DCT

1:21-cv-01486

Boehringer Ingelheim Intl GmbH v. Lupin Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01486, D. Del., 10/22/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Lupin Pharmaceuticals, Inc. is a Delaware corporation and therefore resides in the district. It is further alleged that Defendant Lupin Ltd., as a foreign corporation, may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of Abbreviated New Drug Applications (ANDAs) to market generic versions of empagliflozin-based diabetes medications constitutes an act of infringement of a patent covering methods for treating diabetic patients with specific levels of renal impairment.
  • Technical Context: The technology concerns the use of SGLT-2 inhibitors, a class of oral anti-diabetic drugs that lower blood sugar by causing the kidneys to excrete more glucose in the urine.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following a Paragraph IV notice letter sent by Lupin to Boehringer on or about October 4, 2021. In the letter, Lupin certified that its proposed generic products would not infringe U.S. Patent No. 11,090,323 or that the patent is invalid.

Case Timeline

Date Event
2013-04-05 '323 Patent Priority Date
2021-08-17 '323 Patent Issue Date
2021-10-04 Lupin sends Paragraph IV notice letter (approximate date)
2021-10-22 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, issued August 17, 2021.

The Invention Explained

  • Problem Addressed: The patent’s background section notes that the use of many anti-diabetic agents is restricted or requires dose adjustments in patients who also have renal impairment (i.e., chronic kidney disease), limiting treatment options for this patient population (’323 Patent, col. 1:36-47).
  • The Patented Solution: The invention is a method of using the SGLT-2 inhibitor empagliflozin to treat type 2 diabetes in patients with specific, defined levels of moderate renal impairment. The patent provides clinical trial data, such as that shown in Figure 1A, to demonstrate that empagliflozin can effectively improve glycemic control in this specific sub-population, for whom other therapies might be less suitable or contraindicated (’323 Patent, Abstract; col. 33:10-20; FIG. 1A).
  • Technical Importance: The claimed methods sought to expand the utility of SGLT-2 inhibitors to a difficult-to-treat patient group suffering from both diabetes and kidney disease, thereby addressing a need for effective treatments in patients with this comorbidity (’323 Patent, col. 1:41-47).

Key Claims at a Glance

  • The complaint alleges infringement of "at least one claim" of the '323 patent (Compl. ¶45). Independent claim 1 is representative of the asserted method claims.
  • 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 to the patient if the estimated glomerular filtration rate (eGFR) of the patient 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 eGFR of the patient falls below 30 ml/min/1.73 m².
  • The complaint implicitly reserves the right to assert other claims, including dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Lupin's proposed generic drug products containing empagliflozin, empagliflozin/linagliptin, empagliflozin/metformin extended-release, and empagliflozin/linagliptin/metformin extended-release, as detailed in ANDA Nos. 212331, 212335, 213654, and 215072 (Compl. ¶¶10-15).

Functionality and Market Context

  • The complaint alleges that Lupin's ANDA products are generic versions of Boehringer's branded products JARDIANCE®, GLYXAMBI®, SYNJARDY® XR, and TRIJARDY® XR (Compl. ¶1). It is alleged that Lupin's ANDAs rely on the safety and efficacy data of the branded products and contain data demonstrating bioequivalence (Compl. ¶43, ¶58, ¶73, ¶88). The act of infringement alleged under 35 U.S.C. § 271(e)(2) is the submission of these ANDAs to the FDA seeking approval to market these generic drugs for the patented uses prior to the expiration of the ’323 Patent (Compl. ¶45).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement theory is based on the act of filing an ANDA seeking approval for a patented method of use. The following chart summarizes the infringement theory for representative claim 1, based on the allegations in the complaint.

