DCT

1:22-cv-01102

Boehringer Ingelheim Pharma Inc v. DR Reddy's Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01102, D. Del., 08/22/2022
  • Venue Allegations: Venue is asserted on the basis that Defendants are foreign corporations or agents thereof and have previously litigated patent disputes in the District of Delaware without contesting venue.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug JARDIANCE® constitutes an act of infringement of a patent covering specific methods of using empagliflozin to treat Type 2 diabetes in patients with defined levels of renal impairment.
  • Technical Context: The case concerns SGLT-2 inhibitors, a major class of oral medications for Type 2 diabetes that lower blood sugar by causing the kidneys to excrete excess glucose in the urine.
  • Key Procedural History: This patent infringement action was filed under the Hatch-Waxman Act, triggered by Plaintiff’s receipt on or about July 21, 2022, of a Paragraph IV certification letter from Defendant. In the letter, Defendant asserted that the patent-in-suit is invalid or will not be infringed by its proposed generic product.

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
2022-07-21 Plaintiff receives Defendant's Paragraph IV Certification Letter
2022-08-22 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, “Pharmaceutical composition, methods for treating and uses thereof,” issued August 17, 2021.

The Invention Explained

  • Problem Addressed: The patent describes the challenge of treating Type 2 diabetes in patients who also suffer from renal impairment or chronic kidney disease (CKD). The use of many common anti-diabetic agents is restricted in this patient population due to safety concerns or the need for dose reductions, creating a need for effective alternative treatments (’323 Patent, col. 1:12-47).
  • The Patented Solution: The invention provides methods for treating Type 2 diabetes by administering empagliflozin, an SGLT-2 inhibitor, specifically to patients with mild or moderate renal impairment. By inhibiting the SGLT-2 protein in the kidneys, empagliflozin causes excess blood glucose to be excreted in the urine, thereby improving glycemic control in a patient population for whom other therapeutic options are limited (’323 Patent, col. 1:50-58; col. 2:1-2).
  • Technical Importance: The claimed methods address a significant treatment gap for a large and clinically vulnerable patient population where the risks associated with other diabetes therapies often limit their use (’323 Patent, col. 1:35-44).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶30). Independent claim 1 is representative:
  • Independent Claim 1:
    • 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

III. The Accused Instrumentality

Product Identification

  • Defendant’s (“DRL”) proposed 10 mg and 25 mg generic empagliflozin tablets, for which it seeks FDA approval via ANDA No. 212336 (Compl. ¶10).

Functionality and Market Context

  • The DRL ANDA Products contain empagliflozin, the same active pharmaceutical ingredient as in Plaintiffs’ branded JARDIANCE® tablets (Compl. ¶1, ¶10). The ANDA filing asserts that DRL’s products are bioequivalent to JARDIANCE® (Compl. ¶28). The act of infringement alleged under the Hatch-Waxman Act is the submission of the ANDA itself, which seeks approval to market the generic product for uses that are alleged to be covered by the ’323 Patent prior to its expiration (Compl. ¶1, ¶30).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary: The complaint alleges that the use of the DRL ANDA Products as directed would infringe the asserted patent (Compl. ¶33). In a Hatch-Waxman case, this infringement theory is based on the premise that the defendant’s proposed product labeling will instruct physicians and patients to perform the patented method. The following chart summarizes the allegations for representative Claim 1.

