DCT

2:25-cv-03693

Aurinia Pharma Inc v. DR Reddy's Laboratories Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-03693, D.N.J., 05/01/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendant Dr. Reddy’s Laboratories, Inc. maintaining a regular and established place of business in the district, and because Defendant Dr. Reddy’s Laboratories, Ltd. is a foreign corporation subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's LUPKYNIS® (voclosporin) product constitutes an act of infringement of two patents covering methods for treating lupus nephritis.
  • Technical Context: The dispute centers on pharmacodynamic dosing protocols for voclosporin, an immunosuppressant drug, to treat lupus nephritis, a serious autoimmune disease that causes inflammation of the kidneys.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification, asserting that Plaintiff’s patents are invalid, unenforceable, or will not be infringed. Plaintiff received a formal Notice Letter from Defendant regarding the ANDA filing on March 17, 2025.

Case Timeline

Date Event
2017-05-12 Earliest Priority Date for '036 and '991 Patents
2019-05-14 '036 Patent Issue Date
2021-01-22 FDA Approval of LUPKYNIS® (NDA No. 213716)
2023-04-11 '991 Patent Issue Date
2024-12-31 Defendant DRL Ltd. Submission of Type II Drug Master File
2025-03-17 Defendant DRL Sends Notice Letter to Plaintiff
2025-05-01 Complaint Filing Date

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 the standard of care for lupus nephritis (LN) has yielded low rates of complete remission, with partial remission in only about 50% of cases and complete remission in less than 10% (’036 Patent, col. 2:38-44).
  • The Patented Solution: The invention is a pharmacodynamic method for treating proteinuric kidney diseases like LN. It involves administering voclosporin and then adjusting the dosage based on observed changes in the patient's estimated Glomerular Filtration Rate (eGFR), a key indicator of kidney function. The dosage is reduced or stopped if eGFR declines beyond a specific threshold, aiming to minimize side effects while maximizing therapeutic benefit (’036 Patent, Abstract; col. 3:1-19). The patent’s FIG. 1 graphically depicts the clinical study protocol, showing a steroid taper over time alongside voclosporin administration, which underpins the claimed method (’036 Patent, FIG. 1).
  • Technical Importance: The invention provides a personalized dosing strategy that moves beyond a one-size-fits-all approach, purporting to improve the benefit-risk profile of treatment for a serious condition (’036 Patent, col. 2:19-24).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim of the '036 patent (Compl. ¶43). Independent claim 1 is representative:
    • A pharmacodynamic method to treat a proteinuric kidney disease in a subject, comprising administering a predetermined daily dosage of voclosporin for at least 24 weeks.
    • The method further comprises assessing the subject's eGFR at a first and second time point.
    • The dosage is reduced or stopped if the eGFR decreases by more than a target percentage to below a predetermined value.
    • The same dosage is continued if the eGFR decreases by less than the target percentage.

U.S. Patent No. 11,622,991, Protocol for the Treatment of Lupus Nephritis, issued April 11, 2023

The Invention Explained

  • Problem Addressed: Similar to its parent '036 patent, the '991 Patent addresses the need for improved treatment protocols for LN that increase remission rates and manage side effects ('991 Patent, col. 2:40-49).
  • The Patented Solution: This patent claims a more specific method of treating LN. The method begins by selecting a patient with specific baseline characteristics (e.g., eGFR ≥45 mL/min/1.73 m²), administering a starting dose of 23.7 mg voclosporin twice daily along with other standard-of-care drugs, and then administering a reduced dose if the patient’s eGFR subsequently declines within a specified range (’991 Patent, col. 33:58-col. 34:19; Claim 1). FIG. 2 of the patent presents bar graphs showing higher complete and partial remission rates for voclosporin-treated groups compared to a control group, which provides the clinical basis for the claimed method's utility ('991 Patent, FIG. 2).
  • Technical Importance: This method provides a defined protocol, including patient selection criteria and specific dosing adjustments, intended to optimize the therapeutic outcome for LN patients (’991 Patent, col. 2:8-23).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim of the '991 patent (Compl. ¶56). Independent claim 1 is representative:
    • A method of treating LN, comprising selecting a subject based on a baseline eGFR determination.
    • Administering a starting dose of 23.7 mg voclosporin twice daily, along with mycophenolate mofetil (MMF) and corticosteroids.
    • Assessing the subject’s eGFR at a second time point.
    • Administering a reduced dose of voclosporin if the eGFR decreases by >20% to <30% to below 60 ml/min/1.73 m².

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant’s generic voclosporin products for which it seeks FDA approval under ANDA No. 220252 (Compl. ¶1).

