate B (CKD stage 3B) renal impairment ʼ637 Patent, col. 2:46-48 ʼ637 Patent, col. 2:56-57
• Technical Importance: The invention offers a method of treatment for diabetic patients with compromised kidney function, a group for whom therapeutic options were previously limited ʼ637 Patent, col. 1:42-47

Key Claims at a Glance

• The complaint alleges infringement of "at least one claim of the '637 patent" but does not identify any specific asserted claims Compl. ¶40

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 Compl. ¶16
• Technology Synopsis: This patent, sharing a common specification with the lead patents, is directed to methods of treating type 2 diabetes using empagliflozin, an SGLT-2 inhibitor ʼ323 Patent, col. 1:48-54 The invention addresses the specific clinical need for effective diabetes treatments in patients who also suffer from renal impairment or chronic kidney disease ʼ323 Patent, col. 1:24-47
• Asserted Claims: The complaint alleges infringement of "at least one claim" Compl. ¶50
• Accused Features: The accused features are Defendant's 10 mg and 25 mg empagliflozin tablets Compl. ¶8 Compl. ¶50

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 Compl. ¶17
• Technology Synopsis: This patent relates to the use of the SGLT-2 inhibitor empagliflozin for treating metabolic disorders like type 2 diabetes ʼ166 Patent, col. 1:48-54 It focuses on providing a therapeutic method for patient populations with renal impairment, for whom other anti-diabetic agents may be unsuitable or require dose adjustments ʼ166 Patent, col. 1:33-47
• Asserted Claims: The complaint alleges infringement of "at least one claim" Compl. ¶60
• Accused Features: The accused instrumentality is Defendant's proposed generic empagliflozin tablets Compl. ¶8 Compl. ¶60

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 Compl. ¶18
• Technology Synopsis: This patent describes methods of using empagliflozin, an SGLT-2 inhibitor, to treat type 2 diabetes and related metabolic disorders ʼ906 Patent, col. 1:48-54 The invention is particularly directed to methods for improving glycemic control in patients with chronic kidney disease or renal impairment ʼ906 Patent, col. 1:42-47
• Asserted Claims: The complaint alleges infringement of "at least one claim" Compl. ¶70
• Accused Features: The infringement allegations are directed at Defendant's proposed generic 10 mg and 25 mg empagliflozin tablets Compl. ¶8 Compl. ¶70

III. The Accused Instrumentality

Product Identification

• The accused products are Defendant Ridhisidhi's 10 mg and 25 mg empagliflozin tablets ("Ridhisidhi NDA Products") Compl. ¶8

Functionality and Market Context

• The complaint alleges that the Ridhisidhi NDA Products are a generic version of Plaintiff's JARDIANCE® (empagliflozin) tablets Compl. ¶1
• Defendant has allegedly represented that its NDA relies on the Plaintiff's JARDIANCE® NDA and contains data demonstrating bioavailability or bioequivalence to JARDIANCE® Compl. ¶23 The complaint does not provide further technical details regarding the accused products' formulation or methods of use, noting that Plaintiff's analysis has been hindered by Defendant's refusal to produce its NDA Compl. ¶28
• The complaint alleges that Defendant intends to manufacture, use, import, offer for sale, and sell the accused products in the United States upon FDA approval Compl. ¶24 Compl. ¶31

IV. Analysis of Infringement Allegations

The complaint does not identify specific asserted claims or provide an element-by-element analysis of infringement for any patent-in-suit. The allegations are made generally, stating that by submitting its NDA to the FDA, Ridhisidhi has infringed "at least one claim" of each asserted patent pursuant to 35 U.S.C. § 271(e)(2)(A) Compl. ¶30 Compl. ¶40 Compl. ¶50 Compl. ¶60 Compl. ¶70 The complaint notes that Defendant's refusal to produce its NDA has hindered a more detailed infringement analysis Compl. ¶28

No probative visual evidence provided in complaint.

Identified Points of Contention

• Procedural Question: A threshold issue is the discovery of Defendant's NDA, including its proposed product labeling, which the complaint alleges has been withheld Compl. ¶¶27-28 The contents of the label will be central to determining whether Defendant will induce infringement of the asserted method-of-use patents.
• Scope Questions: Once specific claims are asserted, a central issue may be the construction of terms defining the patient population, such as specific stages of "renal impairment" or "chronic kidney disease," which are often defined by ranges of glomerular filtration rate (GFR) ʼ637 Patent, col. 2:27-32 The dispute may turn on whether the patient population described in the Defendant's proposed label for its generic product falls within the scope of these claim terms.

V. Key Claim Terms for Construction

The complaint does not identify any asserted claims, precluding an analysis of key terms for construction at this stage of the litigation.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendant's future commercial activities would induce and contribute to infringement of the patents-in-suit (Compl. ¶32; Compl. ¶33; Compl. ¶34; Compl. ¶35; Compl. ¶36; Compl. ¶37). The inducement allegations are based on the premise that Defendant's package inserts and promotional activities will instruct or encourage medical providers and patients to use the accused products in a manner that directly infringes the patented methods Compl. ¶36 Compl. ¶46 The contributory infringement allegations assert that the accused products are not staple articles of commerce suitable for substantial noninfringing use and are especially made or adapted for use in an infringing manner Compl. ¶34 Compl. ¶44
• Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it does request a judgment that the case is "exceptional" and that Plaintiffs are entitled to their reasonable attorneys' fees pursuant to 35 U.S.C. § 285 Compl. Prayer for Relief ¶e

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

• Evidentiary Basis for Infringement: A primary question for the initial phase of the case will be procedural and evidentiary: what will Defendant's NDA and proposed product label reveal? Whether the label's indications for use and instructions direct medical providers to prescribe the generic product for the specific patient populations covered by the patents' method claims will be critical to the inducement analysis.
• Claim Scope and Invalidity: A core substantive issue will be one of definitional scope and validity. The Defendant's Paragraph IV certification asserts non-infringement and/or invalidity Compl. ¶24 The case will likely involve disputes over whether the patents' claims, which are directed to methods of treating specific patient subgroups (e.g., those with "moderate renal impairment"), are both broad enough to read on Defendant's proposed labeled use and narrow enough to be valid over the prior art.
• Infringement under the Doctrine of Equivalents: The complaint repeatedly invokes the doctrine of equivalents in its infringement counts Compl. ¶33 Compl. ¶43 This raises the question of whether, even if the Defendant's product label does not literally align with the claimed patient populations or methods, the Plaintiff will be able to present evidence that the accused methods are nonetheless equivalent.