DCT

1:19-cv-01862

Boehringer Ingelheim Pharma Inc v. Aurobindo Pharma Ltd

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-01862, D. Del., 10/09/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation that resides and has a regular and established place of business in the district. Defendant Aurobindo Pharma Ltd. is a foreign corporation that may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of Abbreviated New Drug Applications (ANDAs) to the FDA for generic versions of Plaintiff's diabetes drugs constitutes an act of infringement of a patent covering methods of using empagliflozin to treat patients with specific levels of renal impairment.
  • Technical Context: The technology concerns SGLT-2 inhibitors, a class of oral anti-diabetic drugs that lower blood sugar by causing the kidneys to remove sugar from the body through urine.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendant’s submission of ANDAs with Paragraph IV certifications. The certifications assert that Plaintiff’s patent is invalid or will not be infringed by the proposed generic products. The complaint notes Defendant’s receipt of Paragraph IV notice letters on or about September 13, 2019.

Case Timeline

Date Event
2013-04-05 U.S. Patent No. 10,258,637 Priority Date
2019-04-16 U.S. Patent No. 10,258,637 Issue Date
2019-09-13 Plaintiffs received Paragraph IV certification letters from Aurobindo
2019-10-09 Complaint Filing Date

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

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.

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 existing anti-diabetic agents are either restricted or require dose reductions in this patient population due to safety concerns or reliance on renal excretion (’637 Patent, col. 1:33-49).
  • The Patented Solution: The invention is a method of using the SGLT-2 inhibitor empagliflozin to treat diabetes or improve glycemic control specifically in patients with mild or moderate renal impairment. The patent claims methods of administering empagliflozin to patients within specific ranges of estimated glomerular filtration rate (eGFR), a measure of kidney function (’637 Patent, col. 2:49-54; col. 3:5-14).
  • Technical Importance: This approach provides a therapeutic option for a specific, difficult-to-treat patient sub-population (diabetics with compromised kidney function) where other treatments may be contraindicated (’637 Patent, col. 1:33-49).

Key Claims at a Glance

  • The complaint alleges infringement of "at least one claim" without specifying which ones (Compl. ¶53). Independent claim 1 is representative of the patent's core contribution.
  • 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 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 specified daily amount (5 mg, 10 mg, 12.5 mg, or 25 mg)
    • wherein the glycemic control in said patient is improved
    • and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m²
  • The complaint does not explicitly reserve the right to assert other claims, but this is standard practice.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the "Aurobindo ANDA Products," which are Defendant's proposed generic versions of JARDIANCE® (empagliflozin), GLYXAMBI® (empagliflozin/linagliptin), SYNJARDY® (empagliflozin/metformin), and SYNJARDY® XR (empagliflozin/metformin extended release) (Compl. ¶¶1, 14).

Functionality and Market Context

  • The complaint alleges that these are generic drugs for which Defendant has filed ANDAs seeking FDA approval to manufacture and sell them prior to the expiration of the ’637 Patent (Compl. ¶1).
  • The infringement alleged is the statutory act of filing the ANDAs under 35 U.S.C. § 271(e)(2) (Compl. ¶53). The complaint alleges that the ANDAs refer to and rely upon the New Drug Applications for the brand-name products and contain data to demonstrate bioequivalence (Compl. ¶47). The commercial context is the future market entry of a lower-cost generic equivalent to Plaintiff's branded drugs.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The central allegation is that the act of filing the ANDAs, which seek approval to market generic empagliflozin products for uses covered by the ’637 Patent, constitutes infringement under the Hatch-Waxman Act (Compl. ¶53). The theory of infringement for these method-of-use claims is that the proposed label for the generic products will instruct or encourage physicians and patients to use the drug in the patented manner (Compl. ¶59).

