DCT

1:25-cv-00862

Boehringer Ingelheim Pharma Inc v. USV Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00862, D. Del., 07/10/2025
  • Venue Allegations: Venue is alleged to be proper on the basis that Defendant is an Indian corporation not residing in any U.S. judicial district, and therefore may be sued in any district.
  • Core Dispute: Plaintiff alleges that Defendant's Abbreviated New Drug Application ("ANDA") to market a generic version of JARDIANCE® (empagliflozin) tablets constitutes an act of infringement of four U.S. patents.
  • Technical Context: The dispute concerns empagliflozin, an SGLT2 inhibitor used to treat type 2 diabetes mellitus, a widely prevalent metabolic disorder.
  • Key Procedural History: The lawsuit was triggered by a notification letter from Defendant stating it had filed an ANDA with the U.S. Food and Drug Administration ("FDA") containing a Paragraph IV certification, asserting that the patents-in-suit are either invalid or will not be infringed by the proposed generic product. The patents-in-suit are listed in the FDA's "Orange Book" as covering the JARDIANCE® drug product.

Case Timeline

Date Event
2007-08-16 U.S. Patent No. 8,551,957 Priority Date
2009-02-13 U.S. Patent No. 12,115,179 Priority Date
2013-04-05 U.S. Patent Nos. 11,090,323 & 11,833,166 Priority Date
2013-10-08 U.S. Patent No. 8,551,957 Issues
2021-08-17 U.S. Patent No. 11,090,323 Issues
2023-12-05 U.S. Patent No. 11,833,166 Issues
2024-10-15 U.S. Patent No. 12,115,179 Issues
2025-05-29 Plaintiff receives notification letter regarding Defendant's ANDA filing
2025-07-10 Complaint Filing Date

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

U.S. Patent No. 8,551,957 - "Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate," Issued October 8, 2013

The Invention Explained

  • Problem Addressed: The patent's background section describes the high prevalence of type 2 diabetes mellitus (T2DM) and the limitations of existing monotherapies, which often fail to maintain long-term glycemic control due to the progressive nature of the disease (’957 Patent, col. 1:26-34).
  • The Patented Solution: The invention is a pharmaceutical composition that combines two different classes of antidiabetic agents: a glucopyranosyl-substituted benzene derivative (an SGLT2 inhibitor, specifically empagliflozin) and a DPP IV inhibitor (specifically linagliptin) (’957 Patent, col. 3:1-12). This combination therapy is intended to provide a more durable and effective treatment for T2DM than either agent alone (’957 Patent, col. 2:58-67).
  • Technical Importance: Combining agents with different mechanisms of action was a key strategy for managing T2DM, aiming to improve efficacy and potentially reduce side effects associated with high-dose monotherapy (’957 Patent, col. 1:35-42).

Key Claims at a Glance

  • The complaint asserts "certain claims" (Compl. ¶27) and references Claim 25, which depends on Claim 1, as representative (Compl. ¶29).
  • Independent Claim 1:
    • A pharmaceutical composition comprising the glucopyranosyl-substituted benzene derivative 1-chloro-4-(B-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene
    • in combination with the DPP IV inhibitor 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine,
    • or a pharmaceutically acceptable salt thereof.

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 addresses the challenge of treating T2DM in patients who also suffer from renal impairment or chronic kidney disease (CKD) (’323 Patent, col. 1:25-46). Many conventional antidiabetic agents are either contraindicated or require dose adjustments in this patient population, creating a need for effective treatment methods tailored to their condition (’323 Patent, col. 1:35-43).
  • The Patented Solution: The invention provides a method of using SGLT-2 inhibitors, specifically empagliflozin, to improve glycemic control in T2DM patients with specific levels of renal impairment, such as moderate renal impairment (’323 Patent, col. 2:46-56). The patent presents clinical trial data demonstrating the efficacy of empagliflozin in patients with an estimated glomerular filtration rate (eGFR) within defined ranges, as illustrated in the table in FIG. 1A (’323 Patent, Fig. 1A).
  • Technical Importance: This invention provided a specific, data-supported method for using a newer class of antidiabetic drugs in a patient sub-population with limited and often less effective treatment options (’323 Patent, col. 1:15-19).

