DCT

1:21-cv-00356

Boehringer Ingelheim Pharma Inc v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-00356, D. Del., 03/09/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because each Defendant is incorporated in Delaware and therefore "resides" in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) seeking FDA approval to market generic versions of Plaintiff's SYNJARDY XR® tablets constitutes an act of infringement of four U.S. patents.
  • Technical Context: The patents relate to the chemical compound empagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, as well as pharmaceutical compositions and methods for its use in treating type 2 diabetes, particularly in patients with renal impairment.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt on or about February 2, 2021, of a Paragraph IV certification letter from Defendant, which asserted that certain claims of the patents-in-suit are invalid or will not be infringed by Defendant's proposed generic products.

Case Timeline

Date Event
2004-03-16 U.S. Patent No. 7,579,449 Priority Date
2009-08-25 U.S. Patent No. 7,579,449 Issue Date
2011-03-07 U.S. Patent No. 10,596,120 Priority Date
2013-04-05 U.S. Patent No. 9,949,998 Priority Date
2013-04-05 U.S. Patent No. 10,258,637 Priority Date
2018-04-24 U.S. Patent No. 9,949,998 Issue Date
2019-04-16 U.S. Patent No. 10,258,637 Issue Date
2020-03-24 U.S. Patent No. 10,596,120 Issue Date
2021-02-02 Plaintiff receives Defendant’s Paragraph IV Certification Letter
2021-03-09 Complaint Filing Date

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

U.S. Patent No. 7,579,449 - Glucopyranosyl-Substituted Phenyl Derivatives, Medicaments Containing Such Compounds, Their Use and Process For Their Manufacture (Issued Aug. 25, 2009)

The Invention Explained

  • Problem Addressed: The patent addresses the need for treatments for metabolic disorders (’449 Patent, col. 4, lines 5-7).
  • The Patented Solution: The patent discloses a class of chemical compounds, specifically glucopyranosyl-substituted benzene derivatives, that act as inhibitors of the sodium-dependent glucose cotransporter SGLT2 (’449 Patent, Abstract). This inhibition is described as a therapeutic mechanism for treating metabolic disorders, including diabetes (’449 Patent, col. 3, lines 60-65). Empagliflozin is a specific compound within this class.
  • Technical Importance: By inhibiting SGLT2, which is primarily found in the kidney, these compounds reduce the reabsorption of glucose from the glomerular filtrate, thereby lowering blood glucose levels in an insulin-independent manner (’449 Patent, col. 3, lines 45-56).

Key Claims at a Glance

  • The complaint asserts at least one claim, and independent claim 25 is representative of the compound at issue (Compl. ¶40).
  • Independent Claim 25:
    • A compound named 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,258,637 - Pharmaceutical Composition, Methods for Treating and Uses Thereof (Issued Apr. 16, 2019)

The Invention Explained

  • Problem Addressed: The patent’s background section describes that many anti-diabetes agents are restricted or require dose reduction in patients with renal impairment or chronic kidney disease (CKD) (’637 Patent, col. 1:39-46). This creates a need for effective treatments for this specific patient population.
  • The Patented Solution: The invention provides a method for using empagliflozin to improve glycemic control in type 2 diabetes patients who have moderate renal impairment (’637 Patent, col. 2:50-55). The method specifies administering empagliflozin within a defined range of estimated glomerular filtration rates (eGFR) and includes a directive to discontinue treatment if the patient's renal function declines below a certain threshold (’637 Patent, col. 39:5-15). The patent presents clinical trial data demonstrating the efficacy of this approach (’637 Patent, FIG. 1A).
  • Technical Importance: This method provides a therapeutic option for a patient population with limited choices, tailoring the use of an SGLT-2 inhibitor to specific levels of renal function.

Key Claims at a Glance

  • The complaint asserts at least one claim, and independent claim 1 is a representative method claim (Compl. ¶70).
  • 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 total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg.
    • Wherein the glycemic control in said patient is improved.
    • Comprising 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 dependent claims.

Multi-Patent Capsule: U.S. Patent No. 9,949,998

  • Patent Identification: U.S. Patent No. 9,949,998, "Pharmaceutical Composition, Methods for Treating and Uses Thereof," issued April 24, 2018.
  • Technology Synopsis: This patent, related to the ’637 Patent, is also directed to methods of treating type 2 diabetes in patients with renal impairment. It claims a method of using empagliflozin to improve glycemic control in patients with a different, but overlapping, range of moderate renal impairment (’998 Patent, col. 1:12-18).
  • Asserted Claims: At least one claim is asserted; independent claim 1 is representative (Compl. ¶55).
  • Accused Features: The proposed use of the Sun ANDA Products to treat type 2 diabetes is alleged to infringe, as the product's label will allegedly instruct physicians and patients to use the product in a manner that practices the claimed method (Compl. ¶58).

