Boehringer Ingelheim Pharma Inc v. Boehringer Ingelheim Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Boehringer Ingelheim Pharmaceuticals Inc. (Delaware); Boehringer Ingelheim International GmbH (Germany); and Boehringer Ingelheim Corporation (Nevada)
  • Defendant: Ajanta Pharma Limited (India)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Kirkland & Ellis LLP
• Case Identification: 1:23-cv-00848, D. Del., 08/04/2023
• Venue Allegations: Venue is alleged to be proper because the Defendant is a foreign corporation not residing in any U.S. judicial district and has previously litigated Hatch-Waxman disputes in the District of Delaware.
• 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 infringes three patents covering methods of using the drug to treat type 2 diabetes.
• Technical Context: The patents relate to methods of treating type 2 diabetes with empagliflozin, an SGLT-2 inhibitor, specifically in patient populations with concurrent renal impairment or chronic kidney disease.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt on or about March 17, 2022, of a Paragraph IV certification letter from Defendant concerning the patents-in-suit. The complaint notes that Defendant has previously litigated other Hatch-Waxman cases in the District of Delaware.

Case Timeline

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

U.S. Patent No. 9,949,998 - "Pharmaceutical Composition, Methods for Treating and Uses Thereof"

• Patent Identification: U.S. Patent No. 9,949,998, "Pharmaceutical Composition, Methods for Treating and Uses Thereof," issued April 24, 2018 (Compl. ¶16).

The Invention Explained

• Problem Addressed: The patent addresses the challenge of treating type 2 diabetes in patients who also suffer from renal impairment or chronic kidney disease (CKD). Many conventional anti-diabetes medications are either contraindicated or require dose adjustments in these patients due to risks associated with renal dysfunction, such as lactic acidosis with metformin (’998 Patent, col. 1:33-36).
• The Patented Solution: The invention is a method of using an SGLT-2 inhibitor, specifically empagliflozin, for improving glycemic control in type 2 diabetes patients who have a specified degree of renal impairment (’998 Patent, Abstract). The method claims define the patient population by a specific range of estimated glomerular filtration rate (eGFR), a measure of kidney function (’998 Patent, col. 2:50-54).
• Technical Importance: This method provides a therapeutic option for a significant and difficult-to-treat patient subpopulation with co-morbid type 2 diabetes and kidney disease, for whom other treatment options may be limited (’998 Patent, col. 1:40-45).

Key Claims at a Glance

• The complaint does not identify specific claims asserted against the Defendant, alleging infringement of "at least one claim" of the patent (Compl. ¶26). U.S. Patent No. 9,949,998 (the “’998 Patent”) contains one independent method claim.
• Claim 1 (paraphrased elements): A method for improving glycemic control in a patient with type 2 diabetes mellitus, comprising administering empagliflozin, wherein the patient has a baseline eGFR of ≥30 to <60 mL/min/1.73 m².
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,258,637 - "Pharmaceutical Composition, Method for Treating and Uses Thereof"

• Patent Identification: U.S. Patent No. 10,258,637, "Pharmaceutical Composition, Method for Treating and Uses Thereof," issued April 16, 2019 (Compl. ¶17).

The Invention Explained

• Problem Addressed: As a continuation of the '998 Patent, this patent addresses the same technical problem: the need for effective and safe treatments for type 2 diabetes in patients with compromised kidney function (’637 Patent, col. 1:12-48).
• The Patented Solution: The invention provides methods for improving glycemic control by administering empagliflozin to type 2 diabetes patients with "moderate renal impairment" (’637 Patent, Abstract). This patient population is further defined in the claims by specific eGFR ranges, including a distinction between moderate A and moderate B renal impairment, which correspond to different stages of chronic kidney disease (’637 Patent, col. 2:49-56).
• Technical Importance: The claimed methods refine the patient population, potentially allowing for more tailored treatment strategies for diabetic patients across different severities of moderate kidney disease.

Key Claims at a Glance

• The complaint alleges infringement of "at least one claim" of U.S. Patent No. 10,258,637 (the “’637 Patent”) (Compl. ¶40). The patent contains multiple independent method claims.
• Claim 1 (paraphrased elements): A method for improving glycemic control in a patient with type 2 diabetes mellitus, comprising administering empagliflozin, wherein the patient has moderate renal impairment, and discontinuing the treatment if the patient's eGFR falls below 45 ml/min/1.73 m².
• Claim 7 (paraphrased elements): A method for improving glycemic control in a patient with type 2 diabetes mellitus, comprising administering empagliflozin if the patient's eGFR is ≥45 ml/min/1.73 m² and <60 ml/min/1.73 m², and discontinuing if the eGFR falls below 45 ml/min/1.73 m².
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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 (Compl. ¶18).

Technology Synopsis

This patent is also in the same family as the '998 and '637 Patents and is directed to similar subject matter. It claims methods of using empagliflozin to improve glycemic control in type 2 diabetes patients with specific levels of renal impairment, thereby addressing the therapeutic challenges in this patient population (’323 Patent, Abstract, col. 1:12-48).

Asserted Claims

The complaint alleges infringement of "at least one claim" of the patent (Compl. ¶54). The patent contains multiple independent claims directed to methods of treatment.

Accused Features

The accused feature is the filing of an ANDA seeking approval to market a generic empagliflozin product for uses that Plaintiffs allege are covered by the patent's method claims (Compl. ¶¶51, 57).