Key Claims at a Glance

  • The complaint asserts "certain claims" (Compl. ¶27) and references Claim 25 as representative (Compl. ¶30).
  • Independent Claim 25:
    • 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," Issued December 5, 2023

  • Technology Synopsis: This patent, like the ’323 Patent, is directed to methods for treating T2DM in patients with renal impairment (’166 Patent, col. 1:10-14). It claims a method of improving glycemic control by first assessing a patient's renal function and then administering empagliflozin if the patient's eGFR falls within a specified range of moderate impairment (’166 Patent, Abstract).
  • Asserted Claims: The complaint provides Claim 13 as representative (Compl. ¶31).
  • Accused Features: The accused feature is the proposed use of Defendant's generic empagliflozin tablets, which, according to the complaint, will be marketed for treating T2DM patients, including those with the specific levels of renal impairment recited in the claims (Compl. ¶¶50-54).

U.S. Patent No. 12,115,179 - "Pharmaceutical composition, methods for treating and uses thereof," Issued October 15, 2024

  • Technology Synopsis: This patent is directed to a triple combination therapy for T2DM (’179 Patent, Abstract). The invention addresses the need for more potent treatment regimens by combining an SGLT2 inhibitor (empagliflozin) and a DPP IV inhibitor (linagliptin) with a third antidiabetic agent, metformin (’179 Patent, col. 31:4-10).
  • Asserted Claims: The complaint provides Claim 13 as representative (Compl. ¶32).
  • Accused Features: The complaint alleges that Defendant's generic empagliflozin product, when used as directed by its label, will be administered in a manner that infringes the claimed triple combination therapy method (Compl. ¶¶59-62).

III. The Accused Instrumentality

Product Identification

Defendant USV's 10 and 25 mg empagliflozin tablets, which are the subject of ANDA No. 220497 (Compl. ¶9).

Functionality and Market Context

The accused products are generic versions of Plaintiff's JARDIANCE® tablets (Compl. ¶1). The complaint alleges that USV's ANDA relies on the JARDIANCE® New Drug Application and contains data intended to demonstrate the bioequivalence of the accused products to JARDIANCE® (Compl. ¶26). The act of infringement alleged is the submission of the ANDA to the FDA seeking approval to manufacture and sell this generic version prior to the expiration of the patents-in-suit (Compl. ¶1, ¶34).

IV. Analysis of Infringement Allegations

The complaint does not provide detailed element-by-element infringement allegations, which is common in ANDA complaints filed to meet statutory deadlines. The infringement theory is based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA for a drug claimed in a patent or for a use claimed in a patent as an act of infringement. The analysis below summarizes the allegations for the representative claims provided in the complaint.

’957 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising the glucopyranosyl-substituted benzene derivative 1-chloro-4-(B-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene The complaint alleges the USV ANDA Products are 10 and 25 mg empagliflozin tablets, which is the chemical name for this derivative. ¶9 col. 3:3-8
in combination with the DPP IV inhibitor 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine The complaint alleges the product would be used as directed in a manner that directly infringes, which suggests the proposed label will instruct for combination use with this specific DPP IV inhibitor. ¶37 col. 3:8-12

’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 The complaint alleges that the proposed label for the USV ANDA Product will instruct physicians and patients to administer the drug to treat T2DM. ¶45 col. 32:22-24
if the eGFR of the patient is ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2 The complaint alleges the proposed label will instruct use in this specific patient population with moderate renal impairment, thereby inducing infringement of this method step. ¶45 col. 32:25-28
wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg The USV ANDA is for 10 mg and 25 mg oral tablets. ¶9 col. 32:29-31
and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m2 The complaint alleges the proposed label will instruct users in a manner that would directly infringe, which includes this discontinuing step. ¶45 col. 32:33-35

