DCT

2:25-cv-03267

Aurinia Pharma Inc v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-03267, D.N.J., 04/25/2025
  • Venue Allegations: Venue is alleged to be proper based on Defendant Teva Pharmaceuticals, Inc. maintaining a regular and established place of business in the District of New Jersey, and on Defendant Teva Pharmaceutical Industries Ltd. being a foreign corporation subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's LUPKYNIS® (voclosporin) drug constitutes an act of infringement of two patents covering specific treatment protocols for lupus nephritis.
  • Technical Context: The technology involves pharmacodynamic dosing regimens for voclosporin, an immunosuppressant used to treat lupus nephritis, a serious autoimmune disease that causes kidney inflammation and can lead to renal failure.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Notice Letter, dated March 11, 2025, in which Defendants provided a Paragraph IV certification against the patents-in-suit. The patents are listed in the U.S. Food and Drug Administration's "Orange Book" for LUPKYNIS®.

Case Timeline

Date Event
2017-05-12 Earliest Priority Date for '036 and '991 Patents
2019-05-14 U.S. Patent No. 10,286,036 Issued
2021-01-22 FDA Approval of LUPKYNIS® (voclosporin) NDA No. 213716
2023-04-11 U.S. Patent No. 11,622,991 Issued
2025-03-11 Teva Sends Notice Letter to Aurinia
2025-04-25 Complaint Filed

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

U.S. Patent No. 10,286,036 - "Protocol for the Treatment of Lupus Nephritis," Issued May 14, 2019

The Invention Explained

  • Problem Addressed: The patent describes that standard treatments for lupus nephritis (LN) have low rates of complete remission (less than 10% of subjects) ('036 Patent, col. 4:40-44). Furthermore, treatment with the immunosuppressant voclosporin can cause an undesirable side effect: a decrease in the estimated glomerular filtration rate (eGFR), a key measure of kidney function ('036 Patent, col. 4:62-65).
  • The Patented Solution: The invention is a pharmacodynamic dosing method that aims to maximize voclosporin's therapeutic benefit while managing its side effects. The protocol involves assessing a patient's eGFR at different time points and adjusting the voclosporin dosage based on specific, predefined changes in eGFR, thereby personalizing the treatment regimen ('036 Patent, Abstract; col. 5:1-19).
  • Technical Importance: This approach represents a shift toward a more personalized and data-driven treatment protocol for a serious autoimmune disease, aiming to improve upon a standard of care with limited success rates ('036 Patent, col. 4:36-44).

Key Claims at a Glance

  • The complaint asserts at least one claim of the '036 patent (Compl. ¶44). Independent claim 1 is representative:
    • A pharmacodynamic method to treat a proteinuric kidney disease by administering a predetermined daily dosage of voclosporin for at least 24 weeks.
    • The method comprises assessing the patient's eGFR at a first and second time point.
    • If the eGFR decreases by more than a target percentage (within a range of 20-45%) to below a predetermined value (within a range of 50-90 ml/min/1.73 m²), the daily dosage is reduced or stopped.
    • If the eGFR decreases by less than the target percentage, the same dosage is continued.
  • The complaint does not specify whether it will assert dependent claims.

U.S. Patent No. 11,622,991 - "Protocol for Treatment of Lupus Nephritis," Issued April 11, 2023

The Invention Explained

  • Problem Addressed: As a continuation-in-part of the application for the '036 patent, the '991 patent addresses the same technical problem: the need for an improved treatment protocol for LN that offers higher remission rates than the standard of care while proactively managing known side effects associated with voclosporin ('991 Patent, col. 2:38-53).
  • The Patented Solution: The patent claims a more detailed method of treatment that combines a specific starting dose of voclosporin (23.7 mg twice daily) with standard-of-care agents mycophenolate mofetil (MMF) and corticosteroids ('991 Patent, Abstract; col. 12:53-62). The method also specifies a pharmacodynamic dose-adjustment rule based on changes in the patient’s eGFR, similar to the '036 patent, and links the method to a specific successful outcome (achieving a UPCR of <0.5 mg/mg) ('991 Patent, col. 13:20-49; col. 16:1-12).
  • Technical Importance: This patent claims a specific multi-target therapy regimen, defining the initial drug dosage and the criteria for subsequent adjustments, providing a more concrete and comprehensive treatment map than its parent patent.

Key Claims at a Glance

  • The complaint asserts at least one claim of the '991 patent (Compl. ¶57). Independent claim 14 is representative:
    • A method of treating LN in a subject.
    • The method includes selecting a patient with LN after determining their baseline eGFR.
    • The method requires administering voclosporin at a starting dose of 23.7 mg twice daily, in combination with MMF and corticosteroids.
    • After assessing eGFR at a second time point, a reduced dose of voclosporin (15.8 mg or 7.9 mg BID) is administered if the patient's eGFR decreases by >20% to <30% to a value below 60 ml/min/1.73 m².
    • The claim includes a "wherein" clause stating that this administration achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg.
  • The complaint does not specify whether it will assert dependent claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Teva's generic voclosporin drug product, for which Teva filed Abbreviated New Drug Application (ANDA) No. 220211 with the FDA (Compl. ¶1).