Functionality and Market Context

The complaint alleges that Defendant's ANDA seeks approval for generic products that are the same as, or substantially the same as, Aurinia's LUPKYNIS® (Compl. ¶33). Infringement is based on the act of filing the ANDA under 35 U.S.C. § 271(e)(2)(A) and on the future, intended use of the product. The complaint alleges that the proposed package insert for Defendant’s generic product will instruct healthcare professionals and patients to use the drug in a manner that directly infringes the patented methods (Compl. ¶¶46, 59). Defendant seeks to launch its generic product prior to the expiration of the patents-in-suit, creating a direct commercial conflict (Compl. ¶33).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart exhibit. The infringement theory for these method claims is based on inducement, where Defendant's proposed product labeling is alleged to instruct users to perform the patented steps.

'036 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmacodynamic method to treat a proteinuric kidney disease... which method comprises administering to a subject diagnosed with said disease a predetermined daily dosage of effective amounts of voclosporin... Defendant's proposed product will be prescribed and used for the treatment of lupus nephritis, a proteinuric kidney disease, according to instructions on its FDA-approved label. ¶¶43-44 col. 3:1-7
(a) assessing the estimated Glomerular Filtration Rate (eGFR) of said subject at at least a first time point and a second time point on different days of said treatment period... The proposed product label will instruct physicians to monitor patient eGFR during treatment, constituting an assessment at different time points. ¶46 col. 3:8-11
(b) (i) if the eGFR of said subject decreases by more than a target %... reducing the daily dosage by increment(s) of 7.9 mg BID or stopping the administering of voclosporin... The proposed label will instruct physicians to reduce or stop the voclosporin dosage if a patient’s eGFR declines by certain amounts, which Plaintiff alleges will meet this limitation. ¶46 col. 3:12-19
  • Identified Points of Contention:
    • Scope Questions: A central question will be whether the instructions on Defendant's proposed label require actions that meet every claim limitation. The court may need to determine if a physician's ability to exercise clinical judgment in monitoring eGFR and adjusting doses is sufficient to avoid a finding of induced infringement.
    • Technical Questions: Does the "target %" decrease in eGFR specified in the claim align with the specific guidance for dose modification that will be on Defendant's product label? The analysis will depend on the precise language of the proposed label, which is not included in the complaint.

V. Key Claim Terms for Construction

  • The Term: "pharmacodynamic method" ('036 Patent, Claim 1)

    • Context and Importance: This term prefaces the entire claim and its construction could define the overall scope of the patent. Practitioners may focus on this term because its interpretation will determine whether the claim is limited to the specific clinical trial protocol described in the patent or covers a broader range of response-guided dosing strategies.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification introduces the invention as a "pharmacodynamic dosing schedule based on individual patient responses," suggesting the concept is not limited to one specific protocol ('036 Patent, col. 2:21-24).
      • Evidence for a Narrower Interpretation: The specification heavily details the AURA clinical study protocol, including the dosing schedule in FIG. 1, which a party could argue limits the claim's scope to that particular embodiment (’036 Patent, col. 4:11-51, FIG. 1).

  • The Term: "reducing the daily dosage" ('036 Patent, Claim 1) and "administering to the subject a reduced dose" ('991 Patent, Claim 1)

    • Context and Importance: The infringement analysis hinges on whether the dose adjustments recommended on the accused product's label constitute the claimed "reducing." The dispute may center on whether any reduction suffices or if it must conform to the specific decrements discussed in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself does not quantify the reduction, which may support an interpretation that any downward adjustment in dosage meets the limitation.
      • Evidence for a Narrower Interpretation: The '036 Patent specification gives an example where reduction occurs in "increments of 7.9 mg" (’036 Patent, col. 7:13-17). A party could argue that this specific example confines the meaning of "reducing" to the particular decrements enabled by the 7.9 mg capsule formulation.

VI. Other Allegations

  • Indirect Infringement: This is the core of Plaintiff's case. The complaint alleges induced infringement, stating that Defendant knows its product, when used according to its proposed package insert, will cause physicians and patients to practice the patented methods (Compl. ¶¶46, 59). It further alleges contributory infringement, asserting that the generic voclosporin products are not staple articles of commerce suitable for substantial non-infringing use for the claimed methods (Compl. ¶¶48, 61).
  • Willful Infringement: The complaint alleges that Defendant has had actual knowledge of the patents-in-suit since at least the date of its ANDA filing and its transmittal of the Notice Letter (Compl. ¶¶41, 54). While a separate count for willfulness is not included, these allegations of knowledge could form the basis for a future claim of willful infringement or a request for enhanced damages.

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

  • A core issue will be one of induced infringement: Will the instructions on Defendant’s proposed product label be found to affirmatively encourage or instruct medical professionals to perform each element of the asserted method claims, or does the label permit sufficient clinical discretion and substantial non-infringing uses to negate a finding of inducement?
  • A key question for validity, which Defendant has raised in its Paragraph IV certification, will likely be obviousness: Can Defendant demonstrate with clear and convincing evidence that the claimed methods—which involve adjusting a drug's dosage based on monitoring a known side effect (eGFR decline) for its drug class—would have been an obvious-to-try or predictable modification of prior art treatment protocols for lupus nephritis?