Identified Points of Contention:

  • Scope Questions: For the method patents (’323, ’166, ’179 Patents), a central issue may be whether the final, FDA-approved label for USV's generic product will contain language sufficient to induce infringement of all claimed steps. This raises the question of whether USV might attempt to "carve out" patented indications or instructions from its label to avoid infringement. For the composition patent (’957 Patent), a dispute may arise over whether the proposed label instructs use "in combination with" the specifically claimed DPP IV inhibitor in a manner that meets the legal standard for inducement.
  • Procedural Questions: As this is an ANDA case triggered by a Paragraph IV certification, the primary dispute will likely center on the arguments raised in USV’s non-infringement and invalidity contentions, which are not detailed in the complaint (Compl. ¶27). The case may turn on whether USV's proposed label successfully avoids the patented methods of use, or alternatively, whether USV can prove the asserted patent claims are invalid over the prior art.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "in combination with" (’957 Patent, Claim 1)

    • Context and Importance: This term is critical for determining infringement of the ’957 Patent. The scope of "in combination with" will dictate what actions by physicians and patients, as instructed by the proposed generic label, constitute infringement. Practitioners may focus on this term because its construction will determine whether prescribing the accused product alongside a separate DPP IV inhibitor, or as part of an alternating regimen, falls within the claim scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification describes that the two active ingredients may be administered "together in one single dosage form, or in separate dosage forms" and that administration can be "simultaneously or sequentially" (’957 Patent, col. 4:54-58). This may support a construction that covers separate prescriptions intended for concomitant use.
      • Evidence for a Narrower Interpretation: The patent's title and abstract focus on a "pharmaceutical composition," and the claim is directed to a "composition comprising" both agents. This could support a narrower construction limited to a single, fixed-dose combination product, which the accused product is not alleged to be.

  • The Term: "administering... if the eGFR of the patient is ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2" (’323 Patent, Claim 25)

    • Context and Importance: This conditional limitation is the core of the invention claimed in the ’323 Patent. The infringement analysis will depend on whether the defendant's proposed label instructs or encourages physicians to make this specific eGFR-based treatment decision.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides extensive clinical data showing the drug's efficacy and safety profile within this specific eGFR range (’323 Patent, Fig. 1A, col. 33:12-21). A court may find that providing this data on a label, even without an explicit "if-then" instruction, necessarily encourages a physician to administer the drug to this patient population, thus satisfying the claim element.
      • Evidence for a Narrower Interpretation: The claim uses the conditional word "if," which may suggest that infringement requires an explicit instruction on the label to administer the drug only when the patient's eGFR is within the recited range. A label that merely provides pharmacokinetic data for this population without a direct prescribing instruction may be argued to fall outside the claim scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that USV's submission of its ANDA will actively induce infringement by physicians and patients (Compl. ¶¶39, 47, 55, 64). The basis for this allegation is the proposed package insert for the ANDA product, which allegedly will instruct users to perform the patented methods of use (Compl. ¶¶38, 46, 63).
  • Willful Infringement: The complaint does not explicitly plead willful infringement for the purpose of seeking enhanced damages. However, it does allege that USV has knowledge of the patents-in-suit and that its actions constitute an "exceptional case" warranting an award of attorneys' fees (Compl. Prayer for Relief, ¶e).

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

  • A core issue will be one of induced infringement and label construction: Will the final, FDA-approved label for USV’s generic empagliflozin product contain instructions or clinical data that would lead a person of ordinary skill (i.e., a prescribing physician) to administer the drug in a manner that directly practices the claimed methods, particularly with respect to specific patient eGFR levels and combination therapies?
  • A second central question will be claim validity: Stemming from USV’s Paragraph IV certification, the litigation will likely involve a significant challenge to the validity of the asserted claims. The focus may be on whether the specific combination therapies or methods of treating renally impaired patients were obvious extensions of what was known in the prior art at the time of the inventions.