U.S. Patent No. 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 comprising administering empagliflozin to the patient... The DRL ANDA Products contain empagliflozin, and their proposed labeling will allegedly instruct administration to patients with Type 2 diabetes to improve glycemic control. ¶33, ¶37 col. 2:1-2
...if the eGFR of the patient is ≥45 ml/min/1.73 m² and <60 ml/min/1.73 m²... The proposed labeling for the DRL ANDA Products will allegedly instruct or otherwise encourage use in patients falling within this specific range of renal impairment. ¶33, ¶37 col. 22:3-5
...wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg... The DRL ANDA Products are formulated as 10 mg and 25 mg oral tablets, and their proposed labeling will allegedly instruct administration of these dosages. ¶10, ¶33 col. 34:1-2
...wherein the glycemic control in said patient is improved... The use of the DRL ANDA Products as directed will allegedly result in improved glycemic control in the specified patient population. ¶33 col. 32:51-67
...and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m². The proposed labeling for the DRL ANDA Products will allegedly instruct or otherwise encourage discontinuation of therapy if a patient's renal function declines to this level. ¶33, ¶37 col. 32:41-43
  • Identified Points of Contention:
    • Scope Questions: A central issue will be the specific language of DRL’s proposed product label, which is not included in the complaint. The infringement analysis will depend on whether the label instructs, encourages, or fails to discourage use in the specific patient population defined by the claim (e.g., patients with an eGFR between ≥45 and <60 ml/min/1.73 m²). DRL may argue its label "carves out" the patented method of use.
    • Technical Questions: DRL’s Paragraph IV certification asserts invalidity (Compl. ¶29). This raises the question of whether the claimed method was obvious. The dispute may focus on whether it was obvious to a person of ordinary skill in the art to administer empagliflozin to this specific renally-impaired population with a reasonable expectation of success, given the state of the art at the time of the invention.

V. Key Claim Terms for Construction

  • The Term: "improving glycemic control"

  • Context and Importance: This term defines the outcome of the claimed method. Its construction is critical because the parties may dispute the threshold for what constitutes an "improvement."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent Summary of the Invention describes the method broadly as "improving glycemic control" without quantifying a specific required level of improvement (’323 Patent, col. 2:1-2).
    • Evidence for a Narrower Interpretation: The Detailed Description includes clinical trial data showing specific, quantified improvements in glycemic markers like HbA1c (e.g., a -0.46% adjusted mean change from baseline) (’323 Patent, col. 33:15-22; Fig. 1A). A party may argue that "improving" should be construed to require a clinically significant reduction, as exemplified in the specification.

  • 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 precise patient population covered by the method of claim 1. Infringement will hinge on whether DRL's proposed label directs use in this population. Practitioners may focus on this term because it is the core element distinguishing the claimed invention from prior uses.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The definition could potentially encompass any reasonable medical method of calculating eGFR that would place a patient in this range.
    • Evidence for a Narrower Interpretation: The patent explicitly defines this range as "Moderate A renal impairment (CKD 3A)" (’323 Patent, col. 22:3-5). Furthermore, the clinical trial examples on which the patent relies state that eGFR was calculated using the specific "Modification of Diet in Renal Disease (MDRD) formula" (’323 Patent, col. 32:51-54). A party could argue the term should be limited by the methodology used to generate the supporting data in the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that DRL will induce infringement by encouraging and instructing physicians and patients, via its package inserts and promotional activities, to use its generic product in the patented manner (Compl. ¶36, ¶37). It also alleges contributory infringement, stating the DRL ANDA Products are especially made for infringing use and are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶34).
  • Willful Infringement: The complaint alleges DRL had knowledge of the ’323 patent and that the case is exceptional, warranting attorneys' fees (Compl. ¶36, ¶40). This allegation is supported by DRL's submission of a Paragraph IV certification, which demonstrates knowledge of the patent (Compl. ¶29).

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

  • A core issue will be one of label-driven infringement: will the final, FDA-approved label for Defendant's generic product instruct or encourage use in the specific patient population defined by the patent's eGFR limitations (e.g., ≥45 to <60 ml/min/1.73 m²), or will it successfully "carve out" this patented method, thereby avoiding direct and induced infringement?
  • A second key question will be one of patent validity: can Defendant demonstrate, by clear and convincing evidence, that the claimed method of using empagliflozin in a specific subset of renally impaired patients was obvious to a person of ordinary skill in the art at the time of the invention, despite empagliflozin's known mechanism of action being dependent on renal function?