  • 11,090,323 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... Lupin's ANDA Products are intended for use in treating type 2 diabetes, which includes improving glycemic control. ¶1, ¶43 col. 2:1-4
...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 that Lupin will induce infringement by providing a product with a label that will instruct or encourage physicians to prescribe the drug to patients in the claimed population. ¶52, ¶53 col. 32:51-54
...wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg... Lupin's ANDAs seek approval for oral tablets in dosages that include 10 mg and 25 mg of empagliflozin. ¶10, ¶11 col. 38, Table
...wherein the glycemic control in said patient is improved... Lupin's ANDA Products are alleged to be bioequivalent to the branded drugs, and therefore their use as directed is expected to result in improved glycemic control. ¶43, ¶58 col. 37:11-14
...and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m². The complaint's theory of induced infringement implies that Lupin's proposed label will contain instructions or warnings consistent with the patented method, including when to discontinue the drug. ¶52, ¶53 col. 32:4-10
  • Identified Points of Contention:
    • Evidentiary Question: A central issue will be the specific language of Lupin's proposed product labels. The case will depend on whether those labels actively instruct, encourage, or recommend that physicians prescribe and patients use the generic drugs in a manner that satisfies all steps of the asserted method claims, thereby inducing infringement.
    • Scope Questions: The parties may dispute the proper interpretation of the claimed patient population. For example, a question may arise as to whether the term "eGFR" is limited to a specific calculation method (e.g., the MDRD formula used in the patent's clinical trials) or if it can encompass other clinically accepted methods (e.g., CKD-EPI), potentially altering the scope of infringement.

V. Key Claim Terms for Construction

  • The Term: "improving glycemic control"

  • Context and Importance: This term defines the purpose and a required outcome of the claimed method. The standard for what constitutes "improvement" is critical for determining whether the method is performed.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification lists multiple metrics for glycemic control, such as reducing fasting plasma glucose, postprandial plasma glucose, and/or glycosylated hemoglobin HbA1c (’323 Patent, col. 2:1-4). A party could argue that a statistically significant improvement in any of these metrics meets the limitation.
    • Evidence for a Narrower Interpretation: A party could argue the term requires a clinically meaningful improvement of the magnitude shown in the patent's own examples and figures, such as the specific HbA1c reductions detailed in Figure 1A (’323 Patent, FIG. 1A).

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

  • Context and Importance: This limitation defines the specific patient sub-population to which the method applies. Its construction is central to both infringement and validity, as it sets the boundaries of the invention.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification defines "eGFR" as being derivable from several known formulas, including the "CKD-EPI equation, the Cockcroft-Gault formula or the Modification of Diet in Renal Disease (MDRD) formula" (’323 Patent, col. 17:45-50). This may support a construction that is not tied to a single calculation method.
    • Evidence for a Narrower Interpretation: The patent’s examples explicitly state that the eGFR for the supporting clinical trial was calculated using the MDRD formula (’323 Patent, col. 32:51-54). A party may argue that the claim scope should be limited to the method actually used to generate the data that demonstrates the invention.

VI. Other Allegations

  • Indirect Infringement: The complaint's primary theory is induced infringement under 35 U.S.C. § 271(b). It alleges that Lupin, with knowledge of the '323 patent, will induce infringement by marketing its generic products with "promotional activities and package inserts" that will instruct physicians and patients to use the drugs in a manner that directly infringes Boehringer's patented methods (Compl. ¶52, ¶67, ¶82, ¶97).
  • Willful Infringement: The complaint alleges that Lupin had knowledge of the '323 patent, at least as of its receipt of the Paragraph IV notice letter on or about October 4, 2021 (Compl. ¶44, ¶52). Based on this alleged knowledge, the complaint asserts that any future infringement will be willful and requests a finding that the case is "exceptional" under 35 U.S.C. § 285, warranting an award of attorneys' fees (Compl. ¶55, ¶100).

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

  • A primary issue will be one of inducement: Once Lupin’s proposed product labeling is produced in discovery, will its language be found to actively encourage or promote the administration of the generic drug specifically to the claimed patient population—type 2 diabetics with an eGFR between 45 and 60 ml/min/1.73 m²—in a manner that meets every step of the asserted method claim?
  • A second key question will be one of claim scope: How will the court construe the boundaries of the claimed method, particularly the definition of "eGFR" and the quantum of "improving glycemic control" required? The resolution of these terms will directly impact the analyses of both infringement by Lupin's proposed use and the patent's validity over the prior art.