DCT

1:22-cv-00220

Boehringer Ingelheim Intl GmbH v. Laurus Labs Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00220, D. Del., 02/18/2022
  • Venue Allegations: Venue is alleged to be proper in Delaware as Defendant Laurus Generics Inc. is a Delaware corporation, and Defendant Laurus Labs Ltd. is a foreign corporation that may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval to market generic empagliflozin tablets constitutes an act of infringement of a patent covering a method of using the drug to treat type 2 diabetes in patients with specific levels of kidney impairment.
  • Technical Context: The technology concerns methods of using empagliflozin, an SGLT-2 inhibitor, to manage type 2 diabetes in a specific, challenging patient population—those with co-existing chronic kidney disease.
  • Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiff received a Paragraph IV Certification letter from Defendant on or about December 29, 2021. The letter asserted that claims of the patent-in-suit are invalid, unenforceable, and/or would not be infringed by the commercial sale of Defendant's proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" for Plaintiff's branded drug, JARDIANCE®.

Case Timeline

Date Event
2013-04-05 U.S. Patent No. 11,090,323 Priority Date
2021-08-17 U.S. Patent No. 11,090,323 Issue Date
2021-12-29 Plaintiff receives Defendant's Paragraph IV Certification
2022-02-18 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"

  • Patent Identification: U.S. Patent No. 11,090,323 (“the ’323 Patent”), “Pharmaceutical composition, methods for treating and uses thereof,” issued August 17, 2021. (Compl. ¶20).

The Invention Explained

  • Problem Addressed: The patent’s background section notes that treating type 2 diabetes is challenging in patients who also have chronic kidney disease (CKD). It states that the use of certain common anti-diabetic agents is restricted or requires dose adjustments in patients with renal impairment, creating a need for effective treatments for this specific population. (’323 Patent, col. 1:27-48).
  • The Patented Solution: The invention provides a method for treating type 2 diabetes by administering empagliflozin, an SGLT-2 inhibitor, to patients with moderate renal impairment. The patent’s specification provides clinical trial data, such as that depicted in Figure 7A, to demonstrate the claimed improvement in glycemic control (as measured by HbA1c) in patients with specific stages of CKD when treated with empagliflozin. (’323 Patent, Abstract; col. 2:35-48; FIG. 7A).
  • Technical Importance: The claimed method provides a therapeutic option for a significant subset of diabetes patients whose treatment is complicated by renal dysfunction, a common comorbidity. (’323 Patent, col. 1:23-35).

Key Claims at a Glance

  • The complaint broadly asserts infringement of "at least one claim." (Compl. ¶28). Independent claim 1 is representative of the patent's method-of-use claims.
  • Essential elements of Independent Claim 1 include:
    • A method for improving glycemic control in a patient with type 2 diabetes mellitus;
    • comprising 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;
    • 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 patient's eGFR falls below 30 ml/min/1.73 m².
  • The complaint does not explicitly reserve the right to assert dependent claims, but its general allegation preserves this option.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "Laurus ANDA Products," specifically 10 mg and 25 mg empagliflozin tablets for which Laurus seeks FDA approval under ANDA No. 212421. (Compl. ¶10).

Functionality and Market Context

  • The products are proposed generic versions of Plaintiff's branded drug, JARDIANCE®. (Compl. ¶1). The ANDA submission constitutes a statutory act of infringement by seeking approval to market the drug for uses claimed in the ’323 patent prior to its expiration. (Compl. ¶28). The ANDA relies on the safety and efficacy data of JARDIANCE® and contains data intended to demonstrate bioequivalence. (Compl. ¶26). The infringement allegation centers on the intended use of the generic product, which would be governed by its FDA-approved label.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement theory is one of statutory and induced infringement, based on the filing of the ANDA for a drug whose proposed label will instruct users to perform the patented method.

