DCT

1:21-cv-01766

Boehringer Ingelheim Intl GmbH v. Mankind Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01766, D. Del., 12/16/2021
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendant Lifestar Pharma LLC is incorporated in the state, and Defendant Mankind Pharma Ltd. is a foreign corporation that may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the diabetes drug JARDIANCE® (empagliflozin) constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical methods for treating type 2 diabetes, specifically for the challenging patient population that also suffers from renal impairment or chronic kidney disease.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV Certification letter on or about November 11, 2021. In the letter, Defendants asserted that the patent-in-suit is either invalid or will not be infringed by their proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" as covering the JARDIANCE® brand drug.

Case Timeline

Date Event
2013-04-05 Earliest Priority Date for '323 Patent
2021-08-17 U.S. Patent No. 11,090,323 Issues
2021-11-11 Plaintiffs Receive Paragraph IV Certification Letter
2021-12-16 Complaint Filed

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's background section notes that many standard anti-diabetic medications are either contraindicated or require dose reductions in patients who also have chronic kidney disease (CKD), creating a need for effective treatments for this specific sub-population (’323 Patent, col. 1:31-48).
  • The Patented Solution: The invention is a method of using empagliflozin, an SGLT-2 inhibitor, to treat type 2 diabetes in patients with specific levels of renal impairment. The patent describes that administering empagliflozin can improve glycemic control in patients with mild or moderate renal impairment, a group for whom other therapies may be unsuitable (’323 Patent, Abstract; col. 2:35-48). Clinical data presented in the patent, such as in Figure 1A, purports to show that empagliflozin reduces key glycemic markers like HbA1c compared to placebo in patients with defined levels of kidney function (’323 Patent, Fig. 1A).
  • Technical Importance: The claimed methods provide a therapeutic option for a difficult-to-treat patient population where the efficacy and safety of other common diabetes drugs are compromised by renal dysfunction (’323 Patent, col. 1:43-48).

Key Claims at a Glance

  • The complaint alleges infringement of "at least one claim" of the patent without specifying claims (’323 Patent, Compl. ¶28). Independent claim 1 is representative:
    • 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 within a specific range (≥45 and <60 ml/min/1.73 m²)
    • wherein the empagliflozin is administered orally as a 10 mg or 25 mg total daily dose
    • wherein the patient's glycemic control is improved
    • and discontinuing the administration of empagliflozin if the patient's eGFR falls below a different threshold (30 ml/min/1.73 m²)

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "Mankind ANDA Products," specifically 10 mg and 25 mg empagliflozin tablets for which Defendants seek FDA approval via ANDA No. 212283 (Compl. ¶10).

Functionality and Market Context

  • The accused products are proposed generic versions of Plaintiffs' JARDIANCE® tablets and are intended to be bioequivalent (Compl. ¶¶1, 26). The act of infringement alleged in the complaint is the filing of the ANDA itself, an artificial act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶28).
  • The infringement theory is that the proposed labeling for Defendants' generic product will instruct physicians and patients to use the drug in a manner that directly infringes the method claims of the ’323 Patent, which is listed in the Orange Book for JARDIANCE® (Compl. ¶¶22-23, 35).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a formal claim chart. The infringement allegations are based on the theory that the label of the proposed generic product will induce infringement of the patent's method claims. The following table summarizes this inferred theory for representative Claim 1.

’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 proposed product label for Defendants' generic empagliflozin will instruct its use for the treatment of type 2 diabetes, with the intended result of improving glycemic control. ¶¶1, 31, 35 col. 38:52-54
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 proposed label will allegedly instruct or recommend prescribing the drug to patients with type 2 diabetes whose renal function, measured by eGFR, falls within this specific range of moderate impairment. ¶¶31, 35 col. 38:55-57
wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg Defendants' ANDA seeks approval for 10 mg and 25 mg oral tablets, and the proposed label will instruct administration of these dosages. ¶10 col. 38:58-60
wherein the glycemic control in said patient is improved This is the claimed therapeutic outcome. Defendants' ANDA relies on the innovator's clinical data demonstrating this efficacy to secure approval. ¶26 col. 38:60-62
and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m² The proposed label will allegedly contain instructions, warnings, or contraindications that direct a physician to stop treatment if the patient's renal function declines to this specified level. ¶¶31, 35 col. 38:62-65

