DCT

1:19-cv-01596

Boehringer Ingelheim Pharma Inc v. Laurus Labs Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-01596, D. Del., 08/28/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Laurus Generics Inc. is incorporated in Delaware and because Defendant Laurus Labs Ltd. is a foreign corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug JARDIANCE® constitutes an act of infringement of a patent covering methods for treating type 2 diabetes in patients with specific levels of renal impairment.
  • Technical Context: The technology involves pharmaceutical methods for managing type 2 diabetes, a widespread metabolic disorder, using SGLT-2 inhibitors, particularly for patient populations with co-existing kidney disease.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV certification letter from Defendant on or about August 15, 2019. 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. 10,258,637 Priority Date
2019-04-16 U.S. Patent No. 10,258,637 Issues
2019-08-15 Plaintiff receives Defendant's Paragraph IV Letter (approx.)
2019-08-28 Complaint Filed

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

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's background section describes the challenge of treating type 2 diabetes in patients who also suffer from renal impairment or chronic kidney disease (CKD). It notes that certain common anti-diabetic medications are either contraindicated or require dose reductions in this patient population, creating a need for effective alternative treatments (’637 Patent, col. 1:24-49).
  • The Patented Solution: The invention claims to solve this problem by providing a method of using empagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, to treat type 2 diabetes specifically in patients with mild or moderate renal impairment (’637 Patent, Abstract; col. 2:50-54). By targeting this specific patient group, the method provides a way to improve glycemic control where other therapeutic options may be limited (’637 Patent, col. 2:4-10).
  • Technical Importance: The claimed method addresses a recognized gap in diabetes care by providing a therapeutic option for a specific patient sub-population with limited or complicated treatment choices (’637 Patent, col. 1:44-49).

Key Claims at a Glance

  • The complaint asserts at least one claim of the patent; Claim 1 is the first independent claim (’637 Patent, col. 37:55-39:4).
  • The essential elements of independent Claim 1 are:
    • 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 the 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,
    • and discontinuing empagliflozin if the patient's eGFR falls below 45 ml/min/1.73 m².

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant's proposed 10 mg and 25 mg generic empagliflozin tablets, identified as the "Laurus ANDA Products" associated with ANDA No. 212421 (Compl. ¶1, ¶10).

Functionality and Market Context

The products are generic versions of Plaintiff's brand-name drug, JARDIANCE®, and are intended for the treatment of type 2 diabetes (Compl. ¶1, ¶21). The complaint alleges that Defendant's ANDA relies on the JARDIANCE® New Drug Application and data demonstrating bioequivalence (Compl. ¶27). The core allegation is that the proposed generic products, when used as directed by their labeling, will be administered in a manner that infringes the asserted method claims of the ’637 Patent (Compl. ¶32).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint's infringement theory is based on the submission of the ANDA under 35 U.S.C. § 271(e)(2). The central question will be whether the proposed label for the Laurus ANDA Products will induce physicians and patients to practice the claimed method.

'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 comprising... The Laurus ANDA Products are generic empagliflozin tablets, a drug used for treating type 2 diabetes, and are alleged to be bioequivalent to JARDIANCE®, which is approved for improving glycemic control. ¶1, ¶27 col. 2:50-54
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 the Laurus ANDA Products, which contain empagliflozin, would be used in a manner that directly infringes the patent, which implies administration to the claimed patient population defined by renal function. ¶10, ¶32 col. 4:43-47
wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, The Laurus ANDA seeks approval for 10 mg and 25 mg tablets, which correspond to dosages recited in the claim. ¶10 col. 8:15-17
wherein the glycemic control in said patient is improved, This element describes the intended result of the method. Infringement is premised on the proposed product being a bioequivalent generic of a drug approved for improving glycemic control. ¶21, ¶27 col. 2:50-54
and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m². The complaint alleges future infringement based on the use of the product "as directed," which implies that the product's label will instruct physicians to discontinue treatment under the specified clinical conditions. ¶32 col. 4:3-9

Identified Points of Contention

  • Scope Questions: In this ANDA litigation, a primary dispute will concern induced infringement. The central question for the court will be whether the proposed labeling for the Laurus ANDA Products actively encourages, recommends, or promotes the administration of empagliflozin to the specific patient population defined by the eGFR range in Claim 1.
  • Technical Questions: A key evidentiary question will be whether Defendant's proposed product label successfully "carves out" the patented method of use. The complaint notes that Defendant’s Paragraph IV certification asserts non-infringement (Compl. ¶28), suggesting a potential defense that the label omits instructions for use that would fall within the patent's claims.

V. Key Claim Terms for Construction

  • The Term: "improving glycemic control"

    • Context and Importance: This term defines the purpose and outcome of the claimed method. Practitioners may focus on this term because its construction determines the evidentiary burden for proving infringement. The dispute may center on whether any degree of improvement is sufficient, or if a specific, clinically significant threshold of improvement is required.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent frequently uses the phrase "improving glycemic control" in a general sense without specific quantitative limitations, which may support a construction covering any measurable improvement (’637 Patent, col. 2:50-51).
      • Evidence for a Narrower Interpretation: The specification includes detailed clinical trial results in its figures, showing specific, quantified improvements in metrics like HbA1c (e.g., a -0.42% placebo-adjusted change) (’637 Patent, FIG. 1A). A party could argue that "improving" should be interpreted in light of these examples to mean a clinically meaningful improvement, not a de minimis one.

  • The Term: "if the eGFR of the patient is ≥45 ml/min/1.73 m² and <60 ml/min/1.73 m²"

    • Context and Importance: This phrase is critical as it defines the specific patient population to whom the method applies. Its construction will determine the boundaries of infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification notes that eGFR can be "derived... from serum creatinine values based on e.g., the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, the Cockcroft-Gault formula or the Modification of Diet in Renal Disease (MDRD) formula," all of which are known in the art (’637 Patent, col. 17:41-48). This may support a construction where the term encompasses values determined by any standard clinical methodology.
      • Evidence for a Narrower Interpretation: The term "estimated" itself suggests a degree of imprecision. A party might argue that the claim requires more than a single, potentially variable eGFR reading, or that the specific formula used to make the estimation (e.g., MDRD, as used in the patent's clinical trials) is a limiting feature of the claim.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendant's "promotional activities and package inserts" will aid and abet direct infringement by instructing or encouraging end-users to perform the claimed method (Compl. ¶35). It also pleads contributory infringement, alleging the Laurus ANDA Products are "especially made or adapted for use in infringing" and are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶33).
  • Willful Infringement: The complaint does not use the term "willful" but alleges this is an "exceptional case" under 35 U.S.C. § 285, which warrants attorneys' fees (Compl. ¶38). The basis for this allegation is Defendant's knowledge of the ’637 Patent, as evidenced by its Paragraph IV certification letter received by Plaintiff on or about August 15, 2019 (Compl. ¶28).

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

  • A central issue will be one of induced infringement: will the final, FDA-approved label for Laurus's generic product contain language that specifically encourages, recommends, or instructs physicians to prescribe the drug to the patient population defined by the claimed eGFR range (≥45 and <60 ml/min/1.73 m²)?
  • A related question will be one of infringement carve-out: can Defendant successfully omit the patented method of use from its proposed label to create a substantial non-infringing use, thereby negating inducement, even if some off-label use within the patented method is foreseeable?
  • A third key issue, raised by Defendant's Paragraph IV certification, will be validity: is the claimed method of administering a known drug (empagliflozin) to a specific patient sub-population, as defined by renal function, non-obvious in light of prior art disclosing the drug's general efficacy and safety profile for treating type 2 diabetes?