Multi-Patent Capsule: U.S. Patent No. 10,596,120

  • Patent Identification: U.S. Patent No. 10,596,120, "Pharmaceutical Compositions," issued March 24, 2020.
  • Technology Synopsis: This patent describes a specific pharmaceutical dosage form. The invention is a tablet comprising an inner core of metformin in an extended-release formulation, which is then coated with an outer layer containing an SGLT-2 inhibitor (like empagliflozin) in an immediate-release formulation (’120 Patent, col. 1:5-15, col. 2:22-31).
  • Asserted Claims: At least one claim is asserted; independent claim 1 is representative (Compl. ¶85).
  • Accused Features: The Sun ANDA Products are alleged to be extended-release tablets containing both metformin and empagliflozin, thereby embodying the claimed pharmaceutical composition structure (Compl. ¶11, ¶83, ¶88).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendant's proposed generic empagliflozin/metformin hydrochloride extended-release tablets (the "Sun ANDA Products") for which Defendant seeks FDA approval under ANDA No. 215529 (Compl. ¶11).
  • Functionality and Market Context: The Sun ANDA Products are proposed as generic bioequivalent versions of Plaintiff's SYNJARDY XR® tablets and are intended for the treatment of type 2 diabetes (Compl. ¶1, ¶38). The ANDA covers dosages of 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg of empagliflozin and metformin hydrochloride, respectively (Compl. ¶11). The complaint alleges that upon approval, these products will be manufactured, marketed, and sold throughout the United States (Compl. ¶12). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a full claim-chart analysis. The infringement theory is based on 35 U.S.C. § 271(e)(2)(A), where the submission of an ANDA for a drug claimed in a patent is a statutory act of infringement. The following tables summarize the core allegations based on this statutory framework.

’449 Patent Infringement Allegations

Claim Element (from Independent Claim 25) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound which is 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene The Sun ANDA Products are alleged to contain empagliflozin, which is the compound recited in claim 25. ¶11, ¶40 col. 67:23-26

’637 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 label for the Sun ANDA Products will allegedly instruct or encourage physicians and patients to use the product for improving glycemic control in type 2 diabetes patients. ¶43, ¶73 col. 39:5-7
administering empagliflozin to the patient if the eGFR...is ≥45 ml/min/1.73 m² and <60 ml/min/1.73 m² The proposed label will allegedly direct administration to patients within the claimed eGFR range, thereby inducing infringement of this method step. ¶43, ¶73 col. 39:8-11
discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m² The proposed label will allegedly instruct discontinuation of the product if a patient's eGFR falls below the claimed threshold, thereby inducing infringement of this negative limitation. ¶43, ¶73 col. 39:13-15
  • Identified Points of Contention:
    • Scope Questions: For the method claims of the ’637 Patent and ’998 Patent, a central issue may be the scope and content of the Defendant's proposed product label. The dispute may turn on whether the label instructs, encourages, or suggests the specific, multi-step diagnostic and treatment method recited in the claims, or whether it allows for substantial non-infringing uses.
    • Technical Questions: For the compound claim of the ’449 Patent, infringement analysis appears direct and will depend on whether the active pharmaceutical ingredient in the Sun ANDA is the claimed compound. For the composition claim of the ’120 Patent, analysis may focus on whether the formulation of the Sun ANDA Products—specifically the extended-release metformin core and immediate-release empagliflozin coating—meets the structural limitations of the asserted claims.

V. Key Claim Terms for Construction

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

  • Context and Importance: This term defines the purpose and outcome of the claimed method. Its construction is critical because it sets the threshold for what constitutes successful practice of the method. Practitioners may focus on this term because its definition could determine whether the use of Defendant’s product, which may produce a certain level of glycemic control, falls within the scope of the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification broadly describes the method as being for "improving glycemic control" without necessarily quantifying a minimum required improvement in the main description, which may support a construction covering any statistically significant improvement (’637 Patent, col. 2:50-51).
    • Evidence for a Narrower Interpretation: The specification includes detailed clinical trial data showing specific mean reductions in HbA1c (e.g., -0.42%) in the relevant patient population (’637 Patent, FIG. 1A). A defendant could argue this data implicitly defines "improving glycemic control" as achieving a clinically meaningful reduction comparable to that disclosed in the patent's examples.

  • The Term: "discontinuing empagliflozin" (from Claim 1 of the ’637 Patent)

  • Context and Importance: This is a negative limitation that constitutes an active step of the claimed method. For induced infringement to be found, a defendant’s product label must be shown to encourage or instruct this specific act of discontinuation based on a patient's eGFR falling below the claimed threshold. The case may depend on whether this specific instruction is present in the label.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The plain language of the claim suggests a simple act of stopping administration.
    • Evidence for a Narrower Interpretation: The context of the entire claim suggests "discontinuing" is not a passive event but an affirmative step taken in response to a specific clinical measurement (eGFR falling below 45 ml/min/1.73 m²). Parties may dispute whether a label's general warnings about use in patients with declining renal function are sufficient to meet this specific limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will actively induce infringement of the method claims through promotional activities and package inserts that will instruct users on how to use the Sun ANDA Products in an infringing manner (Compl. ¶47, ¶62, ¶77, ¶92). It also alleges contributory infringement, stating the Sun ANDA Products are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶45, ¶60, ¶75, ¶90).
  • Willful Infringement: The complaint does not use the term "willful infringement" but alleges that each of the four asserted patents gives rise to an "exceptional case" within the meaning of 35 U.S.C. § 285 (Compl. ¶50, ¶65, ¶80, ¶95). This allegation is based on Defendant's knowledge of the patents, as evidenced by the Paragraph IV certification, and its intent to infringe prior to patent expiration (Compl. ¶39, ¶41).

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

  • A core issue for the method patents (’637 and ’998) will be one of induced infringement: does the specific language of the Defendant's proposed product label, once finalized, contain instructions that will inevitably lead healthcare providers to perform all steps of the claimed methods, including the specific eGFR-based administration and discontinuation criteria?
  • A second key question will relate to validity: assuming the Sun ANDA Products are found to infringe one or more claims, the dispute will shift to whether those claims are valid over the prior art, an issue raised by Defendant's Paragraph IV certification but not detailed in the complaint.
  • A final question will be one of claim scope for the composition patent (’120): does the specific formulation of the Sun ANDA Products, particularly its extended-release and immediate-release components, fall within the literal scope of the asserted claims, or will the analysis turn on the doctrine of equivalents?