Identified Points of Contention

  • Scope Questions: A primary issue will be whether the specific language of the proposed generic drug label will be found to actively induce infringement of the entire multi-step method. The analysis may focus on whether the label merely provides information or affirmatively instructs or encourages physicians to perform the eGFR-based patient selection and discontinuation steps required by the claims.
  • Technical Questions: As this is an ANDA case concerning a bioequivalent product, the key disputes are unlikely to be about how the drug itself works. Rather, a central question for the court will be one of validity. Defendants' Paragraph IV letter asserts the patent is invalid (Compl. ¶27), raising the question of whether the claimed method of treating this specific patient sub-population was obvious to a person of ordinary skill in 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 required therapeutic outcome. Its construction is central to both infringement and validity. Practitioners may focus on this term because the parties will likely dispute the threshold for "improvement"—whether any statistically significant change is sufficient, or if a more substantial, clinically meaningful benefit is required, and whether such a benefit was obvious to expect in this patient population.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent provides clinical trial data showing specific, statistically significant reductions in HbA1c (e.g., a -0.42% difference versus placebo in one cohort), which a plaintiff may argue is objective evidence that meets the plain meaning of "improving" control (’323 Patent, Fig. 1A).
    • Evidence for a Narrower Interpretation: The patent notes that for patients with renal impairment, the use of other anti-diabetes agents is restricted (’323 Patent, col. 1:36-42). A defendant may argue that in this context, "improving" implies a non-obvious, clinically significant benefit, not just any small statistical change that might have been expected.

The Term: "discontinuing empagliflozin"

  • Context and Importance: This is an active, conditional step in the method claim. Proving inducement of this step is critical to the plaintiff's infringement case. The dispute will likely center on whether a warning or contraindication on a drug label constitutes inducement of an affirmative action by a physician.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A plaintiff may argue that the claim language "discontinuing...if the eGFR...falls" (col. 38:62-65) is met by a label that instructs physicians to monitor renal function and cease administration if it declines past the specified threshold, as this is the only way for a drug manufacturer to direct such a step.
    • Evidence for a Narrower Interpretation: A defendant may contend that the term requires an affirmative instruction to take action, and that a label's warnings about use in certain populations are matters of physician judgment, not an induced "discontinuation" step that satisfies the claim element.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is predicated on the proposed product label instructing users to perform the patented method (Compl. ¶¶34-35). Contributory infringement is based on the allegation that Defendants' empagliflozin tablets are not a staple article of commerce and are especially adapted for an infringing use (Compl. ¶¶32-33).
  • Willful Infringement: While the complaint does not use the word "willful," it alleges this is an "exceptional case" warranting an award of attorney fees under 35 U.S.C. § 285 (Compl. ¶37). The basis for this allegation appears to be Defendants' knowledge of the patent, at least as of the date of their Paragraph IV certification letter (Compl. ¶27).

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

  • A core issue will be one of induced infringement: Will the final, FDA-approved label for Defendants' generic product be found to affirmatively instruct or encourage physicians to perform all the steps of the asserted method claims, particularly the specific eGFR-based patient selection and discontinuation criteria?
  • A key question for validity will be one of obviousness: Will Defendants be able to prove with clear and convincing evidence that it was obvious to a person of ordinary skill in the art to treat type 2 diabetes patients with moderate renal impairment using empagliflozin and to expect the claimed improvement in glycemic control?
  • The outcome may also turn on a question of claim construction: Can the method step of "discontinuing" the drug be satisfied by a warning or contraindication on a drug label, or does it require a more direct and affirmative instruction that will not be present on the generic product's label?