’637 Patent Infringement Allegations

(Based on representative Claim 1 and the complaint’s narrative theory)

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 Aurobindo ANDA Products are intended for use in treating type 2 diabetes, and the complaint alleges the ANDAs rely on the NDAs for Plaintiff's branded diabetes drugs. ¶¶1, 47 col. 3:5-9
...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 that upon approval, the Aurobindo ANDA Products would be used in a manner that directly infringes, which implies that their use would be directed to the patient population defined in the claim. ¶¶56, 59 col. 7:1-8
...wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg... The Aurobindo ANDAs seek approval for empagliflozin tablets in dosages including 10 mg and 25 mg. ¶¶10-13 col. 7:11-13
...wherein the glycemic control in said patient is improved; and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m². The complaint alleges that promotional activities and package inserts for the Aurobindo ANDA Products will aid and abet infringement of the claimed method, including its steps and intended outcome. ¶¶59, 60 col. 7:14-17

Identified Points of Contention

  • Scope Questions: A primary question will be whether the proposed labeling for Aurobindo’s generic products will instruct physicians to perform all steps of the claimed method. A defense in such cases often involves attempting to "carve out" the patented use from the generic label. The dispute may focus on whether such a carve-out is possible and, if so, whether it successfully avoids infringement.
  • Technical Questions: The dispute does not appear to center on how empagliflozin works, but rather on the scope of the method claims and the content of the proposed generic label. A key question for induced infringement will be whether the language of Aurobindo's proposed label rises to the level of actively encouraging, recommending, or promoting the infringing use, as opposed to merely providing information.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific disputed terms. However, based on the structure of the asserted patent's method claims, the following terms may become central to the dispute.

"administering empagliflozin to the patient if the eGFR of the patient is..."

  • Context and Importance: This conditional "if" clause is the core of the invention, tying the administration of the drug to a specific biomarker range (eGFR). The infringement analysis will depend on whether Aurobindo's proposed label instructs or recommends initiating treatment based on this specific condition, which is a key element of inducement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims themselves recite this as an affirmative step. One could argue any label that discusses use in patients with this eGFR range meets the limitation.
    • Evidence for a Narrower Interpretation: The detailed description focuses on the efficacy of empagliflozin in this patient group, which a party could argue is informational rather than a required step for initiating treatment (’637 Patent, col. 28:50-58; FIGS. 1A, 7A). A defendant might argue that merely describing outcomes in this population does not constitute an instruction to "administer... if" that condition is met.

"discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m²"

  • Context and Importance: This is an active, negative limitation requiring cessation of treatment. For inducement, the plaintiff must show the defendant's label instructs this specific action. Practitioners may focus on this term because negative limitations in method claims can be difficult to prove are induced.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language is an explicit step of the method. A plaintiff would argue that a label warning against use below a certain eGFR threshold is an instruction to discontinue the drug if a patient's eGFR drops to that level.
    • Evidence for a Narrower Interpretation: The specification provides data on empagliflozin's effects across various stages of renal impairment but does not use the "discontinuing" language outside of the claims themselves (’637 Patent, FIGS. 1A-C, 7A-D). A defendant might argue that a label's safety warning about reduced efficacy or risks in patients with low eGFR is not an affirmative instruction to perform the claimed "discontinuing" step.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement (Compl. ¶¶57-60). Inducement is premised on the allegation that Aurobindo had knowledge of the ’637 Patent and that its "promotional activities and package inserts" will instruct or encourage others to perform the patented method (Compl. ¶59). Contributory infringement is based on the allegation that Aurobindo's empagliflozin products are especially made for an infringing use and are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶57).

Willful Infringement

The complaint does not use the term "willful infringement." However, it alleges this is an "exceptional case" warranting an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶63). The basis for Aurobindo's knowledge of the patent is its sending of Paragraph IV certification letters to the Plaintiffs on or about September 13, 2019 (Compl. ¶¶48-51).

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

  • A core issue will be one of induced infringement: Will Aurobindo’s proposed product label, once finalized, be found to specifically instruct or encourage physicians to prescribe empagliflozin to the precise patient population and according to all the steps recited in the asserted claims of the ’637 Patent?
  • A related question will concern the viability of a "label carve-out" defense: Can Aurobindo successfully omit the patented method of use from its proposed label to avoid infringement, while still obtaining FDA approval for commercially significant, non-patented indications?
  • Finally, the case may turn on claim construction: How will the court define the scope of active method steps such as "administering... if" a condition is met and "discontinuing... if" another condition is met, and will the language on Aurobindo's proposed label fall within those definitions?