III. The Accused Instrumentality

Product Identification

Defendant's 10 mg and 25 mg empagliflozin tablets, for which Defendant submitted Abbreviated New Drug Application No. 217055 to the FDA (the "Ajanta ANDA Products") (Compl. ¶8).

Functionality and Market Context

The Ajanta ANDA Products are proposed generic versions of Plaintiffs' JARDIANCE® tablets (Compl. ¶1). The complaint alleges that the ANDA refers to and relies upon the New Drug Application for JARDIANCE® and contains data intended to demonstrate bioequivalence (Compl. ¶24). As such, the products are intended for oral use to treat type 2 diabetes. The act of infringement alleged in the complaint is the submission of the ANDA itself, which seeks FDA approval to manufacture and sell these generic products for uses allegedly covered by the patents-in-suit prior to their expiration (Compl. ¶¶26, 40, 54).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not identify specific claims asserted against the Defendant, alleging infringement of "at least one claim" of each patent-in-suit. It further does not contain or reference a claim chart. The infringement theory is based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent before its expiration as an act of infringement (Compl. ¶¶26, 40, 54). Plaintiffs allege that the commercial manufacture, use, or sale of the Ajanta ANDA Products, when used as directed by the product's eventual FDA-approved label, would directly infringe the asserted method-of-use patents (Compl. ¶¶29, 43, 57).

• Identified Points of Contention:
  • Scope Questions: Since the patents claim methods of use in specific patient populations defined by kidney function (e.g., eGFR levels), a central question will be whether the proposed label for Defendant's generic product instructs, recommends, or encourages use in a manner that falls within the scope of those claims. The dispute may turn on whether the label carves out the patented indications or if its language makes infringement by physicians and patients inevitable or likely.
  • Technical Questions: The complaint does not provide sufficient detail for analysis of technical points of contention. The core of a future dispute would likely involve comparing the patient populations and treatment outcomes described in the proposed generic label against the specific limitations of the asserted claims.

V. Key Claim Terms for Construction

The complaint does not specify which claims are asserted, making a definitive analysis of key terms premature. However, based on the subject matter of the patents, the construction of terms defining the patient population will be central to the dispute.

• The Term: "moderate renal impairment" (from Claim 1 of the ’637 Patent)

• Context and Importance: This term defines the patient population to which the claimed method applies. Its construction will determine the scope of infringement, as the dispute will focus on whether Defendant's proposed product label induces use in patients meeting this definition.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification explicitly defines "Moderate renal impairment" as an "eGFR ≥30 to <60 ml/min/1.73 m²" (’637 Patent, col. 21:50-52). A party may argue this plain definition should control.
  • Evidence for a Narrower Interpretation: The specification further subdivides this category into "Moderate A renal impairment (CKD 3A): eGFR ≥45 to <60 ml/min/1.73 m²" and "Moderate B renal impairment (CKD 3B): eGFR ≥30 to <45 ml/min/1.73 m²" (’637 Patent, col. 21:60-65). A party might argue that results shown in patent figures (e.g., FIG. 1A) or specific embodiments could be used to narrow the term to a sub-range where efficacy is most clearly demonstrated.

• The Term: "improving glycemic control" (from Claim 1 of the ’998 Patent and Claim 1 of the ’637 Patent)

• Context and Importance: This term defines the therapeutic outcome of the claimed method. Practitioners may focus on this term because a defendant could argue that its proposed product does not claim or cause a clinically significant "improvement" in the specific patient population defined by the patent, potentially avoiding inducement of infringement.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification states that the invention provides a method for, among other things, "improving glycemic control and/or for reducing of fasting plasma glucose, of postprandial plasma glucose and/or of glycosylated hemoglobin HbA1c" (’998 Patent, col. 2:1-4). This language could support a construction where a statistically significant change in any of these markers qualifies as "improving glycemic control."
  • Evidence for a Narrower Interpretation: A party could point to the clinical data presented in the patent's figures, such as the specific percentage reductions in HbA1c shown in FIG. 1A and FIG. 7A, to argue that "improving" requires meeting a certain quantitative threshold of efficacy that may not be met under all conditions of use encouraged by the accused product's label (’998 Patent, FIG. 1A, FIG. 7A).

VI. Other Allegations

• Indirect Infringement: The complaint alleges active inducement of infringement against Defendant (Compl. ¶¶33, 47, 61). The basis for this allegation is that Defendant's promotional activities and package inserts for its ANDA products will allegedly instruct and encourage physicians and patients to use the generic drug in a manner that directly infringes the patented methods of treatment (Compl. ¶¶32, 46, 60).
• Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Defendant had knowledge of the patents-in-suit, at the latest, through the Paragraph IV certification letters (Compl. ¶¶32, 46, 60). It also pleads that the case is "exceptional" under 35 U.S.C. § 285, which provides a basis for an award of attorneys' fees (Compl. ¶¶35, 49, 64).

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

• A core issue will be one of induced infringement: does the language of the Defendant's proposed product label, which is not yet available, actively encourage or instruct physicians to prescribe, and patients to use, generic empagliflozin for the specific patient populations with moderate renal impairment as defined by the patent claims? The outcome may depend on whether Defendant can successfully "carve out" the patented methods of use from its label.
• A key question will be one of claim validity and scope: can the asserted method claims, which cover the use of a known drug in a specific patient sub-population, withstand invalidity challenges based on obviousness? The case may turn on what was known in the art regarding the safety and efficacy of SGLT-2 inhibitors in patients with type 2 diabetes and co-morbid chronic kidney disease at the time of the invention.