’323 Patent 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 Laurus ANDA seeks approval for empagliflozin tablets, a drug indicated for the treatment of type 2 diabetes, the purpose of which is to improve glycemic control. ¶1, ¶10 col. 2:1-3
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 complaint alleges infringement of the patent, which covers methods of use in this specific patient population. Infringement is predicated on the likelihood that the proposed label for the Laurus product will instruct or encourage physicians to prescribe the drug to patients meeting this renal impairment criterion. ¶23, ¶28, ¶31 col. 22:1-3
wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg The Laurus ANDA Products are identified as 10 mg and 25 mg oral tablets. ¶10 col. 35:9-11
wherein the glycemic control in said patient is improved The Laurus ANDA relies on the established efficacy of JARDIANCE®, which includes improved glycemic control. Figure 7A in the attached patent exhibit presents clinical trial data showing this improvement. ¶26; Ex. A at p. 27 FIG. 7A
and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m² The infringement allegation presumes that the proposed label for the generic product will include this safety-related discontinuation instruction, mirroring the likely instructions for the branded drug. ¶31, ¶34 col. 4:8-9

Identified Points of Contention

  • Scope Questions: A primary issue will be whether Laurus's proposed product label induces infringement of the method claims. The case may turn on whether Laurus can successfully "carve out" the patented method of use from its label, or whether the remaining indications and instructions on the label would still lead physicians to directly infringe the claims.
  • Technical Questions: A key question for the court will be one of evidence: what will the final, FDA-approved label for the Laurus ANDA products state? The infringement analysis will depend entirely on the instructions, warnings, and indications for use contained in that label.

V. Key Claim Terms for Construction

  • The Term: "if the eGFR of the patient is..."
  • Context and Importance: This conditional language is central to the asserted method claims. Practitioners may focus on this term because infringement will depend on whether Laurus's proposed label induces physicians to select patients based on this specific eGFR criterion before administering the drug. The construction will determine what actions constitute infringement of this "treatment selection" step.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent frames the invention broadly as a "method for treating... in patients with renal impairment." (’323 Patent, col. 1:9-11). This might support an interpretation where any instruction to treat patients with moderate renal impairment could be seen as falling within the claim's scope.
    • Evidence for a Narrower Interpretation: The claims recite very specific numerical ranges for eGFR (e.g., "≥45 ml/min/1.73 m² and <60 ml/min/1.73 m²"). (’323 Patent, col. 38:51-53). The specification repeatedly ties these specific ranges to defined stages of CKD (e.g., "Moderate A renal impairment (CKD 3A)") and provides clinical data organized by these exact stages, suggesting the inventors viewed these precise boundaries as integral to the invention. (’323 Patent, col. 22:1-6; FIG. 7A).

VI. Other Allegations

  • Indirect Infringement: The complaint's primary theory is indirect infringement. It alleges that Laurus will induce infringement by physicians and patients through the instructions on its proposed product label. (Compl. ¶¶ 34-35). It further alleges contributory infringement, stating that the Laurus ANDA Products are especially adapted for infringing use and are not staple articles of commerce suitable for substantial noninfringing use. (Compl. ¶32).
  • Willful Infringement: The complaint alleges that Laurus had knowledge of the ’323 Patent, at least as of the date it sent its Paragraph IV letter. (Compl. ¶¶ 27, 34). While not using the term "willful," it pleads facts supporting such a claim and seeks a finding that the case is "exceptional" under 35 U.S.C. § 285, which warrants enhanced damages and attorneys' fees. (Compl. ¶37; Prayer for Relief ¶e).

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

  • A core issue will be one of induced infringement by label: Can Laurus successfully "carve out" the patented method from its proposed generic drug label, or will the label's remaining indications and safety information inevitably lead physicians to prescribe empagliflozin in a way that directly infringes the ’323 Patent’s method of treating patients within the claimed eGFR range?
  • A key validity question will be obviousness: Did the prior art concerning SGLT-2 inhibitors provide a person of ordinary skill with a motivation and a reasonable expectation of success for treating type 2 diabetes patients with moderate renal impairment using empagliflozin, thereby rendering the claimed method obvious?
  • A central question for contributory infringement will be one of market reality: If the patented method is the primary or only commercially significant use for empagliflozin in certain patient populations, can its use be considered a "substantial non-infringing use," or is the product effectively designed for an infringing purpose?