Functionality and Market Context

The complaint alleges that the ANDA seeks approval for a generic product that is "the same, or substantially the same, as Aurinia's LUPKYNIS®" (Compl. ¶34). The act of infringement alleged is the filing of the ANDA itself, which seeks approval for commercial manufacture, use, and sale prior to the expiration of the patents-in-suit (Compl. ¶40, ¶53). The complaint's infringement theory is premised on the belief that the proposed package insert for Teva's generic product will instruct healthcare professionals and patients to use the drug in a manner that directly follows the steps of the patented methods (Compl. ¶47, ¶60). The complaint does not provide specific details from the ANDA or the proposed product label.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element infringement analysis or a claim chart. Instead, it advances a legal theory of infringement under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA for a patented drug as a technical act of infringement (Compl. ¶40, ¶53).

The complaint's substantive theory is one of induced infringement, alleging that upon FDA approval, Teva's product label will instruct physicians and patients to perform the patented methods (Compl. ¶46-47, ¶59-60). For example, it alleges that the proposed package insert will "recommend, suggest, encourage, and/or instruct others" to use the generic product in a way that directly infringes at least one claim of each patent (Compl. ¶47, ¶60). The complaint does not provide sufficient detail for analysis of how the instructions on Teva's proposed label map to the specific limitations of the asserted claims.

  • Identified Points of Contention:
    • Evidentiary Question: A central question will be whether the instructions on Teva's proposed (and ultimately FDA-approved) product label direct medical professionals and patients to perform all steps of the asserted method claims. This includes whether the label instructs for a specific starting dose, co-administration with MMF and corticosteroids, ongoing eGFR monitoring, and dose adjustments according to the specific numerical thresholds and ranges required by the claims.
    • Scope Question: For the '991 patent, a dispute may arise over whether infringement requires proof that the patented method actually "achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg," as stated in the final "wherein" clause of claim 14. Teva may argue this is a required result for infringement, while Aurinia may argue it is a statement of the method's intended efficacy that does not add a separate limitation to the claim.

V. Key Claim Terms for Construction

  • The Term: "assessing the estimated Glomerular Filtration Rate (eGFR)" ('036 Patent, Claim 1)

    • Context and Importance: The entire pharmacodynamic method hinges on this assessment. The definition of "assessing" and what qualifies as an "estimated" rate will be critical to determining the scope of the required actions. Practitioners may focus on this term because Teva could argue its product label recommends a different, non-infringing method or frequency of assessment.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim term itself is broad, suggesting any conventional clinical method of estimating GFR could meet the limitation.
      • Evidence for a Narrower Interpretation: The specification explicitly references "the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI)" as a suitable method ('036 Patent, col. 5:20-22). A defendant could argue this reference limits the claim to assessment via specific, validated equations mentioned in the patent.

  • The Term: "wherein the administering of d) achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg" ('991 Patent, Claim 14)

    • Context and Importance: This "wherein" clause appears at the end of the claim and describes a successful clinical outcome. Its construction is critical because if it is interpreted as a necessary condition for infringement, it could make proving infringement significantly more difficult, as it would require showing a specific result in a patient, not just the performance of the method steps.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (i.e., not a limitation): Aurinia may argue this clause merely states the intended purpose and benefit of performing the preceding steps, a common practice in pharmaceutical method claims. The specification defines a similar outcome (UPCR of ≤0.5 mg/mg) as constituting "complete remission (CR)," framing it as an endpoint or result of the protocol ('991 Patent, col. 7:41-44).
      • Evidence for a Narrower Interpretation (i.e., a limitation): Teva may argue that the term "wherein" functions to impose a material condition that must be met for infringement to occur. They could argue that if the claimed steps are performed but the patient's UPCR does not fall below 0.5 mg/mg, there is no infringement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Teva will induce infringement under 35 U.S.C. § 271(b). The factual basis for this allegation is Teva's proposed package insert, which is alleged to contain instructions that will encourage and guide physicians and patients to use the generic product in a manner that directly infringes the patented methods (Compl. ¶¶ 46-47, 59-60). The complaint also alleges contributory infringement (Compl. ¶50, ¶63).
  • Willful Infringement: The complaint does not use the term "willful infringement," but it pleads facts that may support such a claim. It alleges that Teva has had "actual knowledge" of the '036 and '991 patents at least since the date of its Notice Letter on March 11, 2025 (Compl. ¶42, ¶55).

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

This Hatch-Waxman case will likely focus on the specific language of Teva's proposed product label and the proper interpretation of the asserted method claims. The central questions for the court will be:

  1. An evidentiary question of label-based infringement: Once Teva's proposed product label is produced in discovery, does it explicitly or implicitly instruct healthcare providers to perform the complete, multi-step dosing and monitoring regimen recited in the asserted claims of the '036 and '991 patents? Any deviation in the label's instructions from the claimed steps could provide a basis for a non-infringement defense.

  2. A claim construction question of functional scope: Can the "wherein" clause in claim 14 of the '991 patent, which recites achieving a specific clinical outcome (a UPCR of <0.5 mg/mg), be construed as an affirmative limitation on the claim? The court's decision on whether this clause defines a required step for infringement or merely describes the method's intended result will be critical to the patent's ultimate scope and enforceability.